COMECE: EU moet beleid stamcelonderzoek bijwerken

ComeceEU should update its research policy on stem cells

Human embryonic stem cell research is no longer patentable in the EU, it is ethically problematic and therefore is not a consensual research field among Member States and EU citizens. Moreover, it offers less and less clinical promise. COMECE therefore calls on the EU to exclude human embryonic stem cell research from its upcoming research funding programme Horizon 2020 and to focus instead on the more innovative and promising field of alternative stem cell research.

Horizon 2020 is the EU’s new programme for research and innovation running from 2014 to 2020 with an €80 billion budget. This programme has to be welcomed as a major tool for promoting growth and innovation in the European Union. In the field of medical research, in particular, it may lead to innovative treatments for patients.

The European Commission recently presented a package of proposals for Horizon 2020. These proposals improve the current ethical framework by indicating some of the ethical principles which are applicable. Nevertheless, two of the most important principles are missing: protection of human dignity (Article 1, Charter of Fundamental Rights) and putting the interests and welfare of the human being before that of society or science (Article 2, Convention of Oviedo).

COMECE is, however, particularly concerned by one major omission: the new proposals integrate some of the commitments already undertaken by the Commission in its Statement in 2006 but, surprisingly, exclude the commitment (§12) that the EU Commission “will not submit to the Regulatory Committee proposals for projects which include research activities which destroy human embryos, including for the procurement of stem cells”. This means that the current proposals present an ethical framework which is in fact weaker than the one which applies in the current research programme (2007-2013).

No longer market-driven
Furthermore, from the legal point of view, the proposals do not take into consideration the recent ruling of the European Court of Justice in the case Greenpeace vs. Brüstle. The Court clearly defines the human embryo and confirms that biotechnological inventions using human embryonic stem cells cannot be patented. Thus, if the EU legal order is to be consistent and internally coherent, any projects involving the use of human embryonic stem cells in steps subsequent to their derivation should also be excluded from funding.

Moreover, from the perspective of economics, it would seem to be somewhat inefficient to fund research whose possible results are then legally prevented from being turned into actual innovation in the market. As matter of fact, a main focus of Horizon 2020 is to help “innovative enterprise to develop their technological breakthroughs into viable products with real commercial potential”.

No longer clinically promising
Recently, Geron Corp., the world’s leading embryo research company, announced it was closing down its stem cell programme.

As a matter of fact, human embryonic stem cell research has not delivered the expected results. In the meantime, research on alternative sources of stem cells – adult, umbilical cord blood or induced pluripotent – offer real, effective prospects for therapeutic applications or have indeed already demonstrated widespread clinical results. These methods, because they enjoy wide acceptance – both on scientific and ethical grounds – are not controversial among Member States. They should therefore be prioritised in the context of EU funding in the new Horizon 2020 programme.

Less support among EU Citizens
Finally, the Eurobarometer survey on Life Sciences and Biotechnology conducted in October 2010 shows that 56% of Europeans believe that an embryo is a human being immediately after fertilisation (p. 146) and 69% of respondents approve of adult stem cell research whereas fewer Europeans approve of embryonic stem cell research (p.55).

COMECE understands that there is room for ameliorating the proposals during the progress of the legislative procedure which has now started and so expects that the recent legal and scientific developments – as well as the fundamental ethical rules and basic policy options as noted above – will be taken into consideration and clearly reflected in the instruments of Horizon 2020 when it is finally adopted.