Abstract
On 19 December 2008 the Official Journal of Belgium published the ‘Law regarding the procurement and use of human body material destined for human medical applications or for scientific research purposes’. This paper will comment on various aspects of the Law: its scope of application (what is understood by ‘body material’?); its concept of ‘residual human body material’ (with far-reaching implications for the type of consent required for research); the nature of actions with and uses of human body material that are explicitly prohibited; the right of donors to be informed of relevant information revealed by the use of their body material; and the special responsibilities placed on hospital ethics committees. As will be argued in this paper, several of these provisions are highly problematic from an ethical point of view, especially those relating to consent. Meanwhile, the Minister of Public Health has asked the Belgian Advisory Committee on Bioethics for advice on the incorporation of the ‘presumed consent’ model, that applies to post mortem organ donation, into the biobank Law’s provisions on post mortem removal and use of body material. This aspect of the Law effectively extends the ‘presumed consent’ regime, both from organs to body material in general, and from therapeutic uses to research uses.
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Notes
We do not have the space here to comment on all the ethically relevant dimensions of the Law—e.g. we cannot go into its provisions regarding (non)commercialisation and privacy.
Official versions of the Law exist only in Dutch and French. All quotes herein are translations by the authors. Any emphasis in quotes from the Law is added by the authors.
It is also explicitly mentioned that the Law does not affect the provisions of the Law of 11 May 2003 regarding research on embryos in vitro, i.e. it does not apply to the removal of eggs in the context of assisted reproduction. Fertility centres are equated with banks for human body material (definition see infra) and actions with gametes and embryos may only be performed in such centres (Art. 3(4)).
Sadly, however, at the same time Cryo-Save was one of the partners in an EU funded 6th Framework Program project (Crystal).
This Convention (commonly referred to as the ‘Oviedo Convention’) has not been ratified by Belgium, mainly because of its Art. 18(2), forbidding the creation of human embryos for research purposes. The travaux préparatoires of the biobank Law document a discussion in Parliament regarding this inconsistency with the Oviedo Convention. The Minister of Public Health’s response was that this Convention is overly restrictive and prevents the removal of tissues and cells for research purposes. We do not have the space to elaborate on this issue here.
We wish to emphasise that, when we use the words “her” or “his” body material, we are certainly not suggesting that people have or should have property rights in their body or in their body material (detached or not). Rather, our arguments are based on persons’ rights to control/decide what may be done to body material procured from them.
They propose an alternative which they call “conditional authorization”, a kind of contract that “should include explicit clauses” on: the moral and legal status of biological material; consequences with respect to risks and benefits; relationship to other sources of information; conditions for initiating further research on the basis of existing biobank material; and what would happen if any of the parties to the contract breach the conditions [8]. We do not advocate such an approach, for in our view it opens issues to negotiation which should not be negotiable, e.g. for example questions of ownership of the material in the biobank and of remuneration in the event of commercial potential. We believe this would lead to the unsavoury practice of donors authorising any kind of research and discarding any moral or other reservations they may have in hope of some revenue from commercial applications. A “conditional authorization” procedure would only seem desirable in the presence of a binding and effectively enforced legal framework which prevents such an outcome.
We cannot elaborate on these important questions here, but two particular concerns deserve a brief mention. Firstly, because of objections to research use, it is possible that more people will opt out from post mortem donation, so reducing the already limited supply of transplantable organs. Secondly, where the person has not expressed her wishes regarding post mortem organ donation, it would seem that post mortem attempts to secure consent from relatives are likely to stress transplantation and perhaps minimize or ignore research uses which would also be envisaged.
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Sterckx, S., Van Assche, K. The New Belgian Law on Biobanks: Some Comments from an Ethical Perspective. Health Care Anal 19, 247–258 (2011). https://doi.org/10.1007/s10728-011-0181-0
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DOI: https://doi.org/10.1007/s10728-011-0181-0