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Bioethics in the European Community's Seventh Framework Program for RTD (2007-2013)

bridges vol. 12, December 2006 / OpEds & Commentaries

by Franz Pichler

 

Debate on both sides of the Atlantic

In recent years, the use of human embryonic stem cell research has been widely debated on both sides of the Atlantic (Pichler, 2005, 261-271). In July 2006 US President Bush vetoed the US Senate which had proposed more money for human embryonic stem cell research in the US (Der Standard, 20.7.2006).

About the same time, a fierce battle was going on in Europe regarding the use of Community money for human embryonic stem cell research. The European conflict was due to fierce lobbying from the Catholic Church, which was very restrictive in this matter. But this time Europe was moving ahead of the US.

How it could happen that Europe developed in such a different way?

Whereas the religious movements in the US are growing, the importance of the Catholic Church is diminishing in Europe since the death of the charismatic Pope John Paul II.

Furthermore, the Lisbon Agenda , which was considered a lame duck in the early years after 2000, is now moving forward and encouraging European governments to invest more in research and technological development (RTD). At the meeting in Hampton Court in the UK in 2005, heads of government and states recognized that "Europe must do more to harness its creative power and ability to convert knowledge into high quality products, services, and business models for which there is strong global demand. Progress on innovation will be central to the success of the renewed Lisbon Strategy for Growth and Jobs" (Council of the European Union, 14065/06, p.2). Although human embryonic stem cell research will not create immediate results, it is expected to cure diseases like Alzheimer's or Parkinson's in the long run. Therefore countries like the UK, Sweden, Denmark, or Belgium are now investing more in RTD as well as in stem cell research in order to be at the forefront of medical research. Although Austria invests almost 2.4 percent of its GDP in RTD, it is opposed to human embryonic stem cell research for ethical reasons.

{access view=guest}Access to the full article is free, but requires you to register. Registration is simple and quick - all we need is your name and a valid e-mail address. We appreciate your interest in bridges.{/access} {access view=!guest} Human embryonic stem cell research within the European Community's Framework Program for RTD

The EU has developed Framework programs for RTD since 1984. Today Framework Program 6 (2003-2006) is still going on with a budget worth €17 billion (Official Journal of the European Communities, L232, 1-27). Framework Program 7 will be decided at the end of 2006 and start with first calls in 2007. The available budget will be €54 billion for the period from 2007 to 2013. One important area within FP 7 is "Health" which will receive €6.1 billion.

Whereas the EU Member States finance the biggest part of research (almost 95 percent), the Framework programs are funded via the Community budget and aim to overcome the fragmentation of research within Europe.

Human embryonic stem cell research executed within a Member State obeys national rules but, regarding the Framework Program, common rules have to be agreed upon between Member States by a qualified majority.

Stem cell research

Stem cells are basic cells that multiply and differentiate into specialized cells, tissue, and even organs. Stem cell research is a promising area of biotechnology for human health. It offers the prospect of developing new methods to repair or replace tissues or cells damaged by injuries or diseases and to treat serious chronic diseases such as Parkinson's or Alzheimer's as well as more common diseases such as diabetes. Stem cell research is also expected to provide a better understanding of human life and of disease development. It does, however, raise ethical questions when stem cells are derived from human supernumerary embryos.

These stem cells are called "human embryonic stem cells" (abbreviation: hES cells). According to Th. B. Okarma these hES cells cannot "under any circumstance develop by themselves into humans. They are therefore not totipotent, as in the zygote (fertilized egg), which is formed at the time of conception and on its own forms an embryo and placenta in the uterus" (T. Okarma, 2001, 4).

Framework Program 6 (2003-2006)

All research activities carried out under the specific program of FP6 must be carried out in compliance with fundamental ethical principles. Additionally the following fields of research have been excluded from Community funding:

  • Research activities aimed at human cloning for reproductive purposes;
  • Research activities intended to modify the genetic heritage of human beings which could make such changes heritable;
  • 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;
  • In addition, funding of research activities that are prohibited in all the Member States is in all circumstances excluded (Official Journal of the European Communities (OJ), L294, p.8)

Projects presented by the European Commission for approval by Member States have to be discussed in a "Regulatory Committee" where a qualified majority is needed to reject such a proposal and seize the Council (OJ L294/1, Article 6/3, p.3).

Due to a deadlock between conservative and liberal Member States and the end of a moratorium regarding stem cell research, the European Commission in December 2003 developed guidelines for the implementation of stem cell research (Pichler, 2005, p.267). These guidelines followed the opinion of the "European Group on Ethics ," which identified the following principal requirements regarding human embryonic stem cell research and the procurement of embryonic stem cells from supernumerary embryos:

  • Free and informed consent for the donating couple or woman
  • Approval of the research by an authority
  • No financial gain for donors
  • Anonymity of the donors and protection of the confidentiality of personal information of the donors
  • Transparency regarding research results.

Further on, the EU will not fund human embryonic stem cell research where it is forbidden by a Member State. Human embryonic stem cells can only be derived from supernumerary embryos that are donated for research by parents and that were created before June 27, 2002, the date of the adoption of FP6. (European Commission, Press release IP/03/969 from 9.7.2003)

In parallel the Commission was publishing a call for proposals to set up a European registry of stem cells and for contributing to the establishment of public stem cell banks.

Between 2003 and 2006 the Commission funded about 30 projects including the use of human embryonic stem cells based on the above-mentioned implementation rules.

Council of Research Ministers on July 24, 2006

FP7 (2007-2013) repeated the same NO-GO areas as FP6. Due to the pressure of the European Parliament , where a clear majority was in favor of human embryonic stem cell research, the principles were outlined in Article 6 of Framework Program 7 (Council of the European Union, 11826/06, 19 July 2006).

The European Parliament added to FP7 a statement that "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 State(s) involved." (Council of the EU, document 11826/06, Article 6/3).

Although the majority of Member States were in favor of the Commission proposal and the European Parliament's additions to FP7, restrictive Member States like Germany, Luxemburg, and Italy were against it. They were supported by traditionally Catholic countries like Austria, Poland, Malta, Slovakia, and Lithuania. Putting all these countries together, the Finnish Presidency was faced - much like the Italian Presidency in 2003 - with a "blocking minority" in the Council.

At the end of the day Germany, Luxembourg, and Italy were ready to compromise and broke away from the Vatican's lobbying against any kind of human embryonic stem cell research.


Germany's change of position was especially decisive in achieving a compromise:

On one side, there was pressure from the German-born Pope on the coalition government of Christian Democrats and Social Democrats. On the other side, Germany was under increasing pressure from their pharmaceutical and biotech industries which were in favor of stem cell research (Financial Times (FT), EU's stem cell decisions sound alarm bells in Germany, 27 July 2006). In view of a compromise on the European level, Germany together with Italy and Luxemburg asked the European Commission to state that FP7 will not be used to destroy human embryos. The European Commission, supported by the majority of Member States, therefore made the following Statement:

"The European Commission will continue with the current practice and 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. The exclusion of funding of this step of research will not prevent Community funding of subsequent steps involving human embryonic stem cells." (Council of the European Union, 12337/06, Statement by the Commission, para 12). [1 ]
This compromise means, that the US rules regarding the public funding of hES cells (cut-off date 2001) are much more restrictive than rules in the United Kingdom or on the European Community level.

The only group of countries still supporting the traditional view of the Vatican were Austria, Poland, Malta, Lithuania, and Slovakia. They rejected FP7 completely due to the ongoing Community support for hES cell research based on stem cells lines created before FP7 or outside FP7. 2

The FT's correspondent in Brussels, George Parker, described the Political Agreement on FP July 24, 2006, via majority vote as a loss of power of the Vatican:

"However the church's failure to win a ban on EU funding for embryonic stem cell research could also be seen as a reminder of how far its influence has waned - an increasingly rare gesture of defiance against an onrushing secular tide." (FT, Catholic Church fails to halt funding for stem cell research, 25 July 2006).

Stephen Hawking, one of the world's best known scientists, who suffers from a motor neuron disease (ALS), lashed out at what he called the "reactionary" forces in the US and in the EU trying to ban research into stem cells from human embryos. From his point of view, banning the use of stem cells from human embryos was the equivalent of opposing the use of donated organs from dead people. (International Herald Tribune, EU to fund stem cells, 25 July 2006).

Outlook

After the second reading in the European Parliament in November 2006, the FP7 together with the specific programs will finally be adopted in December 2006. Due to recent elections, for instance in Austria, where a coalition government between Social Democrats and Christian Democrats is under preparation, the position on bioethics could alter in December 2006.

The European Commission is currently developing work programs e.g., in the thematic area "Science in Society," where actions are foreseen for the creation and support of pan-European platforms on ethics. The creation of an inter-connected European information and documentation system is anticipated to promote critical debate on issues of major significance in ethics and science. The system should include appropriate links to international organizations, notably UNESCO and the Council of Europe . Further support is also sought for the networking of national ethical councils in order to encourage their cooperation and consultation (European Commission, Science in Society Work Program 2007, informal paper, Brussels, 25.October 2007).

***

The author, Franz Pichler, was Science Attaché at the Austrian Embassy in Brussels, Belgium, and has been retired since November 2006.


This article reflects the opinion of the author exclusively.


Footnotes:

1) The European Commission's Statement understands by "not preventing Community funding of subsequent steps involving human embryonic stem cells" that the following research could be financed:

  • Based on hES cells or stem cell lines created before 1.1. 2007 (beginning of FP7), e.g., to secure the continuation of research started under FP6
  • Based on hES or stem cell lines imported from outside the EU e.g., from the US or Israel
  • With hES cells or stem cell lines financed on the national level if permitted in the relevant Member State


References

Council of the European Union, Communication from the Commission to the European Council (informal meeting in Lahti, Finland, 20.10.2006), document 14065/06, Brussels, 16.10.2006, pp.1-8.

Council of the European Union, document 11826/06, 19 July 2006, pp.1-108.

Council of the European Union, document 12337/06, Draft Minutes of the 2747th meeting of the Competitiveness Council held in Brussels on 24 July 2006, Statement by the Commission, para 12, pp.1-3.

European Commission, Press release IP/03/969 from 9.7.2003.

European Commission, Science in Society Work Programme 2007, informal paper, Brussels, 25 October 2007, pp.1-38.

Official Journal of the European Communities, L232, Decision No. 1513/2002/EC of the European Parliament and of the Council concerning the sixth framework programme of the European Community for research, technological development and demonstration activities, contributing to the creation of the European Research Area and to innovation - 2002-2006. pp.1-27.

Official Journal of the European Communities, L294, Council Decision of 30.9.2002 adopting a specific programme for research, technological development and demonstration: "Integrating and strengthening the European research Area - 2002-2006." pp.1-13.

Okarma, T. "Human Embryonic Stem Cells: A Primer on the Technology and its Medical Applications." In The Human Embryonic Stem Cell Debate, edited by Suzanne Holland, Karen Lebacqz, and Laurie Zoloth. Boston: The MIT Press, 2001, 3-13.

Pichler, F. "Science and Human Dignity," Innovation, Vol.18, No. 2 (2005): 261-71.

Media

"Bush's Veto hält." Der Standard, Vienna, 20.7.2006.

"Catholic Church fails to halt funding for stem cell research." Financial Times, 25 July 2006.

"EU' s stem cell decisions sounds alarm bells in Germany." Financial Times, 27 July 2006.

"EU to fund stem cells." International Herald Tribune, 25 July 2006.

Websites covering FP6 and FP7:
http://cordis.europa.eu/en/home.html
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