Belgium - Draft Legislation Governing Human Body Material
On 27 September 2018, the Bill amending the Law of 19 December 2008 regarding the procurement and use of human body material for human medical applications or for scientific research (the Bill) was submitted to the Chamber of Representatives. A link to the Bill, including the explanatory memorandum, is available here.
The main changes to the Law of 19 December 2008 introduced by the Bill are the following:
- Allocation of human body material – The Bill requires banks for human body material to provide for allocation criteria in their agreements with intermediary structures and biobanks, in accordance with the principles of transparency and equal treatment. The banks for human body material will have to decide on each request for human body material on the basis of these allocation criteria. A new committee within the Federal Agency for Medicines and Health Products, the “Allocation Committee for Human Body Material”, will offer advice on the application of the new rules. Further rules on the allocation criteria and the new committee will be laid down by Royal Decree.
- Intermediary structures – The Bill increases the autonomy of the intermediary structures for human body material. In particular, the Bill facilitates the procurement by intermediary structures of (i) human body material used for the purpose of developing and producing allogeneic advanced therapy medicinal products; and (ii) human body material removed in other EEA Member States or third countries. A Royal Decree will establish further requirements for cooperation agreements between intermediary structures and tissue banks from other EEA Member States.
- Donor recruitment campaigns – The Law of 19 December 2008 prohibits any advertisement campaigns in relation to the removal of, or any other act involving, human body material, with the exception of public campaigns designed to raise awareness for allogeneic donation of human body material that are solely in the interest of the public health. However, many campaigns are not exclusively in the interest of public health, but will also be in the commercial interest of specific actors, e.g., campaigns by fertility centres or campaigns to recruit donors for scientific research. Therefore, the Bill introduces the possibility for banks for human body material to organise campaigns aimed at recruiting healthy donors. The conditions for such campaigns will also be determined by Royal Decree.
- Scope of application – The Bill amends the scope of application of the Law of 19 December 2008. First, human body material removed and destined for use in a clinical trial will fall outside the Law’s scope. If, conversely, the material is destined for another use, irrespective of the moment at which that happens, it must be transferred to a biobank and will thus be subject to the Law of 19 December 2008. Second, faecal material will be added to the scope of application of the Law of 19 December 2008.