Proposition 53K2005

Projet de loi portant des dispositions diverses urgentes en matière de santé.

General information ¶

Submitted by

PS | SP the Di Rupo government

Submission date

Jan. 18, 2012

Official page

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Status

Adopted

Requirement

Simple

Subjects

pharmacist medicinal product pharmaceutical expenses health costs prices price reduction price freeze public health

Voting ¶

Voted to adopt

CD&V Vooruit LE PS | SP Open Vld MR

Abstained from voting

Groen Ecolo ∉ N-VA LDD VB

Party dissidents ¶

• Bernard Clerfayt (MR) abstained from voting.
• Peter Luykx (CD&V) abstained from voting.
• Damien Thiéry (MR) abstained from voting.

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Discussion ¶

Feb. 2, 2012 | Plenary session (Chamber of representatives)

Full source

The rapporteurs, Mr. Van Grootenbrulle and Mrs Dierick, refer to the written report. Ms. Burgeon will deliver an oral report for the complementary report of today’s meeting.

Much has been said about this bill in the committee. I will limit myself to the discussion of our amendment and will make a few concerns.

It is a very good thing that price comparisons are carried out with the surrounding countries of the medicines that are still in patent. We would like to extend that to medicines that are already off patent. All medicines, both original and generic, should be treated in the same way. My friends of the SPAA probably think so, because I have heard from colleague Detiège that we should not make the mistake of walking different paths for patented and generic medicines. I look forward to the SP’s response to this amendment.

As for compulsory substitution, we have already talked about this in the committee. I believe that the amendment submitted by the majority represents an improvement of what is ahead. The therapeutic freedom of the doctor is further recognized. If the doctor in honour and conscience decides that there are therapeutic reasons not to allow substitution, then the doctor should have the freedom to do so.

I have concerns about the modular price reduction of 1.95 %. Manufacturers can modulate that price reduction of 1.95 % across their entire product range. This could lead to distortion of competition for generics. If certain companies would increase the percentage of certain medicines significantly, the generic medicines would get unfair competition. In this provision, therefore, the price of the original and the generic medicinal product is disconnected, but in practice it will appear that the generic medicinal product will always have to continue to follow the price of the original, because one cannot afford that a generic medicinal product is more expensive than the original.

This week there was a meeting of the Public Health Committee. An amendment to Article 10 has been added to this bill. The National Medico-Mutualist Commission reached an agreement on alternative measures to control spending in the pharmaceutical sector on 30 January. It thus proposed to nuance the principle of substitution by introducing the possibility, for the prescriber, to invoke a therapeutic objection. This objection must, of course, be based on serious reasons. The validity of the therapeutic objection may be checked by the INAMI Medical Evaluation and Control Service and by the counseling doctor.

In order for the King to extend the application of the substitution to other classes of medicinal products other than those referred to in Article 11, the opinion of the National Medical-Mutualist Commission shall be requested in addition to the opinion of the Commission for the medicinal products already requested.

by Mr. Bacquelaine is co-author of the amendment and indicated what I just said to you. There was a discussion. by Mr. Thiéry said in the first time pleasantly surprised by the willingness shown by the minister to guarantee the coordination with the sector. However, he had to temper this enthusiasm in that he had received a letter from ABSyM and Pharma.be in which these two actors said they were opposed to the bill, in addition to the fact that they were not consulted. However, consultation must take place. The national medical-mutualist commission does not appear to have managed to forge a concerted solution within it.

If Ms. Snoy also stops at the above-mentioned emails, it is rather to complain that these actors, through a lobbying activity, try to make changes to measures in a direction that is favorable to them. The speaker recalls being in favor of the principle of substitution and a regulation by the authority of prescription behavior. The limits described by Article 10 as initially adopted in a committee seem reasonable to him. This communication not only deals with replacement but also other related issues, such as volume measurements and proton pump inhibitors. What are the measures envisaged in this context by the Minister? The interviewer opposes the 3° of the amendment No. 1 because the capacity of public regulation is abandoned. It asks whether the omission of the word "general", in respect of the intended substitutions, is voluntary.

Ms Fonck rejects the criticism that the government would fold in front of lobbies. In fact, it recalls the main elements of the discussion in the committee and in particular the balance found between the need for substitution and therapeutic freedom. This balance is essential for patients, pharmacists, doctors and the state. The Minister has engaged in a new discussion within the National Medical-Mutualist Commission.

Ms. Deiège submits to the observations of the preopinant. The Minister was listening to the actors within the National Medical-Mutualist Commission. Replacement is necessary, even if it needs to be framed. The letter cited by the first two members was sent before the Commission reached an agreement, demonstrating that the letter had no influence on that agreement.

Ms. De Bont draws attention to the fact that the letter of the two actors does not concern the amendment itself, but the very principle of substitution. The amendment, which surrounds this guarantee faculty, seems to him to constitute an advance over the text initially adopted in the committee.

During the initial discussion, in a committee, the minister had made a distinction between the situation where an agreement is reached in the National Medico-Mutualist Commission and the one where no agreement is reached. To what extent will the different elements of this agreement be taken into account? What are the interesting elements?

Ms. Lambert recalls the approach taken, namely the search for the membership of the largest number, including prescribing doctors. The approach is different from a mere savings measure taken without the consent of these doctors. Once the substitution is marked and adopted, it will still be necessary to evaluate its application and to punish those who refuse it for unacceptable reasons.

by Mr. Beuselinck supports the amendment that improves the replacement system established by Article 10. If an obstacle of a therapeutic nature opposes it, the doctor should not implement it. Nevertheless, the speaker persists in advocating incentives for better prescription. He pledges for a swift adoption of the bill amending the law on compulsory health care insurance and compensation, coordinated on 14 July 1994 with regard to the sale of cheap medicines, which he deposited with other members.

Onkelinx would not want members to confuse the subject of the amendment, which concerns the modalities of replacement following a proposal from the National Medico-Mutualist Commission, and the alternatives sought to the economic measures, also discussed in the committee. The letter cited by the members does not concern the amendment, but the second subject. Alternatives will be operational as soon as possible in 2013. A consensual basis will be sought.

The substitution faculty, as framed, does not follow the pressures of a lobby. As the Minister has already stated during the first discussion, this faculty is necessary and will be implemented in consultation with the sector. The amendment aims to take into account the concern expressed by the National Medico-Mutualist Commission, namely that a derogation should be organised in the event that therapeutic objections persist. This exemption does not constitute a white-seing. Limits are stated.

The doctor who wishes to avoid replacement must indicate this in the prescription. However, the pharmacist who receives such a prescription must mention the refusal to replace in the Pharmanet software. Inami will thus have statistics of rejection percentages for all providers.

Article 73 of the Law on Compulsory Health Care Insurance and Compensation, coordinated on 14 July 1994, provides INAMI with a prescription control tool on the basis of which outlayers, doctors whose prescription behavior deviates from a standard, will be highlighted and brought to justify themselves before the Profile Commission.

Recommendations will also be sent to doctors. Controls will begin after six months of the new rules.

As regards point 3, the Minister confirms that the omission of the word "general" is voluntary. The term "general substitution" is not used anywhere in the Law on Compulsory Healthcare and Indemnity Insurance, coordinated on 14 July 1994. by Mr. Bacquelaine confirms this last assertion. Non-generic medicines have sometimes experienced very serious price drops.

by Mr. Thiéry would have wanted a precise definition of the serious reasons allowing for a derogation from the principle of compulsory substitution, in particular since the prescription in international common denomination also implies such a substitution.

Ms. Snoy supports the Minister’s willingness to carry out a consultation. However, it ⁇ ins that the solution is the result of an undue influence exercised by the pharmaceutical and medical sectors.

The results of the votes were as follows. The amendment was adopted by 15 votes against 1. Article 10 as amended was adopted by 10 votes and 6 abstentions. The entire amended bill was adopted by 10 votes and 6 abstentions.

We have already discussed the amendment in the committee. I already gave my explanation then, but now that you start again, I would like to explain the opinion of sp.a. here too.

It is really important that we have cheaper medicines in our country, and if possible, as cheap as possible. That is why our party will always encourage generics. Those products should be placed on the market as efficiently as possible, at the lowest possible prices.

I tried in the committee to explain how it works in our country today. Remuneration of medicines takes place at RIZIV level in the Committee for Remuneration of Medicines (CTG) according to a specified procedure.

Within the sector there was a discussion at the time how we could ensure that when new products come on the market, they could be refunded as soon as possible. Therefore, a number of years ago, it was decided to market two groups of medicines: original medicines and generic medicines.

The original medicines follow the usual procedure. This means that international comparisons take place and that the quality is weighed. This is an extremely long procedure. Generics follow an accelerated procedure. This is logical because they are produced without patents.

I then warned that committee to give more work because this could cause a delay in the marketing of generics. Then there will be less competition, which keeps the prices of the originals high. In order to keep the market healthy, it is important that the accelerated procedure remains accelerated. If you charge the commission with extra work, you create a problem.

I find it very dangerous to say that prices must always be compared. Belgium can market more expensive medicines than others, but bear in mind that they do not compare apples with pears. It is quite possible that for a particular condition the refund in Spain is much wider than the refund in Belgium, thus the price setting is done in a different way.

On the RIZIV level, by the way, for years there has been a commission that does nothing but price comparisons, but then cluster-based. This means that both the price of the originals and that of the generics is considered in group. Examples are proton pump inhibitors and cholesterol reducers. For this purpose, it is considered group-by-group at what price these medicines can be placed on the market optimally.

I repeat that for these reasons we will not approve the amendment. The reasons are, first, that it is necessary to ensure that the market is ⁇ ined healthy and that the generic medicinal products are promptly placed on the market. Second, the prices must be seriously compared, as is already the case with the cluster-based revision.

Mr. Speaker, I would like to remind you that the survival of our health care model, whose goal is equality in accessibility and quality of care, depends on the responses that the government is capable of giving today, in the context of budgetary weakening we know.

Therefore, my group clearly intends to support and encourage voluntary prescription made in international common denomination, but also supports and encourages substitution. In addition to allowing health insurance to make savings, it produces a positive impact on the patient portfolio.

This must be accompanied by good information. Some patients fear that they will be forced to change their treatment; some prescribers fear that their therapeutic freedom will no longer be respected. The intentions expressed in this project are obviously not at all those.

Also, my group will ensure that this positive measure – I am convinced of it – is nevertheless well understood and accepted by all.

Mr. Speaker, Mrs. Minister, colleagues, our party is satisfied with what is on the table today. These are good, balanced proposals, which are also in line with what was agreed on the subject in the government agreement.

The mission is big. 180 million euros were needed. You have achieved this in a fairly balanced way for both the brand medicines and for the generic medicines. The amendments we approved last week have once again confirmed the importance of keeping the balance.

Referring to the statements of Mr Beuselinck and Mrs Detiège, I must admit that I also have problems with certain matters. For example, I think of the generic PPIs, which make up 80 % of the market, although they are clearly much more expensive than in our neighboring countries. Well, I think they should be included in certain systems and also lower in price. The aim should be to make the patient pay as little as possible. Through the balance in the measures, we also succeed in this.

We are also in favor of making such price comparisons. Therefore, Mrs. Minister, I hope that you will also consult with the sector on this subject in addition to the obligation to communicate, as you promised. I have my connections on the field. It is a measure that is experienced by many people, including the doctors, in a very positive way.

You also know — and it is no secret — that my party has been in favour of the regulation on the name of substances for twenty years, even in the case of substitutions. In that sense, we were very pleasantly surprised at what the texts said about antibiotics and antimycotics, in particular that we could implement the corresponding measures. We have also been able to establish the communication of doctors on this subject in recent days. The amendment that is presented now is a pity. After all, it is partly a return to, which does not mean that we would be against the therapeutic freedom of the doctor. Mrs. Minister, with the original proposal, doctors were allowed to decide which ingredients, which doses and which method of administration they would prescribe. There were even possible exceptions in terms of side effects and allergies.

I have noticed that the amendment adds to it the therapeutic objection, with which we have no problem in itself, although I hope that it is used in the correct way.

Just then, in the committee meeting, you said that it is intended to check it through profiles and the like. You would also be bound by sanctions, and that is necessary. I would not like to see that this becomes the backdoor in which a good measure does not sort out the effect. I support you in this, but I also hope that you will perform the control efficiently. I hope you succeed in finding the resources, because the task will be difficult.

The amendment that we adopted this afternoon in the Health Committee represents a real improvement of the project that is being proposed to us. This makes it possible to reconcile the budgetary objective, which we obviously endorse, and a fundamental principle of medical practice, which is the notion of freedom of prescription.

Of course, we grant the possibility of exercising the right of substitution in the delivery of medicines – antibiotics and antimycotic – but within certain limits. This includes acute treatments. The original text provided only one exception, namely allergy. This seemed to me frankly insufficient. Any other interpretation is inaccurate. The new version introduces the exception of therapeutic objection clearly demonstrated by the doctor and ⁇ in the patient’s medical record.

We therefore remain in compliance with the principle of prescription freedom while respecting the budgetary objective. Ultimately, the patient’s interests are fully preserved. This is a significant improvement in the project that was presented to us.

I would like to conclude by rejoicing that this proceeds from a medical-mutualist consultation. That means that this system has worked again. Therefore, I welcome this reinforcement of the concertation.

Mr. Speaker, I would like to justify the position of our group, which will abstain when voting on this draft submitted by the majority and the government. Even though we agree with the budget objective of reducing the cost of medicines for INAMI and for the Health Budget, we feel that this project does not go far enough and does not provide the means for its objectives. In fact, the regulation of the volumes of medicines and the regulation of prices are not guaranteed. We would have hoped that this project also addresses the issue of the amount of medicines sold and the reduction of doses in the boxes so as to make savings on that side as well. This was stated in the committee last week.

With regard to today’s amendment, Ms. Burgeon explained well the reasons for our opposition. The Minister, saying that she would have to establish a very heavy prescription control, convinced me that we were right to regret this amendment because it will weaken the means of achieving the aim pursued.

We will abstain.

Mr. Speaker, Ms. Snoy indeed said in the committee that there was lobbying work from various sides.

Last week, however, we had a serious debate in the committee on how we could improve something. The Minister then replied that consultations would be undertaken with the Committee of Doctors-Hospital Funds. In my view, this is a recognised body, which brings very good comments. That is why I find the amendment presented today even good; it adds value to the whole discussion on substitution.

I do not follow Mrs. Molly at all on this subject. She has been in favour of substitution for twenty years. Unfortunately, I’ve been graduating for the same time and, as I remember, it was always about substitution, yes or no. It is good that we have dared to put the debate on the agenda today. Even better is that we take into account legitimate comments. Suppose a doctor really has a therapeutic objection, which can be for several reasons. I have seen patients who really needed a placebo effect. So a lady came every week for vermox pills, which I thought she could not have worms for years. But the doctor said she really needed those pills. One must take into account the opinion of a doctor in a particular file.

I may give a funny example, but it is about the essence: a doctor should always be able to weigh what he does with patient A or B. You may have questions about the justification of the reasons. Well, there is protection provided. A doctor can indeed make the choice not to enter the system of substitution and thus consistently prescribe the more expensive medication. Well, there is the patient file. The Minister has given us the guarantee that one must provide thorough reasons why there is a therapeutic objection to deliver the cheaper medicine. The RIZIV can request that for control. If it identifies derogations, it may even impose sanctions under Article 703.

I do not see the problem. There will be, for all certainty, an evaluation to see if there may be doctors bypassing the present proposal. We have already received the guarantee from the Minister that it will effectively apply the sanctions.

We had a long discussion in the committee last week. I had widely mentioned the fact that the text damaged the non-respect in terms of therapeutic freedom. Therefore, I would like to emphasize the opening of the Minister. Indeed, from this committee, Mrs. Minister, you had agreed to discuss this point in Médico-mut.

Dear colleagues, let us acknowledge that health actors have taken their responsibilities. They have reached a consensus on this issue. It is important.

With today’s amendment, there is a real added value, both on the freedom of therapy and on the respect of this freedom of therapy, also on the responsibility of the doctor as the prescriber. Avoid entering a system that would oppose pharmacists and doctors, which would be the worst in a system where all health actors each play their role.

Last but not least, this amendment also brings added value for patients, just because the text thus fits much better with the Patient Rights Act.