Proposition 52K1991

Projet de loi reportant la date d'entrée en vigueur de 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

The Senate

Submission date

April 22, 2009

Official page

Visit

Status

Adopted

Requirement

Simple

Subjects

bio-ethics marketing cytology medical research organ transplant application of the law scientific research

Voting ¶

Voted to adopt

Groen CD&V Vooruit Ecolo LE PS | SP Open Vld MR FN VB

Abstained from voting

N-VA LDD

Contact form ¶

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Discussion ¶

June 11, 2009 | Plenary session (Chamber of representatives)

Full source

I refer to the written report.

Mr. Speaker, Mrs. Minister, colleagues, first of all, I would like to thank the President for the swift agenda of this draft. The law must enter into force from July 14 and this means we meet the deadline.

We discussed this draft in the committee. I will not return to it. It is also the result of a law of 19 December 2008.

Recently, a survey was conducted at the KUL, which clearly showed the willingness of citizens to surrender body material for research. Both during the hearings and during the debate on this draft, there were quite a few critical questions about the existence of the biobanks. However, the research conducted by KU Leuven shows very clearly that people have a lot of confidence in scientific research and that they accept to give up residuair material for scientific research.

Mrs. Minister, I just wanted to come back to that in this general discussion and ask you whether you will take into account this latest study. Are you prepared to take the transitional measures that the sector needs to operate in legal certainty during this period?

The results of the study of K. by U. Lions were not formally communicated to me. I was informed that the VUB will conduct a study on the social support for the use of human body material for therapeutic purposes for scientific research. I ask my employees of the FAGG to inform themselves about these studies.

The second question concerns the situation of existing tissue banks and of companies currently using human body material for the development of therapeutic applications and for scientific research. Within the framework of the December 2008 Act, the implementing decisions that were otherwise submitted to you for review were sent to the State Council for advice. The opinion is expected by 9 July at the latest. After the opinion, the designs will be adjusted and immediately published. There has also been a very constructive consultation between my employees and the industry, including Pharma.be and Bio.be. These couples agree to the modalities of recognition, vigilance and quality control proposed.

The FAGG will have its dispositif for the implementation of the law ready at the end of October 2009. In any case, the draft KB provides for the general standards, the maintenance of the recognitions and transitional provisions allowing companies to obtain a preliminary and subsequent definitive recognition in a smooth manner. The draft KB, which sets out the general conditions for recognition, provides that existing structures that have already carried out an activity will obtain a provisional recognition from the entry into force of the law. Institutions that have already been recognized will retain their recognition until it ceases and will then be recognized provisionally. This is essentially the tissue banks.

On the other hand, it also provides for institutions that are not currently recognised because their activities are currently not regulated. If they exercised an activity within the last three months prior to the publication in the Belgian Official Journal of the December 2008 Act, they will also be recognized provisionally from the entry into force of the Act.

There will therefore, in principle, be no structures that will have to stop their activity, immediately after the entry into force of the law.

Mr. Speaker, I would simply like to draw attention to the fact that this law is terribly important and that I fully endorse the remarks made by Mrs. Minister.

That said, I regularly receive emails in which I am questioned about the title of this law. In fact, we are talking about “human body material.” However, this vocabulary shocks some people. In addition, it is common to draw my attention to the fact that the directive transposed into Belgian law speaks of human tissues and cells. The term "material" shocked some and I wanted to draw your attention to this point. Why has the title of the directive not been taken back?

This is by no means a new fact. We have long discussed this issue in the Public Health Committee and I explained myself on this subject. I would like to refer you to the parliamentary work.

That said, we used other terms than those in the title of the directive simply because the scope of that law is much broader than that covered by the directive. We had to find a suitable word. I do not claim that this is the best or the most poetic to speak of the subject mentioned, but it was necessary to indicate that the scope of application was wider.

I would like to thank the Minister for his explanations. I understood that the scope of application was wider but I do not know if the term chosen was the most appropriate.

Mr. Speaker, I would like to thank the Minister on behalf of the companies and institutions that now have a biobank and which thus acquire greater legal certainty.