Proposition 55K0723

Projet de loi modifiant des dispositions législatives en ce qui concerne la transparence des conventions en matière de spécialités remboursables.

General information ¶

Authors

DéFI Sophie Rohonyi
Ecolo Laurence Hennuy
Groen Barbara Creemers
N-VA Kathleen Depoorter
PS | SP Eliane Tillieux
Vooruit Jan Bertels, Melissa Depraetere, Karin Jiroflée

Submission date

Nov. 7, 2019

Official page

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Status

Adopted

Requirement

Simple

Subjects

administrative court pharmaceutical industry medicinal product health policy administrative transparency

Voting ¶

Voted to adopt

Groen CD&V Vooruit Ecolo LE PS | SP DéFI Open Vld N-VA LDD MR PVDA | PTB VB

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Discussion ¶

April 16, 2020 | Plenary session (Chamber of representatives)

Full source

The rapporteurs are Ms. Merckx and Ms. Sneppe, who refer to the written report.

Mr. Speaker, colleagues, with the Transparency Act, we are taking an important step on the pharmaceutical budget, which we have already discussed this afternoon. Articles 81 and 111 on medicines have come with the best intentions. One would negotiate and find an optimal approach for patients in a small country, together with the pharmaceutical industry. That was very noble and good. We started in the first year with a budget of 41 million, where we are now at 600 million. That’s a third of the pharmaceutical budget and a huge amount. Parliament cannot exercise control over this. I do not know of any other department where it is possible that a member of parliament cannot have access to such a large budget of public funds.

We noticed this especially this summer. We were pressed with the nose on the facts in Italy, I give the example of Lucentis and Avastin. They are two similar molecules that can be used for the same condition, old age blindness, but the price difference is double. If Parliament cannot investigate whether there are possible agreements there, if we hear that it has gone wrong abroad and that there are convictions, then something is wrong. It is the task of the Parliament, when we feel or suspect that there is something wrong with the agreements, to get in touch with them. This is very difficult for the government: it refers to the contract, according to which it cannot break the secrecy.

With this bill, we work on transparency. We have repeatedly stated this in the committee: we are absolutely not concerned with not making such contracts possible in the future. We are very aware that innovation is very important and that accessibility for our patients is even more important. In a small country like ours, it is therefore important to look at that with the pharmaceutical companies and negotiate it so that we get an optimal price for the medication for our patients.

Could it be wider? Yes, it can be. I just referred to it. We can also introduce mechanisms such as a pay for performance.

We are now talking about contracts that are being concluded. We need to look at future contracts. I also know that some members will argue that it is very unfortunate that we cannot look back at the past, but those contracts are already there. In order to maintain legal status, it is very important that we look at future contracts.

Now, Parliament will effectively be able to assign a research assignment to the Court of Auditors to verify whether the interests of our patients have been safeguarded optimally.

That is what we want. It should be Parliament’s starting point to ensure as much as possible that our patients have access to innovation and that we all can exercise control.

After all, it is always about the patient.

The development of innovative medicines that treat certain cancers or rare diseases is essential and even vital for patients. However, the cost of these drugs is exploding due to the expensive state-of-the-art techniques through which they are developed as well as due to the significant profit margins required by the pharmaceutical industry.

Their financing through social security has also become increasingly difficult, but it would be unacceptable that patients who need it do not have or no longer have access to it tomorrow. This is seen in the medicines budget, which has experienced a systematic drop in the last five years, a budget surpass of one billion euros, with one-third of this surpass reimbursed by the pharmaceutical industry and two-thirds absorbed by our health care budget.

Thus, during the previous legislature, the use of confidential agreements (Article 111, formerly Article 81) between the minister and pharmaceutical firms literally exploded. Established in 2010, the procedure for access to the refund of medicinal products, parallel to the conventional procedure, was exceptionally intended to make an innovative medicinal product available to patients while certain uncertainties regarding its cost or effectiveness persisted. Today, it is 118 molecules, out of just over a thousand, that are reimbursed through this type of contract. This represents more than 1,422 billion spending in 2018 out of a total of 4,890 billion. This accounts for approximately 30% of the medical expenditure. The amounts of the returns are the result of the excessive prices requested.

In the absence of cooperation and transparency between states, the system allows the industry to maximize its profits by further reinforcing the information asymmetry between it and the various public authorities.

Recently, the KCE, the federal center of expertise, has formulated a series of paths for improving the system of conventions and putting more emphasis on the benefit for the patient and above all on the long-term sustainability of health insurance.

For our group, the proposal we have co-signed will allow, when the Court of Auditors is referred to a specific request for an investigation relating to one of these contracts, to have wider access to information relating to those contracts.

Another issue that this raises is that of confidentiality. This will be preserved, since the Court of Auditors has already planned to take internal measures in this regard. It also specified that the reports on the results of the investigation will be formulated in such a way that no third party can deduce confidential information, either directly or indirectly.

For our group, these conventions should also be able to be examined closer. We must be able to ensure their necessity and their compatibility with the objectives pursued when setting up this system. We should also be able to base our judgment to evolve and adapt our legislation in this context if necessary.

Mr. Speaker, we are ahead of a bill aiming at greater transparency regarding the so-called Article 81 contracts. These are innovative medicines whose price has been established through secret negotiations between the Minister of Public Health and the pharmaceutical industry. Created as an exception, they usually became the rule. Today there are more than 180 secret contracts. That was not the intention, and it can never be the intention.

The Flemish Interest is therefore in favour of this proposal, but not without any objection. We therefore hope that the patient will continue to have access to innovative medicines, even if the pharmaceutical industry needs to engage. Therefore, we also submitted an amendment to ensure that companies continue to introduce innovative medicines on the market. If they were to disappear, many patients and their families would be left to their fate, and we do not want that.

The Flemish Belang believes that here again a patch is laid on the wound, instead of cleaning the wound completely. It is, of course, a beginning, but in fact, this bill should be part of a complete revision of the procedure for the placing on the market and the pricing of medicinal products. This review should be done in consultation with the various actors, but always with the patient in mind. The Flemish Interest is willing to cooperate with it and to put on the table worthy proposals.

Mr. Speaker, dear colleagues, we are talking here about the “Article 81 conventions,” those conventions denied by some but that give access to innovative medicines quickly for patients who cannot wait.

The proposal provides for access to all documents of the conventions, including confidential annexes, which refer to the refund of those medicinal products whose therapeutic effectiveness has not yet been proven but which is nevertheless intended to be made available to patients.

We will vote on this proposal because amendments have been made in an indispensable way in the framework of our committee work. It was indeed necessary that confidentiality guarantees remain provided in the context of this new access for the Court of Auditors, as it was essential to ensure that conventions already in force that give access to medicines are not challenged. This will allow for increased accessibility to information, while preserving confidential elements.

Colleagues, this bill effectively addresses the secret contracts that have become increasingly effective in recent years, so we do not know how much is actually paid for a medicine. Originally, these contracts were intended as an exception to make innovative medicines accessible to patients, but today we see that it is no longer just under these conditions.

Take the example of Xarelto. It is a well-known medicine to dilute blood. This has been repaid since 2009 and can therefore hardly be considered as an innovative medicine ten years later. However, it is still under contract. Another example is Sovaldi, a very well-known antiviral agent against Hepatitis C. This has been under contract for years in our country. We don’t know the exact price, but we know that it’s about a few tens of thousands of euros per treatment, while we also know that this drug is produced in India for 100 euros per box.

The monitoring report shows that under Ms. De Block’s policy, the medicines budget under secret contract has increased to almost 30 percent. It was 18 percent in 2016. There has been a huge increase in secret contracts. More than 118 medicines are under contract. The criticism of these contracts is therefore very large, including from the Knowledge Centre, which also studied this in 2017 and indicated a number of pistes to change the system. It was therefore made clear that these secret agreements provide a clear benefit, especially for the pharmaceutical sector, and that patients must bear the burden increasingly. The pharmaceutical industry is, of course, very eager, as no one knows exactly how much the taxpayer pays for the medicines.

This bill is therefore a step forward, because in some way there can still be an indirect insight into future contracts. I hope that this legislation will eliminate this practice.

I would also like to come back to the origin of this bill.

In October 2019, a big headline appeared in The Last News: "Farm companies are grabbing half a billion euros from social security and the government is watching." It is about a long-standing problem where two molecules can be used for eye medicine, one of which is much more expensive than the other. For these practices of false competition, convictions have been issued in Italy. Countries such as the United Kingdom and the Netherlands therefore decide to allow the cheap medicine on the market, so that the treatment can be carried out in a much cheaper way. In Belgium, however, we cannot find out the details, as that 500 million euros is calculated indirectly. The next day, the newspaper The Last News titled: "Secret deal comes out The Block conveniently." The problem is that the official price of a Lucentis spray is 650 euros, while the cheap medicine costs only 50 euros. However, we do not know how much we really pay for Lucentis. Minister De Block hides behind the secrecy of the deals. However, we know that the discount is on average about 25 percent, so we can assume that a Lucentis spray may only cost 480 euros. That only 50 euros would be paid for, is not evident from the MORSE reports. We do not know. And effectively, at the end of the month, I reopen the newspaper, this time De Standaard: "Sp.a and N-VA shake hands together against the dark farmadeals." This is how this bill comes to the table.

The bill is motivated by the problem of for example Lucentis versus Avastin. It is stated that we cannot actually know whether the deal with Lucentis is a scandal or not. It is obviously a scandal, but how much exactly we pay for the medicines from secret deals, we still do not know. The purpose of this bill is to find out how much we as taxpayers actually pay.

The bill has been discussed several times in the committee. There was also an opinion of the State Council. I would like to stop at this point, since this hemisphere always considers the opinion of the Council of State to be very important.

Well, in this case, the opinion of the State Council is very clear. The Council of State states that although we have the right of access to both current and future contracts, the Council of State formulates that opinion very cautiously: we must not directly look at those contracts but to do so instruct the Court of Auditors, which can calculate how much was paid. Our access rights are therefore quite indirect and somewhat closed. Further discussions in the Chamber show that the principle of the right of access is, however, acceptable. This is nothing but a clarification of what is already stated in the law.

I still do not understand today, colleagues of sp.a and N-VA, why, despite a large majority in this hemisphere and the positive opinion of the State Council, you have yet to admit and have yet to ensure that one can look only in the future contracts and not in the contracts that are now in effect. These are contracts that weigh 30% of our budget. We really need to know whether they should still stand or not.

I can only decide that you are also plotted for the big lobby machine of the big pharma, because they have swung with processes. What is actually hidden from us? Why will we not be able to look at the contracts that are still ongoing today?

Mr. Speaker, colleagues, as you have heard that article 81 contracts are really up to the imagination. Very bad, for some. We are looking at the expensive price of medicines. Of course, there is something to say for this. We definitely need to look for formulas to keep drug prices affordable.

What are the so-called secret pharmacadeals? This is actually done in a working group, which also includes mutualities. I think they represent the patients in this. They are negotiating with pharmaceutical companies to bring new products to the market. These include discounts, but also other issues.

A pharmaceutical company that gives Belgium a discount for a new medicine would rather not want the whole world to know what discount is given in Belgium. If this is allowed, what is the consequence? That is that our country will always be the last in the row when it comes to access to innovative medicines. Patients will be sick longer and will have to wait longer for ⁇ a life-saving medication. In addition, they do not look at the added value of these medicines. These medications often save lives.

Mrs Merckx, you regret that the agreements currently existing are not covered by this bill. It seems to me obvious that they fall out there. This is also something that Open Vld has very strongly advocated for. We are also happy that this has happened. During the game, the rules of the game cannot be changed. If Belgium does, it breaks the agreement with the pharmaceutical companies and then they can immediately withdraw their medicines from the Belgian market. Then you will probably question Minister De Block about the shame that certain manufacturers take away access to certain innovative medicines from our country.

We said from the beginning that we would agree to additional control of these contracts, but on the condition that confidentiality can be guaranteed in some way. This secrecy has been confirmed to us several times, but I would like, like in the committee, to emphasize the Court of Auditors’ remarks. The Court acknowledges that it will need to be very careful in its reports to avoid that the information it lists in its reports, ⁇ in combination with other sources, could violate the rules of confidentiality. It has also warned that some questions may therefore not receive the answers that the applicants expect from the present proposal.

So we are really in front of a test and if that test goes wrong, it will not remain without consequences. Patients with, for example, a life-threatening or rare condition will be the victims of that, but we have confidence in the Court of Auditors and for that reason we will still support the bill.

The Court of Auditors has experts. On the other hand, it specifies that it does not necessarily have one in order to be able to examine this type of convention.

We will vote on this text, even though we remain convinced that the Medicines Refund Commission is the most appropriate actor to assess the relevance of Article 81, thanks to its mastery and knowledge of the entire aspect of innovation and the issues related to the optimal use of the healthcare budget.

The Commission has already been established. Now, although it knows the content of these famous conventions ex article 81, it is obviously not able to weigh on the choices that have been formed. That is why we propose to strengthen the role of this instance so that it can use its expertise in a more supported way and assume more of its role.

In this regard, I will send a letter to the President of the Public Health Commission. Since our energy is mobilized by the fight against COVID-19, I know that it will not be immediately, but my goal is that we can hear in the House the Medicine Repayment Commission.

Mr. Speaker, Mrs. Minister, dear colleagues, I am ⁇ happy today to support this text as I was happy to co-sign it. I would like to thank Ms. Jiroflée for her initiative, which is ⁇ another step towards better accessibility of medicines. This is especially important at the time of the health crisis we are going through.

On several occasions, the INAMI has denounced these famous "Article 81" conventions that carry uncertainties around the target group, the true clinical effectiveness of medicines but also their budgetary impact. According to Test Purchases, pharmaceutical firms tend to set tariffs that are increasingly higher for their medicines.

Innovative cancer treatments, for example, cost four times as much today as ten years ago. You may ask yourself whether this is due to the cost of research and development. This is not necessarily the case since research is also funded by public money through a series of tax benefits, so that the patient eventually pays his medicines twice: once at the pharmacy and once through his taxes.

Research funded by public funds is not always useful. In fact, of the nine-two drugs that appeared in 2017, only ten would present a real added value compared to what existed already. It would therefore suffice a slight modification without real added value to be recognized as innovative. Because companies do not necessarily share their data, similar research would be conducted simultaneously in the same areas, with the result a multiplication of costs that must be avoided.

The KCE and its Dutch counterpart ZIN developed four scenarios to exit the current system. We prefer public-private partnerships based on binding public procurement, specifying the needs to be able to meet as well as the requirements expected to benefit from public aid and specifying the conditions of access, all in the greatest transparency.

This new model should gradually replace the secret conventions, starting with the needs that are not met. To this end, it should be possible to have a register of diseases for which a lack of medicines is actually found. This registry will be constantly updated.

We also believe that we must be able to build solidarity between the EU member states. Actually, each state negotiates individually with firms, which puts them in a position of strength. I invite you, for all these reasons, to support this bill.

Mr Bertels, you have the last word on behalf of the members of Parliament.

As a last speaker, I would like to thank the members for the constructive cooperation in the committee. Our proposal, for which we have taken as a starting point the previous hearings and the critical comments in Parliament and the reports of the Knowledge Centre, was constructed constructively in the committee and could therefore count on the approval of the overwhelming majority of its members.

Mr. Speaker, I will not repeat everything; that also does not make much sense. It is important that there is transparency where necessary. For one-third of the pharmaceutical budget, we need to be able to take note of the agreements, ⁇ given the fact that some contracts are concluded for several years and are often renewed. At the same time, we maintain Article 81/111 agreements. There is transparency through the Court of Auditors.

The Court of Auditors responded very respectfully in its double opinion. We must therefore also not express suspicion to the Court of Auditors – Mr. De Caluwé is now gone – because it will carry out its task serene, correctly and with respect for all rules.

The Court of Auditors should be able to verify, including the "secret annex", but with respect for the confidentiality of the data. That speaks for itself. Contracts for innovative medicines, which we have talked about very often – remain possible. However, they should remain the exception and not make up 30 percent of the pharmaceutical budget.

I will immediately answer a few questions. After all, I, together with Ms. Depoorter and Ms. Jiroflée, are the main speakers of the proposal.

Following several opinions, including from the Council of State, the RIZIV, the Court of Auditors and the legal services of the Chamber, we have chosen a legally feasible and certain solution, in order to avoid afterwards unnecessary disputes that undermine the system. Therefore, the provisions apply to future contracts. Otherwise, there could be a discussion about civil liability. We have tried to avoid that.

Are we healthy for the big pharma, as Mrs. Merckx describes it? and no. As far as I am concerned, it means a big step forward that we now have a legal text available, which provides legal certainty and which cannot be undermined due to the symbolic approach to problems from the past. Would we also want to deal with old contracts? Yes, but let’s not take legal risks.

Furthermore, the Court of Auditors has explicitly stated that it will perform that assignment and we have no doubt that it will do it correctly.

Finally, we agreed to do the exercise regarding the composition of the cost of a drug, to draw it now very broad. Mr Fonck, we will have to take into account not only the work of the Pharmaceutical Compliance Committee at RIZIV, which sets the conditions of refund, but also that of the Pricing Committee in Economic Affairs, which sets the price of a medicinal product, a price that is important for the pharmaceutical industry for, among other things, exports abroad.

Mr. Speaker, I would like to replicate for a moment, because I was mentioned by Mr. De Caluwé, who urged me to have a great imagination when it comes to those contracts. Well, when I say that Sofosbuvir in Belgium costs tens of thousands of euros, while in India it costs only 100 euros, then that is not imagined, but then that is a fact; then that is proven black on white. When I say that Xarelto has been on the market for ten years and therefore is no longer an innovative drug, I don’t imagine that, but then that is the reality. It is argued here that one cannot change the rules of the game while one is playing, but I think all the players remain at the table and some will not exchange cards in a rear room. This is happening today.

Mr Bertels, you said that you did not want to take legal risks and therefore limited the provisions to future contracts. But sometimes taking legal risks can help the case go ahead. I take the example of Nelson Mandela in the 1990s. How did it succeed in making the medicine for HIV available to millions of people in the 1990s? This was possible through a legal battle, which was initiated by Nelson Mandela.

Sometimes one can take a calculated legal risk. I think we could count on the support of the public if the pharmaceutical industry tries to bring us a trial, because we want to know how much we pay. Take the risk and then we can lower the price of medicines and we can make them better available to patients.

Mrs Merckx, I do not like to be disqualified in that game, ⁇ not on the cap of the patients taking Xarelto, to which you refer. 118 molecules are currently under contract. 118 times as many patients take that medication. Better than anyone here in the room you know that you are playing with the patient’s life, if you take him or her the drug Xarelto. We will not do that! We have a future pact here, on the basis of which we can get acquainted with future contracts.

You asked a number of questions, including to my group. Can there be improvements to the system? of course . We have done our job as a member of parliament. I can understand that it would be very interesting for you and for me and for certain members of the Health Committee to substantially examine how the refund for certain medicines came about. However, as a member of Parliament, we will not interpret scientifically; the task of scientifically interpreting belongs to the doctors, the members of the committee. We will check whether there are anomalies, whether incorrect prices are charged, or whether agreements are made between different firms. In particular, we ensure that our patients have medication. That is the message.

Mr. Speaker, I do it in one sentence: the most important thing is that we have had a constructive cooperation and that we have achieved a good result. I do not do symbolic politics, but I want to make results on the ground.

Mr. Minister, you have the word.

Mr. Speaker, I will be brief. Much has already been said about this. Everyone is for transparency. That is actually the word of the day.

I would like to say something about what a secret contract exactly is.

The secret contract was initiated by my predecessor, Ms. Onkelinx, because it was done in all other countries to give access to innovative medicines, medicines for which there was no agreement through the Commission on Medicines, either because there was not enough evidence, or because it was too expensive. I have always said that this was a good initiative from my predecessor. We did not agree on everything, but we did. So that was a good thing.

When can a secret contract be negotiated? Can a minister simply say that he or she wants to negotiate a secret contract for a particular medicine on the market? No, it cannot be. It should always go through the Medicines Compliance Commission. It is only when an agreement is reached in the Pharmaceutical Accountability Committee, in which the mutualities sit, a representative of the pharmaceutical industry, a representative of the Minister of Economy, a representative of me and also a representative of the Minister of Budget seats – three members of the government are therefore represented – and of course the RIZIV, that a secret contract is drawn up, of course with huge price reductions.

This is a two-part contract. It contains, on the one hand, a section with the scientific leaflet for which the drug serves, its safety and so on. On the other hand, a confidential clause, which describes the price reductions and conditions. The confidentiality of the negotiators must be safeguarded. I have been asked several times to remove that confidentiality, but I did not want to do so. I note to my pleasure that all mutualities and all people sitting there have not blown up that confidentiality, in the interest of the patient, to have access to this type of medication. Otherwise, we can no longer provide access to our people and there are many indications. That has, by the way, become more and more because there are also many new medicines for bear diseases for which we have done a whole collection operation. We have delivered more than twenty new medicines to the patient. There have also been entirely new classes of medication, such as CAR-T and immunological drugs.

They wanted to break those contracts with retroactive effect and to put confidentiality on the front page of the newspapers. This has not succeeded because one cannot simply break a contract with confidentiality. I assume that many doctors think they can do that, but there are plenty of lawyers who indicate that this is not possible.

This task has now been entrusted to the Court of Auditors. This could actually be done before because when it comes to public money, the Court of Auditors can always draw contracts. However, I am very reassured. The Court of Auditors will have to collect expertise and carry out the necessary controls. The Court of Auditors says, like the Council of State, that confidentiality is also guaranteed with them. That confidentiality will therefore also be with them. They will therefore not be able to disclose their findings and conclusions because confidentiality is also guaranteed with them. That reassures me because our patients will continue to have access to innovative medicines.

There was also a small discussion here about other mechanisms of pricing. This exercise is going on in all countries and it can be continued here as well. We do not yet have a whole palette of measures in this area. We have introduced pay for performance and we have already resisted beacons but for these contracts we have not yet found any other solution. This has not happened in other countries either.

Ladies and gentlemen, I will leave it here. I wish you a pleasant vote.

I thank you for your participation.