Insights & news

Belgium - Draft Legislation Governing Human Body Material

  • 02/10/2018
  • Articles

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:

  1. 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.
     
  2. 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.
     
  3. 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.
     
  4. 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.

Key contacts

Related practice areas

Related insights

Sign up for updates
    • 22/04/2021
    • Newsletters

    VBB on Belgian Business Law, Volume 2021, No. 3

    The March 2021 issue of our Belgian Business Law newsletter reporting on the latest developments in a range of areas, including competition, data protection, intellectual property and labour law.

    Read more
    • 22/04/2021
    • Articles

    EU Clinical Trial Portal and EU Database Declared Functional by EMA Board - EU Clinical Trials Regulation Expected to Take Effect on 31 January 2022

    Yesterday, the European Medicines Agency’s Management Board (the EMA Board) confirmed that an independent audit by KPMG has found that the EU Clinical Trial Portal and EU Database are fully functional (see, attached press release). This confirmation, which has been delayed for years due to technical difficulties with the development of the Portal’s and Database’s underlying IT systems, finally paves the way for the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014; the CTR) to take effect on 31 January 2022. The CTR was initially scheduled to become operational in October 2018. In line with Article 82 CTR, the EMA Board will inform the European Commission (the Commission) of its findings. Provided the Commission is satisfied that the EU portal and the EU database are fully functional and meet all functional specifications, it will publish a notice to that effect in the EU Official Journal. The CTR will take effect six months after the publication of the notice (Article 99 CTR). Accordingly, for the CTR to go live by 31 January 2022, as seems to be the shared desire of the EMA Board, EMA and the Commission, the notice should be published on 31 July 2021. Once operational, the EU portal will serve as the single entry point for the submission of clinical trial applications, clinical trial-related information and for all communications by and between clinical trial sponsors and Member State authorities. The EU Database will store all data and information submitted through the EU Portal and, subject to limited exceptions, will be made publicly available.

    Read more
    • 22/04/2021
    • Articles

    European Commission Will Review Illumina-Grail Transaction Even Though EU and National Turnover Thresholds Are Not Reached

    In a controversial move, the European Commission (the Commission) announced on 20 April 2021 that it would review the proposed acquisition of cancer detection test start-up Grail by genomics firm Illumina, both of the US (see, attached press release). The Commission acted on a request of France, which was backed by three further EU Member States (Belgium, Greece and The Netherlands) as well as EEA countries Iceland and Norway, under powers conferred to it by Article 22 of the EU Merger Control Regulation (Article 22). Article 22 allows the Commission to review proposed acquisitions and mergers that would normally escape its jurisdiction because the transactions do not satisfy the turnover thresholds specified by the EU Merger Regulation. The two conditions for the application of Article 22 are that the transaction at issue should (i) affect trade between Member States; and (ii) threaten to have a significant impact on competition within the territory of the countries seeking the Commission’s help. Over the years, the Commission has handled a number of such transactions. However, the Illumina-Grail deal not only does not meet the turnover requirements of the EU Merger Control Regulation, but also remains under the radar of national merger review regimes and would therefore normally have been able to be consummated without being subjected to any competition scrutiny in Europe. For the Commission, the Illumina-Grail transaction offered the perfect opportunity to put into practice its recent Article 22 guidance which seeks to exercise control over acquisitions and mergers which involve firms that play a significant competitive role but generate little or no turnover at the moment of the transaction. According to the Commission, this is a trend that has gained particular traction in the digital economy and the pharmaceutical industry “where innovation is an important parameter of competition”, even if the companies involved “have not yet finalised, let alone exploited commercially, the results of their innovation activities”. The Commission expressed the concern that the combination of Illumina and Grail might, following the transaction, “restrict access to or increase prices of next generation sequencers and reagents to the detriment of the competitors of Grail active in genomic cancer tests”. The Commission’s fears were echoed by the French Autorité de la concurrence and by the Dutch Autoriteit Consument en Markt whose chairman pointed out that, even though Grail is a small company without turnover, Illumina is prepared to pay more than USD 7 billion for the company. By contrast, other national competition authorities took the position that they should not become involved by requesting the Commission’s assistance, because the transaction did not meet the turnover thresholds of their own jurisdiction. Illumina went to court in both France and The Netherlands in an attempt to block the referral to the Commission, but failed. It will now be required to notify its proposed acquisition to the Commission and is precluded from implementing the transaction, pending the Commission’s review. Pharmaceutical firms bent on acquiring a highly innovative player in the sector are reminded of an added layer of complexity in Europe, even if the target is small and its acquisition does not satisfy the EU and national merger control thresholds.

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *