EU should update its research policy on stem cells
Is the EU going to finance research on embryos and embryonic stem cells under the new research framework program Horizon 2020 ?
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 comprising a Communication on “Horizon 2020 – The Framework Programme for Research and Innovation” (COM(2001)808final); a Proposal for a Regulation of the European Parliament and Council establishing Horizon 2020 (COM(2011)809final); a Proposal for a Regulation of the European Parliament and Council laying down the rules for the participation and dissemination in Horizon 2020 (COM(2011)810final); a Proposal for a Council Decision establishing Specific Programme implementing Horizon 2020 (COM(2011)811final); and a Proposal for a Council Regulation on the research and training programme of the European Atomic Energy Community complementing Horizon 2020 (COM(2011)812final).
These proposals improve the current ethical framework by indicating some of the ethical principles which are applicable, for example. 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).
The Secretariat of COMECE has for some time closely monitored these ethical debates related to Research. Its Reflection Group on Bioethics has already issued two Opinions on an issue of particular ethical relevance in this field: research on human embryos and the use of human stem cells. The topic is not new in europeinfos either: we have already published as many as four articles on the same or linked subjects. Moreover, the Secretariat contributed, in May 2011, to the Consultation launched by the European Commission on this new Research programme.
The Secretariat of 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 instruments proposed present an ethical framework which is in fact weaker than the one which applies in the current research programme (2007-2013).
The Secretariat of COMECE indeed considers it paramount, from the ethical point of view, not only to exclude from financing within Horizon 2020 all destructive research on human embryos, which includes research involving procurement of human embryonic stem cells as their derivation process necessarily entails the destruction of early human embryos; but also to exclude research involving the use of human embryonic stem cells in steps subsequent to their derivation since, among other reasons, such funding itself stimulates the procurement of human embryonic stem cells and, thus, escalates human embryo-destructive research.
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).
The legislative initiatives for Horizon 2020 are now to be adopted in accordance with the ordinary legislative procedure, with the involvement of the Competitiveness Council and the European Parliament. In the context of the subsidiarity control mechanism, the National Parliaments will also have the opportunity to make their voices heard and to submit a reasoned opinion.
The Secretariat of COMECE understands that there is considerable room for ameliorating the proposals during the progress of the legislative procedure which has now just 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.
1. All the research and innovation activities carried out under Horizon 2020 shall comply with ethical principles and relevant national, Union and international legislation, including the Charter of Fundamental Rights of the European Union and the European Convention on Human Rights and its Supplementary Protocols.
Particular attention shall be paid to the principle of proportionality, the right to privacy, the right to the protection of personal data, the right to the physical and mental integrity of a person, the right to non-discrimination and the need to ensure high levels of human health protection.
2. Research and innovation activities carried out under Horizon 2020 shall have an exclusive focus on civil applications.
3. The following fields of research shall not be financed:
(a) research activity aiming at human cloning for reproductive purposes;
(b) research activity intended to modify the genetic heritage of human beings which could make such changes heritable;
(c) 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.
4. Research on human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member States involved. No funding shall be granted for research activities that are prohibited in all the Member States. No activity shall be funded in a Member State where such activity is forbidden.
5. The fields of research set out in paragraph 3 may be reviewed within the context of the interim evaluation set out in Article 26(1) in the light of scientific advances.