Proposition 53K2041

Projet de loi visant à renforcer la transparence, l'indépendance et la crédibilité des décisions prises et avis rendus dans le domaine de la santé publique, de l'assurance-maladie, de la sécurité de la chaîne alimentaire et de l'environnement.

General information ¶

Authors

MR Valérie Warzée-Caverenne
PS | SP Colette Burgeon, Marie-Claire Lambert, Yvan Mayeur, Franco Seminara

Submission date

Feb. 6, 2012

Official page

Visit

Status

Adopted

Requirement

Simple

Subjects

pharmaceutical industry public health

Voting ¶

Voted to adopt

CD&V Vooruit LE PS | SP Open Vld N-VA MR VB

Abstained from voting

Groen Ecolo

Party dissidents ¶

• Bernard Clerfayt (MR) abstained from voting.
• Damien Thiéry (MR) abstained from voting.

Contact form ¶

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Discussion ¶

June 12, 2013 | Plenary session (Chamber of representatives)

Full source

You propose the consacrer one only discussion to these propositions of law. (The Assentiment)

I suggest that you devote a single discussion to these bills. (the approval of)

Mr. Speaker, Mr. Minister, Colleagues, first and foremost I would like to thank the absent rapporteur, Mr. Balcaen, for his sound report and for his willingness to report on this bill, which, unfortunately, did not reach the committee.

However, I hope to continue to convince the plenary session of the usefulness and necessity of the adoption of the present bill.

The concerns of this bill have been raised by a royal decree already in 1998 concerning the driving license. That Royal Decree stipulates that a candidate for a driving license who is not competent in French, Dutch, or German may take the theoretical examination, assisted by an interpreter.

There is even the possibility to organize theoretical exams in a language other than French, Dutch or German. The Royal Decree also provides the possibility of passing the practical driving exam with the assistance of an interpreter.

The present bill aims to criticize this Royal Decree because, in our view, passing the driving exam through an intermediary is incompatible with safety on public roads. An interpreter, then even assuming that he is in good faith and the candidate does not consciously or unconsciously assist in solving the questions, can give a good translation, but at the same time forget certain nuances, the context or important details or find themselves in the impossibility to convey them. The use of an interpreter therefore diminishes a good assessment of the candidate’s knowledge of the Road Code.

A final note, however, which is not less important, relates to Article 30 of the Constitution, which provides that derogations from the language legislation can only be introduced by law. In the present case, the derogation is regulated by a royal decree, which is therefore contrary to the Constitution. With this bill, we want to repair this.

During the discussion in the committee, among other things, the position of the Flemish government was pointed out. One might think that the Flemish government attaches importance to the fact that one would be able to pass the driving exam in one of the three national languages. However, the Flemish government did not accept this opinion. She strives for a simple language use in the theoretical and practical driving examination and considers that the instructions of the examiner are not of such nature that nuances or interpretations play a major role. I strongly dispute that.

With regard to the fact that the amendments to the language legislation are contrary to the Constitution, I would like to refer to the discussion in the committee. Apparently, the N-VA also has no problem with the fact that the language legislation was not respected, that that language law was amended by a royal decree and not by an ordinary law.

I was a little surprised at the voting behavior of the N-VA, which in other files has always raised itself, in my view, as a guardian of the language legislation. However, for the driving exam, this is apparently of no value.

Therefore, I ask that this bill still be approved, in order to fill a gap in our current legislation.

I refer to the written report.

Mr. Speaker, dear colleagues, gentlemen ministers, before opening the discussion on this bill which I have carried with great conviction in recent months in the Health Committee, let me remind you of its origin.

During the summer of 2011, our committee devoted two meetings to the problem of the independence of medical experts. These experts, whose decisions contribute to the safety of our health system, to the reliability of pharmacovigilance devices, have been placed under the fire of criticism for several years.

Many questions arise. Was the independence of the experts consulted in the selection of the H1N1 influenza A vaccine guaranteed? How could defective prostheses have been implanted in patients for so long? Is it only because of the state of scientific knowledge that bisphenol A was only very recently classified as an endocrine disruptor? These and many other questions are on the table.

As you can see, when it comes to evaluating or re-evaluating the benefit-risk balance of medicines, medical devices or certain hazardous substances such as chlorine used in pools or fertilizers, it is clear that the competent authorities must take the utmost precautions to ensure that the experts involved in this context are not influenced by the companies that develop the same products.

While during the committee hearing during the summer, to which I have just referred, we were able to find that certain instances, such as the KCE or the Higher Health Council, had internally developed strict procedures aiming, on the one hand, to identify the interests of their experts and, on the other hand, to exclude potential conflicts of interests, the same was not the case for other instances.

While it is true that progress has been made over the years, it may notoriously, in a real or supposed way, prove to be still inadequate today. So, in submitting this text, I wanted the legislator to give a clear signal to the citizens. All bodies involved in the fields of health, health insurance, food chain and the environment will have to turn to the struggle for transparency and against conflicts of interest.

But, of course, the balance is not easy. It is not about stigmatizing experts, depriving oneself of the recourse to external expertise which is justified by the need to find the best specialists, rich in their knowledge and expertise, and whether they are attached to the private sector or to the public sector. Also, this text is the result of important evaluation work and discussions with relevant actors.

As regards the independence of experts, I have proposed to systematize the declarations of interest and provide for appropriate penalties. This obligation applies to any expert, internal or external, as well as to the heads of the aforementioned bodies, for example. This should significantly improve the transparency of decisions.

Regarding the content of this statement, we believe that it should be as broad as possible. In particular, the family ties of the expert concerned will be addressed.

On several occasions during the debates, the possibility of creating a data centralization instance, a super council of expertise, responsible for collecting these data, controlling them and managing in fine the declared interests. From the almost unanimous opinion of the members of the committee and the institutions consulted, this option quickly appeared to be non-operative. Furthermore, it is more accountable for the relevant authorities to manage and control these statements, to evaluate those declared interests and thus eliminate any risk of conflict of interest in the face of seeing the decision taken or the notice made void, for example.

In addition to the obligation to have an internal regulation, a code of ethics and a system for the management of conflicts of interest, all made accessible to the public, these instances will also have to establish a committee whose composition, also made public, will be determined by the King.

This committee will be responsible, on the one hand, to ensure that each expert claiming to participate in the work of the relevant body has completed and updated its declaration of interests; on the other hand, to analyze that declaration to identify potential conflicts of interests and, finally, to decide on the participation of that expert in the work, deliberation and vote. Decisions taken by the committee shall be motivated.

I come to the transparency of decisions, another important measure to guarantee access to information and thus give full measure to the principle of citizens’ participation in decision-making. The agenda of the working meetings, the decisions taken and, above all, the names of the experts who have contributed to them will also be made public.

Some parliamentarians would fear that the enforcement decrees necessary for the effectiveness of this bill still contain interstities, in which one or another actor would risk to sink. In this regard, I will answer that we should not embark on a great witch hunt, but above all – and this will not surprise you – that I have full confidence in the minister who will be responsible for drafting these orders.

To conclude, I reaffirm loudly and strongly that the purpose of this bill is clear and unavoidable. Citizens’ confidence in our decision-making system on health, environment and food chain safety should be strengthened. This bill is based on three fundamental pillars, namely the fight against conflicts of interest, the transparency of information and decisions, and the legitimacy of decisions taken.

I sincerely hope, Mr. Speaker, dear colleagues, that a very broad majority will support this text, which has the ambition to inculcate a new culture and new obligations in terms of transparency and ethics.

Dear President, Dear Ministers, Dear Colleagues, after obtaining numerous written opinions from various bodies such as the RIZIV, the FAGG, the High Health Council and the Federal Knowledge Centre, it was decided to amend the present bill. In fact, the hearing showed that all institutions already have their own procedures to avoid conflicts of interest, but that those procedures vary greatly, which does not benefit the transparency to which every citizen, patient or not, is entitled.

These bodies make decisions or give advice in various areas such as health policy, on refunds, on insurance matters and on food safety. Thus, they can have a significant impact on the well-being of citizens. The establishment of a uniform standard procedure with a single panel of experts is therefore not realistic in the light of those specific domains, where international experts are often required.

Therefore, with this bill we create a framework within which individual organizations can work with their own conflict management procedures, prepared within the own committee set up for this purpose. Working with specialists and experts makes precisely that within that legal framework there must remain breathing space. It was therefore important for us that, when drawing up the declaration of interests, the indirect interests remained limited to those of relatives in the first degree. Otherwise, it becomes almost impossible in practice to employ in certain areas of expertise people who do not have indirect links with similar bodies or companies. After all, it is often a small group of specialists who conclude contracts of certain duration with companies or bodies within a defined domain.

For the same reason, it is good that the reports of the discussions are not made public. We fear that, consciously or unconsciously, this would affect the behavior of the experts: sometimes statements are made less sharp or experiences with other clients are not shared if one knows that everyone will be able to read the reports.

The disclosure of the agenda, the members attending the meeting and the decisions taken provides sufficient transparency for us, as all confidential information, of any nature, will never be made public.

A last point that is important to us is the gradual approach of the committee. Once it is established that a person who has attended a meeting or a vote is involved in a conflict of interests, the Committee shall weigh the validity of the decision, recommendation or opinion taken and make it dependent on the presumed impact on the decision taken. This avoids the automatic annulment of the joint work of the expert group.

This bill thus provides a hoverboard for various bodies that, with their already acquired experience in conflict management and interest management, now begin to work in a more uniform way.

Mr. Speaker, Mrs. Minister, dear colleagues, allow me first to thank Mrs. Marie-Claire Lambert for associating me with the implementation and drafting of this bill, and then to thank all the members of the Health Committee for the support provided to this text.

We are constantly reminded of the importance of the independence of scientific expertise, the impartiality of experts and the necessary transparency in this regard. The case of Mediator, distributed in France and withdrawn from the market in 2009, which caused serious criticism and profound reforms in the functioning of the Agency of Medicines of this country.

The MR Group attaches great importance to public health opinions in compliance with the principles of independence and impartiality, which leads to a high-quality decision in the interests of patients.

The aim of this bill is to aim towards greater transparency and therefore credibility in health-related decisions.

During the discussions, it has been repeatedly ⁇ that it is important to work with the best available specialists while discarding any suspicion about possible conflicts of interest. This is why we have introduced the obligation of a declaration of general interest.

But the proposal also aims to introduce flexibility. All healthcare institutions deal with very different topics according to their working method and their area of competence and expertise. It seemed to us that it was important that each instance could establish its own system for managing conflicts of interest. Each instance, each institution must be able to manage a person’s potential conflicts of interest and decide on his/her involvement in the debate and voting as they are best placed to judge, taking into account the specific context of the case analyzed.

The existence of an interest relationship does not necessarily mean a conflict of interest. It is not because an expert has an interest that the expert is able to constitute a conflict of interest, that is, to influence the conclusions of the instances in order to draw a direct or indirect interest.

This is not about demonizing, quite the opposite! Belgium is a small country with a limited but high-quality expert pool. We must always be able to count on them. Ensuring transparency, enhancing credibility, seeking more independence in public health decisions – these are the goals we set ourselves while building a flexible legal framework to ⁇ this, avoiding unnecessary paralysis of the instances.

Here, Mr. Speaker, Mr. Minister, Ladies and Gentlemen, are the various comments I would like to make in the context of this debate.

Mr. Speaker, Mrs. Minister, dear colleagues, I am glad that you are here because the theme of the independence of the expertise in public health, but also in the field of environment and food security, is very important to us.

Allow me a little lack of modesty at the beginning of the exhibition because it was Ecolo-Groen who brought this subject to the House by requesting hearings. The commission followed us. It was on the basis of these hearings that two bills were submitted, our and Mrs. Lambert’s.

Why this law? Colleagues have already talked about the various scandals that have smashed the news since 2009 due to problems caused by medicines for which pharmacovigilance had not been applied. They had caused serious side effects but the secret was put and expert committees had been questioned for their lack of independence from the pharmaceutical industry.

The management of the H1N1 influenza pandemic has already been a problem at the WHO level because the definition of pandemic has suddenly been changed. It was then believed to be an extremely serious pandemic. Based on the opinions of experts who were not all uninterested, we rushed to vaccines that we purchased massively. Afterwards, however, they turned out to be less useful than expected.

Due to these dysfunctions and governance problems, public opinion has begun to question the legitimacy of scientific expertise, that of healthcare and health institutions.

We pursue the same objectives here: not to cast reproach on experts or to make them intent trials but to better legitimize their work and their opinions and therefore the political decisions taken on the basis of these opinions. We share these objectives. The question is how to reach them.

I would also like to cite the Court of Auditors of the European Union which has seriously questioned the functioning of the European agencies, both the European Food Safety Agency, the European Medicines Agency, and the European Chemicals Agency.

The Court tells us at the end of 2012 that none of the agencies concerned manages conflicts of interest adequately and recommends reforms within them. It also recommends that policies and procedures be established to ensure that conflicts of interest are handled according to a comparable standard in the agencies of the Member States. There is therefore clearly, at European level, a demand for everyone to join in the same way of managing conflicts of interest. The Court also recommends a European regulatory framework. I believe that this European framework for regulating conflicts of interests will come about.

The hearings we conducted in June 2011 allowed MEPs to listen to representatives of the leading Belgian health institutions about their practices regarding the management of declarations of interests and conflicts of interest. It follows that each institution audited (INAMI, KCE, Higher Health Council, Federal Medicines Agency) operates in its own way and has its own rules for declarations of interest. Thus, in the INAMI Drug Repayment Commission, even when interest declarations are filed, abstinence during debates is rather rare in case of conflict of interest. The INAMI representative told us that, so far, no one has left the meeting room at the time of the vote on the file, no one has been dismissed in case of violation of the rules of procedure. So you see that they themselves recognize what I can call a non-management of conflict of interest. It is therefore possible to ask why these declarations of interest requested by experts were used, especially since they are still not made public today.

In the other audited institutions, the conflict of interest was handled on a case-by-case basis. Many people interviewed believe that it is impossible to avoid the existence of such conflicts of interest because expertise is very often acquired through contacts or studies conducted with the private sector.

The hearings also showed that harmonisation of the procedures for declarations of interests and conflict management would be desirable. This harmonisation of the statement was desired by almost all the audited institutions.

What is the purpose of our bill, submitted by myself and my colleagues, Ms. Gerkens and Ms. Bremst? It is to improve the harmonisation and centralization of both interest declarations and the management of conflicts of interest.

Our legislative proposal is based on four key points. First, the creation of a central register of expertise, according to which any expert who wishes to participate in advisory committees must file a declaration of interest on an internet portal. This statement of interests can be made in a general manner and updated as the curriculum develops. Any expert, if he wishes to participate in opinion committees, must register on this portal. This is now accessible to everyone, given the facilities offered by the Internet. The advantage is that you do not have to make statements in one, two, three or four agencies and do not fill out different forms. This corresponded to a wish of the majority of the institutions.

The second point is the establishment of a Higher Council of Expertise, responsible for working on deontology, to refine it as regards the management of conflicts of interest. This board would have the task of verifying that the instances have a harmonised procedure for managing conflicts of interest. It may also participate in the composition of the committees of opinion. In this way, it can play a role of external control and verify that everyone complies with the same standards and has a harmonised deontology.

The third key point of our proposal concerns the transparency of this central register accessible to all, as well as the transparency of the opinions submitted and of the persons who will have submitted such opinions.

We had also made a distinction between opinions that dealt with social issues and that did not require these people to be “neutral” and those of a purely scientific nature – for example, evidence-based. Our proposal and, in particular, the latter elements have unfortunately not been taken back by the committee, and I deeply regret it. In fact, the initial idea was to work in a convergent way. However, the majority did not take any of the elements present in our text.

The proposal presented to you today seems unsatisfactory to us. Thus, we do not know exactly when the declaration of interest should take place, even though it is expected that it should be introduced just before the expert gives an opinion. But where should it be and with whom? Which authority will keep this statement? How will it be made accessible to the public? It is the king who is returned.

You have a job! Indeed, in this text, the King is constantly referred to. The problem is that the law would come into force in twenty-four months. I would like you to make it executable faster, otherwise it would seem a bit dangerous to me. This gives an idea of how much time the government takes to implement a bill that already contains a lot of gaps. Moreover, the majority constantly relies on the King to decide on the manner in which the declaration of interests will be drawn up, on its possible public character, or even on the instance that will retain it.

It is also striking that in the proposal there is no explicit definition of the objective pursued. It is about reducing, minimizing the possibilities of conflict of interest, but this is not mentioned anywhere in the text. Therefore, Mr. Speaker, we are submitting an amendment that specifies that the aim is to reduce conflicts of interest in each opinion committee that will be brought to inform political decisions.

The following criticism concerns the absence of a superior council of expertise. In other words, no instance will control or harmonize the work of others. Each body will therefore handle conflicts of interest within itself. In this case, and I ask the authors of this text, what will the change be made?

It is said that the King will give instructions. How will we ⁇ a harmonisation of practices and procedures in public health institutions? How do we get out of the “little kitchen among friends”? I would like to have an answer on this point.

Finally, the transparency of opinions, since the last amendment introduced by some majority parties, is subject to restrictions in so far as information that could have a character of trade, industrial or even scientific secret cannot be made public. Therefore, I fear that this clause is used too widely.

To conclude, we are aware of a small step forward, but we find it unsatisfactory. So we are quite frustrated to see that the openness to do better has been neglected. The Higher Health Council itself had given a positive opinion on the central register and on this higher expert council, while relativizing, as there were still some adjustments to be made.

In my opinion, the majority has been too subject to individuals or institutions that are less willing to change their practices. I regret, we regret this conservatism that will lead, ⁇ to a slight change of things, but to a lack of guarantees of a real change of the desired practices and culture, of which Mrs. Lambert spoke and which we want more than anything else.