Embryonic stem cell research and therapy: The need for a common European legal framework

Bioethics

Volumn 16, Issue 6, 2002, Pages 557-567

  Romeo Casabona, Carlos M ^a  

^a UNIVERSITY OF DEUSTO   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

CLONING; EMBRYO CELL; EUROPE; EUROPEAN UNION; HUMAN; LAW; LEGAL ASPECT; MEDICAL ETHICS; REVIEW; STEM CELL; STEM CELL TRANSPLANTATION;

EID: 0036837436     PISSN: 02699702     EISSN: None     Source Type: Journal    
DOI: 10.1111/1467-8519.00311     Document Type: Review

References (20)

1. For a more extensive approach concerning the existing regulations in Europe on human embryo research see further: Opinion No. 15 on Ethical Aspects of Human Stem Cell Research and Use, of 14 November 2000. R. Lovell-Badge. Embryo Experimentation in Europe, cit. M.B. Friele, ed. Europäische Akademie, Bad Neuenahr-Ahrweiler. European Group on Ethics in Science and New Technologies to the European Commission.
2. According to the European Group on Ethics in Science and New Technologies to the European Commission, Opinion No 15 on Ethical Aspects of Human Stem Cell Research and Use, cit. (see paragraph. 1.14).
3. This directive stipulates: 'For the purposes of this Directive, the removal, collection and use of tissues, cells and substances of human origin shall be governed, in relation to ethics, by the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of human beings with regard to the application of biology and medicine and by any Member States regulations on this matter' (art. 1.4).
4. Mention should be given to the Charter of Fundamental Rights of the European Union, approved by the European Council on 14 October 2000, which stipulates the prohibition of making the human body and its parts as such a source of financial gain, and the prohibition of the reproductive cloning of human beings (art. 3.2).
5. See European Group on Ethics in Science and New Technologies to the European Commission, Opinion No 15 on Ethical Aspects of Human Stem Cell Research and Use, cit. and Opinion No 16 on Ethical Aspects of Patenting Inventions involving Human Stem Cells of 7 May 2002.
6. At the universal level, the UNESCO Universal Declaration on the Human Genome and the Human Rights of 11 November 1997 does not take a position about the possibility of experimenting with human embryos, although it clearly rejects reproductive human cloning (art. 11). It is a topic that could be pending for a future convention, also universal, about the same matter as the declaration.
7. See Recommendations 1046 (1986), on the use of human embryos and foetuses for diagnostic, therapeutic, scientific, industrial and commercial purposes, and 1100 (1989), on the use of human embryos and foetuses in scientific research.
8. According to art. 2 of the convention: 'The interests and welfare of the human being shall prevail over the sole interest of society or science.'
9. European Group on Ethics, Opinion No 15 on Ethical Aspects of Human Stem Cell Research and Use, cit., opinion 2.3.
10. See A. Pollack. The promise in Selling Stem Cells. The New York Times. August 26, 2001.
11. This distinction has been accepted by the Spanish Constitutional Court in its rulings 212/1996 and 116/1999.
12. See further on this discussion in different focuses some contributions published at the Revista de Derecho y Genoma Humano/Law and the Human Genome Review 2000; 12: R. Junquera De Estefani. El embrión humano: una realidad necesitada de protección. (pp. 31 ff); J. Ramón Lacadena. Embriones humanos y cultivos de tejidos: reflexiones científicas, éticas y jurídicas. (pp. 191 ff); D. Soutullo. Clonación humana no reproductiva: utilización de embriones para la obtención de tejidos para trasplantes. (pp. 213 ff).
13. See further on this discussion in different focuses some contributions published at the Revista de Derecho y Genoma Humano/Law and the Human Genome Review 2000; 12: R. Junquera De Estefani. El embrión humano: una realidad necesitada de protección. (pp. 31 ff); J. Ramón Lacadena. Embriones humanos y cultivos de tejidos: reflexiones científicas, éticas y jurídicas. (pp. 191 ff); D. Soutullo. Clonación humana no reproductiva: utilización de embriones para la obtención de tejidos para trasplantes. (pp. 213 ff).
14. See further on this discussion in different focuses some contributions published at the Revista de Derecho y Genoma Humano/Law and the Human Genome Review 2000; 12: R. Junquera De Estefani. El embrión humano: una realidad necesitada de protección. (pp. 31 ff); J. Ramón Lacadena. Embriones humanos y cultivos de tejidos: reflexiones científicas, éticas y jurídicas. (pp. 191 ff); D. Soutullo. Clonación humana no reproductiva: utilización de embriones para la obtención de tejidos para trasplantes. (pp. 213 ff).
15. See further on this discussion in different focuses some contributions published at the Revista de Derecho y Genoma Humano/Law and the Human Genome Review 2000; 12: R. Junquera De Estefani. El embrión humano: una realidad necesitada de protección. (pp. 31 ff); J. Ramón Lacadena. Embriones humanos y cultivos de tejidos: reflexiones científicas, éticas y jurídicas. (pp. 191 ff); D. Soutullo. Clonación humana no reproductiva: utilización de embriones para la obtención de tejidos para trasplantes. (pp. 213 ff).
16. In this paper I do not intend to deal with an important discussion: whether ES cells are or are not to be considered as a medicinal product or a medical device, and consequently to be regulated as these are. However my opinion is against this focus, as art. 18 of EC on Human Rights and Biomedicine is evidence for the need of a different approach. However, see a contrary position on the subject, P. Brown et. al. 2001. Human cell- and tissue-based products: Progress, promise and regulatory issues. Journal of Commercial Biotechnology; 7: 287-298.
17. For some comments to art. 36 of the Convention see H. Nys. La Convención Europea de Bioética. Objetivos, principios rectores y posibles limitaciones. Revista de Derecho y Genoma Humano/Law and the Human Genome Review 2000; 12: 67-87 (81).
18. Art. 27 of the Convention stipulates: 'None of the provisions of this Convention shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant a wider measure of protection with regard to the application of biology and medicine than is stipulated in this Convention.'
19. This approach seems to be more limited in comparison with the Beyleveld/Pattinson proposal. In their view 'harmonisation for permission seems to be well-nigh inevitable in the medium to long-term.' See Beyleveld and Pattinson. Embryo Research in the UK: Is Harmonisation in the EU Needed or Possible? cit., p. 72. But it is also more extensive than the arguments against the use of human embryos for any purpose defended by Bertrand Mathieu. Les droits fondamentaux: les contraintes du droit international et du droit constitutionnel. Revue Générale de Droit Médical. Numéro Spécial: La recherche sur l'embryon: qualifications et enjeux 2000; pp. 228 f.
20. This approach seems to be more limited in comparison with the Beyleveld/Pattinson proposal. In their view 'harmonisation for permission seems to be well-nigh inevitable in the medium to long-term.' See Beyleveld and Pattinson. Embryo Research in the UK: Is Harmonisation in the EU Needed or Possible? cit., p. 72. But it is also more extensive than the arguments against the use of human embryos for any purpose defended by Bertrand Mathieu. Les droits fondamentaux: les contraintes du droit international et du droit constitutionnel. Revue Générale de Droit Médical. Numéro Spécial: La recherche sur l'embryon: qualifications et enjeux 2000; pp. 228 f.