Monday, October 1, 2012

Europe not Competitive in hESC Research: Patently False

Geoff Lomax is CIRM's Senior Officer to the Standards Working Group

The European Parliament is currently considering its next research funding program called Horizon 2020. Under consideration in that program is the continued level of support for human embryonic stem cell (hESC) research.

The current European research program is similar to U.S. NIH policy, where research involving the use of hESC lines that conform to certain ethical standard is permitted, but the EU does not fund the derivation of new hESC lines. Any changes to that current standard in the 2020 program must be approved by the European Parliament and the Council of Ministers.

Nature recently ran a story pointing out that funding levels for hESC research in the Horizon 2020 program might be at risk. Here’s how they explain the reasoning of those who oppose the funding:
The Legal Affairs Committee of the European Parliament voted last week for its exclusion, referring back to the controversial decision of the European Court of Justice last year that the use of hES cell lines in research was immoral – and therefore unpatentable – because it had once involved destruction of an embryo.
The Legal Affairs Committee argued that since such research was unpatentable in Europe, it could not contribute to European competitiveness. And since the main aim of Horizon 2020 is to stimulate European competitiveness, such research should not be funded by the programme.
Prof. Aurora Plomer University of Sheffield (UK) tracks EU funding policy. I asked for her assessment of the situation. She indicated:
So far, the majority of delegations at the Council have expressed their wish to maintain the status quo. But at the last meeting of the Research Working Party of the Council, on May 16th 2012, proposals were introduced to restrict funding to adult stem cells.
Professor Plomer blogged previously about how the Court’s decision to render hESC research unpatentable in the EU trumped a variety of national and EU-wide policies and showed “complete disregard for the diversity of moral and legal cultures on the human embryo in Europe.” Now it appears the ruling will have the effect of penalizing researchers striving to develop therapies for patients. The problem is this: a researcher in the UK might develop a breakthrough therapy for blindness or deafness, but that groundbreaking research might not receive funding from the EU because it cannot be patented.

It is sad and simultaneously bizarre that the perceived inability to patent therapies would become a sticking point for funding. For years during the development of CIRM’s Intellectual Property Policy, concerns were raised over the potential for patents to hinder access to therapies. (We’ve written an FAQ about our IP policy, which is available here.)

EU members are carrying out highly innovative hESC research. This is why CIRM has formed collaborative funding arrangements with Germany, UK, Spain, and France (here’s more about that program). CIRM values these collaborations and sees them as vital for the advancement of patient therapies.

In our effort to support our EU partners, CIRM recently submitted comments to the House of Lords Select Committee on Science and Technology Call for Evidence. The Committee is considering recommendations for the UK’s research programs. We suggested that the ruling preventing patentability of hESC research could impact commercial development of new therapies in addition to reducing or eliminating hESC funding in the Horizon 2020 research program. In light of that, we recommended that the House of Lords evaluate how the patent ruling could effect national research programs in the UK and consider policies to avoid conditions would impede the development of new therapies.

G.L.

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