Projet de loi modifiant la loi du 19 décembre 2008 relative à l'obtention et à l'utilisation de matériel corporel humain destiné à des applications médicales humaines ou à des fins de recherche scientifique.
General information ¶
- Submitted by
- MR Swedish coalition
- Submission date
- Sept. 27, 2018
- Official page
- Visit
- Status
- Adopted
- Requirement
- Simple
- Subjects
- medical research organ transplant scientific research
Voting ¶
- Voted to adopt
- CD&V Open Vld N-VA LDD MR
- Abstained from voting
- Groen Vooruit Ecolo LE PS | SP DéFI ∉ PVDA | PTB PP VB
Party dissidents ¶
- Jan Vercammen (N-VA) abstained from voting.
Contact form ¶
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Discussion ¶
Oct. 18, 2018 | Plenary session (Chamber of representatives)
Full source
Rapporteur Damien Thiéry ⚙
I refer to my written report.
Catherine Fonck LE ⚙
Mr. Speaker, Mrs. Minister, dear colleagues, innovative therapeutic drugs have a significant potential, especially in relation to serious diseases for which current therapeutic means are not sufficient.
Enabling the manufacture of allogenic innovative therapy drugs and thus not limiting ourselves to autologous innovative therapy drugs is obviously an important thing. I can only be in favor of the overall objective of the project and the challenge related to these innovative allogenic therapies.
However, I have a number of difficulties with the lack of guarantees provided in this project. In summary, it would be possible that a competition would appear between the different final destinations of this human body material. Since no criteria are defined, what will happen in case of multiple applications, for example for clinical use, for an industry or research application? Who will have the priority between clinical research, industry research, or research for a PhD? These questions remain whole from the moment when the tags are not fixed in this bill.
I confess that there are questions about the risk of surplus costs and the affordability of the price of human body material. In this bill, nothing is provided on the issue of financial compensation. Nothing is planned to prevent any commercial or financial interest from prevailing over the interest of patients or clinical research.
Finally, the issue of informing citizens about tissue donation is an important issue.
Many things are done to promote organ donation but not for tissue donation.
The information that must be transmitted correctly and thoroughly for the donation of human bodily material is, today, not at all planned. It is obviously accompanied by the question of consent which, in my view, is equally fundamental. Patients should be able to decide who and what their tissue taken will be used for. For all these reasons, we will abstain from this text.
Ministre Maggie De Block ⚙
Mr. Speaker, Mr. Fonck, the objective of this bill under consideration is to modernise and clarify the access and use of human body material for human medical applications or for scientific research purposes so that Belgium remains in the world’s leading peloton in the field of scientific research, which will also benefit Belgian patients.
As for your question about what to do if there are too many requests for this use, the allocation of human body material is an important aspect of the project. Several basic principles regarding the allocation of human body material are being developed and a allocation committee for human body material will be established. The Bank of Human Body Material is obliged to allocate the body material in accordance with several basic principles including that of equality and non-discrimination.
Furthermore, priority is, in principle, given to the planned human clinical applications. In case of disagreement regarding the implementation or correct application of the allocation criteria by a human body material bank or on any other topic related to the allocation of human body material, the situation may be submitted for opinion to that new allocation committee for human body material to be created.
All stakeholders, including the donor population and public services, will be represented in this committee. This is to avoid situations where you have to choose from too many requests.
It is an important design, which brings us completely to the current time spirit. It should also be read together with the design holding the clinical trials.
Ms. Fonck, you have previously submitted a bill on this subject, though with a smaller scope. So you had the will to address the problems in the sector. Meanwhile, your bill is outdated due to the transposition of the European GDPR Directive. We took all the elements in it and went beyond your proposal. Unfortunately, I could not say this to you in the committee, but I tell you now.