Stem cell research has the potential to bring important advances in our understanding and treatment of crippling diseases such as Parkinson’s, diabetes, stroke and heart disease. It has also attracted significant investment in a number of countries in Europe, notably the UK and Germany, which have established themselves as global market leaders in stem cell therapy and technology. The amount allocated to stem cell research under previous EU programmes has formed a relatively small portion of the overall budget but played a vital role in facilitating collaborations amongst EU researchers which would not have been possible through national funding alone. Yet, the funding of embryonic stem cell research in Europe now lies in the balance.
The first round of discussions of the Commission’s proposals for the funding of EU research in the Horizon 2020 programme drew to a close at the beginning of July. Negotiations reopened at the beginning of September, under the shadow of a potential referral to the EU court if the views of opponents of hESC research do not prevail. MEPs Peter Liese (EPP, Germany), Miroslav Mikolasik (EPP, Slovakia), Gerald Häfner (Greens-EFA, Germany) and Konrad Szymanski (ECR, Poland) announced on the 12th of September that they will challenge the legality of Horizon 2020 if funding is approved. Hitherto, the state of play is as follows.
The EU legal ‘co-decision’ framework requires that the Commission’s proposals be approved by the European Parliament and the Council of Ministers. The negotiation process kicked off in November 2011 with the launch of the Commission’s proposal and is due to be concluded at the end of 2013 (See timeline and process chart).
The Commission’s proposal is to maintain the status quo and to continue to fund hESC research as in the previous programmes. This means that funding would only be available for research on existing embryonic stem cells/lines and not for research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer (Article 16, 3(c)). The funding would not extend to Member States where the research is forbidden (Article 16, 4).
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 16th may 2012, reservations were introduced to restrict funding to adult stem cells. The progress report earmarks the funding of stem cell research as an ‘outstanding’ issue.
Parliamentary Committees have also discussed the Commission’s proposal and introduced a number of amendments calling for an end to EU funding of hESC research. Examples may be found in the report of the Committee on Industry, Research and Energy of 29th June 2012 (2011/0401/COD). They include Amendments by MEPs Elisabetta Gardin (Amendment 571, 583), Konrad Szymański (Amendment 557, 580) and Angela Niekler, who is also member of the legal affairs committee(JURI).
In addition, on the 22nd of May 2012, the Legal Affairs Committee issued a Draft Opinion directed at the Committee on Industry, Research and Energy containing several amendments calling for a ban on EU funding of research which is destructive of human embryos and raising the prospect of a challenge at the EU Court if the funding continues. The Opinion stated that the Brustle judgment “… has an impact on Union law. This Regulation could conceivably be challenged at the Court of Justice if it did not exclude funding for research using human embryonic stem cells. This kind of research should therefore be excluded from EU funding.” (Amendment 3, 2011/0401(COD)). The Amendment was narrowly rejected at the JURI’s committee’s meeting of 18th of September (11 votes in favour, 11 votes against, 2 abstentions). But the effect is more symbolic than real. The compatibility of the funding of hESC research with the Brustle ruling could still be the subject of a legal challenge at the CJEU, even though the Court will not now be able to rely on a majority view at the Legal Affairs Committee.
The procedure for such a challenge allows any EU country – or private individuals – which believes that a law adopted by the European Union is illegal to ask the Court to declare the law null or void. The Court may declare the law void if it considers that the law in question is contrary to the Treaties. The procedure was used by the Netherlands and Italy to challenge the legality and compatibility of the EU Directive on Biotechnological Inventions 1998 with the Treaties. In that instance, the applicants were unsuccessful. Whether or not a legal challenge may succeed in this case is a moot question. A search of the EUR-lex case law database shows that there is no precedent for a legal review of funding decisions under the previous research funding programmes. The issues of principle raised by a putative case would have to involve the interpretation and weighing of fundamental principles of subsidiarity and respect for human dignity in the Treaties in relation to the funding of hESC research. The Brustle ruling might not necessarily provide a legal basis for excluding EU funding of hESC research because, as the Court itself was at pains to stress in its judgment, the legal definition of the embryo and rationale for exclusion in that case were specifically directed to the interpretation of a law relating to patents and not research. Artificial as the distinction may sound, it could provide a legal way forward to confine the impact of the Brustle ruling consistently with respect for the wide diversity of national cultures and laws on human dignity and embryo research in a pluralist and democratic Europe.
The deeper questions regarding the ongoing EU controversy over hESC research and patents concern the possible blurring of ethics and religion and the pandora’s box opened by the Court’s reliance on the concept of ‘human dignity’ to invalidate hESC patents. The Legal Affairs Committee’s Opinion states that it is “largely restricted to ethical issues. But how ethics may be distinguished from religion in the morally charged debates over embryo research is not so clear. In a pluralistic and religiously diverse Europe, what is considered morally offensive on religious grounds and contrary to ‘human dignity’ need not coincide or reflect ethical consensus. The EU Court’s view in the Brustle ruling which ascribes human dignity to 6-8 cell embryos and condemns patients to suffer the cruel indignity of crippling disease, looks conspicuously like a religious perspective. As such, it is potentially inconsistent with Article 9 of the European Convention on Human Rights which protects freedom of religion and freedom from religion. It is also, arguably, at odds with Article 35 of the European Charter of Fundamental Rights which guarantees everyone the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices.
Further negotiations and discussions on the Horizon 2020 are continuing this autumn.