Vision Report on the
eFORESEE Malta Biotechnology Foresight Pilot Project
Realising a Thriving Maltese
Biotechnology Industry by 2015
Dorita Galea and Alex Felice
December 2003
The eFORESEE Malta Project was a co-sponsored foresight project between the European Union and
the Maltese Government, under the Fifth Framework (FP5) STRATA Programme for research,
technological development and demonstration (RTD), which programme promotes dialogue between
researchers, policy-makers and other societal actors on general science, technology and innovation
(STI) policy issues of both European and national relevance.
Index
List of Figures
List of Tables
Executive Summary
Introduction
4
5
6
7
Chapter 1: Foresight: A proactive approach for the future
1.1
Background
1.2
Rationale
1.3
Core Objectives and Key Recommendations
1.3.1
Mission Statement
1.3.2
Recommended Action Lines
8
8
8
9
9
10
Chapter 2: The Foresight Process
2.1
Introduction
2.2
Stakeholder Mapping
2.3
Launching seminar
2.4
Participation in the Biotechnology Pilot Project
2.5
Scenario-building and Questionnaire-based Survey
2.5.1
Questionnaire Survey:
2.5.2
Scenario building
2.6
SWOT Analysis
2.7
Assessment of the Issues and Key Drivers
2.8
The vision for 2015
13
13
14
16
17
18
18
19
20
22
27
Chapter 3: Overview of the Biotechnology Sector in Malta
3.1
Economic environment
3.2
Strengths and weaknesses of the enterprise sector
3.3
Legal and Administrative Environment
3.4
Control of Genetically Modified Organisms
3.5
Intellectual Property and Data Protection
3.6
Teaching, Training and Research
3.7
Research Community - Industrial Cooperation
3.9
Business networks for innovation
3.10
Malta Innovation Scoreboard,
3.11
Biotechnology related sectors present in Malta
3.12
Public Opinion
3.13
Ethical Framework
28
28
29
33
34
36
37
40
43
43
46
48
49
Chapter 4: Overview of Current and Future Issues, Trends and Opportunities in
Biotechnology in Europe and Worldwide
4.1
Why Biotechnology?
4.2
Healthcare applications
4.3
Agriculture and food production
4.4
Harvesting the potential
4.5
Ethical issues
4.6
Regulations
51
51
51
52
52
54
55
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4.7
4.8
4.9
4.10
Annex 1:
Annex 2:
Annex 3:
Annex 4:
Annex 5:
Annex 6:
Annex 7:
Annex 8:
The knowledge base
Europe’s capacity to offer scientific and technological solutions
The US model
Other Countries:
Interviewees and Panel Members
Proposed Terms of Reference
List of Documents and Websites
Biotechnology R&D Questionnaire Survey
Abbreviations
Dates of Pilot Meetings
Launching Seminar Speeches and Newspaper Letters
Applications of Modern Biotechnology
56
57
59
60
62
65
66
69
80
81
82
95
Page 3
List of Figures
Page
2.1
Distribution of work responsibilities within the pilot
15
2.2
Diagrammatic Representations of Scenarios.
20
3.1
Maltese population by gender and age group in 2003
and as projected to 2015
28
3.2
Gross Domestic Product by Industry and Type of
Income
29
3.3
The number of patents registered since 1994
37
3.4
Number of University graduates over a four year period
38
3.5
Standard process followed in the commercialisation of
biotechnology products
41
3.6
Summary of the basic foundations for the successful
commercialisation of biotechnology
43
4.1
Countries who have adopted biotechnology crops
54
4.2
Biotechnology Industry in Europe compared to the US
58
4.3
Comparison of Employment
59
Page 4
List of Tables
Page
3.1
Turnover (millions) and employment in manufacturing
sector over a period of 3 years
31
3.2
Initiatives towards economic restructuring
32
3.3
European Union Regulating Genetically Modified
Organisms and competent authorities in Malta
35
3.4
Malta Innovation Scoreboard 2003 as compared to
European Union (EU) and Associate, Acceding and
Candidate Country (AAC) statistics
45
4.1
Direct and indirect market potential of life sciences and
biotechnology
53
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Executive Summary
Presented here is the documentation of the biotechnology foresight pilot project
carried out as part of the EU fifth framework project eFORESEE. A bottom up
approach was selected and therefore the general opinion of the stakeholders
involved in biotechnology is herein documented.
The core objective of this pilot is to produce a plan to develop the fledgling Maltese
biotechnology industry into a core sector of the Maltese economy by 2015 through a
collaborative venture between academic institutions, the public sector and private
enterprises.
Biotechnology is predicted to be an area for the next economic growth. The
European Commission itself is preparing to reap the benefits of this technology and
has already outlined the strategy to be followed (COM(2002)27final).
A Vision for Malta’s biotechnology industry is herein formulated and the
recommended actions to achieve industrial growth are outlined. Two aspects of
biotechnology are distinguished, that is applications within the health sector and the
non-health sector. A survey of the current local biotechnology activities was carried
out and it was found the number of small companies that exist in the health aspect of
biotechnology are ‘struggling to survive’ because of a number of factors which
include one or more of the following reasons, lack of scientists trained in this field,
lack of cooperation by relevant authorities, lack of entrepreneurial knowledge of
scientist managing these companies. One the other hand, in the non-health aspect of
biotechnology, a strategy already exists and appropriate decisions have been taken to
reap maximal benefit possible within our limitations.
Moreover, biotechnology research and development in Malta is carried out by
government organisations (mainly University), non-government organisations and
the private sector. In the first case all contacts complain of limiting funds while the
other two sectors allocate funds from their profits. Lack of awareness of
opportunities in training and funding offered by EU programmes was a general
shortcoming.
The two main vectors limiting development of the local biotechnology sector were
identified to be STI education and RTDI capacity. Four main scenarios for the
possible development of local biotechnology sector were developed around these
two vectors. Actions to be taken to move from one scenario to another and hence
reach optimal scenario are outlined. SWOT analysis of the local biotechnology sector
identified that our major strengths are the well established medical and engineering
faculties, good health care system, strong ICT sector and a skilled workforce.
However lack of right decisions being taken at the right time might result in brain
drain and low GDP.
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Introduction
eFORESEE is the acronym for Exchange of Foresight Relevant Experiences for Small
European and Enlargement Countries. The overall aim of the project is to help the
smaller economies deal with the structural changes they will be faced with upon
accession. The partners of the eFORESEE Project are Malta, Cyprus and Estonia and
each country has carried out its own thematic national foresight pilots in specific
areas, selected according to the respective country’s priorities. In Malta’s case, the
three foresight pilots within the eFORESEE Project focused on ICT (Information and
Communication Technology) and Education, Biotechnology and Marine Science.
Foresight pilot activities consist of methodologies and processes that allow for the
development of national strategic vision, by taking into account the needs, potential,
interests and priorities of the specific sectors. Foresight is about preparing for the
future. It is about deploying resources in the best way possible - for competitive
advantage, for enhanced quality of life and for sustainable development. Foresight
makes possible the identification of the opportunities and challenges in the future,
and what Government, scientists and engineers should be doing to meet them.
The time horizon of this pilot project is set at 2015 and the exercise itself is completed
in seven months.
The core team is formed of four indivduals, Professor Alex Felice, of the Faculty of
Medicine and Surgery of the University of Malta, the Pathology Division (Section of
Genetics) of the Department of Health and Chairman of Atheneum Biotechnologies
Limited, Dr. Jennifer Cassingena Harper, Manager of the Policy Development Unit of
the Malta Council for Science and Technology (MCST), Ms. Sharon DeMarco, local
coordinator of the eFORESEE pilot and Ms. Dorita Galea, a scientist, acted as
managing secretary, with responsibility for carrying out and final documentation of
this pilot.
As a qualified and experienced scientist with expertise in basic research, genetic
engineering, cloning, protein science, molecular diagnostics, DNA sequencing and
banking the managing secretary firmly believe in the potential of biotechnology for a
small island mostly lacking in resources such as Malta. A Biotechnology sector is
knowledge based, multidisciplinary and in most applications the resources required
are derivatives of living organisms.
The managing secretary would like to most sincerely thank all those who committed
their time, energy, expertise and experience to this exercise, either through their
work on the panels or through their contributions during the consultation stage.
One person who was outstanding in his contribution to this pilot was Dr. Pierre
Schembri Wismayer.
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Chapter 1: Foresight: A proactive approach for the future
1.1
Background
This document presents a detailed account of the results and process of the
eFORESEE Malta pilot on ‘Realizing a Thriving Maltese Biotechnology Industry by
2015’. This was the third Maltese pilot within this two year fifth framework project.
Another two eFORESEE pilots were carried out in Malta. The first was ‘Exploring
Knowledge Futures in ICT and Education in 2020’ and the second pilot was aimed
“Towards enhancing the marine sector’s contribution to the Maltese economy in
2020’. The latter was concurrently documented.
The eFORESEE project was aimed at promoting the Exchange of Foresight Relevant
Experience among Small European and Enlargement countries. Locally it was under
the coordination of the MCST. This eFORESEE pilot was carried out towards the end
of the year two thousand and three. Other partners within this project are Cyprus
and Estonia. The main overall objective of this project was to address the challenges
faced by accession countries in dealing with the structural changes to the economy
through the carrying out of national foresight exercises in their respective countries.
Foresight can be defined as a ‘systematic, participatory, future intelligence gathering
and medium-to-long-term vision-building process aimed at present-day decisions
and mobilising joint actions’.
As Hon. Minister Dalli said during the launching seminar of this project ‘only through
such foresight exercises can we be prepared for the challenges ahead in order to transform
them into opportunities’ (complete text of Hon. Dalli speech is found in Annex 7).
1.2
Rationale
At the beginning of the 21st century, just as Malta is about to join the European
economic block, the Maltese economy is restructuring from a low cost manufacturing
base to a knowledge based, sustainable economy.
Virtually all analyses predict that biotechnology is the basis for one of the next major
economic growth. All major economies are allowing and adapting for an expansion
of this type of industry. According to the National Science & Technology Council of
the USA, biotechnology ‘...may well play as pivotal a role in social and industrial
advancement over the next 10 to 20 years as did physics and chemistry in the post-World
War II period’ (Biotechnology for the 21st century – New Horizons. National Science &
Technology Council, Washington, US, 1995)
On the 23 January 2002 the European Commission itself presented a communication
entitled ‘Life Sciences and Biotechnology – a strategy for Europe’ (COM(2002)27
final). Thus fulfilling a previous commitment, given in March 2001 at the Stockholm
European Council as part of the Lisbon process, to produce strategic guidelines
accompanied by concrete actions.
As Hon. Minister Galea said during the launching seminar of the pilot project
(complete text can be found in Annex 7) ‘Biotechnology has been identified by MCST and
Malta Enterprise as one of the areas to be considered for further national investment in terms
of research and innovation. The EU is also focusing on biotechnology as one of the most
promising of the frontier technologies for helping Europe to compete economically with the
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US and Japan. Such visions and ambitions require substantial investments of resources in
research and innovation based on well-targeted policy measures’.
At the doorstep of EU membership, Malta must reap the maximal benefits possible
from this ‘new technology’. Malta should face this change actively and not be drawn
into an economic sector it is not prepared for. Malta is faced with two major policy
choices: either to adopt a passive and re-active role, and bear the implications of the
developments of these technologies elsewhere, or develop pro-active policies and
exploit them in a responsible manner that is consistent with local values and
standards. The longer our hesitation is the less realistic the second option will be.
As Hon. Minister Galea said during the launching seminar of this eFORESEE pilot
project ‘eFORESEE Project is a strategic initiative for Malta which presents a challenge. It
forces us to think again about how to best formulate strategic national policies and strategies.
It is significant and important that the MCST is coordinating this initiative in Malta, given
the need for such approaches in the area of science, research and innovation.’
This pilot project has aimed to provide an opportunity for the academia, the public
and private sectors and society to participate in dialogue and consultation where
opinions were aired and visions shared for an optimal future in this field. The
process itself helped forge closer working partnerships between the various sectors
(academic, business and public sectors) in Malta to tap emerging market niches in
biotechnology as well as provide an appropriate direction and support for publiclyfunded research.
This pilot project has aimed to create a national effort to boost the biotechnology
sector. All constructive criticism and suggestions were taken in consideration and
put forward at a round table of experts during the consultation process.
1.3 Core Objectives and Key Recommendations
1.3.1 Mission Statement
The objectives of this eFORESEE pilot were formulated around the title ‘Realising a
Thriving Maltese Biotechnology Industry by 2015’
The core objective was ‘to produce a plan to develop the fledgling Maltese
biotechnology industry into a core sector of the Maltese economy by 2015 through a
collaborative venture between academic institutions, the public sector and private
enterprises.’
The core objective was further divided into four main tasks, these being
i. To map biotechnology-related activity and resources in Malta current and
as projected by 2015.
ii. To identify developments in biotechnology that will impact on the Maltese
economy and society by 2015.
iii. To develop a basis for a national biotechnology strategy that will provide
the basis for the national investment of resources in this area and also help
to attract direct investment.
iv. To stimulate the formation of new networks and create an awareness of the
fundamental changes required within the public, private and academic
sectors for the Biotechnology industry to take root.
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1.3.2 Recommended Action Lines
In this section the recommended action lines as drawn up by the panel of
biotechnology experts during panel meetings and one to one interviews are put
forward.
RESOURCES BASE
•
The University of Malta ought to offer Biotechnology related credits in
Science degrees. The curriculum of the biology Bachelor’s degree should be
revised to include more biotechnology and applied biology (Annex 7
includes related feedback). Applied science diploma can also be offered by
other post secondary institutions such as the Malta College for Arts, Sciences
and Technology (MCAST). It is proposed that the University ought to have
a role in enabling young scientists and maximise their opportunities of work,
together with improving and diversifying the local industry. Opportunities
in biotechnology offered by European programmes such as Comenius and
Erasmus ought to be utilised to a maximum.
•
Invest in people. Since these fields of science are fast moving a whole
spectrum of programmed training is required, together with continuous
education.
•
In order to reach as many potential scientists as possible and to have a
science literate workforce, science education has to be optimized.
•
Help to be offered to Maltese R&D scientist who want to take part in
networks of excellence and integrated projects in order to take up and adopt
new technologies to improve national competitiveness.
•
The University of Malta or the MCST ought to create a forum for students to
encourage interdisciplinary discussions at an early phase of training. This
could take the form of seminars involving more then one faculty at a time.
•
The MCST and Malta Enterprise to tap EU structure funds for the purpose of
biotechnology related R&D and capacity building. Specific measures should
be taken to encourage SME participation.
•
Possible funding for start-ups and expansions by the European Investment
Fund should be investigated by the Malta Enterprise.
•
Government through its various ministries ought to take measures to attract
and retain scientists and avoid brain drain. Foreign tuition and training is
important in such specialised fields, however initiatives should be offered to
scientists who decide to settle and work in Malta. Participation in ‘A
Mobility strategy for a Research Area’ should be both ways. There is much
to be gained by our industry and higher education if we manage to attract
top level scientist to transfer their knowledge to our workforce.
•
The University of Malta ought to train scientists in business (especially
management and marketing); preferably by creating the possibility that final
year thesis project could involve interdisciplinary company formation and
Page 10
business start-up.
•
There should be continuous effective discussion to match a skilled
workforce with job opportunities. The industry through Employers
Association or FOI should continuously push public entities like University,
MCAST, ETC and education department to be accountable and resourceful.
The labour force, secondary and post-secondary students should
continuously be made aware of openings and possibilities within the job
market.
•
Post Graduate Programme of studies should be offered at university.
•
The Inventory of Capabilities and Inventory of Laboratories should be
updated.
RESEARCH
•
National Research Programme (coordinated by MCST) in collaboration with
the European Research Area (ERA) should obtain funding from various
sources (including industry, EU and government) to be used to support early
stage research to be later applied in industry.
•
A Biotechnology Institute with the role of taking up R&D projects from
industry should be created by the government. There is the possibility of
eventual privatisation of such an institute.
•
The MCST should coordinate a network of biotechnology company managers.
•
Government should work on the development of specific legal and ethical
competence.
•
Enhance role of ethical groups vis-à-vis developing regulations, educate the
public and network with European counterparts.
•
Commercialization of research by creating interdisciplinary networks. It is
especially important to train students in research and development and not
just research.
EXPLOITATION OF INTELLECTUAL PROPERTY
•
University should encourage awareness training in the strategic use of
intellectual property rights during the entire research and innovation process
and raising awareness among academics of the commercial potential of their
research.
•
University should encouraging entrepreneurship and movement between
academia and industry.
•
The government should create a strong affordable intellectual property
protection system to function as an incentive for RTDI.
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AID TO EXISTING BIOTECHNOLOGY COMPANIES
•
Existing Biotechnology companies should be aided to improve their standards,
expand, create contacts and carry out waste management.
INFRASTRUCTURE
•
Unite fragmented research and development capacities.
•
Create a Biotechnology Centre.
•
Administration bureaucracy must be uprooted.
•
There should be oversight of Science and Technology possibly by University.
NATIONAL CONVERSATION ON BIOTECHNOLOGY
•
The public must be made aware of the opportunities and treats offered by this
sector and educated to correctly measure possible treats versus opportunities.
STRATEGIC
•
Political responsibility for science and technology.
(European parliaments are even introducing political representation for
biotechnology)
SERVICES
•
An office within Malta Enterprise to cater for the specific needs of the
biotechnology industry should be created.
•
Improve customs law and efficiency.
•
Continuous supply of basic utilities such electricity and water
ensured.
must be
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Chapter 2: The Foresight Process
This chapter provides an almost chronological account of the foresight Pilot as it
unfolded. Certain steps interacted with each other in synergetic, iterative loops
which enhanced the process. The methodology and approaches used include
stakeholder-mapping and co-nomination exercises, the setting up of expert panels,
questionnaire-based surveys, SWOT analysis and scenario-building exercise.
2.1
Introduction
Biotechnology is a term that refers to a broad spectrum of activities. One of
the first tasks of the pilot secretary was to establish a definition for the term
so as to eliminate at an early stage in the pilot possible misunderstandings
and establish a clear idea of what activities the pilot would be referring to.
On advice of a lawyer who is involved in ethical and legal issues related to
biotechnology, the definition of Biotechnology adopted by the pilot is that
used by the Convention on Biodiversity (UN, 1992) ‘Biotechnology means
any technology application that uses biological systems, living organisms or
derivatives thereof, to make or modify products and processes for specific use’.
Malta like a large number of other nations is a signatory of this convention
and therefore this definition is legally acceptable.
Biotechnology Background
The discovery of antibiotics in the 1940s, and the need to develop ‘process fermentations’
capable of large-scale antibiotic production during the World War II years led to striking
new developments in fermentation technology and to the coining of the term
“biotechnology’. In the 1970s, biotechnology went into a remarkable new expansion phase
stimulated by discoveries in molecular genetics. These discoveries led to the extraordinary
powerful technology of recombinant DNA biology and drew attention to the whole field of
biotechnology.
Although the term is relatively recent, man has used biotechnology for thousands of years.
For most of human history, plants and animals have been selectively bred to improve
particular traits, such as yield, disease resistance and hardiness. The making of bread, wine
and beer by microbial fermentation processes are age-old activities, documented in our
historical development even as far back as Egyptian times. Archaeological evidence suggests
that the early Romans recovered copper leached by bacteria from natural copper sulphide
deposits. The first recorded, large-scale bio-mining operation was initiated in the early
1700s in Rio Tinto, Spain.
OECD Definition (1982)
Biotechnology means the application of scientific and engineering principles to the
processing of materials by biological agents to provide goods and services. These principles
cover a wide range of disciplines but rely heavily on microbiology, biochemistry, genetics,
biochemical and chemical engineering.
The umbrella of modern biotechnology encompasses a broad array of technologies, both
“traditional” and “new”. However, the term biotechnology has, to the general public,
become synonymous with genetic engineering. Genetic engineering, in turn, encompasses
recombinant DNA technology, genetic modification, gene technology, genomics and/or gene
manipulation. Genetic engineering makes it possible to cut DNA into its fundamental
functional units, the “genes”, and to splice (recombine) those genes into other DNA
molecules. Thus, it is now possible to enhance the ability of an organism to produce a
Page 13
particular product, to prevent it producing a product, or to enable it to produce an entirely
new product. While maintaining all or most of its original properties, a genetically
engineered (GE) or genetically modified (GM) organism can do something it had not done
before or ceases to do something which it did before.
The ability to manipulate living organisms at the genetic level is one of the principal tools of
modern biotechnology. Although the aim of traditional biotechnology, such as selective
breeding, was to develop new traits or enhance existing functions (or to add or enhance a
particular trait), new biotechnology (or genetic engineering) allows sophisticated
manipulation of the genes in plants and animals which encode for particular characteristics
in a more direct, precise manner.
Genetic engineering is capable of providing an organism with a specifically chosen, designed
and desirable “new” ability or property. In making such a specific manipulation, the
outcome becomes much more predictable, precise and controlled than was feasible with
traditional biotechnology techniques. This level of control is a tremendous asset in the
application of modern biotechnology to sustainable development and improvement of the
quality of life.
To date, the most notable impact of biotechnology has been in the medical and
pharmaceutical arenas. Important medical products such as human insulin and factor VIII
are produced through genetic engineering.
The last decade has seen an exponential increase in the sequencing information available,
with the completion of the human genome and that of other organism, man is now trying to
interpret the language of life. It is now expected that the number of treatments also increases
as information on the human genome is revealed.
Genetic engineering has the potential to modify physical characteristics of production crops,
including their nutritional content, disease resistance and growing season. It can also be
used to produce pharmaceuticals and nutraceuticals in farmed animals and to improve the
growth and fitness of agriculturally important animal species. Genetic engineering has the
potential to improve food production, industrial processes, waste and waste water
treatment, bioremediation, renewable energy generation and biomining. Overall, this
technology has the potential to improve the quality of life and to enhance conservation and
preservation of the environment.
2.2
Stakeholder Mapping
The core group of this project was formed by Professor Alex Felice (Chairman of the
pilot), Ms. Dorita Galea (managing secretary), Ms. Sharon DeMarco (eFORESEE
coordinator) and Dr. Jennifer Cassingena Harper (Manager, Policy Development
Unit, MCST). The managing secretary joined the MCST team on this pilot in May
2003. The first task to be tackled was the identification of experts to take part in this
pilot. Local enterprises that fall under the definition of biotechnology were
identified from business directories like Made in Malta and Trade Directory of the
Malta Chamber of Commerce. Key people from these local biotechnology companies
were contacted by individualised letters, followed by telephone calls and emails.
Those consenting to participate in the project were registered on the mailing list of
the pilot (www.eforesee.info).
Other participants were co-nominated by members of the panels. There were also the
possibility for interested individuals to register and de-register themselves on the
website.
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Two working panels of experts were formed to better manage the number of
individuals per meeting. It was decided by the core group to have people involved in
food biotechnology (panel B) and people involved in human health related
biotechnology (panel A) meeting separately (Figure 2.1). The outcomes of these
meetings were pooled in the final compilation of this document. Individuals from
academia, the public and private sector and students formed part of the two panels
of experts.
The Health Biotechnology Panel (Panel A) was made up of 74 members mostly from
academia, health department and some from the health/pharmaceutical industry.
The Food (Non-Health) Biotechnology Panel (Panel B) was established with 54
members mostly coming from academia, food manufacturing industry, brewing
industry, agricultural sector, aquaculture and the governmental agriculture and
fisheries ministry.
Figure 2.1: Distribution of work responsibilities within the pilot
Figure 0-1
BIOTECHNOLOGY PILOT CORE GROUP
BIOTECHNOLOGY PANEL ‘A’
• Human Health
Pharmaceutical Industry
BIOTECHNOLOGY PANEL ‘B’
• Agro-food Industry,
• Aquaculture
• Environmental Biotechnology
EDUCATION
FINANCIAL
SERVICE
LEGAL & ETHICAL
Key people from biotechnology sector support group including education, finance,
services, legal and ethical sector, formed a wider group to enable a more extensive
consultation. These were consulted by the pilot secretary and the problems identified
by Panel A and Panel B members were put forward to them so that action lines and
recommendations developed were feasible to the support people and as desired by
the biotechnology stakeholders. These also had access to the web site and formed a
panel of 80 individuals.
Panel A and B met and the following standardised questions were put forward to
them:
Q1
Which factors influence achievement within such an industry? These
factors could be social, technological, educational, economic,
environmental, political and/or of ethical values (STEEEPV).
Page 15
Q2
What infrastructure does Malta need in order to support and develop
a thriving biotechnology industry by 2015?
Q3
What areas within biotechnology need to be developed to sustain
successful research and development programmes and business
enterprises in Malta?
2.3
Launching seminar
A half day launching seminar was organised on the 28th July at the MCST premises,
Villa Bighi, Kalkara. The launch was advertised in the local English language
newspapers, and announced by means of email and faxes to University staff,
Department of Health management personnel and other government departments.
This seminar was co-sponsored by the British Council and the Bank of Valletta.
The Agenda for this seminar was as follows:
Opening Session - Chaired by Mr. Peter Diacono, Chairman, MCST
Opening Speech by
•
Hon Louis Galea, Minister of Education
•
Hon John Dalli, Minister for Finance & Economic Affairs
•
H.E. Vincent Fean, British High Commissioner
•
Prof Roger Ellul Micallef, Rector of the University of Malta
Dr Beatrice Leigh, GlaxoSmithKline, UK –
•
Meeting the needs to develop a thriving biotech industry
Second Session – Chaired by Prof. Alex Felice, Chairman
Biotechnology Pilot
Overview of the eFORESEE Biotechnology Pilot – Prof. A. Felice and
Ms. D. Galea
Interventions from the Floor
Speeches of the four main speakers are presented in Annex 7.
This launching seminar was commentated upon in the prime time news of the major
stations on the Island namely TVM and Net television. In the local written media,
the launch was reported on in both the English language newspapers, The Times of
Malta (60% market share) and the Malta Independent (7.2% market share). The only
Maltese language newspaper reporting on the launch was In-Nazzjon (11.2% market
share, Informa Consultants, Media Survey 2003). Other information about the
Launch was available on the website of the local newspapers. Therefore it can be
concluded that the great majority of the Maltese was informed of the MCST initiative
to boost the local Biotechnology sector.
Page 16
The Times of Malta, the most prominent newspaper locally, published an editorial
entitled ‘Coming of age of Biotechnology’ on the 29th August where the launching
seminar of the pilot is mentioned (complete text is presented in Annex 7). It was
hoped by the core group that this media coverage will fuel a public discussion on the
pros and cons of biotechnology as happens in continental Europe. No such thing
seems to have happened locally yet. One letter by Dr. Pierre Schembri Wismayer
(Panel A member, presented in Annex 7) was published in the Times of Malta which
fuelled a couple of replies, including one by Professor Axiak (Head of Biology
Department of University of Malta, complete text presented in Annex 7) and some
comments within regular columns however not much else. The managing secretary
has information that although more letters are sent to the editor these were not
published.
Due to the little foresight experience in Malta, the managing secretary Ms. Galea
attended a ‘Regional Foresight Methods Training Workshop’ organised by the
European Foresight Academy at the Joint Research Centre of Ispra in May 2003 and
established a number of links namely with PREST - Science and Technology Policy
and Management at the University of Manchester, IPTS – Institute for Prospective
Technological Studies, European Science and Technology Observatory and Institute
System and Innovation Research. She was in communication with personnel from
these organisations throughout this foresight exercise.
2.4
Participation in the Biotechnology Pilot Project
High level ownership and government rubber stamp to this project was ensured
when two high profile ministers accepted to attend and address the launching
seminar. There was a high level of cooperation from the service industry including
the educational sector at tertiary level, the Industrial Property Office, the financial
sector and from legal representatives.
The launching seminar was well attended and a lot of new contacts were established
especially with the services providers within the industry.
The industrialists and other stakeholders from Panel A show scepticism on the
possible beneficial outcomes of such a document and hence were reluctant to attend
the panel meetings, although they offer their time and efforts in one to one interview
with the pilot secretary. On the other hand members of Panel B show enthusiasm
and continuous encouragement throughout the pilot project. This was probably
because the food related biotechnology is well established in Malta while the health
related one is still trying to take root, and hence the personnel in the second case are
still facing teething problems in their operations.
One drawback of this pilot was the time setting and the short duration for
completion. The Launch, with the accompanying media publicity took place
towards the end of July, and locally August is a very slow month, with the
consequence that some of the momentum gained during the launching seminar was
lost during the following month. The total time span of the project was seven
months.
Panel members also show reluctance to use the forum due to the ‘complex’ way of
logging in.
The information on the website, our means of communication with the stakeholders,
included:
Page 17
•
Minutes of panel meetings,
•
Reports of meetings including launching seminar
•
Opinions
•
Strategic documents
Empirical evidence was drawn from R&D questionnaire (Annex 4), statistical
information from the National Statistics Office (NSO), interviews, selected reports
like Malta scoreboard and as listed in References.
2.5
Scenario-building and Questionnaire-based Survey
The questionnaire survey as presented in Annex 4 was designed with the principal
aim of partially filling the lacuna within the Malta Scoreboard for the percentage of
GDP used in R&D and also to establish an estimate of the level of R&D taking place
in the biotechnology sector in Malta. This was also meant to give a first indication of
the level of funding of R&D, main scope of R&D in academia and in industry, the
opinion of the management on the purpose of R&D and the number of people
employed in actual R&D activities. Questions about the susceptibility to the ERA
were also put forward to the management of biotechnology research. The survey
was adopted by the pilot secretary from a previous survey designed by Mr. Brian
Restall and Dr. Aldo Drago.
2.5.1 Questionnaire Survey:
A total of 30 R&D questionnaires surveys were posted to the management of
government institutions (46%), non-government organisations (4%) and private
enterprises (50%). In a letter signed by the Chief Executive Officer of the MCST, the
management was given two weeks to reply to the questionnaire. The people who
did not reply were contacted by the managing secretary by means of email and
requested again to fill the questionnaire and send it in. In total 10 filled in
questionnaires were returned.
In addition one person declared that the
questionnaire cannot be completed because of confidentiality reasons while one
other stated that a branch of the enterprise would reply to the survey as in fact it did.
Three replies came from government institutions, one from a non-government
organisation and six replies were filled in by private enterprises.
All government institutions that replied to the survey declare that their R&D funding
is not sufficient. They carry out mostly basic research with some product/process
development. Funding is in this case in-house (University) and from private grants
including UNESCO grants. Staff carrying out the research is insufficient in number
and all three government institutions are looking forward to participating in ERA
and partnerships within EU 6th framework projects.
One non-government organisation that replies to the survey does applied research
from in-house funding. Personnel are very receptive of European opportunities and
are looking for partners in EU funded projects and ERA opportunities.
The private enterprises that reply to the survey include representatives both from
the food manufacturing biotechnology and local pharmaceutical industry. Three of
these enterprises carry no biotechnology related R&D while the other half carry out
extensive R&D projects. Funds for these projects come from the enterprise or from
IPSE. All three enterprises have adequate staff and funding for R&D, however only
Page 18
one of these enterprises has management that is showing interest in opportunities
being offered by the ERA and European framework programmes.
2.5.2 Scenario building
The key vectors of Biotechnology development in Malta were identified during
interviews with key stakeholders of the biotechnology sector to be STI education
together with RTDI capacity. Four possible scenarios were developed around these
key vectors. The scenarios are pictorial representations of future possibilities and
descriptive names selected were: Stupor, The Hurdle, Rooted and On Top.
Stupor
As a nation we are in a torpid state of mind. At low level of STI education and low
RTDI capacity, biotechnology based products are mostly imported and scientific
services are poor. People are not aware what they are consuming and the authorities
are not taking appropriate steps to control importation. We are vulnerable to abuse
and unethical experimentation. The Maltese environment is deteriorating due to lack
of resources and education. Tourism sector gets major setback as we cannot reinvest
money to upgrade our tourism facilities. Neighbouring countries are advancing and
developing. High flying students have to go abroad to specialise however have no
job prospects when they come back to their home country. Most of our employment
is in low wage manufacturing sector with low value added. Standard of living is
low, health care and social policy systems are not sustainable and have to be
downgraded.
The Hurdle
Although STI education is at a high level RTDI capability is low. The number of
graduates in science is adequate and a number of people are specialising in
biotechnology. However all our knowledge is imported and therefore cannot be
called intellectual property and hence cannot be commercialised.
Due to lack of
financial resources for research our start-ups are failing and not proceeding to the
manufacturing phase. Our young scientists are discouraged and hence have to seek
employment in other countries. There is no return on capital invested in the
educational system.
Rooted
At high RTDI capability, governmental schemes to improve science exploitations are
in place. However, the population is not science literate and therefore nobody is
taking up scientific research and developing products for the market. Major
governmental efforts to improve the standard of living of the population are futile.
There is no return on investment in RTDI capability. Advantageous schemes
presented by government are taken up by foreigners, who have to employ foreigners
on research and intellectual property development as the local workforce is not
educated enough in science. The Maltese are still working at the lower wage jobs.
On Top
Simultaneous development in STI education and RTDI capability results in the
seamless development of a knowledge based economy and applications of biology in
industry to our economic benefit. Standard of living improves from the aspect of
better health care system and medicinal and due to economic growth. The country is
Page 19
renowned for its highly educated workforce, with well formed interdisciplinary
networks. Open job opportunities increase scope of specialisation with university
being a hub for opportunities in research and development. Biotechnology industry
support professions are also well developed.
The last scenario entitled On Top is considered to be the most desirable scenario and
to be achieved by 2015 both the RTDI capacity and STI education must be improved.
The diagram shows that any effort to improve STI education without improving
RTDI capability or vice versa would not result in optimal return on investment.
Improving one aspect and not the other would result in human resource
mismanagement and no improvement in economic position of the country as
intellectual property would not be commercialised.
Hurdle
•
•
Start-ups failing
Brain drain as scientists find no
employment and hence seek
foreign opportunities
Research
and
Intellectual
Property are not commercialized
•
S
T
I
E
D
U
C
A
T
I
O
N
On Top
•
•
•
•
Stupor
•
•
•
•
•
Seamless integration of
biotechnology in agricultural,
medical, industrial products
and processes
Highly educated workforce
Interdisciplinary networks
functioning
Sustainable biotechnology
industry employing
professionals from a broad
spectrum of disciplines.
Rooted
Biotechnology products rare
and mostly imported
Lack of Public awareness
Weak educational
programmes
No biotechnology platform
No knowledge on the use of
biotechnology
•
•
Government efforts to boost
local industry futile.
Local funding taken up by
foreign enterprises that
employ foreign nationals on
local R&D projects and the
Maltese work at the lower
wages jobs.
RTDI CAPABILITY
Diagrammatic Representations of Scenarios.
The key drivers for biotechnology sector in Malta are identified to be STI education
and RTDI capacity. The scenario named On Top is the most desirable situation. This
can be achieved through various paths however the longer paths result in wastage of
funding and human resources.
Figure 2.2
Page 20
2.6
SWOT Analysis
Main areas of opportunities, strengths, weaknesses and treats of the Maltese
Biotechnology industry were identified during interviews and panel meetings with
the key stakeholders of the local biotechnology industry. Due to the short duration
and time setting of the pilot, the number of panel meetings held was three, however,
key stakeholders who could not attend the fixed panel meetings were interviewed by
the pilot secretary.
WEAKNESSES
STRENGTHS
•
•
•
Well established engineering and
medical faculties and expertise
Strong ICT sector and ICT
knowledgeable workforce
Good Health Care System
•
Low number of postgraduates in
biotechnology
•
Low Science Education and literacy
•
Weak Research and Development
capabilities
Time lag, most nations are well
ahead in the race to attract
multinational biotechnology
companies
•
•
Strong banking and financial system
•
Skilled workforce which is very
often successful in such ventures
National minimal curriculum
formularised
•
•
Weak IP protection system
•
Lack of natural resources
•
Lack of land
•
Lack of public private sector
partnerships
•
Large financial deficit
THREATS
OPPORTUNITIES
•
Location within the Euro
Mediterranean region
•
Brain Drain
•
Members of the European Economic
Block
•
Poverty because of low per capita
GDP
•
Ability to participate in research and
educational programmes being
offered by EU
Page 21
2.7
Assessment of the Issues and Key Drivers
Maltese Biotechnology stakeholders assessed issues and key drivers influencing the
Maltese biotechnology sector during interviews and panel meetings by addressing
three major questions formulated by pilot secretary. Replies and comments grouped
by subject are presented below. (These may not be the opinions of the core team,
whose main role was to encourage and record open discussion on the local
biotechnology sector)
Q1:
What factors influence achievement within such an industry? These factors
could be social, technological, educational, economic, environmental, political
and/or ethical values.
•
Locally science subjects are not popular with secondary school students.
Following such a curriculum of study has a very high failure rate, and
therefore a high risk is associated with these subjects. High achievers prefer
to follow degrees leading to a career in medicine and pharmacy practice,
where both professions have a fixed prototype of activity. Other science
students are taken up by health related professions like laboratory
technicians, nurses and teachers.
•
The lack of science education results in low level of science awareness, that
is, the important role of science in our every day life. This probably results
from the conservative, textbook teaching of pure science and not the
application of science. People are not being convinced that science is playing
a critical role in their quality of life.
•
Applied biology is not being taught at any level. At tertiary level very little
molecular biology and its applications are being taught. Greater emphasis is
being placed on classical biology and marine biology (the main area of
specialisation of the Department of Biology of the University of Malta). Very
few students are given an opportunity to specialise in ‘modern’ areas of
biology. Not all members of academic staff are abreast with the modern
applications of biology. Such subjects are still being treated as unreachable
and foreign (Feedback from Prof. Axiak head of Biology Department is
presented in Annex 7). In fact even basic infrastructures like library books on
modern applications of biology are sparse at university. Biotechnology is a
very vast and fast moving field of science, modern books are not available.
This is partly because the subject per se is not being taught and therefore no
recommendations for appropriate textbooks are reaching the library
personnel. Biotechnology industry tends to develop in clusters around areas
of academic excellence for example Boston, Heidelberg, Oxbridge (Oxford,
Cambridge and Paris), Carolina Triangle Park and Silicon Valley. Malta still
has very few biotechnology graduates, boosting these numbers must be one
of the first steps to be taken to get the ball rolling towards a sustainable
biotechnology industry.
•
Investment funds for research including basic research are limited. These are
needed as pre-venture funding. No competitive programme for funds is as
yet operating. Funds when available tend to be sparse and for a short
duration. That is, funding of a project may be terminated before an industrial
application is achieved. Development phase of a biotechnological industry is
Page 22
typically long and return on capital takes an unusually long time. Support
measures need to be in place specifically for such a type of industry.
•
No entrepreneurial skills are passed on to the graduates of the Faculty of
Science as opposed to those of the faculty of engineering and the degree in
pharmacy. Teaching of support subjects like basic business subjects and legal
literacy to science graduates is still considered as unessential and
inappropriate. This shows lack of practicality and detachment from the real
applications of such a degree. Students are not being well prepared to work
in industry and to start their own ventures.
•
Academics have no initiative to transfer their knowledge to industry.
Promotion within the University hierarchy should also be influenced by IP
registrations and industrial links and not just scientific publications. On the
contrary academics who are entrepreneurial and strive to establish or involve
themselves in business activities are seen as abusing the system within the
university.
•
Malta is not competitive relative to the regional countries, for example
Tunisia has a good patent protection system, a cheap and educated labour
force and easy tax terms. It will also very soon join the European free trade
zone. Tunisia has established its national biotechnology programme way
back in the 1980’s. For a long term investment we do not compare well at all.
•
Students are not being encouraged to form interdisciplinary groups with the
aim of sharing expertise and translating it into development and innovation.
The mentality to improve financial condition is not very popular and
therefore most science students prefer sheltered secure jobs of lower wages
then more challenging posts with greater potential income.
•
Interdisciplinary networking is essential for successful biotechnology
venture, these should include people with expertise in subjects like
management, marketing, pharmaceuticals, biochemistry, molecular biology,
engineering, physics and chemistry. Within the University there is no
networking which is essential in biotechnology research applications.
•
University has up till now not taken any research stand. The life sciences
research is dispersed. The consequence of this is that there is no pooling of
resources towards a common goal.
•
Work experience during the academic lifetime of a student is still considered
as a hurdle as outcome is not considered important in the final classification
of the degree of the student.
•
Laboratory facilities are dispersed and very little sharing of equipment takes
place. Within the University, equipment maintenance is taken from the
sparse departmental budget and therefore, this creates a mentality that
instrumentation should be protected even though it can become redundant
before optimal use of it has occurred. This needs to be overcome ( if needs be
with all departments and labs pooling into a common insurance fund which
will ensure speedy repair of equipment)
•
There is no parliamentary representation for science and research.
Therefore, there is no central plan or vision for biotechnology.
Page 23
•
Number of science and technology Ph.D.s is low.
•
There is also no intellectual property protection mentality among academics
and local entrepreneurs. No mentality to sell or translate R&D into financial
gain. Money spent on patent protection is not tax exempt.
•
There is a lack of willingness by industry to invest in training and research.
Most innovation is being imported and therefore the net profit is reduced due
to royalties which must be paid for intellectual property.
•
No post graduate programme is in operation and post graduate studies are
not encouraged. In fact very often great personal sacrifices are involved in
specialisation.
•
Legal framework to support and control biotechnology industry is not
complete. Biotechnology industry legal infrastructure would be a whole
array of legislations spanning amongst other intellectual property, control of
genetically modified organisms, research subject protection and disposal of
dangerous chemical and biological waste.
•
One of the hurdles limiting this industry is that negotiates between a foreign
investor and the local authorities generally take a very long time (two years)
which discourages potential investors.
•
There are no local good laboratory practice accreditation laboratories. This
is because service industry is much dispersed, permits take ages to be issued
and most personnel involved are not trained in efficiency.
•
There are very little openings for graduates in the field of biotechnology;
most students holding a post-graduate degree in this field have little
possibility of employment except teaching at higher institutes of learning.
•
No links between University and Industry vis-à-vis post graduate teaching.
•
Such an industry requires chemical products which are often restricted or
considered dangerous.
Customs and Couriers personnel are not
trained/informed about proper handling procedures and generally lack
efficiency in clearing such products out of customs. Increased efficiency is
also required to clear live biological material (including cell cultures). Also
the cost of custom clearance of these products which very often are purchased
in small quantities becomes excessive, together with a huge amount of
paperwork required. This is one of the major hurdles limiting the growth of
small start-up companies. A reform in the customs law is necessary together
with training of customs personnel in proper handling of such a merchandise.
•
During the meetings held with representatives of Malta enterprise we
frequently heard the comment that although a number of schemes for startup companies are in place these are not being taken up by local
entrepreneurs. While entrepreneurs’ frequent comments were that support
schemes are non existent and they are being discouraged by the lack of
business friendliness of the country. Hence we realised that there is a lack of
effective communication between government bodies supporting
entrepreneurs and the entrepreneurs themselves.
Page 24
Q2:
What infrastructure does Malta need in order to support and develop a
thriving biotechnology industry by 2015?
Biotechnology industry is highly dependent on research output. Research spending
is therefore an essential aspect of development of a national biotechnology sector.
No country has developed this sector without investing in R&D and no successful
national development programme has ever been initiated by any country without
addressing this need. Malta has been a very low spender in R&D and this has
seriously limited our ability to develop this sector.
A strong biotechnology infrastructure has many benefits. It will:
1. provide the technology and expertise from which the Maltese Biotechnology
companies will be formed
2. provide the basis for many service industries, as biotechnology companies are
major users of sub-contracted services
3. stimulate multinational companies to put down R&D roots in Malta
4. provide the technology and expertise which indigenous Maltese food and
other companies require to remain competitive in the face of the rapidly
changing technologies in their sector.
5. act as a magnet and anchor for international biotechnology companies.
Infrastructure required include:
•
Laboratory facilities are present however are distributed in a large number
of small laboratories around the island. These being within the Agricultural
Department, University at various faculties and departments, National
Laboratories, Malta Standards Authority and so on. These resources need to
be catalogued and used as a National Scientific infrastructure for the RDI
efforts.
•
Scientific literature at least in the form of database should be available to
research community.
•
A Research Institute should be establish that can do contract research for
industry.
•
Specialised industrial facilities for such a technology are not available from
MDC (now part of Malta Enterprise).
•
The creation of a specific office within the Malta Enterprise to cater for the
specific needs of the biotechnology industry.
•
Oversight mechanisms to ensure good practices within such an industry.
•
No central vision or pooling of efforts has as yet taken place. Such a complex
industry cannot take root without a concerted effort from all those concerned,
including the educational, industrial and support sectors.
A central
coordinator possibly at the level of parliament (as is the practice in other
European countries) must be in place to coordinate all these efforts otherwise
there could be a huge wastage of finance and human resources.
Page 25
Q3:
What areas within biotechnology need to be developed to sustain a
successful research and development programmes and business enterprises in
Malta
It was agreed upon that a Mediterranean regional role for Malta in biotechnology
must be identified. There was a tendency for panel members to indicate their field
of expertise to be the area within Biotechnology that needs to be developed to sustain
a successful R&D programmes and business enterprises in Malta. A local
‘Expressions of interests’ exercise should be conducted and input judged by an
international multidisciplinary panel.
Among the most promising areas for Malta the following were chosen (presented in
alphabetical order):
•
Biofuels (fermentation products)
•
Bioinformatics (combining excellence in IT and Biology)
•
Biomaterials
•
Diagnostic kits and treatment of local prevalent disease including diabetes
(centre of excellence for Mediterranean region).
•
Environmental biotechnology (waste treatment and
contaminated soils of heavy metals and toxic chemicals)
•
Genetic Medicine and Clinical Genomics
•
Medicinal plants (maximise turnover from agriland)
•
Plant development for arid environment, able to tolerate high salt content in
soil and water (including local vine, olive)
•
Products of fermentation/Cell culture at production scale
•
Specialised foods (including those of marine origin)
purification
of
For further information about these fields of biotechnological applications refer to
Annex 8.
Page 26
2.8
The vision for 2015
Education and Training
•
Reformed in school science education to provide for “Science
literacy for all”
•
Increased scope of “Life Science” teaching in undergraduate
programmes.
•
Train research scientists in pure biological science and provide
for specialization at post graduate levels – European mobility
programmes can be utilised for this purpose.
•
Expanded opportunities for research based graduate education
and post-graduate training to satisfy needs for Life science
Ph.Ds – Graduate School in Life Science and Biotechnology.
Funding for Research and Development
•
Increased budgets of tertiary level institutions for research and
development work.
•
Established of a National Programme for Scientific Research,
Technological Development and Innovation at 3% of GDP with
participation of academic, public an private organisations
(Public : Private contributions at 1:2).
•
Increased participation of private sector in funding research
(60% of National spending).
•
Corporate Academy: linking academic research with business
development.
•
Increased participation in EU framework and other R&D
programmes.
Research and Development Capability
•
Promotion of research and entrepreneurial culture among
graduates.
•
Increased number and integration of well equipped research
laboratories.
•
Provide mechanisms for funding by peer review and oversight
of science and technology.
Biotechnology Business Development;
•
Efficient business-friendly infra-structure.
•
Effective Ethical and Legal framework.
•
Sound protection of intellectual property.
•
Venture capital and other investment tools.
Page 27
Chapter 3: Overview of the Biotechnology Sector in Malta
A biotechnology sector is highly influenced by the economic environment of the
nation. A brief overview of the economic environment locally is followed by the
government initiatives to promote the economy and foreign investment. This is
further followed by an overview of the infrastructural setup which includes human
resources and the legal, financial and ethical frameworks.
3.1
Economic environment
Malta has an aging population of around 380,000 (Figure 3.1) and a labour force of
just over 140,000. GDP in 2002 amounted to 4.1 billion euros. The Maltese economy is
small, per capita GDP is estimated at just over one half the EU average (Eurostat
website), placing Malta in third place among the candidate countries. Economic
activity is fairly diversified, with one-fourth of output being generated by
manufacturing and around one-third by services, among which is an important
tourism sector. Services in the financial field and in information technology are
expanding rapidly. In Malta, Government has traditionally had a dominant role in
the economy, from the size of its expenditure to pervasive direct controls, which
have bred a culture of State-dependence and stifled competitiveness and innovation
(Delia, 1986, Cordina, 1992) (Figure 3.2).
Expected Maltese Population in 2015
75+
75+
70 - 74
70 - 74
65 - 69
65 - 69
60 - 64
60 - 64
55 - 59
55 - 59
50 - 54
50 - 54
45 - 49
45 - 49
Age Groups
Age Groups
Maltese Population in Jan 2003
40 - 44
35 - 39
40 - 44
35 - 39
30 - 34
30 - 34
25 - 29
25 - 29
20 - 24
20 - 24
15 - 19
15 - 19
10 - 14
10 - 14
5 - 9
5 - 9
0 - 4
0 - 4
0.0
5.0
10.0
15.0
20.0
Number in Thousands
Males
Females
25.0
30.0
0.0
5.0
10.0
15.0
20.0
25.0
30.0
Number in Thousands
Males
Females
Figure 3.1: Maltese population by gender and age group in 2003 and as projected to
2015 (Data from the National Statistics Office)
Page 28
Gross Domestic Product by Industry and Types of Income
1 2
2% 3%
10
12%
9
11%
3
24%
8
17%
4
6%
7
6%
1
2
3
4
5
10%
6
9%
5
6
7
8
9
10
Figure 3.2 Gross Domestic Product by Industry and Type of Income
(1) agriculture and fishing (2) construction and quarrying (3) manufacturing
including ship repairing and shipbuilding (4) transport and communication (5)
wholesale and retail trade (6) insurance, banking and real estate (7) government
enterprises (8) public administration (9) property income (10) private services
(Information from NSO website)
3.2
Strengths and weaknesses of the enterprise sector
Economic smallness implies that firms may be unable to reap economies of scale to
their full extent, as well as a limited domestic market where competitive forces may
be relatively weak. As is typical of such small economies with relatively few
natural resources, Malta’s economy is highly dependent on transactions with
foreign economies to earn its income and satisfy its expenditure needs.
Exports consist mainly of electronic equipment and tourism services (Cordina and
Anderson, 1993). The most important, though not exclusive, example, is ST
Microelectronics, a subsidiary of a major global microchip manufacturer which
started operations in Malta in the early 1980s employing a few tens of people and has
by now grown to employ a workforce of over 2,000 persons and generating around
one half of Malta’s manufacturing exports (NACE 32 Table 3.1). On the other hand
the manufacture of food products and beverages mainly caters for the local market
employs twice as many individuals and has one fourth the turnover.
In the 1970s and early 1980s, direct foreign investment was mainly attracted by low
costs and financial incentives including tax concessions. At present, the financial
incentives remain in place but the emphasis for the attraction of investment lies on a
skilled and flexible work force as Malta no longer remains cost competitive
compared to other investment locations in Eastern Europe, Asia and North Africa.
Indeed, the investment which had in the past relied exclusively on low costs, most
Page 29
notably in the textiles sector, has by now virtually disappeared from the island
(Cordina and Anderson, 1993). However, investment which relied on technology and
skills has thrived and prospered.
In this context, it is important to note the dichotomous nature of Maltese
enterprises. The typical exporter has a significant foreign participation in its
ownership and/or management, faces international competition and has the ability
to adapt and innovate in response to and in anticipation of market dynamics. The
typical domestic market supplier is locally-owned and managed, probably familyrun business, and either an importer or a producer sheltered to varying degrees from
international competition with very little ability for innovation and for facing
competitive pressures. There are weak connections, if any at all, between these two
spheres of business. Malta’s prospective membership within the EU necessitated a
restructuring programme to assist domestic producers to become effective
competitors within such an environment. Measures undertaken towards this end
include privatisation, programmes aimed at providing finance and expertise for
business restructuring and innovation, as well as business promotion measures for
targeted sectors mainly in the form of tax concessions (Table 3.2).
The availability of different stages of capital financing for the right ventures is still
underdeveloped and enterprises still depend predominantly on individual and bank
finance (White paper on Industrial Policy, Ministry of Economic Services, 2001).
In practice, it is found that a main hurdle in the implementation of these
programmes is the mentality of local entrepreneurs, which is essentially geared
towards family-run concerns serving protected market niches. The concepts of
restructuring and innovation are often viewed as threats to an otherwise stable
business environment, rather than as opportunities to be exploited in an unavoidably
more competitive globalised business environment. This issue is being tackled
through contacts with sectoral representatives in industry aimed at informing the
local entrepreneur of developments in their industry in other countries and to
anticipate the changes necessary for business in Malta.
Page 30
Table 3.1: Turnover (millions) and employment in manufacturing sector over a
period of 3 years (NACE 24 includes the manufacture of basic pharmaceutical
products and preparations)
NACE
code
Number of
employees
Turnover
Description
1999
2000
2001
1999
2000
2001
15
Manufacture of food products
and beverages
127
126
126
4350
4177
4276
17
Manufacture of textiles
18
22
22
811
728
836
18
Manufacture of wearing apparel
65
59
77
3209
2992
3845
24
Manufacture of chemicals and
chemical products
29
27
29
933
907
905
28
Manufacture fabricated metal
products, except machinery and
equipment
20
23
22
1582
1595
1572
29
Manufacture of Machinery and
equipment
14
12
13
533
504
461
31
Manufacture
of
electrical
machinery and equipment
37
32
38
1111
1159
1336
32
Manufacture of radio, television and
communications equipment and
apparatus (including electronics)
442
703
476
2671
3014
3065
33
Manufacture
of
medical,
precision
and
optical
instruments, watches and clocks
30
33
29
1349
1439
1272
35
Manufacture of other transport
equipment
23
20
29
4032
3911
3755
Page 31
Table 3.2: Initiatives towards economic restructuring
Date
Action
Comments
1988
Setting up of MCST
Advisory body to assist in the formulation of a
National Science and Technology (S&T) Policy
1994
National S&T Policy
Outlined the direction of future Maltese activity in
developing effective science and technology policies
1996
Increase University
Budget
To improve research as majority of government
funded research located at University
MCST and the National Coordinating Unit are
actively encouraging the University researchers to
involve the private sector in their research projects
2000
EU’s (5th and) 6th
Framework RTD
programme
To encourage innovation and provide the linkages
required for the joint development of technology
and its transfer from foreign partners.
2001
Business Promotion Act
Intended to attract new investment by means of tax
concessions and other financial incentives
Directed to specific sectors identified on the basis of
their high value added, contribution to technological
improvement, and innovative capability
Research institutions in Malta qualify for tax
concessions
Capital investment in R&D financed through loans
at subsidised interest rates, loan guarantees and tax
credits
2001
IPSE Business
Incubation Centre
To increase the innovative capacity of the country
To assist enterprise restructuring through the
provision of financial packages and expertise
To provide business support services to start-up
enterprises a focus on innovative new-economy
businesses
Biotechnology is named as one of the target sectors
2001
Credit Guarantee Fund
12 million euros were set aside aimed at the
restructuring of the manufacturing sector and the
establishment and growth of innovative SMEs
New enterprise Loan Guarantee post business plan
approval, fund up to 80% of the client’s
requirements (not exceed 96,000 euros
Technology Venture Fund is mechanism for seed
Page 32
and venture capital fund. This is basically a risk
capital financing for innovative knowledge-based
ventures.
It also aims to improves Malta
attractiveness for high-tech investment.
2001
European Innovation
Relay Centre
To seek application of research to create products
and services which can sell
To assist SMEs in sourcing appropriate technologies
2001
Amendment to the
Income Tax Act
120% of any expenditure on scientific research is
deductible from the total income for the calculation
of income tax due.
(this was further improved in September 2003)
2002
Patent and Designs Act
Patent legislation in line with that in the EU
2003
Malta Enterprise Act to
establish the Malta
Enterprise Corporation
To originate, lead and further initiatives relating to
the economic and social development of Malta;
To promote Malta as a location of businesses, to
assist and co-ordinate its promotion as such a
location;
To develop the technological, human resource and
skills bases and to strengthen the capability of
business enterprises;
To undertake strategic assessment and formulation;
To innovate and to undertake
development and design activities;
research,
To provide and manage land, sites, premises,
services and facilities for business enterprises;
To administer schemes, grants and other financial
facilities requiring the disbursement of funds,
including funds originating from foreign sources.
3.3
Legal and Administrative Environment
At the time when this document is being finalized the Malta Enterprise Corporation
is still in the process of formation and selecting its employees. However up to some
time ago companies seeking to set up new ventures in manufacturing and service
industries or to expand their operation on the island were requested to submit a
business plan on their proposed project to the Malta Development Corporation
(MDC). Once the MDC reaches an informed opinion on the project’s feasibility the
investor was informed of the outcome. A favourable answer meant that the investor
is faced with a number of bureaucratic procedures since the concept of a one-stop
shop does not exist.
Page 33
All permits and trade licenses required needed had to be obtained from the police
and trade department whereas water and electricity services and communication
lines needed had to be obtained from three different corporations. This was a rather
lengthy process that discouraged the potential investor.
Local non export-oriented SME’s and in particular small microenterprises
experienced difficulties to find suitable premises. The following are some of the
reasons: scarcity of industrial land, the relative restrictive attitude of the Planning
Authority, regarding the allocation of zone’s for industrial use, MDC’s policy to
reserve industrial estates for export-oriented projects, the growing problems for
SME’s located in residential areas.
Until now MDC had virtual monopoly on all industrial land and premises in Malta
and certainly most of the prime sites. While some cases of private ownership do exist
these sites tend to be small in scale and few in number. Since the private sector is not
able to obtain suitable building sites for industrial development, either through
direct purchase or leasehold, the private property development market in Malta has
been distorted if not destroyed. The lack of private sector participation has been
caused in large part, because industrial land for private development is not available.
In 2001 MDC granted a rent subsidy to its tenants to further attract and encourage
investment, but as from this year the subsidy has been removed so as to be in line
with the ‘acquis’.
The Malta Enterprise Corporation took over the responsibilities of the Malta
Development Corporation, IPSE, METCO and External Trade Company Limited.
Through this act these three entities will be merged together in order to create an
efficient one-stop shop for the business community. Malta Enterprise will influence
all services that have a bearing on industry competitiveness as the educational
institutions. It is being envisaged that this step would reduce the bureaucracy
associated with setting up of a industry in Malta.
Thus a lot of effort is being channelled to create an environment that is friendlier to
high technology ventures. Of course, a lot still needs to be done and all these
initiatives need to be further refined and marketed in order to spur increased
innovation capability in Malta.
Increased Research and Development and
innovation are a EU wide challenge.
3.4
Control of Genetically Modified Organisms
The EU Directives dealing with contained use (Directive 90/219/EEC) and deliberate
release of GMOs (Directive 90/220/EEC) were introduced into Maltese law in
as the Environment Protection Act (Act No. XX of 2001). The Environmental
directorate of the Malta Environmental and Planning Authority (MEPA) was
nominated as the competent authority to administer this Regulation in Malta.
Table 3.3 lists the EU Directives and Regulations currently governing contained and
field use of GMOs in crops, foodstuffs and medical, veterinary and plant protection
products and highlights the relevant Competent Authorities in Malta.
In fact, the procedure for granting or refusing permission is at the moment intensely
laborious and the applicant is required by legislation to submit extensive
environmental risk assessments, which would be scientifically scrutinised and
permission granted or refused according to such assessments.
Page 34
Given the size of the Maltese Islands it is highly unlikely under the current
regulations that any GMO will be released in the environment but R&D is not
excluded.
Table 3.3: European Union Regulating Genetically Modified Organisms and
competent authorities in Malta. In preparation for joining the EU open market most
European legislation controlling genetically modified organisms has been transposed to
Maltese law. The enforcement of this law is not completely in effect, but enforcing bodies are
being formed and manned. These laws basically apply the precautionary principle until
more facts are accumulated upon the possible consequences of GMO/human/environment
interactions.
Directive/Regulation
Purpose
Competent
Malta
Directive
98/81/EEC
amending
Directive
90/219/EEC
Directive 90/220/EEC
Regulates the contained use
of
Genetically
Modified
Micro-organisms (GMMs)
Regulates
the
deliberate
release of GMOs into the
environment for:
• R&D purposes (field trials)
• Placing GMO products on
the market
Regulates biological agents in
the workplace
Regulates the transportation
of certain GMOs
Regulates novel food and
novel
food
ingredients
including GMOs
Regulates the labelling of
certain foodstuffs produced
from GMOs
Establishes a threshold below
which the labelling of
genetically modified food or
ingredients is not required
Regulates GMOs for food
additives and flavourings
Regulates
GMOs
for
medicinal and veterinary uses
Regulates the use of plant
protection products
Regulates the marketing of
GM plant varieties and
amends current Directives
relating to seed
Regulates the authorisation,
marketing
and
use
of
additives in feeding stuffs
Regulates guidelines for the
assessment of additives in
animal nutrition
Biosafety
Committee
Directive 90/679/EEC
Directive 94/55/EEC
Regulation 258/97/EC
Regulation 1139/98/EC
Regulation 49/2000/EC
Regulation 50/2000
Regulation 2309/93/EEC
Directive 91/414/EEC
Directive 98/95/EEC
Directive
amended
70/524/EEC
Directive 87/153/EEC
as
Authority
in
Coordinating
Environmental
Protection
directorate of the MEPA.
Biosafety
Committee
Coordinating
Food Safety Commission
Food Safety Commission
Food Safety Commission
Food Safety Commission
Plant Health
MRA&E
Plant Health
MRA&E
Department
Department
Food
and
Department
Veterinary
Food
and
Department
Veterinary
Page 35
3.5
Intellectual Property and Data Protection
The efficiency of the generation and application of knowledge depends on the degree
and reliability of the protection of intellectual property through patents. Effective
intellectual property protection is an essential cornerstone for creating an attractive
investment climate. Firms planning to develop and market innovative products will
not invest without assurance that their trademarks are protected. Local legislation,
concerning property rights has been recently updated to reflect current practice
within the EU. However the European patent law has been identified as one of the
factors limiting the development of a biotechnology industry (COM(2003) 96 final).
The cost of patents varies with respect to the number of years held. The price ranges
from 60 euros to 180 euros for patents held between 4 to 14 years. All patents that are
registered in Malta fall under the Maltese jurisdiction irrespective of whether these
are made by local or foreign applicants. The Industrial Property Registration
Directorate acts as a receiving and registration office in so far as Patents are
concerned. The Directorate is currently aspiring to set-up a Patent Registration and
Information Dissemination Unit where the function of the unit would not only be the
administrative processing of patent applications but also that of creating an
increased awareness of existing patents amongst the local industry and higher
education institutions.
Application for a patent can be quite time consuming too. Where the applicant has
been notified that his application complies with all the formal requirements, the
Comptroller on payment of the prescribed fee, grants a patent on the application. As
soon as possible after the decision to grant a patent, the Comptroller publishes a
notification that the patent has been granted and publishes the patent in the
prescribed manner. The Comptroller publishes each application filed with it
promptly after the expiration of 18 months from the filing date or, where priority is
claimed, from the priority date of the application. However, where, before the
expiration of the said period of 18 months, the applicant presents a written request to
the Office of the Comptroller that his application be published, the Office of the
Comptroller shall publish the application promptly after the receipt of the request.
Up till now Malta is not a signatory to any international registration conventions on
Patents. Discussions are under way with the European Patent Organisation, and the
World International Property Organization. It is envisaged that by early 2004 Malta
would have joined these two organisations. Figure 3.3 shows the increase in the
number of registered patents since 1990.
Of similar significance is the act for effective data protection. Worldwide Internet
use is growing very fast. This international phenomenon is also affecting trade
practice in Malta where the use of the Internet as well as electronic commerce is
growing too. This creates the need for a regulatory framework, which is suited to this
technology. The Data Protection Act is a step forward towards this end, while
specific regulations on e-commerce would protect both suppliers and consumers
better.
Page 36
200
Numbe
150
100
50
0
1994
1995
1996
1997
1998
1999
2000
2001
2002
Year
Resident -Filed
Non-Resident-Filed
Resident -granted
Non-Resident-Granted
Figure 3.3: The number of patents registered since 1994. Approximately 80% of
locally registered patents come from abroad. The figure also shows a steady
increase in the number of patents registrations. However, none of the patents
registered locally are in connection with biotechnological applications (information
through interview). (Source Industrial Property Office, Ministry of Finance and
Economic Services)
3.6
Teaching, Training and Research
3.6.1
Research
Prof. Roger Ellul Micallef – Rector of the University of Malta during this pilot’s
launching seminar states that ‘life sciences together with Biotechnology have been a
priority target of the University of Malta since the late eighties and will continue to be so, as
may be seen from the University's current Strategic Plan. Considerable funds have been
invested over the last ten years, funds coming mainly from Government, from the Italian
protocol and through participation in the EU framework programmes. Unfortunately
comparatively little funding has been made available by private industry’.
3.6.2
Science Education
Prof. Ellul Micallef continues to state that ‘Greater emphasis worldwide, but perhaps even
more in the EU countries is being given to the teaching of science. Science education in
undergoing extensive reform in order to attract to it as many students as possible. The recent
changes in the National Minimal Curriculum have been an important step forward in
promoting science education in Malta. But there is more to be done. The number of students
taking science subject at tertiary level is still very low which the number of doctoral level
Page 37
research scientists produced is only about 1/10th of the number graduating in other EU
countries (Figure 3.3). It is obvious that a properly funded graduate education programme is
essential to increase numbers. ‘
Humanities
Undergraduate
Number of Student
1000
Sciences
Undergraduate
750
Other Disciplines
Undergraduate
500
Humanities
Postgraduate
Sciences
Postgraduate
250
Other Disciplines
Postgraduate
0
1997
1998
1999
2000
2001
Year
Figure 3.4: Number of University graduates over a four year period. Most popular
courses are the Humanities Undergraduate with a good proportion of these getting a
postgraduate degree. Only a minor proportion of science graduates go on to
specialise. (Data from University Website – Student Statistics)
The need for human resources with high technical skills and with an enterprise
culture to contribute to innovation is strongly being felt. Proposals for direct foreign
investment in Malta are known to have failed simply because of the lack of human
resources with the required skills. Likewise, insufficient skills and inadequate
enterprise attitude are often viewed as the principal hurdle that is impeding business
restructuring from proceeding at a faster pace.
The University of Malta organises an annual Graduate Potential Seminar where
developments in the labour market are discussed and programmes aimed at better
fulfilling these needs are instituted. The first seminar was held in 2000, and has
become the main forum where the policy debate on development of human
resources is carried out on a national basis. After the first Seminar, a working group
was set up which includes top level representation from the Malta Federation of
Industry, the Malta Chamber of Commerce and Employment and Training
Corporation and is chaired by the University. The aim of this group is to enhance the
rapport between the University of Malta and industry and business to maximise the
potential of University graduates in a way which will benefit both the graduates
themselves and their employers.
At the University of Malta topics falling under the definition of Biotechnology are
taught within the Faculty of Medicine and Surgery, the Faculty of Science and the
Institute of Agriculture. There is little cross talk between these entities and no
overlapping credits or other modules of teaching. The Faculty of Science offers a
four year general bachelor’s degree in Science. Two science subjects must be
Page 38
covered. The course content is rich in classical biology however somewhat lacking
in modern molecular biology, human genetics and biotechnology. The Faculty of
Medicine and Surgery has a number of departments, those that are mainly related to
Biotechnology are the Departments of Physiology and Biochemistry, Clinical
Pharmacology and Pharmacy. These teach the medical course and an honorary
bachelor’s degree in pharmacy. Undergraduates in none of these courses are
exposed to practical work in connection with modern molecular biology and
biotechnology.
Graduates in medicine do not usually follow a career in
biotechnology while the pharmacy course is at the moment not offering practical
sessions at all due to lacking infrastructure. Instead students are carrying out their
laboratory practical virtually (information through interview University lecturing
staff). The pharmacy course gives somewhat more emphasis to pharmacy practice
then industrial applications. The Biology Curriculum offered by the Faculty of
Science gives a great importance to classical biology like classification and ecology,
and is run by scientists highly specialised in marine biology. World class research in
marine related science is carried out here, however there is little know-how of
modern molecular biology within this department. The situation locally is
completely opposite to what is taking place in other countries where recombinant
DNA technology is even being offering during one year diploma level courses while
the Maltese graduates in Biology do not even encountered the term in their
curriculum. Each year there are a number of openings for Masters Degrees however
the openings for Ph.D.s are very limited.
In an initiative to make education available to everyone a stipend system in
conjunction with a work experience for students was designed in the 1980s. This was
redesigned a number of times but is basically still existent. However, students
carrying out post-graduate studies or a second first degree do not qualify for such
a stipend system. Such policies discourage further studies and much needed
specialisations.
The Institute of Agriculture offers a Master of Science degree in Agricultural Science
and a one year diploma in Agriculture.
In its Strategic Plan 2002-2006 the University of Malta is committing itself to:
‘Strengthen curriculum development in all Faculties/Institutes to ensure that course content
and delivery reflect academic advances in the subject area’ and ‘continue the process of
facilitating inter-faculty …. student mobility by reinforcing uniform and transparent
assessment criteria together with course structures that are in line with the Bologna
Declaration’.
These two action lines indicate that the University management is aware of the
limitations existing at the moment within the running of some undergraduate
courses and are working to remedy the situation. Through personal communication
it is known that the department of biology is aware of the situation and working to
remedy it. However, the new curriculum is still in the process of formulation.
In order to fulfil some of the lacunae identified, the Malta College for Arts, Science
and Technology (MCAST) has been set up. Training is provided at a certificate level
and is considered to be post-secondary but not of a graduate standard. It is aimed to
satisfy the need for skilled personnel with technical and innovative abilities. It
consists of eight institutes concerning with Art and Design, Information and
Communication Technology, Business and Commerce, Electronics and Engineering,
Page 39
Building and Construction Engineering, Maritime Studies, Community Services and
Agribusiness. The results of this initiative are as yet to be evaluated.
3.7
Research Community - Industrial Cooperation
The University of Malta is virtually the sole institution of tertiary education in Malta
where research is undertaken. The academic staff constitutes 0.5% of the labour force
spread over 10 faculties. The research work of science and engineering nature is
primarily focused on projects involving international collaboration with Universities
abroad, which finds little applicability within the local business. For example the
department of Biology’s main research areas and expertise include Marine
Ecotoxicology; Floristics and Vegetation; Conservation Biology; Faunistics of the
Maltese Islands; Marine benthic ecology and Environmental Chemistry (organotins,
petroleum hydrocarbons); Aquaculture and Fisheries (the only aspect related to
Biotechnological applications and has resulted in a local aquaculture industry due to
expertise of one member of academic staff). While the Faculty of Medicine and
Surgery has quite an extensive range and expertise in research, however the fields of
research interest are much dispersed and are not industrially oriented. Most of the
areas mentioned are covered by just one academic or are transitory (University
website, Current Fields of Research). Within this Faculty there is the know-how of
modern biotechnological applications, however there is little industrial application
because of lack of resources in one laboratory and a different objective of another.
On average 10 research papers are published every year by the Maltese research
community.
The business sector in Malta can be split into two distinct categories. The exportoriented sector is foreign-owned and highly innovative, but generally tends to
import its innovation from abroad or rarely conduct it in-house. On the other hand
the domestic-oriented sector is in great need of restructuring and innovation, but
generally at a lower and less sophisticated level than that which would be produced
by University research. It is for these reasons that, generally speaking, there are very
weak links between the research community in Malta and industry, with these being
limited to the provision of human resources rather than focused on producing
research aimed at promoting indigenous innovation. Figure 3.4 illustrates the
developmental phases of a typical biotechnology company.
The Malta University Services, a company owned by the University to service
business needs, is far more oriented towards educational activities then towards
research.
Thus, due to the small size of the Maltese economy, the research community/
domestic industry collaboration is thwarted by the fact that research bears more fruit
when undertaken in an international context rather than to specifically serve the
small scale of domestic industry. On the other hand, domestic industry has
restructuring and innovation priorities that do not typically match research work
being undertaken. Some exceptions are the collaborations between Amino Chemicals
and the Department of Pharmacy and those of ST Microelectronics with the Faculty
of Engineering. Any efforts to boost the research base of the University with the
hope of improving the innovative nature of the Maltese industry may not bear
Page 40
Research
Project
Start-up
Company
secure research grants
Public Protection and
support
Financial and Business
support
Product development and
marketing
Maltese examples
Figure 3.5
Developing business
Self-sustaining business
file full local &
international patents
protect IP & access 3rd
party IP where necessary
secure development
grants/support
secure tax
concessions/grants
identify potential
investors
secure initial funding
secure further funding
through venture capital &
other investment sources
list company on stock
exchange
identify competing
technologies & potential
market size
identify partners &
collaborators
finalise
marketing/development
deals with partners/
collaborators
bring product to market
with partners
Atheneum
Biotechnologies Ltd
Synergene technologies
Ltd
Optima Laboratories Ltd
Cremona Biogas
The Edible Oil Refinery
Company
file provisional patents &
patent search
identify milestones and
manage research
Institute of Cellular
Pharmacology Ltd
Malta Vaccines
Standard process followed in the commercialisation of biotechnology products
maintain patent portfolio
secure tax
concessions/grants
fruit as there is no direct link between the University of Malta and the local
industry within the area of Biotechnology. However, improving the research
capacity of the University would result in improvement in our status in terms of
basic science research. Academics’ bottom line is the number and quality of
publications in scientific journals as this is what results in their promotions within
the academic scale. Very few academics have a direct interest in industry, not even
from the financial point of view!
As an effect of these factors, and perhaps also partly as a cause, there exist in Malta
no formal research community/business cooperation programmes in disseminating
and applying the results of research.
In the University of Malta Strategic Plan 2002-2006 the University administration sets
as a second most important goal ‘continue to pursue investigative and applied research
that is recognised internationally for its quality and impact on the academic community as
well as on the local population at large’.
Actions to be taken to achieve these objectives include:
•
‘Encourage staff to undertake research projects that are of a Transdisciplinary nature
to seek answers to specific local technological, economic, social and cultural issues.
•
‘Prompt the Research Fund Committee to undertake a research assessment exercise to
review current research projects for their effectiveness, and to implement a clear
policy for future research objectives.
•
‘Support and encourage research programmes that enhance the work of existing or
emerging Centres of Excellence
•
‘Seek contract research from industry, government, as well as from local and
international organisations’
Within this strategic plan the separate faculties are autonomous in the implementing
the action lines. Each one of the faculties would determine independently how best
to achieve these objectives. These actions are all actions in the right direction and
have the potential of injecting manpower to a knowledge society. However, research
stand and directionality has not been taken yet vis-à-vis Biotechnology.
3.8
Commercialisation of Biotechnology
A survey carried out in connection with this pilot identified less then forty
companies engaged in activities broadly related to biotechnology, but only a small
proportion of these are involved in the most recent applications of biotechnology.
Support structures for biotechnology companies existent in other countries are listed
in Figure 3.6.
Biotechnology Venture
Basic Research
Public protection
and support
Financial and
Business support
Product
development and
marketing
• Competence in a
novel platform
technology capable
of spawning
competitive
products, processes
and/or services
• Strong linkages
with academic
institutions
• Access to public
funding
• registration,
maintenance and
protection of
patents
• shared ownership
of IP as in
incentive for
inventors to
commercialise
ideas
• grants and other
support from
government for
concept
development and
proof of concept
• funding for
product
development,
testing, approval
and marketing
• competent
management of
research and
company
development
• business
incubation
• market
intelligence for
strategic
development and
marketing
decisions
• ability to get
products through
trials and
regulatory
agencies
• commercial skills
to get the
product/service
to the market
• expansion capital
Figure 3.6:
Summary of the
commercialisation of biotechnology
3.9
basic
foundations
for
the
successful
Business networks for innovation
As Hon. Minister Dalli comments during the closing speech of the 4th International
eFORESEE Conference ‘An economy’s wealth can only be increased through increasing its
productivity. Productivity can only be increased by looking for new and more efficient ways
of doing what we are doing today. Thus innovation is the key to increasing output and thus
standard of living. Obviously innovation can only by achieved through investing in research’
and its translation into industrially applied projects.
The idea of business clusters and networks is underdeveloped in Malta, so much so
that, local entrepreneurs are sceptic to join forces within the same sector as they fear
that their competitors will take advantage over their competitive edge once they
share their know how. In addition there is no National mechanism or special
financial support that attracts businesses to form such networks.
3.10
Malta Innovation Scoreboard,
Hon. Dalli, Minister for Finance and Economic Services (during this project’s
launching seminar) said that ‘the prosperity of a nation is dependent on its ability to create
value, that is, its value added. Thus increased prosperity can only be sustained by the
production of higher value added products. Innovative products have a high value added as
they can command higher prices due to their scarcity. Therefore, increased prosperity needs
to be continuously fuelled through innovation’. Innovation is one of the essential
elements of a successful biotechnology industry.
A study commissioned by MCST (Micallef, 2003) carried out in line with the
European Innovation Scoreboard, utilised seventeen indicators to measure
innovation. These seventeen indicators are grouped into four categories, namely:
1. Human resources
Page 43
2. The creation of new knowledge
3. The transmission and application of knowledge
4. Innovation finance, outputs and markets
The updated outcome of this study is summarised in Table 3.4.
Malta like all other candidate countries on average lags behind the EU15 in all four
groups of indicators of the innovation scoreboard. The gap seems to be biggest in the
creation of new knowledge and the smallest in the indicators of the ‘innovation
finance, output in markets’ (fourth group).
In terms of human resources for innovation Malta like other candidate countries lags
behind the EU15 on average by 30% when all indicators in this group are taken into
account. Malta is significantly behind in the proportion of the population with
tertiary level education and science and engineering graduates. Indicator 1.1 for new
science and engineering graduates shows that not enough students are choosing
science subjects at post-secondary levels, as is also indicated in Fig 3.3. While
indicator 1.2 is drastically below EU15 and EU25 level because of the very limited
opportunities that were available for tertiary education in Malta for a significant
number of years. Malta still needs to attract significantly more students to take up
science and technology at all post-secondary levels or education and training.
Investment in the creation of new knowledge is the weakest dimension of innovation
capability of Malta and all other candidate countries. This is surprising since other
indicators show that Malta has a high R&D capacity. Significantly higher investment
in R&D and innovation in high-tech areas is necessary in Malta in order to overcome
a major weakness in knowledge generation. Significant increase in public R&D
funding is urgently needed, together with a national R&D policy. The fund should be
open to both institutional as well as industrial applicants. The R&D fund should
cater also for capacity building for research at the precompetitive stage both as
regards human resources training, as well as investment in equipment and
laboratories. Unofficial figure for R&D spending in Malta is 0.007% of GDP which is
well below the EU mean and target of 3% of GDP (Lisbon Summit).
Malta already ranks high in the fourth category of indicators ‘Innovation finance,
outputs and markets’ this augur well to the rest of the economy as Malta can
mobilise funds for innovation. These funds come mainly from self-retained earnings
from domestic firms or in the case of foreign firms from the parent company.
Malta’s foreign direct investment (FDI) is higher then the EU average.
Page 44
Table 3.4 :Malta Innovation Scoreboard 2003 as compared to European Union (EU)
and Associate, Acceding and Candidate Country (AAC) statistics
Indicator
Ref.
1.1
1.2
1.3
1.4
1.5
2.1
2.2
2.3.1
2.3.2
3.1
3.2
3.3
4.1
4.2
4.3
4.4
4.5
4.6
1
2
*
‡
^
Indicator
MT
New
Science
&
Engineering
3.3
graduates (‰ of 20-29 years age
class), includes diplomas up to PhDs
Population with tertiary education 7.00^
(% of 25-64 years age group)
Participation in life-long learning (%
4.4
of 25-64 years age classes)
Employment in medium-high and 7.142 *
high-tech manufacturing (% of
workforce)
Employment in high-tech services (% 3.06*
of total workforce
Public R&D expenditures (% of
-GDP)
Business expenditures on R&D (%of
-GDP)
EPO high tech patent applications
1.5
(per million population)
USPTO high tech patent applications
2.6
(per million population)
SMEs innovating in-house (% of
15.4
manufacturing SMEs)
% of SMEs involved in innovation
4.1
co-operation
Innovation expenditures (% of all
7.82
turnover in manufacturing)
High technology venture capital
-investment (% of GDP)
Capital raised on markets by new
3.68
firms as a % of GDP
% of ‘new to market’ product sales of 37.72
total sales
Number of internet users per 100
25.4
inhabitants
ICT expenditures as a percent of
4.1
GDP
Share of manufacturing value-added
22.42
in high-tech sectors
EU
mean
11.3
AAC
range
3.3 13.1
21.5
8.9-44
8.4
1.123.5‡
1.19.28
7.41
3.57
37.4
1.574.81‡
0.11.33‡
0.051.95‡
0.149.6
0.0221.5‡
4.1-58‡
9.4
4.1-18‡
3.45
0.858.8‡
0.020.9‡
0.233.68‡
6-37.7‡
0.69
1.3
31.6
12.4
0.11
3.68
6.5
32.7
7.0
14.1
4.530.1
2.210.2‡
5.922.7‡
constant over a five year period 1995-2000
highly influenced by one successful multinational enterprise in the electronics sub-sector
inherent strong potential for R&D and innovation
Data is not available for all candidate countries
2000 figure
(Ref: ‘The Innovation Scoreboard for Malta’ MCST sponsored report by Joseph Micallef and Brian
Restall, Sept, 2002;ADE report ‘Innovation capabilities in seven candidate countries: an assessment’ by
Slavo Radosevic and Tomasz Mickiewicz; http://trendchart.cordis.lu/scoreboard2003/html/data_
tables.html)
Page 45
National RTDI Programme (2004-2006) is part of a Government strategy to address
the weaknesses identified in the Innovation Scoreboard. The core objective of the
Programme is to promote national competitiveness through research and innovation.
The Programme which supports knowledge creation is to complement the
Technology Venture Fund, which provides support for commercialization.
The MCST is to launch a National RTDI Programme aimed at promoting a culture
for continuous scientific research and innovation as well as providing the technical
support for Malta to meet its requirements for effective implementation of the Acquis
Communautaire.
The Programme is to encourage public-private sector partnerships and cross-sectoral
synergies, by providing financial support for scientific research over the whole
research and innovation chain, from basic and applied research to near-to-market
innovations. The beneficiaries of the Programme include SMEs, University, Public
and Private Entities including Foundations and Authorities .
The programme will be managed by RTDI Programme Management Committee, set
up by MCST which is to be composed of key stakeholders, including the University
of Malta and Malta Enterprise.
Funding for this Programme is to be made available mainly through the re-allocation
of research funding currently paid to the European Commission in return for the
benefits of full association to the Sixth Framework Programme, as upon accession
Malta will no longer have to pay the related Association fee. Structure funds can also
be used for this purpose, however, the first call has been missed.
The Programme will have sub-programmes covering capacity-building, scientific
research, SME collaborative research and SME in-house innovating activity
respectively. The funds are to be allocated on the basis of public call for proposals
and an external and local peer review system. The call will be open to all legally
established entities in Malta and others from the EU on a reciprocal basis.
3.11
Biotechnology related sectors present in Malta
A number of groups at the University of Malta have conducted research and
development in relevant sectors; in Physiology and Biochemistry; Superoxide
Dismutase, Haemoglobin and Thalassaemia, Neurobiology; in Anatomy;
cytogenetics and congenital anomalies, natural products and cancer; in
Pharmacology; epilepsy, in Obstetrics and Gynaecology, osteoporisis.
The Laboratory of Molecular Genetics (Department of Pathology & BioMedical
Sciences, University of Malta), run by the co-author, initiated molecular genetics
diagnostic services and research in the 1989. It is now also part of the Department of
Health – Division Of Pathology, Section of Molecular Genetics. In addition, the
laboratory conducts maternal and newborn testing and maintains a DNA bank. The
service is intimately connected with the research on genetics epidemiology, genotype
– phenotype relationships and control of globin gene expression. The group has an
interest in blood biotechnology. Three commercial entities have developed out of its
work.
They also participate in EU – Framework Program Funded consortia
including Eurobiobank, Geoparkinson and EUMEDIS – Genetics Network. Between
1996 and 2000, the group was funded by the 4th Italo-Maltese financial protocol
(Molecular Biotechnology Programme)
Page 46
Optima Laboratories Ltd is a speciality neuro-chemical synthesis laboratory which is
housed on campus and has close ties with the Laboratory of Behavioural
NeuroScience (Department of BioMedical Sciences, University of Malta)
Synergene Technologies Ltd operates a DNA sequencing facility and offers
diagnostic services in partnership with a network of connections across Europe
(GENDIA). The company has developed a facility for human identification and
forensic services).
The Institute of Cellular Pharmacology Ltd. (ICP) works closely with Tunisian and
French interests on the extraction of active substances from algae and plants. In
particular they have developed innovative calcimimetics from the Padina pavonic
(maltenedione). An extensive case study on this company co-authored by Joseph
Micallef and Brian Restall was recently published on the MCST website.
MaltaVaccines Ltd produce vaccines for the veterinary market.
In biofuel; Cremona Biogass at the Incubation Center in Kordin. The Edible Oil
Refinery Company (EORC) is now engaged in the production of biodiesel by transesterefication of recovered vagetable oils.
Atheneum Biotechnology Ltd (chaired by co-author of this document) developed out
of the molecular biotechnology programme initially in partnership with Synergene
Genomics Ltd (now Synergene Technologies Ltd). Atheneum is now seeking to
establish a core bio-manufacturing unit in partnership with public and private
organisations from Malta and overseas and other biotech enterprises based on its
developed IP catalogue.
Pharmaceutical industry
Turnover of the chemical/pharmaceutical (NACE 24) industry is less then 5% of the
turnover of the electronics sector (NACE 32). However, a recent development has
been the opening of Delta R&D, a branch of a local generic pharmaceutical enterprise
Pharmamed Ltd. This company has been in Malta for the past 25 years and it is only
recently that it expanded its activity in Malta. In its R&D branch, formulations of
generic tablets take place just before a patent expires. A loophole in the local patent
law allows pileup up to three years before a patent expires. Such an industry would
attract more foreign investment in this sector. The facilities of Pharmamed Ltd itself
have recently been refurbished and upgraded to 24 billion tablet capacity in
preparation to starting operating in the European market once we become members
of the EU. Other established pharmaceutical manufacturers include Pharmamed
Parentals, Starpharma Limited and Arrow Pharm (Malta) Limited. All of these
produce generic pharmaceuticals while Starpharma Limited produces antibiotics.
In Malta there are six units involved in the ‘manufacture of basic pharmaceutical
product’ (NACE 24.41) employing 20 individuals and having a turnover of
LM382,203. Nine units are involved in the ‘manufacture of pharmaceutical
preparations’ (NACE 24.42) employing 350 individuals and having a turnover of 13.7
million. There are also two pharmaceutical manufacturers at the fermentation stage
namely Blaschem Malta Ltd and Amino Chemicals Ltd.
Page 47
Agricultural sector
A small land area combined with a population density ten times the EU-15 average
limits the agricultural sector to 2.5% of GDP. This value is increased a little more
then 6% when all the agri-food chain is considered. This is produced in 11,000
hectors of agriland, half of which is not utilised because it is not good enough for
agriculture.
Agricultural activities face a number of structural constraints, primarily land
fragmentation, water scarcity and the labour intensive nature of this sector. Land is
mostly devoted to grains and forage, crops, vegetables, fruits, flowers, seeds and
other minor crops. Animal production is very intensive including pig, poultry,
cattle, sheep, goats and rabbits.
The population of full-time farmers is less then a thousand, with about 10,000 being
on a part-time basis. Fifty percent of farmers are over 60 years of age. Only 10% of
farmers are less than 40 years old. The agricultural land is very fragmented making
mechanisation difficult.
The Maltese agricultural policy was developed on the basis of a traditional inwardoriented approach, in which the basic functions of the industry were those of
securing domestic supplies to the maximum possible extent. This was achieved
through a fairly wide protection of the domestic agricultural market that had the
effect of maintaining high prices of agricultural products.
Malta is now committed to remove trade barriers, which are substantial for
agricultural and food products. The government has adopted a new vision for the
Maltese agricultural industry which focuses on the sustainable development of rural
areas in Malta in a manner which enhances competitiveness in a demand driven
international market system.
This requires an interim period of adjustment and adaptation during which market
support is necessary so that the sector is equipped to face global competition and
achieve genuine multifunctionality. Malta has developed a Special Market Policy
Programme to support farmers and food processors through the restructuring phase
thus enabling them to face the challenges of a more open market situation. Some of
the actions being taken are
•
Market research to identify specialised niche markets
•
the implementation of the proposed bar-coded produce identification scheme
which would facilitate point-of-sale recording of transactions;
•
the running of the Research and Development Centre, Ghammieri.
•
feeding and housing technologies for livestock including Waste Management
Model Unit;
•
infrastructural works;
•
the development of a Code of Good Agricultural Practice.
A startup on specialized foods already exist locally. Institute of Benthic Algae
Research (IBA Ltd) is producing specialized foods from marine algae and prickly
pears for foreign markets. It is the under the management of a Maltese Graduate of
applied biology of Bristol University and French investment.
Page 48
3.12
Public Opinion
Public opinion on genetic engineering and consumption of GMOs is not yet formed.
Recently a number of articles appeared in the local English papers including an
article by an environmentalist on possible environmental impact of GMOs and in the
consumer column on GMO content of food and food labeling. Usually the Maltese
consumer follows public health warnings and is very cautious when there is an
indication of a possible health hazards. At least one of the major Supermarkets labels
some of the locally packed food as free of GMOs.
In terms of environmental protection, the Maltese population is being educated.
There is much more to be done in terms of increasing public awareness on all types
of pollution. In fact even legislators and planners have been known to choose the
cheaper solutions when it comes to environmental planning, even though the impact
of these decisions in the long term proves to be more expensive to reverse or treat.
3.13
Ethical Framework
As Hon. Minister Galea said during the launching seminar of the pilot project ‘The
social and ethical context of research in life sciences and biotechnology must also be
given particular attention, since public opinion has become critical in this area, as has
been witnessed in recent years with the controversy over Genetically Modified Food
which prevented its take-up in Europe. Other more serious ethical considerations in
relation to cloning and stem cell research among others need to be given serious and
careful attention. The biotechnology sector presents in this sense a good case study
for foresight since ‘scientific and technological progress in these areas raises difficult
policy issues and complex regulatory challenges’
However Maltese legislation lacks the necessary framework to control research and
applications of modern biology. On some occasions, legislation refers more
particularly to outcomes of research and use to be made of research products rather
then to the conduct of the research itself. This is particularly the case relating to
genomic research, where the only legislation to be found is that in the Patents Act
which deals primarily with patenting rather than with the research as such. One
exception to this is the Animal Welfare Act (2000) which deals specifically and in
detail with animal experimentation.
There is also no legislation relating to the setting up and functions of research ethics
committees although reference is made to Research Ethics committees in the Data
Protection Act. The Animal Welfare Act also refers to ‘ethical rules and standards
which may be drawn up by the Council (Article 33 (1)), implying the existences of
such an animal research ethics committee.
In Malta there are the following ethics committees:
1. The Bioethics Consultative Committee. This committee is in the first instance an
advisory body to the Minister of Health. Its role in research is limited to
formulating guidelines to be followed by various institutes and individuals,
as well as to pronounce its views on questions relating to research ethics as
the need arises. It is not involved in the assessment of the ethics of individual
research projects. Its members are appointed by the Minister of Health on a
year-to-year basis. This Committee is not involved in assessing research
projects.
Page 49
2. Research Ethics Committee, Medical School University of Malta. This body was
set up by the Faculty of Medicine and Surgery. It examines research projects
of biomedical nature submitted to it. There is, however no obligation on the
part of researchers to submit their projects to this body. It reports to the
Faculty of Medicine. It has no authority to supervise research projects
authorised by it.
3. Other research ethics committees: the only other research ethics committee is one
set up by the Senate of the University of Malta to deal with non-biomedical
issues. Again there is no legal obligation on the part of researchers to submit
their research for scrutiny of this body.
Research relating to biomedical issues should all go to the Medical Research
Ethics Committee, while all other research that involves human beings should go
to University Research Ethics Committee. There is no obligation on the part of
researchers to submit their research project for approval by an ethics committee
except in the case of research involving animals.
The question of informed consent is not dealt with in Maltese legislation. Malta
is expected to sign and ratify the Convention of Bioethics in the near future,
following which the relevant articles will apply to Malta. The Charter of the
Fundamental Rights of the European Union (200/C/364/01) is not yet binding in
Malta. Also not binding is the Directive 2001/20/EC of the European parliament
and of the Council of 4 April 2001 on the approximation of the laws, regulations
and administrative provisions of the Member States relating to the
implementation of good clinical trials on medicinal products for human use.
In the Maltese legislation there is also no specific reference to human biological
material for research except in the Patent Act (Chapter 417, 2000) dealing with
patentability of tissues and methods of treatment. This law also states no patent
can be granted to ‘the human body, at the various stages of its formation and
development from the moment of conception and the simple discovery of one of its
elements’. The same applies to ‘processes for modifying the germ line genetics identity
of the human body and uses of the human embryo for industrial or commercial purposes’.
Therefore these procedures are not prohibited as such; however, financial gain
resulting from application of these procedures is prohibited.
Page 50
Chapter 4: Overview of Current and Future Issues, Trends and
Opportunities in Biotechnology in Europe and Worldwide
In March 2002, at the Lisbon European Council, Heads of States and governments set
the Union the goal of becoming ‘the most competitive and dynamic knowledgebased economy in the world, capable of sustainable economic growth with more and
better jobs and greater social cohesion’ by 2010. Two years later at the Barcelona
European Council, which reviewed progress towards the Lisbon goal, the Heads of
States agreed that R&D investment in the EU must be increased with the aim of
approaching 3% of GDP by 2010, up from 1.9% in 2000. They also called for an
increase of the level of business funding, which should rise from its current level of
56% to two-thirds of total R&D investment, a proportion already achieved in the US
and in some European countries (COM (2002) 499 final).
As probably the most promising of the frontier technologies, life sciences and
biotechnology can provide a major contribution to achieve the Lisbon Summit’s
objective of becoming a leading knowledge-based economy. The European Council
in Stockholm in March 2001 confirmed this and invited the Commission, together
with the Council, to examine measures required to utilise the full potential of
biotechnology and strengthen the European biotechnology sector’s competitiveness
in order to match leading competitors while ensuring that those developments occur
in a manner which is healthy and safe for consumers and the environment, and
consistent with common fundamental values and ethical principles (COM(2002)27
final).
4.1
Why Biotechnology?
Biotechnology is based on ‘enabling technology’ and advances impact on numerous
industries such as: Pharmaceutical and Healthcare, Medical Devices, Diagnostics,
Agriculture, Food and Drink, Environment and Information Technology. The
industry consists of firms which develop newly discovered knowledge and exploit it
commercially. Many regions, which are establishing themselves as biotech clusters,
frequently include supplier and service companies. This collection of industries is
referred to variously as the biotechnology or life sciences sector.
4.2
Healthcare applications
There is a huge need in global healthcare for novel and innovative approaches to
meet the needs of ageing populations and poor countries. There are still no known
cures for half of the world’s diseases, and even existing cures such as antibiotics are
becoming less effective due to resistance to treatments. Biotechnology already
enables cheaper, safer and more ethical production of a growing number of
traditional as well as new drugs and medical services (e.g. human growth hormone
without risk of Creutzfeldt-Jakob disease, treatment for haemophiliacs with
unlimited sources of coagulation factors free from AIDS and hepatitis C virus,
human insulin, and vaccines against hepatitis B and rabies). Biotechnology is behind
the paradigm shift in disease management towards both personalised and preventive
medicine based on genetic predisposition, targeted screening, diagnosis, and
innovative drug treatments. Pharmacogenomics, which applies information about
the human genome to drug design, discovery and development, will further support
this radical change. Stem cell research and xenotransplantation offer the prospect of
Page 51
replacement tissues and organs to treat degenerative diseases and injury resulting
from strokes, Alzheimer’s and Parkinson’s diseases, burns and spinal-cord injuries.
4.3
Agriculture and food production
In the agro-food area, biotechnology has the potential to deliver improved food
quality and environmental benefits through agronomically improved crops. Since
1998, the area cultivated with genetically modified (GM) crops worldwide has nearly
doubled to reach some 50 million hectares in 2001 (in comparison with about 12 000
hectares in Europe). Food and feed quality may be linked to disease prevention and
reduced health risks. Foods with enhanced qualities (‘functional foods’) are likely to
become increasingly important as part of lifestyle and nutritional benefits. Plant
genome analysis, supported by a FAIR research project, has already led to the genetic
improvement of a traditional European cereal crop (called ‘spelt’) with an increased
protein yield (18 %) which may be used as an alternative source of protein for animal
feed (Van der Bossche, 2001). Considerable reductions in pesticide use have been
recorded in crops with modified resistance. The enhancement of natural resistance to
disease or stress in plants and animals can lead to reduced use of chemical pesticides,
fertilisers and drugs, and increased use of conservation tillage — and hence more
sustainable agricultural practices, reducing soil erosion and benefiting the
environment. Life sciences and biotechnology are likely to be one of the important
tools in fighting hunger and malnutrition and feeding an increasing human
population on the currently cultivated land area, with reduced environmental
impact.
Biotechnology also has the potential to improve non-food uses of crops as sources of
industrial feedstocks or new materials such as biodegradable plastics. Plant-based
materials can provide both molecular building blocks and more complex molecules
for the manufacturing, energy and pharmaceutical industries. Modifications under
development include alterations to carbohydrates, oils, fats and proteins, fibre and
new polymer production. Under the appropriate economic and fiscal conditions,
biomass could contribute to alternative energy with both liquid and solid biofuels
such as biodiesel and bioethanol as well as to processes such as bio-desulphurisation.
Plant genomics also contributes to conventional improvements through the use of
marker-assisted breeding.
New ways to protect and improve the environment are offered by biotechnology
including bioremediation of polluted air, soil, water and waste as well as
development of cleaner industrial products and processes, for example based on use
of enzymes (biocatalysis) (More general information on applications of
biotechnology can be found in Annex 8).
4.4
Harvesting the potential
The potential of life sciences and biotechnology is being exploited at an accelerating
rate and is likely to engender a new economy with the creation of wealth and skilled
jobs. Less certain is the time profile and orientations of this development and who
fully participate (Table 4.1).
Some estimates suggest that by the year 2005 the European biotechnology market
could be worth over EUR 100 billion. By the end of the decade, global markets,
including sectors where life sciences and biotechnology constitute a major portion of
the new technology applied, could amount to over EUR 2 000 billion.
Page 52
Europeans are also likely to become major beneficiaries of solutions offered by life
sciences and biotechnology — in the form of products and services for consumers,
for public benefits and throughout the production system, but to manage this
development and to reap the benefits of a new emerging economy, Europe is
investing to command the knowledge base and to transform it into new products,
processes and services.
Table 4.1:
Direct and indirect market potential of life sciences and
biotechnology
(Beyond quoted figures, comparative data on international competitiveness in biotechnology
are difficult to establish: the main value factor is knowledge, and the usual statistical data on
turnover/sales/exports do not reveal the location where value in terms of intellectual
property has been added.) (From COM(2002) 27 final)
Agricultural:
Although there is a steady increase in the area sown with
genetically modified seeds, the future market value is difficult
to predict, as it would depend on the possible development of a
non-GM feed market.
Million hectares worldwide (ISAAA: International Service for
the Acquisition of Agri-Biotech Applications.):
1998
1999
2000
2001
28
40
44
53
Allowing for the uncertainty of estimates from different
sources, the above would imply that in 2010 there would be a
total world market (excluding agriculture) of above EUR 2 000
billion in sectors where a major portion of the new technology
and a substantial part of the total technology comes from
biotechnology companies.
Industrial:
€1 500 billion market globally in 2010 in sustainable industrial
and environmental technology (only partly biotech) with
environmental technology estimated at €90–120 billion
(UK Government data: from the DTI’s bio-wise programme launched
in 1999: OECD: POST report 136, April 2000).
Pharmaceutical:
EUR 506 billion world market in 2004 (EUR 818 billion in 2010
assuming
constant
increase)
(IMS
Health
(www.imshealth.com).
Page 53
Figure 4.1: Countries who have adopted Biotech crops. In 2002 global areas of
biotech crops was 58.7 million hectares representing an increase of 6.1 million
hectares over 2001.
Source : Clive James, ISAAA (International Service for the Acquisition of AgriBiotech Applications http://www.isaaa.org/)
4.5
Ethical issues
The scientists responsible for developing biotechnology in the 1970s appreciated its
potential and requested appropriate regulation of its application. As a result,
stringent regulations were put in place, starting in the USA in 1976. Since its
inception in the 1970s, there have been many tangible benefits and no significant
accidents or damaging incidents that can be ascribed to biotechnology per se. Most
scientists who work in relevant disciplines believe that biotechnology is as safe as, if
not safer than, many other technologies which are commonplace, and not feared.
As biology is the science of life, people are intensely interested in the potential
impact of biotechnology on their health and on their food in particular. As a result of
the remarkable advances made both in our knowledge of biological processes and in
the application of this knowledge, profound moral issues as well as important
Page 54
political concerns have emerged. Scientists are contributing to many discussions with
the public and the various national and international authorities.
Biotechnology is an extremely powerful technology and many of the moral concerns
expressed are understandable and some are well founded. It is, therefore, important
that these concerns are carefully addressed taking into account the best available
scientific information of how the technology might impinge on widely accepted
norms of morality. Such considerations involving many scientists have led to a
world-wide ban on human reproductive cloning.
Uncertainty about societal acceptance has contributed to detract attention in Europe
for the factors that determine capacity for innovation and technology development
and uptake. This has stifled Europe’s competitive position, weakened the research
capability and could limit policy options in the longer term. The Commission
believes that Europe’s policy choice is, therefore, not whether, but how to deal with
the challenges posed by the new knowledge and its applications.
4.6
Regulations
Traditional biotechnological processes and products are subject to a wide variety of
national and international regulations designed to ensure the safety of food, drugs
and medicines, and to minimise negative environmental impact. The development of
genetic engineering techniques, with the consequent ability to produce genetically
modified organisms and transgenic species, necessitated the development of
additional guidelines and regulations that would allow development and application
of the “new” biotechnology, while minimising the risks to human health and safety,
and avoiding environmental damage.
The desire by leading researchers for appropriate regulation of recombinant DNA
technology was evidenced in 1974 by a call for a moratorium on genetic engineering
research based on the findings of the US National Academy of Sciences (NAS)
Committee on Recombinant DNA Molecules. This led to the landmark Asilomar
Conference in 1975, which was attended by eminent specialists in biotechnology and
risk assessment and which explored all foreseeable implications of recombinant
DNA research. The outcome of the conference was the development of a series of
guidelines designed to ensure the safety of genetic engineering research. It also led to
the establishment of the Recombinant DNA Advisory Committee (RAC) by the US
National Institute of Health (NIH) and the eventual publication in 1976 of what
subsequently became known as the RAC Guidelines. To ensure compliance with the
RAC Guidelines, Institutional Biosafety Committees (IBCs) were set up to assist the
RAC in reviewing recombinant DNA research programmes at institutional level.
Procedures to ensure the safety of genetic engineering research in other parts of the
world generally followed the US guidelines. Over the 25 year period from 1975 to
2000, the vast amount of information that has accumulated on risk assessment of
GMO research has allowed some relaxation of the initial guidelines without
compromising safety.
Commercialisation of the “new” biotechnology processes and products required
development of a regulatory framework, rather than reliance on research guidelines.
The objective of regulation is to ensure maximum consumer protection, while
minimising negative environmental impact. However, it is important to prevent
Page 55
over-regulation to the extent that it may inhibit the development of GM products
and processes that are of benefit to the public at large and to the environment.
US Regulation
In the present US regulatory environment, three agencies share responsibility for
regulating the organisms, products and processes of recombinant DNA technology.
The agencies involved are the Food and Drug Administration (FDA), the United
States Department of Agriculture (USDA) and the Environmental Protection Agency
(EPA). The regulations cover the contained use and deliberate release of GMOs.
European Regulation
The current EU Directives and Regulations governing the application of recombinant
DNA technology and use of GMOs are outlined in Table. While the EU has given
strong commitment to the development of the biotechnology sector, for example
through the Framework Programmes of research, technological development and
demonstration, these EU Directives and Regulations give a clear priority to human
and animal health and to environmental protection and sustainability.
European authorisation of medicinal products for human and veterinary use is
carried out by The European Agency for the Evaluation of Medicinal Products
(EMEA) in co-operation with national authorities. Table 3.3 indicates the relevant EU
Directives and Regulations governing the use of GMO products in human and
veterinary medicine.
4.7
The knowledge base
The life sciences revolution was born in, and is fed and nurtured by, continuing
interest in research. Public research laboratories and institutions of higher education
are at the core of the science base interacting also with enterprise based research and
that of other private bodies.
The role of R&D as a driving force for a competitive and dynamic knowledge-based
economy is linked to the economy’s capacity to turn new knowledge into
technological innovation. Although many enterprises recognise the increased
importance of investing in R&D, they will do so only to the extent that they can
exploit results effectively and expect sufficient returns to balance the short-term risk
inherent in such investment.
One of Europe’s main strengths is its science base; centres of scientific excellence in
specific technologies exist and are at the core of regional clusters of biotechnology
development. However, total European investment in R&D is lagging behind the
United States. Moreover, Europe suffers from fragmentation of public research
support, and from the low level of interregional cooperation in R&D, among
companies and institutions from different regions of several States.
The Commission aims to restore European leadership in life sciences and
biotechnology research. The sixth Community framework programme for research,
technological development and demonstration activities (2002–06) proposes this area
as the first priority and will provide a solid platform for constructing, in
collaboration with the Member States, a European research area (ERA). This should
reinforce R&D capacity and help overcome existing fragmentation of research
policies and efforts. Europeans aim to pool efforts, maximising collaboration and
minimising duplication, to better meet challenges such as the handling of the ever-
Page 56
increasing volumes of data and information and ensure full participation in global
scientific initiatives.
Moreover, European research efforts are focusing on the new prospects that are
opening up through multidisciplinary research. New discoveries are most often
made when biological research is carried out in conjunction with other sciences and
disciplines such as information technology, chemistry and process engineering. For
example, human genome analysis into so-called ‘gluten allergy’ may ultimately lead
to the development of allergen-reduced cereals. A first fully integrated Community
project has recently been launched to ensure leadership at the genomes–medicine
interface where biotechnology is yielding innovative approaches to treatments of
human and animal diseases.
4.8
Europe’s capacity to offer scientific and technological solutions
The potential for applications of life sciences and biotechnology promises to be a
growing source of wealth creation in the future, leading to the creation of jobs, many
of which will be highly skilled, and new opportunities for investment in further
research.
If Europe is to benefit from this, excellence in the science base is not enough: it is
essential to have the capacity to translate knowledge into new products, processes
and services that in turn will generate benefits to society, skilled jobs and prosperity.
The development of new capacity involves the encouragement of the entire research
and innovation process to attract and train researchers, to attract investment and
resources, and to provide a balanced and responsible legal, regulatory and policy
framework.
During the 1980s, biotechnology in Europe developed primarily within large
companies whereas, unlike the United States, the small company sector remained
mostly stagnant. While large companies in the pharmaceutical and chemical sectors
continue to exploit the technology to provide innovative products, we have seen a
rapid expansion of the small company sector in Europe in the recent past. There are
now more dedicated biotechnology companies in Europe (1,570), than in the United
States (1,273). This is an encouraging demonstration of entrepreneurial potential in
Europe.
The industry consists of firms which develop newly discovered knowledge and
exploit it commercially. Many regions, which are establishing themselves as biotech
clusters, frequently include supplier and service companies. This collection of
industries is referred to variously as the biotechnology or life sciences sector.
However, the European SMEs are relatively small companies, whereas the US
biotechnology industry started earlier, produces more than three times the revenues
of the European industry, employs many more people (162,000 against around
60,000), is much more strongly capitalised and, in particular, has many more
products in the pipeline.
The Commission’s 2001 report on competitiveness analysed in detail why
commercial development of EU industry currently lags behind that of the United
States in the biotechnology sector. Intellectual property rights were identified as a
relevant factor to be taken into account.
Structurally, biotechnology SMEs are very capital-intensive, and investments have
long payback periods. Risk capital funding has been increasingly available, but does
Page 57
not appear to be sufficient at all stages of the long company development process.
Insufficient supply of skilled personnel may develop into a major constraint for
industry development.
Figure 4.2:
Biotechnology Industry in Europe compared to the US.
European data for 2000 and 2001 are adjusted by the inclusion of the Swiss biotech
company Serono (Source: (COM(2002) 27 final))
# European
companies
# US companies
Revenue USA
Revenue
Europe
Revenue
Europe (adj)
Eliminating such bottlenecks is as important as fostering an entrepreneurial Europe
with sufficient incentives for innovation and economic risk-taking to create the
necessary dynamics. Europe’s competitiveness should be enhanced through three
main pillars for action: the resource base, networks and a proactive role for public
authorities.
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Figure 4.3:
Comparison of Employment (Source: (COM(2002) 27 final))
Revenue USA
Revenue
Europe
Revenue
Europe (adj)
4.9
The US model
The United States has shown that a biotechnology industry cannot be created
without highly competitive biotechnologies.
In the Unites States these
biotechnologists have been and are being produced mainly through government and
industry funded R&D programmes at the universities. Of course these R&D
programmes also provide much of the information and many of the ideas which are
the feed stock for the industry. Many US entrepreneurs are scientists who started
their careers as researchers, participating in government funded or industry funded
R&D programmes. These people took their ideas and discoveries out of the
laboratories into start-up companies which were an important element in the
biotechnology revolution.
US government strategy: past and present
The US leads in biotechnology because US university scientists invented it, US
entrepreneurs and university scientists commercialized it and the US pharmaceutical
and chemical industries have taken it over and developed it. The comparisons with
the semiconductor and microelectronics industry should be noted. The same alliance
of US government, US science and technology and US business which developed the
microelectronics and information technology industry decided that biotechnology
had the same potential as microelectronics and IT.
‘the actions of the US government (Mostly through the defence budget) that influenced the
development of the US semiconductor industry were many and diverse. Undoubtedly, not
all the effects of the Federal government were intended or anticipated. With the benefit of
hindsight, however, it is apparent that these actions helped to produce a dynamic, healthy US
semiconductor industry. Similar actions by the Federal government could encourage the
development of companies in other high-technology fields such as biotechnology’ (Office
Technology Assistance report, 1984).
Biotechnology emerged from molecular genetics research in US universities in 19701972. The OTA report notes that ’Federally funded research in the United States has been
Page 59
essential to the development of biotechnology’ and that most of this had been conducted
at non-governmental laboratories especially at research universities. Biotechnology
became the key driver in the health and life science industries and services in the US
in the 1980s. The US led the world in the first phase of the biotechnology industry.
The US government has consistently supported biotechnology over the last 15 years
with the result that the is leading the charge in the current phase of the
biotechnology revolution. US companies lead the field in innovation. Luckily there
is too much to be done for the US to do it alone.
4.10
Other Countries:
Brazil
Brazil is emerging as one of the developing country leaders in biotechnology because
of its deliberate strategy of targeting those areas that are of national economic
priority and organizing its R&D activities in such a way as to exploit scientific
expertise and technical infrastructure across the institutional landscape. It has also
created a national biotechnology focal centre that spearheads R&D.
A significant contribution to the understanding of citrus crop diseases and cancer has
resulted from focused funding of genomic sequencing in Brazil. The FAPEPS
genome project has been recognized internationally for its contribution to the
understanding and development of interventions into cancer and crop pests. Brazil
now has a world-class capacity to address local problems, such as the unusually high
incidence of head and neck cancer and specific pathogens that are of local interest to
farmers.
The Oswaldo Cruz Foundation (FIOCRUZ) was a national agency conducting research
and training in medical biotechnology, but has since extended its activities to
agricultural biotechnology as well. Its research focuses on the application of
molecular biology and the development of vaccines for diseases such as tuberculosis.
It has generated a number of recombinant vaccines and diagnostic kits. The
Foundation holds at least two patents for diagnostic kits for hepatitis B and rubella.
Nigeria
Nigeria is one of the African countries that has embarked on a determined
programme to exploit biotechnology for the benefit of its peoples and to ensure that
Nigeria becomes a key participant in the international biotechnology arena within
the next decade. The Federal Executive Council (Cabinet) has approved that
Biotechnology Policy and Programme of Action (Strategy), which places strong
emphasis on the food and agriculture, health and environmental sectors and
bioresource development.
The strategy implemented on a multilevel arrangement of institutions being
The Minister’s Council, responsible for policy formulation and consisting of relevant
ministries
The Technical Committee, consisting of professionals to be drawn from the
ministries, R&D/academic communities, the organised private sector and other
stakeholders.
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The National Biotechnology Development Agency, which is to provide the platform
for networking (both local and international), co-ordination, awareness creation,
R&D management and biotechnology entrepreneurship development.
R&D will be done by specific institutions/universities, with the agency ensuring that
specific research targets are met. The programme has the following components:
• Biotechnology entrepreneurship
• Bioresources development
• Capacity-building in human resources and infrastructure
• Networking (Nigeria is one of the few African countries that have joined the
International Centre for Genetic Engineering and Biotechnology (ICGEB), an
organization that promotes the transfer of technology between countries).
The Federal Government is providing the National Biotechnology Development
Agency with US$263 million per annum for three years as a take-off grant to fund the
executive programmes in agriculture, health, industry, environment and human
resource development.
Tunisia
Tunisia has established an National Plan for Biotechnology as early as the 1980s.
This plan has emphasized education and training in the field of biotechnology, and
many scholarships have been allocated for postgraduate studies in Tunisia, but
mainly in France. The funding for these training programs was provided by the
Tunisian Government and the French Embassy under the Agreement between the
two governments. Also, as an outcome of these preliminary policy-setting activities,
two centres for Biotechnology (The Biotechnology Center in Sfax and the Pasteur
Institute in Tunis) and new laboratories in already existing institutes were
established.
The coordination of the agricultural biotechnology research programs is done at two
levels. The first one is the National Committee for Agricultural Biotechnology of the
State Secretary of Research in Science and Technology, and the second one is the
Program Committee within the Institution of Research and Higher Education of he
Ministry of Agriculture (Cetiner,1995).
Tunisia will join the European
(www.investintunisia.com).
Union
Free
Trade
zone
in
2008
Page 61
Annex 1:
Interviewees and Panel Members
Dr. Anna Mcelhatton,
Department of Pharmacy, University of Malta
Mr. Anthony Theuma,
Department of Pharmacy, University of Malta
Dr. Bernard DeBono
University of Malta
Dr. Chris Scerri
Department of Health, University of Malta, Atheneum Biotechnologies Limited
Dr. Clair Bartolo
Synergene Technologies Limited
Dr. Hank Fray
Delta R&D - Chief Scientist
Dr. Janet Mifsud
Department of Pharmacology, University of Malta
Dr. Marion Zammit Mangion
University of Malta
Dr. Nickola Camilleri
Eurisconsult
Dr. Paul DeBattista
President of Employers Association,
CEO Marsovin Group
Dr. Pierre Mallia
Ethicist; General Practitioner
Dr. Pierre Schembri Wismayer
Lecturer, University of Malta
Dr. Robert Vassallo Agius
Aquaculture
Dr. Simean Deguara
Aquabiotech Innovia – Director
Dr. Sylvana Camilleri
University of Malta,
Malta College for Arts, Sciences and Technology
Page 62
Dr. Tony Vella
Crop Protection, University of Malta
Dr. Victor Farrugia
Director, Plant Health Department,
Ministry of Rural Affairs and Environment
Dr. Claude Farrugia
University of Malta,
Malta Federation of Industry
Dr. Neville Calleja,
Statistician, Department of Health
Ing. Bertram Mallia,
Faculty of Engineering, University of Malta
Mr. Adrian Spiteri
PriceWaterhouseCooper
Mr. Charles Saliba
IBA Ltd – Director
Mr. Godwin Warr
Director Policy & Regulatory Services,
Industrial Property Office within Commerce division of Ministry of Finance and
Economic Affairs
Dr. Joe Buhagiar
Botanical Gardens,
University of Malta
Mr. Mario Salerno
President, Organic Movement
Mr. Martin Galea
FOI vice-president
Ing. Ray Muscat
IPSE, Korradino Business Incubation Centre
Mr.Byron Baron,
Student, Faculty of Science
Mr. Julian Holland
Business Development Department, Bank of Valletta
Ms. Marlene Bonnici
Director, Planning and Priorities Co-ordination Directorate, OPM
Page 63
Ms. Michelle Bonello
Assistant Director (Trade Marks),
Industrial Property Office within Commerce division of Ministry of Finance and
Economic Affairs
Ms. Nadia Lanzon
Environment Protection Officer, Nature Protection Unit, Environment Protection
Directorate, Malta environment and Planning Authority
Professor Alfred Cuschieri,
Department of Anatomy, University of Malta
Professor Anthony Serracino Inglott
Head of Pharmacy Department, University of Malta
Professor Carmelo Agius
Department of Biology, University of Malta
Professor Victor Axiak
Head of Department of Biology, University of Malta
Page 64
Annex 2:
Proposed Terms of Reference
1.
2.
The Biotechnology Panel will be chaired by a champion and supported by a managing
secretary. The Panel is free to adopt its own modus operandi with regard to frequency of
meetings in line with the remit detailed below. The Panel may co-opt other members and/or
set up sub-panels to focus on specific issues.
3.
The Biotechnology Panel will review the proposed mission statement for this pilot and adopt
it. The Panel’s main remit entails:
•
•
•
•
•
•
analyzing the findings from interviews and desk-based research
exploring alternative futures in the area of Biotechnology
scenario-building
SWOT /STEEPV and feasibility analysis
preparing action plans and recommendations
disseminating the results
4.
This work has to be carried out within a short time frame of June – October 2003. The
Biotechnology Panel will review the proposed workplan and adopt it.
5.
The Expert Panel is able to discuss and decide on the time horizon they will work, ideally this
will fall within the range of 2005-2015.
Page 65
Annex 3:
List of Documents and Websites
ADE report ‘Innovation capabilities in seven candidate countries: an assessment’ by
Slavo Radosevic and Tomasz Mickiewicz;
Allansdottir A et.al., (2002) Innovation and Competitiveness in European
Biotechnology. Enterprise Papers No.7. Enterprise Directorate-General
European Commission
Andrade, M.A. and Sander, C. Bioinformatics (1997) From genome to biological
knowledge. Current Opinion in Biotechnology, Vol. 8, No. 6.
Biotechnology for the 21st Century – New Horizons. National Scienc and Technology
Council, Washington, US 1995
Busuttil S. and Demicoli E. (2003) Lengthy talks on Malta’s Agriculture draw to a
close. Aġġornat Special edition No.16
Cetier S. (1995) Biotechnology Seminar Paper –Agricultural Biotechnology in the
WANA region. ISNAR International Service for National Agricultural
Research, The Netherlands. References
Cetiner S. (1995) ‘Biotechnology Seminar Paper – Agricultural Biotechnology in the
WANA Region’ ISNAR Biotechnology Services’
Clive James ISAAA (International Services for the Acquisition of AgriBiotech
Applications http://www.isaaa.org)
Combinatorial Chemistry: A Strategy for the Future, Molecular Connection, March
1995.
Combinatorial chemists focus on small molecules, molecular recognition and
automation. Chemical and Engineering News, Feb. 12, 1996.
Communication from the Commission ‘More research for Europe – towords 3% of
GDP’ COM(2002)499 final
Communication from the commission to the council, the European parlament, the
economic and social committee and the committee of the regions ‘Life
science and biotechnology – a strategy for Europe’COM(2002) 27 final
Cordina G and, Anderson D ‘An Analysis of the Export Competitiveness of
Manufacturing Industry in Malta’, Central Bank of Malta Quarterly
Review, September 1993.
Cording G. ‘Patterns of Fiscal revenue and Expenditure in Malta (1980-1992)’, Bank
of Valletta Review, Autumn 1992
Delia E.P. The Task Ahead. Confederation of Private Enterprise, 1986
Economic Policy Division, Ministry of Economic Services, Economic Survey Jan-Sept
2001, 2001
Enterprise Directorate General (March 2003) ‘Innovation policy in seven candidate
countries: the challenges Vol. 2.4 Innovation Policy Profile: Malta. Island
Consulting Services. ADE in association with SSEES and LOGOTECH
Page 66
Foresight in FP6 ‘Strengthening the dimensions of foresight in the European
Research Area’ Working Document ‘An outline guide to opportunities
offered by the Sixth European Community Research Framework
Programme for supporting co-operation in the fields of foresight in
Europe EC Directorate-General for Research Unit RTD – K.2 –‘Science and
Technology foresight; links with IPTS Draft edition 2002
Forfas ‘Health and Life Science- report from the Health and Life Sciences Panel’
ICSTI Ireland
Gaskell G et.al., (2003) ‘Europeans and Biotechnology in 2002’ Eurobarometer 58.0 A
report to the EC Directorate General for Research from the project ‘Life
Sciences and European Society’ QLG7-CT- 1999-00286
Heim, J. and Furst, P. Molecular Screening Platforms - Perspective 1998. International
Bioforum, Vol. 2, June 1998.
ICSTI Report on Biotechnology Forfas
Joseph Micallef and Brian Restall ‘The Innovation Scoreboard for Malta’ MCST
sponsored report , Sept, 2002;
Life sciences and biotechnology - a strategy for Europe: progress report and future
orientations. Communication from the Commission to the European
Parliament, to the Council and to the Economic and Social Committee.
COM(2003) 96 final
National
‘Research, Technological, Developmental
Programme MCST Oct 2003
and
Innovation
(RTDI)’
National Statistics Office, Labour Force Survey, December 2001
Noorzad H (2001). Biotechnology, Its evolution, Application and Environmental
Implications. Executive office of Environmental Protectional affairs and
OTA
Office Technology Assistance (OTA) report 1984 ‘Commercial Biotechnology – an
international analysis’ NTIS # PB84-173608
Parker I et.al., (2001) A National Biotechnology Strategy for South Africa.
www.dst.gov.za/programmes/biodiversity/ biotechstrategy.pdf
Radosevic S. and Mickiewicz T. (2003) ‘Innovation capabilities in seven candidate
countries: an assessment’ Vol 2.3 Enterprise Directorate-General (Contract
No. INNO-02-06).
Rastan, S and Beeley, L.J. Functional Genomics : going forward from the databases.
1997. Current Opinion in Genetics and Development., Vol 7, No. 6.
Rose, P., Gorman, J., Kurtz, S., Patel, P. and Fernandes, P. The Successful Partnership
of Biotechnology Based Screen Development with High Throughput
Screening.
Net
work
Science
(http://www.netsci.org/Science/Screening/feature06.html).
Single Programming Document 2004/2006 Regional Policy Directorate
Technology Foresight Ireland. ‘Health and Life Sciences’ ICSTI Ireland. Forfas report
University of Malta – Strategic Development Plan 2002-2006
Page 67
Van der Bossche (2001).‘Spelt: a recovery crop for future European sustainable
agriculture’http://europa.eu.int/comm/research/agro/fair/en/be1569.
html
White paper on Industrial Policy, Ministry of Economic Services, 2001
Convention on Biological Diversity
http://www.biodiv.org/default.aspx
eFORESEE website
www.eforesee.info
European Innovation Scoreboard website
http://trendchart.cordis.lu
European Legislation in Force
http://www.europa.eu.int/eurlex/en/index.html
Eurostat website
http://europa.eu.int/comm/eurostat/
Malta Enterprise
http://www.maltaenterprise.com/
Maltese legislature
http://justice.gov.mt/
National Statistics Office
http://www.nso.gov.mt/
University of Malta website
http://www.um.edu.mt
Community research and development http://www.cordis.lu/en/home.html
information services
Page 68
Annex 4:
Biotechnology R&D Questionnaire Survey
CONFIDENTIAL
Dorita Galea
eFORESEE Biotechnology Pilot
MCST,Villa
CSP12
Bighi,
Bighi,
Kalkara,
Tel: 79382887
email: [email protected]
website:
http://www.eforesee.info
Questionnaire on R&D activities in the Biotechnology sector
This survey is intended to obtain a measure of the Biotechnology research and development
(R&D) activity in the Maltese Islands. It forms part of the eFORESEE Biotechnology Pilot
Foresight Project. You are kindly requested to complete and forward this
questionnaire directly to the eFORESEE Biotechnology Pilot managing secretary
in the above mentioned address, within two weeks of receipt.
The questionnaire is meant to be completed by management of companies or organisations
that are either engaging directly in Biotechnology R&D or having Biotechnology R&D
performed on their behalf by other parties.
The information you provide will be treated in strict confidence and will be used
for statistical purposes only. Data will not be published in any identifiable form.
Please consult the attached definitions and notes at the end of the document while answering
the questions to describe the involvement of your organisation in Biotechnology R&D.
If your company/organisation/department does not perform any R&D please fill in
only section A of this form and enter a NIL RETURN in section B. If your company
is/has conducted R&D, please complete both Sections A and B, and return the form
within two weeks of receipt.
• Please read the enclosed instructions before completing this form.
• Report rounded figures. Reasonable estimates are acceptable.
• An electronic version of this survey can be downloaded from the file area at
http://www.eforesee.info/malta
• Please complete this form by the date printed above and return it to the above
address or by email.
• If you need further assistance, please contact Ms. Dorita Galea (contact details
above)
• Please refer to notes at back of document as required.
Page 69
QUESTIONNAIRE ON R&D ACTIVITIES IN THE BIOTECHNOLOGY SECTOR
PART A – INFORMATION ON BIOTECHNOLOGY RELATED ENTITY
COMPILING THE QUESTIONNAIRE
(Section A is expected to be filled in by all companies, organisations or institutions
that are involved in Biotechnology-related activities/operations. Please fill in Section
A even if your entity does NOT undertake any Biotechnology-related R&D. Otherwise
please proceed with section B)
Q.A1
Name of entity/organisation/department:
Q.A2
Details of person compiling the questionnaire:
Contact Person
Q.A3
Position / Office held
How would you classify your entity / organisation?
Mark the appropriate box for each category (⌧)
Academic institution
Biotechnology - based enterprise/business
Organisation with Biotechnology-related responsibilities and activities
Others (Describe) :
Q.A4
Describe the key Biotechnology-related activities conducted by your
entity. (Please refer to note 1)
(Use a separate box for each activity, giving a short description and listing
the scope and goals of the activity. Use additional sheets as necessary)
1.
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2.
Q.A5.1 How many overall staff does your entity employ?
(Report in rounded numbers of full-time equivalent as per note 2.
If the entity is a department or a section of a larger organisation,
give this information only for your department / section. Overall
staff includes those engaged in non-Biotechnology activities.)
- PLEASE CONTINUE WITH SECTION B -
Page 71
PART B – DESCRIPTION OF R & D3 ACTIVITIES WITHIN ENTITY
Q.B1 How would you classify the nature of the R&D exercise that your entity has/is
conducting? Please refer to
note 3. Mark the appropriate box for each category (⌧)
Academic (e.g. pure research to acquire new knowledge with or without
envisaged application)
Product Development (i.e. development of new products to potentially place on
market)
Analysis (e.g. research intended for assessments such as carrying capacity
exercises, impact assessments)
Service Enhancement (i.e. ways to improve a service rendered)
Q.B2
What is the status of your R&D exercise?
Completed
Date of
Completion
Q.B3
Ongoing
Planned
Potential
What is the approximate distribution, in terms of the percentage current R&D
expenditures, of the R&D effort
%
Basic research (no specific practical application in
view)
%
Applied research (with a specific practical
application in view)
% New* product development
% Existing* product improvement
% New* process development
% Existing* product improvement
% New* technical service development
% Existing* technical services improvement
* Please consider “New” to mean totally or essentially new/unknown to the personnel
of your R&D establishment. The product, process or service may exist elsewhere in
the world but your R&D is not aided by this fact since your personnel do not have
access to the information necessary to avoid any of the normal risks of development.
“Existing” would mean that your staff would be improving a product/process/service
about which they have the basic information - the product/process/service need not
be already provided by your company.
Page 72
Q.B4
Please elaborate on the nature of the R&D activity.
Specific targets :
Kind of work :
Q.B5.1 How many staff does your entity (department/section or
even whole enterprise) deploy on this R&D activity
specifically? Report full-time equivalent as per note 3
Q.B6
How would you classify the human resources you have available for the R&D
activity as compared to the actual R&D needs of your entity?
With regard to Number
Q.B7
With regard to Expertise
Adequate
Adequate
Sufficient / Average
Sufficient / Average
Insufficient
Insufficient
How is your R&D activity funded?
In-house funding (i.e. through funds allocated by the entity itself for R&D)
Public/government grants/aid
Private grants/aid (include EU funding)
(In the case of a private or public source of funding, please elaborate (e.g. give name of
project applied for, etc.) )
Page 73
Q.B8
Please indicate the total funding available for R&D activities, including
indications of time frame for use of such funds.
AMOUNT IN MALTESE LIRA
TIME FRAME
Q.B9 Please estimate for each listed category, the percentage use of funds in the
R&D activity.
% Staff (including training)
% Equipment
% Maintenance
% Recurrent expenses
Q.B10 How would you classify the funding available for your R&D activities?
Adequate
Sufficient /Average
Insufficient
Q.B11.1
How do you rate the knowledge of your entity about the R&D
Framework Programme of the European Union? (Please refer to note 4.)
Staff follows regular updates on funding opportunities and partnership
with European counterparts.
Sources of funding hard to get
Just follow it irregularly with no particular interest
Never heard about it
Q.B11.2Did your entity participate in any EU funded R&D projects?
Yes
No
If yes, indicate the level of funding:
1996-1999 Lm
2000-2003
Lm
Q.B12.1
What is the disposition of your entity towards the European Research
Area? (Please refer to note 5)
Page 74
Very receptive and looking forward to take specific actions
Keeping abreast to developments but seeking guidance/advice from
others (e.g. FOI, government, etc.)
Just a matter for intellectuals
Never heard about it
Q.B12.2 Indicate how your entity is preparing to harness the opportunities of
the ERA?
Partnerships with European counterparts
(Describe)
Involvement in European networks of excellence
(Describe)
Plans of joint projects with European partners
(Describe)
Plans for exchange of personnel
(Describe)
Q.B12.3
Write briefly the strategy that your entity intends to follow, to best
integrate into the European Research Area.
- THANK YOU VERY MUCH FOR YOUR RESPONSE -
Page 75
eFORESEE Biotechnology Pilot Foresight Project
‘Realising a Thriving
Maltese Biotechnology Industry by 2015’
Within the framework of the European eFORESEE project, the Malta Council for
Science and Technology has recently launched a Biotechnology Pilot Project
targeting to elaborate a foresight exercise into the future of the Maltese Islands, with
a focus on the Biotechnology sector’s potential in its contribution to the Maltese
economy. The Biotechnology Pilot project’s mission statement entails an assessment
of the current relevance of the Biotechnology-related industries and services to our
economic welfare, and will look at how the various Biotechnology areas can be
optimally redressed and sustainably exploited through emerging science and
technology, in order to meet the future needs of an evolving knowledge-driven
society and a vibrant and diversified economy projected in 2015. It also underpins the
essential management and development strategies necessary to secure an adequate
and timely delivery.
Foresight programs have recently broken new ground with the pertinent approach,
outlook, methodology and aptitude towards the provision of a framework vision into
the future shape of structures and activities at national, regional and global scales.
Through their capability of taking into account diverse controlling factors, and on the
basis of the wide scale of interactions and forcings that can be taken into account,
such foresight undertakings are becoming essential tools in projecting a country’s
needs in the long-term, and in directing synergies towards common and holistic
goals.
Within Biotechnology Pilot project special emphasis will be placed on strategic
questions relating to the future of the Biotechnology sector, and the identification of
likely impacts and forcings that will shape the evolution of local socio-economic
trends. In addition, it is deemed pivotal to promote public understanding on the
importance of the Biotechnology sector to our economy, and to exploit potentialities
through the realisation of private-public partnerships to enable the targeted
achievements.
A core group will work with your inputs to prepare the Biotechnology Vision
Document. A first draft of the document will be presented at an international
conference to be held in Malta next November. The Final Document, to be prepared
by the end of the year, will give a comprehensive vision of the future of the
Biotechnology sector in Malta, and serve as a common basis for future direction and
coordinated initiatives.
It is furthermore the goal of this Biotechnology Pilot Project to render a service to
other local cross-cutting interests/initiatives, and to use the initiative as a catalyst and
framework for the exchange of views between local interested parties, as well as to
stimulate concerted planning activities in the Biotechnology sphere. For further
information please consult the project website at www.eforesee.info/malta/
Page 76
Notes on the Completion of the Biotechnology Research and Development
Questionnaire
Please answer all questions.
PLEASE RETURN THE COMPLETED QUESTIONNAIRE WITHIN TWO WEEKS
OF RECEIPT. If you are unable to do so, please inform us of the expected completion
date. If you require assistance in the completion of this questionnaire or have any
questions, you are kindly requested to contact Dorita Galea, tel: 79392887, e-mail
address: [email protected]
Your best estimates are satisfactory when precise figures are not available. Your
estimates will be better than ours. If you are filling a consolidated return for two or
more related companies please ensure that consolidated figures are used for all
questions (e.g. revenues, employment, R&D expenditures, technology payments).
This reporting unit, as used in the questionnaire, covers groups of related companies
when consolidated return is filed.
1.
Definition of Biotechnology
Biotechnology is defined as any technological application that uses biological
systems, living organisms, or derivatives thereof, to make or modify products or
processes for specific use (Convention on Biodiversity UN, 1992).
2.
Full-time Equivalent (FTE)
R&D may be carried out by persons who work solely on R&D projects or by persons
who devote only part of their time to R&D and the balance to other activities such as
testing, quality control and production engineering. To arrive at the total effort
devoted to R&D in terms of manpower it is necessary to estimate the full-time
equivalent of these persons working only part-time in R&D.
FTE = Number of persons who work solely on R&D projects + the estimate of time of
persons working only part of their time on R&D.
Please base your calculations on a 40-hour week.
Example calculation : If out of 5 scientists engaged in R&D work, one works solely on
R&D projects and the remaining 4 devote only one quarter of their working time to
R&D, then FTE = 1 + ¼ + ¼ + ¼ + ¼ = 2 scientists.
Staff may include supporting staff, such as technicians and technologists. These are
technically trained personnel who assist scientists and engineers in R&D, e.g.
chemical technicians, draftspersons.
3.
Research and Development
Research and development (R&D) is defined as experimental or theoretical work
undertaken primarily to acquire new knowledge, without any particular application
or use in view; original investigation undertaken in order to acquire new
knowledge, primarily directed towards a specific practical aim or objective;
systematic work, drawing on existing knowledge gained from research and practical
experience, that is directed to producing new techniques, products and devices, to
implementing new processes, systems and services, or to improving substantially
those already produced or installed.
Routine activities where there is no appreciable novelty or problem resolution are
not considered to be R&D for the purposes of this survey.
R&D includes basic and applied research in the sciences and engineering. It also
includes design and development of new products and processes and enhancement
of existing products and processes.
Page 77
R&D includes activities carried on by persons trained, either formally or by
experience, in the physical sciences such as chemistry and physics, the biological
sciences such as medicine, and engineering and computer science. R&D includes
these activities if the purpose is to do one or more of the following things:
• Pursue a planned search for new knowledge, whether or not the search has
reference to a specific application. (Basic Research)
• Apply existing knowledge to problems involved in the creation of a new
product or process including work required to evaluate possible uses.
(Applied Research)
• Apply existing knowledge to problems involved in the improvement of a
present product or process.
• (Development)
• Research and development includes the activities described above whether
assigned to separate R&D organizational units of the company or carried out
by company laboratories and technical groups not part of an R&D
organization. Reporting the R&D activities of such latter groups may require
the use of estimates for some of your responses.
Activities to be excluded from R&D are as follows: research in social sciences or
psychology, routine product testing, geological and geophysical exploration
activities and technical services.
4.
Framework Programme for Research & Technological Development
The Framework Programmes are the European Union’s main instrument for the
funding of research in Europe which aims to involve Europe’s research and
scientific networks to transform the EU into the most dynamic and competitive
knowledge-based economy in the world. The Commission is committed to
promoting partnering and collaboration.
Seven key areas have been chosen for the advancement of knowledge and
technological progress within the sixth framework programme (FP6), and over 12
billion Euros are being allocated to them so as to achieve the largest impact
possible. These areas are genomics and biotechnology for health, information
society technologies, nanotechnologies and nanosciences, aeronautics and space,
food safety, sustainable development, and economic and social sciences.
The main focus of FP6 is the formulation of a European Research Area, aiming at
scientific excellence, improved competitiveness and innovation, by promoting
increased co-operation, co-ordination and greater reciprocation at all levels.
Management methods and procedures have been clarified so as to increase
efficiency and impact on the scientific and technological front. The main priority
is the cohesion of activities.
Networks of excellence and integrated projects have been developed, which will
give the EU activities more impact and bring about a stronger structuring effect
on research conducted in Europe. FP6 makes it possible to assemble masses of
resources, co-ordinate national research efforts and expand support activities,
such as the mobility of researchers, research infrastructures and issues of science
and society.
5.
The European Research Area
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The concept of a European Research Area (ERA) was proposed by the European
Commission in January 2000, in its Communication “Towards a European Research
Area”. The ERA was then launched in March 2000 at the Lisbon European Council
and has since received the support of the European Parliament, the Economic and
Social Committee, the Committee of the Regions, the Member States and Associated
States. The establishment of the ERA is Research Commissioner Philippe Busquin’s
chief objective.
Research and its end-products are beneficial to a country’s economy. Although in
many areas of research, science and innovation, European teams are often in the lead,
in many other fields, competition from other major countries is becoming
increasingly overwhelming. There is a pressing need for the establishment of the
ERA mainly because research funding (both public and private) is lower in Europe
than in competing countries, and currently, European research activities are
fragmented, with most research being carried out in the framework of national and
regional programmes. Since there is no coherent Community research policy as yet,
many projects are carried out in duplicate, and other important areas are ignored.
Many of the problems which need to be tackled, such as climate change, are panEuropean in nature, and require a co-ordinated approach by all the Member States.
The questions and challenges of the future cannot be met without the integration of
Europe’s research efforts and capacities, and this is the concept of the ERA. There are
three main objectives in the concept of the European Research Area:
The creation of an “internal market” for research, within which researchers,
technology and knowledge will be able to move freely. This will lead to
increased co-operation, more competition and better allocation of resources.
Improving co-ordination between national research policies and activities.
The development of a European research policy which covers funding matters
and broader issues such as the role of science and technology in society.
Activities are currently underway in many areas, including benchmarking of
national policies, mapping centres of excellence, research infrastructures, private
investment in research, electronic networks for research and issues relating
science and society. In some areas Europe-wide fora have been set up to bring
together actors from the public and private sectors. The scientific community and
industry have spontaneously set up initiatives to further the aims of ERA.
National research organisations are forging and strengthening links with one
another, and setting up exchange programmes for researchers
The ERA is well on its way to becoming a reality. In areas where Member States
are involved, real steps forward have been made. Similarly, progress has also
been made in areas which are well defined and where action is already taking
place at the local level.
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Annex 5:
Abbreviations
AAC
DNA
eFORESEE
Associate, Acceding and Candidate Countries
Deoxyribo Nucleic Acid
Exchange of Foresight Relevant Experience among Small European and
Enlargement countries
European Agency for the Evaluation of Medical Products
Edible Oil Refinery Company
Environmental Protection Agency
European Research Area
Employment and Training Cooperation
European Union
Food and Drug Administration
Foreign Direct Investment
Federation of Industry
Fifth Framework Programme of the European Community for research,
technological development and demonstration activities
Fulltime Equivalents
Gross Domestic product
Genetically Engineered
Genetically Engineered
Genetically Modified
Genetically Modified
Genetically modified Organism
Institute of Benthic Algae Research
Institutional Biosafety Committees
International Centre for Genetic Engineering and Biotechnology
Information Communication Technology
Institute for the Promotion of Small Enterprises
Kordin Business Incubation Centre
Malta College for Arts, Science and Technology
Malta Council for Science and Technology
Malta Development Corporation
Malta Environmental and Planning Authority
US National Academy of Sciences
National Institute of Health
National Statistics Office
Research and Technological Development
Recombinant DNA Advisory Committee
Research and Technological Development
Research Technology and Development Initiative
Science and Technology
Small and Medium Sized enterprises
Science Technology Innovation
Strengths, Weaknesses, Opportunities and Treats
United States Department of Agriculture
EMEA
EORC
EPA
ERA
ETC
EU
FDA
FDI
FOI
FP5
FTE
GDP
GE
GE
GM
GM
GMO
IBA Ltd
IBCs
ICGEB
ICT
IPSE
KBIC
MCAST
MCST
MDC
MEPA
NAS
NIH
NSO
R&D
RAC
RTD
RTDI
S&T
SME
STI
SWOT
USDA
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Annex 6:
Dates of Pilot Meetings
17th July
Panel B meeting
18th July
Panel A meeting
28th July
Launching seminar
4th Sept
Panel A meeting
16th Oct
IP
and
Patenting
informative
discussion
with
stakeholders
Page 81
Annex 7: Launching Seminar Speeches and Newspaper Letters
Hon. Minister Louse Galea – Minister for Education
Launch of eFORESEE Malta Biotechnology Pilot
It is with particular interest and pleasure that I am participating in this opening
session to launch the Biotechnology Foresight Pilot, the last of the three pilots being
implemented as part of Malta’s participation in the EU-funded Fifth Framework
Project project, eFORESEE. The eFORESEE Project is a strategic initiative for Malta
which presents a challenge. It forces us to think again about how we best to
formulate strategic national policies and strategies: Are we involving all the
stakeholders? How should we consult them? Are we thinking in a long-term context
or are we constrained by the here and now? Are we preparing for the future? Are
there ways that we can move from consulting the stakeholders to involving them
actively in ownership and implementation? These are the core challenges of the
project. It is significant and important that the Malta Council for Science and
Technology is coordinating this initiative in Malta, given the need for such
approaches in the area of science, research and innovation.
These approaches are particularly important when strategic policy decisions have to
be taken as Malta makes the transition to the globalising knowledge-based economy
and prepares for EU membership. Foresight can play an important role in helping us
to address the challenge of competitiveness through appropriate and targeted
investments in research and innovation. But beyond this, foresight provides the tools
for optimizing the impact of these investments by ensuring that they are
implemented efficiently and effectively. Foresight’s identification and involvement of
key stakeholders at different levels (the design, implementation and take-up of the
Strategy) allows a “whole of country” approach. This ensures that policies are
formulated across Ministries and sectors and involve consultation down to the
community level.
Foresight has been used in other countries worldwide for different purposes, for
identifying emerging niche areas at the technology frontier, deciding on priorities for
research funding,… but the focus is always on the future impact of science and
technology on the economy and society. The fact that science, technology and
research and innovation, are now recognized as key drivers of competitiveness, has
raised the relevance of foresight within the EU and worldwide.
In the year and half since Malta has been participating in the eFORESEE Project, it
has generated a significant learning curve in carrying out foresight exercises. The
experiences are now being used to inform the design and implementation of this
biotechnology pilot.
Biotechnology has been identified by MCST and Malta Enterprise as one of the areas
to be considered for further national investment in terms of research and innovation.
The EU is also focusing on biotechnology as one of the most promising of the frontier
technologies for helping Europe to compete economically with the US and Japan.
Such visions and ambitions require substantial investments of resources in research
and innovation based on well-targeted policy measures. The social and ethical
context of research in life sciences and biotechnology must also be given particular
attention, since public opinion has become critical in this area, as has been witnessed
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in recent years with the controversy over Genetically Modified Food which
prevented its take-up in Europe. Other more serious ethical considerations in
relation to cloning and stem cell research among others need to be given serious and
careful attention. The biotechnology sector presents in this sense a good case study
for foresight since “scientific and technological progress in these areas raises difficult policy
1
issues and complex regulatory challenges”
These important issues which affect our future and the future of our children require
serious and extensive dialogue and consultation so that all opinions are aired and
visions shared for an optimal future. Beyond this, it is clear that single efforts are not
enough, and we need to build of synergy of efforts and resources to bring together
the best brains to formulate optimal policies and find effective ways for
implementing them. What are the public-private sector partnerships that could be
generated in this area to promote the biotechnology industry in Malta? What are the
drivers that are critical for bringing this about? What action do we need to take now
to ensure that we have a thriving industry by 2015? The vision and strategy is at the
interface of two Ministries, Ministry of Education and Ministry of Finance and
Economic Affairs and I am happy to see this collaboration reflected in this launch
event and even in the way the pilot is being designed and the experts being involved.
It is also important that the pilot’s perspective is broad, taking into account the
emerging global, Euro-Mediterranean as well as European scenario. This broad
perspective will be particularly important for the final eFORESEE conference which
will be taking place in Malta between 12-14 November on the theme “Exploring the
Role of Foresight and similar policy tools in building the Euro-Mediterranean
Research and Innovation Area”
I congratulate you all on taking up this challenge, not an easy one, and look forward
to receiving the results of your work.
Speech by the Hon. John Dalli, Minister for Finance and Economic Affairs
Realising a Thriving Maltese Biotechnology Industry by 2015
eFORESEE Malta Biotechnology Pilot Project – Launching Seminar
Monday 28th July 2003
The prosperity of a nation is dependent on its ability to create value, that is, its value
added. Thus increased prosperity can only be sustained by the production of higher
value added products. Innovative products have a high value added as they can
command higher prices due to their scarcity. Therefore, increased prosperity needs
to be continuously fuelled through innovation.
NSO is currently working in order to compile a full set of economic indicators, as
complete innovation benchmarking is not yet possible. However, statistics on the
local business community published lately by NSO indicate that Malta’s innovative
base is very weak. Employees with higher education constitute only 4 % of total
employees in Malta. On the other hand these constitute 13.5% in the EU-15 with the
highest percentage reaching 20.9% in Sweden and the minimum being 6.6% in
Austria. The number of employees with higher education gives an indication of the
innovative capacity of companies though not a full picture. The NSO survey also
1
European Commission: Life science and biotechnology – A Strategy for Europe (2002) COM
(2002)27
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reveals that only 19.2% of the interviewed enterprises introduce new or significantly
improve products and only 14% introduce new or significantly improved production
processes. The sectors that contribute mostly to innovation are the manufacture of
radio, television and communication equipment and telecommunications. When
asking about the factor hampering innovation activity, the majority of companies felt
that innovation is not important for their product.
The Government has laid down a number of incentives to spur research and
development. During the last budget speech it was announced that 150% of the
expenditure on research and development could be decreased from taxable income.
The Business Promotion Act also gives special tax incentives to companies that set up
to undertake Research and Development. Companies in the Biotechnology sector
qualify for these special tax incentives. Research and development also qualifies for
investment tax credits.
The Government is also helping start-ups in innovative sectors as Biotechnology
through the provision of the Kordin Business Incubation Centre (KBIC) and the
Technology Venture Fund, which are both aimed at highly innovative and
technological projects.
The KBIC provides physical space and technology
infrastructure in a convenient, yet low cost location, along with high speed internet
access to its clients, making KBIC an ideal place to nurture, grow, and launch
technology oriented businesses. It also provides access to finance, the expertise and
the objectivity necessary to refine the venture’s vision, assist in the development of
its business model, and build its teams. The KBIC also offers the necessary training
and mentoring to enable each enterprise to manage its business effectively as well as
networking opportunities. The Technology Venture Fund provides venture capital
for high technology projects. These initiatives are already being availed of by a small
number of companies in the Biotechnology sector.
Incentives need to be complimented with a sound administrative structure. We have
just passed the Malta Enterprise Act through Parliament. Through this act these
three entities will be merged together in order to create an efficient one-stop shop for
the business community. Malta Enterprise has been entrusted with the focus on and
continuous reassessment of niches that Malta is best suited to serve. Malta
Enterprise will also market Malta as an ideal location for investments in these niche
areas. Malta Enterprise will influence all services that have a bearing on industry
competitiveness as the educational institutions. The Omnibus Act, which has also
just been passed through Parliament, brought our Patent legislation in line with that
in the EU.
Thus a lot of effort is being channelled to create an environment that is friendlier to
high technology ventures. Of course, a lot still needs to be done and all these
initiatives need to be further refined and marketed in order to spur increased
innovation capability in Malta.
Increased Research and Development and
innovation are a EU wide challenge.
One must welcome foresight initiatives as the one which is being launched today as
only through such exercises can be prepared for the challenges ahead in order to
transform them into opportunities.
Prof. Roger Ellul Micallef – Rector University of Malta
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The University is not only a major stakeholder in biotechnology but also perhaps a
unique one. The Biomedical Sciences at the University have been an area of
excellence enjoying an international reputation since the mid sixties. Together with
Biotechnology they have been a priority target since the late eighties and will
continue to be so, as may be seen from the University's current Strategic Plan.
Considerable funds have been invested over the last ten years, funds coming mainly
from Government, from the Italian protocol and through participation in the EU
framework programmes. Unfortunately comparatively little funding has been made
available by private industry.
New well equipped laboratories, staffed by fully qualified research workers are
presently carrying out high quality work especially in the fields of cell and molecular
biology and genetics. A number of PhD students have completed their studies in our
departments, some of whom are occupying important positions in other European
Institutions.
Clearly the University has two main interests in the field of Biotechnology; an
educational one, in providing the country with the experts it requires and, of course,
in that of Scientific Research, Technological Development and Innovation.
Greater emphasis worldwide, but perhaps even more in the EU countries is being
given to the teaching of science. Science education in undergoing extensive reform in
order to attract to it as many students as possible. The recent changes in our
National Minimal Curriculum have been an important step forward in promoting
science education in Malta. But there is more to be done. The number of doctoral
level research scientists we produce is only about 1/10th of the number graduating in
other EU countries. It is obvious that a properly funded graduate education
programme is essential to increase numbers. On assuming the Rectorship of the
University in 1996 Prof Ellul Micallef proposed that a National Research Council be
set up an he put the proposal before us again.
Increasingly University has began to play a critically important role in certain areas
of the "Knowledge Economy" such as Computer Science and Artificial Intelligence,
Microelectronics and Material Science. They are now part of our Economic
Restructuring. Naturally, for them to flourish, adequate financial investment is a sine
qua non.
He claimed that he is looking forward to reading the policy document at the end of
the Project.
His Excellence Vincent Fean - British High Commissioner
His Excellence Vincent Fean said that he looks forward today to learning about the
scope for mutually beneficial co-operation between Malta and the United Kingdom
in the exciting, fast-moving field of biotechnology. He wished Prof Alex Felice,
Chairman of the e-Foresee Biotechnology project for Malta, continuing success with
the development of a biotech strategy for Malta in the EU.
This was followed by an outline of pharmaceuticals/biotechnology investment by
UK. He said that the pharmaceutical sector in the UK employs almost 60,000 people,
and half of what is produced in the UK goes for export. The UK was the world’s
largest exporter of pharmaceutical products in 2002.
He also stated that biotechnology is the next wave of growth in the knowledge-based
economy. The UK biotechnology sector is now the largest in Europe, with almost 500
Page 85
companies, producing over 40% of the biotechnology drugs presently in Phase III
clinical trials. On the latest figures available, for 2001, R & D spending in the UK was
over 1.7 billion euros: more than the rest of Europe put together.
He also said that like the Government of Malta, the UK Government is committed to
encouraging scientific development. Both countries share the same policy on tax
incentives in this key area. The UK is pledged to increase funding for science by 10%
year on year in real terms, aiming to reach 4.7 billion euros by 2005/06. UK has 10%
of the world share in R & D, thanks to companies such as Glaxo Smith Kline. He also
sated that he is keen to learn about the scope for synergies between activity in the UK
and activity here in Malta. Ideas on how to harness EU funding for joint research
work will be most welcome. The British delegation in Malta will work closely with
Malta Enterprise, now up and running.
Page 86
The Times Friday August 29, 2003
Editorial
The coming of age of biotechnology
Perhaps the most outstanding phenomenon in science during the latter half of the
20th century has been the unparalleled developments in biology and biotechnology.
The rate of development of techniques to resolve the most intricate mechanisms of
the body has exceeded all expectations and has enabled the unravelling of the genetic
make-up (genome) of humans and other animals.
Biotechnology now is involved in the creation of new products (e.g. GMO’s –
genetically modified organism), the diagnosis of a large number of genetic disorders
opening the possibility of replacement of defective genes, and has even infiltrated
into the law-courts involved in solving complex forensic dilemmas.
How prepared are we in Malta to take advantage of such technology? It is obviously
important that Malta does not slide into a stagnant backwater. What is required is
the availability of energetic individuals who possess the right scientific background.
Unfortunately, however, in Malta the training of scientists has lacked behind that in
other spheres of knowledge. There has been a relatively low number of students
taking science as a profession. Over the past decade, the total number of university
students has increased eight-fold, whereas the number of science students has only
doubled.
It is therefore opportune that his topic was aired and emphasised at a recent launch
of a biotechnology pilot project at MCST in Kalkara, which admitted that Malta has a
‘very weak innovative base’. Unfortunately, there are few incentives for young
Maltese men and women to choose science as a career.
It is encouraging therefore to see that biotechnology has been identified by MCST
and Malta Enterprise as one of the areas to be considered for further national
investment in terms of research and innovation. The EU is strongly supportive of
biotechnology. The so called Fifth framework project encourages collaboration
between European states. In Malta, eFORESEE is now joining with Cyprus and
Estonia to take part in this programme.
Deciding which of the many facets of biotechnology should be encouraged is not
going to b easy. On the other hand there are multiple international governmental
and private business enterprises overseas who are already miles ahead, and who
would present a formidable challenge to a budding industry in Malta. On the other
hand, one should not be too pessimistic about the role of a tiny country like Malta.
Precedents do exist. For instance, remarkable progress has been made in the
computer industry which a decade ago was in its infancy. The same may be said
about the electronics and telecommunication industry.
It is envisaged that Malta should reach such a target by 2015. While this is not
impossible, it will take a most concentrated effort to build an infrastructure, starting
with a veritable revolution in the approach to science studies from an early age,
through university and beyond. It requires a modification of the current mind-set of
both leaders in education and in industry to appreciate that there is a booming future
in biotechnology.
Getting an EU grant to liase with other EU countries in a relatively minor project is
certainly not sufficient by itself, but it is a step in the right direction.
Page 87
Times of Malta – Managing the new biology
Wednesday 17th September 2003
Pierre Schembri Wismayer
On Friday August the 29th, the Times ran an Editorial called - “the coming of age of
biotechnology”. It expounded to educators and policy makers alike, the interesting
wake-up call being highlighted by the MCSTs EU-funded foresight exercise.
Biotechnology has come of age indeed, but this was a while ago. It is already
contributing large chunks to the economies of first and third world nations. One
public piece of evidence was the America’s cup – the most expensive sporting event
in the world, won by a boat owned by a Swiss Biotech billionaire.
Will Biotech ever play a useful part in the Maltese economy?
In order to increase biotechnology in Malta, one necessity is a good output of highly
trained and technologically skilled science graduates and post-graduates. Companies
do not want to have to train their recruits from scratch.
In summer 1994, whilst studying towards my PhD in Scotland, I sent a letter relating
to the need of the University of Malta to specialise in certain key areas of postgraduate education/research. I sent this letter to various local authorities, including
the then rector, health and education ministers and the MDC. At the time, I had
suggested a couple of potential niches. These were biotechnology (which I supported
by an article from the Financial times which said that biotechnology was already the
fastest growing industry in the world), and renewable energy engineering. I received
one recognition of my letter from the MDC and none from any other authority.
Ten years down the line, the potential of biotechnology in Malta is largely
unrealised. The number of science graduates and post-graduate students exiting our
university is very low. The university employs many of its non-medical science postgrads to teach biochemistry and genetics to medical doctors who generally avoid a
research-based career. On the other hand, the biology BSc is generally very light in
areas are exploding, whilst is very heavy on classification, marine biology and
ecology.
I have absolutely nothing against Marine biology, where Maltese
biotechnology may corner part of the niche market, capitalising on local expertise.
However, the major areas of the new biology can be identified by the titles of the
new Nature journals which have mushroomed in the last few years – Cell Biology,
Neuroscience, Genetics, Immunology, Biotechnology, Structural Biology. None of
these elements presently occupy pride of place in our biology BSc course. Nor does
the associated area of Bioinformatics, an area where we can rope in Maltese
computing skill to help wade through some of the masses of information thrown at
us by a decade of high speed sequencing.
It is no use having a biology degree creating mainly teachers and marine biologists,
whilst biotechnologists teach doctors who are unlikely to follow the option of such a
career. How best can one maximise the benefits and minimise the costs? - through
sharing of resources! One option is to create a new Faculty of Biotechnology,
serviced by other departments. Another is to or to fuse the pre-clinical medical
sciences and the biology dept into an Institute of Biomedical Sciences, servicing
both the faculties of Science and of Medicine & Surgery.
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Has biotech industry made any inroads at all into the Maltese economy? It has – just
about. Synergene Technologies Limited has set up shop offering contract DNA
sequencing to International labs and genetic identification services.
More importantly, Charles Saliba has shown, with his companies InCyte
Pharmaceuticals and IBA that it is possible to succeed with very little resources in
our small island, having adequate training and using one’s own entrepreneurial skill
to develop an idea. An important benefit of biotechnology is that with relatively
little money, ideas can be used so as to attract investment and realise a new company
creating new, knowledge based wealth. As Charles Saliba has succeeded, others can
too, with basic training and a suitable package of incentives from Malta Enterprise,
MDC’s successor. Regarding the latter, a panel of experts from the MCST foresight
exercise are already working on recommendations.
In order to create such an output of new graduates and biotech entrepreneurs, the
University of Malta needs to invest in Science. Just as Malta is encouraging girls to
follow a science career with Michelle Grech’s posters, it needs to provide education
facilities to train these scientists of tomorrow. Science education needs labs,
expensive equipment and experienced trainers. This is a heavy investment, but it is a
necessary one. It may require a relative shift of funding away from the arts and
toward the sciences as is being done in many universities in the UK.
Arts can contribute to the economy - we already compete on a world market when it
comes to the teaching of English as a foreign language. Maybe we should look into
teaching Arabic in the same way.
However, the world is heading into an always more knowledge-dependant
economy. Science (and in particular biology) will be driving much of this economy
in the future. The human genome project is only the first step. The large bulk of
biological knowledge and application is still waiting to be unravelled and
understood. This is not about GMOs only, not at all. It is about possible new
treatments for an ageing population, about new detergents for washing machines,
about degradable bio-materials made by microbes, about new ways of
bioremediation, helping remove toxic and non-toxic waste, about new biocomputers, new ways of harnessing energy. The possibilities are endless.
Investment in engineering (largely driven by the colonial need for training as a naval
base) helped prepare us for business in the last century, the century of Physics and
Chemistry, attracting the likes of ST Microelectronics and Brandstatter.
The present century has been dubbed, across the world as the one of Biology and
Bioinformatics. Today, we make the choices. Will we make the right ones? Will we
have the skills to compete?
Times of Malta – Knowledge-society and chattering nature
Thursday 25th September 2003
Ranier Fsadni
Every parent develops repertoire of threats and incentives with which to deal with
children reluctant to go back to school. I am afraid this article will not enrich that
repertoire. The reasons for going to school and university remain pretty much the
same ones that have been around for decades.
Page 89
What I want to do is raise two questions. What happens to society when knowledge
is characterised by frequent discovery and rapid dissemination? What happens to
knowledge when different kinds of social institutions – industry, medicine,
government, family etc – are organised around it?
One answer would focus on the people you need to produce this knowledge and
then to handle it. In an age dominated by information science and biotechnology, it
is tempting to think that the balance tilts in favour of people trained in the sciences,
rather than the arts. But I believe this would be a mistake.
It is a mistake that even some smart people make. For example, writing in this
newspaper last week Pierre Schembri Wismayer made an acute argument for the
planned development of a Maltese economy based on knowledge (especially that of
biotechnology). But when he mentioned the arts in the context of a ‘knowledge
dependent economy’, he placed them very much second-place in importance to the
sciences.
But this is not what a number of people (like Charles Leadbeater, Fernando Flores
and John Gray) who have studied knowledge-enterprises are saying. On the
contrary, they argue that knowledge-based economies require an education that
trains people in the interpretive arts – the kind of training in listening to people’s
narratives and attention to the shape of their lives that a good education in
philosophy, history, literature, etc can give you.
How come? For a start, take what happens to society when knowledge is
characterised by frequent discovery and rapid dissemination.
This kind of world is not simply one where scientists slave away to get nature to
whisper its secrets. Once nature whispers, what it said changes our lives – our
identities and their meanings.
If the Bible portrays a world where God is talkative (all those signs, instructive
plagues, and miracles), knowledge – society is a world where Nature is garrulous. It
just cannot stop whispering.
And its chatter is doing radical things to economies – not just to what new products
come on the market, but also to how work is organised, how people buy and sell,
how they spend, save and plan, and to all those things that give meaning to people’s
economic participation.
It is an economy of constant change and so a world where the possibility of failure is
always around the corner; just because one successfully adapted yesterday does not
mean one will manage tomorrow.
Such a world is full of moral hazard. The meaningfulness of one’s life-story is under
pressure to become a life experienced as a series of disconnected short stories, a life
that escapes one’s control as one moves from project to project.
Mr.Flores and Mr.Gray argue that today business design, the skills of team-building,
and entrepreneurial innovation all involve a certain kind of intelligence that is
informed by the arts of interpretation – listening to what people say about their
identity, where their lives are in disharmony. One might add that even the care of
persons in knowledge-society – and welfare is not divorced from the economy –
requires these arts.
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In short, you still need people with a cultural training to tackle the culture of a
knowledge-based economy – not only but not least to address issues that are vital to
that economy. Yet the relevance of the arts is there even when one considers what
happens to knowledge when society is organised around it.
A multi-disciplinary approach that includes the arts is needed for the production of
21st century knowledge. There is a great awareness, nowadays, that knowledge
consists not only of the object of discovery, but also of the intellectual tools used to
probe it. The intellectual tools would include the language, media of communication
and means of persuasion of a particular discipline.
This is a difficult argument, but a simple illustration might help. When a scientist
like Richard Dawkins said that the human body is a ‘machine’ for the replication of
genes, he is not using the metaphor simply to clarify what he is saying. His machine
metaphor actually shapes the way he thinks about things.
Metaphors are incidental to the validity of scientists’ experiments. But they are not
incidental to the directions taken by scientists’ thought (or to the popularisation of
their ideas). Think of Einstein’s refusal o believe that God ‘plays dice’ with the
universe. These metaphors grip the imagination, cast a spell on it, and can have a
formative influence, for better or worse, on the direction of research.
What is true of metaphor can be enlarged to encompass language. And that is the
reason why the production of 21st century knowledge calls for people whose training
has alerted them to the ways in which language and stories can bewitch thought –
the thought of scientist as much as anyone else’s.
Times of Malta - Bioinformatics
Friday 26th September 2003
Neville Calleja
I have followed the editorial of August 29 and Pierre Schembri Wismayer’s ‘Opinion’
(September 17). Being a medical statistician, I strongly believe that bioinformatics is a
field to which Malta can contribute greatly.
Our population, being small, lends itself very well to the establishment of databases.
Other countries’ national statistics offices can only dream of having a central
relational database similar to what the Government of Malta started up a few years
ago. This resource alone is priceless for research in the Maltese nation’s genetic
make-up and consequently, to the global community. Moreover, there is enough
expertise in the mushrooming IT industry in Malta to be able to cope with the
technical aspects.
In addition, our population has a number of medical conditions or variants that
occur more frequently than in other countries. Clear examples would include
diabetes and thalassaemia. Experts in the field will surely volunteer a number of
other conditions. Given the ease of applying bioinformatics to the population, Malta
would be fertile ground for research, both academic and industrial, into these
genetically influenced diseases.
What can be applied to the human population may also be applied to other species,
plant and animal.
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In summary, one must understand this potential characteristics that the Maltese
population possesses – manageable size. With the right ethical considerations to
ensure anonymity, this could work out to be quite a profitable quality.
At this point, I hope to provoke discussion among readers, scientist and ethicists
alike on this subject.
The Times of Malta - The ‘new biology’ and the biology department
Thursday, October 9, 2003
Victor Axiak
Prof. Axiak is head, Department of Biology, University of Malta
The aim of the Department of Biology at the University of Malta is to provide our
students with the best possible teaching programmes so as to give them a sound
background to the subject as well as to provide them with the necessary skills to
enable them to effectively contribute towards Malta's changing needs and
requirements.
All this is to be achieved within very tight constraints of financial and infrastructural
resources. Pierre Schembri Wismayer has recently given us a gratuitous opinion
("Managing the new biology", September 17) on whether or not the Department of
Biology is achieving its aims.
The fact that Dr Schembri Wismayer is not a graduate of the Department of Biology,
has never visited the department, has never participated in any of its activities and
has never discussed the matter with any members of its academic staff is besides the
point.
I firmly believe that being a public-funded entity, my department must stand up to
public scrutiny at any time and must be able to adapt itself whenever and wherever
the need arises. However, if any criticism is not based on solid facts, then it is bound
to be counter-productive and will fail to produce the desired results. So, let's get the
facts right.
Since its reconstitution in the late 1980s, the Department of Biology has been offering
a joint biology/chemistry B.Sc. degree as well as postgraduate degree programmes
up to doctoral level.
The first group of B.Sc. graduates terminated their studies in 1990. While every effort
is made to address the most relevant and newly emerging aspects of the subject at
any time, the compromise with maintaining a fairly broad base in the biological
sciences has to be constantly kept in line with the needs of a small country such as
Malta.
We do not produce "mainly marine biologists and teachers", as Dr Schembri
Wismayer suggests. We produce graduates with a broad overview of all of biology,
which they can apply to any field, including biotechnology, fisheries, agriculture,
environmental protection and management, conservation of biological resources and
biodiversity, microbiology, marine biology and a whole list of other fields!
We can only hope to satisfy Malta's diverse requirements in the biological sciences by
avoiding the type of specialisation in any single field, as Dr Schembri-Wismayer
suggests, while at the same time equipping our graduates with the necessary basic
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skills and approaches that allow our graduates to specialise in particular fields if they
so wish.
Have we succeeded in doing this? We are currently building a database on our past
students that includes information on their employment profile and posts occupied.
Some very interesting results are already available.
Since 1990, over 240 students graduated in biology and chemistry. Of these, almost
70 per cent chose to take up an elective project in biology during their final year; 31
per cent of them continued for a Masters degree, while almost 16 per cent followed
(or are following) Ph.D and M.Phil. courses at our university or elsewhere.
This brings the total percentage of graduates with first degree in biology who take up
postgraduate studies to 47 per cent! Evidently, postgraduate courses by their very
nature must be highly specialised and there is every evidence to prove (including
external examiners' reports) that the graduates we are producing have absolutely no
difficulty in following such more advanced courses with great success.
Of all biology elective students to date (those that carry our a final year research
project in biology), preliminary data shows that about 24 per cent took up a teaching
position; 28 per cent went to private industry; 19 per cent are in academia/research
at our university and elsewhere and 26 per cent have taken up key scientific
administrative jobs with various government departments and authorities (fisheries,
agriculture, the Water Services Corporation, the Malta Environment and Planning
Authority, the Malta Resources Authority, the Drainage Department, etc.).
Incidentally, four have taken up a religious vocation.
We are producing mainly teachers and marine biologists, aren't we?
Now, what about biotechnology? We fully recognise the fact that this should play a
much greater role in our economy and it is certainly not any fault of my department
that the situation is as it is.
I am sure that Dr Schembri Wismayer is aware of the fact that he works in
laboratories which are in good part staffed by our graduates. He has singled out
Charles Saliba as one who with his biotech companies has shown that it "is possible
to succeed with very limited resources in our small island, having adequate training
and using one's own entrepreneurial skills to develop an idea". Excellent!
As Dr Saliba would be the first to acknowledge, it was through the Department of
Biology that in the first instance the companies mentioned were attracted to Malta.
This, in turn, paved the way for the developments mentioned through continuous
and close collaboration with the same department and, no doubt, others, given the
need for an interdisciplinary approach.
A significant amount of R & D data generated by these companies is through
research students registered with the Biology Department. So, we are doing it right
after all!
Before I conclude, I would also like to mention the fact that all of the five full-time
members of academic staff in my department are actively involved in research fields
which are directly relevant to Malta's needs.
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These include fisheries biology and marine aquaculture; marine pollution and
environmental quality; local flora, fauna and ecology; population genetics;
assessment of biodiversity and conservation of biological resources.
Our students actively participate in our research programmes. This has greatly
helped their academic preparation as well as professional skills which will serve
them in good stead when they go on to occupy key positions within the private and
public sectors.
It is sometimes claimed that research at the University of Malta is not sufficiently
well publicised and that research data and results are not accessible to the potential
end-user. While there may be some truth in this claim, I believe that for the past 10
years the Department of Biology has done its utmost to publicise its research data
and information, both through publications in peer-reviewed journals as well as
through its annual biological symposia and the associated abstracts booklets that we
produce. I hope to see Dr Schembri Wismayer at our Biology Symposium 2003, to be
held on December 6.
Certainly, there is room for improvement in our teaching and research and we are
currently going through an internal exercise of restructuring our B.Sc. (Hons.) degree
programme.
As head of department, I welcome any contribution to such an exercise, provided
that it will be translated into real benefits to our students and our country and not to
the sort of "forced marriage" that is being advocated by Dr Schembri Wismayer.
At a time when the university authorities instruct us to utilise only a certain
percentage of our (already low) recurrent funds, we would be more than glad to
make use of all possible laboratory and other resources from other faculties. This
makes economic sense.
We also support Dr Schembri Wismayer's plea to the university (and to the
government) to invest in science and science education. In the meantime, we will
continue to fulfil our role within the given constraints. And we will do so by
avoiding any myopic vision and by producing graduates who are fully capable of
adapting to new circumstances and to satisfy the wide range of national
requirements as they unfold.
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Annex 8:
Applications of Modern Biotechnology
In the next decade biotechnology is going to reveal more knowledge in the coming
decades than all other technologies put together. This prediction arises from two
facts. First, plants and animals contain virtually infinite and evolving store of
knowledge within the genetic, biochemical, cellular and physiological systems of
each species and their ecosystems. Every plant and animal has a vast library of
biological information which can search for useful knowledge. Second humanity
now has the tools to find this knowledge and the tools to analysis and utilisation this
knowledge are now available. There has been a revolution in biotechnology caused
by a single invention, perfected in the early 1990s - automated DNA sequencing.
DNA sequencing is the basis of the science of genomics and is by far the most
significant of the tools used to obtain biotechnology data. Bioinformatics and
proteomics are by far the most important tools for analysis. The biotechnology
companies have other tools that are needed to utilise the knowledge.
MEDICAL AND PHARMACEUTICAL
1. Genomics
There are over 100,000 genes in the human body. These have all been fully sequences
by the Human Genome Project. Meanwhile biotechnology companies involved in
genomics have established major proprietary databases of EST (expressed sequence
tags) for a large proportion of human genes and are using these in association with
positional cloning strategies. ESTs are created by partially sequencing randomly
chosen gene transcripts that have been converted into cDNA. This is a simple but
enormously powerful tool from which to probe or monitor every gene. Prior to 1990
only 1,000 genes had been identified in the human genome. Within a few years EST
technology increased that number by almost two orders of magnitude. Many
companies have created vast relational databases of EST derived information
including sequence, homology, functional annotation and gene expression data.
Positional cloning aims to identify genes which are associated with diseases in
human tissues as novel targets and has led to the identification of a range of
important genes (1).
2. Functional Genomics
Although vast libraries of EST data and full length sequence data are available, only
a tiny fraction of the genes are known as to their function. The area of functional
genomics aims to identify gene function with the objective of identifying novel
targets for drug discovery. Functional genomics involves a number of different
fields. As well as the Human Genome project, the full genome of a number of
organisms has been fully elucidated. As genes are highly conserved across evolution,
the study of these simpler organisms can result in gene identification and the
corresponding gene in humans can then be identified. Gene function can also be
studied in human cells using various genetic approaches to identify function. The
process of function identification has emerged as a major bottleneck in genomics
research and there is likely to be an effort to apply here the same types of automation
which are used in gene expression.
3. Gene Chip Technology
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A key technology for genomics R&D is the recent development of gene chips. The
gene chip is a technology which permits the automation of differential gene
expression. Differential gene expression between normal and diseased cells is a key
technique aimed at identifying key disease genes. The gene chips are plastic or glass
arrays onto which large numbers of cDNA fragments have been spotted at particular
addresses. Hybridising cDNA or mRNA from the cells in question allows
identification of which genes are ‘switched on‘ through hybridisation on the chip.
One product, for instance, contains 27,000 human genes. This is a very powerful
technology which will have a major impact on many areas of biological research
including the study of diseases and drug discovery. It is also likely to have a major
impact on diagnostics. It is likely that future routine diagnostic tests on patients will,
through this technology, be able to produce a read-out of the expression levels of the
patients’ genes and rapidly identify aberrant expression levels or aberrant tissue
expression.
4. Bioinformatics
Bioinformatics is a science of recent creation that uses biological data and knowledge
stored in computer databases, complemented by computational methods to derive
new knowledge. There are a range of major public databases containing gene
sequence data and others with protein sequence data. When a novel gene sequence is
discovered, rapid progress on identifying its function can often be made by
comparing it for similarity (homology) to other sequences in the databases whose
function is known. This approach is becoming a major discovery tool. Companies
involved in this area use public databases but also have their own proprietary
databases such as the EST databases of companies such as Human Genome Sciences
and there are also databases containing the complete genomes of a number of microorganisms. The study of comparative genomes between species is rapidly advancing
and is expected to be very useful in function studies. Special software has been
developed for these homology searches and we can expect ongoing innovations in
this.
5. Transgenic / Knockouts
The ability to generate knockout mouse models has improved greatly over the past
couple of years and the service is now available commercially so that one can start
with a gene and end up with a knockout animal. The ability to achieve tissue specific
knockouts is also very important. However, despite the above, the process is
technically difficult and normally takes about one year to achieve. This time problem,
combined with its cost, means that it cannot yet become a mass screening system for
gene functional analysis. There is an urgent need here for a rapid high-throughput
system combined with rapid phenotype analysis. This is a very important area of
R&D and any research group or company which can improve on current capabilities
would have a very commercial proposition. Related to this are recent advances in
cloning especially in producing second and third generation mouse clones. These are
likely to be of considerable interest for pre-clinical research.
6. Chemistry methodologies
As with traditional drug design, combinatorial chemistry relies on organic synthesis.
The difference is the scope - instead of synthesising a single compound,
combinatorial chemistry exploits automation and miniaturisation to synthesise large
libraries of compounds. Combinatorial libraries are created by one of two methods:
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split synthesis or parallel synthesis. In split synthesis or ‘split and pool’, compounds
are assembled on the surface of microparticles or beads. In each step, beads from
previous steps are partitioned into several groups and a new building block is
added. The different groups of beads are then recombined and separated once again
to form new groups; the next building block is added and the process continues until
the desired combinatorial library has been assembled. Combinatorial libraries can
also be made by parallel synthesis in which different compounds are separated in
different vessels without remixing, often in an automated fashion. Split synthesis is
used to produce small quantities of a relatively large number of compounds,
whereas parallel synthesis yields larger quantities of a relatively small number of
compounds. These technologies are used for lead identification in screening and lead
optimisation. While huge progress has been made there are still major opportunities
to develop this technology further; these include such areas as new linkage methods,
the creation of highly diverse universal libraries, the development of new assays and
methods, the integration of combinatorial chemistry with structure based design and
probably most importantly the further integration of combinatorial methods with
functional genomics and proteomics. [3,4,5]
7. Screening & Screen Development
Screening assays in use today use recombinant cellular assays in microbial or yeast
cells. The target protein is expressed inside or on the surface of a cell and binding of
the ligand to the receptor results in intracellular changes which can be detected by
use of a reporter gene construct. For instance use of a luminescence gene will give
luminescence on binding of ligands. Other techniques in yeast can be used to analyse
biochemical pathways and determine protein-protein interaction. These techniques
are a key link in the discovery process between the identification of a target and its
protein and the use of combinatorial libraries to screen against. On-going innovation
is expected in the development of screens. It is likely that there will also be major
developments in the use of mammalian cells as assays as these are slow and costly to
operate today. [6,7,8]
8. IT/Biotech Convergence
The impact of robotics on drug discovery R&D has been very significant over the
past few years allowing the development of high-throughput screening systems to
match the flood of new chemical diversity emerging from combinatorial chemistry.
Whereas a few years ago compounds were tested in 96 well microtitre plates, today
mixtures of compounds are tested in 384 up to 864 well plates. This process of
miniaturisation is only at an early stage and R&D is currently well advanced to
develop a ‘lab on a chip‘ which would use extremely small quantities of compounds
for testing. It is likely that a significant amount of compound testing as well as
molecular biology and cell biology techniques will be automated and miniaturised
over the next decade and this will give rise to a new type of technology which will
combine elements of IT with chemistry and molecular biology.
9. Proteomics
Proteomics is the study of the sequence, function and control of expression of the
total number of proteins made by an organism. It is the name given to a renewed
interest in proteins rather than genes and the link to diseases. Proteomics uses a
combination of 2 D gel electrophoresis and high-throughput screening. However
there are many difficulties in resolution and automation of this area of R&D. There
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are many times more proteins than genes due to variations in post translational
modification and other factors and this makes the problem a huge one. The use of
mass spectrometry combined with chromatographic separation may provide a way
forward. Although this is a young field, it may have major long term potential and
importance.
10. New Diagnostic Technologies
Increasingly diagnostics will be influenced by the information and technologies
emerging from the area of genomics. Molecular biology has already had a significant
impact for instance in the widespread use of PCR in diagnostic and forensics. This
trend towards gene based diagnostics is likely to expand due to a number of factors;
the identification of genes with predictive use in disease prognosis; the identification
of disease susceptibility genes; the development of pharmacogenomics and
consequent ability to diagnose drug suitability to patient sub-populations and the
development of novel technologies such as gene chip technology. These trends may
ultimately result in rapid gene analysis technology being available to general
physicians which would have major consequences for the way in which the clinical
diagnostics market operates today.
11. Biosensors
Biosensors are devices in which a biological component, giving specificity, is coupled
with a physical detection technique to produce an electronic signal. Biological
components include antibodies, enzymes, nucleic acids, receptors and cells and the
physical component includes optical fibers, piezoelectric crystals and electrodes for
electrochemical devices. While work has been underway for about forty years only
one biosensor of note, the home measurement of glucose by diabetics, has succeeded
commercially with sales of about $100 million per year. There are many difficulties to
be overcome before other biosensors reach the market. Problems include those of
sensitivity, stability, selectivity, quality control and difficult manufacturing
techniques. It is still believed that certain niche markets will develop for these
devices e.g. in the doctor’s office they will compete with central labs where rapid
turn around is needed so long as simplicity and low cost can be achieved. Many
problems need yet to be solved before the promise of biosensors becomes reality.
12. Drug Delivery
Many patients are required to administer regular or daily injection(s) of drugs for
therapeutic reasons. These include drugs such as insulin for treatment of diabetes
and growth hormone for growth stature defects in children and adults. In addition,
cancer patients are required to administer, on a frequent basis, drugs such as
morphine to relieve pain, usually using an external pump system.
The development of alternative drug delivery technologies which make it easier for
patients to take drugs (such as peptide and protein based drugs like EPO, growth
hormone, insulin, interferons, heparin etc.) by the oral route in tablet or capsule
form, will have a number of important benefits both to patients, to the length of
hospital stays required by patients, to administrative costs, to nursing need
requirements, to the exchequer and to society in general. This applies to all patient
populations including the paediatric, the young, the elderly and adult population. In
addition, developing such innovative technologies will result in high-tech
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manufacturing employment, product production employment
improvement employment, again benefiting the economy.
and
process
FOOD AND AGRICULTURAL INDUSTRIES
The food and agricultural industries are another area that can greatly benefit from
advances in biotechnology. The benefits that advanced techniques of biotechnology
are capable of conferring on food and agricultural industries include the following:
• Development of genetically engineered plants that have internal resistance to
drought, frost, insect pests and infestation.
• Reduction in dependency of plants on chemical fertilizers and identification of
alternatives to expensive fertilizers such as nitrogen fertilizer, which require very
large amounts of energy for their production.
• Replacement of dangerous chemical pesticides with biopesticides (microbial
pesticides) to manage and control the problem of pests.
• Reduction in the reliance on chemical treatments to control weeds by engineering
herbicide tolerance into crops.
• Production of plants that have high yield and enhanced nutritional value.
• Development of novel biomass products as foodstuffs, using organisms such as
algae, fungi, bacteria, and yeast.
Prior to the use of recombinant DNA technology, traditional methods such as
crossbreeding were used to obtain hybrid species of plants or animals. This method,
however, needed many plant or animal generations before the genes with desirable
characteristics were brought together.
Today, using recombinant DNA technology, the gene can be spliced into the DNA of
the plant in a single generation. Also, with the help of recombinant DNA technology,
foreign genes can be introduced into plant genes, which could not be done by the
cross breeding method.
A number of biotechnology companies using recombinant DNA technology have
been trying to develop food products with extended shelf life. Applying the modern
techniques of biotechnology, Calgene Inc. in Davis, California has developed the
FLAVR SAVR tomato. The FLAVR SAVR tomato has been genetically altered to
delay the softening and decay that follows natural ripening and to have an extended
shelf life. This has been achieved by reversing one of the genes responsible for
producing an enzyme that causes softening. The FLAVR SAVR tomato has been
produced using vectors, which carry an antisense copy of the tomato
polygalacturonase gene and a bacterial neomycin phosphotransferase gene with
associated regulatory sequences.
Calgene Inc. has also developed genetically engineered canola plants in southern
Georgia. By inserting a thioesterase gene from the California Bay tree into the
genome, Calgene Inc. has been able to produce canola oil seed crops with nearly 40%
laurate. Lauric oils are an important raw material used in soaps and other personal
care products. According to Calgene Inc., the plant will offer a reliable domestic
supply of laurate for the U.S. manufacturers of soaps and detergents. At present,
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lauric oils, obtained primarily from coconut and palm kernel oils, are imported
mostly from Southeast Asia.
DNA Plant Technology Corp. of Cinnaminson, New Jersey, in collaboration with
ZENECA Group PLC of Great Britain, is in the process of developing genetically
engineered slower ripening bananas. Like Calgene's FLAVR SAVR tomato, the gene
that produces the hormone responsible for ripening will be suppressed. According to
DNA Plant Technology Corp., this technique will allow the fruit to be left on the
plant longer, improving flavor and nutritional value. It will also make possible the
shipping of different varieties, such as a red banana that is crisper and starchier.
In the field of agriculture, the application of modern techniques of biotechnology has
not been confined solely to plants. Transgenic techniques have been used to produce
transgenic animals having improved disease resistance, improved meat quality and
quantity, and useful proteins in milk.
The transformation method uses retroviruses to produce transgenic animals.
Recently, this method was tried for transformation of cells in goat udders, by
infusion with a retrovirus carrying a gene for growth hormone. When lactation was
induced in these goats, the resulting milk contained large quantities of growth
hormone. Thus, this method is effective for producing proteins of interest, whether
they are small quantities of highly valuable proteins or larger quantities of proteins
of lower value.
Monsanto Corporation has used Bovine Somatotropin (BST) to boost milk
production. BST is a growth hormone produced naturally by cows in small
quantities. Using recombinant DNA technology, by inserting the gene for BST
production into bacteria, Monsanto Corp. has been able to produce commercial scale
amounts of BST. The injection of BST into cows can increase milk production by as
much as 15%.
For many years chemical pesticides were used as weapons in the battle against
insects, infestations, and weeds. Scientists are attempting to control these problems
biologically using microbial pesticides. They have identified several strains of
bacteria, fungi, and viruses that produce toxins detrimental to insects. Using
recombinant DNA technology, the genes that code for the production of these toxins
could be cloned and inserted into bacteria that are normally present on crops. For
example, Monsanto Corp. has taken from the microorganism Bacillus thuringiensis
(BT) the gene that codes for production of a protein that kills insects and has
transferred it into plants such as tomatoes.
Also, Upjohn Company of Kalamazoo, Michigan developed a squash line (called ZW
20) that contains the coat protein genes of watermelon mosaic virus 2 (WMV2) and
zucchini yellow mosaic virus (ZYMV). The modifications have demonstrated
remarkable field resistance against the two viruses. The ZW-20 squash has been
developed with the use of vectors, promoters, and terminators from plant pathogenic
sources.
Another accomplishment of biotechnology in the area of agriculture has been the
development of insect resistant rice by Japanese scientists at Plantech Research
Institute of Yokohama. Plantech has introduced a truncated deltaendotoxin gene
crylA (b) from BT into a japonica rice. The Transgenic rice plants efficiently express
the BT gene. Under tests, R2 generation plants were exposed to two major rice insect
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pests, striped stem borer and leaf folder; a subsequent bioassay revealed that the
plants expressing the BT gene protein proved more resistant to the pests than nontransformed plants.
Furthermore, to combat grapevine fanleaf virus (GFLV), scientists at LVMH, Inc. in
Paris, France have used a bacterium vector to introduce a GFLV coat protein gene
into a chardonnay grape variety. According to LVMH, Inc., the gene has been
effectively transferred and the engineered grapevines have exhibited resistance to
infection by the virus.
Also, applying modern techniques of biotechnology, agricultural scientists have tried
to introduce herbicide and frost resistant genes in plants. Researchers discovered that
certain proteins, found in the bacteria Pseudomononas syringe that grow on the leaves
of plants, are "ice-nucleation proteins" responsible for frost damage to the plant.
Using recombinant DNA technology, they were able to identify the genes that code
for these ice crystal-forming proteins and delete them from the bacterium.
To control weeds, chemical herbicides have come to play a significant role in
agriculture. However, there are risks associated with the use of chemical herbicides.
In addition to causing serious environmental problems due to chemical
contaminants, chemical herbicides themselves have undesirable effects on non-target
organisms. With the help of recombinant DNA technology, scientists are hoping to
genetically modify plants tolerant to herbicides. Herbicide tolerance can occur when
the phytotoxic compound fails to be taken up by living tissue or is rendered nonphytotoxic by conjugation, hydrolysis, or another metabolic event (detoxification). By
using recombinant DNA technology, the genes that code for the protein involved can
be identified, isolated and modified by directed mutagenesis and introduced into
plant cultivar to confer the herbicide-tolerant phenotype.
To reduce dependency on chemical fertilizers, agricultural biotechnologists are
conducting considerable research using genetic manipulation to increase the range of
plants that can fix atmospheric nitrogen.
CHEMICAL INDUSTRIES
Chemical industries are involved in the production of specialty chemicals such as
amino acids, enzymes, polysaccharides, vitamins, sweeteners, food additives,
flavors, fragrances, etc. These industries are also interested in converting biomass to
produce specialty chemicals from either plants or biological wastes, such as those
generated from agriculture and food processing. Although advanced techniques of
biotechnology have not yet played a significant role in chemical production, there are
areas of chemical industries, however, where this technology can have substantial
impact, such as the production of amino acids, enzymes and polysaccharides.
Manufacturers are particularly interested in the potential for producing existing and
new chemicals at lower cost with reduced energy requirements and waste disposal
problems. Biocatalytic chemical production has the added advantage of specificity,
controllability, low temperature operation, environmental acceptability, and
simplicity. For example, much of the present organic chemical industry is based
upon petroleum and most of the chemical intermediates generated are partial
oxidation products. Specific, controlled, partial oxidation is difficult to achieve by
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conventional catalysis. By using microorganisms, this type of reaction can be easily
realized.
Amino Acids
Amino acids are the building blocks of proteins in animals, plants, and
microorganisms. Twenty different amino acids have been identified in proteins.
Amino acids are also important as nutrients, seasonings, flavorings, and precursors
for cosmetics and pharmaceuticals. As nutritional supplements in foods, lysine and
tryptophan are used to enrich vegetable protein. Amino acids, as precursors, are
used for the manufacture of detergents, polyamino acids (used in synthetic fibers
and films), polyurethane, and agricultural chemicals.
Amino acids can be produced either by isolation from natural materials – from
hydrolysis of plant proteins – or by chemical, microbial, or enzymatic synthesis.
Whereas chemical synthesis produces a racemic (optically inactive) product that may
require additional resolution, microbial and enzymatic syntheses give rise to
optically pure amino acids.
Commercially, amino acid producing bacteria have been used since the 1950s. With
the help of biotechnology, strains have been subsequently improved genetically by
the generation of auxotroph or regulatory mutants.
Enzymes
Enzymes are biochemical catalysts and, as a specific class of proteins, constitute the
most useful tools of biotechnology. Enzymes increase the speed or efficiency at
which a chemical reaction takes place without being altered itself. Common uses of
enzymes include the production of starch, cheese, detergents, meat tenderizers, and
high fructose corn syrup. Enzymes have certain characteristics, of which the most
significant ones are:
1. High molecular weight proteins (> 10,000 molecular weight);
2. Extremely efficient – drive reactions 108 to 1020 times faster than normal;
3. Highly specific;
4. Can be extracellular or intracellular; and
5. Coded for DNA.
Using modern techniques of biotechnology, scientists are attempting to improve the
yield of an enzyme by transferring the encoding gene to a microorganism capable of
producing the enzyme in larger amounts. Because they are large and fragile
molecules, enzymes tend to change their nature when exposed to heat, solvents, and
other extreme conditions that characterize most industrial processes. To remedy
these problems, the current research seeks to modify the genetic information coding
for an enzyme in order to introduce new chemical properties into the molecule, such
as new chemical bonds that stabilize its structure.
Recently, the Recombinant BioCatalysis Inc. of Sharon Hill, Pennsylvania began
commercially offering kits of enzymes, called CloneZymes, which may be tailored to
do biocatalysis in specific chemical processes. According to the manufacturer, the
DNA of enzymes is screened in order to isolate those that have desirable qualities
such as resistance to higher temperature and organic solvents. The DNA of a selected
enzyme is copied, inserted into a host organism, such as E. coli, and then produced
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by fermentation. The kits of enzymes offered by Recombinant BioCatalysis Inc.,
include:
1. Aminotransferases, for making chiral intermediates;
2. Esterases-Lipases, for resolving racemic mixtures of alcohol and carboxylic acids;
3. Glycosidases, which work on hydrolysis and synthesis of sugars; and
4. Phosphatases, for hydrolysis of phosphates
Polysaccharide
Polysaccharide has important application in the food, cosmetics, chemical, medical,
and oil industries. Yeast, fungi, and bacteria produce polysaccharides and are also
naturally available as cellulose, lignin, and chitin. Polysaccharides are used as
lubricants, viscosifiers, flocculating and gelling agents in food processing, and for
stabilizing liquid suspensions. At present, significant research is being conducted to
apply modern techniques of biotechnology to the production of microbial
polysaccharide.
Using advanced biotechnology, current research is also directed toward the
conversion of biomass feedstocks to fermentable substrates, such as cellulose to
glucose. While this generally requires relatively expensive microbial enzymes
(cellulose) possessing desirable characteristics such as thermostability and high
activity, manufacturers are also able to combine the desirable characteristics of
several less optimal cellulose enzyme producers using recombinant DNA
technology. Many laboratories are involved in the detection, identification, isolation,
and gene transfer for strain improvement.
ENERGY INDUSTRIES
Biotechnology can play an important role in the production of fuels from organic
matter via biomass conversion. Petroleum, the most prominent fuel presently, is a
non-renewable source that poses environmental risks in its extraction and use.
Biotechnology, by using available and abundant sources of biomass, could generate a
renewable and less environmentally hazardous source of energy called bio-energy.
The biological processes involved in producing bio-energy include harvesting of
energy (photosynthesis), improving of feedstock (biomass), and conversion to fuel
(fermentation). Advanced techniques of biotechnology, including the use of tissue
culture, protoplast fusion, single gene transfer, haploid, radiation-treated pollen
transfer, chemical mutagen, transmission of chloroplast genome, etc. offer improved
varieties of plants for increased productivity and improved microorganisms for the
conversion processes. Bacteria consuming sewage sludge in anaerobic conditions
may also produce bio-energy in the form of methane gas.
Modern techniques of biotechnology can also be used to enhance oil recovery. It is
believed that conventional oil-extracting technologies are capable of extracting only
50% of the world's oil supply, while the remaining 50% is trapped in rock or is too
thick to pump. To enhance the recovery of trapped oil, scientists have isolated a fatty
substance produced by a bacterium that reduces the viscosity of crude oil. The
injection of this substance into oil wells makes the pumping of thick oil possible.
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MINING INDUSTRIES
The environmental and health hazards associated with traditional mining
technologies have led many mining industries in the past few years to turn to a more
efficient and environmentally risk-free method for extracting minerals from ores,
which use microorganisms to leach metals from mine dumps. Currently, more than
10% of the copper produced in the United States is leached from ores by
microorganisms. Also, microbial leaching to a more limited extent has been applied
to extract uranium from pyritic ores. Microbial mining has improved recovery rates
and reduced costs.
The iron-oxidizing bacterium Thiobacillus ferooxidans has been used for bacteriumcatalyzed leaching. It is naturally present in certain sulfur-containing materials and
sequesters energy by oxidizing inorganic materials, such as copper sulfide minerals.
This process releases acid and an oxidizing solution of ferric ions, which can wash
out metals from crude ores. Sulfuric acid-ferrous iron solution is applied to piles of
crushed copper ore or mine waste, which encourages the growth of Thiobacillus
ferooxidans. As the bacteria oxidize the ore the copper is released and the sulfuric
acid-ferrous iron solution is recycled.
With the help of recombinant DNA technology, genetic modification of the ironoxidizing leaching bacteria can produce microorganisms with desirable
characteristics such as resistance to toxic metals and metalloids (which inhibit
microbial activity), fixation of atmospheric nitrogen, resistance to chloride, and the
ability to withstand high temperature conditions in mines. Using recombinant DNA
technology, it may be possible to genetically engineer bacterial strains that are able to
leach heavy metals such as mercury, cadmium, and arsenic that poison normal
microbes and slow the bioprocessing. To resolve the problem of high temperature,
researchers are turning to thermophilic bacteria found in hot springs and around
oceanic vents. These bacteria could function in a high temperature oxidative
environment.
The beneficial impact of biotechnology could be the use of modern biotechnology
techniques to control pollution and reduce or eliminate toxic substances. The adverse
effects of biotechnology on the environment, on the other hand, could involve the
use of toxic materials and the generation of toxic by-products by the biotechnology
industries. This section assesses the potential benefits and risks that biotechnology is
capable of imparting to the environment.
ENVIRONMENTAL PROTECTION
The application of biotechnology in the area of environmental protection is not a new
phenomenon – it was in the early part of the 20th century that an activated sludge
process, utilizing microorganisms for mineralizing organic waste, was first
developed. Since then, this process has become more complex and sophisticated,
incorporating many modern technologies. Meanwhile, the use of anaerobic digestion
processes for the treatment of wastes and the coincidental production of biogas
(mainly methane and CO2) has become an important source of energy generation. It
is believed that recent development in biotechnology could play an increasingly
important role in pollution prevention and toxic waste treatment via bioremediation,
biotreatment and biofiltration.
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Bioremediation
Bioremediation may be defined as a process by which microorganisms degrade
certain hazardous and toxic substances. Alternatively, bioremediation may be
considered as a process by which microbes metabolically transform toxic organic
compounds into harmless by-products. In general, microorganisms can be
considered as biocatalytic agents, requiring organic and inorganic nutrients for food
and energy sources. In most cases, bioremediation is considered to be safer than
incineration or other treatment technologies and, according to EPA, is the most
rapidly growing of the cleanup technologies.
Bioremediation is mostly an in-situ process, meaning that the treatment of
contaminated groundwater and other subsurface contaminants is done at its original
place without excavating the overlying soil. For in-situ bioremediation, the necessary
process components such as microorganisms, electron acceptors, nutrients, etc. are
delivered to the site of contamination. Equipment and systems generally include
injection wells, extraction wells, wastewater treatment systems, pumps, instruments,
and/or containment systems.
For bioremediation to occur the contaminant to be remediated must be
biodegradable and there must be a sufficient number of naturally occurring
microorganisms that are capable of degrading the contaminant. The subsurface
conditions must be optimum to promote microorganism growth. Moisture levels
should be appropriate – too much moisture inhibits gas diffusion into the soil,
rendering the site anaerobic (eliminating aerobic microorganisms) and too little
moisture in the soil prevents microbial activity and growth. Nutrients must be
present, such as nitrogen, iron, potassium, and phosphorous, in relative amounts to
meet the requirements of microorganisms. The temperature should be conducive to
the normal growth of microorganisms, the soil pH should be maintained between
pH 6-7.5, and if an aerobic subsurface condition is needed, the oxygen level may
need to be augmented.
Sometimes, bioremediation does not result in the complete mineralization of the
targeted organic compound. It may instead lead to the partial degradation of the
compound to a point sufficient to render it environmentally acceptable.
Advances in Bioremediation Technology
In 1972, the bioremediation of petroleum hydrocarbons was developed and since
then has been used in the treatment of contaminated soils and ground water.
Bioremediation technology has been successfully applied in the clean up of oil spills
and biodegradation of creosote, pentachlorophenol (PCP), and petroleum
hydrocarbons. Originally, the technology used in-well aeration along with the high
concentration of ammonium salts and orthophosphates. However, this method was
limited by the system of oxygenation and as a result sites with high degree of
contamination could not effectively be remedied.
The ultimate goal of the bioremediation field is to use existing and newly emerging
technologies to treat and clean up contaminated sites efficiently and with relatively
low cost. At present, advanced aeration technologies to improve the oxygenation are
being used, such as soil vapor extraction (SVE), bioventing, and air sparging or
oxygen release compound (ORC) technology, and have proved effective in cleaning
up of contaminated zones.
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Soil Vapour Extraction
At many sites, the limiting operating parameter for bioremediation is the lack of
oxygen present in the subsurface. Through soil vapour extraction, the oxygen
limitation is removed and the biomass activity increased. The process of soil vapour
extraction includes the installation of vapor extraction wells, collection lines, and an
extraction blower. At some sites, off-gas treatment equipment may be required. The
extraction rates are managed to optimize biodegradation without excessive stripping
or drying of the soil matrix.
Bioventing
Bioventing is used to remediate contaminants that are biodegradable under aerobic
conditions. This technology introduces air into unsaturated subsurface soils to
provide oxygen thus stimulating biodegradation of organic pollutants by aerobic
microorganisms. Equipment used in bioventing consists of vertical injection wells,
lateral trenches, piping networks, and a blower or vacuum pump for aeration or gas
extraction. Bioventing technology, although potentially applicable to any aerobically
degradable compound, has two practical limitations:
1. Compounds with a high vapor pressure volatilize too rapidly to be degraded with
bioventing technology. Bioventing is most effective for middle distillate fuels that
have low volatility and are aerobically degradable.
2. Hydrocarbons with high molecular weights take far too long to degrade with
bioventing. The slow rate results in longer clean up time – frequently on the order of
ten years or more – to reach standards acceptable under relevant environmental
regulations.
Biosparging
Biosparging or air sparging technology injects air or pressurized oxygen into the
saturated zone (groundwater). As it passes through the saturated zone, the oxygen is
dissolved into the water and stimulates biodegradation. The air moves in channels
from the injection point to the unsaturated (vadose) zone. With the biosparging
system, it is possible to remove the highly volatile compounds from groundwater
and transport them to the vadose zone. There, the contaminant may biodegrade or
may be removed using soil vapor extraction or bioventing techniques.
Oxygen Release Compound (ORC)
As noted above, moisture and nutrients are generally present in sufficient quantities
for aerobic bioremediation to occur, but oxygen is often the limiting factor. To
stimulate aerobic microbial activity and growth, additional oxygen is required. The
Oxygen Release Compound (ORC), developed by Regenesis Bioremediation
Products Co., releases oxygen to enhance in-situ aerobic bioremediation of dissolved
phase hydrocarbons. ORC is solid, insoluble magnesium peroxide that slowly
releases oxygen when hydrated. The by-products of the magnesium peroxide-water
reaction are oxygen and ordinary magnesium hydroxide.
Biotreatment
Biotreatment involves the detoxification of waste effluents, particularly hazardous
and toxic wastes, prior to their release to the environment by appropriate enzymes or
microbes capable of degrading specific compounds. Industrial wastes can be
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classified into two broad categories: those generated by biologically based industries
such as food processing and those generated by chemical industries.
Biological oxidation is used to treat wastes from biologically based industries, yet the
method is relatively expensive and does not assist in reducing the volume of dilute
wastes from this source. To help minimize residue, enzymatic treatment has been
suggested. This process has been used in the treatment of starch-containing food
wastewater with amylase and lactase for treating dairy wastes. For example, whey, a
by-product of cheese making and a rich source of lactose, is used to produce
commercial yeast by the enzymatic hydrolysis of lactose to glucose and galactose.
The system employed is the immobilized lactase system, developed by Corning Inc.,
where the lactase enzyme is derived from Aspergillus niger.
Unlike the biologically based industries, the majority of wastes generated by the
chemical industries require chemical or physical pre-treatment prior to the
application of conventional biological effluent treatment. Common chemical waste
effluents include dyes and pigments released into the environment by the textile and
dyestuffs industries. With the notable exception of cationic dyes and benzidine, most
dyes and pigments are not considered toxic or carcinogenic to fish or mammals.
Microorganisms have been identified which are capable of degrading dyes of higher
concentration, for example a number of microorganisms have been found to possess
non-specific enzymes that catalyze the reductive fission of the azo group.
Biofiltration
Biofiltration, developed fairly recently, is a biological air pollution control (APC)
technology designed to treat off-gases containing biodegradable volatile organic
compounds (VOCs) or inorganic air toxics. Although this APC technology has been
used on a limited scale in the U.S. thus far [EPA established biofiltration as the best
available control technology (BACT) for controlling air pollution], it has been
successfully applied since the early 1980s in European countries, particularly in
Germany and Holland. In these countries, biofilters are used to treat off-gases
generated by industrial facilities (such as adhesive production, coating operations,
chemical manufacturing, film coating, iron foundries, and print shops), food
processing industries (such as coffee roasting, coca roasting, fish frying, fish
rendering, flavor and fragrance, pet food manufacturing, and slaughter houses), and
waste treatment industries (such as industrial and residential waste water treatment
plants, composting facilities, landfill gas extraction, and waste oil recycling). The
large volumes of off-gases emitted from these sources contain only low
concentrations, typically less than 1,000 ppm methane, of the organic target
pollutants. The primary application of an APC biofiltration system in food
processing and waste treatment industries (Noorzad, 2001).
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