Modern Biotechnology Activity in New Zealand Modern Biotechnology Activity in New Zealand Statistics New Zealand gives no warranty that the information or data supplied contains no errors. However, all care and diligence has been used in processing, analysing and extracting the information. Statistics New Zealand shall not be liable for any loss or damage suffered by the customer consequent upon the use directly, or indirectly, of the information supplied in this product. Published in April 2001 by Statistics New Zealand Te Tari Tatau Wellington, New Zealand ISBN 0-478-20767-0 Preface This report contains the first set of official statistics on the modern biotechnology industry in New Zealand. It was undertaken by Statistics New Zealand, with funding sponsorship from the Ministry of Research, Science and Technology. The analysis is based on a survey of known participants in the industry; the first of its type carried out in New Zealand and only the third of its type carried out by any statistical office in the OECD. The survey, known as the 1998/99 Biotechnology Survey, drew upon the experience of overseas statistical offices and the advice of a group of industry experts from within New Zealand. The industry experts provided advice on the processes and products that were likely to be used by enterprises involved in modern biotechnology activity in New Zealand. This helped define the scope of the survey. The expert panel comprised: Professor Diana Hill Global Technologies Limited Dr Max Kennedy Past President of New Zealand Biotechnology Association Industrial Research Limited Dr Selwyn York Chairman of New Zealand Biotechnology Association New Zealand Pharmaceuticals Limited Dr William Rolleston President of Biotenz South Pacific Sera Limited Statistics New Zealand is grateful for the support provided by these individuals and for the cooperation of the enterprises that participated in the Biotechnology Survey. Brian Pink Government Statistician Blank Page 4 Contents Page Introduction 7 Defining Modern Biotechnology 8 Development of Modern Biotechnology Activity in New Zealand 9 Summary Statistics 10 2.00 Survey Results 11 2.01 Analysing the Enterprises that Use Biotechnology Processes 11 2.02 Utilisation of Specific Biotechnologies 12 2.03 Nature of the Utilisation of Specific Biotechnologies 13 2.04 Biotechnology Activity Output 14 2.05 Adoption of New Products and Processes 16 2.06 Strategic Alliances 18 2.07 Intellectual Property Rights 20 2.08 Measurement of Human and Financial Resources 23 2.09 Barriers to Acquiring and Implementing Biotechnology 25 2.10 Recruitment from Overseas 26 3.00 Survey and Methodology 27 3.01 Criterion for Selecting the Survey Population 27 3.02 Creation of the Survey Population 29 3.03 Survey Response Rate 29 3.04 Classification of Biotechnology Processes 30 3.05 Classification of Activities Utilising Biotechnology Output 31 3.06 Industrial Groupings for Classifying Respondents to the Survey 32 Contents - continued Appendix 1 Post Survey Study 34 Appendix 2 Supplementary tables 39 Appendix 3 Glossary of Terms 43 Classification of Biotechnology Output Activity (Biotechnology Activity Output) 48 Glossary of Statistics New Zealand Terms 50 References 51 Modern Biotechnology Activity in New Zealand 7 Introduction Modern biotechnology has potential applications across a broad spectrum of human activities, ranging from the production of food to the treatment of illnesses and the management of waste products. The realisation of this potential over coming decades may significantly increase the contribution of ‘modern biotechnology’ to the New Zealand economy. The 1998/99 Biotechnology Survey and this accompanying analysis are intended to establish a benchmark measure of this contribution, as well as improving our understanding of the uses of modern biotechnology in New Zealand. The funding and development of the survey predated the voluntary moratorium on new trials of genetically modified products initiated, on 14 June 2000. The analysis contained in this report is based almost exclusively on the 1998/99 Biotechnology Survey, a postal survey of 426 enterprises that were identified as being those most likely to participate, either exclusively or otherwise, in biotechnology activities. Of the 419 enterprises that responded to the survey (a response rate of 98.3 percent), 180 indicated they used at least one biotechnology process. Modern biotechnology embraces a set of processes. These processes can be used in a variety of industries to produce a range of outputs. However, it is not an industry or an output. Therefore, the analysis of this activity takes place outside the statistical industry-based framework, which a statistical agency will typically use. Instead the outputs of modern biotechnology have been classified into a framework that links output to the activity in which it is used. The framework used to classify the output of biotechnology activity is described in section 3.05 at the rear of this report. Because the 1998/99 Biotechnology Survey was the first of its kind conducted in New Zealand, Statistics New Zealand also conducted a Post Survey Study (PSS) to evaluate the quality of its survey responses. This study, which is reported in detail in Appendix 1, employed the technique of telephone re-interviewing a sample of the initial survey respondents. The major finding of the PSS was that respondents had considerable difficulty in isolating and measuring the human and financial resources that enterprises devoted to modern biotechnology. This, together with noted variability between respondents in their understanding of what is meant by modern biotechnology, suggests caution in the use of quantitative financial and human resource data contained in this report. 8 Modern Biotechnology Activity in New Zealand Defining Modern Biotechnology There are many definitions of modern biotechnology. A broad interpretation might be the application of any modern technologies to the processing of biological materials, or the processing of material by biological agents. A narrower interpretation relates to genetic engineering and covers a range of different but related technologies, including gene manipulation, gene transfer, DNA typing and cloning. A narrower definition was accepted as being more appropriate to this study, and appeared in the Biotechnology Survey as: “The application of scientific and engineering principles to the processing of material by biological agents, and the processing of biological materials to improve the quality of life, by isolating, modifying and synthesising the genetic instructions responsible for actual biological processes.” In practice, the latter part of this definition proved to be too narrow, so after initial contact with survey respondents, the definition was expanded to include processes which are dependent on genetic manipulation. An example of such a process is the manufacture of vaccines. Where a new vaccine is developed on the basis of genetic modification, or where the production of antibodies is stimulated through the introduction of gene constructs, the production of the vaccine can be defined as modern biotechnology, even though the specific production process may not use genetic manipulation. Modern biotechnology, therefore involves genetic manipulation and includes the following: • • • • • • Bioprocessing - manufacture of fermented products like cheeses, yoghurt, breads, brewing, pharmaceutical and vaccine manufacture and so on, provided that genetic manipulation has occurred. Bio-prospecting - genetic engineering to produce new goods or services whose practical applications may not yet be known. Modern gene/protein technologies (genomics and proteomics): eg producing genetically modified organisms. Other genetic manipulations eg antibiotic strain improvement and selection. DNA based services - includes gene technologies used in diagnostics (medical, food hygiene, and forensic and environmental diagnostics). Bio-informatics - the electronic data management of biological information, such as the archiving of gene sequencing information. Enterprises involved in modern biotechnology will also frequently be involved in other productive activities that include the more traditional biotechnologies. Given the difficulty of defining a biotechnology as modern or traditional, it is possible that the survey results may include data related to modern processes which do not include genetic engineering, and hence are outside the intended scope of the survey. Modern Biotechnology Activity in New Zealand 9 Where possible, the data relating to the following traditional biotechnologies were excluded from the scope of the survey: • • • Fermentation (as in traditional beer brewing and bread making). Use of oxidation ponds to treat sewerage. The use of screening and filtration, or reed beds to treat sewerage. These processes are excluded because they are not likely to include the modification of genetic material. The products and processes produced by modern biotechnology activity in New Zealand are utilised in: • • • The process of producing other goods and services, for example the use of gene technologies in diagnostics (medical, food hygiene, forensic and environmental diagnostics). The production of output that can be sold directly to an end user, for example the development of vaccines involving genetic modification of genetic materials. Inputs into research and development, an example of this is the development of Bio-informatics which is the electronic data management of biological information, such as archiving gene sequencing information. Development of Modern Biotechnology Activity in New Zealand In the early stages of the adoption of a new technology, the majority of the activity utilising the technology is usually focused on research and development. The research and development activity is aimed at adapting the technology to suit local conditions and the development of new processes that have application to local conditions. The results of the survey indicate that the majority of known modern biotechnology activity is centred on research and development. The majority of responses indicating the use of modern biotechnology processes were in the research and development phase. Enterprises in the scientific research and tertiary education industrial groupings utilised the largest number of modern biotechnology processes. A significant number of respondents indicated that they had implemented either a new biotechnology product or process in the last three years. Enterprises in the survey had registered 59 biotechnology-related patents in the year to June 1999. The importance of research and development in the utilisation of modern biotechnology processes and the introduction of new products and processes in the last three years indicates that the introduction of modern biotechnology to New Zealand is in its early stages of development. The new products and processes produced by the research and development activity are likely to be utilised by enterprises outside the scientific research and tertiary education industrial groupings in the future as the activity matures in New Zealand. 10 Modern Biotechnology Activity in New Zealand Summary Statistics The results of the survey are summarised below: • The value of income estimated by respondents to be associated with modern biotechnology is $475 million, in the year ended June 1999. This compares with the furniture manufacturing industry, which has total income of $938 million1. Respondents in the private sector estimated they earned $326 from modern biotechnology activity. Respondents in the public sector estimated they earned $149 million from modern biotechnology activity. • The value of expenditure estimated by respondents to be associated with modern biotechnology is $405 million, in the year ended June 1999. Respondents in the private sector estimated they spent $276 on modern biotechnology activity. Respondents in the public sector estimated they spent $129 million on modern biotechnology activity. • Biotechnology processes currently are most frequently utilised at the research and development stage. • Enterprises classified to the scientific research and tertiary education industrial groupings currently utilise the largest number of biotechnology processes. • Thirty seven percent of respondents indicated they had implemented a new biotechnology product in the last three years. • Thirty eight percent of respondents indicated they had implemented a new biotechnology process in the last three years. • Enterprises involved in biotechnology activity had registered 59 patents in the year to June 1999. In the last five years 156 biotechnology related patents were issued. • Enterprises that are undertaking biotechnology are more likely to be aligned with New Zealand based Crown research institutes and universities than foreign-based institutions. • The lack of capital, regulations, and access to suitably trained and suitably experienced personnel are identified by survey respondents as barriers to the development of biotechnology. • Employment in the biotechnology activity represents 0.2 percent of the total employment. Forty percent of employees involved in modern biotechnology hold a post-graduate qualification. 1 1999 Annual Enterprise Survey, Statistics New Zealand. Modern Biotechnology Activity in New Zealand 11 2.00 Survey Results The following sections describe the way in which processes are used, the outputs produced, the industries in which biotechnology is used, the development of new processes and products, and the financial and human resources devoted to biotechnology. There is also a discussion of strategic alliances used by enterprises involved in modern biotechnology; use of intellectual property rights; the problems associated with the development of modern biotechnology; and recruitment from overseas. The data in the tables produced in the main body of the report and the appendices which represent counts of responses have been randomly rounded to comply with the confidentiality provisions of the Statistics Act 1975. 2.01 Analysing the Enterprises that Use Biotechnology Processes Identification of the types of firms that use modern biotechnology processes will enable a better understanding of the characteristics of the modern biotechnology in New Zealand. One hundred and eighty one enterprises2 indicated use of at least one form of modern biotechnology process. The industrial groupings used in Table 2.04 are defined in section 3.06 of the chapter on survey methodology. Table 2.01 Industrial Classification of Enterprises that Used at Least One Biotechnology Process Industrial grouping Primary products Food manufacturing Non-food manufacturing Scientific research Local government administration Tertiary education Health services Other Total 8,122 1,268 591 5,404 Number of enterprises involved in modern biotechnology activity 6 33 24 36 Number of processes used by enterprises in each industrial grouping 33 207 153 522 201 76 3,536 25,036 44,234 33 9 24 12 180 150 723 237 60 2,088 Total number of enterprises in each industrial groupings3 The food manufacturing, scientific research and local government administration industrial groupings reported the largest number of enterprises involved in biotechnology. However, enterprises in the scientific research and tertiary education industrial groupings reported using the largest number of processes. 2 3 Please refer to the glossary at the end of the report for a definition of an enterprise. 1999 New Zealand Business Demography Statistics, Statistics New Zealand. 12 Modern Biotechnology Activity in New Zealand To give some indication of the significance of modern biotechnology activity, the 180 enterprises involved in the activity compares with approximately 1200 enterprises in the Research and Development Survey administered by Statistics New Zealand. Enterprises in the Research and Development Survey population have indicated they are involved in research and development through their response to the Statistics New Zealand Annual Business Frame Update Survey, or they have received funding from the Foundation of Research Science and Technology. All universities and most Crown research institutes participate in research and development activity. Less than 0.1 percent of the total number of enteprises recorded on Statistics New Zealand’s Business Frame4 have an involvement in modern biotechnology. 2.02 Utilisation of Specific Biotechnologies In order to identify the biotechnology processes used by enterprises involved in modern biotechnology activity, a range of 58 biotechnology processes was included in the questionnaire. The processes ranged from fermentation to genetic engineering/recombinant DNA. The processes were grouped together into four categories: • DNA based technologies using chemistry of DNA as a major component. • Biochemistry/immunochemistry based: technologies which utilise immunochemistry/antibodies or enzymes as a major component. • Environmental Biotechnologies: technologies used for pollution control. • Bioprocessing based: technologies that process any natural material or material of biological origin. Table 2.02 records the number of responses to the questions on the types of biotechnology processes used. For example, enterprises in the primary products industrial group indicated they use 6 processes that involved DNA technology. 4 Please refer to the glossary at the end of the report for a description of the Statistics New Zealand Business Frame. Modern Biotechnology Activity in New Zealand 13 Table 2.02 Distribution of Modern Biotechnology Processes by Industrial Grouping. Industrial grouping5 Primary products Food manufacturing Non-food manufacturing Scientific research Local government administration Tertiary education Health services Other Total DNA based 6 Categories of biotechnology processes6 Biochemistry/ Environmental Bioprocessing immunochemistry based based 9 0 18 Total 33 6 69 33 99 207 6 66 18 69 153 120 198 36 168 522 0 18 66 66 150 222 30 6 393 264 147 18 786 24 3 12 192 213 57 24 714 723 237 60 2,088 Biochemistry/immunochemistry based technology processes attracted the largest number of responses. The largest number of the responses were sourced from enterprises in the scientific research and tertiary education groupings. Utilisation of bioprocessing based technologies is spread across a wide range of industrial groupings. This is a result of the applicability of the bioprocessing based technologies to a wide range of productive activities. Environmental technologies are in the main used by the local government and food and non-food manufacturing industrial groupings. Enterprises in the scientific research and tertiary education industrial groupings indicated they used the largest number of biotechnology processes, and between them accounted for 60 percent of all processes used. This result is consistent with the hypothesis that the adoption of modern biotechnology into New Zealand is at an early stage. 2.03 Nature of the Utilisation of Specific Biotechnologies The nature of the utilisation of a technology can provide an insight into the development of the use of the technology. In the early stages of development, the utilisation of the technology will centre on research and development The questionnaire asked enterprises to indicate whether they used a biotechnology process in ether the research and product process development, or as part of the production process or as part of the product sold. 5 6 The industrial groupings are described in section 3.06 of the report. A distribution of responses by process is given in table A2 in Appendix 2. 14 Modern Biotechnology Activity in New Zealand The table below records the responses of enterprises that indicated they used at least one form of biotechnology process. For example, 63 processes based on the use of DNA based technologies are used in the production process. Table 2.03 Summary of Responses to the Use of Biotechnology Processes and their Utilisation Stages Technologies DNA based Biochemistry/immuno chemistry based Environmental Bioprocessing Total Research & product/ process development Stage of utilisation Part of the production process Part of product sold 360 63 30 579 81 297 132 168 30 489 1,506 348 843 141 369 Utilisation of biotechnology processes as part of research and product process development attracted the largest number of responses. Environmental technologies recorded the highest percentage of responses that indicated their use in either the production process or the product sold. This results from the use of environmental technologies by enterprises in the local authority industrial group to treat sewage and wastewater. Enterprises in the scientific research and tertiary education industrial groups indicated they used the largest number of processes. These two results indicate a significant proportion of biotechnology activity carried out by enterprises in the survey is focused on research and development. 2.04 Biotechnology Activity Output In New Zealand modern biotechnology is used to produce a range of products and outputs that can be used across a range of activities. In the survey questionnaire, respondents were asked to classify the activities that utilise the biotechnology products and processes produced by their enterprise. The classification of the activities is described in section 3.05 in the chapter on survey methodology. Table 2.04 records the number of times respondents indicated their output was used by an activity. The output of modern biotechnology activity in New Zealand is mostly utilised in the following activities: • Environmental • Human health biotechnology • Agriculture biotechnology • Food processing. Modern Biotechnology Activity in New Zealand 15 Environmental activity attracted the largest number of responses. Enterprises in the scientific research, tertiary education and local authority administration industrial groupings provided the largest number of outputs to this category. The enterprises in the local authority administration industrial group use these processes in their treatment of sewage and wastewater. Human health biotechnology activity mainly utilised processes associated with diagnostic testing and the development of new treatment techniques in research facilities such as universities and Crown research institutes. Agriculture biotechnology activity will be utilising biotechnology processes in areas such as the treatment of disease and the production of new and improved products. Food processing activity utilises biotechnology processes in areas such as testing to ensure that their output meets quality standards for domestic and foreign markets. Enterprises in the tertiary education and scientific research industrial groups are most active in human health and agricultural biotechnology activities. 16 Modern Biotechnology Activity in New Zealand Table 2.04 Classification of Use of Biotechnology Output by Industrial Grouping and Activity Activity Primary products Human health biotechnology Bio-informatics Agriculture biotechnology Food processing Aquaculture Mining/energy/petroleum/chemicals Forest products Environment Other Total 0 3 3 0 0 3 3 0 0 9 Industrial grouping Food Non-food manufacturing manufacturing 0 0 3 36 0 0 0 3 3 48 9 0 21 9 3 0 3 9 3 57 Scientific research 21 12 33 15 15 3 3 27 6 135 Table 2.04 Continued Activity Human health biotechnology Bio-informatics Agriculture biotechnology Food processing Aquaculture Mining/energy/petroleum/chemicals Forest Products Environment Other Total Industrial grouping Local government Tertiary education 0 0 3 0 0 0 0 51 3 57 48 24 36 18 18 0 6 30 9 186 Health services 27 3 3 0 0 0 0 3 0 33 Other 0 0 6 3 3 0 3 12 3 27 National total 108 42 102 81 36 6 15 135 27 555 2.05 Adoption of New Products and Processes As noted in earlier chapters, the results of the survey indicate that a large proportion of modern biotechnology activity is devoted to research and development. One outcome of research and development activity is the development of new processes and products that can be used in either production processes or in further research and development. Respondents were asked about the new or significantly improved products and processes that had been implemented in the last three years, or that they planned to implement in the next three years. Modern Biotechnology Activity in New Zealand 17 New Products Sixty-six respondents (or approximately 37 percent of respondents who use at least one form of biotechnology process) indicated they had implemented new biotechnology products in the last three years. Enterprises in the scientific research industrial group plan to introduce the largest number of new biotechnology products in the next three years. Table 2.05 Implementation of New Biotechnology Products Industrial group Primary production Food manufacturing Non-food manufacturing Scientific research Local authorities Tertiary education Health services Rest of the world Total Number of respondents that implemented a new biotechnology product in the last three years Number of new biotechnology products implemented in the last three years Number of respondents that plan to introduce a new biotechnology product in the next three years Number of new biotechnology products planned to be implemented in the next three years 3 4 3 6 6 12 11 26 12 18 3 9 9 6 66 33 44 4 24 44 15 180 16 20 6 22 13 3 94 48 84 9 66 50 9 298 Enterprises in the scientific research, tertiary education, and health services industrial groupings introduced the largest number of new biotechnology products in the last three years. A larger number of new biotechnology products were planned to be introduced in the next three years. Enterprises in the food and non-food manufacturing industrial groupings plan to introduce 26 and 48 new products respectively in the next three years. The survey was conducted before the voluntary moratorium on field tests of genetically modified organisms initiated on 14 June 2000. The voluntary moratorium may influence plans to introduce new biotechnology products. New Processes Sixty-nine respondents (or approximately 37 percent of respondents who use at least one form of biotechnology process) indicated that they had implemented a new biotechnology process in the last three years. 18 Modern Biotechnology Activity in New Zealand Enterprises in the tertiary education and the scientific research industrial groups implemented the largest number of processes that were either new to New Zealand or new to the world. This result is consistent with the two industrial groups’ significant utilisation of biotechnology processes at the research and product process development phase. Table 2.051 Adoption of New Biotechnology Processes Industrial grouping Primary production Food manufacturing Non-food manufacturing Scientific research Local authorities Tertiary education Health services Rest of the world Total Number of respondents indicating that they implemented a new process in the last three years Number of new processes implemented in the last three years Number of processes new to the business Number of processes new to New Zealand Number of processes new to the world 3 11 6 6 2 6 6 6 4 0 15 18 6 9 12 3 69 42 36 6 27 38 11 177 36 30 6 21 33 12 144 19 17 1 14 1 2 64 9 15 0 13 0 0 39 Enterprises in the scientific research, tertiary education, health services, and non-food manufacturing industrial groupings introduced the largest number of new biotechnology processes in the last three years. The research and development focus of enterprises in the scientific research and tertiary education industry groupings means they are more likely to either develop new or significantly improved processes or adapt existing processes as part of their focus on research and development. The enterprises in the health services and food manufacturing industrial groupings would have either adopted processes developed within New Zealand or imported processes previously developed overseas. A significant number of the processes developed by enterprises in the scientific research and tertiary education industrial groupings were either new to New Zealand or new to the world. 2.06 Strategic Alliances Cooperation between enterprises that have an interest in the technology is an important component in the development of new technology. The questionnaire asked respondents if they had a strategic alliance, the purpose of the alliance, and the nature of their strategic partners. Modern Biotechnology Activity in New Zealand 19 Table 2.06 Alliances Used by Enterprises Involved in Modern Biotechnology Types of alliances used by biotechnology enterprises Product/process development Clinical/field trial Manufacturing Marketing/distribution Regulatory affairs Finance Other Total Number of alliances reported by respondents 96 48 27 30 24 9 18 249 Percentage 39 19 11 12 10 4 7 100 Fifty-eight percent of alliances were for either product/process development or clinical/field trial, both of which are elements in the development of new biotechnology products and processes. This is consistent with the results from the question on the nature of the utilisation of biotechnology, where the majority of responses were in the use of the processes in the research and product/process development. Table 2.061 New Zealand Based Strategic Partners Organisations with whom biotechnology enterprises have alliances Crown research institute University Polytechnic Related-business research/professional association Unrelated-business research/professional association Total Number of alliances reported by respondents 69 66 3 Percentage 37 33 2 39 21 12 189 6 100 Seventy percent of partners in alliances were either Crown research institutes or universities. These two sets of institutions have been classified in the scientific research and tertiary education industrial groups. Enterprises in the scientific research and tertiary education industrial groups provided the largest number of responses to the utilisation of biotechnology processes at the research and product/process development stage. Table 2.062 Distribution of Foreign Based Strategic Partners Type of overseas organisations University Research Other organisation Australia 24 0 18 USA 24 0 24 Country Europe Asia 21 12 0 0 18 9 Other 3 24 3 Total 87 24 69 20 Modern Biotechnology Activity in New Zealand The majority of enterprises with a foreign-based strategic alliance are involved in an alliance with a foreign university. 2.07 Intellectual Property Rights The biotechnology industry is based upon knowledge acquired from research and development. Unfortunately, the knowledge gained through the investment in research and development can be lost through theft or the loss of staff. Biotechnology companies and research institutions have attempted to protect their investment by acquiring patents. The use of patents enables research institutions to protect their intellectual property and control its dissemination. The section on intellectual property rights in the questionnaire was designed to obtain information from respondents on the following topics: • • • • • The role of intellectual property rights in the development of biotechnology projects Disputes surrounding the availability of information and data necessary for projects to go ahead Informal arrangements to share information Acquisition of intellectual property and successful patent applications Publications from biotechnology enterprises. The respondents were asked to indicate if they have had to abandon or not start biotechnology activity as a result of intellectual property rights or some knowledge protected by another organisation. They were also asked to indicate the cause for the abandonment. A small number of respondents indicated that intellectual property rights hindered the development of projects. Eleven of the 17 respondents were from enterprises in the scientific research and tertiary education industrial groupings. Table 2.07 Intellectual Property Rights Question Has this organisation ever had to abandon, or not start a biotechnology development activity because further work was blocked by intellectual property rights or some knowledge protected by another organisation Reasons why the project was abandoned: Project abandoned because enterprise is unable to purchase the IP Project abandoned because enterprise is unable to license the IP Any other reason Total Number of positive responses 15 9 6 9 21 Less than ten percent of respondents indicated they had to abandon projects as a result of access to research data. Modern Biotechnology Activity in New Zealand 21 Table 2.071 Litigation concerning Patents and Access to Research Information In the last 3 years has this business been involved in litigation relating to patent infringements In the last 3 years has this business been involved in disputes relating to access to research information Number of positive responses Number of cases or disputes 12 16 15 41 Ten of the 27 responses to these two questions were from enterprises in the scientific research and tertiary education industrial groupings. A further eleven responses came from enterprises in the food and non-food manufacturing industrial groupings. Table 2.072 Informal Agreements Concerning the Sharing of Information Classification of partner Another business University Crown research institutes Hospital Other Total Partner in New Zealand Number Percentage 63 26 72 29 75 30 27 11 12 5 249 100 Partner outside New Zealand Number Percentage 51 55 39 39 0 0 3 3 6 3 99 100 Universities and Crown research institutes are involved in the majority of information sharing agreements. The majority of foreign partners in informal agreements were classified as ‘another business’. Table 2.073 Source of Intellectual Property Rights Acquired Source of patents acquired by respondents Another business University Crown Research Institute Hospital Other Total Based in New Zealand 18 21 21 3 3 60 Based outside New Zealand 18 9 0 0 3 27 The majority of respondents indicated that they acquired their intellectual property rights from either a university or a Crown Research Institute. The number of successful applications for patents can be viewed as an indication of the progress in the development of modern biotechnology processes. Table 2.074 lists the number of successful patent applications by enterprises in this survey. 22 Modern Biotechnology Activity in New Zealand Table 2.074 Successful Application for Patents Period in which successful applications were made In the year ended June 1999 In the last 5 years Number of successful applications 56 156 7 Total patents granted in New Zealand8 3,806 16,400 Biotechnology related patents represented 2 percent of the total number of patents issued in the year to June 1999 and 1 percent of total patents issued in the last five years. The total number of patents issued in New Zealand is boosted by a large number of patents applied for by foreign companies in the areas of pharmaceuticals and electronics. Enterprises in the scientific research and tertiary education industrial groupings obtained 49 of the 56 patents granted in the year ended June 1999. Enterprises in these two industrial groupings also obtained 120 of the 156 patents related to biotechnology in the last five years, that were granted to respondents to the survey. This result reflects the high level of research and development activity carried out by these two industrial groups. Respondents were asked to indicate if they had a staff member who in the year to June 1999 had: • Published an article on biotechnology in a refereed journal, or • Attended a conference (national or international) on a biotechnology subject, or • Presented a research paper at such a conference (national or international) on biotechnology. Table 2.075 Biotechnology Related Conference, Presentation and Publishing Activity Publications and conferences attended by employees of biotechnology enterprises Publish an article on biotechnology in a refereed journal Attend a (national or international) biotechnology conference Present a research paper to a conference (national or international) on biotechnology Total number of responses Responses from enterprises in scientific research and tertiary education industrial groupings 66 54 162 75 90 60 Table 2.075 shows that most people publishing articles or presenting research papers at conferences were employees in the scientific research and tertiary education industrial groupings. This is consistent with the emphasis on research and development within these industrial groups. 7 8 Intellectual Property Office Total may include biotechnology patents issued to enterprises not covered in this survey. Modern Biotechnology Activity in New Zealand 23 2.08 Measurement of Human and Financial Resources Respondents to the survey were asked to quantify the financial and human resources the enterprise devoted to modern biotechnology. They were asked the total income and expenditure of the enterprise and the percentages of both that were associated with modern biotechnology activity. The human resources supporting modern biotechnology activity were measured in terms of a head count and the number of full time equivalent employees. The Post Survey Study found that respondents had difficulty in determining the financial and human resources the enterprise devoted to modern biotechnology. The difficulty resulted from the following factors: a) Enterprises were involved in producing goods and services other than modern biotechnology output. The modern biotechnology process utilised was a component of the production process. This made identification of the cost and revenue associated with the modern biotechnology component difficult. b) Employees have a range of tasks including those associated with modern biotechnology. This made it difficult for respondents to estimate the proportion of time their employees spent on modern biotechnology activity. The values of the quantitative variables produced below are based on estimates made by respondents, so care should be taken when interpreting the results. Estimated Income and Expenditure The value of income estimated by respondents to be associated with modern biotechnology is $475 million. Respondents in the private sector estimated they earned $326 million from modern biotechnology activity. Respondents in the public sector estimated they earned $149 million from modern biotechnology activity. The Public Good Science Fund contributed $17.5 million to revenue earned by respondents through its investment in research involving genetic engineering. The value of expenditure estimated by respondents to be associated with modern biotechnology is $405 million. Respondents in the private sector estimated they spent $276 million on modern biotechnology activity. Respondents in the public sector estimated they spent $129 million on modern biotechnology activity. 24 Modern Biotechnology Activity in New Zealand Table 2.08 Distribution of Estimated Income and Expenditure Associated with Biotechnology Activity Range $million Less than 1.0 1.0 – 5.0 5.0 - 10.0 10.0 plus Total Percentage of respondents whose estimated income from biotechnology fell within the range 63.4 22.6 5.3 8.7 100.0 Percentage of respondents whose estimated expenditure associated biotechnology fell within the range 67.5 20.6 4.1 7.7 100.0 The significance of the activity can be gauged by comparing the ranges to the point estimates for the following industries from Statistics New Zealand’s 1999 Annual Enterprise Survey data. Table 2.09 Income and Expenditure Comparison with Other Industries Industry Modern biotechnology activity Furniture manufacturing 9 Food beverage and tobacco manufacturing 9 Other health services including pathology and laboratory services 9 Estimated income $ million 475 938 Estimated expenditure $ million 405 907 18,872 18,918 1,099 935 Respondents were asked to indicate the level of human resources supporting modern biotechnology activity in terms of: • Head count as at 30 June 1999 • Full-time equivalent employees involved during the year ended 30 June 1999. Table 2.10 The Number of Employees Supporting Biotechnology Processes by Qualification Qualification Bachelor of Science degree Master of Science degree PhD Diploma/certificate Other Total Head count of Employees associated with biotechnology 735 390 702 588 315 2,727 Percentage distribution 26 14 27 22 12 100 Sixty-seven percent of employees held a graduate or postgraduate degree. These qualifications are important in research and development of new products and processes, which requires a high level of technical and theoretical knowledge. 9 1999 Annual Enterprise Survey, Statistics New Zealand. Modern Biotechnology Activity in New Zealand 25 Employment in the modern biotechnology activity represents 0.2 percent of total employment. Table 2.11 presents the results from a 1993 survey carried out by the New Zealand Biotechnology Association. In the survey, 97 organisations identified as users of biotechnology were asked for information on the qualifications of trained employees. The distribution of responses to the 1993 survey is very similar to those recorded in the 1999 survey. Table 2.11 Results of the 1993 New Zealand Biotechnology Association Survey on Qualifications of Employees Employed by Members of the Association Qualification Bachelor of Science degree Master of Science degree PhD Diploma/certificate Total Head count of employees associated with biotechnology 106 40 148 54 348 Percentage distribution 30 11 43 16 100 2.09 Barriers to Acquiring and Implementing Biotechnology Analysis of the barriers to the development of modern biotechnology activity aids the understanding of the current state of the activity in New Zealand. Table 2.12 Barriers to the Development of Modern Biotechnology Factors acting as barriers to the development of modern biotechnology activity Number of responses Access to capital 96 Access to management experts 27 Access to personnel suitably trained in biotechnology 51 Access to suitably experienced biotechnology personnel 48 Access to biotechnology research data and/or information 21 Access to technology 39 Lack of information about markets 33 Regulations 66 Implications of Treaty of Waitangi claims 21 Other 24 Access to capital was identified as the greatest barrier to development. As noted in chapter 2.03, the majority of biotechnology processes are being utilised at the research and product processes development phase. Investors may be reluctant to put funds into research and development given the uncertainty as to whether it will result in a commercial application. 26 Modern Biotechnology Activity in New Zealand A significant number of respondents to the survey identified regulations and access to suitably trained and suitably experienced biotechnology personnel as barriers to the development of modern biotechnology. The lack of personnel will impede both the adoption of new processes and the creation of new and significantly improved biotechnology processes by enterprises in New Zealand. The funding and development of the survey predated the voluntary moratorium on new trials of genetically modified products that was initiated on 14 June 2000. 2.10 Recruitment from Overseas Respondents indicated that staff shortages are a barrier to development. Of these 27 attempted to recruit staff from overseas. Table 2.13 Recruitment from Overseas. Questions Recruited from overseas Responses 27 Country of origin Australia 9 Asia 6 Europe 15 USA 12 Other 6 Twenty-four of the 27 enterprises which successfully recruited from overseas were in the scientific research and tertiary education industrial groupings. Seven respondents indicated that they were unable to recruit staff from overseas. The largest given cause of the failure to attract overseas staff was the inability to match the salaries being offered by overseas enterprises. Modern Biotechnology Activity in New Zealand 27 3.00 Survey and Methodology This chapter describes the survey methodology used for the Biotechnology Survey. 3.01 Criterion for Selecting the Survey Population Enterprises selected for the survey were those that fitted the following two categories: • • Units whose predominant activity was likely to be modern biotechnology. Units whose predominant activity was not modern biotechnology, but who were considered likely to engage in some modern biotechnology activity. The approach was adopted because modern biotechnology is a process that cannot be tied into an industrial classification as set out in the Australia and New Zealand Standard Industrial Classification (ANZSIC)10. Experiences of other statistical offices that have attempted to measure the activity have found that the users of modern biotechnology are likely to be spread over a range of industrial classifications. The following set of criteria was constructed with the assistance of the expert panel, drawing on the experience of overseas statistical offices that have attempted to measure biotechnology activity. Criterion one: units whose predominant activity is likely to be modern biotechnology. This category includes 1) All enterprises on Statistics New Zealand’s Business Frame with any of the following key words in their legal and or trading name: • Bio-informatics • Bioprocessing • Bioreagent • Biotechnology • Biotransformation(s) • Chromatography • Clonal • Concentrates • Extract • Extraction • Fluid Extraction • Functional Foods • Genetic(s) • Genomic(s) • Industrial Microbiology • Monoclonal • Nutraceutical(s) 10 Please refer to the glossary at the end of the report for a description of the Australia and New Zealand Standard Industrial Classification. 28 • • • Modern Biotechnology Activity in New Zealand Proteomic(s) Supercritical Transgenic. 2) Enterprises whose names appear on the Biotenz membership list. 3) Enterprises whose names appear on the New Zealand Biotechnology Association’s membership list. 4) All institutions whose names appear on the 1997 and/or 1998 Foundation of Research, Science and Technology (FoRST) lists of applicants receiving funding to carry out biotechnology related research and/or development activity. 5) Local authority sewerage treatment facilities 6) Crown research institutes (CRIs). 7) University departments that have an interest in biotechnology 8) Microbiology units in metropolitan hospitals. 9) The New Zealand Blood Service. 10) Institutions on the Health Research Council list of funding contracts for the support of biotechnology-related research and/or development activity. Criterion two: Businesses whose predominant activity is not modern biotechnology, but who are likely to engage in some modern Biotechnology activity. This category includes 1) All enterprises on Statistics New Zealand’s Business Frame with any of the following key words in their legal and/or trading name: • Biological • Bioscience(s) • Diagnostics • Health • Life Science(s) • Pharmaceutical(s) • Pharmaceutics • Science(s) • Scientific • Serum. All enterprises that have geographic units11 on Statistics New Zealand’s Business Frame with one of the following ANZSIC codes. These industries were identified as most likely to make use of biotechnology processes: • A0301 Forestry • B1101 Black Coal Mining • B1200 Oil and Gas Extraction • C2121 Milk and Cream Manufacturing 2) 11 Please refer to the glossary at the end of the report for a definition of a geographic unit. Modern Biotechnology Activity in New Zealand • • • • • • • • • • • • 29 C2122 Ice Cream Manufacturing C2129 Dairy Product Manufacturing C2161 Bread Manufacturing C2182 Beer and Malt Manufacturing C2183 Wine Manufacturing C2331 Pulp, Paper and Paperboard Manufacturing C2543 Medicinal and Pharmaceutical Product Manufacturing C2544 Pesticide Manufacturing L7810 Scientific Research L7829 Technical Services nec O8431 Higher Education O8611 Hospitals. 3.02 Creation of the Survey Population The various membership lists were not always fully up to date, so they were matched against the Statistics New Zealand Business Frame to identify those units that were no longer functioning. These were removed from the survey population. Enterprises that fitted criterion two were selected from the Statistics New Zealand’s Business Frame with information on the number of full time equivalent employees and the level of GST sales income activities. Those enterprises whose GST sales were less than $5 million per annum were removed from the list of potential respondents to the survey. Modern biotechnology is a capital-intensive activity. Enterprises, whose predominant activity is not modern biotechnology, will require a cash flow that will be sufficient to finance the capital requirements of both their predominant and modern biotechnology. The $5 million GST sales cut-off is consistent with the cut-off applied by other statistical offices that have attempted to measure biotechnology activity. Enterprises that fitted criterion one were assumed to be enterprises whose predominate activity was biotechnology, so, the $5 million GST sales cut-off was not applied to those units. A list of enterprises that met the criterion listed above was then drawn up. The enterprises were then contacted to see if they were involved in modern biotechnology activity. Those that indicated that they did not undertake modern biotechnology activity were removed from the survey population. The pre-notification phone call also enabled the identification of the staff member(s) who were best able to complete the questionnaire. 3.03 Survey Response Rate Questionnaires were sent to 426 enterprises. The diverse nature of departments at universities and hospitals made it difficult for one person to complete the questionnaire on behalf of the whole organisation, and as a result some universities and hospitals completed more than one questionnaire. The survey achieved a 98.3 percent response rate. Of the enterprises that responded to the survey 42 percent or 180 enterprises indicated that they used at least one biotechnology process. All known significant participants in the activity responded to the survey. 30 Modern Biotechnology Activity in New Zealand The main emphasis of the respondent follow up process, was on those enterprises whose predominant activity was modern biotechnology. The enterprises whose predominant activity was not modern biotechnology were also included in the respondent follow up process, but were given a lower priority. The responses could not be obtained from seven enterprises in this category. No imputation was made because only a small percentage of these enterprises would be involved in modern biotechnology. 3.04 Classification of Biotechnology Processes Modern biotechnology is a process. This differentiates it from an industry or an output that would fit into a standard industrial classification used by statistical offices. Fifty-eight biotechnology processes were listed in the questionnaire. The processes and the groupings are based on the experience of overseas statistical offices and the advice of an expert panel. The expert panel validated the use of the processes in New Zealand and the classification of the processes within each group. The processes were grouped as indicated in Table 3:01. Table 3.01 Classification of Biotechnology Processes Classification Biotechnology processes DNA based: technologies using the chemistry of Genetic engineering/recombinant DNA as a major component DNA, gene probes Bio-informatics Genomics Pharmacogentics DNA sequencing DNA synthesis DNA amplification Gene therapy Rational drug design Peptide synthesis Biochemistry/immunochemistry based: Vaccines technologies, which utilise Immune stimulants immunochemistry/antibodies or enzymes as a Drug design and delivery major component Combinational chemistry Diagnostic tests Peptide/protein sequencing Cell receptors Cell signalling Bio-sensing Pheromones Three dimensional molecular modelling Structural biology Antigens Monoclonal antibodies Microbiology/microbial ecology Biomaterials Environmental biotechnologies: technologies Bioaugmentation used for pollution control Bioreactors Biological gas cleaning Bio-remediation Phytoremediation Modern Biotechnology Activity in New Zealand 31 Table 3.01 Continued Classification Bioprocessing based: technologies that process any natural material or material of biological origin Biotechnology processes Cell culture Tissue culture Embryo culture Cell manipulation Tissue manipulation Embryo manipulation Fermentation Bioprocessing Biotransformation Bio-leaching Biopulping Bio-bleaching Bio-desulphurisation Bio-pesticide manufacturing Extraction/concentration/purification/separation Biofiltration Bioindicators Micro-selected breeding of plants and animals Micro-inoculates Somantic embryo-genesis 3.05 Classification of Activities Utilising Biotechnology Output The processes developed by modern biotechnology activity can be applied to a range of outputs. Therefore, the analysis of this activity takes place outside the statistical industry-based framework that a statistical agency will typically use. Hence, a framework for classifying the output of the activity was created. The framework is based on the classification of the activities that utilise the output of the enterprises involved in the activity. This differs from a standard statistical classification for an industry that centres on the characteristics of the commodities produced by the industry. As noted above, the output produced from modern biotechnology activity can be used across a range of activities. In order to classify the output of modern biotechnology it is necessary to link its output to an activity in which it is used. Set out below is a classification framework for the output of modern biotechnology that links output to the activity in which it is used. The classification system is based on the experience of overseas statistical offices and has been validated by members of the expert panel. 1) Human health biology a) Diagnostics b) Therapeutics c) Gene therapy 2) Bio-informatics a) Genomics and molecular modelling 3) Agricultural biology a) Plant biotechnology 32 Modern Biotechnology Activity in New Zealand b) Animal biotechnology c) Biofertilisers/biopesticides/bioherbicides/biological feed additives/microbial pest control d) Non-food applications of agricultural products 4) Food processing a) Brewing/wine producing b) Baking c) Dairy d) Functional foods/nutriceuticals 5) Aquaculture a) Fish health b) Broodstock genetics c) Bioextraction 6) Mining/energy/petroleum/chemicals a) Microbiologically enhanced petroleum/mineral recovery b) Cleaner industrial processing in mining; petroleum; and chemical production 7) Forest products a) Silviculture b) Cleaner industrial processing of forest products 8) Environment a) Biofiltration b) Bioremediation and phytoremediation c) Diagnostics c) Custom synthesis - chemical or biological 9) Other 3.06 Industrial Groupings for Classifying Respondents to the Survey Each enterprise in the survey was assigned to one of eight industry groupings using the Australian and New Zealand Industrial Classification (ANSZIC) for it on the Statistics New Zealand Business Frame. The industry groupings were created by combining together groups of industries, which are likely to be using processes in a similar way. The industrial groupings were developed to take into account the context in which the processes were utilised, for example, enterprises in the food manufacturing group are likely to be utilising biotechnology processes differently from enterprises in the health services group. The industrial groupings were also constructed in order to protect the confidentiality of the respondents of the survey. Modern Biotechnology Activity in New Zealand Table 3.02 Industry Groupings for the Analysis of the Results of the Survey. Three digit ANZSIC classification A021 Services to Agriculture A030 Forestry & Logging B120 Oil & Gas Extraction C211 Meat and Meat product Manufacturing C212 Dairy Product Manufacturing C215 Flour Mill and Cereal Food Manufacturing C216 Bakery Product Manufacturing C217 Other Food Manufacturing C218 Beverage and Malt Manufacturing Industrial grouping Primary Products Food Manufacturing C233 Paper and Paper Product Manufacturing C253 Basic Chemical Manufacturing C254 Other Chemical Manufacturing C272 Basic Non-ferrous Metal Product Manufacturing Non-food Manufacturing L781 Scientific Research L782 Technical Services Scientific Research M811 Government Administration Government Administration Tertiary Education Health Services N843 Post School Education O861 Hospitals and Nursing Homes O863 Other Health Services D370 Water Supply, Sewerage and Drainage Services F452 Mineral, Metal and Chemical Wholesaling F471 Food, Drink and Tobacco Wholesaling F479 Other Wholesaling L785 Marketing and Business Management Services O864 Veterinary Services P923 Parks and gardens Q952 Other Personal Services Q963 Public Order and Safety Services Other 33 34 Modern Biotechnology Activity in New Zealand Appendix 1 Post Survey Study Introduction This appendix summarises the results of the post survey study (PSS) of the Biotechnology Survey 1998/99. The complete study report will be published separately. The purpose of the Biotechnology Survey PSS was to assess the quality of survey data. It involved checking and clarifying answers from a sample of 50 businesses selected from those that returned questionnaires. Why Carry Out a Post Survey Study? Two main reasons prompted Statistics New Zealand to undertake the study. Firstly, there has been limited international experience with conducting biotechnology surveys. As with any of our surveys, Statistics New Zealand carries out a range of testing to try to ensure that the questionnaire will meet the data needs and be easily and consistently understood by respondents. However, despite this testing, Statistics New Zealand was still concerned that some questions may not have been consistently understood by respondents, in particular from the perspective of modern biotechnology. Secondly, the absence of any single ANZSIC category describing this industry meant that it was necessary to ask a series of filter questions in the questionnaire to assist in determining the survey population. As with any collection, which relies on a survey population developed in part from industry lists as well as survey questions, there was a risk that the survey population would not be an accurate representation of the true population engaged in modern biotechnology. The study gave Statistics New Zealand an opportunity to assess whether the filter questions were correctly screening the survey population. Post Survey Study Methodology The PSS was based on a sample of 50 businesses. These were selected from among those who completed and returned their survey questionnaires. For the purpose of sampling, the respondents to Biotechnology Survey population were classified into ten groups based on their industry activity. Approximately five units were selected from each group to represent both biotechnology businesses and those which did not carry out biotechnology activities. In the sample, about one-half of the units were active biotechnology businesses, while the rest were not. The people who completed the survey questionnaire in the selected businesses were contacted by phone to request their assistance as part of a survey audit. An indirect approach to checking their answers was used. This involved asking a description of their business activity combined with probing to determine whether their business was actively engaged in modern biotechnology. Modern Biotechnology Activity in New Zealand 35 The key areas checked were involvement of the business in modern biotechnology, the activity which respondents indicated utilised their biotechnology output, business income and expenditure, staff numbers involved, biotechnology partnerships and problems in commercialising biotechnology. Three types of analyses were done of the activities of biotechnology businesses. Firstly, they were analysed in order to determine whether or not each unit was actively involved in modern biotechnology. Secondly, the processes used by the business were checked to see if they were consistent with the definition of modern biotechnology used in the survey questionnaire. Finally, the information on the output produced by the business was used to derive the bio-industry sector applicable to the business. This information, together with other data relevant to the biotechnology operations of the business, was compared with what the survey had produced for the same unit. These comparisons revealed whether or not the survey data were different from the PSS and if so the extent to which the data from two sources deviated from each other. This is the first post survey study of an economic survey that has been done by SNZ or other statistical offices, so there is no benchmark for determining the significance of the difference between the two responses. It is likely that the differing collection methodologies and the use of two surveys to collect information would have produced some variation in the results, although this cannot be measured. Key Findings The PSS showed that the Biotechnology Survey collected a large amount of useful information on modern biotechnology activity in New Zealand. However, there were some questions that were not answered well by respondents and these are discussed below. Firstly, the results of the PSS showed that some respondents in the survey were uncertain as to whether the biotechnology processes they used fitted into the definition of modern biotechnology in the survey questionnaire. As a result, estimates of the size of the modern biotechnology activity should be treated with care. Secondly, the PSS showed that the respondents had considerable difficulty in isolating and measuring the financial and human resources that businesses devoted to modern biotechnology from the rest of their business activity. This suggests care should be taken when interpreting quantitative data presented in the main report. These issues raised by the PSS should be taken into account when interpreting the results of the survey. 36 Modern Biotechnology Activity in New Zealand Data Quality Issues The PSS has identified six areas of concern. These issues are listed in the order that they appear in the questionnaire: • • • • • • Identifying modern biotechnology Classification of output Biotechnology partnerships Income and expenditure Number of biotechnology staff Problems in commercialising biotechnology. Identifying Modern Biotechnology Of the 50 enterprises in the PSS, 18 enterprises reported involvement in modern biotechnology. A further 18 enterprises reported involvement in modern biotechnology when responding to the survey. However, only 15 enterprises indicated in both the survey and the PSS that they were involved in modern biotechnology. This occurred because three enterprises who indicated that they were not involved in modern biotechnology in the survey, were recorded in the PSS as being involved in modern biotechnology. Similarly three businesses which reported in the Biotechnology Survey that they were involved in modern biotechnology, were not involved in modern biotechnology according to the PSS. Accordingly, some care needs to be taken when interpreting finer level breakdowns. The variance noted above was mainly caused by the use of modern biotechnology processes as a minor element of the processes used by the enterprise. Hence, enterprises were more likely to see themselves as not being involved in modern biotechnology. At an overall level, the total number of businesses engaged in modern biotechnology as shown by the survey is probably about right. Classification of Output The PSS results indicated that seven businesses had misclassified the activity that utilised their biotechnology output. The misclassified sectors were related to forestry, the environment and other activities. This was due to respondents not being able to classify the most appropriate activity that utilised their output. As with the level of biotechnology activity discussed earlier, there were no biases in any one direction. Biotechnology Partnerships The study had a sample of 50 enterprises. In the survey 10 of these reported 16 biotechnology partnerships. The PSS identified 18 enterprises, which had 22 biotechnology partnerships. The PSS differed from the Biotechnology Survey at least in two areas. Firstly, the PSS identified several new types of partners such as research associations, overseas consortiums, international institutions, etc not listed in the survey questionnaire. Modern Biotechnology Activity in New Zealand 37 Secondly, some enterprises did not report all their partnerships in the survey. What the above suggests is that the survey data did show some of the broader types of partnerships, but understated the complexity of the partnership types and their combinations. Income and Expenditure: The PSS found income and expenditure estimates for seven out of nine biotechnology businesses were significantly different between the survey and the study. The PSS highlighted difficulties encountered by respondents in providing accurate estimates of income and expenditure on modern biotechnology. The reason for the difficulty is twofold. Firstly, the relevant figures are not recorded separately in enterprise accounts. Secondly, the biotechnology processes used by enterprises are closely integrated with the other activities carried out by the enterprise and were not easily separated from the remainder of the processes used by the enterprise. The values of income and expenditure published in the report are based on estimates by respondents. Therefore they should be treated with care, especially when desegregated. Number of Biotechnology Staff The PSS revealed that staff numbers and full-time equivalent staff were different for 11 out of 18 biotechnology businesses. As with other variables, the deviations between the survey and the PSS were not biased. Respondents reported that their difficulties arose from two factors: i) Their staff worked on a range of tasks, which supported both modern biotechnology activity and other activities. The systems used for recording the hours worked by staff did not separately record time spent on modern biotechnology activity. ii) The biotechnology processes used by enterprises are closely integrated with the other activities carried out by the enterprise and were not easily separated from the remainder of the processes used by the enterprise. These factors made it difficult for respondents to measure the human resources devoted to modern biotechnology activity and so care should be taken when interpreting the results in this report. 38 Modern Biotechnology Activity in New Zealand Problems in Commercialising Biotechnology The PSS suggests that the range of problems encountered in commercialising biotechnology may have been understated by some respondents, while for others the problems may have been overstated. This question involves an element of opinion, so the response will vary depending on circumstance. The deviations between the survey and the PSS were unbiased. Conclusions The PSS found that some respondents may have misinterpreted the definition of modern biotechnology leading to a situation where some units were excluded from the results of the survey where they may have been included and vice versa. However, the significance of the coverage issue is hard to measure. The PSS highlighted the difficulty some respondents had in separating their involvement in modern biotechnology activity from the other activity carried out by their enterprise. This resulted in estimates being made of the human and financial resources devoted to modern biotechnology. It is likely that the differing collection methodologies for the Biotechnology Survey and the PSS, and the use of two surveys to collect the same information would have lead to variance in the information that was gathered by the two surveys. However, the information gathered by the PSS has enabled further analysis of the survey results, which would not have been possible without the study. The issues raised by the PSS should be taken into account when interpreting these results. Modern Biotechnology Activity in New Zealand Appendix 2 Supplementary Tables Table A2 Distribution of Biotechnology Processes DNA based Number of responses Bio-informatics 54 DNA amplification 69 DNA sequencing 48 DNA synthesis 39 Genetic engineering/recombinant DNA 45 Gene probes 60 Gene therapy 3 Genomics 42 Other DNA based 3 Pharmacogenetics 9 Rational drug design 15 Total 393 Biochemistry/immunochemistry based Number of responses Antibodies Antigens Bio-sensing Biomaterials Cell receptors Cell signalling Combinatorial chemistry Diagnostic tests Drug design Immune stimulants Microbiology Molecular modelling Monoclonal antibodies Other biochemistry Peptide sequencing Peptide synthesis Pheromones Structural biology Vaccines Total Environmental biotechnologies Bio-reactors Bio-remediation Bioaugmentation Biological gas cleaning Other environmental Phytoremediation Total 78 63 39 63 39 33 9 75 18 39 117 24 60 3 36 15 12 30 27 786 Number of responses 57 42 48 12 3 36 192 39 40 Modern Biotechnology Activity in New Zealand Table A2 Continued Bioprocessing based Bio-bleaching Bio-desulphurisation Bio-leaching Bio-pesticide manufacturing Bio-pulping Biofiltration Bioindicators Bioprocessing Biotransformation Cell culture Cell manipulation Micro-selected breeding Embryo culture Embryo manipulation Extraction Fermentation Microbio-inoculants Natural products Other bioprocessing Somatic embryo-genesis Tissue culture Tissue manipulation Total Number of responses 3 0 0 18 3 42 75 39 48 102 39 15 18 12 69 57 6 60 3 12 66 27 714 Table A3 Use of Biotechnology Processes by Stage of Development Industrial groups R&D Production process Product Sold R&D Production process Product Sold R&D Production process Product Sold Bioprocessing based technologies R&D Production process Product Sold 6 6 0 0 0 0 6 33 3 51 0 24 0 9 0 27 0 6 9 42 9 87 6 30 6 105 0 219 15 6 360 0 18 0 24 15 3 63 0 9 0 9 12 0 33 45 183 3 261 33 12 579 45 48 15 24 96 12 297 36 21 6 6 72 3 168 9 30 3 24 0 0 81 12 9 66 6 0 9 135 6 12 3 0 0 3 30 51 147 3 210 21 9 489 45 48 63 39 39 15 348 27 24 6 21 21 3 141 Modern Biotechnology Activity in New Zealand Primary Production Food Manufacturing Non-food Manufacturing Scientific Research Local Government Tertiary Education Health Services Other Total Biotechnology processes Biochemistry/immunochemistry Environmental technologies based technologies DNA based technologies 41 42 Modern Biotechnology Activity in New Zealand Table A4 Use of Biotechnology Processes by Stage of Development and Institutional Sector Biotechnology processes DNA based biotechnologies Institutional sector Research and product/process development Central government Local government Private sector Total 285 0 72 360 51 0 12 66 27 0 3 33 387 6 183 579 135 18 147 300 75 6 84 168 42 3 33 81 12 75 45 135 3 3 24 30 324 9 159 489 117 69 162 348 48 6 84 141 Biochemistry/immuno chemistry based Central government biotechnologies Local government Private sector Total Environmental Central government biotechnologies Local government Private sector Total Bioprocessing based Central government biotechnologies Local government Private sector Total Part of the production process Part of product sold Table A5 Distribution of the Industrial Classification of Output by Institutional Sector Activity Human health biotechnology Bio-informatics Agriculture biotechnology Food processing Aquaculture Mining/energy/petroleum/chemicals Forest products Environment Other Total Private Central Local sector government government enterprises enterprises enterprises 33 6 45 57 9 3 9 30 12 210 75 33 54 24 27 3 9 45 12 282 0 0 6 0 0 0 0 60 3 66 Total 108 39 102 81 39 6 18 135 27 555 Modern Biotechnology Activity in New Zealand 43 Appendix 3 Glossary of Terms Biotechnology process DNA based Genetic engineering Gene probes Bio-informatics Genomics Pharmacogenetics DNA sequencing DNA syntheses DNA amplification Gene therapy Rational drug design Description Technology using chemistry of DNA as a major component. The manipulation of an organism’s genetic endowment by modifying, introducing or eliminating specific genes through modern molecular biology techniques. A section of DNA of known structure or function which is marked with a radioactive isotope, dye or enzyme so that it can be used to detect the presence of a similar sequence from any biological material. Computer-based analysis of biological information (bio-info) especially genomics and molecular modelling (eg DNA/RNA/protein sequencing and databases for humans, plants animals and micro-organisms). The use and organisation of information of biological interest, including the construction and analysis of genes, that may be used to search for new genes of interest, matching existing genes, etc. The study of the genetics of drug production or action or assimilation. A method to determine the order of nucleotides on a DNA fragment or molecule. Design and synthesis of DNA molecules from existing information of its constituent bases. Process of increasing the number of copies of a particular gene or chromosomal sequence. Replacement of a defective gene in a organism suffering from a genetic disease. Analysis of the structures of active sites of enzymes and receptors in order to design pharmacologically active synthetic molecules. 44 Modern Biotechnology Activity in New Zealand Glossary of Terms Contd. Biotechnology process Biochemistry/immunochemistry-based Vaccines Immune stimulants Drug design and delivery Combinatorial chemistry Diagnostic tests Peptide/protein sequencing Peptide/protein synthesis Cell receptors Cell signalling Biosensing Description Technology utilising Immunochemistry (antibodies) or enzymes as a major component. The agent containing antigens produced from killed, attenuated or live pathogenic microorganisms or parts of micro-organisms used to stimulate the immune system to protect the host. Compounds that induce the immune system to produce antibodies or antibody containing lymphocytes. Development of drugs where the raw materials and/or processes involve the use of Biotechnology. An approach to chemical synthesis that enables the creation of large numbers of organic compounds by putting chemical building blocks together in every possible combination. It is used to synthesise compounds, which are screened, or tested, against biological targets as part of the drug discovery process. A test used to determine the source of a problem, or the method of determining the nature of a disease by analysing the symptoms. The process of determining the sequence of a polypeptide or cluster of polypeptides, or the process of creating a new substance from precursor molecules. Procedure to link two or more amino acids joined by linkage called a peptide bond. Functional proteinaceous structures found in the membrane (surface) of cells that tightly bind specific molecules (organic, protein or viruses). This binding often causes a chain of events to occur within the cell. The mechanism used by cells to induce or trigger events at remote sites within cells. Use of a biological molecule eg enzymes, antibodies in the conjunction with a transducer to a low-level detection of substances such as sugars and proteins in body fluids, and pollutants in water etc. Modern Biotechnology Activity in New Zealand 45 Glossary of Terms Contd Biotechnology process Pheromones Three dimensional molecular modelling Structural biology Antigens Monoclonal antibodies Antibodies Microbiology/microbial ecology Biomaterials Environmental biotechnologies Bio-augmentation Bio-reactors Description Compounds emitted by insects and spread through the air for the purpose of attracting the opposite sex. Description of the characteristics of molecules through a three dimensional spatial representation. The study of the three dimensional structures of biological molecules (such as proteins) and their mutual interactions as a means of understanding the functions of these molecules within the cell. A substance that stimulates the production of specific neutralising antibodies in an immune response. Any chemical substance, usually protein, that interacts with an antibody. A monoclonal antibody is a highly specific antibody which is derived from a line of cells and which recognises only one specific complimentary antigen. Proteins that circulate in the blood stream and bind to foreign invading substances (antigens) (eg bacteria, toxins, certain viruses) with a great deal of specificity. Study of organisms that are too small to be seen with the naked eye. Any biologically derived material which is used for its material properties rather than its biological properties. Group of five biotechnologies used for pollution control: bio-augmentation, bio-remediation, bioreactors, phytoremediation, and biological gas cleaning. The process of increasing the efficiency of the naturally occurring microbial population to concentrate or accumulate specific compounds. This is usually achieved by adding nutrients, oxygen or water. Enclosed containers in which micro-organisms are maintained under controlled conditions for the purpose of creating or destroying specific compounds. 46 Modern Biotechnology Activity in New Zealand Glossary of Terms Contd Biotechnology process Biological gas cleaning Bio-remediation Phytoremediation Bioprocessing based Cell culture Tissue culture Embryo culture Cell manipulation Tissue manipulation Embryo manipulation Fermentation Bioprocessing Biotransformation Bio-leaching Bio-pulping Bio-bleaching Description The use of micro-organisms to breakdown or degrade hazardous substances in a gas stream into less hazardous or non-toxic substances. The use of naturally occurring or genetically modified micro-organisms to breakdown or degrade hazardous substances into less hazardous or non-toxic substances. The use of plants to treat or clean environmental pollution. The processing of any natural material of biological origin. A population of cells grown for microbiological testing, cell culture development, to study their structure, or to manufacture products. A technique for growing cells from multicellular organisms in a liquid medium. The ability to grow and modify a range of tissue types under laboratory conditions. Ability to grow and modify a range of cell types under laboratory conditions. Ability to grow and modify a range of tissue types under laboratory conditions. Ability to grow and modify a range of embryo types under laboratory conditions. Micro-organic process in which the metabolism of sugars for energy is accompanied by the formulation of alcohol and/or lactic acid and solvents. Includes processes such as wine, cheese and yoghurt making, brewing, yeast production etc. Production stages that include fermentation, recovery and purification. Conversion of one chemical or material into another using a biological catalyst. Use of micro-organisms to leach metals from ore. The use of enzymes to degrade wood structures to produce pulp for papermaking purposes. The use of enzymes to bleach paper fibre. Modern Biotechnology Activity in New Zealand 47 Glossary of Terms Contd Biotechnology process Extraction/concentration/purification/ separation Biofiltration Bio-indicators Micro selected breeding of plants and animals Natural products chemistry Microbio-inoculants Biosensing Bio-pesticide Somatic embryo-genesis Description The retrieval of a compound of interest from a raw material eg plant chemicals, herbal extracts, and milk fractions. The treatment of sewage or industrial wastewaters using active biomass growing on a solid support. The use of organisms to indicate the status of an environment. Use of biotechnology processes to accelerate natural selection. The study of a biological material or biological-derived material using chemical methods, normally being the isolation and identification of the chemicals within a biological material. Naturally occurring bacterial inoculates used to promote plant growth. Process that uses a biological molecule eg enzymes, antibodies in conjunction with a transducer to low level detection of substances such as sugars and proteins in body fluids, pollutants in water etc. Biological pest control through the use of naturally occurring microbes or bacteria. Propagation of genetically desirable plant and tree lineage by tissue culture methods. 48 Modern Biotechnology Activity in New Zealand Classification of Biotechnology Activity Output Activity Human health – biotechnologies • Diagnosis • Therapeutics/pharmaceuticals • Gene therapy Bio-informatics Genomics and molecular modelling Agricultural - biotechnology Plant biotechnology Animal biotechnology Biofertilizers/biopesticides/bioherbicides/ biological feed additives/microbial pest control Non-food applications of agricultural products Food processing Bioprocessing in brewing, baking dairy etc Functional foods/nutriceuticals Whole natural products Aquaculture Fish health Broodstock genetics Bioextraction Mining/energy/petroleum/chemicals Microbiologically enhanced petroleum/ mineral recovery Examples Immunodiagnostics, gene probes, biosensors Vaccines, immune stimulants, biopharmaceuticals, rational drug design, drug delivery, combinatorial chemistry, production, extraction and purification of phytopharmaceuticals Gene identification, gene constructs, gene delivery DNA/RNA/protein sequencing and data bases for humans, plants, animals and microorganisms Tissue culture, embryogenesis, genetic markers, genetic engineering Diagnostics, therapeutics, embryo transplantation, genetic markers, genetic engineering. Bacteria, fungi, yeasts Natural source chemical pesticides Using enzymes, bacteria and yeast culture Probiotics, unsaturated fatty acids Herbs, bee pollen, velvet or other dietary supplements Diagnostics, therapeutics Tracking superior traits, genetic modification/engineering Carageenan from seaweed, antifreeze proteins from fish, flavours Modern Biotechnology Activity in New Zealand 49 Classification of Biotechnology Activity Output Continued. Industrial processing (cleaner) Biodesulphurization, bio-cracking, biorecovery Forest products Silviculture Industrial processing (cleaner) Environment Biofiltration Bio-remediation and phytoremediation Custom synthesis - chemical or biological Ectomycorrhizae, tissue culture, somatic embryogenesis, genetic markers, genetic engineering Biopulping, biobleaching, biological prevention of sapstain Treatment of organic emissions to air/water Detection of toxic substances using bioindicators, biosensors, immunodiagnostics Peptides, proteins, nucleotides, hormones, growth factors, biochemicals 50 Modern Biotechnology Activity in New Zealand Glossary of Statistics New Zealand Terms Term Enterprise Geographic Unit Statistics New Zealand Business Frame Description An enterprise is a single business entity operating in New Zealand as a legally constituted body such as a: -company -partnership -trust -local government trading organisation -central government trading organisation -incorporated society -sole proprietorship. A geographic unit is a kind-of-activity (KAU) or part of a KAU and is normally an unbroken physical area/site on or from which one or predominantly one kind of economic activity takes place on a permanent basis. Employment and location data must be able to be produced for a geographic unit. The Business Frame is a database of New Zealand businesses and their structure. It records details such as names and addresses, predominant type of industrial activity performed, employment levels, and the degree of overseas ownership. The population for the Business Frame is consists of enterprises who are actively trading and whose annual GST sales and expenses are greater than $30,000. Businesses are identified from the Goods and Services Tax (GST) registrations suplied by the Inland Revenue Department. Australian and New Zealand Standard Industrial Classification (ANZSIC) ANZSIC was jointly developed by by the Australian Bureau of Statistics and Statistics New Zealand. It reflects contemporary economic activity in Australia and New Zealand, and is also closely aligned to the International Standard Industrial Classification. The ANZSIC has a structure comprising categories at four levels, namely divisions (the broadest level), subdivisions, groups and classes (the finest level).The classifications used in the report are at the group level. Modern Biotechnology Activity in New Zealand 51 References 1. Arundel, Anthony, Diffusion of Biotechnologies in Canada, Statistics Canada. 2. 1999, Modern Biotechnology and the OECD, OECD Observer. 3. Food and Agriculture Organisation of the United Nations. 4. Australian Biotechnology-A National Strategy, Commonwealth of Australia 2000. 5. US State Department International Information Programs. 6. New Zealand Biotechnology Association. 7. New Zealand Biotechnology Association website: www.biotech.org.nz. 8. Biotenz website: www.biotenz.org.nz. 9. Kennedy, M J and Yorke, S C 2000, The Status of Biotechnology in New Zealand: An Agricultural and Environmental Perspective, Asia Pacific Tech Monitor, 17(6), 37-41. 10. Kennedy, M J 1999, The Plant-Based Natural Health Product Industry in New Zealand, Primary Industry Management, 2(1), 22-29. 11. Maddox, I S and Gutierrez N A 1996, Biotechnological Developments in New Zealand, Critical Reviews in Biotechnology, 16(2), 119-143. 12. Kennedy, M J and Davies, R J 1994, The Impact of Biotechnology on New Zealand Industry, 1984-1994 A Decade of Rapid Change", SIR Publishing. 13. Kennedy, M J 1993, Biotechnology in New Zealand, Australian and New Zealand Biotechnology Directory, 15-19. 14. Kennedy, M J and Maddox, I 1993, What is Biotechnology?, ALPHA 86, SIR Publishing. 15. Kennedy, M J 1992, The Evolution of the Word Biotechnology, Trends in Biotechnology, 9(7), 218-220, 1991. Reprinted in Trends in Food Science and Technology, 3(7), 154-156. 16. Hunt, D M, Clarke, R T J, Bell, D J, Earle, R L, Joblin, K N and Scott 1983, Biotechnology in New Zealand, DSIR Discussion Paper No 8. 17. Response to parlimentary question from Rod Donald. Foundation of Research Science and Technology (FORST).
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