Proposition 53K2322

Projet de loi modifiant la loi du 25 mars 1964 sur les médicaments.

General information ¶

Submitted by

PS | SP the Di Rupo government

Submission date

July 2, 2012

Official page

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Status

Adopted

Requirement

Simple

Subjects

EC Directive pharmaceutical industry pharmaceutical legislation medicinal product health policy drug surveillance market approval public health

Voting ¶

Voted to adopt

Groen CD&V Vooruit Ecolo LE PS | SP ∉ Open Vld N-VA LDD MR VB

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Discussion ¶

July 13, 2012 | Plenary session (Chamber of representatives)

Full source

The draft law implements the European Directive 2010/84, which was to be implemented urgently by the end of July. The aim is to strengthen the pharmacovigilance system, a system that ensures monitoring of the use of medicines and their possible undesirable side effects. This is a problem that Europe considers important. It was therefore appropriate that Belgium set itself in order. The bill also covers veterinary medicines. It calls for drug side effects to be recorded, not only by health professionals, but also by patients. They can record their comments on a website or send them to the Federal Agency for Medicines and Health Products.

The bill also requires companies to conduct safety and efficiency studies. It allows the government to suspend the distribution of a medicinal product on the basis of notification of undesirable side effects, or even to prohibit its placing on the market if the severity of such effects is established.

It greatly improves the advertising of data communicated on the Internet and appearing on labels. In addition, it advocates the strengthening of the services of the Federal Agency for Medicines and Health Products and calls on companies to provide a person responsible for the monitoring of the side effects of each medication and thus to establish a risk management system.

It also provides for exemptions for professionals in case of emergency, for example in case of an epidemic.

This is the proposal that was submitted to us by the Minister.

Several questions were asked by the members of the committee. First, it was about knowing the cost and resources that would be granted to the Federal Medicines Agency. The Minister confirmed that additional resources would be available.

Questions were asked about how to allow patients to report unwanted side effects. The minister responded that efforts would be made. I will return to this later, referring to an amendment that has been submitted.

Questions were raised on the independence of the assessments carried out by the companies and on how to ensure external control of those assessments, which may not always be objective. Questions were also raised regarding the transition period, as everything that was registered and authorized before July 21 of this year remains subject to the old risk management system.

I submitted two amendments which were accepted by the committee. The latter demanded that the government actually take measures in terms of training, awareness, facilitation for all professionals and patients, in order to proceed with the registration of side effects. The proposal was unanimously voted by the committee.

I will now express my group’s point of view on this project. It would almost have been dealt with too quickly, because the subject would have deserved more debates to go to the bottom of the issue. Indeed, in recent years, we have witnessed a frequent questioning of certain drugs, with suspicions of side effects. The affirmations sometimes ⁇ in the media have caused concerns among the population. Thus, we talked about Motilium that would have unexpected heart effects. We talked about antitussives for children that could have negative side effects. We talked about sleeping pills that cause risks of early death. Vaccines have also been mentioned, which have been the subject of many controversies regarding the side effects related to the adjuvants contained in vaccines, these containing aluminum particles in particular.

The use of antibiotics has also been questioned. We consume too much, which undermines their effectiveness, both in humans and animals, since they are administered to cattle. It is important to know the repercussions of this very, very broad administration of antibiotics. One of the major public health concerns is that antibiotics are no longer effective.

That is to tell you the importance of this law, of this pharmacovigilance system!

As much as our group supports the strengthening of the pharmacovigilance system, so much remains questions about how it will be implemented.

I will give you some questions that still hurt us. They involve external control of data provided by companies.

I worked a lot on this and our group submitted a bill on the independence of public health expertise. For us, it is essential that the data provided by companies on medicines and the side effects they record are checked by independent experts. It is obviously very tempting for companies, given the turnover that a drug sometimes represents, not to reveal negative side effects. Scandals revealed in France, including the Mediator scandal, have demonstrated that some companies could be guilty of hiding the truth and continuing to sell a drug while it had serious side effects.

Furthermore, the question arises of how doctors will report these side effects. How will they be able to notify them easily? With an electronic system I suppose, it is the system that becomes the most common and easiest. How will they be held accountable in this regard? Should all side effects be ⁇ , even if they are mild? How will this actually happen?

We see that there are already possibilities. Doctors are already asked to report these side effects but often they do not do so due to the administrative burden.

The amendment we submitted obliges the government, on the one hand, to verify the concrete and certain implementation of these notifications by health professionals and, on the other hand, to make the system accessible to patients and patient associations. It makes the revelations made by patients be taken seriously. It is primary.

We hope that this will be realised in the facts and that the system will not remain just a pious wish. Often, in fact, a system is envisaged and it is seen that it encounters implementation difficulties.

Our group also wishes not to abuse the exemptions provided, for example for professional use. When medicinal products are administered directly by health professionals, when they need to be administered massively, reliefs are provided with regard to labelling obligations. It is necessary to be careful not to excessively facilitate these liabilities. In our view, Article 9 still contained a difficulty with regard to a term that allowed too much ease to dismiss the information contained on the label.

With regard to the transitional regime for all licensed medicines, will the latter also be followed with the same rigor as what is imposed on us from July 21?

The key question is what will be done when more or less serious side effects are observed. How will the precautionary principle be applied? Will we order scientific studies, which will take three or four years, before taking a measure, or will we be more cautious? The French system has been revised in this regard. He now anticipates much faster reactions from the French Medicines Agency. Here, we often react more slowly than France, we let doubt settle; we order studies, opinions.

We wonder whether the government will be rigorous enough to take certain precautions against medicines that may have side effects but still pose very important economic challenges. Sometimes it is difficult to fight against important economic interests, therefore it is absolutely necessary to maintain a rigorous and strong regulatory power.

Our group will support this bill while demanding that it be applied with the utmost rigor.

Mr. Speaker, dear colleagues, Mr. Secretary of State, as already stated in a committee, the text submitted to us today, by ensuring the transposition of the European Directive, helps to strengthen the existing rules on pharmacovigilance. More clearly, this means that the safety of medicines will be improved, that the protection of patients will be strengthened and that greater transparency and better communication of information on the matter will be guaranteed.

This is obviously not anodine. The consumption of medicines, all classes confused, continues to increase with a particular expansion for children and the elderly. These two age groups are ⁇ sensitive to the effects of medications.

Remember: Drug side effects are responsible for 5% of hospital admissions and are identified as the fifth cause of hospital death. This accounts for around 197,000 deaths per year in Europe and a total cost for society of 79 billion euros. If this human and financial cost can be reduced, it must be taken care of.

By optimising our national pharmacovigilance system, but also by harmonising the systems specific to each Member State, the risk of leaving in circulation an improper medicinal product, whose benefit-risk balance would be deficitary, should therefore be significantly reduced. This is crucial, as it allows, on the one hand, to gain in reactivity with the faster withdrawal from the market of medicines deemed dangerous and, on the other hand, to adapt faster the conditions of reimbursement of medicines.

As a committee, I was ⁇ concerned with the importance, in my opinion, of the possibility granted to patients and not only to healthcare providers to report adverse effects of medicinal products directly to the relevant authorities.

I would like to reiterate this provision. Indeed, this direct notification is fundamental: it will collect a greater number of data, have information about free-release medicines, have more concrete information, because it is not interpreted and filtered by healthcare providers, shorten the time to transmit information and make patients more actively participate in their own treatment.

It is therefore with insistence that I ask – I am sure that Mr. The Secretary of State will forward my request to the Minister – that this provision quickly come into effect and that it has a very wide publicity. In the budgetary and demographic context we know, it seems to me essential to promote a rational use of medicines and to be interested in the opinion of those who take them. The provisions that we will vote about right now perfectly meet these two objectives.

The N-VA agrees with the present draft. We cannot do otherwise either. It is a transposition of the European Directive.

I agree with Ms. Snoy’s concern about Article 9. It gives the King the power to no longer make the necessary legal information on the label and the leaflet mandatory in certain circumstances. The first circumstance is if the drug goes directly to professional practitioners and veterinarians. We agree with this.

However, there is also a statement: "or when there are problems with availability". We do not consider it in the interest of public health that, in the event of a problem with the availability, the possibility of placing medicines on the market is created with a leaflet not drawn up in the three national languages, with a package without the statutory obligatory indications.

We find that dangerous. We discussed this in the committee. The Minister would clarify. If “or” is replaced by “and”, we agree. If the provision "or" remains included, we still have some concerns in this regard.