Proposition 55K0229

Projet de loi modifiant diverses législations, en ce qui concerne les pénuries de médicaments.

General information ¶

Author

N-VA Kathleen Depoorter

Submission date

Aug. 28, 2019

Official page

Visit

Status

Adopted

Requirement

Simple

Subjects

fine medicinal product shortage public health

Voting ¶

Voted to adopt

CD&V Vooruit LE Open Vld N-VA LDD MR VB

Abstained from voting

Groen Ecolo PS | SP DéFI PVDA | PTB

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 ¶

Dec. 19, 2019 | Plenary session (Chamber of representatives)

Full source

The rapporteur is Mrs Karin Jiroflée, who refers to the written report.

The unavailability of medicines and the shortage of medicines in the Belgian pharmacies was one of the issues I brought to Parliament from my pharmacy. When I took the oath with you, that was one of the points I absolutely and first wanted to take, because it is very important, because it is for our patients and because it is for the proper functioning of public health.

This problem has been raised for years and there have been many attempts, but it has never really been worked on. I am pleased that we were able to hold a first hearing on this issue in the Public Health Committee already in July and that everyone has contributed to the beautiful bill that is presented here today.

Unfortunately, we do not have a magic stick in our hands. The unavailability of medicines is a very broad problem that will need to be addressed at many levels. One step forward, one step for the patients, one step for the healthcare providers in our country. The bill is drafted in such a way that it is immediately enforceable and applicable. Therefore, it is not necessary to work on it for a very long time. Patients will be able to apply to this law as early as February.

My colleagues pharmacists spend an average of five to six hours a week dealing with the drug shortage. Recently I had a conversation with a colleague who said she had promoted herself to full-time problem manager. This meant that in her pharmacy she was full-time looking for alternative medicines for her patients. That cannot be the intention.

Today there are 650 CNKs, in other words 650 available boxes, with the same drug in, if necessary, but with other milligrams or in another form, not available to the patients. As a patient, it is very frustrating to go to the pharmacy with a prescription and there again to hear that the drug is not there and that the pharmacist will first call the doctor, after which the patient must return to the pharmacy. This is a huge loss of time for the patient. It also damages the trust between doctor, pharmacist and patient. A patient finds it strange that the pharmacist does not have the medicine, but the pharmacist can of course do nothing about it.

The same patient also finds it strange that his doctor prescribes a drug that is not available on the market. That confidence of patients in doctors and pharmacists is actually still quite high at the moment, otherwise higher than in practitioners of other professions. Doctors and pharmacists deserve that patients have confidence in them and we must work on that as policymakers.

Finally, what really struck me as a healthcare provider was that the surplus price of an alternative to an unavailable medicine was borne by the patient or the pharmacist who then, out of honest shame, dropped it. That cannot be the intention.

Colleagues, the bill is based on four pillars: prevention, inventory, address and action.

First, how do we prevent? We do this by guaranteeing a faster reporting of unavailability. We will ensure that the doctor immediately sees in his prescription software that a medication is unavailable. We are already dealing with the source of the problem.

Second, it comes to stricter and faster inventory. We will inventory the cause of the shortages so that the government gets a very clear picture of what is missing, why it is so and where in the production process should be intervened.

Third, we also address the deficits. If a particular medicinal product is missing for the Belgian market too often or too long, we ensure that an export ban can be issued. This is something completely different from the export ban law, which was voted in April. The proposed measure is targeted and does not cover all medicines, but the medicines with which a problem may arise. We also address the problem by imposing the obligation on wholesalers to deliver the medicines to the pharmacy or wholesaler within three working days as part of the public service.

This includes an amendment aimed at imposing the delivery within one working day. I would like to anticipate this. I told you at the beginning: we have made sure that the proposed legislation is enforceable. This is the essence of the provision relating to the three working days.

We consulted with the field and it was not always possible to move to a term of 1 working day in case of deficits. That is why these three working days have come. Colleagues, you all know that people who work in healthcare really take their responsibilities, both the pharmaceutical firms as well as the pharmacists and wholesalers. If a medicine is urgently needed, it will be delivered to the pharmacy within 24 hours, if available. So I suggest that those 3 working days be kept for workingability so that we have an effective solution and do not start creating an additional problem.

The patient should not be fooled by the fact that a medicinal product is not available on the Belgian market. The patient must have a reliable partner with the government, a partner through whom he knows that he will receive his medicine at the agreed price. This bill ensures that this is so. Neither the patient nor the health insurance will pay for this. The pharmaceutical companies that are at the base of the unavailability will also have to pay for it.

A final measure in this law was added by amendment and I am actually very grateful for that as a pharmacist. It is a huge relief that the substitution law is finally poured into a legal framework today. We heard during the hearings that the pharmacists were trained for this. They can, they know the chemical composition and they know perfectly when they can replace a medicine with another medicine for the same price. What pharmacists have been doing for years is now finally regulated by law.

We will therefore support the colleagues’ additional amendment on this subject. The substitution right is already included in the proposal. Now there is another amendment to extend that substitution right a little so that it is immediately applicable.

I have also read the amendment of Mr. Fonck. It requires that the doctor be notified in the event of substitution. This is obvious: doctors are informed via the electronic prescription. If a medication is prescribed electronically, then it will be perfectly possible for the doctor to know that another medication with the same action has been given. This will then go to the doctor’s global medical record.

Finally, as I have said, I would like to thank you all for following this path and for the hearings we have organized and for listening to the field and the professors present. I would also like to thank colleague De Caluwé that he along with me broadened the way to take care of the patients and improve the health care policy so that there can be more for the patients. I would like to thank you for taking the lead with all of us and making a big step forward in Parliament on this issue.

Thank you for the explanation of the present proposal, Mrs. Depoorter.

This is indeed a big problem. Thro ⁇ the summer, we organized hearings to put both the solutions and the causes side by side. We all learned in the committee that there is no magic rod to solve the problem.

I am convinced that with this law we are taking a number of steps in the right direction. Together with the software interventions planned at the level of the doctors, at the level of the FAGG and at the level of the pharmacists, we will indeed set big steps forward. I also hope that a next government with full powers will work towards a more transparent cooperation with the manufacturers of the medicines so that everything starts smoothly. I fully support the proposal so far.

You also say that we must cooperate at all levels, but there we go with this law on smooth ice. We key to the import-export ban in case of unavailability and then we also go to the import out and export to other countries. We are convinced that a TRIS notification is then necessary with respect to our European counterparts. We must adhere to those rules of the game. We want to move forward quickly, but with this we may base the law on legal sand. We consider that a too great risk. In the previous legislature there was another such situation, which I did not participate in, but that law was eventually suspended. The comments on this subject also referred to the TRIS notification that had not occurred. We think this matter is too important to take risks.

The problem is urgent, but hurry should not push us to take too big risks and make mistakes. We believe that a law that ignores European rules is based on legal floating sand. This is why our group will abstain. We find it very good to anticipate steps, but we must respect all levels.

Mr. Speaker, we consider the bill a step in the right direction in order to shorten or suspend the lists of medicines that are too short.

We supported this in the committee. We will do that here too. We would like to evaluate this measure after some time so that we are sure that the problem is resolved and the measure benefits the patient. We support this for the time being.

Mr. Speaker, Mrs. Minister, 680, here is the number of packaging of medicines listed as being unavailable today on the AFMPS website. This affects all specialties (colyres, antibiotics, medications for heart failure, anti-cancer or psychiatric treatments).

So, yes, there are sometimes alternatives to treatment but obviously this is not the case for everyone. This is problematic for the patient who, he, finds himself unable to benefit from the treatment he needs or who sees the cost of his treatment simply explode because the available alternatives are obviously much more expensive.

Think about the shortage of Clamoxyl injectable, namely amoxicillin used specifically for endocarditis or septicemia in babies under three months. Let’s think about the shortage of Femara, this indispensable drug for treating breast cancer. This was unavailable for several months and it was not even notified on the AFFMPS website. Let’s think about Camcolit. This medication was not reimbursed until recently but it still palliated the unavailability of a reimbursable treatment for bipolar disorders, tripling the price. We went from 9 euros to 27 euros.

These situations are worrying. They place doctors and pharmacists before difficult choices and sometimes misunderstood by patients concerned about not being able to dispose of prescribed medications and therefore concerned about the evolution of their health status.

A new application called PharmaStatut has recently collected and published information on the availability of medicines in Belgium. It should inform the patient, the doctor, the pharmacist of all possible alternatives. At the moment, however, it appears that doctors do not have the opportunity to see the available alternatives. We hope that in the long run, this application will be an effective tool to address the concerns of one another.

Let’s get to the causes of these shortages. As mentioned very correctly by my colleague but also the French daily Le Monde, a few months ago, the causes of these unavailability are multifactorial. Dysfunction in the production chains, difficulties in the supply of raw materials, too rigid standards, these are the elements highlighted by the laboratories.

But the shortages are also generally the consequence of the fact that these structures and industries, in recent years, are subject to increasingly stronger imperatives of profitability. The hearings we conducted on the subject showed nothing else: cost rationalization, abandonment of the manufacture of medicines deemed unprofitable, preference given to the countries that report the most at the expense of those whose healthcare system forces them to rogue on their margin.

My group does not intend to make the pharmaceutical industry a black beast. Probably not !

We, on the other hand, believe that it is time to re-balance the financial interests of this industry against the health interests of patients. As I said, if the causes of unavailability are multifactorial, the answers to be given are equally. It is true that the proposal we are examining today tries to provide some solutions to these difficulties of shortage.

Why did we choose to abstain? Simply because we did not get clear and concrete answers to the questions we asked during the committee debates. Because we continue to doubt the effectiveness of measures on current and future shortages. Because we struggle to believe that the concertation will indeed be made with all stakeholders while the text contains many delegations to the King and that some royal decrees will have to be taken very quickly.

On the measures as such, questions remain. It provides for a more precise obligation to notify the cause of the unavailability, including when there is no delivery or in the case of incomplete delivery. The obligation is there, but there is nothing about the sanctions that currently, as we know, are lacking because rarely or even never applied.

The proposal also provides for a limitation or even a ban on exports in case of unavailability. We obviously agree with the authors on the fact that the public service mission must first. It is unacceptable that economic considerations prevent Belgian patients from obtaining the medication they need or to say it clearly, when the medication can sell itself more expensive abroad.

Provisions had already been voted in the previous legislature to suspend exports in case of shortage but the Constitutional Court eventually canceled them. Therefore, another arrangement will need to be put in place, but at the moment, we do not have sufficient precisions on the terms envisaged and especially on the legal solidity of these.

It also provides for an obligation for wholesale distributors to deliver, within the framework of their public service obligations, the wholesale distributors and the workshops within three working days. This may pose questions regarding accessibility to treatments. As mentioned in the commission, if we add a weekend, we are talking about a five-day wait. It is unnecessary to specify the consequences that this could have on the health of certain patients.

The text also provides for the establishment of a procedure to make the additional costs related to unavailability by pharmaceutical firms bear. As we have repeatedly said, it is completely unacceptable for us that these costs be borne by patients or by our health insurance.

But the questions remain many. How will the compensation system work? How will responsibilities be determined? We discussed the creation of a fund. How will it be financed? All these questions remain open and the uncertainties do not allow today to give our white-seing to this text.

Finally, I would like to return to one element that sparked a very interesting debate in the committee: the right of substitution – the right to grant the pharmacist when he is unable to provide his patient, due to a shortage. When we submitted our amendments to legalize this substitution, we marked it. However, others wanted to condition this right to a royal decree. This means not recognizing this right, since we know that this decree may never be taken, if some partners around the table oppose it. There is a.

We have therefore re-submitted an amendment which clearly acts the right of substitution and which will leave the King the possibility to fix the additional conditions and modalities, as they will obviously be necessary in terms of control or reimbursement.

We will not cover our faces. This substitution is already implemented. Today it is in the patient’s interest. It is therefore in the interest of everyone to be able to frame it.

In conclusion, for my group, I repeat that it is important to find quick and effective answers to this question of drug shortage. We are not convinced that the proposal on the table will solve the problem and provide answers to pharmacists, doctors and patients who are facing it. We are also convinced that a new comprehensive drug policy needs to be quickly developed, re-balancing the interests and duties of each of the stakeholders and guaranteeing patients quality and affordable long-term treatments. This applies to the health of our health insurance and even more to that of our patients.

Mr. Speaker, dear colleagues, I want to be able to say on behalf of my group, the MR, that this text is the result of a work resulting from the hearings we held within the Health Committee. We have heard many experts and professionals since October.

This text provides for a number of very concrete measures primarily to combat the consequences of unavailability of medicines. This is known in our country, but not only. As we know, the whole of Europe is affected.

This text addresses, among other things, the recording of the exact causes of unavailability or the responsibility for additional costs associated with unavailability – an extremely important element for our group.

In this regard, I would like to clarify that we have submitted a bill to introduce a substitution right for the pharmacist in the event of unavailability. The pharmacist is in the first line with the patient when he is answered that the prescribed medicine is not available in our country.

The establishment of this right, which is the subject of our proposal, in the context of an unavailability notified by the AFMPS, could be proposed by amendment during committee work. We welcome this, as it will allow, on this specific point, to move forward quickly and favorably for patients and pharmacists.

Our group therefore supports this text.

Mr. Speaker, Mrs. Minister, yesterday I called the pharmacist of the well-known Institut Bordet to treat cancers in our country. She explained to me what she had experienced a few weeks ago due to the loss of stock of paclitaxel, a substance used in chemotherapy. I quote it: “For a while, we counted every bottle here. We had to ask doctors not to start new treatments and we had to import the drug.”

The example of paclitaxel demonstrates the extent to which stock loss is a public health problem. Imagine having to start a chemotherapy treatment later than expected or having to stop your treatment, as is currently the case for patients treated with Tomudex which is out of stock. This situation is truly unacceptable!

Of course, every factory can encounter a problem at some point. A factory can burn. A sterility problem can arise in a production chain. A temporary stock breakdown may occur due to an accident. Currently, however, the problem of stock breaks is increasing. Pharmacists spend about five hours a week finding solutions for patients.

Therefore, we are entitled to ask why the phenomenon of stock breaks increases everywhere. Are more and more factories being burned in recent times? Of course not! The phenomenon of stock breaks is increasing, because behind these stock breaks, mechanisms for maximizing profits are set up by firms. Thus, for example, firms cause or do not resolve stock breaks of cheap and unprofitable medicines. Doctors are then tempted to prescribe another treatment often more expensive and often present in the stock portfolio of the same company.

Another cause of stock breaks is the price difference between different countries. Some will import or export medicines from one country to another in order to record some or a lot of profits. For their part, the firms are trying to counter these exports by introducing, for example, quotas, which also generates serious problems of stock breaks, as was the case last summer with Femara, prescribed in the treatment of breast cancer, which has long been unavailable.

To demonstrate this, I will return to the example of paclitaxel for chemotherapy. While Pfizer claimed a stock loss due to a production problem at its Zagreb site, our pharmacists had no problem ordering the drug in the Netherlands and Germany, but with bills up to three times more expensive than the price offered in Belgium. I even brought an invoice for those who are interested.

Another stock breakdown is still ongoing and interpels. This is the Clamoxyl, which has been ongoing since March. It was on the occasion of this stock breaking that health professionals were angry. In a white card in Le Soir in July, they denounced the imperatives of profitability that are in conflict with public health. Indeed, serious questions can be raised about the breakdown of the stock of Clamoxyl. It is an antibiotic that is on the list of essential medicines of the World Health Organization. It is used for septicemia for infants under three months, or for some endocarditis and meningitis. There is no need to draw yourself: here too, we have a serious problem.

Today, this medicine is rationalized. But how is it possible that the antibiotic Amoxiclav, produced by the same firm GSK, which contains the same active substance as Clamoxyl, i.e. amoxicillin, is actually available in Belgium? How is it possible that GSK cannot increase its production capacity while the firm is in the top 10 of Big Pharma’s most profitable firms?

The case of Clamoxyl ensured that with PTB, we proposed, in July, to hold hearings in the Health Commission, around the medicines.

Madame de la N-VA, at that time you voted against holding these hearings.

During these hearings, we asked the following question.

Mrs Depoorter, do you ask the word for a personal fact?

Mr. Speaker, I just want to correct something. We have not voted against. We were absolutely in favour of hearings. You have misunderstood this, Mrs. Merckx.

I think you voted against. Mr has voted. We will look at it in the report.

With regard to the breakdown of Clamoxyl stock, we have asked ourselves many questions about the policy to be carried out in this kind of case. How can companies that do not deliver their medicines face their responsibilities? How are they punished? How can we verify the reasons they invoke?

As such, the subsequent hearings and debates proved interesting. In fact, we learned that while the law provides for fines in case of stock loss, they are never applied. How do you want companies to settle or solve the problem if no sanctions are taken? When I exceed speed or burn a red light, I get a fine – and that’s normal.

As for the question of the authenticity of the reasons invoked by the company, we were entitled to an answer to the least worrying. When I asked the Minister if the reasons GSK has invoked regarding the breakdown of the stock of Clamoxyl had been verified, she offered me to visit the facilities of this firm myself. This response continues to confuse me. I don’t know if any officials have performed the necessary controls.

We will abstain from voting on the bill that is presented today. We think that it does not adequately address the causes I have just described.

We also do not agree that while there was nothing about this in the original text, companies now have 3 days to deliver a medicine. This is too long for some medicines. We will also no longer be able to sanction companies if that provision applies. We disagree that the original text, which provided for an increase in fines, was eventually very much weakened.

We find it positive that pharmacists have the right of substitution in the event of a deficiency and that the costs associated with the possible import of medicines in the event of a deficiency are no longer transferred to the patients.

We believe that the existing law should be effectively enforced with an effective sanction policy and that there should be a check on the reasons of unavailability that the firms indicate. We must take care that the patient has priority over the profit.

Collega Depoorter, dear colleagues from the Health Committee, colleagues in this Half-Round, I would like to thank you very much for the great work done in the committee.

As previously noted, the Health Committee has already worked very hard to address, among other things, the shortages of medicines. We all know stories of people who could not get their vital medicine on time. Often, all kinds of miracle solutions were promptly pushed forward, but we do not believe in miracle solutions. The hearings have taught us that the situation is often slightly more complicated than a few slogans.

A shortage of medicines can have various causes. We just heard a few of them. For example, one cause could be a manufacturer’s withdrawal of its medicinal product from the market, which means that the only alternative available can no longer follow production. There may also be a problem with the quality of production. There are many reasons that could explain a shortage.

Do we have the miracle solution with this proposal? and no. We will not claim that either. Ms. Depoorter has just said it: we do not have a magic rod. Over the past two weeks, however, progress has been made by FarmaStatus.

FarmaStatus, dear colleagues, is a system in which pharmacists, patients and the prescribing doctor can see when a medicine is not available. We consider this to be an important step, because in this way the doctor can immediately see when prescribing a medication that a particular medication is not available and can propose an alternative. This is also important for the therapeutic faith.

As I said earlier, this proposal provides a partial solution to the problem of drug shortages. For us, there are four important elements in this proposal. I will briefly explain them.

First, when a deficiency is ⁇ , the medicinal product should no longer be exported. We believe that this is important.

Second, wholesalers must deliver to distributors within three working days, insofar as the delivery falls within the scope of a public service obligation. This has been discussed with the sector. This is also a viable deadline. We can say that three days is long and that it should be able in one day, but that requires logistics pretty much from those suppliers. We do not believe that one day is feasible, so we do not want to simply impose it.

If the traders do not deliver within three days, this will automatically be considered a temporary discontinuation.

Third, the pharmacists can offer an alternative, the substitution right in the case of a shortage of a medicine.

Fourth, when a patient has to resort to a more expensive alternative, for example by importing the medicinal product, the additional costs will not be borne by the patient and not by the health insurance company, but by the manufacturer or by the person who caused the deficiency.

I would like to talk about the substitution law. It has just been addressed by several colleagues: it is indeed not a general substitution right. We have chosen to limit it to shortages of medicines. A general substitution right, as we learned from the hearings, could increase the problem of deficits.

The problem could aggravate because larger pharmaceutical companies could give large discounts especially to pharmaceutical chains. This would make it difficult for smaller pharmaceutical companies, which are now often the generic manufacturers, and threaten to push small pharmacies out of the market.

Moreover – and that is what we think is most important – those discounts would not benefit the patient or the health insurance. We choose solutions that benefit the patient in the first place.

From time to time, it was encouraged to grant high fines in the event of a deficit. This idea is also supported in the final proposal. In fact, the hearings showed that this measure would also have an opposite effect. In the Czech Republic, for example, a country that is comparable in terms of population to Belgium, fines were introduced. Many products have since disappeared from the market.

It would again be the manufacturers of cheaper and again often generic medicines who would no longer want to take the risk of high fines and will disappear from the market.

Mr. Speaker, colleagues, a shortage of medicines means that patients cannot get their medicines, neither in the pharmacy nor in the hospital, where the problems are often even greater. But whether 500 or 600 medicines are too few, every deficiency is one too much. We must try to remedy this.

This is an important social problem that affects many citizens. I suppose you’ve all met people who couldn’t get their pill or otherwise their sister, aunt, grandmother, grandfather, neighbor. This causes a shock to society. It is good that we were able to take the issue to heart, to discuss it in committees and to attend hearings following the hearings during the previous legislature. The sp.a-fraction has taken a constructive approach, which is always our attitude. We have been constructively looking for solutions.

Thanks to the approved amendments to the initial proposal – there were many – a sufficiently balanced proposal is now on the table, a proposal that is in line with the previous pill plan of sp.a. I would like to emphasize that the proposal is sufficiently balanced, and that are important words. It is sufficient but not ideal. The other colleagues also referred to it, it is not the ideal solution but it is in the given circumstances a sufficient solution.

The proposal is indeed balanced, but there is still something to be done with regard to the pharmaceutical industry. We must look for a pax pharmaceutica, a new drug pact, which is much wider than a solution to shortages, which is a particle of it. Mrs. Minister, we must responsabilise the pharmaceutical industry, probably in different fields and, as far as we are concerned, in different ways depending on the pharmaceutical actor – I try to pronounce it diplomatically in order to ignore anyone. This will definitely be a hot item. I am ready to engage in the discussion on this.

I would also like to speak to my colleagues from Ecolo-Groen.

The present proposal is sufficiently balanced with, in our opinion, sufficient respect for European rules. We indeed take a risk with it, but let us take that responsible risk, because we can take steps in the right direction with it and that is the core of the matter. There will probably be more steps to follow, but we can take this step and we should not miss that opportunity. The next steps are still to be discussed following a draft drug pact.

On some points, we can really take a step forward. I will outline some concrete and feasible measures that can be put into practice.

The first point is a faster and better registration of a potential problem or cause of a shortage of medicines with a clearer reporting obligation than the existing, so that the decision-making tree of the FAGG, a well-known jargon for the members of the Health Committee, works better. This can lead to better and faster results. This includes a link between the FAGG database and the software of the general physicians, which is now almost fully operational. That connection is, although not yet 100% in order, a good evolution. FarmaStatus is therefore effectively a step forward, even if there is still work to be resisted, so that a prescribing doctor can immediately see which medicines are available where. The patient therefore does not needlessly go to a pharmacy to determine that a medicinal product is not available there, since the prescribing doctor can inform the patient of the availability of medicinal products once the link of the software satisfies. Let’s work on this link on the ground.

Secondly, the introduction of a temporary or definitive ban in the event of a shortage of medicines is an essential measure for us. For some reason, usually for profit purposes, medicines are intended for the Belgian market, in case of a shortage exported abroad. We want to prevent this by imposing an export ban.

Third, we must grant the pharmacist a limited substitution right for medicines if there is a deficiency. Medicines are classified in the category switch or no switch, with which I again use jargon. Switch medicinal products are, in simple terms, similar medicinal products that are interchangeable without hazard to public health and in compliance with the guidelines of the FAGG.

There is a limited right of restitution. Should we continue to discuss this right of restitution? Yes, because we must take into account the legitimate concern that Mr. De Caluwé has raised, that the right of substitution could be abused to organize stock sales. We also ask for a balance. Let us not disturb certain balances, with which I also aim at some amendments that would disturb that balance and are clearly not feasible on the ground. We must not mislead ourselves and the people in the field; we must look for feasible solutions.

For the sp.a. fraction, the arrangement under which the patient, who must purchase and take the medicinal product, does not have to pay additional costs, if a medicinal product that should be available is not available for some reason, is of fundamental importance. It is not possible that the patient must pay the additional costs if the pharmacist, for example, has to purchase a medicine abroad. The patient should always be freed. The patient and the health insurance company should not become the financial victim of a deficit that should not exist.

Mr. Speaker, colleagues, the present bill is a step forward, a step in the right direction, but the work is not yet finished.

First of all, you need to work now. Implementation decisions are still needed, and quickly. I hope you will finalize those KBs soon. The FAGG working group has been working on this for a long time. They are ready. You have known for a long time that they must come. Let the KBs, which are ready, arrive very quickly, so that the scheme can enter into force in an appropriate manner and by 31 January 2020 at the latest. These KBs should be opposed.

Mrs. Minister, I hope that you will also quickly issue the KB that does not come from the FAGG working group, so that additional costs will not be charged to the patient. For us, indeed, it is of fundamental importance that the spirit of our proposed arrangement, when it comes to costs for the patient, arrangement that is hopefully approved, is kept in it. This is in the interest of everyone’s health, our own and that of the patient.

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, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker.

Unavailability of medicines is a public health problem that is all but negligible. First and foremost, for the patient. Beyond the inconveniences of the walks and coming to the pharmacist, this raises much more existential issues of observance and rupture of the observance of treatment. This is also a problem for pharmacists, for doctors, but also for social security, because often this unavailability potentially leads to additional costs.

Let us not be foolish. There is no magic rod that would allow us, with one or more measures, to miraculously arrange everything. It is rather through a beam of measurements on the entire circuit of medicines that we can advance the matter and, above all, act more effectively against the unavailability of medicines.

From production, to the level of pharmaceutical firms, through distribution, being careful to prioritize the Belgian market over export, and not to allow the trap of an export of medicines to markets where the medicines would bring a higher benefit for pharmaceutical firms, which would then directly penalize our patients.

Production, distribution and notification much faster, which is indispensable. And, even if we haven’t talked about it, I personally plead that we can examine the importance of setting up tampon stock, for a number of medicines – not for all, it ⁇ ’t be useful – identified by Public Health.

It is well, you will have understood, that every actor in the circuit of medicines should be responsible.

This proposal provides for numerous delegations to the King. I will not repeat them here, but, Madam Minister, in this regard, we want to advance two important tags to these royal orders. On the one hand, there should be no extra cost for the patient in case of unavailability of a medicine, and especially when the situation forces a pharmacist to have to order the medicine abroad. On the other hand, that there be a real concertation, as I pledged in committee, with the various stakeholders of health. I say “concertation” and not just “information” because we need practical solutions as well as legally solid solutions in the rulings – one will remember that a bill you voted for in the previous legislature was rejected by the Constitutional Court.

The AFFMPS again exchanged the last fifteen days with a few stakeholders and announced dates. I allow myself to insist again with you that it is a real consultation and not just an information of the unilateral decisions that would have been taken.

Finally, as regards the possibility of replacing pharmacists in this text, it is determined in a strict framework. It can only occur when there is a clearly identified and notified unavailability. It is strict because it is never but the transposition of what is actually done in practice today, in case of unavailability. It must be strict and aim at the continuity of treatment for the patient.

Madame Depoorter, if I actually reintroduced an amendment on the importance of informing the prescribing doctor, it is because the situation is not as simple as you describe it. Of course, there is an electronic prescription, but it does not cover 100% of the prescriptions. The quality and continuity of care as well as the safety at the level of treatment imply that the prescribing doctor is informed when the patient returns to see him.

The amendment I am submitting here is a little different from the one I had submitted in the committee. It is not different in the purpose, but in the way. Indeed, it seems to me that it is also the role of public authorities to ensure that this information passes well from the pharmacist to the prescribing doctors with the least administrative burden, and if possible not at all administrative acts made by the pharmacist. This is a crucial element if we want to keep the patient at the heart of care, and ensure continuity between the different health partners and actors. Finally, the priority is the quality of care.

Mr. Speaker, Mrs. Minister, the bill submitted today to the vote of our assembly is an interesting response to a complex problem that concerns the entire chain, ranging from production to distribution: the shortage of medicines. This problem has shaken our current situation in recent months and we had to respond to it, in particular by organizing the hearings we had in the Public Health Committee.

Indeed, the unavailability of medicines, by its gravity and recurrence, really puts the health of our fellow citizens at risk. Who says drug shortage says longer convalescence, worsening symptoms of a disease, hospitalization that could have been avoided, or even death in a shorter term. To palliate this, and have access to their medications, patients try everything for the whole. Doctors and pharmacists try to keep track of a difficult treatment by prescribing another drug, sometimes with a different dosage, which multiplies the risks of administration errors. Today, no less than 641 packaging of medicines are unavailable. They were 573 at the beginning of October 2019, and 497 in July 2019. These figures refer to the types of packaging concerned.

In the committee, experts, but also patient representatives, all rightly emphasized how much we are now facing a real public health problem. Because if alternatives to shortage medicines exist, they are sometimes more expensive, and can disrupt the treatment of a patient. We are talking here about treatments against cancer, against disorders such as bipolarity, against migraines, against heart failure, against sexually transmitted diseases such as syphilis. It also includes palliative care. It is believed that one in four patients would potentially be affected by the situation.

For my group, this bill is undoubtedly a first step in the right direction in ordering pharmaceutical firms to deliver their medicines very quickly to wholesale distributors, independent pharmacists or hospitals.

It is also a step in the right direction because it enters the right of substitution into the law. This right is conditioned by the adoption of a royal decree. I call on the Minister to do everything to ensure that this Royal Decree can be adopted as soon as possible. For, indeed, pharmaceutical firms have a social responsibility that should force them to make the first thing why a drug was produced – saving lives – in search of profits. This social responsibility applies in particular when these firms have a monopoly in the treatment of a disease.

The bill therefore offers a diligent response to the cancellation of the law of 7 April 2019 amending the law of 25 March 1964 on medicines. This is what made it worth to be validated by the AFFMPS. Nevertheless, the work carried out in the committee could have been more exploited to respond to the confusion of pharmacists and patients. We believe that while the shortage of medicines requires our vigilance, the material and financial accessibility of patients to their medicines requires equally.

Associations such as Test Purchases, Doctors of the World and Kom op tegen Kanker sent us, at the end of October, recommendations on the development and accessibility of drugs. It is therefore our responsibility to propose also a legal and political response that is more comprehensive than that proposed by the bill we are called to vote on.

The ventilation of available medicines according to their category, generic or not, exported or not, has never been communicated. The proposal remains incomplete.

Professor Dogné highlighted the fact that in order to lower its costs, the pharmaceutical sector produces the vast majority of the drug raw materials outside the European Union. It would therefore be appropriate to require companies to retain 30 % buffer stocks. This idea was not included in the proposal.

For all these reasons, my group will abstain from this bill.

The shortage of medicines is a public health problem that is getting worse from year to year. This is a real calvary for chronic patients and the APB estimated that the lives of 1,200 patients had been put at risk because of the shortages. Pharmaceutical industries do not produce products like others and they have a particular responsibility in managing their supply chain.

We all agree that this problem is complex and that if there were ready-made solutions on the shelf, we would not be there. This bill submitted by Ms. Depoorter is a first response to a very important parliamentary work. Today’s proposal is a good answer. The importance of reporting and the reasons for the shortage, the possibility of suspending exports, the possibility of replacing the pharmacist and the financial accountability of the pharmaceutical sector go in the right direction.

As my colleague Barbara Creemers explained well, in the grounds of the appeal brought before the Constitutional Court against Mrs De Block’s law in April 2019, the absence of notification to the European Commission had already been cited. We therefore continue to think – not like Mr. Bertels – that in this very complex matter, all legal guarantees must be put in place. But I note that legal certainty is a matter of variable geometry in this assembly. Even if there is an emergency, it is necessary first and foremost that the law is legally robust so that enforcement measures are taken quickly to start stopping the problem.

Today, we will abstain, but we continue to work on additional proposals, including mandatory licenses and strategic stocks. It will also be crucial to evaluate the implementation of the measures that will be taken so that it can be verified whether they have the expected effect.

Regarding the part of the notification to the European Commission, I find it a pity that you did not ask – but it is not too late! – a legal notice to the services of the Chamber or to the AFMPS, which could have responded to us with greater certainty. We support the text but if we could have all the elements to reassure and lock this issue, it would avoid any difficulty.

This is just a small suggestion that I allow myself to do here.

Mrs Fonck, thank you for your suggestion, but the people of the administration, including the FAGG, have already responded. During the hearings and the discussion of the proposal, they responded that it was a reasonably acceptable risk. We have already received that answer, so we will not ask it twice.

Indeed, the question was asked to the AFFMPS, which recognized the existence of a risk.

We will see it later.

I have finished, Mr. President.

Ladies and gentlemen, I will be brief. I am glad that I already have a sister in this Parliament.

I am pleased with the presentations, and I refer to the words of Mr. Bertels, which were sufficiently balanced. This, however, testifies to the fact that we are all convinced that this is a problem that needs to be addressed and in which we need to take a step forward.

I said it in my introduction. It is not a magician. It is just a step. The parties who abstained have indicated that it is not a total solution, but we do not claim that. It is a beginning.

I think that from now on, we can continue to work on this issue and continue to work on a more performing public health.

Mrs. Fonck, I find it very good that your amendment has been adjusted, but what I most appreciated in your presentation is that you said that the patient is very quick when the primary care communicates with each other. That’s exactly what we all want, communication for the benefit of the patient and legislation for the benefit of the patient.

Mrs. Depoorter, I would like to come back to the little incident of that time.

On July 16, I intervened in the Health Committee following the breakdown of Clamoxyl. Then I asked for a hearing. We had asked for this two days before. That was on the agenda to do that the next day. You voted against the N-VA.

I watched the video again. You voted against it. I did not just say anything here. That is the truth.

I am pleased that you subsequently appeared and found it interesting to hold the hearings.

You have refreshed my memory. I can inform you that I submitted this bill on 21 June. I think I was really working on this issue and that I was really happy that we started shooting. That we voted against would have had another reason.

We have worked with all of them. I don’t think I can be blamed that this was a problem that I only wanted to address later, because June 21 is a long way before July 17.