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AIFA European Conference on Clinical Research for Decision Making
Sergio Dompé - Farmindustria
Rome, March 30th, 2007
Access to market by new medicines and pricing criteria
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 researchIncrease 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
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
Source: ATA
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R&D agreementAssegnee (n° per patent)
BiologyMedicine
ChemistryPhysics
Engineering
BasicResearch
Clinical Research
AppliedResearch
Innovative technology
New medicines
New opportunities for interdisciplinary Research
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BIOLOGICALSRNAi
Genic therapyPharmacogenic-SNP
REWARD INNOVATIONHigher Research costs
Rewarding/incentivizing measuresAd-hoc legislation
INNOVATIONNew cutting-edge technologies
Interdisciplinary Research Competitiveness
Spill-over into other sectors
SOCIO-ECONOMIC IMPACTless hospitalisation (=savings)creating highly-qualified jobs
higher turnover and tax revenuegreater R&D investments generation of R&D clustersPrivate-Public Partnerships
The virtuous Research cycle
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Source: ATA
Highly interconnectednetwork
Strong presenceof the private sectorin the clusterin the coming years
OPPORTUNITIES
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2006
Milan: an example of a cluster of excellence in scientific Research
Source: ATA
The value of innovation includes
- Pharmacological and technological innovation
- greater efficacy and tolerability
- greater conformity to treatment
- better life quality
Breakthrough Innovation
Incremental Innovation
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
Therapeutic and clinical value
Quality of life
Social value
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.
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
"Rewarding" reimbursement mechanisms:
• time to market
• price determination
• tax system and R&D incentives
A stable legislative and regulatory framework, at a national and community level, to allow faster access to innovationand the recognition of its added value.
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A pricing system to give leverage toResearch and Innovation
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
To enhance Research
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
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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
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
It is necessary to work towards a competitive re-equilibrium of the industry in Italy
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 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).
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.
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