Proposition 51K2437

Projet de loi relatif à la création et au fonctionnement de l'Agence fédérale des médicaments et des produits de santé.

General information ¶

Submitted by

PS | SP MR Open Vld Vooruit Purple Ⅰ

Submission date

April 24, 2006

Official page

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Status

Adopted

Requirement

Simple

Subjects

pharmaceutical product medicinal product drug surveillance public administration civil service

Voting ¶

Voted to adopt

Vooruit Ecolo PS | SP Open Vld MR

Abstained from voting

CD&V LE N-VA FN VB

Party dissidents ¶

• Maya Detiège (Vooruit) abstained from voting.

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Discussion ¶

May 24, 2006 | Plenary session (Chamber of representatives)

Full source

I saw him.

Mr. De Crem, he is registered as speaker. I just want to know if he wants to explain his report as well.

He wishes to present his report in the presence of the competent minister.

He requested the presence of the competent minister. The report is for the Chamber. This can happen without the Minister. However, the discussion must take place in the presence of the competent minister. Mr De Crem, you also know that the report is submitted to the plenary session on behalf of the committee. There is no need to be a minister.

For the discussion, the responsible minister must then be present, which is now the case.

Mr Goutry refers to his report. He is registered as a speaker in the General Meeting. Is that the right interpretation?

I assume that Ms. Detiège returns to her written report.

Then the general discussion can begin.

I have several members who have registered. Inscribed on the list of speakers are Mr. Goutry, Mr. Verhaegen, Mrs. Lejeune, Mrs. Burgeon, Mr. Bultinck, Mrs. Avontroodt and again, for the same group, Mr. Verhaegen, Mr. De Groote — he comes to me that fluff in my ear, which of course is no problem — et Mrs. Gerkens.

Mr. Goutry, would you like to start? Are you ready to speak now? Then I will give you the word.

I will then give the floor to a French speaker. Mrs. Lejeune, do you want to speak in second place?

by Mr. Dresden is also registered. We will see well

Mr. Goutry, you have the word in the general discussion. I was looking for you and found you.

( ... ...

That has already been done.

( ... ...

I would like to see you in the room, but I didn’t see you then. You can still intervene in the general discussion.

( ... ...

Will you talk long?

I will keep it very short.

It is an exception to the exception.

Should it be?

I am in a good mood today. It is good. Mrs. Detiège, you were there afterwards. I saw you, but you later escaped my eye. Can you give a brief report?

I give you the word for your report, on behalf of both of you, I suspect. Short and brief.

Mr. Speaker, I would very much like to briefly report on the meeting of the Committee on Public Health, in connection with an important bill on the establishment of the Agency for Medicines.

The Minister has indicated the interests why the Agency for Medicines should come. I will not repeat it all, but the essence is that everyone should be aware that almost all other European countries have a drug agency and that Belgium cannot be left behind. He emphasized this with a number of arguments. The Minister also explained the objectives and functioning of the Agency. I will not list them all. The essence will be that the Agency will be able to work more autonomously compared to the Directorate-General and that the government still has an important role in this regard by monitoring its proper functioning. Responsibility of staff is also important. There will be a huge psychological aspect associated with it, so that they can work even better than before.

During the general discussion a number of points were raised. I’m not going to name all of the members of parliament, but I think most of us supported the objective of the bill. They thought it was important and said it had to come. Some of them had concrete questions, primarily about the State Council: why did the minister not take his comments? There was a little fear of uncontrollability because it would become a mastodont. Another pain point was related to the workforce because in the past, during the audit of the Directorate-General, there had already been a staff shortage. The question is what the situation will be in making this Agency autonomous. Will or will there be any improvement? Another observation was that the draft law is quite general and that the method of financing is also not so clearly mentioned in the draft law.

Some examples have been cited of why the reform of the Directorate-General is attached importance, such as the control over the companies, the distributors, the pharmacies, the granting of licences, the placing on the market of products.

There is also a certain backwardness for a number of tasks. I think, for example, of the clinical trials, the side effect, the vigilance, the marketing of products. I think that was a legitimate question from some members.

Then we discussed the control on the field. There was concern about drug promotion and its control. Can this really be done by the agency?

So a lot of comments were formulated. The Minister has given his answer. I’m going to get my report quickly, right? I think I’ve already covered 20 pages.

That is a good rhythm.

The Minister has repeated that Belgium will really have to follow the trend of the other European countries and that therefore a agency should also be established here, in Belgium. The challenge for him is that the agency must strive to ⁇ excellence. The Agency will be able to respond to concrete questions faster and will work with great flexibility. The Minister also wants a good cooperation with EMEA and he wants to provide the guarantee for the independence of each staff member.

The Agency also enables better drug promotion and control.

The Minister also says that the existing backwardness in connection with, among other things, the clinical trials has been largely overcome, on the one hand by computerization, i.e. by improving the procedures, and by investing more money in that part, and on the other hand by the introduction of sixty full-time relationships over a period of eighteen to twenty-four months.

There would have been a number of shortages in the Medicines Fund – with reason – resulting from, for example, the establishment of antiviral stocks and computerization. In the future, these stocks will be paid through dissociated credits.

A minor question was where the agency would be established. It would be in Brussels. There would be continued contact between the Agency and the FOD Public Health.

Thank you, Mrs the reporter.

Where is Mr. Goutry now? He is listed on the speaker list. It cannot be! I didn’t have a reporter then, now I don’t have a speaker.

I will start with someone else. Madame Lejeune, you have the word.

Mr. Speaker, Mr. Minister, Mr. Colleagues, Currently, the General Directorate of Medicines (DGM) within the SPF Public Health assumes the various tasks in the field of medicines. However, it is important to note that concrete difficulties have arisen. Despite some occasional improvements, the DGM is currently not working satisfactorily.

Among the shortcomings of the current system will be the late issuance of marketing authorisations, far too long deadlines for the issuance of authorisations in Belgium for generic medicinal products and medical devices, also very long deadlines for the recording of waiting times for veterinary medicinal products intended for domestic animals, and generally insufficient controls. So here are some examples of a system deficiency, and the list is far from being exhaustive. In addition to these problems, our country is still one of the last Member States of the European Union not to have an autonomous entity such as a drug agency. France, the United Kingdom, Germany, Spain, Denmark and many others have established such an entity in their country. by

The proposed legislation pursues a double objective. First, the most important objective is the indispensable visibility that the Health and Medicines Authority must have in the increasingly competitive European context. In fact, headed by the European Medical Association (EMA), national authorities must be performing and credible. The other goal is also large. It is about creating a powerful structure to ensure important public health tasks. It is also about ensuring control over the entire process from the design to the use of medicines and other products. A non-optimal functioning in this area can have no negligible consequences for the health of everyone obviously or for the competitiveness of pharmaceutical firms established in our territory. by

We fully support the objectives of this bill. The pharmaceutical sector is, in Belgium, the main driver of the promotion of the knowledge economy and an instrument for raising the level of public health in our country even higher.

We have long been a host country for pharmaceutical and medical research. Given these different shortcomings that I have just mentioned, there is therefore an urgent need to optimally develop an autonomous and responsible drug agency, visible at European level and performing, so that our country remains a hub of excellence in this area.

Here, Mr. Speaker, Mr. Minister, dear colleagues, are the various considerations that I wanted to bring to this debate. by

The MR group will support this project without any reservation.

Mr. Speaker, Mr. Minister, colleagues, I thank my co-rapporteur Mrs. Detiège for the joint work. Given that the part I would report on is the article-by-article discussion, which is almost entirely limited to the CD&V amendments I have included in my speech, I refer, for my part, to the written report. In order not to duplicate myself, I will limit myself to my speech.

Mr Goutry, will you also address your amendments during your speech, or would you like to reserve this part for the article-by-article discussion?

Mr. Speaker, I will discuss this in large part during this discourse.

Mr. Goutry, you know that you still have the right to ask the word during the article-based discussion.

Thank you, Mr President. The present draft legislation is of great importance. It concerns the operation of a service, so far the General Directorate of Medicines, shortly DG3, which from now on will be transformed into an independent Federal Agency for Medicines and Health Products. What is the importance of this? This agency monitors the entire process from the manufacture of a medicinal product to the registration, the granting of the authorisation, the authorisation of the marketing, the testing on the human person, the clinical trials and the use by the patient. This is a very important process where control primarily takes place on the effectiveness of a medicinal product, on its safety, side effects, quality and availability. This is essentially the task of such a service.

To date, all these tasks have been carried out by the Directorate-General for Medicines in Public Health. It is also called DG3.

If we have understood it correctly, the Minister with this bill wants to take over DG3, including personnel and resources to accommodate it in a new management structure of category A. By analogy with the Medicines Fund, we will now have a federal agency for the surveillance of the medicines.

For all clarity. Pharmaceutical policy has to do with three departments: on the one hand with Public Health for the tasks I have just listed, on the other hand with Economic Affairs because every medicine must receive an approved public price, and finally with Social Affairs because for certain medicines refunds are made through the health insurance. These refunds are arranged within the RIZIV, in particular within the Committee on Repayment of Medicines.

Colleagues, I also said in the committee that we are not just in favour of a federal drug agency in terms of monitoring, quality and availability. We are also in favor of a second agency that would primarily deal with the refund of the medicines. The second agency should be a kind of agency that starts from a need planning: what do we need in our country of medicines, based on the diseases that occur?

That agency should employ both people who come from the health-economic angle, who know everything about the pricing of medicines and monitor the world market on that level, as well as people who are therapeutically very well informed, namely scientists and doctors who can tell us what the value of a medicine is, what the innovative value of a medicine is, what the added value is and to which the government should spend its money. In the field of medicine policy, there are constant choices to be made. The Minister will receive opinions and files on this subject. He must decide when to repay and when not. He can determine that there are already many of one type of medicines and of another type not yet.

It is precisely in that area that there is a lack of an agency that would manage all those tasks, that would advise the government and let the government make choices about how our drug policy should be developed in the future. In other words, the second agency, which we propose for the future, is a reimbursement agency, which is actually focused on what could be called the bidding policy. What is the best drug in terms of effectiveness and effectiveness, coupled with the best price? Of course, the cheapest and most effective is also the best medicine.

We have thoroughly amended this. We have proposed to the members of the majority, to the minister and to the government to establish, in addition to the federal agency, a second agency dedicated to the reimbursement of the medicines and to the coaching of everything related to the price. We have not really been able to open a debate on this. We were not followed in this, our amendment was rejected. I therefore assume that the current political majority only sees salvation in an agency that ensures vigilance, efficiency and quality, and that it also does not immediately want to build up an equally autonomous body that would engage in needs studies, pricing, determining reimbursement rates, preventing over supply, organising public procurement and so on.

Colleagues, I want to make it clear that we are in favor of the principle of a drug agency. The Christian Democrats are therefore in favor of quite extensive independence and for free initiative in the administration. We want people to take full responsibility, because such an agency works responsibly. They have their own budget, their own management and their own staff. One must maintain its own accounting and organize its own personnel service. One becomes, like the Food Agency, a fully autonomous body, which can work more flexibly, can quickly play on the ball, may also be faced with less civil servants and therefore could act more performantly.

We are not the inventors. Europe has already done this for us. The European Medicines Agency (EMEA) is based in London. Most countries adopt this form of organization. So far there is no problem for us. We are in principle in favour, if we do not believe that there are conditions linked to it. Their

If one transfers an existing service to a more autonomous form of organization, then one must take care that one also transfers the means and that one also transfers the necessary manpower. There are the two main pain points for us. Mr. Speaker, I would like to discuss this briefly. Their

First, let’s talk about the financial resources that this agency will be able to work with. In other words, they are the same financial resources as those available to DG3 today. The Directorate-General for Medicines in Public Health currently has two main sources of income. The Minister has said that this is what will be transferred. Those funds will be transferred. The two current sources of income are a state dotation of about 15% and the very largest part, 85%, comes from the sector itself, from the pharmaceutical industry. Indeed, the companies, the pharmaceutical producers must pay for every file they issue to Public Health. The file in which Public Health examines vigilance, side effects, safety and effectiveness, must be paid. This is called the registration procedure. Because of these funds, this service works in a very self-sufficient way. Their

Mr. Minister, I have asked you this question. I have asked you how the famous Medicines Fund, which is now fed by the industry and which serves to ensure the functioning of that service, suddenly happened. Their

I also asked if you could provide me with a balance sheet of the revenue and expenditure of the Medicines Fund. What are these funds used for today? Where do they come from? Their

Mr. Minister, in all sincerity, it disappoints me that in the report of the work — as I had asked it — a balance sheet of six lines, only on the expenditure, was eventually added. You gave a very summary, in six lines, an overview of the expenditure in the Medicines Fund, from which, however, I cannot comprehend at all what those funds are accurately listed. I can’t even figure out, on the income side, where those resources come from. For example, I also do not see where and for which campaigns funds from the Medicines Fund have been used which in fact should have been used for the DG3 and its functioning. Their

For example, we bought a stock of Tamiflu: following the bird flu we armed and bought those antiviral agents. This is taken from the budget of the Medicines Fund and can therefore no longer be spent on the functioning of the Directorate-General for Medicines. One can use it only once: either one buys a stock of medicines with it, or one uses it for the operation of the service. Their

Colleagues, we should be a little cautious when one says that 18 million euros have been made available to the drug surveillance service, because that is not the case. Of those 18 million, only 13 million have actually reached the service. The other millions of euros have been used for other things, but are on the balance sheet, therefore on the account of the Directorate-General. This gives a totally distorted picture. Their

This also nourishes the fear on which we base ourselves to inform the Minister that if the funds of today’s Medicines Fund – in addition not fully used for the Directorate-General – are transferred to the Agency, there will be insufficient funds for the Agency. The agency was amputated in advance. It is as if one puts a new façade stone into the today’s somewhat embroidered house in Public Health, that is to say, what is going to be called up on the outside, without changing anything inside. Then you still have a bad home, even though it looks better outside. That is our main concern for the agency. Their

Let me summarize the financial gap. It is my opinion that the means of action are largely insufficient. Furthermore, the Medicines Fund, which was to serve the functioning of the Directorate-General, was used for this purpose only for two-thirds. The costs charged for, for example, the files relating to clinical trials are too low compared to other countries. In addition, the operating costs of an independent agency will be higher than the operating costs today within the Ministry of Health. Therefore, more resources will be needed. Their

Colleagues, the decision is alleszins that the financial gap for the Directorate-General today and the agency in the future is insufficient. With the financial resources there within Public Health and which will be transferred to the agency, we will not get there. Their

Am I alone with this criticism? It might seem like I’m standing here perorating from the speech floor while only a few people from my group are ready to listen and I don’t get much attention for the rest. (Protest on the banks) Now I know that you are still there, colleagues, for which I thank you!

Colleague Anthuenis, what I wanted to say is that we are not alone with our criticism. Strange but true, this Parliament, Mr. Speaker, has taken other forms. Parliament and especially the committees have actually become occupation therapy today. The Minister appears there and gives a brief explanation. The majority hardly responds, to a few people after who have some comments that are not underlying. Then there is a vote, somewhat benefiting from the fact that I could not be present at the vote.

Now I understand why you say that, Mr. Goutry.

I apologized for this. What then appears? The vote was voted out in ten minutes and approved everything without comment and criticism. What are we determining today? Today we open The Tomorrow and it contains a large article with a large photo of colleague Detiège who literally questions the agency. She says: “I am very concerned about this because the agency does not have the necessary resources.” She says that literally, I can quote her because I naturally brought it. “The agency does not have the necessary resources. I am very worried about it.” She makes a much more thorough criticism: “In addition, the agency’s independence is not guaranteed at all.” She says she is very concerned about this because it is mainly the industry that will pay. She adds: “It could be that the industry also shaves itself over that agency.” She also says that those who in fact need to be judged objectively are those who pay and in fact sit on both sides. They do both the application and the assessment. This is what Mrs. Detiège says today in a press article. She has been silent about this in the committee because that is not important. Such things should be launched in the press...

If Mrs. Detiège has been silent, she wants to speak now.

Everyone can tell their story and I will tell my own later. You constantly talk about Mrs. Detiège, but I would like to tell my own story. thank you .

You speak as the last or the last.

Mr. Speaker, I assume that when we report and define our position in relation to the work of the committees, we can only name colleagues. Forgive me if I do that.

They are also mentioned in the report, with name and surname. There was a time, Mr. Goutry, when the reports from closed committee meetings came. At that time there were no names, and they were always talking about "a member".

... ...

Mr. De Crem, that is not a report of the committee, that is a newspaper.

Mr. Speaker, my colleagues, I have mentioned this...

... ...

Mr. De Crem, your spokesman is here. Mrs. Detiège will be on the turn.

Colleagues, what I regret — and I have already done it a few times, Mr. Speaker, in this Parliament, where I have been sitting for 14 years, so I have already been able to build some antiquity — is the evolution that I perceive. I sincerely believe that, colleagues. Previously, in the au fond committee, discussions were held: each in his own field, each from his own point of view. We could have had a good discussion. All the arguments came on the table. This is not happening today. There is a pressure to say: guys, we are not going to get too tired here, it is all discussed in advance; we have a short intervention and we profile ourselves later, at the expense of Jan and Alleman. This is not a proper parliamentary work. If you have something to say, say it in the committee. Then we can discuss this. Then you should not say it in the press afterwards, because this way we will never be spoken out.

Of course, everything you could read about it, colleague, in the press today, I have all spoken literally in the committee. Everything is verbal! Everything is verbal!

It is the evidence itself that when one speaks first in Parliament, one can then report on it in the press. That would only be lacking. But the opposite is regrettable, please admit. This does not lead to a serious debate. But well .

A second case that is heavily accused by Mrs. Detiège, today in that article in De Morgen, is that she says that we will not have enough staff. Mr De Crem could quote the article. He has it with him. I am not immediately at hand here. He could literally read that Mrs. Detiège says that she is concerned because the employment of today is insufficient to ensure the provision of services.

Effective, except that Mrs. Detiège says that the text is very vague — but you will approve here later, that vague text where much too little is capable — there is literally: "Also in terms of control and inspection there are, according to the sp.a. chamber member, too few guarantees." Here is ! That is for the newspaper. What happens to the rest does not matter.

She goes on to say literally, colleagues: "To let the autonomous work..." — that new agency — "...there is a need for a doubling of the budget." Meal two! What am I here to do?

You showed my quotation in The Tomorrow error.

You may be wondering what I am here to say. When she talks about personnel policy — which I will talk about later — Mrs. Detiège says the following. She says: “I want clear guarantees...” — again — “...that the staff will be strengthened.” She wants clear guarantees that the staff will be strengthened.

What did we say, colleagues? We have said that there are too few resources. We have not even talked about a doubling. And we said that there are too few people. And everyone said, come, it will go; we will do our best.

We have submitted amendments to which we want to allocate more and more people. These amendments were rejected without discussion.

They will then sell talk in the newspapers. In this way we can work for a long time.

Does Mr. Goutry today speak on behalf of his group or is he only obsessed with Mrs. Detiège? and laughing)

The two, Mr Geerts. I think it

I am sorry that I was unmasked.

Colleagues, if one understands the importance of this bill and knows what is at stake in terms of safety and quality of medicines, then one must be obsessed with it, as a member of the public health committee. After all, these are very important issues. It is about a budget of approximately one billion Belgian francs of resources, all in the service of public health and of a good drug policy. Their

That is why I am obsessed with it. I am all the more obsessed with people who speak with split tongue, who when they have to speak, keep their mouths, and when they would rather be silent, suddenly become open-minded. That is my criticism.

As for personnel policy, you can say that I stand here as an opposition member. However, as an opposition party, we are so strong that we do not simply dare to make statements that we do not dust. What have we done? We have examined the audit of the Directorate-General for Medicines.

Three years ago, a business process purification audit of the Directorate-General for Medicines was conducted, paid with government funds. This is an important report. It examined the full performance situation of the Directorate-General for Medicines.

Do you know what the finding is? The audit shows that, in order to function properly, the Agency must have 340 employees. Do you know how many people have it today? About 194 people. In other words, 146 is too short. There are almost as many too short as there are effective. You have to imagine that.

It is said that this should not be a problem. It is said that this staff will be transferred. The Agency is made an independent agency. The expectations are high and there is a shortage of 146 employees. This is stated by an independent audit agency that has examined the operation, assignments and performance of this service.

Of course Mrs. Detiège is right. She has an excess of right when she says there is a staff shortage. She knows that. She is an expert in this field and is also aware of that audit. She knows that and therefore says very rightly that there is a staff shortage.

However, it is a pity that she says that now. If she had said that in the committee, ⁇ we could have stopped the draft and first asked for guarantees from the government before voting on this text. Once we have put him to vote, it is too late to ask for guarantees.

You should always ask for guarantees before signing the contract. First approving the design and then talking about guarantees, of course, has no meaning.

Colleagues, however, a few figures that might convince you. Today, the Agency receives its income from the registration of medicines. Approximately 12,000 files are drawn up each year. Did you know that only 7,000 to 8,000 files can be processed? So there are 4,000 files each year that cannot be processed. Colleagues, are you surprised that you are being addressed, you have already experienced it all, by people from the pharmaceutical industry who ask to investigate at least the dossier? They are struggling to submit a file. It should also be investigated in time. A quarter of the cases cannot now be investigated in time. It can not be otherwise, because there are 146 people too little on the service.

Mr. Goutry, can I interrupt you for a moment?

Mr. Speaker, I regret that the Chinese delegation is in the midst of such a fierce debate on medicines.

Medical herbs...

However, I think that this topic will also interest them. After all, this is a global problem of public health, health care and medicinal interventions.

Colleagues, do you know that any medicinal product must be clinically tested before it is put into circulation and can be taken by the patient? This means that medicines must be tested in three phases by humans, in terms of effectiveness and safety. Well, the services are only still able to thoroughly examine Phase 1 of all those files. Phase 2 and Phase 3 of the thousands of dossiers on human drug testing are only yet to be handled administratively. They are no longer thoroughly examined. They do not have people for that.

Colleagues, do you know that, as regards the control of the safety of medicines, there should be regular inspections in public pharmacies and in hospital pharmacies? Well, a sample indicates that most pharmacies in ten years have never been inspected. No one from Public Health comes there to inspect the case and check in that pharmacy if everything goes according to the legislation. Colleagues, do you know that we have a law to restrict the promotion of medicines? Therefore, one should not make commercial advertising for medicines for which one must have a prescription. This law is being violated on all sides. Do you know what the service says? They act only if they receive complaints.

Decisions are no longer made, there is no initiative from the service — they have the means for it and the people do not — and they wait until it becomes too bitter. If someone makes a complaint, they shoot at work. Does this mean that these people are not working well, colleagues? In this regard, I want to help all the uncertainty from the world. The 194 people who work today at the DG3 are highly driven, competent people who are making every effort to ensure that no wheels fall out, as this has to do with public health. These people roast with too few rowers and with too many short ribbons. In this way, of course, one gets into difficulties in the middle of the stream and one even has a high chance that one would drown in the long run.

Colleagues, do you know that in the DG3 most people are contractually hired? There are no more statutory appointments. Did you know that bets are not competitive? They bet on high-level personnel — people from the scientific world — who can compete with the industry with less than a tenth. Those people will pass. We are losing those people. They go from the government to the commercial sector and the government does not have expert people to carry out the necessary controls.

I would like to come to my conclusion regarding the employment policy. I have demonstrated, with all the necessary evidence, that the staff framework is largely inadequate. Only the most necessary is done in the service. There is a structural file lag, there are too many contracts and there is no perspective. I come to the little story of the story: if you have looked at the bill for a moment — you have done it all — you have seen that half of the bill is not about the operation, resources or staff of the agency, but about the assessment, the procedure that will be carried out to appoint the head of the agency.

However, this procedure is a copy of what Copernicus prescribes to us in this regard. This is the usual assessment procedure. It is inscribed in the law. We get some sort of prejudice and wonder why one is so busy with the management of that service. Could management be more important than the service itself? Could it be a forerunner of the fact that the Director-General of the DG3 may soon not become the new delegated director? Per ⁇ the resources and personnel are not pushed up, but only the switch is used to keep a cheek in management. Who knows the agency is used - this would be very bad - to try to appoint as many people as possible to important positions according to an old tradition, first with purple-green and then with purple. I hope that is not the purpose of this bill. It shouldn’t be that there just comes a new agency to be able to appoint a new Director-General, from its own ranks, who, in the current constellation and in accordance with the tradition of the purple majority, does not inject much criticism, and to consolidate that appointment for years, in case it would ever be necessary. I would be very sorry if that were the case. The truth always outweighs the prediction. If that is the case, then we will remind you of it for a period of time and then we will, I think, be deeply unhappy with all of it.

I conclude with the following conclusion again. I want and will listen attentively to the criticism of the other parties. It must be my heart that the contribution from the majority parties in the debate was very minimal. The criticism was very mild to barely existing. I would understand if there might be a political agreement on this. Then it is better not to make trammel about it, except in the newspaper. One can, of course, also be under the influence of the pharmaceutical industry, such as the VLD, which will soon hold a conference on the care of the elderly and will be sponsored in Parliament by Pfizer, a pharmaceutical firm. Then I wonder where the independence of parliamentarians is. I wonder what we are actually doing here with a parliament of sensible people, where the largest party, the liberals, is under pressure from the pharmacy, which sponsors their convention. The liberals should, however, protect the independence of the agency. They burned themselves behind their ears.

Ms. Detiège is silent in the committee, but she tries to fill the newspaper with criticism.

Mr. Speaker, I am pleased that Mr. Goutry is reading The Tomorrow, at least today.

Mr. Chevalier, I have received an invitation from you. There was “Pfizer”.

Mr. Goutry, the difference between me and Mrs. Turtelboom on the one hand, and people from other parties on the other, is as follows. If we do something, we do it with an open eye. We have made very clear agreements with Pfizer. This is the difference with other parties: we work with open visor and not in the dive.

Interruption of M. The cream)

I take note of this.

Mr De Crem did not ask for the word. He made a comment that I do not accept. He talked about butter with fish. As for the organization of that roundtable conference, we try to discuss a social issue very clearly, for at least half a day. We will give the floor to various speakers. I invite Mr. De Crem to come to us to determine how much it cost and who pays which share. For the rest, it stops. We are not going to drive for a particular pharmaceutical industry. We do not let ourselves be bound. We set very clear conditions. We stick to it and others will do so.

It was not only butter at the fish but, as they say in French "poisson pourri". They have been with us too. We said it would not succeed with us, but that they should try with the VLD. You are trapped in it. That is the difference!

Mr. Speaker, I assume that the judgment of Mr. De Crem will be included in the comprehensive report of the Chamber.

Everything is recorded, Mr Chevalier! by Verba Manent.

Mr. Speaker, I repeat this again. What the VLD does is open and not like others commit it, in the dive.

Mr. Goutry, you have the word to finish your argument.

What is the morality of the story? The majority in Parliament is under pressure from the pharmaceutical industry. There is a difference: the liberals openly advocate this, while the socialists remain silent about it! That is the difference.

For CD&V, it doesn’t matter much. It only makes the matter more painful. You could laugh at it if it wasn’t a drama. CD&V will abstain at the vote and I am pleased that.

The way in which the debate over such an important draft as the one that is forthcoming, which will create an organic framework and establish an agency paid with community money and which raises high expectations for public health, has ended, and the level of it calls on me the following consideration of "poor commodity".

I conclude with the words of the Minister himself. In the committee, CD&V asked many questions. We asked for an organogram. It goes with the report. The organogram lists 186 employees, since it dates from October 2005. Today there are 194 and not 340, as the audit requires. I also asked the Minister to give me a balance. The balance sheet can be found in the report. These are the six lines on expenditure. Finally, I also asked the Minister to give a perspective. I quote him. He said: “The establishment of the agency is necessary. The questions that can be asked are: how will the agency work? What will be her tasks? With what personnel and resources will the agency work and in what normative framework?"These are the logical questions of the minister, which we also ask.

But then the minister decides: "It was chosen to establish the agency step by step." We did not understand that. What does this mean: step by step? This should be written on paper, with a growth plan and figures. That step by step of the minister we have translated as follows: that is not the matter now, but we will do that step by step. His successor, therefore, will have the conscience!

Mr. Speaker, Mr. Minister, dear colleagues, our group supports this bill, important since it concerns medicines, their control, their reliability, their qualities and their safety.

It is an essential task of the public authority to ensure these elements. In fact, it must ensure that patients are quickly available to all the most innovative medicines to alleviate their suffering.

The Directorate-General for Medicines is no longer able to properly perform its tasks. It lacks the necessary resources. At present, our country does not have the structure capable of addressing the many challenges that arise. Nevertheless, most countries already have a competent agency for medicines and health products. It is therefore important to follow the trend of other European countries and to equip ourselves with all the tools to ⁇ excellence in this field.

This agency will also serve as a priority interlocutor with EMEA (European Agency for the Evaluation of Medicines) in order to pursue a coherent and transparent policy at European level. This is also an added value for the entire pharmaceutical sector.

However, Mr. Minister, I would like to make a small comment. Test-Achats and the League of Health Service Users fear that patients will be purely excluded from the Agency’s Advisory Committee, unlike the pharmaceutical industry, mutual associations and other stakeholders. Could you reassure them on this point?

On this subject, which seems to me all but insignificant, I will allow myself to react. In this case, when representative organizations of more than 8 to 9 million patients in the country intervene through mutual associations, I find that it takes a lot of hassle to say that patients are not represented.

Mr. Minister, thank you for your response.

If the text explicitly provides for the possibility of extending, by royal decree, the composition of the Agency’s Advisory Committee, would it not be appropriate to involve patients in the analysis of the side effects of pharmaceutical specialties, in the assessment of the effectiveness of medicines or in the improvement of the readability of notices?

I can easily conceive that the problem of representativities may arise, but ⁇ it would be necessary to decide on a thorough reflection on this matter. You have just given us your opinion on this and we will forward it.

Mr. Speaker, Mr. Minister, Ladies and Gentlemen, first and foremost, I would like to come to a confession. People who have known me in this Room for some time know that I mainly hold short and core-like interventions. I regret that our way of working is not always equally efficient. Sometimes we have the bad habit of repeating debates. That is why I actually planned not to intervene today. This was clear to the opposition. There was a good debate in the committee. The members of the opposition said what they thought they should say.

I should apologize to you, because I, like Mr. Goutry, opened my newspaper this morning and then broke my bump, Mr. Minister. I tried to see if we had the same debate in the committee and whether we had the same topic. I now turn to Mrs. Detiège. Either there was a mistake in the pressure tests, or the Vlaams Belang had received a completely different report.

However, after a thorough review of the report, there was nothing wrong with the report, but rather with the tone of Mrs. Detiège in the committee, where she was very mild. If I can make a caricature of it, the intervention of Mrs. Detiège was in fact almost limited to a classical intervention. Just walked in, gave a nice kiss to the minister, and the colleague was gone. No punitive intervention. The intervention was therefore limited to the friendly kiss to the minister. Today there was the big surprise. We open The Tomorrow and note that Mrs. Detiège had a very critical opinion about the design. She apparently did not have the courage to say this in the committee, so that we would at least have a chance to conduct a serious debate on this.

Mr. Speaker, our group deeply regrets this. I think this is not a good or correct way of working. I could therefore almost limit my intervention today to analyzing and quoting the very critical language spoken by Mrs. Detiège on this draft. I hope she will be able to convince us a little later. I am glad that she is back in the hemisphere. She will soon have to convince us in her intervention of the great tone difference between what is stated today in The Tomorrow and what she has very lovingly limited in the committee to the classic kiss to the minister. I return to the seriousness of the situation.

Mr. Minister, our group supports the great importance of the present draft. In principle, the Vlaams Belang, in a very good smile and weak moment of opposition, could even approve this draft. We support the great principles. We are fully aware that our country is one of the last European countries that does not have such a drug agency. Therefore, it is necessary to address this. The necessary work must be done on the ground.

For each of us, the audit of the famous Directorate-General has made it clear that this institution does not really function as it should. We must at least make an effort to improve this situation, with the design presented today.

A second important issue — you have heard me say it several times, Mr. Minister, and I cannot emphasize it enough — is the importance of the pharmaceutical industry for the knowledge economy, especially here in Flanders, for scientific research and for employment. I have already said several times in the committee, following similar drafts, that we are pleased that the war rhetoric, which was initially somewhat driven from this majority towards the pharmaceutical industry, has been retained and that common sense is slowly returning.

Before the establishment of the agency, important consultations with the sector were held. Mr. Minister, we had no problem with this. On the contrary, I was one of the colleagues in the committee who congratulated that there was explicit consultation on this agency. However, I now come to the critical tone in today’s famous newspaper article by colleague Detiège. She says that at the moment she has no guarantees as to the independence of the Agency.

Mr. Minister, who am I then, as a simple member of the opposition, nota bene then another Flemish Interesters of service, to question the strong and very biting commentary of colleague Detiège? You will not blame me for asking you to clarify whether or not there are guarantees regarding the independence of the Agency. I can blame no one that his or her opinion evolves or that, after a night of quiet sleep, the light begins to shine in difficult files, but of course we must now get a very clear answer to this. Their

Mr. Minister, another element is the persistent demand for transparency in this type of files. I think that we too, from the opposition, have pointed out the problem with the Medicines Fund, as it now works. The funds are not used exclusively for what they should actually serve, namely for the registration of medicinal products. A number of other initiatives are also regulated and financed from the Medicines Fund. I think there really needs to be transparency and clarity in the field.

I would like to return, Mr. Minister, to a question I asked you on 1 February 2005 concerning the huge lag in the file of the registration of new medicines. It was about the gap of mutual recognition, where we were then with an average of 35 days behind the statutory period of 120 days. On the other hand, it was about the gap of the national registration where there was indeed a fairly large backwardness. I think you need to convince us a little more today that much of that backwardness has been removed in the meantime and that this federal agency, by definition, will be able to improve the situation. In fact, in the course of the debate, we have in no way – and that is essential – obtained the certainty that there are additional means to completely overcome this downturn. On the other hand, it is also not expected that many inspectors will attend. How can one give us the guarantee at this time that the backwardness can be sufficiently removed and that there will actually be a clean lease on the ground?

As already stated, the financing gap remains quite unclear. I look for a moment in the direction of colleague Detiège because I see that she also has very explicit questions about it. She says that the funding in large part comes from the pharmaceutical sector. Collega Detiège says that she is not sure that this agency will be able to work independently. Who are colleague Goutry and I, Mr. Minister, to doubt the wise words of colleague Detiège and not to join us with her critical questions in order to make them — I can’t actually say that — also our own? I find with satisfaction that colleague Detiège, between the committee work and the plenary session, with her intersection through the newspapers, today does indeed also ventilate in those newspapers the critical questions that we have put here as members of the opposition in the committee. In that sense, it is no more than normal for us to call you back and ask you to give us real clarity.

As for the appointment of the general administrator of the new federal agency, Mr. Minister, the Federal Agency for the Safety of the Food Chain is an example of where it works well. So many years later, all of us, beyond the boundaries of majority and opposition, can easily acknowledge that the general administrator, Mr. Vanthemsche, does a brilliant job. So I would like to ask you to continue on that impulse. You must try to convince us today that the appointment of this general administrator for the new Medicines Agency will not be a classic purple political appointment in which one must find somewhere for someone a job and there someone parachutes for as long as the purple story will continue. I hope, Mr. Minister, that you will do this in all seriousness and that, like with the Federal Agency for the Safety of the Food Chain, you will put the most skilled man in the right place. That is essential.

Mr. Minister, the comments of the State Council were very serious. The State Council made it very clear that you should begin to define the task package much more accurately. This is true where the State Council stated that the delegation of powers was far too extensive. You answered me in the committee that the established custom that now exists is adopted within DG3 and that nothing special has happened there. In writing today, I note that we all have received, as members of the committee concerned, both because of the Flemish Patients Platform and because of Test-Buy, that they too take on the criticism that the members of the opposition of the State Council had taken over. So, I hope you can give us an even more accurate answer in this area than in the committee.

I would like to say, Mr. Minister, the following. I have not received an answer to this detailed question from you in the committee and I hope that you will correct it today. Establishing a new agency also means that we need language frameworks again for that agency, which ultimately should regulate the personnel affairs. You will understand that with our group the classical sensitivity remains. On what basis will these language frameworks be regulated? Will this be done based on the workload? I would like to get very correct answers today, if possible.

Then, Mr. Speaker, if you allow me, I will return for a moment to the concerns expressed to all members of the committee in the writing of Test-Acquisition and of the Flemish Patients Platform. You have just tried, after a question from colleague Burgeon, to answer it: the total absence of patients in the entire structure of the new Federal Agency for Medicines and Health Products. Ultimately, by analogy of the Federal Agency for the Safety of the Food Chain, there would be valid reasons to involve the patient.

You say this very clearly, both in the committee and here and now, that the insurance institutions – in other words, the health funds, for that is the concrete matter – must represent the patients. I dare here from my group, Mr. Speaker, Mr. Minister, to ask the critical question and to doubt whether these health funds always defend the interests of the patients.

You know, we are the requesting party to redirect the health funds to that kind of essence. Let them be engaged in defending the interests of the patients. In our eyes, they are too many payment institutions and too few the correct representatives of the patient’s interests. Therefore, I am not sure that this, with the structure as it presents, is currently guaranteed, and that I still feel something for the suggestion of Test-Acquisition and of the Flemish Patients Platform to provide that patients are also involved in this.

You have another suggestion, Mr. Minister, and it is good to point out that yet. On the famous patient reporting system, they say they are very clearly in favour of it. We all know the problem of side effects of medicines, to which now a number of sectors can actually respond. Also there, the ordinary patient lacks the opportunity to report a number of problems regarding side effects. It would not be bad if you would later try to give us an answer to whether or not you are considering setting up a clear reporting system.

I would like to react on two things.

The first concerns the coercion or the possibility of creating a point through which one can inform. What those who make this proposal forget is that it already exists today. The form is obviously an important question: is it done, yes or not, within the framework of public structures?

The question can also be asked for the agency itself. When, in the Agency, patients and mutualities are invited as representatives, one can question their representativity. And much more can be questioned about the representativity of many patient associations that sometimes themselves have a form of commercial corporations. This is how patients’ advocacy associations are, in reality – I’m obviously not talking about those cited by Mr. The deputy – facades to sell commercial products; it has been seen again recently in advertisements that have also been the subject of interpellations in Parliament.

I would be very cautious on this question and I would say that we must try to make sure that we recognize what exists in Belgium. Within the Drug Refund Commission, there are a number of interlocutors that do not disrupt ordinary gambling. It is perceived that everyone feels represented, even though corrections are always possible. In the agency we are setting up, things remain to be defined. There is, for example, a advisory committee for which one will have to determine who can come and give a different voice in order to enrich the debates.

Mr. Speaker, I will try to finish.

Mr. Minister, I thank you for your immediate response to my immediate question. That will later allow you to keep your replica very short.

You will understand that at this moment it can be very difficult for us to be required to support your design, even if it was only because today we have taken very critical words from the majority. I want to say very clearly that we will not support the draft. Our group will abstain from voting later because, on the one hand, a number of responses in the committee did not go far enough and we received insufficient clarity and I give you the advantage of the doubt.

On the other hand, you know our healthy Flamingo consideration. You know our position on healthcare and you will understand that we are not a requesting party for the establishment of any new federal agency. We want to integrate health care to the communities.

Let me look at colleague Detiège. If the majority already has doubts about the financing and independence of the new agency and asks whether there will be enough staff for the agency, you cannot expect us as members of the opposition to approve the draft.

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, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker. However, I read the report of the discussions carefully.

It is clear that environmentalists are in favor of the creation of this autonomous federal agency responsible for monitoring and controlling the quality of medicines in all their forms, from their production to their consumption and its effects.

The “autonomous” character of this agency is ⁇ important. Its autonomy will depend on the resources it will be given. by

We have been able to see, through the Federal Food Safety Agency, that this type of tool requires means, organization and competent people.

Given what I have read and following what I have heard today, I would like the Minister to give us guarantees regarding the financing of this Agency.

The fact that pharmaceutical companies need to participate in funding does not worry me. This practice exists for other control tools. Thus, if I take the example of the Federal Agency for Nuclear Control, which I know well, it is the structures and actors of the nuclear industry that finance. As soon as an agency has sufficient assessment and analysis capacity in its structure, rules of operation and resources, its autonomy may be preserved.

The second aspect concerns the advisory committee. I was interrogated by the LUSS (Ligue des Utilisateurs des Services de Santé) and Test-Achats about the lack of patient representatives, healthcare consumers. I have taken note of your response. Thus, you said that mutualities also represent patients. If it is true that they represent them, they also defend other interests. I find it therefore interesting that there are patients, i.e. users or consumers of health products within this committee.

Furthermore, I share your concern in that, indeed, patient associations are voluntarily or not the spokesmen of the pharmaceutical industry. These are patients who, for example, having very few medicines at their disposal, relay the application for recognition or support of a product from a pharmaceutical company.

I would find it interesting that this law clearly stipulates the type of association representing the patients that one would like to see present in this Advisory Committee.

I submitted an amendment aiming to add, within this committee, the representation of recognised associations of health system users and consumers. It can be formulated in a more restrictive way, but it seems to me more interesting that at the same time, the presence of a representation is guaranteed, while being chained to prevent its users from actually, ⁇ sometimes unconsciously, the spokesmen of the pharmaceutical company.

This is one last point that I would like the Minister to reassure me about. One of the elements that will enable the agency to operate autonomously will be the independence of its actors from the pharmaceutical company. The law stipulates that the King shall define the modalities for declaring potential conflicts of interest. It does not strictly mention the prohibition of a conflict of interest or of occupying a mandate or a position that could lead to a conflict of interest. I would like to know why the law is not more categorical on this subject.

Furthermore, I would like the Minister to give us assurances regarding the needs, both in terms of financial and personnel.

I submitted my amendment at the same time as my speech.

I thank you. I will take this into account when reviewing the articles.

Mr. President, Mr. Minister, colleagues, I am pleased that Mr. Tant is in the hall. Mr. Tant, it makes me remember the animosity that existed at the time when the Food Agency was established. Mr. Speaker, I said at that time that I had a precox feeling with some colleagues. I clarify again that that precox feeling has to do with not recognizing certain discourses. I look at the bank behind you. I’m not really aiming at you, on the contrary. However, I do not recognize Mr. Goutry. I do not recognize Mr. Goutry’s speech at all.

Mr. Goutry, we have all been given a list of the questions raised in the present text. The listing is precisely the reason why an agency needs to come now. Yes, there is currently a lag in the files. Yes, there is currently a shortage of resources and people. These problems are indeed present today. This is also why our group firmly supports the establishment of the agency.

I would like to refer to the past. Ladies and gentlemen, this is very important. We experienced the same at the time. Mr. Goutry, I regret that Mr. Brouns is not here to confirm my words. Then too, there were people — not you — with a so-called glass ball. It failed; it was not enough; it was too much or too little; there was too little transparency; there were too few resources; it was impossible to gather the staff or get them to collaborate. All questions are a duplicate of the questions that were also asked at the time.

Ladies and gentlemen, what is the result? The Food Agency is there. The Food Agency is working. The Food Agency has even expanded and deepened its expertise. Even then you looked at the same banks in the same glass ball. You also warned then that it would not succeed because there was too much or too little of this or that.

Does that mean I have no questions now? and no. My questions and expectations, by the way, I have expressed very clearly in the committee, unfortunately to those who envy it. In particular, it must be our intention to set up a Belgian Medicines Agency that will be able to play in Europe the role that Belgium currently cannot play.

I have also said that this agency should be able to play its role in Europe, while this is not currently possible. I have said more: it is our intention that Belgium, which is not now requested as a reporter for EMEA, will then be.

You have also listened carefully in the committee. We said there that there can be no doubt that we are in principle in favour of a self-establishment of DG3. We are absolutely in favour of the agency formula, both in organic form and in category A, as well as in organizations with own management and flexibility, and so on. I supported all those arguments, but only the explicit question repeatedly asked whether more resources and more personnel would come. The Minister has only stated that this would be step by step and has not confirmed anything concrete. He said that in the first instance there would be only a transfer of funds, while according to an audit there are 146 people too short. This is confirmed in all banks. Their

Should one then say that to overlook, that a glass ball is of no importance, that one must also from the opposition but that trust in the government team? Should we say that if it is not good now, it will be good someday? That cannot be asked! That does nothing about it. When you are building a house, you should be able to say in advance whether and what furniture you can put in it. What about a house you can’t live in because it’s not furnished? This is absolutely not guaranteed today and that is our fundamental criticism. I have no response from the government.

Yet yes! Mr. Goutry, let’s be honest. You say you want an agency. In principle, you agree with the structure. Well, it is there now. Their

You or your colleague Tant know better than anyone that the Food Agency also first laid the legal basis before it entered into force. You also know that the communication cell and the advisory body were not composed from the first day: this also took time. Their

Mr. Minister, I also said that we have our questions. For example, what I do not find explicitly in the text — the parallel with the Food Agency is there — is a communication point. This, in fact, also affects in part what consumer organisations and patient organisations demand. The independent communication cell must, in my opinion, be further expanded. This is not stated as such in the text, but that does not prevent it from being established in the agency. I assume that will be the case too.

Mrs Avontroodt, you point out a certain analogy between the FAVV and the new agency. I would say: horresco references. Remember how this should be achieved. Do you remember the visits we made at the time to what had to continue as the then agency? It was nothing more than a sign above the door. With the arrival of Piet Vanthemsche, it has finally gone in the right direction. Post hoc non ergo propter hoc: it is not because it comes later that it comes by it.

I understand that with your comparison of the two agencies you chase Mr. Goutry in the curtains.

Nowadays, there is a need for something more.

If I hear the criticism of Mr. Goutry, it threatens to evolve analogously. Resources are too short. Staff is too short. I would be careful with your analogy. I am honored that you associate the creation of the agency with my person, wrongly, because the first idea actually came from Mr. Brouns. He has submitted proposals in this regard. It is only after a lot of consideration that the government was willing to accept the proposals.

Mr. Minister, maybe we should learn from this, because it is only from the moment when people from the various services were sufficiently integrated that the agency could work well. If the new agency wants to build credibility, I think it is necessary to provide the necessary people and resources.

Mr. Bultinck, I like interruptions in a debate, but you know that they should be incisive and short. You have the word.

Mr. Speaker, I understand the honest attempt of Mr. Avontroodt to convince the members of the opposition of the right way, by analogy of the Federal Food Safety Agency, on which we with the Federal Medicines Agency should go to an ideal situation.

However, you cannot blame us, as members of the opposition, today that we have serious doubts. Even the minister was unable to convince us. If today even members of your own majority, Mrs. Avontroodt, openly express their doubts in the newspapers, how can you ask us to be boundlessly naive? It is one or the other.

Per ⁇ the majority parties should negotiate. There is really a problem. You can’t blame the opposition members for not being naive or good faithful, if your own majority members today express serious doubts in the press. I say again that I regret that this did not happen in the committee, because otherwise we could have had a serious debate there.

Mr Bultinck, Mrs Detiège is registered in the debate.

Mrs. Avontroodt, if there is a similarity between the Federal Food Safety Agency and the Federal Medicines Agency, that is indeed the bosses. Mr Vanthemsche is an excellent manager who has brought the FAVV to a high level. Mr. Van Calster is the one who holds DG3 today with his team above water. That is the similarity between the two.

Another similarity is the fact that the Federal Food Safety Agency also still struggles with a shortage of resources. As a member of the Committee on Public Health, you know that questions about this are asked weekly, including from your group. Do not refer too much to the FAVV. What is good there is management, as is the case with DG3. Everything else is being destroyed due to lack of people and resources. That is the truth.

Let Ms. Avontroodt now keep her speech quiet.

Once again, I have different opinions with you. This may not be the last time. I’m one who looks more at the positive results.

It is true that this has arisen in a crisis situation. The whole country was under economic pressure and there were human dramas in the companies. This is not the case here, and yet you continue to refuse this perspective.

As for the reference to my majority, it is first and foremost not my majority. The questions extended outside the Parliament are questions that some of you also ask, questions that can be asked, but which are mainly related to the future. For this, the Minister has already partially created an opening, in particular the notification point.

Madame Avontroodt, Mrs Gerkens would like to intervene. I know it’s hard for the speaker to be interrupted but I appreciate that the debate is interesting.

Mr. Speaker, I sometimes understand the rivalry between the VLD and CD&V but, regardless of these, everyone recognizes the well-foundedness of a Federal Medicines Agency.

Nevertheless, AFSCA’s experience has shown that sufficient financial and human resources are needed for a service to operate autonomously. It seems to me that asking for guarantees on these points now does not mean that we are against the Federal Medicines Agency.

Thank you, Madame Gerkens. I had well understood the meaning of your intervention. I am now referring to different banks.

Mr. Goutry, you are asking for more participation and more representation. Rightly, because I ask for that too. Unfortunately, the VLD has already launched a number of proposals regarding patient representation. A bill was submitted in this regard. I will refresh your memory. About this proposal you said that you found it a good proposal and would like to support it. You subsequently informed me that CD&V could not support the representation of the patient or the organisations representing the patient because for the Christian Democrats the health funds are the representatives of the patient.

I would like to refer again to the remarks of Mrs. Gerkens. It was the only one who expressed the view that the health fund can represent the patient in part, but that the health funds are not independent patient representatives.

Mr. Goutry, I invite you to be consistent and together in the Public Health Committee to add the act to the word and effectively recognize the patient organisations and the representation of the patient.

You would like to ask the Minister de bien vouloir me listen. Mr. Minister, I would like to replicate what you just said. You wondered how we can guarantee the transparency of the representation of the patient organisations, in short, how we can know who our interlocutor is. Their

You say that the health fund represents the patient, but that is, I think, not correct. The health fund represents the patient for certain interests. In addition, the health fund does not represent every patient, as there are many patients who, although they are members of a mutuality, have an opposite interest to that of the health fund. Healthcare funds are still healthcare providers. Therefore, that independent representation of the patient by the health fund does not exist.

Mr. Minister, I know how educational you are and how open you are to a future-oriented health policy. The Netherlands and Germany have already had an agency. With our new agency we get a place in Europe. I am confident that we will do that well. In the Netherlands, a model has been developed for the representation of the patient in an independent way, though with government support. I invite you with an open visir to look at that perspective. We have submitted a proposal to Parliament. I am convinced that it requires additional study work and requires even more dialogue. Yesterday, a signal was given to your cabinet in all the banks. Independence, transparency, communication and representation of the patient-consumer are, in my opinion, in 2006 the key to an open participatory health policy involving the patient as a full partner. Progressive parties cannot be left behind in this debate. This is contrary to a modern health policy. We will fully support the establishment of the Agency for Medicines. However, there are still questions, including on pension rights and on matters relating to the staff of the Agency. Will the agency, for example, have to build up the pensions of its staff members itself, a rumor that does the round? I would like to receive a reassuring response from you, Mr. Minister. After all, such decisions could hypothesize the motivation and job satisfaction of the staff at the beginning. I hope that you can give the reassuring message here that the agency should not be responsible for the pension rights itself.

If not, I think a Pandora box will be opened, which is not parallel to what happened in the Food Chain Safety Agency.

Now Mr De Groote has the word. Mr Verhaegen will be the last speaker of his group. I will conclude the list of speakers for the general discussion. Now comes colleague De Groote, then Mrs. Detiège, Mr. Drèze and Mr. Verhaegen. The list is closed.

Mr. Speaker, Mr. Minister, colleagues, let us say that we welcome a number of principles, especially as regards the structure and the possible — I say “possible” — benefits.

First, we support the design because it is an autonomous government. It has an autonomous governance, which in fact involves a large form of responsibility and in fact can also result in greater flexibility in order to be able to respond. That is the first point.

Second, there is a financial autonomy that allows you to manage your own budget and make independent choices.

Third, there is also the possibility to intervene quickly in the event of a crisis or risks to public health. We have also been able to set such targets with the Federal Agency for the Safety of the Food Chain. We must admit that this works very well.

Mr. Minister, in the committee you said that the Federal Agency for the Safety of the Food Chain could serve as an example. The last will be the first and the first will be the last. This was actually the case with the Federal Agency for the Safety of the Food Chain. Belgium was the first to have a food safety agency, but then four years left the funding of the agency and then this was hunted by it in a week time, on a drafte. I hope that you will not use this as an example for the Federal Medicines Agency, because we are the last before we leave anyway. Our country is one of the last European countries, colleagues, where there is not yet an autonomous body competent for medicines. This time we are really the last, because the new instrument is already seriously questioning its independence and functioning. We have heard enough today. The intention should actually be that the Agency controls the process of production from registration to use of medicinal products. The industry claimed at the time that there was a large lag in the registration of medicines by the Directorate-General for Medicines. The huge waiting lists compromised the competitive position of the Belgian pharmaceutical market versus abroad. At least that was the criticism. This is probably one of the reasons why the pharmaceutical sector is willing to put more resources at its disposal, but this – as previously cited – puts independence at risk.

The new agency should actually speed up the process. We believe that faster treatment can actually be achieved only if more staff is hired. Mr Goutry correctly referred to the audit of the independent audit agency, which stated that 340 people are needed to function optimally, while only 194 are active. Probably therefore also the criticism of Mrs. Detiège. That was the big, sensitive point. The question is whether we need a new agency for this.

Another reasonable comment in the committee was the question of whether this expansion of trained personnel will be there. The Minister has stated that the staff of the Directorate-General for Medicines will be taken over. At the State Council’s comment to define the tasks more clearly, the Minister replied that they are the same tasks as at the General Directorate. Eventually, everything seems to remain with the old, except for the aforementioned benefits that I have just outlined in the structure.

According to the audit, the operating resources of the Directorate-General for Medicinal Products also proved to be insufficient to carry out all the tasks it had. There were no resources for the DGG. Now apparently there is yet — it is joyful to establish that — a reserve built up.

I have a strong impression that it is mainly a name change and I fear that the Federal Medicines Agency will face the same problems, and that we will soon be able to hear the same criticism.

According to the consumer organisations, one of the biggest gaps is the lack of participation or representation of patients or consumers. Mrs. Avontroodt also responded to this. Health products would also be covered by the Agency. As a result of this underrepresentation, the support area is immediately much smaller. I wonder if the information and opinions of the patients are not really important. For example, in the new Agency, which will serve as a control body, there is nowhere a patient notification point for adverse effects of medicinal products. This was rightly cited by the consumer organisations. We were the last in the row, and as the last we could actually have learned from abroad. Such a notification point exists in the Netherlands, the United Kingdom, Denmark and Sweden. Their

This was also clearly the question of the consumer organisations. I think this is a missed opportunity.

Mr. Speaker, I am going around. You always ask me to keep it short. So I will do that too. It is primarily the pharmaceutical companies and insurance institutions that will be allowed to determine the policy on medicines. That is not entirely logical.

The Agency is intended to act as a control body. I fear that the independence of the new agency will be compromised, because you never know what impact the pharmaceutical industry will have on this control body. Colleagues, I just said that the structure is very good, but any good structure falls when there are insufficient resources.

I will abstain for the reasons I have just cited. Mr. Minister, of course I do not have to tell you — you know it from my previous speeches — that I am a Flemish nationalist. Finally, I support the regionalization of healthcare. I do not always give the federal agency a warm heart. I conclude with the note that I am not convinced that the brilliantly working Federal Food Agency will be equated by this new agency.

Mrs. Detiège has the word, then the gentlemen Drèze and Verhaegen.

I will try to clarify the matters that I find important, in my own name and not in the name of some of my colleagues. I am pleased that some colleagues have called me a specialist. I will try to tell a nuanced story today, but thank you for the compliment.

First, for me it is essential — I have also said it in the committee — that the agency comes there. Why Why ? Mrs. Avontroodt has just formulated it very clearly and Minister Demotte has already said it in the committee: we cannot stay behind, since almost all European countries have an agency.

Secondly, the General Directorate is currently underprivileged. This is also an important point. I have said this repeatedly in the past. I am a little scared for the future.

I hope that Minister Demotte can give a little more clarity on this issue.

I find it a little strange to say that I have never said anything about it since, for example, about medicines and the internet, I have expressed my views in detail in both oral questions in the committee and in a debate on the Seventh Day.

A third point that I think is important...

Let her speak. Mr. Goutry, I know this is not easy. Let her get a little to the temperature and then interrupt her.

Let me tell you everything first...

Let her tell you everything first and then come in.

I always keep it a little shorter than you.

... ...

Sometimes we can binge, but usually it goes well. Now I have lost the thread. Where was I?

Point three. It is about the autonomy of the agency. Everyone knows that the conversion of the Directorate-General for Medicines to an autonomous agency will mean almost a doubling of the existing budget. Therefore, in order for the agency to function properly, I ask that the contribution of the government that exists now be increased. I hope that the Minister can create a little more clarity on this. I am pleased that Ms. Avontroodt has also applied to this. When it comes to personnel costs, for example, I think we should also see a certain concession on the part of the government.

Fourth, we must guarantee independence. I am convinced that a legal basis is always needed, even in this case. In order to create an agency, we need to have a bill. This has been the case for the CTG and this is now the case for the agency. Today it cannot, but I want for the future the guarantee that, like in the reform of the CTG, we will also have a good domestic regulation for this agency. Why do I repeat this? In the report it is stated that the Minister responded that KB will provide arrangements on how to avoid conflicts of interest and that each staff member must provide a guarantee for its independence. I would just like to emphasize — and I think the plenary session is the right time to do so — that the reform of the CTG was an incredibly good reform, but that the Rules of Procedure has long waited for itself. I know this was not your fault, it was due to a number of circumstances. However, I would like you to work for this agency.

Therefore, for all these reasons — I have some sensitivities that have already been cited in the past — I would like to see that we undertake an evaluation within a normal period to verify whether the agency is operating properly, what the pain points are and what we can do about it.

I think this should be discussed in a mature way in the committee.

Finally, I want to emphasize that I am convinced that the Minister has done a good job in the past and will do so now. I find it a little regrettable that some people started bringing such an unnuanced story. I trust the Minister, but I want more clarity on the points I have quoted.

Waiting for the Minister’s answers, I would like to say that the SPA supports the bill because everyone in us is firmly convinced that we should have such an agency for the future.

Now I let Mr. Goutry interrupt you, now that you have finished your reasoning.

Now he can react. There is no problem.

See, Mr. Speaker, that is exactly what I am concerned about. Again, I am greatly disturbed by that.

Either we are busy keeping each other here and everything is already as it is and we don’t talk about it anymore, or we push to the core of the debate. If someone says: I demand guarantees, in terms of resources...

of course .

... ... in terms of more personnel, in terms of greater independence. If someone says, before the minister answers, that she hopes—that’s already a lot—that the minister...

I said I will wait for the Minister’s response.

... ... He responds, but before hearing the minister's answer, adds that it is not a problem and that they will approve it, what are we doing?

No, you are not listening well.

Well, we will listen to the answer.

It is always so. You are not listening well. You are not listening well here. You never listen well.

Double the resources, more staff. I will listen carefully to what the Minister answers.

Well, that is good.

... ... I will then look at your voting behavior.

Mr. Minister, you are given the word. Then they will all listen.

There are two things I will not accept today! The first would be to accuse this agency, even before it comes to light, of not being independent! The second is to ask, now, to define all the means that will be put in place in the future (for governments that will also follow) for the strengthening of the tools of this agency.

Let it be clear! I will not accept the criticism, for two very simple reasons.

1 of 1. For this text, we are inspired by the same philosophy that has prevailed for most agencies established in the European Union and for which these rules of independence are not challenged.

2 of 2. Other similar systems have already been implemented in our country.

Take the Federal Agency for the Safety of the Food Chain — I will not go to the end of the comparison because there are differences between the two agencies —, we find a common point: these are sectors that participate heavily in the establishment of control for the safety of the food chain. In addition, these sectors are associated in a number of opinion committees and it is no less true that the agency remains independent!

In casu, it is the same philosophy; I want to be clear; I will not allow any ambiguity to float on this topic. I would find that annoying. If a member of the majority or of the opposition is not certain of this principle, he shall not vote on this text.

Mr. Speaker, I am very seriously shocked by the speech of Mrs. Detiège.

I am not afraid of that.

I am referring to the article of Tomorrow today. I had, gently speaking, the impression that I had to deal with a stupid pupil of the class of the majority if I could use that imagery. The discourse that the person concerned now holds on the floor is one of the pupil who does his best to be very brave and hang out the fluent pupil. After listening to the Minister’s response and ⁇ its tone, I do not have the impression that the members of the opposition and the majority have received much more guarantees than during the committee work.

The crucial question arises before you, colleague Detiège, what voice behavior you will display later. You have screamed murder and fire in the press. You were very good at the speech. You have informed that your group will approve the draft. Of course, you are in the majority. Do not ask too many critical questions. However, I do not have the impression that the Minister leaves very much room for interpretation, nor has he given any additional guarantees that you have requested. You asked for black and white guarantees on more personnel, on independence and adequate funding. I think the Minister’s response to these points was not very clear.

Mr. Speaker, I do not want to make too many words dirty on this. The story I did in The Tomorrow, I have repeated here again. Were you a colleague? and no. So then.

I regret that if one of the parts of the story gets meaning in the newspaper, the whole Parliament is jumping up. I am surprised by this.

Do not exaggerate Mrs. We have already experienced worse than that.

Mr. Speaker, I am delighted that there is "finally" a little atmosphere in the debate. When I see the impact of a reaction in a newspaper like De Morgen, I assume that I will do this even more in the future.

I find it strange that one responds in this way to the concerns I have communicated several times in the past about the Directorate-General and repeat today again. I insist on evaluating in the future whether the operation is good or not. Minister Demotte has in the past promised a staff reinforcement. I hope he remains with his position.

You hope that. Are these guarantees? These are not guarantees.

I have told the journalist of De Morgen that I wish the minister to evaluate after a certain period, a year, for example. I think that is the normal course of affairs.

Mrs. Detiège, you want to shake them off, but you challenge them. Mr Bultinck, in brief. You will lose your reputation if you continue to do so!

Mr. Speaker, this is essential. Collega Detiège has asked for harsh guarantees in the newspaper. I now see that she is much less satisfied.

That is not true.

Or you have to tell this Parliament that the journalist did it wrong and provided an incorrect presentation.

No, of course not.

That would advocate for you: then you have been gentle here on the tribune and the journalist has put things in your mouth that you did not say. Or you are taking a lot of gas back here right now. It is not a shame to say that a journalist has misrepresented you, but it is essential — you can’t blame us for that — that you are polite in the discussions in the committee and in the plenary session, and your parliamentary discourse keeps only in the newspaper. This is an unworthy parliament. As a member of Parliament, I am not involved in this.

They don’t talk about the dignity of another.

When it comes to worthlessness, I would be silent, Mr. Bultinck.

Have you done talking?

I could talk about it for another hour or repeat it again, but okay.

Mr. Speaker, we have heard a number of different views and I would like to talk about this in concrete terms. Their

A new structure is being established, a new agency. You said that it is too little independent. That is the first point. The second point is that the inspection fails due to a lack of staff. The third point is that the Minister has also acquired extensive powers. Is that your impression of the bill?

I just repeat what I said here. The points that I find important are an increase in the number of staff members, a greater financial contribution from the government and a sound household regulation. For this reason, I would like to see a longer-term evaluation. Their

I also told everyone, including in the committee, that I will support the agency from the beginning, because this is so tremendously important. If we, as Belgians, do not compete with the rest of Europe, we will not be able to compete with the other Member States. We cannot allow ourselves to do so.

It is quite surprising! As there is a vacation tomorrow, we have a session this Wednesday afternoon to move things forward and you do everything you can to prevent them from moving forward!

Mr. Dresden, you have the word. You are a highly applied and very serious member. Demonstrate it !

Mr. Speaker, if you wish, I can feed the discussion with my colleagues until tomorrow.

Or until afternoon. It doesn’t bother me, I’m used to it.

Mr. Speaker, since my group leader asks me to do so, I will go to the goal.

Mr. Minister, in the committee and in the plenary session, our excellent colleague Mr. Luc Goutry raised many relevant questions, including on a few points that I will return to. First, the lack of staff within the current General Directorate of Medicines. Second, some management issues; we talked about them through oral questions in the committee. Third, questions about the financing arrangements and the dependence or independence of the Agency at this level from the pharmaceutical industry.

Mr De Groote, Mr De Crem, the attention of the Chamber that you asked there later...

Finally, the ability to combat excesses in the promotion of medicines.

Mr. Minister, you have responded in the committee and you have sent documents that are attached to the report. Unfortunately, most of Mr. Goutry is still. You said in a committee of the current General Directorate of Medicines, I quote the report: "It fails to properly perform its tasks, due to lack of sufficient resources." You added: "This situation causes a significant delay in the processing of files and results in failures in the execution of tasks."

At the level of staff, you have indicated that the creation of an agency will enable it to be empowered and, in this way, to get out of the current difficulties that would be – and this is partially true – due to a legacy from the past.

You add that, ultimately, the current tasks of the General Directorate are simply taken over by the Agency. You say that the staff of the DG3 will be taken back with ⁇ ining its status and its oldness. You conclude: “An existing situation is thus confirmed.”

It is therefore difficult, Mr. Minister, to discern what will really enable the Agency to be effective where the DG3 is experiencing serious difficulties. by

Do you really believe that independence will solve everything? Personally I doubt, at least on one point: the industry weighs too directly on the agency by its significant participation in its financing. You indicate the following in the report: "If the industry is satisfied with the functioning of the Agency, it is willing to put more resources at its disposal." You indicated that the financial reserves currently amount to 22 million euros, an amount greater than the annual budget of the Directorate-General for Medicines. As you mentioned, the budget of expenditure for 2006 is 14.4 million.

Regarding these important financial reserves, you explain that this is due to the lack of flexibility of the DG3. In other words, you announce the color. In response to the lack of financial resources, the new agency will be able to draw on the reserves that will be transferred from DG3 to the agency, as you announced. Mr. Minister, when the reserves are eaten, what will you do? Refinancing the agency? The answer is derived from your comments in the committee: "If the agency works well in the eyes of the industry, it will increase its contribution." Goutry is right when he says it is self-control. I just heard your warning. I respect it, but I cannot censor my words and I believe that the debate should take place.

Through various questions in the committee, I have asked you several times about the possibilities of self-regulation in case of lack of public funds, due in particular to problems in the field of medical devices or the findings of clear and regular violations in the field of promotion of medicines. I find that your answer today to these questions about self-regulation leads you to link the controller and the controlled by direct financing that risks enslaving the controller to the controlled. The option is taken. I respect her. It is supported by a majority. It may be relevant, ⁇ our warnings are unfounded but, in any case, we will have to remain extremely vigilant on this point.

Finally, regarding the representation of patients, you are right to remind Ms. Burgeon, among other things, that the first representatives of patients are mutual. This, no one disputes it. However, it seems important to us that in one way or another – we can reflect on different formulas – associations of patients participate in the device. Indeed, in some cases, the experience has shown that a pedagogical dialogue with patients has helped to better inform and restore confidence.

Having multiple channels can be helpful. I think, for example, of the recent problem of very expensive and non-refunded medicines by the INAMI.

Lastly, unless some amendments are submitted – let them be by Mr. Goutry or Mrs Gerkens – if they are adopted just now, we will not be able to support the government’s project. We support the objective. We support the creation of an agency, but not without deeper reform. Therefore, unless certain amendments are adopted, the CDH will abstain at the time of the vote.

The last speaker is Mr. Verhaegen.

Mr. Minister, you have already answered several times, but you have the right, the constitutional privilege, to intervene at the end of the debate.

Mr. Speaker, Mr. Minister, colleagues, I am not telling news when I say that health spending is rising four times faster than economic growth. The confrontation with ageing will really be very brutal for our society.

If we want to maintain the system of social security, then we must dare to turn to the system. Then we must realize that the time for easy solutions to difficult problems is finally over. Keeping our health system manageable, that means for me to bear responsibilities. Paars has stunned the moment with the announcement that the expenditure of the health insurance can increase by 4.5% annually. According to the Study Committee on Ageing, that was too much. The National Bank has described this as unsustainable. Paars stunned that moment, because there was no conversation at that time and there could still be tough agreements made with all healthcare providers about the necessary changes to make the system manageable. A growth perspective in exchange for cooperation on change, we would have done so. Unfortunately, this has never happened.

Patients always have to pay more. Under purple, the patient’s personal costs increased by as much as 26%. The counter is still running. With the agency, the brave patient, who always pays more, the first concerned, has nothing to break in the box. He has no representation in the Advisory Committee. Test-Acquisition and the Flemish Patients Platform rightly tied the cat to the bell. If the Minister wants to create a support, then this must be remedied quickly.

This is why we have decided to help the Minister. We have submitted a sub-amendment to include the patient organisations, which for us are not commercial organisations. I therefore hope that Ms. Avontroodt will be consistent with the bills submitted by her party in Parliament, and we will receive support for our sub-amendment.

I also hope that there is no fear of cold water and that more transparency can be achieved in the operation of the Agency through the Advisory Committee.

There should also be no doubt that we are well aware of the great importance of the pharmaceutical industry in Belgium. The pharmaceutical industry is for Belgium what Nokia is for Finland. This is clear to us. It is not so much about the companies that simply import and export medicines and live of marketing, but especially about the companies that invest in Belgium, which engage in research and innovation and create highly qualified jobs for 26,000 people.

The establishment of this Agency can therefore be a way for us to better position our pharmaceutical companies at the European level.

Society should also continue to demand that public health should be given priority over making profits by industry. Public health should be at the forefront. Community funds and contributions to social security are also being used to pay for the drug policy.

Today there is a knowledge gap with the pharmaceutical industry. That is why we have long been advocating from the opposition for the establishment of a fully independent center of knowledge for medicines. Now we get this with the Federal Agency for Medicines and Health Products.

The Federal Agency, and who knows later also a Flemish or a Wallish agency, must provide the government with the necessary know-how to be able to formulate a good policy. Knowledge is power, but power must always be able to be controlled. We strongly advocate this.

I note that the FAVV is used as a bright example for this new agency. However, I automatically ask myself whether we will need to spend another four years to get the funding around. You know that the situation is already acute and therefore waiting four years would be unacceptable. The law on the financing of the FAVV came only five years after the dioxin crisis, four years after the establishment of the FAVV.

What the FAVV also has in common with this agency is that the debate is pursued with the same speed by the Parliament. We hardly had time to hear experts. We always found it too fast and the approach was bad too.

However, we are partly in favor of the principle of structure. A parastatale A is also good for us. It gives the necessary autonomy, the necessary independence to attract higher-educated people – which is very important – and to be able to use the budget much more flexibly. These are indeed advantages.

We may ask ourselves whether, in view of the existing large differences in health care between the north and south of our country and the ever-growing insights in health care – I refer to the drug consumption in Wallonia which is almost 20% higher than in Flanders – we would not have better awaited a new step in the state reform before establishing a federal agency. The Flemish government agreement, by the way, also clearly advocates for the division of health problems.

Like Mrs. Detiège, we are skeptical of the far too large powers that the Minister has assigned to himself in order, in our opinion, to undermine the autonomy and the objective functioning of this Agency even before it is held above the baptism.

The Minister was very nervous about this. In any case, our criticism is similar to the opinion of the State Council, which the minister has submitted side by side.

I therefore think, Mr. Minister, that the ignorance of the State Council is typical of the socialist tenacity with which you, though with the greatest affection — that I must admit — oppose some important legitimate reforms addressing the transfers between the north and the south. I cannot let it say that.

Our substantial criticism then is that the Federal Agency for Medicines and Health Products plays a purely technical role. It is not finished and offers only a partial solution. It has no health-economic assignment: about pricing and the refund schemes, there is no talk. That is in Economic Affairs, colleague Goutry said, and also in part in the RIZIV, through the CTG, which must advise the RIZIV. You choose a partial approach to a complex problem. We regret that.

Therefore, we have submitted an important amendment. It is the first thing we submitted and immediately the most important. In this context, we advocate the establishment of two agencies: a technical and a financial agency. The financial agency can then, for example, also fulfill a number of contracts that have now been avoided, for example concerning the me-too medicines and call marketing and also prepare the tenders. All this could be done to support the CTG, in order to be able to do real therapeutic market exploration. That gap is clearly missing, in our opinion.

Mr. Minister, you had twisted in the explanation about "the unsatisfactory operation of DG3", but I think you should definitely look first in your own belly. I think this is a real depreciation of the employees there. Last week I read the 2005 annual report. I have seen all the actions of those employees. These illustrate that DG3 works with a vision and that there is only one major problem: the acute shortage of personnel, which makes its proper functioning impossible. I also think — this has already been quoted by several speakers here today — that it is really pumping or sucking at DG3. It can therefore not be otherwise, as I conclude, that DG3 can only carry out the important tasks and that it simply cannot carry out equally important but ⁇ less priority actions. This then indeed leads to great insecurity, vigilance can no longer be guaranteed and so on. So, that is a problem. It seems to me a wonder that DG3 can still present such a palmares, as we have identified in the annual report, especially because the audit revealed that there is almost half-power work. This is very important for the proper functioning of the service.

I really have the impression that purple wants to abuse the problematic staff force to settle with the management, then maybe appoint some political friends, who knows. I ask that question.

Mr. Speaker, colleagues, our amendments concern the guarantee for Parliament to guarantee that independence from the pharmaceutical industry, to avoid conflicts of interest and to increase transparency for the Advisory Committee. Who can be against it? I am firmly convinced that the committee members have not even read the amendments seriously. I have seen how the majority just blindly wiped them off the table, without much explanation. They just said “no” or “it’s not going.” I regret it, because these are thoughtful amendments, on which we have worked really hard.

We want a demand-driven policy, based on the needs of the community, rather than a supply-driven medicine policy. This is crucial for us. Health policy should also be adapted to the needs. By starting from research on the needs of medicines and by using cheap medicines, we would be able to unlock resources to provide opportunities for innovative research and innovative new medicines. In this way, we can also improve the medical arsenal. We would give companies space to innovate. We would not punish them linearly, just because they are pharmaceutical companies.

We would ⁇ have also, within the framework of this bill, organized an hearing with the Directorate-General for Medicines, in order to assess the situation, before making such a fundamental decision. We would better consider whether the Federal Medicines Agency can provide an answer to today’s questions. We would also provide the guarantees for a truly independent agency. That is the core of the case. We would use more resources, especially for a preventive health policy.

Finally, Mr. Minister, I have a lot of questions — I have already said it — with regard to the innumerable number of KBs that will come to clarify the case. I can’t get rid of the impression that this bill is just wallpaper, which is glued over DG3. The façade must be fixed. It is typical of purple: only the street side counts. The façade is important and the rear face will then be laid up a little later. Even the subsequent documents, colleague Goutry also referred to, can not give me any clarification about the funding. From this, it can be inferred that there is no perspective for the structural shortage of active agents.

I therefore have a strong suspicion that the government here does not sell old wine in new bags, but that one simply wants to sell old wine in old bags. Only the colloquium of the VLD is apparently new because it will be coincidental or not. So I wonder where the headquarters of Pfizer is located. Because of the absence of colleague Turtelboom, I think that asking the question is also answering the question.

I would like to conclude, Mr. Speaker, colleagues, by saying that such an unfulfilled bill will ⁇ not take away our approval. We believe that agreeing to such a design is not good for health.

Mr. Verhaegen was the last speaker on the list of the general discussion.

Mr. Speaker, this debate was long, interesting, with rebounds, even outside of this assembly. No one will complain about it, except ⁇ consistency.

To answer the questions left unanswered so far, some clarifications will help to understand that we want to establish transparency on all points, even those left in the shadow.

A question was asked in the committee, for which Mr. Goutry did not seem to have yet received a satisfactory response; it was the use of funds, including the Medicines Fund, to settle certain campaigns. The “Generics” campaign in 2004 would be a good example. This campaign had all its utility; in total, it cost about 1 million euros. The fund was used only once. With regard to the establishment of the strategic inventories of antivirus, it has been drawn to the fund for a recovery, but in the future we will provide funding to the agency through the dissociated credits technique in order to set up these new strategic funds.

The issue of independence has been addressed from several angles. First, financing: if, tomorrow, new needs appear, what will be the methods of financing the agency? This is similar to the AFSCA. Attention, I limit the comparison to this element to remain reasonable. Indeed, the AFSCA can play on remuneration, on the contribution of sectors and on its dotation of the State. Let us maintain the same vision with regard to the Agency of Medicines, which must be able to rely on the same three elements.

When it comes to remuneration, if we are forced to increase remuneration rates tomorrow, it does not mean that we will become more dependent on the industry. Indeed, these are mechanisms by which we pay for various services provided, allocated to the repayment of tasks, but they allow to release funds to carry out checks and inspections. This is a guarantee of future independence. This is the answer to the questions posed on this subject.

Another element: the representation of patient organisations. In my opinion, mutualities play a fundamental role in this area. I have always defended this option and I have never closed the door to certain sensitivities to complete this vision. Apart from some reservations on the nature of the representation, which must offer a guarantee of serious.

It happens, for example, that for the promotion of a number of medicines, all associations of patients that gravitate around a single pathology are oriented towards the same medication. In this case, we obviously cannot take the risk of opening the door to this type of excess. In addition, it happens that the representativity of some extremely varied associations is itself subject to caution. Therefore, it is necessary to be cautious if, tomorrow, the Advisory Committee considers their integration in one form or another. Madame Avontroodt, however, be aware that it is not in our intention to limit representation to what it is today. We want a more dynamic approach. This is clearly the spirit of this government and this text allows it.

As regards incompatibility, the incompatibility rules, in particular those contained in the Act of 1 May 2006, are obviously applicable to members of the Agency’s staff. There must therefore be no conflict of interest in the head of the members of the Agency. They must be free of the risk of being confused with the pharmaceutical industry if they provide services or have a direct interest in it, for example in the form of shares in that industry, which could affect their decisions. The conditions of independence are clearly guaranteed.

In the context of the linguistic framework, Mr. Bultinck, of course, is the 1963 law that will guarantee the linguistic balance. We will start from the current key of the federal public service. How will we proceed to see if this key still corresponds to reality? The Act of 1963 establishes a framework that must take into account in particular the nature of the benefits. In this case, the nature of the benefits is related to the number of Dutch and French-speaking cases filed. Based on these files, we will see how to correct the framework. In any case, we will not be very far from the current figures. In my opinion, and I’m talking about memory here, the current keys should be in the order of 52-53 and 4748.

The last element I wanted to address at this stage is that of the independence guaranteed by the nature of the Agency: a type A parastatal means more flexibility. Thus, a number of management choices will no longer depend on the entire administrative and financial process that is currently applied under the SPF. by

In other words, this is not an insignificant matter. Remember the debate we had within the committee on the release of a number of means that were always dependent on a series of relatively long decisions and that, in the end, disappointed a large number of actors, hence the interpellations and questions on the subject. Remember also the debate about the computerization of services. by

I will conclude with a political consideration. One can always improve the systems, one can always make sure that the laws texts creating the organs are improved, but like the metaphor used by Mr. Goutry in commission seems right to me, I will now take it back. We are really busy building a house. It may be regrettable that this house is summarily furnished. Personally, I think this does not mean prejudice to how we will equip it. by

If other things need to be executed, these choices will have to be made based on the BPR that took place in 2003. Knowing also that a number of BPR recommendations are already implemented in the perspective of the preparation for this agency that will come into being and that the established agency will have to continue to move in the direction indicated by the BPR. If the Agency determines that the performance of its tasks is subject to increased human and financial resources, it shall use different tools.

Obviously, in my capacity as a Minister who has the tutelage on this organ, I will be attentive to his requests. But let’s not put the chariot before the cattle. We will see the situation as soon as the Agency begins to take its first steps.

I think we had a good discussion, well animated!

Mr. Speaker, Mr. Minister, I would like to give you another reply. You have listed something. However, I can call this very concrete answers. You explained the funding, the salaries, the grants and so on. However, you have not given any guarantee. I understand that this technique of grants and remuneration will be used. I also understand that if you provide more services, you can ask for more pay. Their

Today, however, this cannot guarantee that the necessary resources will be available to the Agency. For me, that is the precondition of existence. That is the essential condition to be able to speak of an independent, well-functioning, independent Agency. Secondly, you said that there should be additional staff. The BPR is there, but you should look at it. However, this has been done for three years. Certain things from the BPR have been done in the meantime, but the major criticism remains that there is far too little manpower for the work that needs to be done. Their

I will give an example. Ladies and gentlemen, do you know that there is currently on the DG3 one person for communication on drugs? There is one person. It should be able to counter the 4,000 physician visitors who are sent back every day by the firms to the doctors. This is a disproportion. It cannot. That is impossible. Their

You know that for a long time before the vigilance there was not even a doctor available. There was no doctor and there was no replacement. Finally a doctor was recruited. Mr. Minister, these are understated conditions. If they are not addressed structurally, then you do a transfer of problems, but not a transfer of solutions. That is my fundamental criticism. I think, in order to be clear, that there is absolutely no way to talk about guarantees in terms of resources, in terms of personnel. Their

Independence is in the middle. You say that it is clear, that there should be no mixture, that there should be no mixture of interests, and so on. How is this arranged? This is not regulated in the bill today. You are asking delegations. There are no sanctions provided. What is the value of the law that we approve today? It would then have been much better to provide for the implementing decisions that you have to make in this regard, which are essential, in the law itself. There could not be any discussion about this. Their

I honestly think the following, with all the good will of the world. I will continue to repeat it. We are in principle in favour of the organizational form, we are in principle in favour of a flexible, autonomous, self-employed agency, but not under these conditions. There are no guarantees. For us, that is an extra reason not to approve it. Their

I am convinced that the Sp.a. will refrain from this, due to the lack of guarantees – the Minister’s response shows that there are no guarantees – because of the lack of guarantees.

My remarks are perfectly complementary to what Mr. President has just said. and Goutry. If I simplify the words of the minister, and he recognized it in committee, I would affirm that the current Direction does not work well. To solve this problem, we do not increase the resources, neither financial nor personnel, but we bet on autonomy.

In this regard, Mr. Minister, I have one last question. You said in committee that the revenue of the DG in 2006 amounts to 16.5 million of which 11.175 million are allocated by public authorities. These are your words. I deduce from this that the balance, i.e. 5,325 million, comes from industry. Thus, a third of the current funding comes from the industry. You added that if the industry is satisfied with the way the Agency works, it is willing to put more resources at its disposal. by

My question is simple: the industry now funds a third. To what level of industry intervention are you ready to go? 40 percent, 45 percent, 50 percent, 55 percent. To what extent do you think industry financing is compatible with the Agency’s autonomy?

This is a question that can be asked by an opposition member. But I cannot answer it in the terms in which he puts it because I think those terms are not the right ones. The question of percentage is not important to me. The question is how this money will be used. by

There are needs that are in particular related to the agency’s tasks, which we have talked about so far, such as the increase of remuneration, as was done for AFSCA. This was justly mentioned by one of you recently. It took some time to determine how AFSCA was funded, it did not do it overnight, while we all agreed on the principle. By the way, this was very difficult because every time a financing track was proposed, there were counter-reactions: one sector reacted, then another and there was no possibility to immediately set an ideal framework. by

We will experience the same thing with the Agency of Medicines. I will not answer in terms of percentage because the real question is what are the absolute resources that will be needed according to the needs defined by the Agency, which must first start operating.

I would like to correct one last thing. Regarding the starting point, I did not say that the reason why the Agency was created was due to the failures of the Management. I read this in the interventions of all members of the social Christian opposition, French and Dutch-speaking. by

For my part, I never said that. You can look at the texts. I have been extremely cautious on this subject because the question of management in the future structure must meet competence criteria. If the skills are there, regardless of the person, whether he is a member of one or the other structure, as soon as he makes the assessment and his skills are recognized, I do not attach any importance to the political color. The proof ? In the parastatals under my responsibility, there are people of all obedience; in my political cabinet, there are people of various political obedience and not only of mine. And I am proud to have competent people around me!

On the one hand, I am pleased with what you say about the shares. I think it is very important that, in order to safeguard their independence, the inspectors and the staff of the Agency can function properly. I am pleased with the share section.

What I miss a bit is the story around that evaluation. I would really like to discuss this in the committee in Parliament. The date can be specified further. The draft law on the Agency is there, the backbone is there. We need to look into the future, whether it is going well. I would like to clarify this a little more.

Thank you for letting Parliament have the last word.

Mr. Minister, I give you my answer regarding the maximum percentage: in my opinion, it is 0%. by

However, since I recognize that there is a need for funding and a scarcity of public funds, I would have preferred that the 5.3 million euros be allocated directly by the industry to the general budget of the INAMI, by increasing industry taxes and other elements. The INAMI could then finance the Medicines Agency 100% and in a completely impartial manner. In this hypothesis, the Agency would be equally well funded, but there is no doubt as to its control by the industry.

I would like to complete the speech of Mr. I agree with Drake, with whom I do not fully agree. The request for a financial contribution from actors controlled through such an agency does not prevent that agency from operating in full independence if the rules of operation are clear.

On the other hand, it is important that the calculation of their contribution is defined through the law, through decrees that can change according to new needs, but it can in no way be a contract that is negotiated between the agency and the companies. I cite the case of nuclear control, in particular the one where the agency must negotiate with the producers of nuclear materials and waste, how they will self-finance. In this regard, one can actually fear negotiation problems between the controller and the controlled. In the case that concerns us, it is a fear that I do not have.

So, Mr. Minister, you consider that the amount of 16.8 million planned for 2006 will allow the agency to fulfill its tasks and function properly during that period.