Through an Act of 22 June 2016 providing for various provisions relating to health, published on 1July 2016 in the Belgian Official Gazette (Staatsblad/Moniteur), several amendments have been brought to the provisions of the Act of 19 December 2008 on the procurement and use of human biological material (HBM Act).
The changes relate to the rules applicable to the biological material intended for scientific research:
- the material scope of the HBM Act is clarified. The act specifies that the act does not apply to hair (except follicles), nails, urine, breast milk, stool, tears and sweat, unless these are intended for scientific research without a human application. These types of biological material thus will fall within the scope of the law when they are intended for research.
- it is specified that Article 10(7) of the HBM Act (which provides that without prejudice to the obligations relating to consent and the Act on the right to privacy, the donor or her/his representative must expressly consent to the processing of personal data that would result from the law or its implementing decrees), applies to the consent to the possible processing of data in the framework of second use. The donor or her/his representative must thus also consent to the processing of data in the context of second use.
- the concept of 'transformation' of HBM is introduced in the law, and is defined as "every manipulation that modifies substantially the genetic code of all cells composing the human biological material in such a way that the material is not related at all with the donor and cannot generate significant information about the health status of the donor anymore."
- when HBM is collected for the purpose of scientific research, the donor or her/his representative must be informed of the possibility of transformation of the collected material
- a specific regime for the waiver of traceability applies to HBM that has undergone a transformation: the HBM manager of the biobank may waive traceability in two cases:
- if the donor or her/his representative has given prior consent thereto
- if the HBM has undergone a transformation. In that case, the manager of the HBM may only discontinue traceability after the researcher has declared on her/his word of honour that the material has undergone a transformation
- when it is established that Article 11 of the HBM Act should apply (generation of data significant to the health status of the donor), traceability can only be discontinued insofar the procedures under Article 11 has been complied with, also in the context of scientific research activities.
- HBM that has undergone a transformation and of which traceability has been waived, can be made available for another use than that for which an authorisation was given on the basis of Article 10 or 20(1), or no refusal was communicated based on article 20(2), or against which no opposition was expressed on the basis of Article 10 of the Act of 13 June 1986 on organ collection and transplantation.
The amendments will only enter into force on a date to be determined by a Royal Decree, which should also contain the general implementing rules in relation to Belgian biobanks.