February 2005
Summary
Réalités industrielles
Medication and innovation: Making the new French model
Complete issue
Avant-propos
By Jean-Pierre Raffarin
Premier Ministre
Une industrie en pleine mutation
Pharmaceutics : The role of innovation
By Jean-Michel Yolin
Conseil général des Mines
Pharmaceutical firms’ activities involve quite different but complementary persons and parties depending on the chain, from innovation to the marketplace, for developing drugs. Reinforcing France’s attractiveness calls for interventions in phases upstream in the development process. A network of start-ups is a major condition for the installation of pharmaceutical firms, whose major activity consists in bringing to the market innovative molecules discovered by start-ups.
Research and drugs: Scientific revolutions and the multiform evolution of firms
By Bernard Lemoine
Vice-Président délégué du Leem (Les entreprises du médicament)
A new scientific era is opening in drug research. Greater complexity, the exploding costs of developing new products and the necessity of a multidisciplinary approach all have implications for the structure of companies and the organization of research. Despite quite real advantages, France, we must admit, does not have a “pole of excellence” capable of positioning itself internationally and helping the drug industry benefit from a host of new companies innovating in ground-breaking techniques.
The future of European research in pharmaceutics
By Jean-François Dehecq
Président-Directeur général, Sanofi Aventis
Europe has a strong scientific base but lends too little support to research and scientists. The prospects for research in pharmaceutics depend on fairly remunerating innovation, which must be seen as an investment instead of a cost. Innovation is a source of competitive advantages. The competitiveness of industry and public health are complementary, not incompatible, objectives.
Les défis à relever
Earlier access to medication
By Patrick Le Courtois
Agence européenne pour l'évaluation des médicaments (EMEA)
Thanks to a recent modification of EU pharmaceutical regulations and new administrative practices, in particular, the centralized procedure of the EU Agency for the Evaluation of Medical Products (in charge of testing biotechnological products), patients will be able to obtain new drugs more quickly. Time will be saved, in particular, during the phases before and after the authorization for commercializing a new product.
Integrating clinical research in oncology in a European Research Area
By Véronique Diéras et Pierre Bey
Institut Curie
Clinical research is a key to transferring data from basic research toward practices in clinics. It is also a key to improving biological and medical knowledge, and developing new therapeutic strategies while offering patients the best guarantee of safety and efficacy. Furthermore, clinical research plays a major federative role. Support for it via public funds is indispensable. In France, the National Cancer Institute could be used for this aid and for funding projects in the framework of “canceropole networks of excellence”.
What if France were no longer but a counter for distributing medication?
By Francis Fagnani
Cemka-Eval
François Saint-Cast
Cemka-Eval
Sabine Gadenne
Cemka-Eval
Jean-Luc Hertz
Laboratoire Sanofi-Aventis
et Véronique Ameye
Laboratoire Sanofi-Aventis
Not only are foreign drug-makers no longer setting up research centers in France, but they are even starting to delocalize. If this trend continues, it will have a major considerable on the French economy. Conducted with the Aventis Laboratory, this study tries to quantify the potential macroeconomic effects of delocalization on R&D and the production of drugs.
Catching up in biotechnology
By Philippe Pouletty
Président de France Biotech et du Conseil stratégique de l'innovation
Europe has fallen quite far behind in the strategic sector of biotechnology. It lags far behind the United States, and even China might outstrip it if no remedy is found for chronic underfunding in this sector. This underfunding can be set down to the low level of risk capital, the absence of a European stock market for the growing technological sector, and the weak performance and productivity in research. There is still time for France and Europe to reposition themselves in the race by undertaking structural reforms that will make a strong impact.
Soutenir l'innovation : l'efficience du modèle français en question
On the leading role played by the United States in the drug market
By Antoine Masson
Conseil général des Mines
Major trends in the supply of drugs in OECD countries take their origin in the United States, among them: the rising costs of, and longer time taken by, R&D; the development of a market for generic medication; and the shorter delays for obtaining the approval of new medical products.
Efficient public policies for supporting pharmaceutical innovation: The United Kingdom and Spain
By Antoine Masson
Conseil général des Mines
The United Kingdom and Spain have set up partnerships with industrialists and adopted policies for boosting the innovative pharmaceutical industry. These policies work, if judged by the dryg-makers’ increasing outlays for R&D in these two countries. Is France able to take advantage of its neighbors’ experiences?
EU member state policies supporting innovation in biotechnology
By Thomas Reiss
Fraunhofer Institute Systems and Innovation Research, Karlsruhe
et Elena Prats
Direction générale Entreprises et Industrie, Commission européenne
Government authorities can intervene in the process of innovation in biotechnology in four fields: the development of basic knowledge and human resources; the transmission and application of knowledge; demand and the market; the growth of industry. These policy initiatives should be complementary and reinforce each other. This is the angle from which the EU is suggesting a framework program.
Innovations thérapeutiques et équilibre des comptes sociaux
International comparisons of drug prices: France at the average European level ?
By Christine de Mazières
Conseillère référendaire à la Cour des Comptes
The government sets the price of most medication in France. For this reason, industrialists suspect they are not being fairly remunerated for their efforts in innovation. And state authorities think public health is costing more than in other countries.
Toward the economic evaluation of medical products by public authorities
By Claude Le Pen
Université Paris-Dauphine
Some countries, in particular the United Kingdom, have adopted the economic assessment of medical products in health policy. In France however, official policy concerning the costs of health products and services and their reimbursement hardly mentions it. It is often said that the studies conducted on this topic are not very credible. The refusal to economically evaluate medical products and services leads to incoherency and ends up a blind alley. An awareness of this issue must arise.
Generic medication: From expectations to reality
By Romain Lesur
Economiste de la santé, THEMA
Developing generic drugs opened the way to significant savings for public and private insurers. People must now be persuaded to use them. But generic medication might fall victim to the emerging biotechnology.
The parallel trade in medication in the EU: A useful curse?
By Blandine Fauran
Directeur juridique et fiscal, Les entreprises du médicament (LEEM)
After thirty years of EU jurisprudence in favor of importing medication in parallel, the advantages of this for patients, member states and the construction of Europe are quite limited in comparison with the disadvantages for innovative firms and research. This approach was acceptable in view of advancing the common market and in the absence of major public health problems, but it is coming under question in the new, bigger Europe. A major turnabout in jurisprudence would be welcome.
Conclusion
Can France be made more competitive and attractive for the pharmaceutical industry?
By François Rain
Administrateur civil au ministère de l'Economie, des Finances et de l'Industrie
For ten years now, France has been the front-ranking producer of medication in Europe. However there is cause for worry, especially concerning research and new technology in the field of health. Pharmaceuticals, though in the throes of change, are probably one of the most promising branches of industry in this century. Let us make a virtue out of necessity. To increase France’s force of attraction on this sort of activity, the main thing to do, besides technical measures, is to assert a willingness and a clear strategic vision. Other countries have made this choice. What are we waiting for?
Hommage à Jean Marmot
By Philippe Séguin
Premier président de la Cour des comptes