Between Legislation and Bioethics: The European Convention on Human Rights and Biomedicine

  • Felicity CallardEmail author
Part of the International Library of Ethics, Law, and the New Medicine book series (LIME, volume 45)


The chapter explores the role that regional legislation plays in framing human rights and ethical principles in psychiatry by considering the Council of Europe’s Convention on Human Rights and Biomedicine. The chapter identifies the Convention’s contribution to an emergent legislative, regulatory and discursive formation, which is characterized by its alloy of human rights and bioethics. The author draws attention to articles within the Convention that have implications for psychiatry as regards its engagement with patients, with those on whom it depends to conduct research, and with the public. As well as indicating how various States within the Council of Europe have responded to the Convention, the author considers how the Convention attempts to align human rights and ethics through the regulation and formalisation of the relationship between doctor and patient, and researcher and research participant. This alignment is taking place at the same time as biomedicine is putting pressure on concepts (such as autonomy and informed consent) central to bioethics and human rights discourse.


Research Participant Therapeutic Alliance European Convention Biomedical Ethic Additional Protocol 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



Council of Europe Ad Hoc Committee of Experts on Bioethics


Council of Europe Steering Committee on Bioethics


Council for International Organizations of Medical Sciences


Council of Europe European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment


Good Clinical Practice


International Conference on Harmonisation (of Technical Requirements for Registration of Pharmaceuticals for Human Use)


ICH Harmonised Tripartite Consolidated Guideline for GCP



The author acknowledges financial support from the National Institute for Health Research (NIHR) Specialist Biomedical Research Centre for Mental Health award to South London and Maudsley NHS Foundation Trust (SLaM) and the Institute of Psychiatry, King’s College London. She thanks Dr Dula Rušinović-Sunara of the Croatian Association of Patients’ Rights for providing her with material on the Association’s attempts to reform patients’ rights legislation in Croatia.


  1. Andorno R (2004) The right not to know: an autonomy based approach. J Med Ethics 30:435–439CrossRefGoogle Scholar
  2. Andorno R (2005) The Oviedo convention: a European legal framework at the intersection of human rights and health law. J Int Biotech Law 2:133–143Google Scholar
  3. Ashcroft R (2008) The troubled relationship between bioethics and human rights. In: Freeman MDA (ed) Law and bioethics. Oxford University Press, Oxford, pp 31–51CrossRefGoogle Scholar
  4. Babić-Bosanac S, Džakula A (2006) Patients’ rights in the Republic of Croatia. Eur J Health Law 13:399–411CrossRefGoogle Scholar
  5. Bartlett P (2003) The test of compulsion in mental health law: capacity, therapeutic benefit and dangerousness as possible criteria. Med Law Rev 11:326–352CrossRefGoogle Scholar
  6. Bartlett P, Lewis O, Thorold O (2007) Mental disability and the European convention on human rights. Martinus Nijhoff, Leiden/BostonCrossRefGoogle Scholar
  7. Bernardet P, Douraki T, Vaillant C (2002) Psychiatrie, droits de l’homme et défense des usagers en Europe. Editions Erès, Ramonville Saint-AgneGoogle Scholar
  8. Borst-Eilers E (2005) The role of public debate and politics in the implementation of the convention. In: Gevers J, Hondius E, Hubben J (eds) Health law, human rights and the biomedicine convention. Martinus Nijhoff, Leiden/Boston, pp 247–254Google Scholar
  9. Braake TA (2004) The Dutch 2002 Embryos act and the convention on human rights and biomedicine: some issues. Eur J Health Law 11(2):139–151CrossRefGoogle Scholar
  10. Buchner B, Hart D (2008) Research with minors in Germany. Eur J Health Law 15:127–134CrossRefGoogle Scholar
  11. Callahan D (1996) Escaping from legalism: is it possible? Hastings Center Report 26(Nov-Dec), 34–35Google Scholar
  12. Callon M, Rabeharisoa V (2004) Gino’s lesson on humanity: genetics, mutual entanglements and the sociologist’s role. Econ Soc 33(1):1–27CrossRefGoogle Scholar
  13. Corrigan O, Tutton R (2006) What’s in a name? Subjects, volunteers, participants and activists in clinical research. Clin Ethics 1:101–104CrossRefGoogle Scholar
  14. de Wachter MA (1997) The European convention on bioethics. Hastings Cent Rep 27(1):13–23CrossRefGoogle Scholar
  15. Dressing H, Salize HJ (2004) Compulsory admission of mentally ill patients in European Union Member States. Soc Psychiatry Psychiatr Epidemiol 39:797–803Google Scholar
  16. Farmer P, Campos NG (2004) New malaise: bioethics and human rights in the global era. J Law Med Ethics 32:243–251CrossRefGoogle Scholar
  17. Freeman M (ed) (2008) Law and bioethics. Oxford University Press, OxfordGoogle Scholar
  18. Gevers S (2008) Health law in Europe: from the present to the future. Eur J Health Law 15:261–272CrossRefGoogle Scholar
  19. Goffin T, Borry P, Dierickx K, Nys H (2008) Why eight EU Member States signed, but not yet ratified the Convention for Human rights and biomedicine. Health Policy 86(2–3):222–233CrossRefGoogle Scholar
  20. Goffin T, Zinovieva D, Borry P, Dierickx K, Nys H (2007) Patient rights in the EU – Bulgaria. European Ethical-Legal Papers (Vol. No 8). LeuvenGoogle Scholar
  21. Gostin LO (2001) Beyond moral claims: a human rights approach in mental health. Camb Q Healthc Ethics 10:264–274CrossRefGoogle Scholar
  22. Gostin L, Gable L (2004) The human rights of persons with mental disabilities: a global perspective on the application of human rights principles to mental health. MD Law Rev 63(1):20–121Google Scholar
  23. Hale B (2007) Justice and equality in mental health law: the European experience. Int J Law Psychiatry 30:18–28CrossRefGoogle Scholar
  24. Hansen B (2004) Embryonic stem cell research: terminological ambiguity may lead to legal obscurity. Med Law 23(1):19–28Google Scholar
  25. Honnefelder L (2005) Science law and ethics: the Biomedicine Convention as an ethico–legal response to current scientific challenges. In: J Gevers, Hondius E, Hubben J (eds) Health law, human rights and the biomedicine convention. Martinus Nijhoff, Leiden/Boston, pp 13–22Google Scholar
  26. Hottois G (2000) A philosophical and critical analysis of the European convention of bioethics. J Med Philos 25(2):133–146CrossRefGoogle Scholar
  27. Hunt P, Mesquita J (2006) Mental disabilities and the human right to the highest attainable standard of health. Hum Rights Q 28:332–356CrossRefGoogle Scholar
  28. Ianeva E (2006) Biopolitics in Eastern Europe: specific political and legal challenges. Paper presented at the Connecting Civil Society – Implementing Basic Values Conference, Berlin, March 17–19. Retrieved 2 February, 2009, from
  29. Jansen S (2000) Recommendation No R (99) 4 of the Committee of Ministers to member states on principles concerning the legal protection of incapable adults, an introduction in particular to part V Interventions in the health field. Eur J Health Law 7:333–347Google Scholar
  30. Katholieke Universiteit Leuven/Centre for Biomedical Ethics and Law (2008) Facts: Biomedicine Convention. Retrieved 1 February 2009, from
  31. Katholieke Universiteit Leuven/Centre for Biomedical Ethics and Law (2009) European Ethical-Legal Papers. Retrieved 2 February, 2009, from
  32. Knoppers BM, Chadwick R (2005) Human genetic research: emerging trends in ethics. Nat Rev Genet 6(1):75–79CrossRefGoogle Scholar
  33. Laurie G (2002) Genetic privacy: a challenge to medico-legal norms. Cambridge University Press, CambridgeCrossRefGoogle Scholar
  34. Legemaate J (2005) Psychiatry and human rights. In: Gevers J, Hondius E, Hubben J (eds) Health law, human rights and the biomedicine convention. Martinus Nijhoff, Leiden/Boston, pp 119–130Google Scholar
  35. Lewis O (2002) Protecting the rights of people with mental disabilities: the European Convention on Human Rights. Eur J Health Law 9:293–320CrossRefGoogle Scholar
  36. Lötjönen S (2005) Research on human subjects. In: Gevers J, Hondius E, Hubben J (eds) Health law, human rights and the biomedicine convention. Martinus Nijhoff, Leiden/Boston, pp 175–190Google Scholar
  37. Lötjönen S (2006) Medical research on patients with dementia – the role of advance directives in European legal instruments. Eur J Health Law 13:235–261CrossRefGoogle Scholar
  38. Lötjönen S (2008) Medical research on minors in Finland. Eur J Health Law 15:135–144CrossRefGoogle Scholar
  39. Macklin R (2003) Dignity is a useless concept. BMJ 327:1419–1420CrossRefGoogle Scholar
  40. Manson NC, O’Neill O (2007) Rethinking informed consent in bioethics. Cambridge University Press, CambridgeCrossRefGoogle Scholar
  41. Manuel C, Hairion D, Auquier P, Reviron D, Giocanti D, Terriou P et al (1999) Is the legislation of European states in keeping with the recent convention on human rights and biomedicine? Eur J Health Law 6(1):55–69CrossRefGoogle Scholar
  42. Mol A (2008) The logic of care: health and the problem of patient choice. Routledge, LondonGoogle Scholar
  43. Niveau G (2004) Preventing human rights abuses in psychiatric establishments: the work of the CPT. Eur Psychiatry 19(3):146–154CrossRefGoogle Scholar
  44. Nys H (2008) The biomedicine convention as an object and stimulus for comparative research in the European Journal of Health Law. Eur J Health Law 15:273–283CrossRefGoogle Scholar
  45. Nys H, Stultiëns L, Borry P, Goffin T, Dierickx K (2007) Patient rights in EU Member States after the ratification of the convention on human rights and biomedicine. Health Policy 83:223–235CrossRefGoogle Scholar
  46. Parker C (2007) Developing mental health policy: a human rights perspective. In: Knapp M, McDaid D, Mossialos E, Thornicroft G (eds) Mental health policy and practice across Europe: the future direction of mental health care. Open University Press, Maidenhead, pp 308–335Google Scholar
  47. Reuter L (2000) Human is what is born of a human: personhood, rationality, and an European convention. J Med Philos 25(2):181–194CrossRefGoogle Scholar
  48. Roscam Abbing HDC (1996) Human rights and medicine: a Council of Europe convention. Eur J Health Law 3(3):201–205CrossRefGoogle Scholar
  49. Roscam Abbing HDC (1998) The Convention on human rights and biomedicine: an appraisal of the council of Europe convention. Euj J Health Law 5(4):377–387CrossRefGoogle Scholar
  50. Roscam Abbing HDC (2004) Rights of patients in the European context, ten years and after. Eur J Health Law 11:7–15CrossRefGoogle Scholar
  51. Rose N (2007) The politics of life itself: biomedicine, power, and subjectivity in the twenty-first century. Princeton University Press, Princeton, NJGoogle Scholar
  52. Rose D, Wykes T, Leese M, Bindman J, Fleischmann P (2003) Patients’ perspectives on electroconvulsive therapy: systematic review. BMJ 326:1363–1366CrossRefGoogle Scholar
  53. Rušinović-Sunara D, Finka D (2008) Reflections on the development of health care and patients’ rights in Croatia. Med Law 27(2):357–364Google Scholar
  54. Salako SE (2008) The Council of Europe Convention on Human Rights and Biomedicine: a new look at international biomedical law and ethics. Med Law 27(2):339–356Google Scholar
  55. Sándor J (2008) Human rights and bioethics: competitors or allies? The role of international law in shaping the contours of a new discipline. Med Law 27:15–28Google Scholar
  56. Sartorius N (2002) Iatrogenic stigma of mental illness. BMJ 324:1470–1471CrossRefGoogle Scholar
  57. Schmidt H (2007) Whose dignity? Resolving ambiguities in the scope of ‘human dignity’ in the universal declaration on bioethics and human rights. J Med Ethics 33(10):578–584CrossRefGoogle Scholar
  58. Sperling D (2008) Law and bioethics: a rights-based relationship and its troubling implications. In: Freeman M (ed) Law and bioethics. Current legal issues 2008, vol 11. Oxford University Press, Oxford, pp 52–78Google Scholar
  59. Sprumont D, Gytis A (2005) The importance of national laws in the implementation of European legislation on biomedical research. Eur J Health Law 11:245–267CrossRefGoogle Scholar
  60. Steering Committee on Bioethics (CDBI)(2000) Convention on 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 (ETS No 164) Preparatory work on the Convention. Strasbourg: Council of EuropeGoogle Scholar
  61. Stultiëns L, Goffin T, Borry P, Dierickx K, Nys H (2007) Minors and informed consent: a comparative approach. Eur J Health Law 14(1):21–46CrossRefGoogle Scholar
  62. Tannsjo T (2004) The convention on human rights and biomedicine and the use of coercion in psychiatry. J Med Ethics 30:430–434CrossRefGoogle Scholar
  63. Tutton R (2007) Constructing participation in genetic databases: citizenship, governance, and ambivalence. Sci Technol Human Values 32(2):172–195CrossRefGoogle Scholar
  64. Walin L (2007) Ambiguity of the embryo protection in the human rights and biomedicine convention: experiences from the Nordic countries. Eur J Health Law 14(2):131–148CrossRefGoogle Scholar
  65. Welie SPK, Berghmans RLP (2006) Inclusion of patients with severe mental illness in clinical trials: issues and recommendations surrounding informed consent. CNS Drugs 20(1):67–83CrossRefGoogle Scholar
  66. World Health Organization Regional Office for Europe (1995) Promotion of the rights of patients in Europe: proceedings of a WHO consultation. Kluwer Law International, The Hague/LondonGoogle Scholar
  67. Wynne B (1991) Knowledges in context. Sci Technol Human Values 16(1):111–121CrossRefGoogle Scholar

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© Springer Science+Business Media B.V. 2010

Authors and Affiliations

  1. 1.Health Service and Population Research Department, Institute of PsychiatryKing’s College London, PO 34 Service User Research Enterprise, Institute of PsychiatryLondonUK

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