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Abstract
The European Convention of Human Rights and Biomedicine is the first binding international document that provides a general juridical and ethical framework on medicine and scientific investigation. In this sense, it represents a major effort from the Council of Europe member states, which has proved to be a daunting task to achieve. Nevertheless, this convention leaves many empty spaces and gives rise to some discrepancies. Probably it could not have been in any other way. After all, medical law and bioethics configure an enormous vast domain and it is difficult to create a broad and harmonised regulation for these fields, especially when facing so many different legal orders and divergent ethical and juridical values. The aim of the present study is to offer a critical perspective on the European Convention of Human Rights and Biomedicine with the objectivity gained from having a 15-year gap after its entry into force.
Note on contributor
Vera Lúcia Raposo holds a law degree, a post-graduate degree in medical law, a master’s and a PhD in juridical-political sciences, all obtained in the Faculty of Law of Coimbra University, Portugal. She worked as an Auxiliary Professor at the Faculty of Law of Coimbra University and at the Faculty of Law of Agostinho Neto University (Angola). In addition, she also acted as of counsel in some law offices in Lisbon (Portugal), especially in the field of health law. Presently she is Assistant Professor at the Faculty of Law of Macau University. She has authored several books and articles in Portuguese, English and Spanish, in particular about health/medical law and human rights and she is a member of several institutes and international organisations dedicated to this area of research. She is also a frequent speaker at international events on these topics.
Notes
1. For a general analysis of the convention see Vera Lúcia Raposo and Eduardo Osuna, ‘European Convention of Human Rights and Biomedicine’, in Legal and Forensics Medicine, ed. Roy Beran (Berlin, Heidelberg: Springer-Verlag, 2013), 1405–23.
2. Herman Nys, Medical Law in Belgium (Alphenaanden Rijn: Kluwer Law International, 2010).
3. Maurice Wachter, ‘The European Convention on Bioethics’, Hastings Center Report 27, no. 1 (1997): 13–24.
4. See the history of the convention in Christian Byk, ‘The European Convention on Bioethics’, Journal of Medical Ethics 19 (1993): 13–16; E.W. Dommel and D. Alexander, ‘The Convention of Human Rights and Biomedicine’, Kennedy Institute for Ethics Journal 70, no. 3 (1997): 259–76; Gabriella Scuderi, ‘Gli Indirizzi Dati da Alcuni Atti Internazionali alla Normativa Italiana Relativa agli Aspetti Bioetici della Ricerca Scientifica’, Annali dell’ Istituto Superiore di Sanità 37, no. 2, (2001): 195–206.
5. Referring to those difficulties, see Jessica de Alba Ulloa, ‘Dificultades del Proceso de Negociación de la Convención para la Protección de los Derechos Humanos y la Dignidad del Ser Humano con Respecto a las Aplicaciones de la Biología y la Medicina (y un Llamado a su Adhesión)’, Gaceta Médica de México 148 (2012): 307–20.
6. The intimate connection between both documents is also underlined in the Explanatory Report to the ECHR (Council of Europe, Explanatory Report to the Convention for the Protection of Human Rights and Dignity of the Human Being With Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, European Treaty Series – No. 164).
7. ‘The minimum rank of protection, required by the European Council, cannot be understood as the defense of a liberal position on this matter, since it is expected that ratifying States go beyond and above the level required by the ECRTHRBMed [the authors are referring to the Oviedo Convention], by accommodating the generic guidelines imposed therein to their own realities’ (Raposo and Osuna, ‘European Convention’, 1407).
8. Ibid., 1406.
9. All referred articles belong to the Oviedo Convention, unless another legal text is expressly indicated.
10. Raposo and Osuna, ‘European Convention’, 1406–7.
11. Cf. Barbara Böckenförde-Wunderlich, Präimplantationsdiagnostik als Rechtsproblem (Tübingen: Mohr Siebeck, 2002), 191–41; M. Frommel and Others, ‘Embryonenschutzgesetz (ESchG) und die das VerfahrenregelndeRechtsverordnung (PIDV)?’, Journal für Reproduktionsmedizin und Endokrinologie 10, no. 1 (2012): 6–17; Carol Muller, ‘The Status of the Extracorporeal Embryo in German Law (Part I)’, Revista de Derecho y Genoma Humano 22 (2005): 133–51; Carol Muller, ‘The Status of the Extracorporeal Embryo in German Law (Part II)’, Revista de Derecho y Genoma Humano 22 (2005): 139–65; Ralf Müller-Terpitz, ‘Genetic Testing of Embryos in Vitro – Legal Considerations with Regard to the Status of Early Human Embryos in European Law’, German Yearbook of International Law 54 (2011): 489–520; Vera Lúcia Raposo, O Direito à Imortalidade (O Exercício de Direitos Reprodutivos Mediante Técnicas de Reprodução Assistida e o Estatuto Jurídico do Embrião In Vitro) (Coimbra: Almedina, 2014), 1103–7; Christian Starck, ‘Embryonic Stem Cell Research According to German and European Law’, German Law Journal 7 (2005): 625–56.
12. Wachter, ‘The European Convention on Bioethics’, 16–18.
13. Cf. Austin Garwood-Gowers, ‘Contemporary Issues in the Regulation of Artificial Reproduction and Embryology in the UK’, Revista de Derecho y Genoma Humano 21 (2004): 67–101; Thérèse Murphy and Geraóid Ó’Cuinn, ‘Taking Technology Seriously: STS as a Human Rights Method’, in Law and New Health Technologies, ed. M.L. Flear and Others (Oxford: Oxford University Press, 2013), 285–308; Raposo, O Direito à Imortalidade, 1119–22; Peter Thompson, ‘Reproductive Therapy: HFEA Responds on Germline Therapy’, Nature 500 (2013): 276.
14. Also sharing this opinion is Richard E. Ashcroft, ‘Could Human Rights Supersede Bioethics?’, Human Rights Law Review 10, no. 4 (2010): 639–60, 657.
15. Pointing out some discrepancies in the translation of international human rights texts, see Vera Lúcia Raposo, Catarina Prata, and Isabel Oliveira, ‘Human Rights in Today’s Ethics: Human Rights of The Unborn (Embryos and Foetus)?’, Cuadernos Constitucionales de la Cátedra Fadrique Furio Ceriol 62/63 (2010): 95–111.
16. Ibid., 101 ff.
17. Şule Toktaş, ‘Internationalization of Bioethics: The Search for Common Norms of Bioethics in the EU and the Council of Europe’, Kocaeli Universitesi Sosyal Enstitusu Dergisi 12 (2006): 172–94.
18. Raposo, Prata, and Oliveira, ‘Human Rights in Today’s Ethics’, 95 ff.
19. Ibid., 95 ff.
20. Alain Garay, ‘El Consentimiento al Acto Medico a la Luz de la Convención Europea de los Derechos Humanos’, Revista Latinoamericana de Derecho Medico e Medicina Legal 2, no. 2 and 3 (1997/1998), 4–6.
21. Raposo and Osuna, ‘European Convention’, 1412–16.
22. ‘No restrictions shall be placed on the exercise of the rights and protective provisions contained in this Convention other than such as are prescribed by law and are necessary in a democratic society in the interest of public safety, for the prevention of crime, for the protection of public health or for the protection of the rights and freedoms of others.’ Criticising this norm, see Gilbert Hottois, ‘A Philosophical and Critical Analysis of the European Convention of Bioethics’, Journal of Medicine and Philosophy 25, no. 2 (2000): 133–46.
23. de Alba Ulloa, ‘Dificultades del Proceso de Negociación’, 310.
24. ‘Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited.’
25. ‘Tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counselling.’
26. Roberto Andorno, ‘Human Dignity and Human Rights as a Common Ground for a Global Bioethics’, Journal of Medicine and Philosophy 34, no. 3 (2009): 223–40.
27. Council of Europe, Explanatory Report, 3.
28. F. Seatzu, ‘The Experience of the European Court of Human Rights with the European Convention on Human Rights and Biomedicine’, Utrecht Journal of International and European Law 31, no. 81 (2015): 5–16.
29. Catherine Dupré, ‘Human Dignity in Europe: A Foundational Constitutional Principle’, European Public Law 19, no. 2 (2013): 319–39.
30. T. Caulfield and R. Brownsword, ‘Human Dignity: A Guide to Policy Making in the Biotechnology Era?’, Nature 7 (2006): 72–6.
31. Discussing this issue, see A. Gitti, ‘La Corte Europea dei Diritti dell’ Uomo e la Convenzione sulla Biomedicina’, Rivista Internazionale dei Diritti dell’ Uomo 3 (1998): 719–35.
32. Also curious is the fact that sometimes those references appear in cases concerning member states that have not so far ratified the Oviedo Convention. See ECtHR, Evans v. The United Kingdom, Appl. No. 6339/05, judgment of 10 April 2007 or ECtHR, Ada Rossi v. Italy, Appl. No. 55185/08, judgment of 16 December 2008, both referring to non-ratifying states. Even more bizarre is the fact that some of the judicial references came from judges representing those non-ratifying states, as for instance the vote of the Belgian Judge Marcus-Helmons (in ECtHR, Cyprus v. Turkey, Appl. No. 25781/94, judgment of 10 May 2001, dissenting opinion), despite the fact that Belgium is not yet bound by the convention.
33. ‘Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.’
34. ‘The Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful infringement of the rights and principles set forth in this Convention at short notice.’
35. ‘Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Convention.’
36. CNE – Commission Consultative Nationale d’Ethique, Convention pour la Protection des Droits de l’homme et de la Dignité de l’être Humain à l’égard des Applications de la Biologie et de la Médecine: Convention sur les Droits de l’homme et la Biomédecine – Avis 1/1999 de la Commission Consultative Nationale d’Ethique pour les Sciences de la Vie et de la Santé (1999): 72–3.
37. Hottois, ‘A Philosophical and Critical Analysis’, 139.
38. For texts about the concept of dignity in international human rights documents, see Hector G. Espiell, ‘La Dignidad Humana en los Instrumentos Internacionales sobre Derechos Humanos’, Anuario de Derechos Humanos. Nueva Época 4 (2003): 193–223.
39. Cf. Louis Dubouis, ‘La Convention sur les Droits de l’ Homme et la Biomédecine’, Revue de Droit Sanitaire et Social 2 (1998): 211–22; Maurizio Mori and Demetrio Neri, ‘Perils and Deficiencies of the European Convention on Human Rights and Biomedicine’, Journal of Medicine and Philosophy 26, no. 3 (2002): 323–33.
40. About the Universal Declaration on the Human Genome and Human Rights, see Noelle Lenoir, ‘Comment: Universal Declaration on the Human Genome and Human Rights: The First Legal and Ethical Framework at the Global Level’, Columbia Human Rights Law Review 30 (1999): 537–87.
41. Underlying this omission, see Vicente Bellver Capella, ‘Los Diez Primeros Años del Convenio Europeo sobre Derechos Humanos y Biomedicina: Reflexiones y Valoración’, Cuadernos de Bioética XIX, no. 3 (2008): 401–21.
42. Raposo, O Direito à Imortalidade, 340–6.
43. Ruth Macklin, ‘Dignity is a Useless Concept’, British Medical Journal 327 (2003): 1419–20.
44. Describing these two meanings of human dignity, see Roberto Andorno, ‘The Oviedo Convention: A European Legal Framework at the Intersection of Human Rights and Health Law’, Journal of International Biotechnology Law 2 (2005): 133–43; Roberto Andorno, ‘La Tutela Della Dignità Umana: Fondamento e Scopo della Convenzione di Oviedo’, in Bioetica e Dignità Umana. Interpretazioni a Confronto a Partire dalla Convenzione di Oviedo, ed. E. Furlan (Milano: Angeli, 2009), 77–94; Roger Brownsword, ‘What the World Needs Now: Techno-Regulation, Human Rights and Human Dignit’, in Human Rights, ed. Roger Brownsword (Oxford: Hart, 2004), 203–34, especially 206 ff.
45. European scholars keep trying to present a proper argument to justify the limits imposed on self-determination, supposedly to protect human dignity. For instance, Meulders-Klein states that dignity is the supreme value and self-determination merely one of its consequences, thus, it can be restricted in order to protect dignity (M.T. Meulders-Klein, ‘Biomédecine, Famille et Droits de l’Homme: Une Même Éthique pour Tous?’, Révue Trimestrielle des Droits de l’Homme 43 (2000): 429–42, 451).
46. CNE, Convention pour la Protection des Droits, 12.
47. Unless we sustain that the prohibition is protecting the self-determination of future generations, as Bellver Capella (‘Los Diez Primeros Años’, 409) states, but we cannot see how to justify this statement when future generations do not have rights of their own. Regarding the juridical status of future generations see Raposo, O Direito à Imortalidade, 995–7.
48. X v. The United Kingdom, Application No. 7992/77, judgment from 12 July 1978.
49. Laskey, Jaggard and Brown v. The United Kingdom, Application No. 21627/93; 21628/93; 21974/93, judgment from 19 February 1997.
50. Pretty v. The United Kingdom, Application No. 2346/02, judgment from 29 April 2002.
51. De Wilde, Ooms e Versyp (‘Vagrancy’) v. Belgium, Application No. 2832/66; 2835/66; 2899/66, judgment from 18 June 1971.
52. Lambert and Others v. France, Application No. 46043/14, judgment from 5 June 2015.
53. Daniela-Ecaterina Cutas, ‘Looking for the Meaning of Dignity in the Bioethics Convention and the Cloning Protocol’, Health Care Analysis 13, no. 4 (2005): 303–13.
54. Macklin, ‘Dignity is a Useless Concept’.
55. Cf. Alba Ulloa, ‘Dificultades del Proceso de Negociación’, 309–10.
56. On the German reaction see Wachter, ‘The European Convention on Bioethics’, 16–18.
57. ‘The interests and welfare of the human being shall prevail over the sole interest of society or science.’
58. ‘Scientific research in the field of biology and medicine shall be carried out freely, subject to the provisions of this Convention and the other legal provisions ensuring the protection of the human being.’
59. About the unborn status in the ECHR, José Díaz de Valdés, ‘Análisis Crítico de la Jurisprudencia de la Corte Europea de Derechos Humanos sobre el Estatus del no Nacido en la Convención Europea de Derechos Humanos’, Revista Actualidad Jurídica 18 (2008): 69–104.
60. Cf. Pieter van Dijk, Fried van Hoof, and Arjen Van Rijn, Theory and Practice of the European Convention on Human Rights (The Hague: Kluwer, 1998), 300 ff.; Louis Favoreu, ‘Les Juges Constitutionnels et la Vie’, Droits. Revue Française de Théorie Juridique 13 (1991): 1–75; Gregor Puppinck, ‘Abortion and the European Convention on Human Rights’, Irish Journal of Legal Studies 3, no. 2 (2013): 142–193; Vera Lúcia Raposo, ‘O Tribunal Europeu dos Direitos do Homem e o Direito à Vida’, Jurisprudência Constitucional 14 (2007): 59–87.
61. Cf. Patrick Fraisseix, ‘La Protection de la Dignité de la Personne et de L’Espèce Humaines dans le Domaine de la Biomédecine: L’Exemple de la Convention d’Oviedo’, Revue Internationale de Droit Comparé 52, no. 2 (2000): at 371–413; Raposo, O Direito à Imortalidade, 651–4.
62. Referring to the most relevant critics, see Raposo and Osuna, ‘European Convention’, 1416–19.
63. Cf. Aitziber Emaldi Cirion, ‘Las Intervenciones sobre el Genoma Humano y la Selección de Sexo’, in El Convenio de Derechos Humanos y Biomedicina. Su Entrada en Vigor en el Ordenamiento Jurídico Español, ed. Carlos Romeo Casabona (Bilbao-Granada: Editorial Comares, 2002), 205–31.
64. For a brief description of sex selection regulation see Raposo, O Direito à Imortalidade, 1037–41; Heather Strange and Ruth Chadwick, ‘The Ethics of Nonmedical Sex Selection’, Health Care Analysis 18 (2010): 252–66.
65. Discussing the saviour sibling, see M. Couverta and Others, ‘Le Double Diagnostic Pré-Implantatoire et ses Conséquences : « Bébé-Médicament » ou « Bébé du Double Espoir » ?’ [Preimplantation Genetic Diagnosis With HLA-Matching and Consequences: “Designer Baby” or “Double-Hope Baby?”], La Revue Sage-Femme 13, no. 4 (2014): 187–94; Raposo, O Direito à Imortalidade, 941–50.
66. Toktaş, ‘Internationalization of Bioethics’, 187–8.
67. The argument is from John Harris, Clones, Genes and Immortality (Oxford: Oxford University Press, 1998), 29.
68. Cf. Raposo and Osuna, ‘European Convention’, 1418.
69. Cf. Hottois, ‘A Philosophical and Critical Analysis’, 144.
70. Case C-34/10, Brüstle v. Greenpeace e V [2012] All E.R. (EC) ECJ 809 Grand Chamber, decision commented on in Shawn Harmon, ‘Dignity, Plurality and Patentability: The Unfinished Story of Brüstle v Greenpeace’, European Law Review 38, no. 2 (2013): 92–106; and Vera Lúcia Raposo, ‘Juridical Status of Human Embryos and Fetus at the Oviedo Convention’, Lex Medicinae 9, no. 17 (2012): 171–85.
71. International Stem Cell Corporation v. Comptroller General of Patents, Request for a preliminary ruling from the High Court of Justice of England and Wales, Chancery Division (Patents Court), United Kingdom.
72. The exceptions are the Netherlands and Belgium.
73. An omission noted by Arthur Roger, ‘European Bioethics Treaty Finally Approved’, Lancet 348 (1996): 953; Danuel San José, ‘Nota Sobre la Ratificación por España del Protocolo Adicional al Convenio para la Protección de los Derechos Humanos y la Dignidad del Ser Humano con Respecto a las Aplicaciones de la Biología y la Medicina, por el que se Prohíbe la Clonación de Seres Humanos, Hecho en Paris el 12 de Enero de 1998’, Anuario de Derecho Europeo 1 (2001): 221–9.
74. Carmel Shalev, ‘Human Cloning and Human Rights: A Commentary’, Health Human Rights 6, no. 1 (2002): 137–51.
75. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings. On this Protocol, see San José, ‘Nota Sobre la Ratificación’, 221–9.
76. Also sustaining this thesis, see Carlos Romeo Casabona, ‘Ethical, Legal and Social Issues Related to Cell Therapy’, Revista Derecho y Genoma Humano 28 (2008): 141–58.
77. About those concepts, Íñigo Beriain, ‘Necesidad de Redefinir el Embrión Humano’, in Biotecnologia, Derecho y Dignidad Humana, ed. N. Martínez Morán (Bilbao-Granada: Editorial Comares, 2003), 105–35; Pedro Femenia López, Status Jurídico del Embrión Humano, con Especial Consideración al Concebido In Vitro (Madrid: McGraw-Hill, 1999); Silke Hetz, Schutzwürdigkeit menschlicher Klone?: Eine interdisziplinãre Studie aus medizinrechtlicher Sicht (Baden-Baden: Nomos, 2005); Cosimo Mazzoni, ‘Real Protection for the Embryo’, Revista de Derecho y Genoma Humano 22 (2005): 115–32; Vera Lúcia Raposo, O Direito à Imortalidade, 491; Mary Warnock, ‘In Vitro Fertilization: The Ethical Issues’, The Philosophical Quarterly 33, no. 132 (1983): 217–37.
78. Cf. Raposo, O Direito à Imortalidade, 965.
79. Mori and Neri, ‘O Direito à Imortalidade’, 328.
80. Ibid., 330.
81. Bellver Capella, ‘Los Diez Primeros Años’, 405.
82. Cinzia Piciocchi, ‘La Convenzione di Oviedo sui Diritti dell’ Uomo e la Biomedicine: Verso una Bioetica Europea’, Diritto Pubblico Comparato ed Europeo III (2001): 1301–14.
83. Ibid.