Abstract
Clear differences exist between European Member States’ and interest groups’ positions concerning the moral status of the early human embryo. Some adhere to absolute protection for such embryo from its very conception while others take a gradualist approach. However, human embryonic stem cell research promises great advances for human health and as such is one of the showpieces of innovation the EU wants to facilitate with Horizon 2020. In order to determine the norms that should guide EU funding of research with human embryos in the context of this financial instrument, the Member States have negotiated with each other and with the European Commission. As a result the EU only funds research activities involving existing human embryonic stem cell lines. However, the European Citizen’s Initiative One of us recently has pleaded for a total ban on human stem cell research.
In this article the question of whether the EU norms for funding research with human embryos have been established in a democratically legitimate way will be addressed and an argument will be developed about how to determine whether this is the case.
A draft version of this chapter was discussed at the authors’ conference in Amsterdam. I would like to thank the conference participants, and especially Baerbel Dorbeck-Jung, Lisette ten Haaf, Lonneke Poort and Wibren van der Burg for their helpful comments. I thank Adam McCann for his corrections of the English.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
One of us proposes an amendment to Article 16 of the Proposal of a Regulation of the European Parliament and Council that establishes a framework program for research and innovation (2014–2020) – Horizon 2020- COM (2011) 809 final edition. Section 3 of this article, that concerns the ethical principles, stipulates what research areas are not funded and the proposed amendment is to add here under d: research activities that destroy human embryos, including those aimed at obtaining stem cells, and research involving the use of human embryonic stem cells in subsequent steps to obtain them (Proof of legal act on official website).
- 2.
However, different to Van Klink and following Dahl and Lindblom (1953), political in this contribution refers to (efforts to) resolve inevitable conflicts in a peaceful manner.
- 3.
The European Convention on Human Rights in Evans v UK has left the protection granted to human embryos to the discretion of member states in recognition of the diversity of national moral cultures on this question.
- 4.
Although some of the rules in this Act are also straightforward prohibitions, for example, the prohibition on the development of an embryo in vitro beyond 14 days. Human Fertilisation and Embryology Act 1990, schedule 2, para. 3 (2) and (6).
- 5.
With the Act, the HFE Authority – as a statutory body – was set up and made responsible for licensing the use of embryos in research. In order to get the approval of the HFE Authority, researchers who wish to use embryos in their research must submit a research protocol that makes clear that the research is “necessary or desirable” for one or more of the purposes of the HFE Act. Desirability is assessed in terms of the contribution to scientific knowledge or human health that can be expected from the research. ‘Necessary’ means that creating such embryos (instead of using other sources of stem cells) is necessary for the research. In addition to being convinced on the latter point, the Authority cannot issue a license unless it is satisfied that the creation and/or use of embryos are necessary for the research.
- 6.
In addition, the use of human embryos in research is only allowed under the following four conditions: Firstly, such research has to comply with the necessity principle which means that the results expected could not be reached otherwise. Secondly, the research must serve the research aim of increasing scientific knowledge in basic research or medical knowledge for the development of diagnostic, preventative or therapeutic methods to be applied to humans. Thirdly, there must be informed consent of the donors of the embryos in accordance with national law and the donor’s personal data have to be protected; Fourthly, research proposals will be subject to scientific and ethical review.
- 7.
This is because human embryonic stem cells that already have been harvested are pluripotent and not totipotent and by this definition do not fall within the ambit of the Act. Pluripotent cells are cells capable of giving rise to every type of cell found in the human body, whilst totipotent cells are also capable of developing into cells needed for human development, including extra-embryonic tissues, for example the placenta. The definition of embryo adopted by the Embryo Protection Act encompasses totipotent, but not pluripotent, cells.
- 8.
This Act stipulates what stem cell lines could be allowed to be imported: Firstly, these have to be derived before 1 January 2002 in the country of origin according to legal provisions applicable in that country (the cut-off date criterion); secondly, were obtained from embryos produced by medically-assisted in vitro fertilisation in order to induce pregnancy, but were no longer used for this purpose and, thirdly, no compensation or other benefit in money has been granted for donation of ESC (embryonic stem cells). The setting of the cut-off was meant to make sure only stem cells of supernumerary embryos that already exist at the moment of enactment can be imported in order to avoid an indirect pressure on foreign IVF-clinics to produce more human embryos in future than before in order to have more supernumerary embryos left which could provide in German scientists’ need for stem cell lines.
- 9.
Robert Dahl is an important theorist on pluralism who also did empirical research into whether and how pluralism works in practice.
- 10.
Provided that in other policy areas the policy would be formulated by other minorities.
- 11.
Such deliberation can result in decisions based either on consensus or a majority.
- 12.
In fact, also in the cases Poort (2012, 2013) analysed the deliberative procedures run through in addition to and not instead of representative democratic procedures. In the Dutch context the CAB, for example, sends it recommendations to the Minister who decides. This offers opportunity to parliament to ask questions concerning these decisions.
- 13.
The European Commission has the monopoly of legislative Initiative. The European Parliament, the European Council as well as a quarter of the member states can ask the commission for a law proposal. With the ECI also citizens under certain conditions can ask the commission to initiate such law proposal.
- 14.
In article 1 of Regulation (EU) No 211/2011 this is formulated as follows: “citizens’ initiative” means an initiative submitted to the Commission in accordance with this Regulation, inviting this commission, within the framework of its powers, to submit any appropriate proposal on matters where citizens consider that a legal act of the Union is required for the purpose of implementing the Treaties.’ The Regulation, containing the rules and procedures governing the ECI, was adopted by the EP and the Council of the EU on 16 February 2011. The Citizen’s Initiatives could be launched from April 1, 2012.
- 15.
The minimum number of signatories per member state is the number of Members of the European Parliament delegated by the state multiplied by 750.
- 16.
Regulation (EU) No 211/201, article 10 (1) (c).
- 17.
European Citizens’ Initiative: European Commission replies to ‘One of us’, press release, 28 May 2014, Brussels.
- 18.
Including the creation of human embryos by means of somatic cell nuclear transfer (commonly referred to as therapeutic cloning).
- 19.
The European Group on Ethics in Science and New Technology is a group of experts who advises the Commission, the European Council and the European Parliament on issues concerning science and technology.
- 20.
Another manner in which the EU contributes to optimizing research, while at the same time making sure embryonic stem cell lines will only be created if necessary, is the funding of a European registry for human embryonic stem cell lines. On 29 March 2007 it was announced in press that the European Commission had agreed to fund such registry in their Research Framework Programme. The main objective of this registry is to provide comprehensive information about all human embryonic stem cells lines available in Europe.
- 21.
The commission motivates this proposal as follows: ‘In order to allay fears that Community funding might indirectly encourage the production of embryos by in vitro fertilisation (IVF) over and above the number required and to send out a political signal, the Commission is proposing that only supernumerary embryos created before 27 June 2002 (date of adoption of the 6th Framework Programme) can be used.’
- 22.
The compromise was that the Sixth Framework Programme would fund ‘research on “supernumerary” early-stage (i.e., up to 14 days)’by which were meant ‘embryos genuinely created for the treatment of infertility so as to increase the success rate of IVF but no longer needed for that purpose and when destined for destruction’. European Parliament (2001).
- 23.
The European Humanist Federation (EHF) unites more than 50 humanist and secularist organisations from about 20 European countries and promotes a secular Europe, defending equal treatment of everyone regardless of religion or belief, fighting religious conservatism and privilege in Europe and at the EU level.
- 24.
Franz Obermayr (NI, AT) Konrad Szymański, Ewald Satdler and Miroslaw Piotrowsk (ECR, Poland) 20 November 2013.
- 25.
MEPs, such as Carvalho, rapporteur of the Horizon 2020 specific programme, have declared this in the hearing concerning One of Us.
References
Blokland, Hans. 2011. Pluralism, democracy and political knowledge. Robert A. Dahl and his critics on modern politics. Farnham: Ashgate Publishing Limited.
Bomberg, Elizabeth, et al. 2012. Introduction. In The European union. How does it work? ed. Elizabeth Bomber et al., 3–18. Oxford: Oxford University Press.
Bovenkerk, Bernice. 2011. The biotechnology debate. Democracy in the face of intractable disagreement. Dordrecht: Springer.
Burg, Van der. 2014. The dynamics of law and morality. Farnham: Ashgate Publishing Limited.
Dahl, Robert, and Charles Lindblom. 1953. Politics, economics and welfare . New York: Harper & Row.
Dahl, Robert. 1961. Who governs? Democracy and power in an American City, New Haven. New Haven: Yale University Press.
Dahl, Robert. 1970. After the revolution? Authority in a good society. New Haven: Yale University Press.
Decision 2002/834/EC of the European Parliament and of the Council of 30 September 2002 c oncerning the Sixth Framework for research and technology, Official Journal L 294, 29/10/2002.
Decision 2006/1982/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007–2013).
European Commission. 2003. Proposal from DG of the European Commission, 26 November 2003. (15385/03), p. 2.
European Group on Ethics in Science and New Technology. 2000. Ethical aspects of human stem cell research. Opinion no. 15 to the European Commission.
European Group on Ethics in Science and New Technology. 2002. Ethical aspects of patenting involving human stem cells. Opinion no. 16 to the European Commission.
European Group on Ethics in Science and New Technologies. 2007. Recommendations on the ethical review of hESC FP7 research projects, Opinion no. 22 to the European Commission.
European Parliament. 2001. Proposal for a European Parliament and Council decision concerning the multiannual framework programme 2002–06 of the European Community for research, technological development and demonstration activities aimed at contributing towards the creation of the European Research Area, COM(2001) 94, 14 November.
European Parliament. 2003. Resolution on the proposal for a Council Decision amending Decision 2002/834/EC on the specific programme for research, technological development and demonstration. Integrating and strengthening the European Research Area (2002–06), COM (2003)390, 19 November.
European Humanist Federation. 2013. Keep dogma out of European Research. Position paper on the Framework Programme for Research and Innovation. “Horizon 2020” (2014–2020). http://humanistfederation.eu/wp-content/uploads/2012/05/2.-Horizon-2020-EHFs-amendments-proposals3.pdf. Accessed 10 Apr 2014.
European Union. 2013. Regulation No 1291/2013 of the European Parliament and Council of 11 December that establishes Horizon 2020 – The framework program for research and innovation (2014–2020).
Gutmann, Amy, and Dennis Thompson. 2004. Why deliberative democracy. Princeton: Princeton University Press.
Held, David. 1987. Models of democracy. Cambridge: Polity Press.
Klink, Bart van. 2014. Symboolwetgeving. De opkomst, ondergang en wederopstanding van een begrip. Regelmaat 29: 5–26
Lee, R., and D. Morgan. 2001. Human fertilisation and embryology. Regulating the reproductive revolution. London: Blackstone Press Limited.
Munnichs, Geert. 2000. Publiek ongenoegen en politieke geloofwaardigheid. Democratische legitimiteit in een ontzuilde samenleving. Assen: Van Gorkum.
Plomer, Aurora. 2010. Human Dignity, Human Rights and Article 6(1) of the Biotech Directive. In Embryonic stem cell patents. European law and ethics, ed. Plomer Aurora and Torremans Paul. Oxford: Oxford University Press.
Poort, Lonneke. 2012. An ethos of controversies. A critical analysis of the interactive legislative approach. Legisprudence 6: 35–55.
Poort, Lonneke. 2013. Consensus & controversies in animal biotechnology. An interactive legislative approach to animal biotechnology in Denmark, Switzerland, and the Netherlands. Den Haag: Eleven International Publishing.
Puppinck, G. 2013. Synthetic analysis of the EJC case C-34/10 Oliver Brüstle v Greenpeace eV and its ethical consequences. European Center for Law and Justice. http://eclj.org/Resources. Accessed 10 Feb 2014.
Research Europe. 2003. EU stem cell guidelines raise supply issues. Research Europe, July 31, p. 4.
Salter, Brian. 2007. Bioethics, politics and the moral economy of human embryonic stem cell science. The case of the European Union’s sixth framework programme. New Genetics and Society 26: 269–288.
Sudbery, Imogen. 2003. Bridging the legitimacy gap in the EU. Can civil society help to bring the union closer to its citizens? Collegium 26: 75–95.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2016 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Zeegers, N. (2016). The Democratic Legitimacy of Interactive Legislation of the European Union Concerning Human Embryo Research. In: van Klink, B., van Beers, B., Poort, L. (eds) Symbolic Legislation Theory and Developments in Biolaw. Legisprudence Library, vol 4. Springer, Cham. https://doi.org/10.1007/978-3-319-33365-6_15
Download citation
DOI: https://doi.org/10.1007/978-3-319-33365-6_15
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-33363-2
Online ISBN: 978-3-319-33365-6
eBook Packages: Law and CriminologyLaw and Criminology (R0)