Proposition 51K1272

Projet de loi modifiant la réglementation relative à la lutte contre les excès de la promotion de médicaments.

General information ¶

Submitted by

PS | SP MR Open Vld Vooruit Purple Ⅰ

Submission date

July 6, 2004

Official page

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Status

Adopted

Requirement

Simple

Subjects

veterinarian doctor pharmaceutical industry medicinal product advertising

Voting ¶

Voted to adopt

Vooruit PS | SP Open Vld MR

Abstained from voting

CD&V Ecolo LE N-VA FN VB

Contact form ¶

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Discussion ¶

Nov. 18, 2004 | Plenary session (Chamber of representatives)

Full source

Mr. Speaker, Mr. Minister, colleagues, I am also presenting this report on behalf of my colleague rapporteur, Mrs. Avontroodt, who will probably also present her part of the report. On behalf of both of us and all members of the committee, I would like to thank the services of the Chamber for the work they have done.

Together with Mrs. Avontroodt, I am therefore a reporter for the draft law on the fight against money laundering in the promotion of medicines. Thirty-six amendments were submitted to the committee. All amendments were submitted by CD&V. Finally, after the explanation of Minister Demotte, 11 amendments were withdrawn. Six amendments were adopted.

Amendments were submitted to clarify the scope of the law, in particular to include, inter alia, taking the definition of a medicinal product from existing royal decrees and extending it to medical care materials or medical devices. The Minister stated that he had no principled objections to the amendments, but he considered them unnecessary. The scope of the law is clearly defined. Both the medicines and the medical care materials fall within the scope of Article 10 of the Medicines Act of 1964, as amended by the draft.

On the general principle of prohibition of anticipating, offering and granting premiums or benefits, three major exceptions were made. The exception for premiums or benefits of very small value, the first exception, can not, according to CD&V, since the Medicines Act of 1964 does not contain exceptions. The Minister defends the exception by referring to European Directive 2001/83, which allows such an exception, on the one hand, and to the 1995 KB on advertising for medicinal products, on the other. After all, that KB also disregards benefits of low intrinsic value.

Additional amendments and sub-amendments provide for the King to determine what exactly should be understood by a very small value or, analogous to the royal decree of 1995, also in the present draft law to speak of the small intrinsic value. Colleagues, the second exception to the prohibition principle aims at the hospitality associated with the organized scientific manifestations. According to CD&V, two of the five cumulative conditions associated with the granting of the exemption are not sufficiently clearly defined. An amendment was submitted to determine, in analogy with the explanatory memo, for the offered hospitality maximum amounts per manifestation, per firm and per professional practitioner, with an annual maximum per professional practitioner. However, the Minister considers that it is not appropriate to include amounts in the law.

Subsequently, CD&V submits an amendment to introduce a reporting obligation for all premiums and benefits of very small value and for all manifestations. Such a pre-notification obligation is the only way to ensure a sound control over the implementation of the law.

CD&V submits amendments to the third exception "compensations for legitimate performance insofar as they remain within reasonable limits". Such words are too broad. The Minister says that this case must be determined on a case-by-case basis and leaves its assessment to the Directorate-General for Medicines or to the judge himself.

The following aspect of the bill concerns the visa application for demonstrations with at least one overnight stay and the conditions under which the visa procedure will be provided by the institutions still to be recognized by the King. Through amendments, CD&V wants to obtain that either every manifestation, regardless of the duration, must have a prior visa application, or that each manifestation is ⁇ to the pharmaceutical inspection service of the FOD Public Health. The Minister cannot agree with this.

For CD&V, it is also not possible, by the means of the King’s assistance, to appoint interested institutions that will study a visa application. Therefore, they should make amendments aimed at removing the provision giving the King this power, or to provide for an independent body to review the applications. This can be excluded by excluding institutions with direct or indirect links to the industry or by providing for an independent visa check by the Directorate-General for Medicinal Products of Public Health. The Minister specifies that the recognition of the institution indeed belongs to the government, but that a recognition can be suspended or withdrawn at any time.

The draft law also contains a provision on the establishment of a reporting point for infringements relating to the fight against laundering in the promotion of medicinal products. It will be established by a royal decree. For CD&V, it is necessary to specify in the law that the reporting point will be established within the Public Health Department. Ms. Detiège asserts that the General Directorate of Public Health is suitable for this. The Minister clarifies that the explanatory note to the provision already states that in practice the Directorate-General will take on this task, making the amendment unnecessary.

Amendments are submitted to allow the notification point not only to collect suspected infringements but also to monitor and handle them. In this regard, the King must also determine the manner in which the treatment and the possible punishment shall be carried out. The Minister does not agree with this. According to him, it is not the task of the notification point but of the inspectors to check the notifications. Therefore, three additional pharmacists and inspectors will be hired. The Minister may agree to the CD&V amendment that the contact point prepares a report and submits it to the House of Representatives. Annual reporting is too difficult. It is agreed to submit a two-year report to the Chamber.

In analogy with the amendments to clarify the scope of application and to clearly define what should be understood by medicines, amendments are submitted to also amend the Veterinary Medicine Act. The amendment to include medical devices in that law, in addition to medicines, is accepted by the Minister.

Finally, CD&V proposed that the law should enter into force on 31 December 2006.

The Public Health Committee adopted the amended bill with 11 votes in favour and 4 abstentions.

Mr. Goutry, I suggest the following. If you speak now on behalf of your group, then I will then have Mrs. Avontroodt speaking as rapporteur and on behalf of her group. Can you also let Mrs. Avontroodt speak first?

It seems to me appropriate that you now develop your presentation on behalf of your group, Mr. Goutry. I will apply the same procedure for Mrs. Avontroodt.

The Ladies Detiège and Tilmans, as well as Mr Bultinck, are also registered as speakers.

Mr. Speaker, in the presence of my President, I will briefly and concisely again present the position of the CD&V Group on the fight against waste in the promotion techniques of medicines.

First, we recognize the therapeutic importance and the need for medicines. We fully support scientific research to improve existing medicines and to develop new, effective medicines.

Second, the use of medicines and the evaluation of their therapeutic usefulness assume proper guidance and all necessary information. The producer must play an irreplaceable role. In addition, the government must ensure that it has the know-how and expertise to verify, test and objectivise all information.

Third, there is an urgent need for independent and scientifically supported information, which is at the service of doctors. They can rely on it to make the best choices depending on the price and quality of the drug. Quality depends largely on scientific and therapeutic evidence.

Fourth, drugs are therapeutic devices that must be marketed on the basis of a strict deontology and in accordance with medical ethics. They cannot be treated as a commodity. Commercial advertising techniques and commercial sales techniques are completely unacceptable and irresponsible here.

Fifth, we therefore support any effective legislation and regulation that prevents and combats all of the above-mentioned laundering. However, the present draft law does not provide any added value in this regard. It is merely a transposition of Articles 94, 95 and 96 of Directive 2001/83. The new legislation does not guarantee an effective fight against promotional laundering and abuse.

Sixth, there is a total lack of effective control capabilities and enforcement policies. The Minister stated that in principle no additional funds are registered for the control and detection of the abuses. Well, colleagues, we are convinced that the law will remain dead letter in those circumstances. The prohibition on commercial promotion has existed since the law of 1964 and in practice this law has ⁇ not curbed the abuses. An effective enforcement policy is based on real package opportunities and a consistent control system.

Seventh, we support the principle of self-control by the various producers themselves and by the trade union. After all, we support all efforts made by the sector in terms of internal, deontological codes. However, the value of self-control is based on the knowledge that the government must clearly monitor. For example, self-control has not yet led to a reduction in the number of medical visits.

Eighth, we support the establishment of a notification point. We also called for a two-year report of the point of contact to the Parliament. However, we fear that the joint point will not receive sufficient resources to develop properly and to become a full-fledged co-player.

Mr. Speaker, colleagues, in view of all these concerns, in view of the shortcomings we identify in the legislation and in view of the lack of any guarantee that there will be an effective intervention now and that the control possibilities will be enhanced, we will abstain from voting soon. We agree with the principle, but the concrete implementation is not guaranteed at all.

I would like to conclude with three specific questions to the Minister following this discussion. They are, of course, also intended for colleagues who may want to get involved. There is uncertainty and the industry has a lot of questions. When you read Article 2, you see that it does not leave much space. Those engaged in the manufacture, administration and delivery of medicinal products should, in principle, never receive any benefit in cash, in kind, directly or indirectly. I think there are three situations that we still need to clarify. First, there are discounts given to rest homes due to the joint purchase for the residents residing there. It is a widely applied practice that rest homes make a tender from several pharmacists from the region. Based on the discounts proposed by the pharmacists, certain grants are granted. The rest house tries, in other words, to buy medicines in the cheapest possible way. I think that is a sensible policy. In most cases, rest homes simply pass those discounts to the patients. The residents of the rest homes are the beneficiaries. Mr. Minister, will such a discount given by pharmacists because they are given the exclusive right to deliver to rest homes be prohibited by law?

The second issue concerns the reductions in hospitals. It is usually the hospital pharmacist who negotiates with the suppliers of medicines and medical materials. A widespread practice in hospitals – it is, in my opinion, even a practice of good management – is that the buyer tries to get as much discount as possible. He tries to buy the products at the best possible price. I think that will be even stronger in the future. The Minister has announced that he will further forfaitarize the medicines in hospitals. This means that hospitals will no longer be able to fully charge the medicines they deliver to patients. They will only be allowed to charge a fixed amount per patient for medicines. If that is the case, the hospital will have to take even more care to withdraw the medicines in the best commercially most interesting and therefore cheapest way, so that the difference with the package fee is minimized as possible. My second question is the following. Can discounts, price reductions, better price conditions negotiated by hospitals with suppliers be further conditioned in the future?

Of course, pharmacists also buy in large quantities. They try to buy as many medicines as possible and often receive discounts. For example, they buy 100 packages and get 120. He uses that discount for himself, because he will sell the packaging to the patients at the official price. Will a pharmacist still be able to impose price reductions, discounts or price reductions on the supplier in view of Article 2 of the law, so that his commercial profit or commercial turnover will still benefit from this?

Mr. Minister, these were the three precise questions to which I think it is important to get an accurate answer in order to avoid further discussion.

Mr Goutry, you also submitted eleven amendments. Will you explain them briefly because they all relate to Article 2?

Mr. Speaker, Mr. Minister, Ladies and Gentlemen, in the report, I will continue to reflect on the views of the other groups. In his introductory presentation, the Minister has very clearly explained the purpose of the bill, in particular not to prohibit any form of promotion but rather the excesses. This is a huge difference from what is possible today. My colleague Goutry has referred to the substantial amendments to Article 10 of the Pharmaceutical Act with the prohibition of premiums and benefits as the only starting point, with the three exceptions, so that I do not have to repeat this.

It was also made clear that there were consultations with the pharmaceutical industry and that there was even a constructive collaboration. In June 2003, an initiative was already taken in the form of self-regulation which, however, is not enforceable but which by this law becomes enforceable. This is definitely a step in the right direction.

Finally, the minister also paid attention to the differences between the United States and Europe. In the United States, the largest pharmaceutical companies spend 14% of their revenue on research and 30% on marketing, while in Europe 12% is spent on research and 24% on marketing.

In the general discussion, Mr Goutry’s CD&V group by monde pointed out the great importance of the bill, but at the same time he also discussed a number of points. According to him, medical visitors are more likely to be trade representatives who do not provide objective information. He also said that the bill does not provide the right solution.

According to Mr Goutry, Article 10 already contains a ban on premiums and benefits, but there is no control over this ban. The bill emphasizes the mechanisms of self-regulation, but this also has its limitations. The industry itself has drawn up a code, but the abuses have only increased. Wouldn’t it be better, Mr. Goutry suggests, to limit the number of permitted visits for promotional purposes? Sanctions should be aligned with the company’s turnover and significant budgets. One should be strict to doctors and hospitals but flexible to patient associations as they would often depend on pharmaceutical companies for their survival, said Mr. Goutry.

Mr Bultinck emphasized the ambiguous attitude adopted by the Minister towards the pharmaceutical companies. On the one hand, according to Mr. Bultinck, the minister promises a budget that matches the reality, and on the other hand, he now submits an aggressive bill. According to Mr Bultinck, it would be better to tighten the deontological codes and introduce a control mechanism. At the same time, he also asks for an evaluation of the existing controls.

From the PS Group, Ms. Marie-Claire Lambert also pointed out the need to clarify the relationship between doctors and industry. She raised questions regarding the exceptions for the benefits of very low value and, more specifically, how they should be assessed. This was also a question asked by other members. It also pledged not to impose excessively compelling administrative formalities. It is also the requesting party to make public the decisions of the notification point. She also pointed out the need for effective control, a role ⁇ for the High Council for Deontology. Ms. Detiège welcomed the draft law and stated that a own code was useful but also has limitations. She also explained the amount that companies spend on promotion and stated that it was difficult to defend that this was higher than what is spent on scientific research.

Ms. Tilmans also expressed her support for the draft law that should responsibilise both doctors and the industry. She also asked the same questions, such as what is low value. She also asked for additional staff at the Directorate-General Medicines. Where can people go with their complaints?

Finally, we have called for the attention of the VLD group for greater transparency and greater acceptability and verification of this draft law. At the same time, we also pointed out to the Minister the added value of scientific congresses and in a discussion formulated a proposal to ⁇ that balance. The promotion may affect the prescription behavior, but one should not ignore the fact that the pharmaceutical industry also allows new treatments. We have advocated a differentiated approach depending on whether innovative or non-innovative medicines are promoted.

In his response to all these questions, the Minister said that until today there has been no evaluation of the objective or independent physician visitors. He stated that there was absolutely no ambiguous attitude. The industry has not made much objection to the bill and also acknowledges the need for the regulation. Therefore, it is not intended to harm the industry but to act in the public interest. That was the Minister’s response. He also requested not to lose sight of the purpose of the law, in particular a clear distinction between unauthorized promotion and educational activities of a clear scientific nature.

In addition, there is also clarity created around the medical materials that were not mentioned in this bill. An exception was made for veterinary medicine. It is not intended to also question the prostheses and the necessary medical materials for hospitals.

The question of the reductions was quoted quite at once, also in the report. I agree, in this regard, with what Mr. Goutry has said. I will return to this during my speech on behalf of our group. We should not throw the child away with the bath water. Their

Until then, Mr. Speaker, my report. Their

Next, I can briefly explain the intervention of our party. We believe that this text has a clear merit, because it translates generally accepted and practiced principles into regulation, which ultimately makes these principles enforceable. This provides greater legal certainty for those facing this. The draft explicitly prohibits the granting of benefits of any value as compensation for prescribing certain medicines. It also clearly formulates the conditions under which benefits in the form of a scientific congress are possible, without making the scientific congress impossible. This is also very important. I am pleased that the Minister was so wise not to ban the scientific loop. In this way, the child would be thrown away with the bath water. Their

Finally, it also becomes clear that a prescriber — this is also important — should not claim an advantage for prescribing a particular pharmaceutical product. By introducing this, there is a balance in the design.

However, there are some things that need to be relativized. Can we here expect all salvation from this draft, to reduce spending and budgetary growth in this sector? The future will have to show that. Personally, I think this will be just a small incentive or incentive. I think there are two major gaps around drug policy to be added to the debate. First, for which medicines should research be further stimulated worldwide, especially at the European level? How can one give this a certain direction, so that there are no gaps in the field? Second, the anchoring or insurance of innovation should be ⁇ ined. Their

I have already talked about the second element during my discussion on savings, but it is also discussed here. In the future, there will be a clear right to information. I referred to the statement of Pat Cox, the former President of the European Parliament, who says that ignorance only costs. A well-informed patient costs no more; on the contrary, a well-informed patient can contribute against abuse or can ⁇ be a positive contribution in controlling the budget. This is not only because quick intervention and rapid treatment have a beneficial effect, but also because this excludes abuse. Therefore, I advocate for better direct to consumer information. Information is not marketing or promotion. This debate will also need to be held.

When it comes to scientific information for doctors, I don’t say that I’m not a big advocate of independent physician visitors, because there are other methods. We will first have to make the scientific analysis of how a message comes directly to the one who needs to receive it. There are various possibilities. There are networks such as Cebam, which directly provide scientific information. I think it is also about Public Health to put validated information on the net. That is ⁇ no more expensive than sending a whole regiment of independent physician visitors on the way. How will these people be able to stay up-to-date? I have big questions about it. In my opinion, you should first make a good analysis of how the right information reaches the stakeholders it needs to reach. This is not stated in the draft, but it has to do with the control you propose, Mr. Minister.

The following questions for clarification remain standing.

First of all, like the other colleagues, I am appalled for the administrative burden. In what way will you be overloaded, Mr. Minister, with questions whether something is scientifically relevant or not, or is something of great or small value? We have held that debate. I think it is real and realistic that this will require a large form of autosponsabilisation, but you can trust it to a committee, which can work with the greatest transparency. What happens if, for example, you do not respond to a prior advice? Where does one end up? Can we organize or not? I think it can be a tough task for you and your services.

Colleague Goutry and colleagues in the committee also referred to the reporting point. What happens to the notifications? How will it be registered and published in an evaluation report?

Provisions on veterinary medicine did not need to be immediately in the design for me, but it is now in it. It will not be harmful, but we found it not directly linked to health insurance.

The main question, Mr. Minister, has also been quoted by Mr. Goutry: what about the common practices in rest homes and hospitals. I will read our interpretation and then I hope, Mr. Minister, that you create clarity on this. We understand that the prohibition contained herein has as its essential objective to avoid prescribing or administering medicines being motivated by motives not related to public health in general and to extend the best therapeutic arsenal for the patient in particular. The prohibition of premiums and benefits, as defined in your new Article 10, is, in fact, the transposition into Belgian law of Article 94, § 1, of Directive 2001/93, which imposes a similar prohibition on premiums and benefits relating to medicinal products for human use. Paragraph 4 of Article 94 of the same Directive further states that the prohibition referred to in Paragraph 1 does not prejudice the existing measures or commercial practices relating to price margins and discounts in the Member States.

This is of course very important. This has come into the text in order, of course, to implement a price policy on medicines within Europe.

I apologize for the technicality in this matter, but it is so important that it is correctly expressed in the report, because otherwise it could have great repercussions.

Medicines in Belgium have only a maximum price. The trade practices relating to price margins and discounts referred to are the common trade practices used between the actors involved in the distribution of medicinal products. Mr. Goutry also cited the examples. The question of whether or not discounts on current payments are allowed has not yet been raised by Mr Goutry, but it is also part of it. Can there be a discount for current payment? Is it considered or not an advantage in nature? Are discounts, for example, as a result of the liquidation of a stock, considered to be a benefit in nature? Does it fall under the law or not? Does this also apply to reductions for a limited percentage when purchasing large volumes of human medicinal products? What is a limited percentage or how much is the discount meant by it?

I emphasize that these practices do not affect the therapeutic arsenal offered to the patient through his prescriber and/or pharmacist. Therefore, it is our interpretation that commercial practices concerning prices, margins and discounts, as referred to in Article 94, §4, do not fall under the prohibition of premiums and benefits, as referred to in the new Article 10, §1, 1st paragraph of that bill. Finally, Mr. Minister, I think that some practices in certain hospitals, such as those on which Mr. Goutry asked you this afternoon, should also be addressed in that context. It is of a completely different order. I have pledged, in the discussion of your note to the industry actors, that transparency and other elements should be addressed in the hospital legislation and in the financing of the hospitals.

Some discounts are today an essential element of funding for hospitals. In the story that was accused, one does nothing but stimulate consumption for purely production reasons, for purely profitability reasons, for purely business reasons, and that is contrary to what you want to guarantee. The debate on this issue has just begun.

Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker.

The bill, which is presented today, aims to clarify and refine the existing legal framework with regard to the promotion of medicines for the pharmaceutical industry and this in order to combat the found abuses. The aim is to strengthen the patient’s confidence in their doctor.

This project covers several principled prohibitions, three of which I would like to explain to you. The first is the prohibition of granting benefits of any kind whatsoever to persons who prescribe, deliver or administer medicines. The second is the prohibition for doctors, dentists, pharmacists, physical therapists to directly or indirectly request bonuses or benefits from other care providers or third parties. The third is the prohibition for veterinarians to conclude, with wholesalers in particular, agreements on the price of medicines.

Mr. Minister, we fully support the objectives of this project because it is part of the accountability of pharmaceutical firms, healthcare providers and veterinarians. Furthermore, this project was expected by the sectors concerned and in particular by the pharmaceutical industry, which had itself issued a code of ethics based on the self-regulation of the sector.

When we talk about the excesses of drug promotion, we most often think of the relationship between doctors and the pharmaceutical industries. Nevertheless, I would like to draw special attention today to veterinary practice and, unlike my colleague Avontroodt, I am delighted that this is discussed in this bill. I think of those veterinarians who are carriers of medicines and who prospect the farms, we have already long talked about it and I thank you for being attentive. These people want to flow out significant stocks of medicines—this is what is called “motorway veterinarians”—and buy astronomical amounts of medicines under very favorable financial conditions, which allows them to resell them 15 or even 30% cheaper.

In addition, they encourage farmers to buy large amounts of medicines, without prior animal examination and out of any responsibility.

These practices can effectively lead to overconsumption with, as a result, resistance to certain antibiotics and certain anti-parasitic drugs, and this without worrying about the potential risks to public health, or the effectiveness of remedies for this or that pathology. The only purpose is to make money.

These practices are clearly in breach of the spirit of regulations, Belgian and European. They are also in violation of public health objectives such as epidemic surveillance and good drug control.

Therefore, I am delighted with my group that this bill also targets veterinarians and that it will be able to end the common and very dubious practices practiced by these "motorway veterinarians".

Finally, I will talk about medical devices. We have received, and we welcome, your assurances, Mr. Minister, that training and educational activities aimed at learning how to use medical devices cannot be considered as bonuses, nor as monetary benefits. It is also not a natural benefit. There can be no ambiguity in this regard. As regards the teaching medical equipment used in the context of learning, it is also not subject to the prohibition referred to in this bill.

Here, Mr. Speaker, Mr. Minister, Ladies and Gentlemen, are the various remarks we wanted to make regarding this bill which fully corresponds to our wishes.

Mr. Speaker, Mr. Minister, colleagues, allow me to make a first consideration in connection with the discussion of the present bill. I find that the atmosphere and the circumstances in which we conclude that discussion today are fundamentally different from the atmosphere we knew on 29 September when we started the discussion in the committee.

I explain myself more closely. On 29 September, I declared very clearly, on behalf of our group, that fundamentally since the health dialogue, we believe nothing has actually happened. We were not a step further. We have then very clearly formulated that, in our opinion, the present bill of the results of the megaministery councils was only a small element. It was a small result, and that was it.

In the meantime, we are a step further. I would say: Luckily. Slowly, however, we get the fundamental debate about the drug policy that we and our group have long been asking for. Now I must be honest: for the first time since you took office as Minister, in 2003, we have had to make the conclusion that the evening consultation of 9 November that you held with all parties was held at least on the basis of a sound note.

You know very well, Mr. Minister, that on the one hand, we have been saying for a long time that, in our opinion, you may show a little more action. It is more than necessary to demonstrate the effectiveness of this document. On the other hand, I have retreated for a moment from pure nostalgia, Mr. Minister — as a preparation for my intervention today — to the arguments in the large thematic debate on the drug policy that we held on 28 March 2000 with your two predecessors, Mrs. Aelvoet and Mr. Vandenbroucke. I must tell you that for a lot of very many things from this seem very familiar to me. I can’t get rid of the impression, Mr. Minister, that in recent years a lot of precious time has been wasted and that there has been too long waiting for structural intervention. Let this very clearly be a first consideration of our group, which I thought I should make today.

A second consideration I make from our group, Mr. Minister, is that we also very clearly acknowledge that there are abuses in the promotion of medicines. In Europe, 12% of the pharmaceutical industry’s resources go to scientific research, while 24% go to marketing and promotion. Also our group finds it logical that measures are taken to somehow regulate this promotion somewhat more strictly. In that sense — it is good news for you, Mr. Minister — we do support your goal of more clearly outline what could be a normal relationship between, on the one hand, the health professionals and, on the other, the manufacturers of medicines.

We also support the idea that the prescription behavior of doctors is indeed influenced in a little scientific way by physician visitors coming from the industry. In the previous legislature we have already said that we were willing to give the government an opportunity to send objective physician visitors. However, we also warned of excessive public extortion. This is my first concrete request for information. We are very clearly asking party to get a quick view of and be able to make a quick evaluation of the initiatives that date from the previous reign. You know very well that the government, among other resources, is crossing through the VZW Farmaca. Therefore, I find it not more than normal that the members of Parliament quickly get an insight into the effectiveness of the information systems implemented in the previous legislature.

A third consideration in connection with the discussion of the present draft law is the very strong question of the added value that this draft law provides in our opinion. I refer to the Act of 25 March 1964 on medicinal products, which prohibited the provision of benefits or premiums, directly or indirectly, in the delivery of medicinal products. Mr. Minister, we must dare to ask ourselves whether it is not rather a lack of control over the compliance with existing laws and whether the tightening of deontological rules and the self-regulatory system that the pharmaceutical sector actually has would not have been more efficient than taking another legislative initiative.

A fourth consideration that I want to expressly formulate today is about scientific research. The pharmaceutical sector in this country plays an important role in scientific research, and therefore also implicitly in employment. In this sense, it is obvious that scientific meetings to which doctors are invited by the industry may remain. It would still be lacking. Louter scientific congresses are indeed the cornerstone of a permanent training of the medical corps. I wonder whether the visa now required for the organization of any scientific meeting will not bring additional administrative burden. I had understood that this government had at least set as an ambition to implement administrative simplifications. I am afraid that this may be a missed opportunity. With this visa we re-impose an administrative obligation. Practice will have to show whether our fear of additional administrative congestion was or was not justified.

I come to my fifth consideration, with my very clear question to show some nuance in this debate. Mr. Minister, you have shown very clearly, already in the past and during the discussion in the committee, that the pharmaceutical industry is not the only culprit for the excessive use of drugs. However, I must honestly confess to you that sometimes it seems — hopefully unfairly — that the debate about this situation in which the expenses in health insurance are completely out of hand is indeed threatening to result in a declaration of war on the pharmaceutical industry.

Our group makes it very clear that it really needs to be sought for a difficult balance with all actors. It would not be correct to only responsibilise the pharmaceutical industry. All other sub-sectors, implicitly the patients, should also be accountable.

Mr. Minister, I read very carefully the interview with you in the magazine Knack of 17 November. If you allow me, I would like to ask you a very precise question on this. At some point, you say that eight out of ten consultations result in a prescription of a medication for acute treatment. This is often done on the patient’s insistence. The following sentence is very crucial: “A higher brake money should change that behavior.”

Mr. Minister, I would like to receive a concrete answer from you on the following relevant question. What is stated here in this interview goes far beyond what you originally mentioned in your note that we discussed last week in the Joint Committee? The note refers to people who would not properly follow a particular care path. What you explained or did not explain in the Knack interview goes much further, hence my request for clarification regarding your statement that the brake fees for the patient could be increased.

I conclude my intervention with a final question. I refer again to your note that you distributed in the mixed committee last week. Under the "fight against excessive advertising by companies" point, please inform you that a working group was established to determine the necessary elements required to get a better knowledge of the exact cost of a medicinal product, namely an analysis of the part dedicated to the spending on marketing and research, on the one hand, and a possible analysis of the measure to limit the marketing of the companies, on the other. Mr. Minister, this is my third concrete question: can you give me more details regarding the composition and functioning of this working group, the precise moment of its establishment and what has already been concretely decided?

Mr. Speaker, Mr. Minister, these were some critical remarks that I wanted to make on behalf of our group and which should make clear why we will abstain at the final vote on this bill.

For many years, the relationship between prescribing doctors and the pharmaceutical industry has raised many questions. Certain ambiguities and some continuous insinuations help to discredit the whole of a profession that, most often, has not changed prescribing behavior, regardless of the requests.

This bill aims to define more clearly what is a normal relationship between health professionals and pharmaceutical firms. This is a decisive step that we are proposing today to clarify the relations between the different actors. A legislative initiative was all the more necessary because the patient, increasingly aware, must not have the impression that the medication prescribed to him is not always the most suitable, in particular due to certain commercial practices. Although representatives of the pharmaceutical industry have already drafted a code of conduct and a self-regulation system has existed since 2003, it is important to note that the current system is not sufficient to solve all problems, even if it is a step in the right direction. The Directive transposes Articles 94 to 96 of the Directive of the European Parliament and of the Council of 6 November 2001 establishing a Community Code relating to medicinal products for human use. Article 10 of the Medicines Act is reviewed in depth in order to best understand the problem of bonuses and benefits, scientific events, hospitality and legitimate compensation of professionals.

The basic principle is the prohibition of promising, offering or granting premiums and advantages to all persons authorised to prescribe, deliver or administer medicinal products, as well as to persons who supply themselves with medicinal products for human and veterinary use.

There are three exceptions to this principle.

The first exception concerns the advantage of insignificant value and having a connection with the exercise of the profession of the recipient.

The second exception relates to scientific events to which healthcare professionals are invited and for which they may receive hospitality. What is strictly prohibited are promotional events.

To be recognised as exceptions to the prohibition, scientific manifestations must meet five cumulative conditions, determined by the law itself.

The third exception is the reasonable compensation of health professionals for legitimate services they have provided.

In addition, a preliminary visa procedure for all events that include at least one overnight is established. Another a priori arrangement provides for the possibility of requesting prior opinion from the Minister of Health on the eligibility of the benefits to be provided.

Finally, a "Drug" contact point will be organized within the General Directorate in order to centralize all information relating to facts likely to constitute violations of the rules on abusive promotion.

These are mostly the proposed legal provisions.

Permit me, however, Mr. Minister, and although we have had some reassurance on the subject in committee, to return to a few points that may appear to be problematic in the near future.

One of the exceptions to the prohibition rule is for negligible value benefits. It is ⁇ not appropriate to fix an arbitrary amount, but it will probably be necessary to objectivize this notion of "negligible value". The approximate value of 125 could, as mentioned during the committee work, serve as a benchmark as a basis for assessment. Another problem is that of manifestations of a purely scientific character. How can we evaluate the quality of the programmes of this type of demonstrations?

The bill conditioned demonstrations involving a night out to the prior obtaining of a visa. What will be the deadlines for submitting applications and issuing visas? Certainly, the establishment of these rules must still be the subject of discussions, both with the administration and with the sector, but it will be necessary to ensure that too compelling administrative steps do not unnecessarily burden the organization of these scientific events.

The creation of a contact point, which already exists, but in an unstructured way, to centralize information requests and complaints is, in any case, an excellent initiative for greater transparency.

In conclusion, Mr. Speaker, Mr. Minister, dear colleagues, we will support this project because it constitutes a real step forward for a voluntary drug policy, not by opposing the interests of the industry but to favor the general interest.

Mr. Speaker, Mr. Minister, colleagues, despite the annual increase of 4.5%, there are budget surpluses in healthcare every year. In October, new data from the RIZIV indicated an even greater excess than was initially ⁇ . Their

That’s why the federal government – as everyone may now know – together with the social partners and health care actors must look for additional savings. The recent savings note presented by the Minister to the various actors in the healthcare sector clearly shows which are the main excesses. I sum up the five most important: the medical fees 127.48 million euros, the RVT and ROB institutions and the CIJ’s 54.3 million euros, the MAF 58.43 million euros, medicines 335.1 million euros and hospitals 19.17 million euros.

These figures clearly show that almost half of the budget surplus comes from spending on medicines. The debate on affordable healthcare should not be limited to the medicines policy. If we want to stay within the annual growth of 4.5%, a number of structural measures will need to be taken in this area if we seriously address the exploding pharmaceutical budget.

The Sp.a is deeply concerned about the sharp increase in spending on medicines. Halfway 2003 it was more than 10% higher than the year before. In part — I see that the opposition is looking up — this was due to your predecessor Vandenbroucke, Mr. Minister. In 2002, he introduced a new — although necessary — procedure for the refund of medicinal products, which made the refund of innovative medicinal products much faster. That acceleration from more than 450 days to a maximum of 180 days caused a hit in 2003. However, this only partly explains the expenditure explosion. The Farmanet data shows that not only the cost of medicines, but also the use of medicines in Belgium continues to increase. Our country is absolutely not doing well in terms of, among other things, the use of antibiotics, benzodiazepines. An even more remarkable fact — the minister himself cited this in the draft law — is the following. A recent study by the American Consumer Association Public Citizen quantified the average cost of putting a new drug on the market and came to the conclusion that in 2002 the major pharmaceutical companies spent only 14.1% of their revenue on research and development and 30.08% on marketing and advertising.

Therefore, I am pleased that Minister Demotte has prepared a draft law in which he wants to address the waste of the promotion of medicines. The present bill is a first step in the right direction.

In any case, I think that it alone is not enough to counter the farmalobby. To begin with, there is an urgent need – as Ms. Avontroodt has also said – for transparency in, among other things, the pricing of medicines. In Belgium, the figures that companies actually spend on marketing are not yet known. If it turns out that, like in America in our country, an immense portion of the revenue goes to marketing – and that possibility is real – then I fear that addressing the discharge alone will not be enough. Influence at all levels should be avoided and more fundamental interventions will be needed.

We should not step into the fable of Mr. Neels, general director of the pharmaceutical industry Pharma.be, that the farmalobby will control itself. The aggressiveness with which the sellers approach the doctors and pharmacists has only grown. The industry’s assertion that they now have a deontological code and that we should leave it alone now is not valid. Also in the Committee on Repayment of Medicines, CTG, the industry has managed to be present during the vote on whether or not to approve a repayment file, which unfortunately often holds millions of euros. She, of course, may not blame, but she will see if the scientists in the committee vote for or against. By giving the industry the right to sit during the vote, it is assured of the easiest way to exert pressure. I know from my personal experience that the lobby is very strong here too.

I also advocate for a sound domestic regulation for the CTG. Anyone who holds shares of a pharmaceutical company and has a seat in the committee can today talk about files that concern the company. Professors who have done studies for a company’s drug are indeed well placed to provide information to the CTG, but I think they can’t thumb at that time. Medicines — and I’m becoming a little philosophical...

Mrs. Avontroodt, you want the word?

I look a little at what is all explained here on the speech floor. I think the contribution of the industry has its value and its knowledge in the CTG...

Certainly, but when it comes to the committee, I think that is another issue.

If I were an expert, I would rather see a number of experts present at the meeting. I remember that they only have an advisory voice. I would ⁇ not want to miss that expertise for such a committee.

That expertise is indeed necessary, but it can be done in two ways. What often happens now in practice in the CTG is that an hearing is held. That is, the expert, often from the industry itself, comes to give an explanation. He leaves the chamber at the time of the vote. However, some experts, Mr. Eeckhout for example – I don’t want to mention people with name and surname – are constantly present at the committee’s meeting.

This is a false signal to the other participants.

I will conclude a little philosophically. Medicines are not consumer goods like others. They are used only for a specific purpose and the user expects his medicine to be safe and effective. He also expects that as a layman he can trust that in full objectivity and independence he gets the best remedy for his condition. Their

Inadequate or excessive consumption of medicines is, in the long run, at least as harmful to the health of the patient as underconsumption. Their

Mr. Minister, as you will understand from my reasoning, the SPA supports the present bill. Since the work has not been completed, we hope that you will soon submit additional measures for the pending problems.

Colleagues, all registered speakers were given the word in the general discussion and I now give the word to the Minister for a brief presentation.

My answer will be brief. I had prepared a text, but I will not read it. I will immediately answer the exact questions of the various speakers.

A number of questions concerns the reduction. Article 2 prohibits the granting of premiums and benefits in cash and/or in kind. If the design is adopted, what will then happen to practices such as the discount, given, for example, by the wholesaler or pharmacist? Well, I can be very clear about this. The draft law is included in the Public Health Regulation. It amends three regulatory texts, namely on the medicines, the health professions and the practice of veterinary medicine. Their

Therefore, I repeat clearly that discounts belong to the economic sphere. Commercial practices are not affected by the current design. To be even clearer, the draft does not change the existing regulation for those practices.

I will give you another concrete example following the specific questions asked in particular by our colleague Mr. Goutry about holiday homes that benefited, for example, from opportunities to negotiate discounts. I take this example in particular to illustrate the fact that the general rule I have just defined is perfectly valid in all cases of figure that are addressed. Rest houses that have discounts at pharmacies retain the option to still negotiate these discounts. Even to echo jurisprudence, this also relies on a very recent judgment (25 June 2004) of the first instance court of Namur in a case that opposed a pharmacist and a rest house and which confirms "that no particular legal provision prohibits the granting by the pharmacist of restitutions. It would also be relevant to question the legality of a possible prohibition in the field of competition.” I think that is very clear. All the rules of reductions referred to therefore fall within the commercial domain.

For the other questions I could be very short given that these are the final questions. All the others were grouped in the answer I just made. I will not repeat what I said in committee on prostheses and medical equipment and which has already been mentioned by others on the tribune. However, I was asked the following question: "In terms of evaluation culture in the drug policy logic, beyond the issue of promotion that is today on the agenda, will you see what are the impacts of the measures taken previously and those you are taking at the moment?" We cannot drive a vehicle by only looking in the mirror. Therefore, we must take forward-looking measures but also evaluate the arrangements taken by my predecessors. This will be done in the framework of parliamentary work. I also count on you to remind me if the memory is missing.

That said, there remains a specific aspect that I find interesting: it is the question posed about the transparency of medicines’ prices. I don’t want to improvise in this extremely interesting area, but oh how complex. That is why I remind all those who have had the opportunity to touch on this subject of the transparency of the prices of medicines — and I see three among us: Ms. Detiège and Avontroodt and Mr. Detiège. Bultinck — which I entrusted to the "kenniscentrum", the Federal Centre of Expertise, a very precise task that should be echoed in the first half of 2005 and which is to clarify the methodological elements and databases that will allow us to advance in the question of the relative weight of scientific research, on the one hand, and the other constituent elements of the price of the drug, on the other.

I was also asked a question about a statement I made recently about moderator tickets. We are not here discussing the promotion of the drug, but I still want to answer.

It is clear that there are elements, especially cultural, that can influence the behavior not only of clients, patients, consumers that we are all but also prescribers. I am therefore ready to look for ways and means to respond to this situation with sanctions.

Let’s take the example of antibiotics that I talked about in my orientation. At some point, it may be necessary to make arrangements, through moderator tickets, to moderate the use of a number of antibiotics. This is one of the tips I put on the table. We'll see if she can withstand the contact test with healthcare actors that is scheduled to take place on the 23rd.

For the rest, I think I have addressed all the questions that have been raised. I recall that, in the first point I addressed, that is, the issue of reductions, I did not detail the reductions by category on the question of whether or not there are possibilities to maintain the current system. However, I would like to say that on a generic level, we are not concerned with economic law which remains governed by ad hoc rules.