Proposition 54K3599

Projet de loi modifiant la loi du 25 mars 1964 sur les médicaments en ce qui concerne les indisponibilités de médicaments.

General information ¶

Authors

CD&V Nathalie Muylle
MR Damien Thiéry
Open Vld Dirk Janssens

Submission date

Feb. 26, 2019

Official page

Visit

Status

Adopted

Requirement

Simple

Subjects

pharmaceutical industry medicinal product health policy shortage health insurance

Voting ¶

Voted to adopt

Groen CD&V Vooruit Ecolo PS | SP DéFI Open Vld MR PVDA | PTB PP

Abstained from voting

LE ∉ N-VA VB

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Discussion ¶

March 28, 2019 | Plenary session (Chamber of representatives)

Full source

I am referring to my written report.

Mr. Speaker, today we are voting on a measure to address the shortages of medicines, a question that has long lasted. I just spoke about the language requirements in the law on the exercise of health care professions and, if you look at it carefully, we are actually in the same scenario here.

In 2015 – I checked it once – I asked for numbers on this for the first time after a case on this subject. There are more, because drug shortages are a huge problem, affecting both patients and pharmacists and having a huge amount of extra work. Also on this I asked questions from the beginning of the legislature and addressed the problem and also there you actually sent me every time with a clock in the roof. You said that you were working on it and would resolve it and that a working group would come. A working group has been working on proposals since 2014. After all those years, one proposal comes out of the bus, which then means the export ban. Of course, we did not wait for that proposal, but we have developed a thoughtful approach, a comprehensive approach, which really requires the problem. In this light, the present proposal is completely insufficient. It is incomprehensible that this is the only thing you come with.

The numbers related to drug shortages are increasing and registration is incomplete and insufficient. We have held hearings with the entire sector, the various stakeholders and scientists working around the problem. From that point of view, together with everyone, we have written a bill that guarantees a comprehensive approach and that commitment in various areas, in particular: prevention, addressing and evaluating.

We want to avoid the problem by guaranteeing the security of supply. Especially for life-necessary medicines, this must be possible or even imposed in order to protect the population. In addition, today there is a reporting obligation, but it is as leaky as a seed. In the causes one can also induce "other", so today we do not know exactly how many shortages of medicines there are, let alone why. That the reason should be better registered, of course, has everything to do with the fact that one can only act. If a drug shortage is caused by a case of force majeure, such as a factory fire, then there is no need to intervene.

If it is really a matter of discretion, for example, market coverage, or because a player thinks they can make more profits on the patient’s cap, then there must be action. We demand that fines be imposed in such cases. Also in the Netherlands this was decided after the Thyrax case in which hundreds of thousands of Dutch people were disabled because they could no longer reach their thyroid medication.

Fines and any additional costs should be borne by the responsible. Our bill provides for this. We assume the principle that our people and our patients must be protected. Not we, our social security or our patients have to pay for the additional costs that are due to a third party.

Our proposal also includes a better registration. This registration should also be practically incorporated into the list of pharmacists and the officinasoftware. In this way, our pharmacists will be better aware of the shortages so that they can respond to them faster. In addition to a penalty approach, our pharmacists also need to be supported so that they can offer alternatives more easily. This frustration, by the way, is shared by pharmacists and patients today. In addition, an export ban should be introduced for players who continue to create problems. This proposal for a unilateral export ban is present today. We envisioned this as a stick behind the door for players who have permanent problems. We consider this to be a proportional measure.

Finally, there is also the evaluation. You propose a unilateral measure imposed on the wholesale distributors. All other players are respected. All other causes are not addressed. Only the wholesale distributors and – additional problem – all wholesale distributors.

This reminds you of your measure to read the eID in the home nursing. For a few rotten apples, an entire sector is affected. This is a sad thing for players who are doing well today. You are in favor of unilateral measures to extinguish fires, while we had a comprehensive approach on the table, supported by the whole sector.

I also note that no other Member State has passed to such a total ban imposed on the entire sector of wholesale distributors. Therefore, we really wonder whether the ban will pass the test of the European Court of Justice. When we look at the explanatory note of the European Commission on the prohibition of expert medicines, we pose great questions about it. What does she write? An export ban may be “as long as such restrictions are justifiable as appropriate, necessary and proportionate”. This provision is already completely overlooked. It also specifies that it should be limited to "pharmaceuticals for which a shortage is likely or certain".

We had included in our bill that only the rotten apples would be effectively addressed and that not a whole sector would be fished because of a problem for which that sector may not be responsible.

We expect that some things will be challenged legally.

We will remember the proposal. It extends to honour that at least one proposal came from the bus, which is better than nothing. However, we fear that, after the legal challenge of the measure and taking into account the explanatory note of the European Commission, the proposal will not have a long life. As a result, our patients and our pharmacists will keep you in the cold, which is ⁇ regrettable. We would have liked to see it differently.

Mr. Speaker, Mrs. Minister, dear colleagues, we have supported this bill in committees and we will continue to support it today, but with little enthusiasm. However, let’s not be mistaken, the measure envisaged in terms of restrictions on the export of medicines for reasons of public health is insufficient. It is not in itself a comprehensive response to the problem of the shortage of medicines that we now know.

On March 7, the press was still reporting 428 medicines in shortage: aspirin, painkillers, antibiotics, antihypertensive drugs, etc. A real record of shortages that puts the health of patients at risk. Although there are sometimes alternative treatments, this is not the case for all medications. The lack of information and transparency about the causes and timelines for re-supply is also very appealing.

As for exports, it must be acknowledged that they are far from being the main cause of these shortages. It is therefore necessary to provide for balanced enforcement orders for this purpose. In fact, it is known that the vast majority of medicinal shortages are due to problems related to the production or supply of raw materials, and are therefore directly the responsibility of the pharmaceutical industry.

For our group, other answers could have been provided by the minister to effectively combat these shortages. But for this, and as we continue to repeat, we should have wanted to work for patients by addressing the main causes of shortages, those that are the responsibility of the pharmaceutical industry, and not to walk hand in hand with the pharmaceutical industry to protect its interests, as this government has done.

For our group, further advances will need to be made in the future.

Our concern is the patient, the patient’s interest. And it is again the patient that I want to emphasize today as in virtually all the interventions that have been made in relation to the legislative proposals that are being implemented in recent times. The patient’s interest prevails in the context of the unavailability of medicines. It is precisely to answer a problem that the patient faces when he is at his pharmacist that we are here. In fact, it is necessary to realize that if this unavailability of course affects the pharmacist, it affects primarily the patient.

A few retrospects. Initially, we were dealing with a bill that was later transformed into a bill submitted by my colleagues Dirk Janssens, Nathalie Muylle and myself. I add that this project transformed into a proposal is also the result of a work that has been carried out over two years. This was not sufficiently mentioned during the discussions.

The sector was represented, for once, in its entirety: Pharma.be, Febelgen, BACHI, APB, OPHACO, the Belgian Association of Hospital Pharmacists, the National Association of Wholesale Distributors of Pharmaceutical Specialties and Insurance Organisations.

I suppose everyone is aware. There are mainly two causes of unavailability of medicines: unavailability in the strict sense or contingent. Unavailable in the strict sense, Ms. Van Camp touched a word. This is, for example, a production defect, unavailability through a company that is no longer able to supply, due to a production defect or due to concerns about manufacturing or even due to concerns about the nature of the product delivered. As you all know, these products are subject to extremely important control.

In addition to these strict unavailability, the contingent should be mentioned. This refers to a stock pre-defined by the manufacturer of the medicinal products concerned. Deliveries are limited there, in order to prevent the medicines manufactured here from leaving our territory for the benefit of other European countries. However, as the industry has repeatedly ⁇ , we realized that the contingency disrupted the traditional pharmacy supply chain and continuity of care.

The reviewed text works on part of the availability solution – about 50 percent – but does not only concern contingentation. I agree with Mr. Senesael’s statement: of course, this is a first measure, but it will not be sufficient. We are therefore interested in the wholesale distributor. I recall – because this is not done sufficiently, unfortunately – that the latter must, first of all, comply with an obligation of public service, including as regards the making available of the medicinal product in the pharmacy in the interest of patients. It is specified that the wholesale distributor can only supply the products to colleagues, pharmacists or a hospital. Indeed, exports through a wholesale distributor will now be impossible. However, this does not mean that exports themselves will become impossible. These can always take place through wholesalers with a license for this purpose.

I had the opportunity to talk to some wholesalers who thought the measure penalized them. Now, frankly, if it is taken in the patient’s interest, the wholesalers who have received the export license will obviously be able to continue exporting. Where appropriate, with certain exceptions, alternative solutions are provided that are known to the interested parties.

I will not be much longer. The proposed law aims to strictly define the role of the wholesale distributor.

This retains its right to be mandatory supplied by drug manufacturers and other wholesale distributors. In order to prevent medicines intended for the Belgian market from being sold elsewhere, it is planned that it can only deliver to pharmaceutical offices, hospital offices and other wholesale distributors. As I said at the beginning of this intervention, the priority is therefore reserved for Belgian patients.

Mr. Speaker, let it be clear, our group supports the principle of this bill, which, in our opinion, provides a solution to the unavailability of medicines, which patients in Belgium unfortunately regularly face.

That unavailability may be due to force majeure, such as a production problem with the manufacturer, but also to the quota. The manufacturer delivers to wholesalers only the quantities that are strictly necessary for the Belgian patients, out of fear that the medicines intended for our country will be exported to other countries, where the sales price is higher.

This bill aims to strictly define the role of the wholesaler-distributor. Although it remains that he must be supplied by the pharmaceutical manufacturers and other wholesalers, but in order to prevent the medicines intended for the Belgian market from being sold elsewhere, this legislative proposal aims to allow wholesale distributors to supply only to the pharmacies, hospital pharmacies and other wholesale distributors. The Belgian patient is given priority.

Colleagues, let it be clear, we know that this bill is not perfect and that more needs to be done. For us, however, this bill is a first step in reducing deficits. If this eliminates the outflow and the deficits caused by intermediaries, then there must also be work on the resposabilisation of the producers.

Health before profit, I’ve seen someone call it on social media. It is just like that. We will, with a fresh resentment, ⁇ support this bill.

The essence has already been said by other colleagues.

We support the bill that is on the table for the following reasons.

The main reason is that today, with this proposal, we get more transparency. Is it ideal? Maybe not. Will it solve the entire problem? Maybe not. We also find, like other colleagues, that all actors in this story must be held accountable.

I hope that this measure will be incorporated into a larger plan that further addresses the unavailability.

We also have doubts about the European audit, but the communication of the European Commission was not unambiguous. Probably – that’s what the industry announces – a procedure will follow after the vote, which will show what the outcome will be. In any case, I think that transparency is good.

There was a lot of information in the press that wasn’t true. It is said that exports are not the cause. You also know that medicines, when unavailable, only come on the list after fourteen days. So everything that is not available in the short term is not yet in the numbers. It is good that we can measure and know this. We do not know the real reason today.

It’s not ideal, but for us this is an important first step that we definitely want to support.

Mrs. Minister, we are concerned, and many companies with us, about the clinical trial. There has already been an addition, but some vigilance can be built into it. I hope that you will continue to listen to the specific concerns and needs of the companies active in the field of clinical research.

There is a lot of reference to the pharmacy, but important here is also the support of the pharmacists themselves. They also support this first important step.

Mr. Speaker, I can make it even shorter than Mrs. Muylle, because most of it has already been said. I agree with the positive elements.

Unavailability is a problem that has existed for ten years and continues to increase. With this bill, we can provide a solution. It is irresponsible that profit-making would jeopardize the patient’s health.

This clearly involves a shared responsibility of producers and distribution. Since they fail to collectively assume this responsibility, the government must intervene, in the interest of health. This is clearly not a violation of the free movement of goods, something that some retailers, however, claim in the media.

We will support this bill. We are delighted that the pharmacist’s cupols see this bill as a good step forward.

The title of the question is positive since it aims to prevent the unavailability of medicines. And it is important to note that many patients regularly face medication shortcomings while it is a chronic treatment. I am in favor of the title.

However, when you dig a little into this bill, you are forced to ask questions that really pose me a problem, Mrs. Minister.

The first question relates to the fact that the text under consideration has not been submitted to the State Council. I also have questions about European law.

I really believe that the State Council could have validated, made amendments aimed at reinforcing this text or criticized it. The fact that I have not submitted this text to him therefore constitutes a problem, since I am not sure that it complies with European law. This is for the first aspect that relates to the method, but also to legal certainty!

Now I would like to address a second aspect. Of course, it is necessary to be very clear about patients affected by shortages and parallel exports. These exports cannot and should never lead to shortages of medicines in Belgium and no patient should be affected by them.

When we look at the missing medicines lists of the Agency for Medicines and the APB, we are quite surprised to find that at the end of 2018, almost half of the missing medicines were generic drugs. These medicines are generally not exported as they are available at much lower prices than in many European countries.

Moreover, a small hundred of the missing products were hospital products only available in hospitals. They are not exported either. For a small hundred medicines that are very rarely prescribed, this is also a packaging problem.

Based on these different elements, Mrs. Minister, I am concerned that the device you put in place offers little or no solution in relation to the problem of unavailability.

What about compliance with European law? Very clearly, I think the State Council should have been consulted? What is efficiency compared to the aim? In addition to this, other measures should have been taken on the problem of unavailability. I also have questions about the impact not of large industrial companies but more ⁇ of small exporting wholesalers. When you look at the palette of medicines that were unavailable, it is worth noting that the majority of them are not exported. There are problems at the source.

You have to raise your shoulders. I’ll give you an appointment in a year, or even in six months. I think we will then have to see that nothing has been settled regarding the unavailability of medicines.

Therefore, I will not support this text. I think we’re going beyond the essential. The situation is really problematic for the patients concerned. This happens almost every week. Mr. Minister, while working groups had been set up and had made a whole series of ambitious proposals on the subject, you did not follow them. We stay here with a proposal that, beyond the title, risks being legally fragile and not being effective on the ground.

Therefore, I fear that advances for patients are unfortunately null and unavoidable. We will not support this text. We give you an appointment to review, in a second time, the effective measures to be taken and also the risks associated with legal uncertainty.

As my colleague Dedry said, we will support the text. We believe this is a first step in the right direction. The problem is crying, urgent, and we believe that there will be much more global measures to be implemented in the future. We have repeatedly advocated for the establishment of a mandatory licensing mechanism.

It is also necessary to look at the practices of large firms which are organizing the scarcity and playing on the scarcity and competition between the different States, or working at the flow of tends and having deployed in other countries to maximize their profits. We find ourselves in a situation where ruptures of stocks are produced. Since there is a small pépin in the supply chain, a medicine is no longer available. The medicine is not like any other product. Des patients and dependents, qu'il s'agisse de leur vie, de leur santé ou de leur confort It is urgent to put something in place at the different levels of the chain, and not only at this one, but we will support already this premier not in the good sense.

Mr. Speaker, Ms. Fonck is gone but I will comply with her rendez-vous, because I know that this is a good measure.

Mrs. Van Camp is also gone. In my opinion, she was not present in the committee, otherwise she would know that this is not a complete export ban for medicines. Exports will still be possible, as Mr. Thiéry said. These products can still be exported, only not by the wholesaler-distributor, because its role is to deliver the medicines to the pharmacies so that the patient does not experience interruption of his therapy. Again, the expert is still possible.

This measure has indeed emerged from the working group, which has worked within the FAGG for two years. The working group also proposed other matters for which no legal provisions were needed, such as the website that is unique and where one can consult everything, as a patient and as a pharmacist, to verify which stock breaks were announced and for what reason. These medicines, which fall within the quota, could not be found on the website because it was not a permanent unavailability, but for example a week, a week and a half, or a few days. This has indeed been signaled to us. Ms Fonck refers to the generic medicines, but those that were dealing with them are also not found on the FAGG website. The FAGG therefore had no view of the unavailability due to the quota and export.

This is exactly what we want to change with this bill, so that even a short-term but difficult unavailability is visible and must be ⁇ to both the patient and the pharmacist. This should be understood more strictly and the FAGG should have a full view of the problem.

We learn in the field that unavailability, even short-term unavailability, is a real problem. In this regard, the pharmaceutical associations have developed a tool that allows pharmacists to order a quota product directly from the firm. Over a period of seven days, 281 products were ordered with this tool, including in the top five Clexane, a blood thinning agent; Combivent Monodose, against respiratory problems; Pulmicort, against allergies and respiratory problems; Depo-Provera, a hormonal preparation and Innohep.

That is the proof that it is an important factor and that it brings great problems for the patient. The measure has been reviewed and does not violate the free movement of goods within the European Union. We have requested an opinion from the European Commission on this matter, an informal opinion. Our proposal is fully in line with the reports quoted by the European Commission. That is important.

There will therefore be a reinforcement of the delivery and reporting obligations for the pharmaceutical industry, as today they must report a stock break of at least fourteen days, but if it is shorter, they must not report it. Under the new regulations, they will have to notify them as soon as they cannot meet the delivery obligation for three working days.

In terms of unavailability for patients, we are therefore making a big step forward.

Mr. Speaker, I have a meeting with Ms. Fonck in six months.