Abstract
In this chapter the legal issues concerning the use of amniotic membrane are analyzed, in particular the problems of informed consent, data protection, transplantation of tissues, biomedical research, biobanks and the prohibition of financial gain; the European Directives concerning technical quality and safety of human tissues and cells will also be briefly presented.
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Notes
- 1.
Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin, Strasbourg, 24.I.2002. This Protocol applies to the transplantation of organs and tissues of human origin carried out for therapeutic purposes. This protocol has already 12 ratifications/accessions and 9 other States have signed it but not yet ratified (like Portugal). Entered into force in 1.5.2006.
- 2.
See also Commission Decision of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council.
- 3.
Moreover, although not directly applicable to human tissues, one shall mention the Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation, implemented in Portugal by Law no. 36/2013, 12 June.
- 4.
See Recommendation 4.1.1. of the National Statement on Ethical Conduct in Human Research, Australia, 2007 (Updated December 2013).
- 5.
See Recommendation 4.1.6. of the National Statement on Ethical Conduct in Human Research, Australia, 2007 (Updated December 2013).
- 6.
See European Commission of Human Rights, Petition no. 8416/78 (W.P. vs. UK); in USA, see Planned Parenthood of SE Pennsylvania v Casey [1992] 112 S Ct 2791 (US Sup Ct).
- 7.
That is stated in Articles 12 and 13 of the Additional Protocol: “The donor (…) shall beforehand be given appropriate information as to the purpose and nature of the removal as well as on its consequences and risks. (…).” “An organ or tissue may be removed from a living donor only after the person concerned has given free, informed and specific consent to it either in written form or before an official body. The person concerned may freely withdraw consent at any time.”
- 8.
A similar norm is to be found in Article 22 of the Biomedicine Convention: “When in the course of an intervention any part of a human body is removed, it may be stored and used for a purpose other than that for which it was removed, only if this is done in conformity with appropriate information and consent procedures.” See also Article 18 (5) of the Portuguese Law 12/2005: “The biological samples collected for a particular purpose should not be used for other health care or biomedical research purposes unless the person from whom it was collected gives consent to it (…).”
- 9.
See Article 24 of Portuguese Law 12/2009, of 26 March and Article 8 of Law 12/93, of 22 April, changed by Law 22/2007, of 29 June. The problem of donation by minors or adults with diminished capacity due to metal illness is regulated in the following paragraphs. It allows donation of renewable tissues (that could the case of amniotic membranes) in the case of minors after parental authorization, in case of mental ill patients after court authorization (see also Annex IV of Law 12/2009). This Law Establishes the legal regime concerning the quality and safety the donation, procurement, testing, processing, preservation, storage, distribution and application of tissues and cells of human origin, transposing into national law Directive 2004/23/EC of the European Parliament and of the Council of 31 March, Directive 2006/17/EC, the Commission of 8 February and Directive 2006/86/EC, the Commission of 24 October.
- 10.
See Articles 1, 26 and 35 of the Portuguese Constitution.
- 11.
Article 18 of the Oviedo Convention is not important in this case, since the amniotic membrane tissue does not contain an embryo anymore.
- 12.
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, Strasbourg, 25.I.2005. There were so far (28.12.2013) 9 ratifications/accessions and 13 signatures not followed by ratification (the case of Portugal). It entered into force in 1.9.2007.
- 13.
Last revision: 64th WMA General Assembly, Fortaleza, Brazil, October 2013.
- 14.
In the international literature, some Authors defend the concept of broad consent, or an open consent for research with samples stored in a Biobank – see [8]. The model termed ‘broad consent’ has been adapted by many current Biobank projects, like UK Biobank, CARTaGENE (Montreal, QC, Canada) and the Norwegian HUNT study.
- 15.
Anonymisation is the process of turning data into a form, which does not identify individuals and where identification is not likely to take place. This allows for a much wider use of the information.
- 16.
Zahid et al. [9] emphasize the main ethical aspects of Biobanks of human tissue as being confidentiality, informed consent, organizational policies, and respect for scientific standards.
- 17.
In Portugal, the collection and storage of biological samples from the Biobank-IMM (Faculty of Medicine – University of Lisbon) are authorized by the Ethics Committee of the North Lisbon Hospital Centre – Hospital de Santa Maria. The collection and processing of clinical data associated to samples are authorized by the National Commission for Data Protection.
- 18.
Implemented in Portuguese Law by Law 67/98, of 26 October.
- 19.
See also Articles 12, 14 and 15 of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.
- 20.
The Helsinki Declaration states: “32. For medical research using identifiable human material or data, such as research on material or data contained in Biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.”
- 21.
Lowrance [10] argues for a change in European Data protection law, so that health research is fostered and, by the same token, confidentiality of data is respected.
- 22.
National Organ Transplant Act: 42 U.S. CODE § 274E – Prohibition of Organ Purchases.
- 23.
Article 12 of the Directive 2004/23/CE is related to the principles governing tissues and cells donation. In its paragraph one establishes that “1. Member States shall endeavor to ensure voluntary and unpaid donation of tissues and cells. Donors may receive compensation, which is strictly limited to making good the expenses and inconveniences related to the donation. In that case, Member States define the conditions under which compensation may be granted. Member States shall report to the Commission on these measures before 7 April 2006 and thereafter every three years. On the basis of these reports the Commission shall inform the European Parliament and the Council of any necessary further measures it intends to take at Community level”.
- 24.
See Article 21 of the Biomedicine Convention and Article 3 Charter of Fundamental Rights of the European Union. In the USA, see the Moore v. Regents of the University of California (51 Cal. 3d 120; 271 Cal. Rptr. 146; 793 P.2d 479) – this was a landmark Supreme Court of California decision filed on July 9, 1990, which dealt with the issue of property rights in one’s own body parts. John Moore underwent treatment for hairy cell leukemia at the UCLA Medical Center. Moore’s cancer was later developed into a cell line that was commercialized. The California Supreme Court ruled that Moore had no right to any share of the profits realized from the commercialization of anything developed from his discarded body parts. See also Recommendation 4.1.20 (d) and (e) of the National Statement on Ethical Conduct in Human Research, Australia, 2007 (Updated December 2013) – “the woman shall be informed, “(d) whether there is potential for commercial application of outcomes of the research, including the development of cell lines; (e) that she will not be entitled to a share in the profits of any commercial applications.”
- 25.
See about the problem of patenting of human genes, the decision of the European Court of Justice, Case C-34/10 Oliver Brüstle v. Greenpeace e.V.; See the analysis of Pereira [11].
References
Dua HS, Azuara-Blanco A (1999) Amniotic membrane transplantation. Br J Ophthalmol 83:748–752
Niknejad H, Peirovi H, Jorjani M et al (2008) Properties of the amniotic membrane for potential use in tissue engineering. Eur Cell Mater 15:88–99
Mamede AC, Carvalho MJ, Abrantes AM et al (2012) Amniotic membrane: from structure and functions to clinical applications. Cell Tissue Res 349:447–458
ASST (2009) Statistical report – organs and tissues donation and transplantation. http://www.asst.min-saude.pt/SiteCollectionDocuments/RelatorioEstatistico2009.pdf
Loureiro JC, Pereira AD (2004) Portuguese report. Clin Trials Med Eur Rules Trial 259–293
Pereira AD (2011) Country report Portugal. In: Deutsch E, Duttge G, Schreiber H-L et al (eds) Die Implementierung der GCP-Richtlininen und ihre Austrahlungswirkungen. Springer, Berlin, pp 255–270
de Oliveira G (2013) Consentimento informado para biobancos. Livro homenagem a António Barbosa Melo. Almedina, Coimbra, pp 257–283
Steinsbekk K, Myskja B, Solberg B (2013) Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem? Eur J Hum Genet 21:897–902
Zahid HM, Chakma K, Miah M, Nessa A (2010) Ethical perception of tissue banking in Bangladesh. Bangladesh J Bioeth 1:11–19
Lowrance WW (2013) Privacy, confidentiality and health research. Cambridge University Press, Cambridge 204
Pereira AD (2012) Human genes as corporate assets? Nature, morals and the role of intellectual property in healthcare innovation. Rev Port direito da saúde – Lex Med 17:127–146
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de Oliveira, G., Pereira, A. (2015). Ethical and Legal Concerns of the Use of Amniotic Membrane. In: Mamede, A., Botelho, M. (eds) Amniotic Membrane. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-9975-1_14
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