Proposition 54K2296

Projet de loi relatif aux essais cliniques de médicaments à usage humain.

General information ¶

Submitted by

MR Swedish coalition

Submission date

Feb. 17, 2017

Official page

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Status

Adopted

Requirement

Simple

Subjects

EC Directive medicinal product medical research experiment on humans

Voting ¶

Voted to adopt

CD&V Vooruit PS | SP DéFI Open Vld N-VA LDD MR

Voted to reject

PVDA | PTB

Abstained from voting

Groen Ecolo LE ∉ PP VB

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Discussion ¶

April 20, 2017 | Plenary session (Chamber of representatives)

Full source

Thiéry and Gustin, rapporteurs, refer to the written report.

The draft law on clinical trials of medicinal products for human use is extremely important. It touches the whole of clinical research clinicians who are studying new molecules to advance the scientific world and treatments. In many cases, these treatments are very innovative, in rare pathologies or pathologies for which we do not yet have sufficient treatment options.

These are important studies, which are initiated by the pharmaceutical industry. Nevertheless, we recognize that these studies allow, above all, patients, who are always put at the center of debates in the Health Commission, to benefit from innovative medicines during the duration of the studies and to benefit from these treatments, which in some cases save lives.

Of course, this bill is in favor of the pharmaceutical sector, but I would also like to recall the scope of this project within the framework of the ethical committees and the hospital world. I would like to emphasize the importance of clinical trials in Belgium. Our country is a leader at the European level and almost global in this field. This is an asset. I assure you that Belgium is recognized as such in the world. When you attend a congress of certain specialties, you can find that Belgians have participated in the studies that are presented. This global leadership is not only beneficial to patients, but also to physicians and researchers, as it allows them to have greater visibility on the international square. Not to mention all the benefits that this represents for our economy.

The number of applications for clinical trials launch in Belgium increased by 6% in 2015. That is why we can say that we are in the head of the peloton. In 2015, 1,578 clinical trials were conducted in Belgium.

This represents 170,000 patients directly affected by these studies and who can benefit from them.

This project also implements a European regulation on clinical trials. This means that we are in a system of harmonisation of our system of clinical trials with respect to what is recommended at European level.

It is no surprise that our group will enthusiastically vote on this bill, which is defined by five relatively simple objectives. The first is to ensure the safety of people participating in clinical trials. The second is to facilitate the rapid development of innovative therapies and their access to patients. The third is to provide a quality assessment within the specified timeframe, or even faster. The fourth is to harmonize and simplify procedures that are often too heavy – which has been denounced by our experts and by the medical body. The fifth is to maintain and improve Belgium’s attractiveness and dominant position in Europe for the conduct of these clinical trials.

Mr. Speaker, this bill is both necessary and interesting to support the development of clinical trials. It provides elements that seem interesting for structuring the assessment of trials through structures independent of the pharmaceutical sector and the sites where these trials will take place.

The aim is also to have a contact point as well as a centralized organization, a coordination of these tests. Therefore, we are obviously in favor of such a approach, which transposes a European directive. Nevertheless, Mrs. Minister, in the exchanges we have had in the committee, some points require deepening, or even questioning – in any case, in our eyes.

Among these elements are the accredited ethics committees, whose number across the territory will be limited (between eight and ten) and who will be responsible for the evaluation of the tests. In addition, they will have to comply with a requirement of independence, but will be approved according to different criteria. When we asked you about them, before the Easter holidays, you answered that the decree would define them. I know that you would like the text to be adopted quickly in order to launch pilot projects. I do not know whether these criteria have been delimited. In any case, it is difficult to support 100% of the provisions aimed at improving quality through, precisely, a reduction in the number of approved committees since the project to be adopted today does not provide any information relating to these criteria.

Among other points raised during the discussions, it is worth mentioning the inclusion by this project of a portion of funding by promoters of clinical trials that do not engage in a commercial activity – essentially, universities or associations that would stimulate certain projects and trials. You have been questioned about this. An amendment was submitted by colleague Fonck so that the tests that are conducted by these non-commercial actors can take place without a contribution to the funding of the arrangement. You answered that these were less professional tests requiring, therefore, more work from the assessment bodies. Of course, this answer cannot satisfy us. Indeed, that we engage in means for greater professionalism and a more harmonised deployment of projects is one thing.

But making them contribute to financing, while some economic actors have very large resources and can pay themselves with staff allowing them to make test projects better constructed, is creating an imbalance at the expense of mainly academic actors.

Difficulties persist also with the financing of ethics committees as they depend on the funding of hospitals, the BMF. You said there will be no change for existing committees. Other committees, however, will need to receive financial contributions in order to continue to exist.

With regard to independence and conflicts of interest, questions remain. You gave some responses during the discussion. You say that where the bill does not stipulate that there must be total independence, it is the law on the declaration of conflicts of interests that is imperative and must be respected. Unfortunately, both in the pharmaceutical and chemical sectors, it is recognized that there is not always a declaration of conflicts of interest and that, even when there is no declaration of conflicts of interest by all actors, national or European institutions regularly consider these opinions to be valid and can be taken into account. However, normally, an opinion should be refused if there is no certification and declaration of all potential conflicts of interest. The bill does not provide additional security in this regard. We will abstain from this bill.

Mr. Speaker, Ladies Ministers, Dear colleagues, clinical research is recognized or, in any case, our researchers are ⁇ recognized and fully invested, which is fundamental. But it is equally fundamental to be successful in the ethical assessment of clinical trials.

In this regard, Belgium has been regarded for many years as a ⁇ successful country. Our ethics committees have a solid clinical and scientific expertise as well as knowledge of the ethics and legal framework for biomedical research. This is essential for the protection of patients. It is therefore essential to maintain this expertise.

Several steps have led to your draft law. In fact, your original project has been largely reworked. In particular, the Conference of Academic Hospitals of Belgium (CHAB) has invested enormously and helped to significantly improve the text of your bill.

If I can be positive about the main lines of this project, you know as well as me that a number of major points still need to be resolved. As a commission, you have pledged that royal decrees are drawn up in consultation with the sector. We will see if you keep your commitment.

There are still two major problems. The first is the financing of this new legislation. This question is crucial in enabling all active ethics committees – many of them – to continue to invest in clinical research. But ethics committees do not only deal with clinical research. Following the financing arrangements, there is a risk that the other tasks they perform will be undermined, which would have detrimental effects on patients.

The second central problem, on which I spoke in the committee: the clinical research projects of the pharmaceutical industry that our colleague Damien Thiéry spoke about recently. This bill is not just about that. It is always forgotten that there are noncommercial clinical trials. They are extremely important. I heard in the committee that they would be less serious, precise and rigorous. It is shocking. Their promoters are academic and it is the expertise and scientific rigour of the universities that is questioned. In relation to this, Mrs. Minister, your bill is a serious retreat because the previous 2004 law allowed special support for non-commercial research, through the discharge of remuneration to the Agency of Medicines. I wanted to go back to it by providing for a full and complete exemption for academic projects, but the amendment was rejected by the majority.

Since this project passed into commission, I have also had contacts with the hospital research departments. They sent clarification requests to the Drug Agency. Several weeks have passed and they have not received a response. You will therefore allow me to be their relay since requests have been addressed to your services to see whether the current law, such as that of 2004, could still be interpreted correctly with regard to the exemptions for non-commercial experiment promoters, including the exemption from the free supply of the study drug, when it would have been prescribed independently of its participation in the clinical trial.

My question is very clear. A long argument has been sent to your services. Will the items to comply with health insurance (Law of 1 July 1994), Articles 34, paragraph 3, and 34, paragraph 4, fully apply to non-commercial clinical trials, as was the case in the Law of 7 May 2004? I think it is important that you can answer. I will then relate to those who have asked me about this subject.

Even though I am in favour of this bill in general, I keep questions and denounce the decline in academic clinical trials, which are just as important as clinical trials in the industry and the pharmaceutical industry.

We will not support the text and we will abstain.