Proposition 51K2377

Projet de loi réformant les cotisations sur le chiffre d'affaires des spécialités pharmaceutiques remboursables.

General information ¶

Submitted by

PS | SP MR Open Vld Vooruit Purple Ⅰ

Submission date

March 28, 2006

Official page

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Status

Adopted

Requirement

Simple

Subjects

pharmaceutical industry medicinal product pharmaceutical expenses quasi-fiscal charge public health health insurance

Voting ¶

Voted to adopt

Vooruit Ecolo PS | SP Open Vld MR FN VB

Abstained from voting

CD&V LE N-VA

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Discussion ¶

May 11, 2006 | Plenary session (Chamber of representatives)

Full source

On behalf of the Committee on Public Health, Environment and Social Renewal and on behalf of Mr Bacquelaine, I am presenting a report on the draft law reforming the taxes on the turnover of reimbursable pharmaceutical specialities.

In his presentation, Mr Demotte, Minister of Social Affairs and Public Health, acknowledges that the pharmaceutical industry has contributed to the financing of social security since 1995 through the payment of taxes on the turnover rate of the reimbursable pharmaceutical specialties.

These fees were originally intended as solidarity contributions, but due to the excesses of the pharmaceutical budget they have become a scheme of co-sponsabilization. Together they account for more than 10% of the budget.

This, however, is a heavy burden for companies and therefore the government has switched to a less linear system in which certain pharmaceutical specialties are no longer taken into account in the calculation of the turnover rate. These include the orphan medicines (these are medicines for rare diseases), the medicines of category Cx and the medicines based on blood derivatives.

What should companies do for this? They get reduced burden when they invest in scientific research and in the development of new specialties. It was also thought of the small enterprises that mainly research and distribute generics and non-patented medicines.

There is also a 5% reduction in fees if they reduce their advertising spending by 25% compared to the previous fiscal year.

At the general discussion, Mrs Avontroodt of the VLD is very pleased with this design and especially with the fact that the orphan medicines are also taken into account. However, she would have preferred that further work was done and that the patients and the associations that represent them would also have a voice. It also asks whether the growth hormones also belong to the category of medicinal products based on blood derivatives.

Mr. Luc Goutry of CD&V is the only one who is not happy with this design. He asks if the industry will not recover the imposed duties in another way. Mr. Bultinck of the Flemish Belang, Mrs. Detiège of sp.a, Mrs. De Block and myself are satisfied with this design.

Daniel Bacquelaine, co-rapporteur, would also go further in this draft and considers that small enterprises can make an important contribution here. A lot has been achieved in the field of biotechnology. He is therefore wondering whether there would be no further reduction of the taxes for those companies that will also establish themselves in Belgium.

There were some colleagues who questioned whether this is correct and whether this is not illegal state aid. The Minister could assure us that the European Commission has given its fiat and that the conditions for state aid are not at all fulfilled. Their

In the vote, Articles 1 to 6 were adopted with 9 votes in favor of 1 abstinence by CD&V. The entire bill was adopted with 9 votes in favour against 1 abstinence by CD&V. Their

Mr. Speaker, that was my report, if you allow me to give another brief interpretation on behalf of my group. Their

The VLD will support this bill because it has the merit of promoting scientific research in Belgium and will also benefit small enterprises. After all, we must not forget that our country consists of a lot of highly educated scientists. We want to keep those highly educated people here in the pharmaceutical companies. Their

It is positive that some items have been withdrawn from the basis on which the tax is made. First of all, I think of the orphan medicines. This is an additional incentive for companies to develop and produce orphan medicines. Their

Finally, it has been realized that new and often expensive medicines can also generate savings in other branches of health care, namely a reduction of hospitalization and the avoidance of medical interventions. Per ⁇ the Knowledge Centre should also pay more attention to this. Their

The small ⁇ were also not forgotten. It is very important that they receive a fee reduction when they support scientific research. However, it is also important that their economic position can be improved. Their

In summary, this tax modulation is the missing piece in the policy to still offer the pharmaceutical companies some perspective in Belgium despite the taxes that are required from them. This is an important contribution to the knowledge economy. It is the first time in years that Belgium has taken positive measures to keep the pharmaceutical industry in Belgium.

Mr. Goutry bites the spike, then Mrs. Burgeon and Mrs. Avontroodt.

Mr. Speaker, Mr. Ministers, Mr. Colleagues, I do not understand two things well in Mrs. Dierickx’s presentation.

First, as far as the report is concerned, she says that I was the only one who was not happy with it. That would surprise me. I will later explain why I am surprised.

Second, for all clarity, not only I, but my whole group will not approve your bill later, Mr. Minister. We will remember. We think we have good reasons to do so.

Colleagues, Ms. Dierickx concluded with the judgment that this is at least once something with which the pharmaceutical industry in our country will be satisfied and about which she will say that this is once an effort of the Belgian state in front of the pharmaceutical industry. Colleagues, I do not understand that well, because what you will approve here later are taxes, taxes on the turnover of the pharmaceutical companies.

You think the pharmaceutical companies approve of this. You think that they will welcome this and say that this is at least another effort by the Belgian government in the face of the pharmaceutical companies by setting rounded 10% taxes on their turnover. Well, colleagues of the VLD, it is not more than this afternoon that we have been in contact with representatives of the pharmaceutical industry. Those people are not at all happy with the taxes that under this purple majority rise hand in hand in the face of the pharmaceutical industry. On the contrary, they say that they can hardly sell to their multinational parent houses that in a country like Belgium is constantly taxed on the turnover that is achieved. They have said it. They did not wish us congratulations. However, we have no problem. We have said that we do not agree at all and we are in principle opposed to taxes and taxes on the turnover of companies which thus hinder their growth.

Colleagues, what is the truth of the story? We have been struggling for years with our pharmaceutical budget that goes red and grows too fast. We cannot control it because we have no sight of it. We only know half and a half what we spend money on. There is no need study. The Knowledge Centre is now working on this, but we have no clear indications. We cannot control this budget. There is an optimization from the industry, from the market. They offer and we follow. We continue to follow. We continue to approve files. We continue to repay until we suddenly find out that we are overwhelmed and have shortages in the health insurance.

We simply have no vision on that matter. What do we then do? We start taxing linearly. If we do not know what is the cause of the excess, then it is the same for everyone, for the good, for the bad and for everyone. There is a percentage tax on sales. They have to give it back to us and for the rest they have to draw their plans.

Well, that is, of course, a totally wrong signal, ladies and gentlemen colleagues, because the companies are already calculating those taxes. They already know in advance how much tax they will have to pay. Like every good merchant and shopkeeper, they account for those taxes in their budget. For them, therefore, in a way of speaking, of course, it remains a kind of zero operation, even if there is a very bad picture on it. That does not give a good impression, which ⁇ does not give the impression that we are creating a good investment climate for the industry here.

We would be able to do so if – and that’s what the design opens a small door for – we start working not linearly but punctually. The design says that those who do R&D here, to R&D, the companies that invest here in innovation will be taxed less than the rest. That is actually what is stated in the draft and what probably inspired the rapporteur to say that one finds the right design because now finally something is being done. We will reduce taxes on companies that innovate with us and invest in research. This, however, is still on the negative side, but it is taxed less.

Colleagues, one can try to sell it to whoever one wants, but not to me or to our group. We have always said that we do not support such a policy. If one wants to do health policy, one must start from the needs. It is necessary to determine what is needed and even organize public procurement.

That’s not the way you want to do it, Mrs. Detiège. These are not public procurement, they are market surveys. That is something very different. There is a long question about whether they could not let their prices down a little. No, public procurement must be organised objectively, well supported by law and in accordance with European regulations so that the product is awarded to the cheapest provider on the market. This should be done on the basis of needs research and entered into a volume-price contract. If one offers the product at a certain price, according to the need study, a certain turnover must be guaranteed. This can be taken from the figures. This can be seen in the prevalence of the conditions for which those medications are needed. Ladies and gentlemen, for the clarity...

Per ⁇ you feel too hot? I see that you are staying. I don’t know if you are wiping yourself away or if you are making a throw-off bear in my direction. It would then be better that you come here later to defend why you as VLD tax the companies and tax the pharmaceutical...

Mr. Goutry, you are challenging something. You wanted her to intervene and now it’s over.

I see in Mr. Goutry that he would like to get some weather from the public to get a little breath. You say what you want and I do with my hand what I want.

You say that you are against taxes and that you therefore do not want a reduction in taxes. I don’t understand you, there’s a missing link somewhere. You can continue with your explanation, maybe I will find out.

I would also like to say something about the linear price drops. I am a little surprised, as in practice the companies have proposed punctual price drops and prices fall immensely. That is more than 50% in some cases. For example, I think of Zantac, for which — I don’t know from the outside — a price drop was around 80%. Thus, by the fact that the government takes initiatives, there are actually price drops.

You say on the one hand that we need to take action and on the other hand that it is not good. I really wonder what policy you want. For example, the kiwi model, which is also an enormous good initiative, is always cut off by you, while in practice we see that the companies are already ready to participate. So I really start to ask questions about the direction CD&V wants to go in this way.

Mr. Goutry, you have made the Room very alert.

Mr. Goutry, you are against the taxes. Of course, we are all in favor of paying as little taxes as possible. However, you cannot deny that a uniform system is now being introduced here in the taxation of the pharmaceutical companies.

What a mess it was before! At least the companies now know what they stand for. Previously, 2% was charged according to the claw-back system. Companies did not know in advance what taxes they would pay. Now at least there is clarity.

The most important are the investments in research in Belgium, which are linked to the fees. We can now keep the scientists here. There will be less or even no more braindrain. The scientists will come to Belgium thanks to the bill. You cannot deny that.

We also do not forget about small ⁇ . This is also very important.

Colleagues, you have heard it. VLD’s main argument is that companies are taxed and taxed, but that they now at least know how much they will be taxed. They knew this before, but the tax was indeed more blatant. Now they know it, but they’re being tainted. That is the argument.

We think that is the wrong policy. First you let the soup overcook and then you clean up. You’d better look at what is needed for medicines in advance, how much is needed, what type and at what price they are needed, and how they can be included in the budget. That way, you let the companies do and encourage them to innovate. Now they are punished linearly, just because they are a pharmaceutical company, tout court. If they fall under the pharmaceutical companies, they are taxed through a tax. The companies that work well are taxed just as much and in exactly the same way as the pot digesters. It is a linear measure that is not stimulating at all.

Mrs Dierickx, I assume that you also have contacts with representatives of the pharmaceutical industry. Ask them what they think about the bill that comes here this afternoon. Fortunately, they are pleased that the innovative companies can save the furniture even a little bit by providing in a negative design in something less and somewhat weakening the taxes for companies that innovate and do research.

This is not a way of conducting policy. That is to let happen what happens and if there is a shortage, recover it afterwards. In this way we will never get there. Mrs. Detiège, for all clarity, on the kiwire regulation we could set up another tree. However, if measures are to be taken — you have said it yourself, colleagues — do you think it is normal for companies to suddenly lower the price of certain medicines by 80%? We are standing to watch. Now we are starting to squeeze the prices a little bit and we notice that they can fall by 80%. Well, in that case, we should have been conducting such a policy for a long time. We had to work with a price policy and a volume policy. We should not have worked with taxes.

Furthermore, colleagues, can I submit another authoritative argument, namely the report of the Court of Auditors? We discussed it in the committee. The Court of Auditors has bowed over the system of taxes on the pharmaceutical companies. The report is quite destructive. The Court of Auditors mainly addresses three points.

First, it is a technique that is entirely linear and thus does not diversify or reward.

Second, the Court of Auditors states that the government is not even clear about whether it is imposing the right taxes on companies. Sales figures are manipulable. Therefore, it is possible that certain companies are under-taxed and other companies are over-taxed.

Colleagues, you have, of course, read it all; it is literally stated in the report of the Court of Auditors, which we have received on this subject.

If these are not authoritative arguments, what should we then bring to this House, Mr. President? I ask myself. Their

We can continue to polemize, but I read everywhere in the newspapers that there is a huge distrust between the coalition partners. It is no longer in the majority: they can no longer make decisions together. Mr. Bonte says this week: “The VLD is unreliable. We cannot continue with it anymore.” I feel it on all sides. How else to explain, colleagues, that we are discussing this week in the committee the establishment of the Agency for Medicines, the royal income for the medicine policy in our country. We discuss that in the committee and there are not even colleagues from other parties, a few small presentations not to mention from members who find it difficult to keep a serious discussion about it. Their

We have been discussing the Food Agency in the committee weeks ago. I call Mr. Bultinck as a witness: it was approved this week at ten minutes and we talked about it for an hour. That is much less long than the resolution on dementia that is just a resolution and, by the way, will lead to nothing. About a bill that will appear in the Staatsblatt and that has such great consequences, we have hoped and discussed it for an hour. One is movingly disagreeing with one another, one has a duty of silence — so much is clear — and in this way no policy can be conducted anymore.

Mr. Goutry, you were absent in the afternoon. You have not even voted. Most of the discussion was absent.

Yes, that is true. I am pleased that the Pope is still unanimous. I get the signal here that purple is disintegrating. I think these are indeed frustrations of exceptional MPs who express their feelings. I also discovered in the committee that we are still on the same wavelength. Their

Indeed, Mr. Goutry was absent from the article-specific discussion of the Medicines Agency. Minister Demotte has very clearly stated what the Medicines Agency stands for. The strength lines are very explicitly explained and we all stand behind them. We will wait for its completion, including personnel policy and whether there will be reinforcements. All comments were made. Their

In terms of ideology, we must absolutely support this. Almost all European countries already have such a well-functioning agency. Belgium can only support this. I am very sorry that you with CD&V say to be suspicious and not to participate. This trend has been ⁇ ined in our committee for a long time.

Colleagues, can I be a little intimate? Can this be in this room? Then I may be able to tell you the following, Mrs. Detiège.

The agency that will come — that’s why you were so silent this week — is actually a duplicate of what exists now. It is an administration consisting of three general directors of Public Health. This is doubled. This is done with the same money, as the Minister told us this week. But there is a general administrator on Public Health that one would rather get away from there. And one has already someone else in place, it seems that it will be someone of sp.a. This is one of the major actions that must be done now in this coalition. That is why this coalition stands together. Someone from the S.P. should become the big boss of the agency. Per ⁇ Mrs. Detiège is a candidate? That could be because she is a very ardent defender.

Colleagues, if we continue to speak with each other at that level, then this is the Chamber unworthy. Sorry, but from your side, I do not hear any other arguments than those. I hear no substantial argument against our assertion that it has no point at all to pursue a defensive drug policy, to always only follow the facts, and then to play a kind of schoolmaster by punishing the companies subsequently by means of taxes, because one is unable to clear in advance what one needs to do price setting, to make volume restrictions, such that one can control that sector, like other sectors. One has completely released the trappers, one has released the rope, one has lost that sector and can now only begin to determine taxes afterwards. That is your responsibility. I am very pleased that I do not have to approve of such things. It will only reinforce the bad image that exists about our country. We have already seen this in today’s rankings, where we are now sliding down in terms of investment attractiveness, in terms of socio-economic position. We are currently in the twenty-seventh place. We are always going backwards. And that happens under purple. It would finally change with the liberals in the government. Well, colleagues, the balance sheet of your policies will, at least as far as I am concerned, ⁇ not be formidable.

Finally, Mr. Minister, you know my position. If one wants to responsabilise companies, it should not be done by tackling them all. This is not a responsibility, but a solidarity. Then it is simply said that what is lacking is solidarily demanded back, from everyone, through taxes. In this way, there is no responsibility. However, responsibility is the motto in healthcare. If we ever want to gain control over the expenditure of the health services, it will have to be done by allowing everyone, each in his own place, to take responsibility. Not taxing is the answer, but responsibility.

Mr. Speaker, Mr. Minister, dear colleagues, the turnover made by pharmaceutical companies on reimbursable specialties is largely due to health insurance.

While it is fully justified to ask these companies for a contribution according to the principle of co-responsibility, it now appears that it is desirable to refine the system in a less linear manner since the total amount of contributions is 10%. Following this important bill, the effort of solidarity is distributed according to several factors.

The first of these factors concerns certain specific groups of specialties due to their production costs or reduced INAMI intervention. This is the case for medicines for orphan diseases: medicines intended for the treatment of diseases so rare that promoters are unwilling to develop them under normal marketing conditions. The process ranging from the discovery of a new molecule to its commercialization is long (average ten years), costly (tens of millions of euros) and very random since out of ten molecules tested, only one may have a therapeutic effect. Developing a drug for the treatment of a rare disease does not always allow, as it is now, to recover the capital invested in its research. For a long time, these diseases were ignored by doctors, researchers and politicians.

I dare hope that this measure will be able to encourage research for the greatest benefit of people affected by Huntington’s disease, Crohn’s disease, Kaposi’s sarcoma, spiral amiotrophy, or other serious, chronic, evolutionary diseases where life prognosis is often at stake. Spectacular progress has already been made for certain diseases, showing that we must not lower our arms but, on the contrary, continue and intensify the effort of research and social solidarity. by Mr. Goutry may hear what I am going to say to him. Families who have a child suffering from such a rare disease hope that the researchers will engage in the research. Believe me: Whether there are 500, 5,000 or 500,000 people sick, the family whose child is affected by a rare disease hopes that we can deal with this disease. This is very important.

A second determining factor of the project is to reduce the burden for pharmaceutical companies that make significant investments in scientific research and the development of new specialties. We will never say enough about the importance of the research process in the pharmaceutical sector. This investment in health should not lose sight, however, that the main component of a medicine is undoubtedly in its human value because it relies on patience, creativity and the collaboration of multidisciplinary teams. In this regard, an appropriate scheme for small enterprises is essential.

Finally, the last important factor of the project, the encouragement for companies to reduce sometimes unjustifiable expenses in terms of promotion, advertising and marketing. The Act of 16 December 2004 on combating excessive promotion of medicinal products was already an important step forward in combating certain practices deemed unethical by certain pharmaceutical firms.

They are supported here by a new incentive tool for those who comply with the regulatory framework and change their behavior.

Mr. Speaker, Mr. Minister, Dear colleagues, it is therefore very favourable that our group considers this amendment that complements the regulation on contributions on the turnover of pharmaceutical companies. Indeed, we believe that it is capable of stimulating research and promoting employment in this future sector.

I thank you for your attention.

Mr. Speaker, Mr. Minister, Ladies and Gentlemen, much has already been said. My colleague, Mrs Dierickx, has put emphasis. Their

Mr. Goutry, I really listened very well. However, I would also like to ask for a little intellectual honesty. We are not a party asking for taxes, never. We are a demanding party for stability, certainty and predictability for companies and the industry, but especially for patients. I came up with that because I have hardly heard the word patient fall here.

You said that these taxes will be included in the prices anyway. Well, I think this is not so. What is possible with this design, with these measures?

This is the case with the taxi Busquin. I think you, or your party, were in the cockpit when the busquin tax was introduced. Right or not right? So it is a principle that is not new, and it has something to do with the fact that those conversion taxes and the taxes on the pharmaceutical industry were introduced, at least with the consent of your party.

What can this design remedy? First, it provides certainty, the certainty of tax cuts, linked to employment, research and innovation.

Are we asking for more conversion taxes? Of course not. We are not a requesting party for this. With the accompanying, flankering measures taken by this government, we realize the responsibility of the providers, the encouragement and awareness of correct prescribing – regarding evidence-based prescribing – and it supports the struggle against the “me-too” coupled with the struggle for true innovation and genuine scientific research. Their

And yes, — Mr. Minister, you said it — the budget is not yet fully under control. However, I would not dare to say that you, Mr. Goutry, nor Mr. Demotte, will be able to keep it completely under control and predictable. I mean not, precisely because of the fact that the evolution of science and technology, the explosion of everything that is biotechnological development – for which we are; and for which, by the way, the Flemish government also works; and for which stimulating measures are also taken in the Wallish government; and what we as a country can put in the showcase – is an evolution that fortunately takes place worldwide.

I ⁇ ’t want to approach it so negatively.

What I am concerned about is the availability of new medicines and the availability of the right latest medicines for even the rare diseases. The text provides a first step for the branch modulation of the orphan medicines. Mr. Minister, you know that I find it a still too modest initiative, but I am already pleased that there is a provision in it. It is ⁇ not enough. Therefore, by the way, there is a proposal on the orphan drugs; the orphan drugs, submitted in the committee, which we still have to discuss.

This is one of our priorities, it is the path that we must follow. I hope that the stability and the pax pharmaceutica, which has been created, will have a more lasting effect than the ever-changing conversion rates and measures that change year after year.

In this context, our group approves the law on tax modulation.

Do you still want to intervene?

Welcome to you, Mr. President! Some of the things that have been said seemed to me both interesting and paradoxical.

by Mr. Goutry said, in particular, that we have a relatively anarchic budget, because it evolves uncontrollably. In this regard, Ms Avontroodt reacted by saying that it was not possible or desirable to impose standards on this budget, because it is the mobile product of constant innovation: new products arrive on the market and must, in principle, replace old products on the same market.

Mr. Speaker, when we make savings in the field of medicine, we should rather talk about recycling measures. In fact, the goal is to raise financial resources by removing some extra costs related to old medicines, to repay new molecules. Whenever these molecules are funded by the money of health insurance or the money of citizens — we are obviously aware that not everything is covered by health insurance — we want to make sure that these new products will have an affirmed therapeutic value.

We are therefore attentive to me-too’s, copycats, all these allegedly innovative products, sometimes still in the testing phase. We have also given specialized agencies a mandate to identify them and tell us if they are really innovative medicines or rather false innovative medicines.

For the true innovators, those who bring this obvious therapeutic value, we provide significant financial resources. I think in particular of recent debates that have taken place, in particular on Ercetubix (treatment of colon cancer) and on Herceptin (treatment of cancer with HER2 type receptor). These are important financial resources that amount to several tens of thousands of euros! As for Ercetubix, we are talking about 40,000 euros per year per patient. We would have been unable to pay them if we had not consented to these efforts!

Recognition of the innovative value of the pharmaceutical industry is not an element in contradiction with a number of measures taken. This is a complementary element: on the one hand, we had to release resources, on the other hand, they were reallocated.

I come to the question of the reduction of the level of contribution, of levy – let’s call it as we want it – paid by the industry in the shell.

During her speech, Mrs. Burgeon said something quite correct. This is one of the sectors supported by a redistribution and solidarity mechanism. The responsibility of the pharmaceutical sector is therefore extremely large in its ability to ensure its sustainability. This sustainability is based on two different pillars. On the one hand, those who organize the redistribution of resources must not constantly face too large deficits. On the other hand, we must ensure that, with the measures we take to avoid any overflow of deficit, we do not put the pharmaceutical industry in trouble. That is why it is also at the request of this sector and as part of a dialogue we have entered into with him that we have established a protocol that emphasizes, for example, two positive points. There is, on the one hand, the system that favors the companies that spend the most resources on the innovative industry and, on the other hand, the Agency’s response to one of the questions raised by the pharmaceutical industry. I repeat that this question does not concern the modalities of reimbursement of molecules but more about the registration of medicines and procedures that fall within the European environmental framework.

Mr. Speaker, I think this is a good project, a project that is the collective child of this majority and that wants to both guarantee the quality of care and access to this care to the greatest number, while respecting the innovation policy led and supported by the federal entities of our country, led by the companies of the pharmaceutical sector and encouraged by a number of standards on the federal level.