AIFA European Conference on Clinical
Research for Decision Making
Access to market by new medicines
and pricing criteria
Sergio Dompé - Farmindustria
Rome, March 30th, 2007
The discovery of new medicines
Higher investments, lower
"productivity", and higher
rates of failure.
Increased costs of clinical and
general research to make new
active ingredients available.
Considerable medical progress:
the focus is now on more
complex areas and
Research requires time
Re-launch innovation is important.
Pursuing projects and making the products accessible
in Italy and in Europe is equally important.
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Specific new challenges facing research
Increase in innovative -medicine research costs (up to € 1 billion)
Heightened complexity levels of R&D projects
Higher degree of specialisation and division of innovative work on a worldwide scale
Assegnee (n° per patent)
R&D agreement
Source: ATA
The challenge is represented by the greater need for health.
The tools to deal with it:
greater commitment by the Companies, the development of new
technologies and synergies for the life sciences, the creation of a network of
skills, dialogue and cooperation with the institutions for a win-win strategy
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New opportunities for interdisciplinary
Research
New medicines
Chemistry
Physics
Biology
Medicine Engineering
Applied
Research
Innovative
technology
Clinical
Research
Basic
Research
3
The virtuous Research cycle
BIOLOGICALS
RNAi
Genic therapy
Pharmacogenic-SNP
SOCIO-ECONOMIC IMPACT
less hospitalisation (=savings)
creating highly-qualified jobs
higher turnover and tax revenue
greater R&D investments
generation of R&D clusters
Private-Public Partnerships
REWARD INNOVATION
Higher Research costs
Rewarding/incentivizing measures
Ad-hoc legislation
INNOVATION
New cutting-edge technologies
Interdisciplinary Research
Competitiveness
Spill-over into other sectors
Source: ATA
4
Milan: an example of a cluster of
excellence in scientific Research
2006
Highly interconnected
network
Strong presence
of the private sector
in the cluster
in the coming years
OPPORTUNITIES
Source: ATA
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The value of innovation includes
Breakthrough Innovation
Incremental Innovation
- Pharmacological and technological innovation
- greater efficacy and tolerability
- greater conformity to treatment
- better life quality
Apart from breakthroughs, innovation should be considered
a continuous and multi-dimensional process (not duplication but evolution),
an often cumulative development of many different actions and incremental
improvements, including small incremental steps
Innovation is not an absolute value
(“black or white”, “it is or it isn't”)
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How many values for innovation
Effective medicines for diseases
not adequately treated or which,
in terms of the therapeutic
index, improve available
treatments.
Clinical advantages, such as side
effects reduction, higher efficacy
vis à vis existing treatments,
better compliance.
Therapeutic and
clinical value
Quality of life
Innovation
Social value
This means public health,
measured in terms of economic benefits,
such as medicines that can guarantee
improvements for society (e.g. avoiding
surgery, reducing hospitalization, slowing
down the degenerative process of diseases)
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Incentives to generate innovation
with social value
A stable legislative and regulatory framework, at a national and
community level, to allow faster access to innovation
and the recognition of its added value.
"Rewarding" reimbursement mechanisms:
• time to market
• price determination
• tax system and R&D incentives
8
A pricing system to give leverage to
Research and Innovation
To enhance Research
Multi-year agreement, that quantifies the commitment of
companies, according to investments in preclinical and clinical
research, production and exports, as well as the therapeutic value
and growth in the portfolio of reimbursable products.
For innovative products prices, reimbursement and access times
comparable with those of the main European countries
While the reference price
should be avoided, as it penalises the patients, limits the physician's
choice, only creates short-term savings, refers only to the commercial
aspect of medicines and belittles their industrial and research aspects
9
Tax system and research incentives
In the pharmaceutical sector, research is funded for more than 90% by
companies (through their profits).
In Italy profitability is squeezed by price cuts, high costs and the
differential taxation applied to the industry
It is necessary to work towards a competitive
re-equilibrium of the industry in Italy
The tax credit provided for by the Finance Act is a first positive signal
important but still not sufficient to bridge the gap with other countries
Reinforcing tax relief on R&D investments either private
or those made to comply with public sector commissions
(for which a 50% rate can be expected)
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Innovation must be placed at the
centre
Innovation must be given leverage, and correct recognition and it
should be able to count upon adequate resources.
Its evaluation cannot be based on its financial compatibility with the
Health System, that is, exclusively in terms of budgetary constraints
and without a cost/benefit approach.
Innovation cannot ignore the European context in terms of price,
reimbursement and access times.
The commitment of all the actors in the Innovation System must go in
the same direction and the state’s medicine policy must constantly
provide incentives for companies that invest, in order not to nullify the
efforts made (and waste resources).
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