Wider ethical aspects of donation evaded in the ATMP Regulation

where stem cell research is translated from bench to bedside, in particular in terms of tissue donors’ right to self-determination and privacy.⁵⁰⁶ As discussed in Section 6.2. of this study, despite some significant ethical concerns were raised and discussed during the legislative process of the ATMP Regulation regarding commercialisation of altruistic cell and tissue donations, integrity of the person and the inviolability of human dignity,

501Herder, M.”Proprietary Interest and Collaboration in Stem Cell Science: Avoiding Anticommons, Countering Canalyzation” in Hug, K., Hermerén, G. (eds.) Translational Stem Cell Research. (New York, Dordrecht, Heidelberg, London: Springer), 2011, 267-282.

502 Op.cit., 281-282.

503 See also Gitter, D.M. Resolving the open source paradox in biotechnology: A proposal for a revised open source policy for publicly funded genomic databases. Houst Law Rev. 2007;43:1475-521.

504 Eisenberg, R.S. Patents and datasharing in public science. Ind Corp Change 2006;15:1013-31.

505 Herder, supra note 501, 282. Herder refers to WARF’s rigid control of its hESC patented cell lines illustrates patenting inventions that are perceived foundational to a field of inquiry can impede research progress.

506Hartlev, supra note 135, 258-260.

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the proposed ethical amendments were left outside the scope of the final version of the ATMP Regulation due to the fact that such ethical considerations are outside the scope of the EU’s legislative mandate.

Yet, the Recital 8 of the ATMP Regulation states that fundamental rights and principles reflected in the Charter of Fundamental Rights of the EU and the Biomedicine Convention have been observed. Article 3.1 of the Charter requires among other things that everyone has the right to respect for his or her physical and mental integrity. In addition Article 3.2 specifies that in the fields of medicine and biology the free and informed consent of the person concerned, according to the procedures laid down by law the following must be respected. Also under Article 10.1 of the Biomedicine Convention everyone has the right to respect for private life in relation to information about his or her health.In addition, more specifically, Recital 15 of the ATMP Regulation notes that

“[a]s regards the donation of human cells or tissues, principles such as the anonymity of both donor and recipient, altruism of the donor and solidarity between donor and recipient should be respected“. Therefore, human cells or tissues contained in ATMP should be procured from voluntary and unpaid donation. Also, Recital 19 of the ATMP Regulation notes that the summary of product characteristics, labelling and the package leaflet of an ATMP should comply fully with the patient’s right to know the origin of any cells or tissues used in the preparation of ATMPs, while respecting donor anonymity.

Furthermore, as it will be discussed in Section 7.3.3., the new EU Data Protection Regulation imposes specific requirements for controlling and processing of personal data. Also the Recital 28 of Clinical Trials Regulation specifies consent requirements for clinical trials for re-use of data collected for purposes of clinical trials:

“[i]t is appropriate that universities and other research institutions, under certain circumstances that are in accordance with the applicable law on data protection, be able to collect data from clinical trials to be used for future scientific research, for example for medical, natural or social sciences research purposes.

In order to collect data for such purposes it is necessary that the subject gives consent to use his or her data outside the protocol of the clinical trial and has the right to withdraw that consent at any time. It is also necessary that research projects based on such data be made subject to reviews that are appropriate for research on human data, for example on ethical aspects, before being conducted.”

Especially, in case of commercial stem cell repositories, it should be noted that tissue donors may have a particular interest in self-determination and privacy protection in regards to those samples.⁵⁰⁷ Such legitimate interests of the donors should be balanced against the interests of other actors, including but not limited to patients that can potentially benefit from the donated samples and the society at large benefiting from creation of new scientific knowledge. The Report of the Unesco International Bioethics Committee (IBC) on the ethical aspects of human embryonic stem cell research emphasises the importance of prior, free and informed consent of hESCs:

507 See e.g. Hartlev, supra note 135, 254.

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“Whatever form of research involving embryos is allowed, steps should be taken to ensure that such research be carried out within the framework of a State-sponsored regulatory system that would give due weight to ethical considerations, and set up appropriate guidelines. When authorisation of donations of supernumerary pre-implantation embryos from IVF treatments for therapeutic embryonic stem cell research is under consideration, particular attention should be given to the dignity and rights of both parental donors of embryos. Thus, it is essential that the donation be made only after the donors should have been given full information as to the implications of the research and have given their prior, free and informed consent. The purposes for which such research is carried out, and the way of its performance, should be subject to assessment by the appropriate ethics committees, which should be independent of the researchers involved. This assessment should include ex post facto ethical evaluation of such research. ...”⁵⁰⁸

To safeguard interests of tissue donors and potential patients in need of advanced therapies, it would be very important to acquire prior, written, informed consents from donors to ensure that the persons who donate tissues for research also consent to possible secondary uses of the donated tissues. In addition, the donor should be adequately informed about his/her rights to revoke the consent for any reason and the possible use of personal data after such revocation if such use is after revocation of the consent allowed by a law under some specific circumstances. ⁵⁰⁹ Furthermore, it is relevant to consider whether anonymisation of a tissue sample (that still contains genetic information of the research subject) takes the interests of the research subject adequately into consideration.⁵¹⁰ Hartlev has argued that anonymisation as such may not be a sufficient measure. Regarding the perspective of recognition of the principle of self-determination, for some the possibility to define or decide for which purposes their tissue samples are being used may also be a matter of even greater significance.⁵¹¹

508 Report of the Unesco International Bioethics Committee (IBC) on the ethical aspects of human embryonic stem cell research (6 April 2001).

509 For instance, according to Section 6 the Finnish Medical Research Act No. 488/1999, as a main rule medical research on persons may not be conducted without the research subject’s informed consent in writing. When it comes to revocation of consent: “[r]esearch subjects shall be entitled to withdraw their consent at any point prior to the completion of the research. They shall be informed of this right before the start of the research. Withdrawal of consent and resulting withdrawal from the research shall not involve any negative consequences for the research subject.” However, subsequent to a recent amendment to (inclusion of a new Section 6a), the personal data of the patient may be used for purposes of the study for which the clinical trial subject has given his/her consent under some specific circumstances even after revocation of the consent. Requirements for such use of personal data are following: the use of personal data is necessary for assessment of use, properties or effects or efficacy of a medicine, medical device or a method, or for purposes of quality assurance, effectiveness or safety of a medicine, medical device or a method, and the research subject knew when giving his/her consent that such personal data would be processed as a part of compilation of research data.

510 Hartlev, supra note 135, 260-261.

511 Op.cit., 260.

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7.3.3 The EU Data Protection Regulation imposing requirements for