Abstract
The implementation of Directive 2001/20/EC changed considerably the legal regulation of clinical trials in Portugal. The rights of the participants in research, including minors and incompetent adults, are now more accurately described and the possibility of non-therapeutic research with minors was introduced. Moreover, the new administrative procedure and the role of ethics committees changed substantially, since the new National Ethics Committee for Clinical Research was given extensive power and the traditional local ethics committees have seen a decrease in their functions and activities.
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Notes
- 1.
‘Non-interventional trial’: a study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data.
- 2.
See Jorge Sinde Monteiro, Manuel da Costa Andrade & José de Faria Costa, with the collaboration of André Dias Pereira, ‘Country Report Portugal’, in Erwin Deutsch & Jochen Taupitz (eds.), Forschungsfreiheit und Forschungskontrolle in der Medizin—Zur geplanten Revision der Deklaration von Helsinki/Freedom and Control of Biomedical Research—The Planned Revision of the Declaration of Helsinki (1999), 149-154; Jorge Sinde Monteiro & André Dias Pereira, ‘Landesbericht Portugal’, in Jochen Taupitz (ed.), Zivilrechtliche Regelungen zur Absicherung der Patientenautonomie am Ende des Lebens—eine internationale Dokumentation/Regulations of Civil Law to Safeguard the Autonomy of Patients at the End of their Life—an International Documentation (2000), 819-866; André Dias Pereira, ‘Portuguese Country Report’, in Jochen Taupitz (ed.), Das Menschenrechtsübereinkommen zur Biomedizin des Europarates - taugliches Vorbild für eine weltweit geltende Regelung?/The Convention on Human Rights and Biomedicine of the Council of Europe—a Suitable Model for World-Wide Regulation? (2002), 705-738; João Carlos Loureiro & André Dias Pereira, ‘Portuguese Report’, in Erwin Deutsch, Hans-Ludwig Schreiber, Andreas Spickhoff & Jochen Taupitz (eds.), Die klinische Prüfung in der Medizin—Europäische Regelungswerke auf dem Prüfstand/Clinical Trials in Medicine—European Rules on Trial (2005), 259-293 and bibliography indicated in that paper.
- 3.
Cf. AMG—Gesetz über den Verkehr mit Arzneimitteln. Cf. Erwin Deutsch & Andreas Spickhoff (eds.), Medizinrecht, (6th ed. 2008), at 689.
- 4.
According to Art. 8 (2) of the Constitution: Conventional law has a higher ranking than national legislation.
- 5.
The Directive refers to the 1996 version of the Helsinki Declaration. Or, according to the principle of interpretation of law according to European Law, the Portuguese lawyer shall accept only—with a binding force—that version of the Helsinki Declaration.
- 6.
See CIOMS (Council for International Organizations of Medical Sciences): International Ethical Guidelines for Biomedical Research Involving Human Subjects (Genebra: CIOMS/OMS, 2002), WHO and ICH Guidelines for Good Clinical Practice; UNESCO: Universal Declaration on Bioethics and Human Rights (2005).
- 7.
Ratified by Law 29/78, of 12 June.
- 8.
See also Art. 9 of the Oviedo Convention.
- 9.
Tom Beauchamp & James Childress (eds.), Principles of Biomedical ethics (2001).
- 10.
See Francis Fukuyama, Our Posthuman Future: Consequences of the Biotechnology Revolution (2003).
- 11.
See also Art. 6 (7) of the Directive 2001/20/EC.
- 12.
Article 42 (Freedom of cultural creation): 1. Intellectual, artistic and scientific creation shall not be restricted. 2. This freedom shall comprise the right to invent, produce and publicize scientific, literary and artistic works and shall include the protection of copyright by law.
- 13.
Article 73 (Education, culture and science): 4. The state shall stimulate and support scientific research and creation and technological innovation, in such a way as to ensure their freedom and autonomy, reinforce competitivity and ensure cooperation between scientific institutions and businesses.
- 14.
Art. 15 of the Oviedo Convention: “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.”
- 15.
As Joaquim Canotilho, Direito Constitucional e Teoria da Constituição (7th ed. 2003), at 1225 states: “The principle of practical concordance means—in its essential feature—the coordination and combination of “legal goods” in conflict in order to avoid the (total) sacrifice of some towards the others.”
- 16.
INFARMED—National Authority of Medicines and Health Products, IP is a Government agency accountable to the Health Ministry. The objective is to monitor, assess and regulate all activities relating to human medicines and health products for the protection of Public Health.
- 17.
For more information on Portuguese tort law, see André Dias Pereira, ‘Portuguese Tort law: a comparison with the European Principles on European Tort Law’, in Helmut Koziol & Barbara Steininger (eds.), European Tort Law 2004 (2005), 623-648.
- 18.
Former French law only provided no-fault liability in case of therapeutic research. Since the law of 9 August 2004 (Loi n.º 2004-806) there is a unification of the provisions: there is a presumption of fault in all cases of clinical trials; the sponsor (and not the physician/investigator) has the burden of proof that there was no fault.
- 19.
Carla Gonçalves, A Responsabilidade Civil Médica: um Problema para além da Culpa (2009), at 66.
- 20.
Jorge Sinde Monteiro, Manuel da Costa Andrade & José de Faria Costa, with the collaboration of André Dias Pereira, ‘Country Report Portugal’, in Erwin Deutsch & Jochen Taupitz (eds.), supra note 2, at 154.
- 21.
See Art. 6 (5) of Law 100/97, of 13 September.
- 22.
“Investigators should ensure that research subjects who suffer injury as a result of their participation are entitled to free medical treatment for such injury and to such financial or other assistance as would compensate them equitably for any resultant impairment, disability or handicap. In the case of death as a result of their participation, their dependants are entitled to compensation. Subjects must not be asked to waive the right to compensation.”
- 23.
However, that distinction is still important to interpret the rule of Art. 7 (1) (e), as it allows research with direct relation with the clinical condition of the minor, or “some direct benefit for the group of patients is obtained from the clinical trial”. In this case the research is non-therapeutic for the minor. On the contrary, in case of incompetent adults such non-therapeutic research is not allowed.
- 24.
Information concerning placebo in blinded trials or double-blinded trials is mandatory. European Guidelines accept the use of placebo and those methodologies. According to ICH Harmonised Tripartite Guideline (EMEA) (1.10) Blinding/Masking means: “A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).” (1.14) Comparator (Product): An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
Some protocols do use placebo and the Ethics Committee has a careful approach to these cases, generally applying the international standards: The Additional Protocol to the Convention on Human Rights and Biomedicine (signed by Portugal but not yet ratified), concerning Biomedical Research states (Art. 23 (3)): “The use of placebo is permissible where there are no methods of proven effectiveness, or where withdrawal or withholding of such methods does not present an unacceptable risk or burden.” The Helsinki Declaration (October 2008) affirms (32): “The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances: The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.”
- 25.
Art. 5 of Law 3/84, of 24 March; Ordinance 52/85, of 26 January. The woman after 16 years has the right to consent in an abortion (Art. 142 (3) (b) of the Penal Code).
- 26.
Art. 17 (4) of Law 12/2005, of 26 January: the minor must co-consent in case of genetic tests. Art. 8 of Law 22/2007, of 29 June: co-consent on the donation of renewable organs and tissues to a brother.
- 27.
Jens Kuhlmann, Einwilligung in die Heilbehandlung alter Menschen (1994), at 215.
- 28.
Art. 1902 (1) of the Civil Code.
- 29.
Art. 7 (3) of Law 22/2007, of 29 June.
- 30.
Art. 21 of the Biomedicine Convention.
- 31.
Consideration 3 of the Directive explains the purpose of this exception.
- 32.
Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004 (Official Journal of the European Union, 27.12.2006).
- 33.
On 21.1.2009, the Portuguese Government approved a decree that assures the fulfilment of the national obligations that arise from Regulation (EC) No. 1901/2006.
- 34.
André Dias Pereira, O Consentimento Informado na Relação Médico-Paciente (2004).
- 35.
See consideration 4.
- 36.
The distinctions therapeutic/non-therapeutic research; direct benefit/indirect benefit; and medical indication are discussed by Rainer Schweizer & Benedikt van Spyk, ‘Arzt und Forschung’, in Moritz W. Kuhn & Tomas Poledna (eds.), Arztrecht in der Praxis (2nd ed. 2007), at 538 et seqq.
- 37.
Cf. Erwin Deutsch & Andreas Spickhoff, supra note 3, at 627-628.
- 38.
Art. 16 of the Biomedicine Convention (iii): “The research project has been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of the research, and multidisciplinary review of its ethical acceptability.” Guideline 2 of CIOMS states: Ethical review: “The ethical review committee is responsible for safeguarding the rights, safety, and well-being of the research subjects. Scientific review and ethical review cannot be separated : scientifically unsound research involving humans as subjects is ipso facto unethical in that it may expose them to risk or inconvenience to no purpose; even if there is no risk of injury, wasting of subjects’ and investigators’ time in unproductive activities represents loss of a valuable resource. Normally, therefore, an ethical review committee considers both the scientific and the ethical aspects of proposed research. It must either carry out a proper scientific review or verify that a competent expert body has determined that the research is scientifically sound. Also, it considers provisions for monitoring of data and safety.”
- 39.
Art. 9 (5) of the Directive 2001/20/EC and Art. 17 of Law 46/2004.
- 40.
Art. 9 (7) of the Directive 2001/20/EC and Art. 17 (6) of Law 46/2004: This authorization shall be issued without prejudice to the contained use of genetically modified micro-organisms and the prohibition of deliberate release into the environment of genetically modified organisms.
- 41.
- 42.
We assume that the second semester will have similar results as the former three semesters.
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Pereira, A. (2010). Country Report Portugal. In: Deutsch, E., Duttge, G., Schreiber, HL., Spickhoff, A., Taupitz, J. (eds) Die Implementierung der GCP-Richtlinie und ihre Ausstrahlungswirkungen. Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim, vol 37. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-13177-6_15
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