EU and industry in shock agreement - Pharmaceutical Executive

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EU and industry in shock agreement



Given the capacity of the European Union for dissension, it is quite an event when agreement breaks out. This month some unusual convergence is likely to be displayed in Brussels on how to get more orphan drugs through the 'death valley' of development.

It is the urbane French centre-right Member of the European Parliament Françoise Grossetête who has been moved to introduce such dramatic language into the discussion. As one of the key figures in the upcoming debates, she is strongly backing recent EU proposals for greater support for treatments for rare diseases, and is arguing strenuously for more hard cash to be put behind the process.

Her views will be music to the ears of industry executives, currently fighting to defend the limited assistance currently available. She points out that even with products with a potentially wide market, companies feel comfortable about making the massive investments needed for registration and launch only when they are reasonably sure of market success. For orphan drugs, the mathematics is much tougher, she underlines. "Between the proof of concept and the investment of the substantial private funding required before the marketing authorisation stage is reached, rare diseases have to go through a 'death valley' much longer than that faced by commoner diseases, with their much greater market potential, she says in a report she will present this month to the Parliament's committee on industry and research.

The problem she identifies so emphatically is that, despite the current EU measures encouraging the development of treatments for rare diseases, "taken individually, these diseases do not constitute viable markets." So Grossetête is calling for "substantial and clearly identified fundingê for research and development, and additional national provision for reimbursing access to treatments. It is essential, she says, that rare diseases be made a priority at European level, "to deal properly with the needs of several million citizens suffering from misdiagnosis and thus receiving no treatment to cure their diseases." Unless there is urgent action by the EU, some treatments "will never see the light of day," she concludes, adding - apparently heedless of President Obama's bid to rebuild transatlantic relations - that "the only treatments which will be marketed will come from the other side of the Atlantic, at prohibitive prices."

Meanwhile, the Parliament's committee on public health is also due to report on the proposal, and here too there is uncharacteristic enthusiasm for taking a pro-industry line. A greater commitment to boosting action on rare diseases is "an absolute necessity," according to the draft prepared by Greek MEP Antonio Trakatellis from Greece (also centre-right - the pharmaceutical industry lobby will be quietly jubilant that hostile MEPs have not been put in charge of these reports). He focuses on the cumulatively wide impact on Europe's population from the many rare diseases, and is demanding that the EU puts in place by 2012 firm budgetary measures, as well as networks of centres of expertise, clearer data, and greater mobility of experts.

The only dissension evident at this stage - unlikely to cause any nightmares - is the insistence by Trakatellis that the EU's current plan for support does not go far enough. "… It is not possible to produce a viable programme out of it," he says, because it does not describe the necessary funding and co-funding by EU and member states or other organisations.

By the spring, this debate in the Parliament should be over - and if it goes well, it could signal a new springtime for companies researching treatments for rare diseases too.

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