Proposition 54K3519

Projet de loi modifiant des dispositions relatives à la remise des avis scientifiques et techniques par l'Agence fédérale des médicaments et des produits de santé et portant sur le financement de l'Agence fédérale des médicaments et des produits de santé ainsi que sur la création d'un bureau du cannabis.

General information ¶

Authors

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

Submission date

Feb. 6, 2019

Official page

Visit

Status

Adopted

Requirement

Simple

Subjects

pharmaceutical industry medicinal product health policy public administration public health scientific research

Voting ¶

Voted to adopt

CD&V Vooruit PS | SP Open Vld N-VA MR PVDA | PTB PP

Abstained from voting

Groen Ecolo LE DéFI ∉ VB

Party dissidents ¶

• Olivier Maingain (MR) abstained from voting.

Contact form ¶

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Discussion ¶

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

Full source

The rapporteur, Mr Benoît Piedboeuf, refers to the written report.

Mr. Speaker, Mrs. Minister, I will be speaking here quickly on the amendment we introduced with Ms. Lijnen and Van Hoof regarding the creation of a cannabis office. This is, in our opinion, an extremely important step. This is the therapeutic cannabis, cannabidiol.

The legal basis is provided for the extension of the AFMPS’ competence for the organization of cannabis cultivation and the establishment of a cannabis office. More and more countries recognize the use of cannabis as a medicine or for medical purposes. Cannabis for medical use has been holding attention for some time as studies demonstrate a potential added value of cannabis compared to conventional pharmacotherapies.

In Belgium and under this legislature, the drug Sativex, based on two cannabis extracts, was approved in the treatment of symptoms related to moderate to severe spasticity due to multiple sclerosis. This is a very probative case since we found that, for some patients for whom conventional treatments did not work, Sativex allowed, nonetheless, to have a constructive and effective treatment.

What we are doing today is a rather limited step. It is true. But it will allow at least a fully regulated and controlled culture in the matter and a distribution to the pharmaceutical sector, as well as for any other dangerous raw material, by the way.

This, of course, is not a legislation intended for recreational use. We are well in the therapeutic field. It is also not about delivering medical cannabis to anyone who would ask for it. It is not even about approving new medicines or other indications. This is part of another process that provides for the necessary scientific guarantees. It is therefore simply, I insist, to organize a cannabis culture in Belgium for a purpose of scientific research and therapeutic interest.

Mr. Speaker, Mr. Minister, I rarely intervene, but I want to do so on the basis of an amendment.

First of all, I would like to welcome the work that is advancing in the field of therapeutic cannabis in particular. I introduced an amendment because I think that in cannabis policy in general, we live in an unbearable hypocrisy.

You know that legally, cannabis remains completely banned in Belgium except for therapeutic cannabis when we have voted just recently. His detention and his culture, even at very small percentages, are punished. In 2005, the College of Attorneys-General issued a circular, according to which personal use of cannabis, in particular, by an adult person, would give rise to a contravention and this should constitute the lowest degree of prosecution policy. The current government, Mrs. Minister, has taken a royal decree that reinforces opacity. This decree permits that this system, which could be called tolerant, can be put to an end. We are in an extremely vague situation and we are pleased in hypocrisy.

What is the reality? You know that today, there are very many offices (European, Belgian or foreign countries) that study the cannabis phenomenon. In our country, there are no less than 1.5 million people who have responded and who claim to have consumed cannabis. I don’t know if you realize: 1.5 million citizens! The vast majority are young people. In order to acquire cannabis, these young people are thrown into the arms of mafia and criminal circles. I will not hide that this is not just a political issue. It is a moral question. It is unbearable to think that our youth must project themselves into criminal arms to acquire cannabis.

In addition, the quality of the products supplied by the resellers is mediocre. All the analyses indicate this. There are, for example, stained glass, solvents and other very harmful products, which is totally unacceptable.

The state, as a whole, uses enormously many means of repression: police, justice, prisons... But my experience as a mayor leads me to say that when the police are called, they intervene in a place A. Of course, for a few days, this place is no longer frequented by dealers and dealers, but 500 meters or 1 km away, we find exactly the same trade for a simple reason: the demand is considerable.

It is also said that the profits for the criminal circles in our country would be in the order of 500 million to one billion a year. These are astronomical amounts.

To defend this amendment, I just want to refer to other countries. In Canada, for example, the current government has liberalized. This government can be cataloged as a liberal-liberal open government, as it has reduced the retirement age to 65 years. Uruguay, along with the Grand Duchy of Luxembourg, liberalized several U.S. states and the Netherlands. It is urgent that our public authorities take control of the phenomenon and develop a policy beneficial to our citizens.

Statistics show that in the most advanced countries I mentioned, there is no increase in cannabis consumption.

It is even the opposite. With 40 years backwards, the average consumption in the Netherlands is below the European average.

In the past, we have made provisions for alcohol and tobacco. I don’t understand why we shouldn’t make arrangements for cannabis as well. Our political and moral responsibility is committed. I think we need to take the step and allow cannabis.

How to do? Very quickly: you know that there are more and more cannabis social clubs that are creating themselves. Many are quickly discovered by the repressive circles – the police or the judiciary. But across the country, hundreds and hundreds of people gather to work and see what can be done.

I think we can work with these cannabis social clubs. They can cultivate and sell under the control of a Belgian cannabis agency, which would itself be controlled by the Federal Medicines Agency. It would ⁇ not be unconditional. I already hear the comments: “Of course, this is the door open to debauchery. Everyone will start smoking cannabis on the street.” Sometimes I think that some would do better to do it, but I don’t think that is the case.

The conditions would be the legal ban on the sale of cannabis to minors. This would be a rejection of banalization; the prohibition of places proper to consumption; the obligation of a permanent quality control; the traceability of the entire chain from the producer to the consumer; the authorization of production and consumption on a personal basis.

The state would benefit significantly from this in terms of taxation, taxation. This money could be used to conduct real national prevention campaigns, indicating the effects of cannabis.

Finally, if we approve this amendment, there would be a considerable reduction in the use of police officers, magistrates and judges. There would be more room in prisons. I do not doubt that colleagues will be attentive and will vote. I didn’t say how they would vote, but I hope it will be positive.

Ladies, gentlemen, dear colleagues, madam the minister, I invite you to get out of the hypocrisy in which we find ourselves and to get our young people out of the grip of the criminal and mafia circles. I look forward to today’s vote with impatience.

Mr. Speaker, Mrs. Minister, Mr. Minister, colleagues, this proposal aims to establish a public agency under the control of the FAGG. This agency, the cannabis agency, will have to take care of the full organization of the cultivation of medicinal cannabis. The cannabis office will have to provide for the permits of the land on which it can be cultivated, and for the permits of the growers who will cultivate the medicinal cannabis.

Through such legislation we finally make it possible to cultivate medicinal cannabis in a legal way, and this under the strict control of the government and within the contours of evidence-based medicine. In this way, we respond to a real demand from the medical world and the patients.

Colleagues, more and more countries recognize the use of cannabis for medical purposes. Numerous studies prove the potential added value compared to the traditional pharmaceutical solutions.

As early as 2014, a working group under the FAGG discussed the issue of medical use of cannabis in Belgium. This working group then concluded that there can be added value. Importantly, these are specific cases where traditional medicine has little or no effect. Medicinal cannabis will have it, and in many cases it can improve the quality of life of many patients.

In terms of public health, this is a significant step forward for many people. This will also have a huge impact on innovation and economics. Belgium will become a pioneer. In addition to leading work in biotechnology, a new ashes are being developed here, in particular the cannatech.

I would like to thank you and all your employees. You know it or you don’t know it, colleagues, but the cabinet of Minister De Block was almost round with the text. However, due to the fall of the government, it was not possible to continue. That is why we took the initiative from Parliament to provide the legal basis for the establishment of the cannabis agency. Many employees from the Cabinet, the Administration and the FAGG have collaborated on this. I would like to expressly thank them for their commitment in this regard. Together with us, they are writing a piece of history that is important for many patients and for our country, both in terms of innovation and for our economy. Together with us, they can be incredibly proud of it. In addition, I would like to thank all the colleagues who have approved this bill in the committee, as well as all the colleagues who will later support it.

Mr. Speaker, Mrs. Minister, dear colleagues, I would like to intervene briefly with regard to this bill establishing the Cannabis Agency.

This is very important for my party. Together with colleagues Lijnen and Thiéry I have therefore submitted the amendment to establish the cannabis agency in the womb of the FAGG.

The establishment of the cannabis agency is a first, important step in allowing medicinal cannabis or better, the therapeutic use of cannabinoids. This has nothing to do with the legalization of cannabis, which for us is not at all concerned and which can never happen. CD&V will always be committed to the quality of life of people, especially of patients who are seriously ill. The medical use of cannabis or the therapeutic use of cannabinoids can mean a world of difference for these patients. We want to create the legal framework and encourage scientific research to help these patients. For this, the cannabis agency, thanks to this bill, is of crucial importance.

What should this agency ultimately serve? The Cannabis Office at the FAGG will be responsible for controlling the production of cannabis for medical and scientific purposes. There is still a great need for medical and scientific research into the therapeutic effects of cannabis-based medicines. Today there is Sativex, a spray that is refunded for MS patients. Many clinical studies have shown that the agent is also good for ALS patients. Because of their condition, they benefit more from a spray than from an oil, which they can hardly swallow. It is therefore of great importance that Satifex becomes reimbursable for various conditions. Now that we will have the cannabis agency as a lever, I hope that several pharmaceutical companies will apply for it. It is very important for symptom relief in pain and severe muscle contractions. This can also slow the progression of the disease. These medicines have proved very clearly that they can give the patients some comfort again. They sleep better and get their appetite again. Therefore, it is important that we promptly market medical cannabis for this group of patients.

This requires a cannabis agency at the FAVV. I have submitted a draft resolution in support of the Minister’s proposal on the Cannabis Agency. Many groups of patients testified that they were going to obtain cannabis oil illegally in the Netherlands, because other medicines do not provide sufficient comfort. I think that’s not a good thing, because self-medication is never a good thing.

Therefore, it is necessary that we quickly obtain medical scientific research with clinical trials to ensure that a tailor-made product comes out for those patient groups. Then they will not use the wrong doses and we will prevent them from getting sick even more by misuse of cannabis oil.

The ultimate goal is to market medicines and make them available in Belgium. Certain physicians-specialists can then prescribe cannabinoids for some therapeutic treatments and pharmacists can get them in their form with approval by the FAVV and use the raw materials for magistral preparations. The medicines should then be made available to all groups of patients for whom clinical trials have proven that medicinal cannabis is the only agent that contributes to their quality of life. That is the future for us.

For us, it is a step-by-step approach. The first step is the establishment of the cannabis office. Every step we can take to improve the quality of life of seriously ill people in a safe and scientifically supported way, we must, of course, do.

I would like to thank everyone who has contributed to this, including the minister and her cabinet, which allowed us to submit the amendment. I want to thank the League as well. She gave the proposal for my draft resolution, which was ultimately not addressed, but that was in the spirit of the bill. For the ALS League, it is important that we do not confuse the debate with the legalization of drugs. They do not want to be associated with drug users. She wants to be known for her advocacy for medicines that are not available today, while increasing the quality of life.

I would therefore expressly advocate not to confuse today’s debate on medicines with the legalization of cannabis. Therefore, we cannot agree with the amendment of the PS.

First of all, I would like to talk about the treatment of cannabidiol.

As much as we are not in favour of the legalization of cannabis, so much we support the advances in the therapeutic use of cannabidiol. It already exists in Belgium. Indeed, some seem to believe that it is this bill that will allow the use of therapeutic cannabidiol, but it already exists with Sativex.

In addition, it is quite appealing to see the little availability, outside of Sativex, of therapeutic cannabidiol for Belgian patients who suffer from refractory epilepsy or certain types of severe chronic pain, in particular oncological, for which other analgesics are not effective. This low availability in Belgium is questionable.

I think this problem should have been managed for a while. Indeed, this lower availability compared to existing medicines in neighboring countries has resulted in, and ⁇ favoured, the installation of a whole series of small shops that sell cannabidiol without the current legislation being complied with, which obviously poses a problem.

We support this part of the bill.

However, the rest of the bill raises a number of questions as the exact scope of the different articles is difficult to evaluate accurately. It includes potentially negative minds. And, as I said in the committee, I regret mostly – I have also opposed this article – the very clear increase in an existing tax for pharmacists, hospital pharmacists and veterinarians.

I can absolutely not support this extra tax for pharmacists. I am opposed to this arrangement of your bill.

For the rest, given my favorable position on therapeutic cannabidiol, we will abstain from the entire device.

Mr. Minister, we will abstain from this bill because we consider that the strategy is not clear enough. Affirming that if a sector requires more self-control, it is normal that it bears the cost, this seems to us a bit short as reasoning. We primarily think about the consequences for small offices.

However, I would like to clarify that we appreciate the creation of a Cannabis Bureau. As I had already pointed out at parliamentary questions a year ago, we regret that the Royal Decree of 15 June 2015 formally prohibits the delivery of cannabis for medical purposes in Belgium. Only Sativex can be used in the treatment of aggressive pain due to multiple sclerosis and is only refunded in this case, and in case of delivery by the hospital pharmacist on prescription of a neurologist.

However, more and more voices rise in favor of a use aimed at calming pain, for example in cases of fibromyalgia or cancer. According to some publications, it would also have anti-epileptic properties. Therefore, we want to reform the use of medical cannabis on the basis of scientific data and in particular on the basis of developments seen abroad. Several countries such as Germany, Austria, Finland, Italy and recently the United Kingdom allow it. France also studies the issue for the treatment of refractory pain through accessible therapies, certain forms of epilepsy, in supporting care in oncology and palliative situations.

We support the chapter of the bill that establishes a Cannabis Office and we will follow with interest the outcome of all its work.

Are there any other members asking for the word? (No to)

Mr. Minister, you have the word.

Mr. Speaker, I will briefly comment on the fact that Mr Di Rupo had written an amendment that was somewhat in the wrong place.

His amendment is about legalizing the use of cannabis and thus actually belongs to the Committee for Justice and not within the framework of a legislation that concerns the competence of the Federal Agency for Medicines and Health Products.

I think it is advantageous to create the possibility of having a product grown under the control of AFMPS, stabilized, of which we are certain of the dosage, to relieve patients who need it and according to indications that are evidence-based.

I am not in favour of the amendment of the PS because it is an element that must be discussed in the Justice Committee.