Proposition 51K2189

Projet de loi portant révision de la législation pharmaceutique.

General information ¶

Submitted by

PS | SP MR Open Vld Vooruit Purple Ⅰ

Submission date

Dec. 23, 2005

Official page

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Status

Adopted

Requirement

Simple

Subjects

EC Directive EC Regulation veterinary medicine pharmaceutical industry pharmaceutical legislation medicinal product health policy drug surveillance Internet organisation of health care public health over-the-counter drug

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Discussion ¶

March 8, 2006 | Plenary session (Chamber of representatives)

Full source

Mr. President, Mr. De

Minister, the committee discussed the draft law during its meetings of 31 January and 14 February 2006. In its introductory presentation, the Minister of Social Affairs and Public Health noted that the bill on the revision of the pharmaceutical legislation aims at transposing three directives very important for the pharmaceutical sector. The draft also includes amendments to the Belgian legislation.

The text was discussed with the sectors involved, including the representatives of the pharmacists, the pharmaceutical industry, the producers of generic medicines and the veterinarians. The deadline for the transposition was 1 November 2005. However, Belgium was one of the first countries to effectively transpose those directives.

In particular, technical provisions need to be transposed: the different authorisation procedures for the placing on the market of medicinal products, a simplified five-year review, the introduction of the sunset clause, a number of provisions on publicity and readability for patients of the envelope, the obligation to draw up envelope accessible to blind and visually impaired persons and the obligation to place the name of the medicinal product in braille on the envelope.

An important part of the draft legislation concerns generic medicines, the production of medicines, wholesale distribution and pharmacovigilance.

The changes are as follows.

A joint committee shall be established to provide advice to the Minister when there is doubt about the applicable legislation for certain products. Distance sales are regulated. The sale on the Internet of medicinal products which are freely available on prescription is allowed. The sale via the Internet of medicines that require a prescription remains prohibited. The distribution system of veterinary medicinal products is amended. The veterinarians can supply themselves directly from the wholesalers. The delivery of veterinary medicinal products by veterinarians remains possible.

The draft adds two cases in which it is possible to make non-approved medicinal products still available to patients or to those responsible for animals.

First, there is the use in urgent cases of medicinal products for which clinical trials are still underway, or for which the application for marketing authorisation is still under consideration, for patients suffering from a chronic disease, a disease that seriously undermines health, or which is considered life-threatening and which cannot be satisfied with a licensed medicinal product.

Second, there is the use in the light of medical emergency programs. These are cases where the medicines are already authorised, but not yet for that specific indication. In addition, the Act of 28 August 1991 on the practice of veterinary medicine and the Act of 21 June 1983 on medicated animal feed are amended.

During the general discussion, Mr. Goutry talked about the establishment of the Agency for Medicines. Mrs Tilmans describes the problem of veterinarians selling large amounts of medicines to farmers while Mrs Avontroodt talks about the biosimilars and Mr Bultinck talks about the mixed committee, which will be established. Ms. Detiège spoke about the Directorate-General for Medicines. Mr. Mayeur treated the medicines that are licensed in neighboring countries but are not used in Belgium and in hospitals.

The article-by-article discussion deals with the Joint Committee, which should provide advice on the legislation covered by a product. Industry will also be represented. The appointments should be independent, clear and transparent.

Article 4 deals with the pharmacopoeia, the composition of the current pharmacopoeia committee does not change. In the past it was an informal structure. With the designed article, it is formalized.

Article 5 aims to make the sale on the Internet of medicinal products for which no prescription is required subject to certain rules. The sale should take place in a pharmacy open to the public. In addition, it will determine what information the pharmacist will have to provide the patient with about the medicines. Such arrangements can only be adopted for Belgium.

Article 7 deals with information relating to the use of medicinal products provided by the government.

In Article 8, the Minister clarifies the specific conditions under which the Minister has the possibility to recognize medicinal products not authorised in Belgium, and has the possibility to grant that authorisation for medicinal products already authorised in other countries, so that the medicinal product can also be authorised in Belgium.

Regarding Chapter 8, Mr Goutry notes that the procedure for generics may be initiated after 8 years. However, if it can be demonstrated for the original medicinal product that there is a new indication for its use during the period in which it is on the market, its term shall be extended by one year. The Minister clarifies that the term is extended from 8 to 10 years. However, it is intended to stimulate innovation.

Regarding Article 11, I myself ask the Minister how he has taken into account the comments of the State Council on the article. The Minister reminds that favorable advice can be given for some products that are not licensed in Belgium. Furthermore, the Minister points out that medicines can be used in medical emergency programs before they are authorised on the Belgian market. This has no effect on whether those medicines are eligible for a subsequent refund.

I come to the votes. Their

Articles 1 to 7 were adopted unanimously. Their

Article 8 was adopted with 11 votes in favour against 2 abstentions. Their

Articles 9 and 10 were adopted unanimously. Their

Article 11 was adopted with 12 votes in favor and 1 abstinence. Their

Article 12 was unanimously adopted. Their

Article 13 was adopted with 12 votes for and 1 abstinence. Their

Articles 14 and 18 were adopted unanimously. Their

Articles 19 to 21 were adopted successively by 12 votes in favor of 1 abstinence.

The entire legislatively improved draft was adopted with 12 votes in favor and 1 abstinence.

Mr. Speaker, Mr. Minister, this was my report. Their

The VLD has fully supported this bill.

Mr. Speaker, the project under consideration is essentially aimed at transposing in Belgium three European directives bringing major changes to the regulation on medicinal products. The changes affect many aspects: manufacturing, marketing authorisation, distribution, pharmacovigilance, advertising, etc. by

This transposition is crucial because it realises significant advances in our domestic law in the field of marketing authorisation for medicinal products, taking into account the scientific and technical developments in the context of the broadened European Union.

Changes are likely to further improve the free movement of medicinal products while ensuring a good level of protection of human and animal health. We support and emphasize the quality of the technical work carried out by the government.

However, there are four amendments. The first three concern the entry in the law of the maximum deadlines for processing applications for authorisation. Amendment No. 1 concerns the application for wholesale distribution authorisation with a maximum period of 90 days. Amendment 2 concerns the application for a marketing authorisation with a maximum period of 210 days. Amendment No. 3 concerns the application for a manufacturing authorisation with a maximum period of 90 days. by

The option was taken to incorporate in the law most of the provisions of the Community Code, but also the provisions that were previously contained in the enforcement orders. We can accept this logic. The basic principles regarding authorisation of marketing, distribution, manufacturing, etc., must be found in the law, at least for two reasons: - first, it is important to submit these basic principles to democratic control; - then, it is about adopting a single basic text that ensures good coherence rather than seeing the rules scattered in a thousand rulings in which nothing is found!

However, we find that although this logic has been followed for 99% of the new regulation, it has not been followed for the enunciation of deadlines for processing applications for authorization. We therefore propose to reintroduce these maximum deadlines in the law; on the one hand, for consistency with the logic followed for the rest, on the other hand, because these deadlines are essential elements to give the industry satisfactory guarantees of competitiveness in relation to the global market.

The fixing of maximum deadlines in the processing of applications for authorisation gives the companies that introduce them a certain guarantee of rapid access to the European market. This is an important competitive element. This is one of the elements that motivated the revision of European pharmaceutical legislation. We would not understand that this element is not included in the law itself, as is the case with most other provisions. by

Also, on these three amendments, I ask the Minister to reflect with rested heads in order to examine the possibility of following us in this matter.

The last amendment, amendment No. 4, concerns the creation of a legal basis allowing the King to regulate advertising for medicines through controlled self-regulation.

Advertising, promotion for medicines is a complex matter. If you believe some press articles, it seems to be as much regulated as not respected. According to some, advertising for medicines would be responsible for many misrepresentations in prescription medicines, resulting, on the one hand, in a number of public health problems and, on the other hand, inadequate spending on health insurance.

While information about medicinal products to the attention of the medical body is necessary in order to keep the medical body up-to-date with the latest advances in science, it is also important that such information is well framed so that it does not lead to an abusive promotion resulting in prescriptions that would not be scientifically founded. However, if the regulation exists, it is its control that, for years, has been lacking.

The Public Health Administration, the DGM, lacks resources, which contrasts with the striking force of the pharmaceutical industry. Our Fourth Amendment aims to find a constructive alternative solution to this crucial lack of resources. It is proposed to also entrust a self-regulatory body with a subsidiary competence to control, or even to punish, abuses in this area.

Self-regulation appears to us as a solution for the following reasons: - an organ of self-regulation is composed of people of the field who know the sector, who know where the bug hurts and how to remedy it; - such an organ is flexible in its way of functioning and costs nothing to the community; - it is expressly considered as a possible solution by the Community Code itself. I refer to Article 97 of Directive 2001/83. - Finally, self-regulation is already envisaged as a solution in our domestic law for the control of scientific congresses and other collective scientific events. I refer to article 10 §3 of the current law of 25 March 1964 on medicines.

Self-regulation has, as I know, disadvantages. The main criticism is that this body would be judge and party and would lack credibility, since the actors themselves would not be inclined to punish themselves. We believe that this risk exists, but that the means to remedy it also exist. Therefore, we propose four paths. First, that this body should be composed equally by all health care actors (industries, doctors, pharmacists, patients and authorities). Second, that this body be established in a legal form that guarantees its independence from the industry. Thirdly, this body must be subject to full transparency in its way of functioning and in its decisions. Those decisions should be published. Finally, this body should be regularly inspected and audited by the authority. It would also be subject to renewable approval.

In conclusion, in order not to weigh the law itself, these rules will be specified by royal decree in consultation with the sectors concerned. Our amendment simply aims to create the legal basis for the King to use the proposed tool. by

As was the case for the first series of amendments, I ask the Minister to reflect by tomorrow — I imagine in fact that we will vote tomorrow — and to pay the best possible attention to our arguments.

Mr. Speaker, first of all, I would like to thank the parliamentarians for the quality of their work as part of the discussion of this important text. It is the result of numerous meetings and consultations. As I said, an important work has been done in this Parliament, but also outside the Parliament.

I can tell you — and I am happy — that Belgium is one of the first Member States to transpose the directives, even though the deadline was 1 November.

That was a very good thing, Mr. Minister.

Mr. Speaker, I would like to focus on the essential and say that ultimately, this text responds to many requests and offers positive advances in several areas: the different possibilities of procedure for marketing authorization of medicines; the easing of the five-year review, the introduction of the so-called "sunset" clause, the provisions concerning advertising and readability of notices, the obligation to make notices available to people who are blind or visually impaired. Important parts of this text are also devoted to generic medicinal products, the manufacture of medicinal products and their wholesale distribution as well as pharmacovigilance.

In other words, I think we have made great progress with this text. I also look forward to the contributions of each other. Members of the committee have, indeed, worked a lot on the subject and have thus testified to the quality of parliamentary work.