Regulation of clinical research and bioethics in Portugal

Bioethics

Volumn 21, Issue 5, 2007, Pages 290-302

  Carvalho, Fatima Lampreia ^a,b  

^a UNIVERSITY OF SUSSEX   (United Kingdom)

^b Marie Curie Excellence Grant ^*  (United States)

Author keywords

Bioethics; Clinical investigation; Commissions; Culture; European Directive; History of health ethics; Portugal

Indexed keywords

ARTICLE; BIOETHICS; CLINICAL RESEARCH; DRUG INDUSTRY; GOOD CLINICAL PRACTICE; MEDICAL ETHICS; MEDICAL EXPERT; PORTUGAL; PUBLICATION; RESEARCH ETHICS; SOCIOLOGY;

BIOETHICS; CLINICAL TRIALS; ETHICS COMMITTEES, RESEARCH; HUMANS; PORTUGAL;

EID: 34247501629     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/j.1467-8519.2007.00555.x     Document Type: Article

References (81)

1. This idea was raised by Prof. José Pacheco Pereira in the 9th Seminar promoted by the National Council of Ethics for Life Sciences (CNECV), November 2005, Lisbon.
2. See Law n°46/2004, 19 August, 2004. Articles 15 to 17 - Previous authorisation., Procedures for Previous Authorisation and Special Cases. Diário da República, Portugal. See also f1 f1_legend_spanFigure 1, p. 292.
3. Ethics Committees for Health (Comissões de Ética para a Saúde), hereafter CES.
4. The ED-REG-HAR project funded by the European Commission's Marie Curie Excellence Grant, led by Dr. Adam Hedgecoe, will be documented in a forthcoming book, in which the Portuguese case study is contrasted with research in the UK, Sweden and Hungary.
5. Hereafter the National Ethics Committee for Life Sciences is referred to as the CNECV.
6. The notion of a 'thin' and universalistic morality as opposed to a 'thick' and particularistic morality, are expanded by M. Waltzer. 1994. Thick and Thin, Moral Argument Home and Abroad. London: University of Notre Dame Press.
7. Directive 2001/20/EC of the EU Parliament and of the Council of 4 April 2001. Official Journal of the European Communities 2001.Article 1 Scope § 2, 1.5.2001: L 121/34.
8. The Belmont Report. Available at: http://ohsr.od.nih.gov/guidelines/ belmont.html "Accessed 19 December 2006".
9. See Ethical-Juridical Documentation in M.C. Patrão Neves. 2004. Comissões de Ética, das Bases Teóricas à Actividade Quotidiana. Coimbra. Pólo Açores, Gráfica Coimbra: 511-515.
10. John H. Evans 2002. Playing God? Human Genetic Engineering and the Rationalization of Public Bioethical Debate. Chicago: The University of Chicago Press.
11. Patrão Neves, op. cit. note 9.
12. Source: interview with Dr. M.C. Patrão Neves. July 2005.
13. Ibid.
14. Ibid.
15. A.A. Bignamini. 2000. Ethics Committees in Central & Eastern Europe. J. Glasa, ed. Bratislava. Charis - IMEB Foundation: 95.
16. Ibid.
17. Daniel Serrão. 2003. Uso de embriões humanos em investigação cientifica. Lisbon. Ministry of Science. Available at: http://www.danielserrao.com/fotos/gca/Livrobranco.pdf "Accessed 11 January 2007".
18. Ibid.
19. In Prof. Serrão's view, a personalist bioethics is based on the premise that 'Abstract thought singularizes human being'.
20. Ibid.
21. Daniel Serrão. Utopia and Bioethics. Available at: http://www.danielserrao.com/gca/index.php?id=122 "Accessed 11 January 2007".
22. Ibid.
23. Ibid.
24. A.L. Cardoso. 1996. The Self-Responsibility of the CNECV in Public Debate. Actas do III Seminário do Conselho Nacional de Ética para as Ciências da Vida. Lisbon. Coleção Bioética. Presidência do Conselho de Ministros: 11"Translated by the writer".
25. Interview with Dr. Walter Osswald in Prisfar News. Newsletter n° 10. October 2003 - Available at: http://www.prisfar.pt/uk/news/news-n10-f.asp "Accessed 11 January 2007". "Translated by the writer".
26. Ibid. "Translated by the writer".
27. Available at: http://www.danielserrao.com/gca/index.php?id=174 "Accessed 11 January 2007".
28. Ibid.
29. Volney Garrafa. Origin and evolution of Bioethics in Portugal and Brazil: the identity question. Available at: http://www.portalmedico.org.br/revista/ bio11v2/simposio13.htm. "Accessed 11 January 2007". Translation is my own.
30. L. Archer, J. Biscaia & W. Osswald, eds. 1996. Bioética. Lisbon: Editorial Verbo.
31. L. Archer, L; J. Biscaia, eds. 2001. Novos Desafios da Bioética. Lisbon: Verso.
32. J.H. Evans, op. cit. note 10.
33. M.L. Tina Stevens. 2000. Bioethics in America. Baltimore, London: The John Hopkins University Press.
34. Report and Opinion 39/CNECV/2001. Documentation Volume VIII. Lisbon. Presidency of the Council of Ministers. CNECV 2001; 127-137.
35. Report and Opinion on the Ethical Implications of Genome Research, 40/CNECV/01. Documentation Volume VIII. Lisbon. Presidency of the Council of Ministers. CNECV 2001; 189-200.
36. Patrão Neves, op.cit. note 9.
37. Patrão Neves, op. cit. note 9, p. 500.
38. Prof. Serrão is in disagreement with a 'deliberative bioethics' arguing that bioethics must not be situated in a juridical dimension.
39. P. Martinho da Silva. 1997. Convenção dos Direitos do Homem e da Biomedicina. Lisbon: Edições Cosmos Direito.
40. M.L. Tina Stevens, op. cit. note 32, p. 46.
41. E. Freeman. The God Committee. New York Times Magazine. May 21, 1972; 30-32.
42. J. Biscaia. 2004. Centro de Estudos de Bioética. In Comissões de Etica, das bases Teóricas a Actividade Quotidiana, 2nd revised and extended edition. M. Patrão Neves, ed. Coimbra. Gráfica Coimbra: 77. "Translated by the writer".
43. Ibid.
44. For example in L. Archer, 2006. Da Genética à Bioética. Portuguese Bioethics Association, Service of Medical Ethics and Bioethics (FMUP): Gráfica de Coimbra. See also J.M. Pereira de Almeida. Diante de quem morre. Apontamentos de uma perspectiva ética. Communio 1998; XV, n.1 and Fr. V. Feytor Pinto. Pastoral da Saúde. Um serviço à Plenitude da Vida. Communio 1991; VIII, n.2.
45. Patrão Neves, op. cit. note 9, p. 73.
46. M.C. Patrão Neves. 2002. Bioética e sua exigência de fundamentação (Bioethics and its demand for a foundation). In Contributos para a Bioética em Portugal. J. Ribeiro da Silva, A. Barbosa and F. Martins do Vale, eds. Faculty of Medicine. Univ. of Lisbon. Lisbon. Edições Cosmos: 137-160.
47. Ibid.
48. M. Renaud. A educação em bioética: problemas e perspectivas. Cadernos de Bioética 2002 12 : 97 104
49. F.S. Cabral. Ética e Debate ou Ética em debate. Coleção Bioética - Ética da Vida: Concepções e Debates. Actas do III Seminário do CNECV. Presidência do Conselho de Ministros. CNECV 1996; 63-83.
50. A.F. Cascais. 2002. Genealogia, Ambito e Objecto da Bioética. In Contributos para a Bioética em Portugal. J. Ribeiro da Silva et al., eds. Faculty of Medicine, Univ. of Lisbon. Lisbon. Edições Cosmos: 47-136.
51. L. Archer. Reflections on the CNECV and its functioning: from 1991 to 2001- Documentation Volume VIII. 38/CNECV/01. Presidency of the Council of Ministers. CNECV 2001; 113-125.
52. L. Archer. 2004. Conselho Nacional de Ética para as Ciências da Vida. In Comissões de Ética, das bases Teóricas a Actividade Quotidiana. M.C. Patrão Neves, coord. Coimbra. Gráfica Coimbra: 84.
53. This was aattended by the Minister of Justice, Dr. Laborinho Lucio and Noelle Lenoir, President of UNESCO's International Bioethics Committee, as well as members of existing research ethics committees (RECs) established before 1995.
54. Comissões de Ética - II Seminário do Conselho Nacional de Ética para as Ciências da Vida. Coleção Bioética. Lisbon. CNECV 1996: 160.
55. Maria de Belém Roseira was Portuguese Health Minister during the government of the Socialist Prime Minister Antônio Guterres (1995-2001). Dr. de Belém Roseira was Portugal's Minister for Equality at the Council of Europe in 2000. In the new government she is Council President-in-Office at Brussels and President of the Parliamentary Committee for Health at the Republican Assembly of Portugal.
56. Comissões de Ética, II Seminario do CNECV. Coleção Bioética. Lisbon. CNECV 1996; 145.
57. The same is true for CEIC, whose source, the European Directive, elaborated by the EU Parliament, is not so concerned with bioethics and human rights as with the pharmaceutical industry's requirements. A comparison with the Council of Europe's 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 (4th May 1997) illustrates the point.
58. Dr. Ribeiro da Silva is ex-President of the Society of Medical Sciences of Lisbon, and President of the Portuguese Academy of Medicine. Dr. da Silva presides over the Federation of Academies of Medicine in Europe.
59. Institutional Review Boards have been at work in the United States since the 1960s. Their compulsory character was established by the North American Congress in 1974. IRBs were instituted then as a specific commission for revising scientific projects in all institutions carrying out investigation on human beings and financed by the federal government.
60. See f1 f1_legend_spanFigure 1, p. 292, Directive 2001.20 EC in Portugal 2005-07.
61. Ethics Committee in Hospitals (Comissões de Ética nos Estabelecimnentos Hospitalares). Lisbon. Direção de Servicos de Prestação de Cuidados de Saúde 2000. According to an introductory note, such reports resulted from the formulation of questionnaires, sent to every one of the 99 Portuguese Hospitals, and 91.9% of which were completed and returned."Translated by the writer".
62. W. Osswald. 1994. Comissões de Ética: Uma Reflexão sobre a sua justificação. In Comissões de Ética, das Bases Teóricas à Actividade Quotidiana. M.C. Patrão Neves, coord. Coimbra. Pólo Açores, Gráfica Coimbra: 125-129.
63. Ibid: 127.
64. Ibid: 128.
65. See methodological section. After my fieldwork interview, Dr. Filipe de Almeida was appointed as one of the 34 members of the newly created National Ethics Committee for Clinical Investigation - CEIC.
66. F. Almeida. 1994. Comissões de Ética para a Saude: Sua Natureza e Tarefas. In Comissões de Ética: das Bases Teóricas à Actividade Quotidiana. M.C. Patrão Neves, coord. Coimbra. Pólo Aççores, Gráfica Coimbra: 131-139.
67. Ibid: 133.
68. Law n°46/2004, 19 August, 2004. Article 3 - Primacy of the Person §1. Diário da República, Portugal.
69. From January 2006 this executive committee has had only eight members and this number will probably drop to six due to a controversial law preventing retirees from working in public posts, despite being officially nominated as CEIC members.
70. See Diario da República. 2005. Dispatch n.3978/2005 (2nd series) - II Series n.38-23 of February 2005. Lisbon. Ministry of Health: 2668.
71. Guilherme Valente (ed) Medicina do Corpo. Medicina do Espirito, Gradiva, Lisbon, 2002.
72. INFARMED is a public institute of the Health Department that is responsible for the evaluation, regulation and control of activities relating to the use of medicines for human and veterinary use. Specific areas of focus within INFARMED include the Farmacovigilance, the Medicines of Human Use and Veterinarian Products of Health, Quality Control, and Pharmaceutical Inspections.
73. Assertion based on interview with a member of CEIC's Executive Committee, July 2006.
74. See Chart Directive 2001.2000 EC in Portugal 2005-07.
75. Information based on a meeting with CEIC's Executive Committee, in October 2005.
76. In November 2005, it was already known that in only six months of activity, CEIC had already rejected several applications for clinical trials in Portugal.
77. CEIC's delegates are expected to adopt the Guidance on Conflicts of Interest as formulated in the EMEA's Code of Conduct, a system used in interaction with CPMP (Committees Responsible for Preparing Opinions on Medicinal Products for Humans).
78. Source: Interview with Dr. Walter Osswald (CEB), July 2005.
79. L. Archer. Reflections on CNECV and its functioning: from 1991 to 2001, Documentation Volume VIII, 38/CNECV/01. Lisbon. Presidency of the Council of Ministers, CNECV: 2001; 119.
80. Ibid.
81. Source: interview with Dr. Walter Osswald (CEB), July 2005.