Proposition 54K3555

Projet de loi portant des dispositions en matière de remboursement des spécialités pharmaceutiques ainsi que de frais d'administration, d'efficacité et de transparence des organismes assureurs.

General information ¶

Authors

CD&V Nathalie Muylle
MR Damien Thiéry
N-VA Yoleen Van Camp
Open Vld Dirk Janssens

Submission date

Feb. 14, 2019

Official page

Visit

Status

Adopted

Requirement

Simple

Subjects

medicinal product health policy health care social security public health health insurance

Voting ¶

Voted to adopt

CD&V Open Vld N-VA MR

Voted to reject

Vooruit PS | SP DéFI

Abstained from voting

Groen Ecolo LE ∉ PVDA | PTB PP VB

Contact form ¶

Do you have a question or request regarding this proposition? Select the most appropriate option for your request and I will get back to you shortly.

Discussion ¶

March 21, 2019 | Plenary session (Chamber of representatives)

Full source

Mrs Ine Somers, rapporteur, refers to the written report.

Mr. President, Mr. Minister, this bill comes from this government. It should have been presented to us many months ago as it is expected to implement a series of measures related to the 2019 budget. These are savings measures planned for the entire year 2019 and can only be implemented from April. A deficit in the medical budget is likely to grow even more, I will return to it.

When we know that last November, the general council of INAMI already forecasted a surpassing of 82 million for 2019, we say that we could undoubtedly add – and it is deplorable – several tens of millions of euros due to the delay in the execution of the savings measures that are subject to us today. I wish good luck to the one or the one who will succeed you in a few months and who will start with a famous stone in his shoe.

This text once again clearly highlights your "two-weight two-measure" policy on medicines, in favor of the pharmaceutical industry and at the detriment of patients. It is true that you often recall that you lowered the prices of 1,300 medicines with 11 million euros of savings for the patient. But we also remind you that you increased antibiotics, stomach medicines and nasal sprays in 2017 and that this raised the bill of more than 40 million euros.

The result is that the bill for our fellow citizens has increased by 9% while it is already the first spending item in the health budget of Belgian households.

Two-weight two-measures in favor of the pharmaceutical industry and at the expense of patients since between 2015 and 2019, the budget of the pharmaceutical industry will disappear by almost 1 billion euros.

He has paid back $365 million. There is this famous clawback mechanism forcing the pharmaceutical industry to repay part of its budget surpass, but in a very limited way. The result: a note of approximately 600 million, charged with the health care budget of the Social Security; a situation that you have tolerated, or even backed up. For my group, it is incomprehensible that you have never sought to correct this.

Without wanting to exaggerate, I also want to recall the savings made on the healthcare budget. During this legislature, this represents almost 2 billion euros. Everyone paid the high price: patients, healthcare professionals and hospitals. One sector has been saved, that of the pharmaceutical industry.

Last July, you must have seen a new significant increase in spending on medicines in 2018 as well as, already, a surpass announced for 2019. You have therefore decided to impose on the pharmaceutical industry the payment of an additional contribution in the amount of 105 million euros. You had only planned it for 2019 while the excess of the drug budget is structural. This amount should have been added to the usual clawback mechanism.

Then you present this text.

Let us read attentively his article 9, which became the 10th. As drafted, there will be no additional reimbursement from the pharmaceutical industry for the announced surpass in 2019. This was as you committed to the Insurance Committee to reform the terms of the compensatory fee in order to strengthen the sector’s budgetary responsibility and limit possible excesses. In fact, you are removing the compensation mechanism and thus the accountability mechanism of the pharmaceutical industry.

We have therefore resolutely reintroduced the amendment that we had submitted in the committee and that you had swept from the back of the hand to enable the correct execution of the 2019 budget decision, namely a compensatory contribution of 105 million, plus the usual clawback. We know that once again you will not support it, that your former majority, as long as it still exists, will not support it, while access to many medicines has never been so problematic, that shortages have never been so numerous, and that the prices of some medicines have literally blown up.

Mr. Speaker, it is time for our group to protect the healthcare budget and to put the interests of patients above those of the shareholders of the pharmaceutical sector, by empowering the sector, by having the will to counter the monopolies built on patents that explode prices, by setting conditions for the financing of research and by imposing conditions of financial accessibility to medicines. It is not your choice.

You have chosen your camp by systematically protecting the pharmaceutical industry at the expense of our social security, our healthcare budget and patients. Therefore, my group will vote against this text. I thank you.

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. You probably won’t be surprised if I don’t have quite the same interpretation of the bill as it is presented, especially in relation to the savings that are made. It is essentially at this level that I would like to intervene because all the measures that are taken here had already been decided and approved by the General Council of INAMI. As you said, Mr. Frédéric, these measures were actually taken as part of the preparation of the 2019 budget.

I insist on the fact that virtually all the measures that have been taken have been in the interest of saving the healthcare budget, without affecting the patient. This is a fundamental element that does not quite go hand in hand with what I have heard before.

The volume cliff is introduced. This is a fundamental element. This measure comes in addition to the patent cliff, which we discussed some time ago. This measure should contribute to about 10 million euros of savings per year, without however, I repeat, that patients are not impacted. Patients will also benefit from this. The 10 million I mentioned represent, of course, the profit that patients could make from it, but the impact of the complete measure revolves around 55 million euros.

With the patent cliff, drug prices drop drastically once the patent expires, instead of successive reductions as before. It is also an important step forward that ultimately facilitates the administrative task for absolutely everyone.

Thanks to the cliff volume, the price of medicines will decrease even more depending on the volume sold and, a small particularity, the price of the medicine for which there is no generic alternative will thus also continue to decline.

Other measures are put in place by this bill: the maximum price and the cheapest medicines. From 1 January 2018, the Minister has introduced maximum prices for medicines in conventional pharmacies. This means that, two years after the expiry of a drug’s patent, health insurance will only refund the medicines that fall into the category of the cheapest medicines. This mechanism is now extended to medicines delivered in hospital environments. At the same time, doctors in hospital settings will be forced to reach a certain percentage of cheaper medicines or what was called, at the time, "cheap medicines", in their prescriptions. This economy is estimated at approximately nine million euros per year.

The definition of “cheap prescription” is strengthened. In the hospital environment, much of the reductions received by hospitals on medication prices will return to healthcare insurance. For category F medicines, prices for these old medicines drop after twelve or fifteen years of repayment in our country. For medicines of this category F, this was not the case. As of April 1, this will change. The price will also decrease.

In addition to the above amounts, for each of the measures covered by this bill, other measures have been taken that do not specifically require a legal basis and for which approximately 25 million savings are expected in 2019, with an average of 33 million annually.

As regards the extension of the scope of contractual confidentiality provided for in Article 81, the draft text corresponds to the decision that was taken into the budget note for healthcare 2019, also approved by the General Council on 15 October 2018.

I recall that this procedure has enabled patients in our country to effectively access the latest treatments. This is a very important point that I mentioned in the committee. All the benefit goes to the patients, especially since you have to find yourself in a situation where you have a loved one who is suffering from a relatively serious illness for which a medicine is made available but not specifically refunded or payable. There are here agreements through this article 81 that allow not only to help patients in relation to their quality of life, but also and we must dare to say, to save patients from their pathology.

These contracts are the result of negotiations between the authorities and the company. It is neither the authority nor the company alone that decides. There is a preliminary consultation.

These contracts may be launched at the request of the CRM (Commission for Repayment of Medicines): if it considers that there is a budgetary or clinical uncertainty; or if it issues a negative opinion or no opinion, for that reason, at the moment. In this case, the authorities may initiate additional negotiations based on the outcome of the treatment, the burden of the disease or the medical need, taking into account the cost-effectiveness, which is always a criterion taken into consideration, as well as the budgetary impact. Thus, the Belgian patient will still be able to have access to this medicine, as I said, in certain situations where there is no other possibility. This decision is fundamental. He had to be raised.

Madam the Minister, dear colleagues, it is on the basis of these concrete elements, which allow again to make savings in the healthcare budget 2019, but which will not, I recall, have no impact on the patient, that we will support this bill.

I thank you.

Mr. Speaker, Mrs. Minister, colleagues, to begin with, this proposal contains a number of good measures.

We even share the central concern. Interventions should be taken to prevent medicinal products from excessively penetrating the health insurance budget. However, the gifts you give to the pharmaceutical industry will also continue. In recent years, the recovery of budget surpluses, the clawbacks, was too low.

What the system of recovery will give next year, we are in the dark about. We wonder whether in the next legislature there will be no longer a barrier on the spending in the pharmaceutical sector.

The proposal, submitted by the former Swedish majority, implements the decided savings in the field of medicines, more specifically for the pharmaceutical companies, which in recent years went hundreds of millions in red.

Everybody is behind the starting point. The savings operation in the pharmaceutical sector should not affect the patient and one should focus on the budget surpluses organized by the firms themselves.

Mrs. Minister, you are claiming that you are doing everything possible to condition the price drops for medicines offpatent. You argue that you then combine that with offering generic alternatives, at the end of which a price dynamic with ceiling prices is installed.

That is correct. You can actually put a few plugs on your hat, such as making medicines for hepatitis C and HIV more accessible and cheaper, as well as some oncological drugs.

Only, this is not really about us here. The provisions that we will approve in the proposal are necessary because the medicines offpatent continue to have an excessive cost for health insurance and therefore need to be intervened.

Unfortunately, it is too little, too late and it is not going far enough. Therefore, together with our colleagues from the PS, we will again submit an important amendment at this plenary session, in order to provide for an additional refund of 105 million euros by the pharmaceutical sector, which should be added to the already planned clawback. The clawback, also called the protection contribution, also affects generic medication patients, and even disproportionately.

It is precisely the sector of generic drugs that is a key partner in the whole story of controlling the drug price. That is why my colleague, Ms. Temmerman, submitted an amendment of the sp.a in the committee to repeal it. We will submit this amendment again today.

Another amendment submitted and rejected by Ms. Temmerman will also be submitted again. It is an amendment that should allow researchers from the Federal Knowledge Center for Healthcare to also have access to the actual evolution of net spending on the medicines under the so-called Article 81 contracts, the notorious secret contracts in which more expensive orphan medicines are arranged, through a negotiation between the minister and the producer, so that patients can be helped. Inquiry by the KCE in all data would, in our opinion, lead to better advice from the knowledge center.

An important and unanswered question is whether the system of the clawforward, thus advancing the imposed savings, will continue to exist even after 2019. If I re-read the reports of the debates, the present proposal does not exclude this, which will be the upheaval and the displacement of the pharmaceutical budgets for the next government. That is at least not clean and it will sooner or later have an impact on the prices for the patient.

The Swedish parties, if I can say so, are proposing to further deepen the price declines after fifteen years on the basis of the step-by-step system, with the deepening increasing according to the volume. In addition, the system of ceiling prices will be extended to the medicines that are only available in hospitals. Last year, the ceiling price system was already introduced for medicines delivered in open officina. The proposal also introduces the system of cheapest prescriptions in hospitals and introduces corresponding quotas. These are some good elements in the text. We have been advocating with sp.a for a decade to maximize that ceiling price model in the pharmaceutical policy.

In the debates, we, together with the colleagues of the PS, asked why the government did not incorporate the mitigating measures for the pharmaceutical companies already taken in October into the law on various social provisions of 21 December 2018. As a result of the delay, the deficit, caused by the pharmaceutical sector, has increased in recent months to several tens of millions more. Extrapolated to a full year, it is estimated that the past and current year can be taken into account with an increasing deficit of EUR 82 million.

Mrs. Minister, if I have been properly informed, you have coupled those observations with the notice that the measures could not previously be incorporated into a law containing various provisions or into a program law due to the fall of the government. However, you could have known, as a former member of Parliament, that you could have had a large majority in the House to start work immediately. You have chosen not to do that.

In conclusion, what we can say today, and that may best be considered to me as a final balance of your pharmaceutical policy, is that from the beginning of this government period you have dealt with the pharmaceutical sector with fluffle gloves.

The so-called Future Pact with the pharmaceutical industry, which you signed in July 2015, stipulated that spending on medicines would not increase by more than 0.5 % per year. Since then, the cumulative excess of your budget for the pharmaceutical industry amounts to almost one billion euros. The shareholders are concerned, the patients are not.

I repeat what colleague Karin Temmerman stated in the committee. The budget surpluses of the pharmaceutical industry must not be compensated by the hospitals, nor by the patients. For example, the profits generated by hospitals on their pharmacies should be used primarily to compensate for the underfinancing of their healthcare contracts.

Mrs. Minister, we are again submitting a number of amendments to update the mechanism installed today so that it is fair. The pharmaceutical sector needs to contribute more, the sector of generics manufacturers should be liberated, and the KCE should gain greater insight into the secret drug contracts.

With this text, which the Swedish parties were so kind to submit to you on the runway, Big Pharma comes away with a low invoice. Therefore, we will also vote against in this plenary session.

The actual bill will probably follow in the next legislature, when the new government can pick up the matter. We can only hope that the patients and the hospitals will not, with a few years of delay, turn up for it.

Mr. Speaker, for us this bill – not to say a bill – is generally in the right direction, in particular by approving savings in the pharmaceutical sector, a measure of savings that must be taken as soon as possible to not further burden the health care budget.

Article 9 is a problem. While it helps to prevent the pharma sector from falling less in the red in 2019, it does not solve the problem of the systematic budget exceeding by the pharmaceutical sector. In 2015, the budget of pharmaceutical specialties exceeded 192 million net. In 2018, there would still be a minimum of 373 million gross surpass and a minimum of 205 million net surpass. It is huge!

Between 2018 and 2019, the growth of the budget for pharma specialties granted by the firm is approximately 7.3%. By the way, by the way, workers say in the earphone that they are interested in such a rate of increase in their wages.

By offering the pharmaceutical industry to refund only 105 million for 2019 instead of the existing accountability mechanism, you are giving them a magnificent gift. They could not have dreamed better.

Mr. Minister, you are missing the opportunity to structurally solve the problem of excess budget for pharmaceutical specialties. Since this measure is not compensated by parallel structural efforts, it will only have effect for 2019, if it does not change anything in the future to the reimbursement by the firms, usually made on a basis of 0.5 % of their budget when an excess is revealed. For the following years, 2020, 2021, it also generates a calculation point starting from a new base, 7% higher than the current base. This new start for the pharma is very cheaply paid, only 105 million, when it is known that the legal growth standard applied to health care and therefore to other healthcare sectors is 1.5%.

In addition, you allow them to escape a higher refund in the event of a higher exceeding for the year 2019, as the year is not yet completed.

Finally, you do not implement the structural reduction of the pharma budget in order to contain the costs for the coming years and thus leave a very bad gift to your successor for the next legislature.

Together with the PS and sp.a, we have co-signed amendments that will allow structural settlement of the problem of budget surpluses. I invite my colleagues to support these amendments, in which case we will abstain on the text.

Mr. Speaker, our group will support the proposal, although I have an amendment to Article 9. I would love to illuminate that. Article 9 sets out the flat-rate amount for 2019 given by RIZIV to the health funds in order to pay their administrative costs.

It is not insignificant that the Financial Inspectorate has issued an opinion on the amount of those administrative costs, which it considers too high. In the calculation of the flat-rate amount, EUR 36,165 million is deducted as a result of the transfer of powers to the provinces. But that amount is based on an estimate of the insurance institutions themselves, which take the revenue of 2016 as the starting point.

The amount is just wrong and too low. According to the Financial Inspectorate, 39.320 million must be deducted. It clarifies that as follows: "If the parameter formula for the period 2016-2019 is applied to this amount for 2016 and the additional amount for the German-speaking Community is taken into account, this results in an estimated amount of 39,320 million". That amount of 39.3 million is mentioned in a note to the general board of the RIZIV. Although the amount of EUR 36 million is entered in the budget for 2019, the Financial Inspectorate points out that it is impossible to verify the amount on the basis of the information provided. She asks not to take this into account.

It is not the first time that calculations are made by the insurance institutions themselves, which afterwards appear to be insufficient and erroneous. Moreover, it is now also apparent that the accountability of the amendment incorporating the article in the bill also indicates that the counties will adjust approximately 40 million euros for the financing of the administrative costs of the health funds as a result of the transferred powers. In other words, both by what the Communities will ultimately contribute and by what the Financial Inspectorate says, the logic is actually entirely searching if one continues to stick to those 36,165 million.

These are many numbers but with the amendment I propose to go for the calculation made by the Financial Inspectorate. This will actually save €3.2 million in a very simple and correct way. I hope the amendment will be fully supported.

Mr. Speaker, I will be brief now, as the discussion in the committee took a lot of time.

No sector has contributed so much to a reduction of spending – always talking about savings – in healthcare. The growth rate for the health sector as a whole was 1.5 % per year, but for the pharmaceutical sector an average of 0.5 %.

Very many innovative medicines have been brought directly to the patient through a system that all our neighbors envy us. It is not just about oncological medication, but also about drugs against hepatitis and HIV, which were brought faster to the patients, including children. And indeed, the budget is exceeded, but if we leave the silobe approach, the budget exceeding falls with regard to the reductions in other posts of social security.

The pharmaceutical sector contributed the most. In fact, all exceeds of the 0.5% growth standard were reimbursed by the sector itself through measures, saving only the patient. This is again the case, as Mr. Damien Thiéry has already said. Furthermore, the pharmaceutical sector also accounts for approximately EUR 400 million in taxes and contributions each year, while the claw back this time amounts to EUR 105 million. This includes all the measures that are approved each year in different program laws.

I think the policy was conducted fairly. The claim that more money for medicines is a gift for the pharmaceutical industry is not valid, as it is a gift for the patient. After all, the patient has access to the medicines and he has a right to that. We have ensured that the patient has the best chances of healing or can increase their quality of life.