Medication and innovation: Making the new French model Pierre-Noël Lirsac, issue editor Foreword Jean-Pierre Raffarin An industry in the throes of change  Pharmaceutics : The role of innovation Jean-Michel Yolin 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 Bernard Lemoine 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 Jean-François Dehecq 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. Taking up the challenge Earlier access to medication Patrick Le Courtois 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 Véronique Diéras and Pierre Bey 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? Francis Fagnani, François Saint-Cast, Sabine Gadenne, Jean-Luc Hertz and Véronique Ameye 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 Philippe Pouletty 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. Supporting innovation: The French model’s efficiency under question On the leading role played by the United States in the drug market Antoine Masson 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.

Insert: France as seen by big American pharmaceuticals Frédéric Champavere Efficient public policies for supporting pharmaceutical innovation: The United Kingdom and Spain Antoine Masson 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 Dr. Thomas Reiss and Elena Prats 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. Therapeutical innovations and balancing the books of public health International comparisons of drug prices: France at the average European level ? Christine de Mazières 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 Claude Le Pen 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 Romain Lesur 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? Blandine Fauran 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? François Rain 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? A tribute to to Jean Marmot Philippe Seguin