The importance of national laws in the implementation of european legislation of biomedical research

European Journal of Health Law

Volumn 12, Issue 3, 2005, Pages 245-267

  Sprumont, Dominique ^a   Gytis, Andrulionis ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PRACTICE; CONFERENCE PAPER; DRUG INDUSTRY; ETHICS; HEALTH CARE; HEALTH INSURANCE; HUMAN; INDUSTRY; INSURANCE; LAW; LEGAL ASPECT; MEDICAL PRACTICE; MEDICAL PROFESSION; MEDICAL RESEARCH; PHARMACY; SCIENCE;

BIOMEDICAL RESEARCH; DRUG INDUSTRY; EUROPE; INTERNATIONAL COOPERATION; LIABILITY, LEGAL;

EID: 29144442100     PISSN: 09290273     EISSN: None     Source Type: Journal    
DOI: 10.1163/157180905774857952     Document Type: Conference Paper

References (48)

1. See Rettig R.A., The industrialization of clinical research, in Health Affairs 19 (2000), pp. 129-146.
2. http://csdd.tufts.edu/InfoServices/ImpactReportPDFs/ ImpactReportSumrnaryJulAug2003.pdf (last consulted December 27th, 2004).
3. See Lucas Berkamp, Medical Research Involving Human Beings: Some Reflections on the Main Principles of the International Regulatory Instruments, in European Journal of Health Law 11 (2004), pp. 61-69.
4. Bartha Knoppers and Dominique Sprumont, Human Subjects Research, Ethics, and International Codes on Genetic Research, in Encyclopedia of Ethical, Legal and Policy Issues in biotechnology, John Wiley & Sons, 2000, pp. 566-576.
5. See Dominique Sprumont and Pascal Arnold, The 'Nuremberg Code': Rules of Public International Law, in Ulrich Tröhler and Stella Reiter-Theil (eds.), Ethics Codes in Medicine: Foundations and Achievements of Codification since 1947, Ashgate, Aldershot 1998, pp. 84-96.
6. See for instance in the European Union, the Council Resolution of 14 December 2000 on paediatric medicinal products, O. J. C 017, 19/01/2001 P. 0001-0001. See also in the USA, the Pediatric Research Equity Act of 2003 (Public Law No: 108-155) and the Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Final Rule (21 CFR Parts 201, 312, 314 and 601).
7. See for instance article 13 of the Geneva Convention relative to the Treatment of Prisoners of War, article 12 of the Geneva Convention for the Amelioration of the Condition of the Wounded and Sick in Armed Forces in the Field or article 32 of the Geneva Convention relative to the Protection of Civilian Persons in Time of War.
8. This being said, it is surprising that none of those international law instruments were raised in two cases before the European Court of Human Rights having to do with nuclear tests conducted by the UK in the Pacific Ocean in 1957-1958 (McGinley and Egan v. the United Kingdom, Strasbourg, 28 January 2000 (Applications nos. 21825/93 and 23414/94) and L.C.B. v. the United Kingdom (9 June 1998, Reports of Judgments and Decision 1998-III, p. 1404). In their dissenting opinion in the case McGinley and Egan v. the United Kingdom, the Judges de Meyer, Valticos and Morenilla acknowledged the fact that the UK should have taken more adequate measures to protect its servicemen during the nuclear tests, i.e. by establishing the state of health of the participants before and after the tests and by monitoring its development. Yet, there is no mention in their opinion of the basic rules applying to biomedical research, not even questioning whether such rules were relevant in the case.
9. Proceedings of the First International Conference on Harmonization : Brussels 1991, P.F. D'Arcy and D.W.G. Harron (eds), Belfast 1992.
10. See Dominique Sprumont, Legal Protection of Human Research Subjects in Europe, in European Journal of Health Law 6 (1999), pp. 25-43.
11. http://www.wma.net/e/policy/b3.htm (last consulted December 27th, 2004).
12. OJ L 91, 9.4.2005, p. 13
13. See Trudo Lemmens et al., CIOMS' Placebo Rule and the Promotion of Negligent Medical Practice, in European Journal of Health Law 11 (2004), pp. 153-174.
14. See Peteris Zilgalvis, European Law and biomedical research, in Council of Europe (ed.), Ethical Eye, Biomedical research, Strasbourg, 2004, pp. 163-176.
15. OJ L 121/34.
16. OJ L 91, 9.4.2005, p. 13
17. OJ L 311, 28.11.2001, p. 67.
18. th, 2004). See Zilgalvis Peteris, European Law and biomedical research, in Council of Europe (ed.), Ethical eye, Biomedical research, Strasbourg 2004, pp. 166 ff.
19. See also Henriette D.C. Roscam Abbing, The Convention on Human Rights and Biomedicine, An Appraisal of the Council of Europe, in European Journal of Health Law 5 (1998), pp. 377-387.
20. th, 2004).
21. Desmon Dian (ed.), Encyclopedia of the European Union, London, Macmilan, 1998, p. 140.
22. Judgment of the Court of 5 February 1963. - NV Algemene Transport- en Expeditie Onderneming van Gend & Loos v Netherlands Inland Revenue Administration. - Reference for a preliminary ruling: Tariefcommissie - Pays-Bas. - Case 26-62, European Court Reports 1963, p. 1.
23. Desmon Dian (ed.), Encyclopedia of the European Union, London, Macmilan, 1998, p. 141.
24. See also Jo Shaw, Law of the European Union, Houndmills 2000, p. 244;
25. P.J.G. Kapteyn and VerLoren van Themaat, Introduction to the Law of the European Communities, London 1998, p. 326.
26. See P.J.G. Kapteyn and VerLoren van Themaat, Introduction to the Law of the European Communities, London 1998, p. 330.
27. See Jean-Marc Favret, Droit et pratique de l'Union européenne, Paris 2003, p. 333.
28. See Henriette D.C. Roscam Abbing, The Convention on Human Rights and Biomedicine, An Appraisal of the Council of Europe Convention, in European Journal of Health Law 5 (1998), pp. 377-387. See also Glass v. the United Kingdom, Strasbourg, 9 March 2004 (Application no. 61827/00), paragraph 58 and 75.
29. France, Ireland, Luxembourg, Netherlands, Portugal and Sweden.
30. For an overview of those legislations, see also Eugenijus Gefenas, Central and eastern Europe: research-related problems for transition countries, in Council of Europe (ed.), Ethical eye, Biomedical research, Strasbourg 2004, pp. 121-132.
31. Paragraph 13 of the 5th revision of the Declaration of Helsinki, Edinburgh, Scotland, October 2000.
32. ICH-GCP
33. See Marie Hirtle, Trudo Lemmens and Dominique Sprumont, A Comparative Analysis of Research Ethics Review Mechanisms and the ICH Good Clinical Practice Guideline, in European Journal of Health Law 7 (2000), pp. 265-292.
34. See EU Directive article 7.
35. In an affix of this law it is stated, that the law is in compliance with 2001 April 4 European Parliament and Council directive. 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
36. The Convention on the Rights of the Child does not either impose an age limit to define childhood and the States keep some autonomy in defining the scope of protection of the convention. See article 1 of the United Nations Convention on the Rights of the Child: "For the purposes of the present Convention a child means every human being below the age of 18 years unless, under the law applicable to the child, majority is attained earlier. For more details on this issue, see Sharon Derrick (ed.), The United Nations Convention on the Rights of the Child, A Guide to the "Travaux Pré paratoires", Dordrecht Boston London 1992, pp. 115-119.
37. See also Philip E. Veerman, The Rights of the Child and the Changing Image of Childhood, Dordrecht, Boston, London 1992, pp. 17-19, 185-187.
38. According to provisions of the Lithuanian Civil code, while deciding on the reduction of a person's legal age to consent to marriage, the court must hear the opinion of the minor's parents, guardians or curators and take into account his or her mental or psychological condition, financial situation and other important reasons why the person's legal age to consent to marriage should be reduced. Pregnancy shall provide an important ground for the reduction of the person's legal age of consent to marriage.
39. § 3 paragraph 3 of the Estonian Procedure for Conduct of Clinical Trials of Medicinal Products and paragraph 11 of the Latvian Procedure for clinical trials on medicines and pharmaceutical products and for observational studies.
40. Article 5 of the Law on Ethics of Biomedical Research states that minors are ascribed to vulnerable subjects group, but the age limit, when it is compulsory to get consent of such persons for conducting biomedical researches, is not stated. Provision of article 7, stating that conducting biomedical research with a minor, a consent of both parents must be obtained (one, if they live separately) or a consent of legally acceptable representatives of the minor, and the children's rights protection agency of a district or a city, is logically misleading, because the provision itself does not impose the minor's participation in this process. Such provisions of the law should be detailed, altering their formulation or the limit of age, when opinion of a minor should be considered important, stated in law.
41. The Constitution of the Republic of Lithuania, which is a single and directly applicable act, was approved by the citizens of the Republic of Lithuania in the Referendum on 25 October 1992.
42. Liability for and Insurability of Biomedical Research with Human Subjects in a Comparative Perspective, in J. Dute, M.G. Faure and H. Koziol (eds.), Tort and Insurance Law, Vol. 7, Springer, Wien, New York 2004, p. 358.
43. Application for compensating a research-induced damage can be subjected during the period stated by the insurer and the policyholder in the insurance contract, but the Insurance Rules state that this period can not be shorter than 5 years after the end of the study.
44. Essais cliniques, responsabilité civile et contrats d'assurance. Bulletin des médecins suisses 40/2002, pp. 2092-2096, Dominique Sprumont, Séverine Boillat and Hermann Amstad.
45. On this issue, see also Liability for and Insurability of Biomedical Research with Human Subjects in a Comparative Perspective, in J. Dute, M.G. Faure and H. Koziol (eds.), Tort and Insurance Law, Vol. 7, Springer, Wien, New York 2004.
46. Benn Steil, Competition, Integration and Regulations in EC Capital Markets, Royal Institute of International Affairs, London 1993
47. See Stephen Woolcock, Competition among Rules in the Single European Market, in International Regulatory Competition and Coordination, William Barton, Joseph McCahery, Sol Piccioto and Colin Scott (eds), Clarendon Press, Oxford 1996, p. 313.
48. For more details on that conference an its follow-up, see Facing the Future Together, Conference on Research Ethics Committees in Europe, Brussels 27-28 January, 2005 http://europa.eu.int/comm/research/conferences/2005/recs/ publications_en.htm