Proposition 54K1838

Projet de loi portant des dispositions diverses en matière de santé.

General information ¶

Submitted by

MR Swedish coalition

Submission date

May 18, 2016

Official page

Visit

Status

Adopted

Requirement

Simple

Subjects

administrative formalities pharmacist doctor labelling medicinal product health policy health care smoking aesthetic surgery social security tobacco veterinary drug public health health insurance

Voting ¶

Voted to adopt

CD&V ∉ Open Vld N-VA LDD MR

Voted to reject

PVDA | PTB

Abstained from voting

Groen Vooruit Ecolo LE PS | SP DéFI VB

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Discussion ¶

June 9, 2016 | Plenary session (Chamber of representatives)

Full source

The rapporteurs are Mr. Piedboeuf and Mrs. Thoron.

I am referring to the written report.

I do not see the Minister.

For the information of the groups, the Minister is abroad and therefore absent. Being a co-signator of a small part of this text, I will try to represent it.

Mr. Minister, dear colleagues, just a few words to justify my group’s abstention on this bill containing various health provisions. These are extremely technical measures that have been presented to us and for which we unfortunately did not have all the precise answers to the questions raised in the committee.

First, as regards pediatric conditions and the possibility that is given to the King to fix a particular period allowing to extend to less than eighteen years the refund of a specialty already included in the list of reimbursable specialties, if it is already refunded in the more than eighteen years in the same indication, giving a faster treatment to beneficiaries under eighteen years is obviously interesting. However, we still do not know what conditions must be fulfilled in this procedure and in what context it could be applied.

Indeed, this new indication for children should be subject to the same attention as another extension of indication. It is not because a medication is allowed for children that it is the best treatment option available. There may be other treatments that are less burdensome for the child or cheaper for health insurance. It should also be noted the importance of encouraging pharmaceutical firms to conduct more studies on specialties concerning children in particular.

Secondly, in relation to the changes made to the Health Care Insurance and Compensation Act, in order to allow the establishment of the oral care routes provided in the Dento-Mutualist Agreement 2015-2016, the primary question we ask ourselves and we still ask ourselves is whether this modification, i.e. the fact of increasing the personal quotas in dentistry, is of general scope or whether it will only aim to allow the establishment of these care routes.

Furthermore, if we understand the importance of oral care tracks, we remain convinced that this differentiation in the reimbursement of benefits among those who follow this route and those who do not follow it will not be effective among disadvantaged audiences, among the most fragile audiences.

By increasing the personal quota of these patients for priority benefits if they have not consulted a dentist the previous year, you will undoubtedly only accentuate the gap that already exists in this area. Because you know how difficult it is for these people to go to the dentist. Financial access to dental care remains complicated for many citizens.

Other measures should be considered for the most disadvantaged public. The compulsory paying third party is obviously an important track. There are others, but for now, we do not see any progress in this area.

Third, the new exemption to decrease by 7.5% after eighteen years or when a biosimilar arrives for long-acting insulines appears unjustified to us, especially since Ms. Minister De Block had previously granted a reduction exemption of 19%, which is valid for all medicines and not only biological. The minister justifies only the new exception on a measure that specifically targets the biological by the fact that they have the first, which targets all medicines. This is not a real motivation. Long-acting insulins cost twice as much for the same volume as short-acting insulins, with comparable methods and therefore comparable production costs. With the budget surpass announced for 2015 in medicines, it seems to me that these decisions, gifts I should say, should be more thoughtful.

Finally, a last word on the fight against tobacco. The European Directive was to be transposed in May. The provisions you have inserted in this project with various provisions in this framework are no longer minimalist. It is little to say. We hope that it is because it has been agreed that we will be able to have a very wide debate in the Health Committee on this important issue and that you want to let us move forward in this context. Thank you for your attention.

Before I specifically emphasize the dossiers that are important for our group in the context of this bill containing various provisions, I would like to correct something that the previous speaker has completely misinterpreted or understood, in particular regarding the extension in connection with the indication pediatrics. The Minister has also clarified this point in the committee. The previous speaker argued that without studies there would simply be an expansion of the target audience, which, of course, is not the case. This is never the case. The point is that the procedure, which now takes seven to thirteen months, will be shortened, of course based on studies. That is always the case.

You advocate that firms should be more encouraged to investigate their indication for children. This is precisely the purpose of the bill, which, for example, also includes agreements on price drops, which are present at the moment when the indication is extended to children. As a result, it is often less interesting for firms to invest in them, even given the long procedure. It is just the combination of shortening the procedure and removing the price drops at an indication for children that will facilitate access to important drugs, including against cancer and psoriasis.

In the proposed bill containing various provisions, our group also considers the dossiers on oral care, on medicines shortages and on the use of antibiotics in animals very important. We are of course also very satisfied with the implementation of some of the agreements of the pact with the pharmaceutical sector, such as the accelerated access to medicines, including for children, as I have already clarified. This is of course beneficial to the patient.

The measure related to the oral care pathway is controversial, even though it is intended to encourage individuals to have their teeth checked regularly. Various misinformation was sent to the world from certain angles, but only by the announcement of the measure were citizens encouraged to have their teeth checked. This shows how positive that measure is and why we advocate that it be put into practice as soon as possible.

We hope that the efforts will not be limited to this measure, but will also be spread, for example, to the very important group of diabetic patients, of which only four out of ten go to dental examination annually, while they are equally much more susceptible to dental problems, and to children.

Figures show that the latter group also has major problems in this area, especially south of the language border. There are still efforts needed. More should be invested in preventive care, which has been shown to be cheaper in the longer term and much better for the well-being of patients and society.

With regard to the shortage of medicines, we in the committee welcomed the new measures. We hope, however, that further steps will be taken. We see much salvation in a holistic approach, of which this bill may be the beginning for us. As many stock breaks as possible should be avoided by clear arrangements on the refund procedure. Certainly vital medicines should always be available.

In order to prevent stock breaks, there should be a clear inventory, with the obligation to report the penalty of a fine. If there is a shortage, a solution should be found as soon as possible. Not only do pharmacists need to have more room for movement to use alternatives. Those who caused the deficit must also be held accountable: they must pay the cost of finding alternatives.

We also see salvation in an ultimate stick behind the door. A clear and coherent approach to stock breaches needs to be developed, ⁇ when they occur regularly.

The legal basis for inventory of the use of antibiotics in animals, we find a great step towards a solution to the problem, which often reaches the media.

We have said very clearly that this is a first step for us. We still have a lot to do, for example, with the introduction of mandatory indication registration. Furthermore, the veterinarian, who should play a central role in the registration and not the farmer, should no longer correct entered data.

Finally, I want to talk about the procedure for medical devices. We welcome the initiatives to incorporate the evidence-based medicine approach into the entire policy. We think that is a good step. Of course, we will fully support the bill.

During the general discussion in the committee, I have already expressed my appreciation for the fact that the present bill contains a number of provisions for the implementation of the Pact with the pharmaceutical sector. Our country is a champion in clinical research in Europe and we are among the best in the world. MSD and Janssen Pharmaceutica carry out 90 percent of Phase 1 clinical trials in our country. Pfizer has its own laboratory. Those clinical trials are not only important to keeping pharmaceutical companies as an economic player in our country or to serve pharmaceutical companies, as the committee suggested. No, domestic clinical trials are ⁇ important for patients. It also means that our patients will have faster access to innovative medicines.

In order to maintain that position, the Minister has entered into a pact with the pharmaceutical industry, including not only financial measures, but also a range of measures to make procedures more efficient and faster, to make medicines more readily available to the patient, as well as biobanks with attention to the consent of the donor, taking into account the use of transformed material. Therefore, it is also important to say that with the draft the minister fulfills a significant part of its commitments and we can only support that as a group.

Yoleen Van Camp has already stated that the non-availability of medicines is a problem in our country. I asked a question about it to the Minister some time ago and she then replied that there was already a reporting point for unavailability. With the draft, our Minister also tightened the mandatory notifications, because also a temporary unavailability must be ⁇ . I am pleased that wholesalers will also be required to report, as part of the problem naturally arises in parallel trading. Only if we have a good view of the unavailabilities can we work on the remedy. From our group, we are, of course, looking forward to the measures taken to substantially remedy the problem and, not least, to the results that will be achieved by the task force at European level.

With this legislation, we also create a legal basis for a follow-up system at the FAGG for antibiotic use in animals. Although this is a matter of agriculture, it is also a matter of public health.

Antibiotic resistance, which in our country is very high and poses a danger to public health, has to do with the excessive human use of antibiotics, but also with the too generous use of antibiotics in animals. The measure is not coming too early and I am pleased that the government is working on it. I hope that the implementation of the measure and the control of the implementation will be monitored very closely. There is a lot at stake here.

We are pleased that the foundation is also laid for long-term dental care. The increase of the brake fee from 10 % to 20 % for rightholders with an increased benefit and from 25 % to 40 % for ordinary rightholders who did not have a consultation with the dentist the year before may appear in an initial phase as unaccountable. However, it is essential that we encourage people to conduct an annual consultation. This is necessary because today only 60 % of people go to the dentist annually, even though in the past many measures have been taken to enable people to consult the dentist. I mean the full refund of the oral examination, the removal of dental stone, the filling or restoration of teeth, the treatment of dental nerves and the pulling of teeth in children under 18 years of age. The limited results of those measures made other measures necessary, as only regular visits to the dentist can ensure a healthier tooth.

Finally, I think that all-in RIZIV funding for all care-related costs in the forensic psychiatric centers is a good thing given the vulnerability of the people who reside there. It shows that the government takes the situation of interned people at heart. Open Vld will therefore fully support the design.

Mr. Speaker, Mr. Minister, Ladies and Gentlemen, I will make a relatively short general speech, since the discussions have already taken place in committee. I would simply like to point out that the project that is submitted to us brings together, as traditionally, different varied but indispensable measures in the field of health care. It also introduces administrative simplifications. In this regard, I agree with Mr. Senesael who also talked about the technical aspect. This project also concrete accelerations of procedures for the benefit of the patient. It is considered, for example, as has been said, to reduce the time between the moment of the decision to refund a medicine and the realisation of the measure.

I also point out, obviously with satisfaction, the new procedure aimed at reducing the waiting period between the granting of authorisation in the context of a pediatric condition and the refund of medicines that have already been refunded for adults. It is true that at present, a company that wishes to market a pharmaceutical specialty must first develop it for adult patients, and only then will it eventually be able to adapt it. Some doctors already prescribed this medication to children with the consequence of a lack of refund and the responsibility of prescription. Through this new approach, children will be able to reap a real benefit.

I also support the introduction of a system of comprehensive financing for the reimbursement of the costs of care in the legal psychiatric centres and I recall in this regard, as I said in the committee, that the lack of adequate reception for interned persons who are currently in prison must be stopped. All our citizens deserve to receive quality care at the right time and above all at the right place.

Articles 19 and 20 relate to the increase of moderator tickets for dental care. This is a patient accountability measure that aims to encourage people to undergo dental checks each year. This is a measure from the National Dento-Mutualist Commission in the Tariff Agreement 2015-2016. We can only subscribe to it.

Article 31 provides for the obligation to notify the unavailability of medicines, even temporarily. This positive measure will anticipate possible problems in the field, when a drug may be exhausted. I gave a very specific example in the committee. It is true that in some cases there may be abuses. We therefore have here the will to have a great collaboration between the actors and above all to ask them to take their responsibilities. This is also an important point that needs to be raised.

I will end by highlighting the new transitional measures for pharmaceutical and technical assistants, which were expected by the sector. This was also stated in the committee. Now there are provisions and I think the whole sector will benefit. These are the various remarks I would like to make in relation to the current debate. It is clear that the MR group will strongly support this bill. I thank you.

Mr. Speaker, Mr. Minister, colleagues, we discussed this draft containing various health provisions several weeks ago in the committee after it was submitted to us. In our view, this bill contains a number of technical issues that will be resolved in a positive way and a number of complex procedures that will be simplified and made more transparent. To that point, bravo.

Despite this good news, there are still two major points in this bill on which we fundamentally disagree.

The first concerns the adjustment of the brake money ceilings for dental care. This is in line with the measure established in the agreement between dentists and hospital funds. The brake fee when visiting the dentist is therefore sensibly increased for those who do not go to check at least once a year. I fully agree, our group fully agrees that we should try to encourage people to go to the dentist and to have their teeth checked on a regular basis, but this is really not done by punishing them.

For a lot of people today, the threshold to go to the dentist is already high, not so much because of the initial costs for that first visit, but because of the fear of the costs if something is wrong. We all know that oral care is not really cheap. If the financial threshold for the first visit still rises, then the most vulnerable in our society will be cut off first. The measure means that anyone who has not visited his dentist in the past year or forgot to visit his dentist in the past year pays the following year 14 euros in brake money instead of 7 euros. We are firmly convinced that this measure punishes just those people who already have very difficult access to dental care.

Mr. Speaker, Mrs. Jiroflée, these are the untruths that I have already mentioned. This is not entirely correct. You should be informed about the facts. It is about that those who have not been on check with the dentist in the year before, will have to pay a higher brake fee: not for a regular check, not for the routine examinations, not for the routine interventions, but if then it turns out that there have been problems that could have been avoided by an annual visit.

For example, we are talking about the larger procedures such as a tooth extraction or a cyst. It’s not about things like checking the teeth and removing plaque. That is not correct at all.

You notice that the financial barrier is raised and that people don’t go to the dentist because they don’t dare. I am very interested in what you propose. For example, for children, the visit to the dentist throughout the line is free. Nevertheless, we see that the problem of non-compliance with the annual visit to the dentist is much worse.

So what is your alternative? What exactly do you suggest to encourage people to go to the dentist?

Mr. President, Mrs. Van Camp, you know our position on this subject. Whenever the price for a visit or the brake money is raised, people will be discouraged. Certainly people in a vulnerable situation do not always understand how the system is in place. People will be scared.

What we are talking about is the following.

We also want to encourage people, especially those in a vulnerable position, to go to the dentist. For us, however, here too much of the stick and too little of the root is used. Anyone in education will tell you that people should be encouraged to get positive results. These results are not obtained by punishing people.

That is why we do not agree. We all benefit from a well-treated tooth. However, we are convinced that these vulnerable people will be cut off.

Therefore, we will submit our amendment on the third-payer scheme to the dentist again.

A second point that we would like to draw attention to here is the adjustments relating to tobacco products.

With the extension of the definitions that also include e-cigarettes and the like, we agree entirely. This is a good measure for us.

The venin, however, is here once again in the tail, namely in the very last article of the present draft, in which the labelling of tobacco products is adjusted to bring them into conformity with the European directive.

Mr. Minister, I hope that you communicate to your colleague that this is really a missed opportunity. It was the opportunity to start with the so-called plain packaging, in which the cigarette packages are removed from all advertising and hippe imagery of cigarettes to which young people are so sensitive. We also all know that it is those young people that we should try to stop smoking because they are the most likely to become addicted and remain.

Meanwhile, the system of the neutral package has proven its usefulness in several places.

That the Minister lacks this opportunity and absolutely wants to wait until 2019 to start with the plain packaging, is, in our view, a lack of format.

In summary, I can say that the design contains a number of good technical adjustments and two material shortcomings. We will abstain from the vote.

Mr. Speaker, Mr. Minister, dear colleagues, this bill containing various provisions includes interesting measures that we will support.

Following our discussions in the committee, Mr. Minister, on policies to better control the use of antibiotics for animals in order to reduce their consumption, given the risks of antibiotic resistance, we have concluded that we should support this measure, which we consider to be positive.

Other provisions of the bill under consideration are also interesting. However, various questions remain unanswered while certain provisions may appeal. Thus, the Minister did not respond satisfactorily, on the occasion of the exchanges we had with her, to our questions regarding the conditions for the management of certain measures taken to facilitate access to medicines;

It is true that the purpose of the provisions that are presented to us is to facilitate, to speed up access to certain medicines, to certain refunds. However, the methods used are sometimes questionable. Thus, changing a list of medicines authorised or not and publishing, a posteriori, through a decree, the amendment of that list rather than making it compliant with a decree constitutes a first that opens doors to how to authorize and negotiate directly with pharmaceutical firms without ensuring that the regulatory and regulatory role will effectively be fulfilled by the INAMI bodies. It also raises the question of taking arrests or taking legislative measures in parliament, when this proves mandatory.

The text also sacralizes the non-transparent negotiations between the Minister, the SPF Public Health and pharmaceutical firms, as part of the agreement between the pharmaceutical industry and the Minister of Health “for the benefit of patients” – in any case, this is what is stipulated in this pact – but also and above all for the benefit of pharmaceutical actors who develop innovative products and new molecules. In this regard, the text seems to us to be too positive, too focused on self-control and too little on the need for politics to assume its role.

Two points are really problematic. The first concerns the measures taken to penalize the person who does not regularly consult the dentist to have access to the moderators ticket as low as possible. The device penalizes financially the person who is not sufficiently responsible. This is placed as part of the desired oral-dental care journey.

We find that there is a deviation, a deviation from the concept of care journey. The path of care is not to define a straight line from a point A to a point B for the person who has a health problem, here in this case a need for dental care. If the person deviates from this line, he is subject to penalties. In some cases, it will be excluded from certain care. In others, she will be punished financially under the pretext of accountability.

But a journey of care is not that. This means considering the person as a whole, including the different stakeholders concerned by the different care they need and, between the patient and these care providers, considering how to give the patient access to the necessary services. It is well known that oral-dental care is the most difficult thing in health. The impoverished person, the one who has a poor self-image, who has no confidence in himself, who has no confidence in others, is often among the poorest people. We have noticed it. These people do not go enough to the dentist. They come from disadvantaged socio-cultural environments. These people will be punished because they do not go to the dentist.

What should be done? In any case, take pro-action measures towards these people. It is necessary to play a proactive role and adopt behaviors that "will go looking for them." You need to be able to better inform them and make sure they feel confident to visit the dentist. It is not necessary, of course, to penalize them or strengthen the image that they make of the price of dental care: they are expensive. They are generally expensive, but these people benefit from rates sometimes tailored to their income. However, they are convinced that such care is too expensive and thanks to your project, we are further reinforcing this idea.

I think the opposition is not listening to what Mrs. Van Camp just said about dental care. I will repeat this very briefly.

Do you think that one punishes a patient if one makes sure that he can go to a dentist every year for a check, and that he, if problems still occur, receives a better refund, rather than a patient to say that he does not have to come to a check every year, and if after twenty years his teeth fall out, then one also expects the government to pay for this?

Do you think this is good for the patient? You must give a sign to the patient. The government does not only pay back to pay back. At first, this is not an austerity measure. We want to ensure that every patient who walks around here in this country has a healthy tooth. You call it penalization, I think that’s about it.

These are theoretical arrangements taken by people in an office. Not being on the field, they do not see that this goal that we all pursue, namely regular visits to their dentist, does not work in fact! You say it yourself: when care is free, people don’t go to the dentist. What oral dental care represents is not interpreted in the same way by everyone, which makes some people not go there. You have to work to help them get there, you have to take steps to ⁇ the goal, but you have to do something other than what you do. We have already experimented with the removal of refunds as well as penalties; it has not worked. This does not hold people accountable. It is not responsibility that is at stake, but trust!

Also that is really thick sewer and testifies to a lack of file knowledge. This measure does not even come from the government, but was proposed by Dentomut. Who is in it? The dentists themselves, yet people who work with people on the ground daily and provide dental care. Do you not think?

Secondly, you and the previous speaker are only talking about the opportunity groups, while this arrangement does not apply to the increased respondents, so please do not proclaim any more falsehood about this too.

I am a sociologist of education. Sociological research shows very clearly that when one works with people in poverty, rewarding works much better than sanctioning. A lot of research has been done on this.

We can read the level of poverty from the teeth. I ⁇ don’t want to polarize, but the way in which some groups in our society are sensitized and how people go to the dentist can go in a different direction, especially for children.

I have to fall into repetition. I just said, but you don’t listen exactly, that this doesn’t apply to people with an increased reception. What you say, therefore, does not hold up at all.

It’s going to stop, and I join with Mrs. Gerkens and Mrs. Dedry. Anyone who has already worked with opportunity groups knows that a difficult regulation leads to people not going out of fear. In addition, punishment achieves the opposite effect.

It’s not because it doesn’t apply to people with an increased response. People do not understand it! Make sure that people can go to the dentist in a good way, that children do not degrade and are not degraded in their education, that children as adults can apply with a beautiful mouth full of teeth.

I have the impression that Mrs. Van Camp and Mrs. Somers have never seen a group of poor people with small children in close proximity.

Mr. Speaker, I have quite a bit of experience in the sector and I can assure you that it is not really just about the cents. It is about a total package of values and also fear for a number of things. In families living in poverty, but also in families living just above the poverty line and having other values or other perceptions about society, one sees a very great fear of going to a dentist. You only go to the dentist when you have pain, so it is already too late. That is the daily reality.

The number of fake teeth and fake teeth that I have paid as OCMW chairman, you simply cannot imagine.

We also discussed this in the committee. I am very sorry that we have not taken a step further. The problem is also that the health gap only grows, as the number of dentists who are partially or entirely out of convention only increases. This was shown in a response from Minister De Block to a question I asked her. The risks figures are clear.

This is at the expense of those who do not know the difference between conventional and unconventional. Especially the poorest groups of the population can no longer pay the dentist. That is just organizing the health gap.

Mr. Speaker, this is a decision of the Dento-Mut, which cannot be said to be composed only of people in offices. They know the realities of the field quite well. You will need to be vigilant to see how children, adolescents and even adults will see their dentist on time and on time. It is a shame that the Minister of Health is not there because I would really like to plead with her and the government for a regular evaluation of the effects of this mechanism.

I can hear "maybe we will be effective" but we will have to be careful that we are not more detrimental to a certain number of children, adolescents or adults and that they are further removed from the circuit and regular monitoring by a dentist, which risks to pay very expensive on the qualitative level for patients, but also on the level of social security because the care will be much heavier and will be reimbursed anyway.

I therefore advocate for a regular evaluation with Dento-Mut so that we can truly ensure that there is no scaly and harmful effect of this device. One can believe that one does good, but sometimes one does evil without wanting it, hence the importance of carrying out this evaluation.

Mrs De Coninck, you say, from your experience in the OCMW, that we cannot imagine how often a tooth should be refunded. That is exactly what it is about. Those people should go to the dentist before.

The [...]

But they do not go! Make sure in an OCMW then that people are encouraged. Dental care under the age of 18 costs nothing. Dental care for disabled people costs nothing. The base costs nothing, they can go to the dentist for free every year, but they do not go. There are also boundaries.

I am joining Mrs. Fonck. This should not even be said here, but in the context of good governance every new method, every new procedure and every new intervention is evaluated in time. In good governance, this is a basic rule.

I understand that you react that way, because you confirm all the prejudices about disability that live in society. What is the difference between someone who lives in poverty and someone who does not live in poverty? This is the lack of long-term thinking. One often only goes to the dentist when you have pain and when a tooth needs to be pulled. This is often the reality. They must go much earlier, but why don’t they do it? Because they do not realize that a good tooth is important for the rest of their lives, also to apply and be presentable. That is so for many things. They also often go to the laundry room because they do not have the means to buy a washing machine, although that is cheaper in the long run. These are just a few dynamics that play.

Through education, through school and through contacts with parents and organizations, one can raise awareness about this.

I will be brief. I hear both opinions. As I am also in charge of Social Integration, I hear some comments and points of view. This is one of the elements about which Ms. Maggie De Block was informed and arrested in the commission. She wanted to sign her agreement on an assessment, as Ms Fonck has just mentioned, so that we can then go back to the time in committee to see what are the desired and possibly unwanted impacts of the measure in question. In this way, we can share the findings together if necessary.

Mr. Minister, I am pleased to hear this answer, because it will be indispensable in the face of the fears that many here evoke, given the difficulty that a whole number of people have to go to the dentist and given the penalties that they risk to suffer, and therefore their even greater distance from dental care. In relation to this, it is important that the impact of measures can be examined.

But this is also important given the intentions that go through this debate. Such an agitation to demonstrate that you still need to be sufficiently responsible for yourself by going to the dentist regularly really translates everything that goes through the policies you are conducting in both health and social matters. It is to consider that he who does not do enough, who does not demonstrate that he has enough merit, is penalized or excluded.

This is one example, but there will be others in other provisions. One of the solutions is to give people confidence, to stop wanting to exclude them, and ⁇ also to stop impoverishing them through some arrangements taken in the past few years.

I would like to comment on a last point concerning tobacco measures. I am confused, because we are waiting for the transposition of the European Directive in its various components, which was to take place at the latest in May of this year.

The parliamentarians of the Public Health Committee have submitted bills and resolutions for more than a year. We are trying to work with the minister on this, but we have not yet reached the end. The Minister had undertaken to develop provisions against the consumption, advertising and marketing of tobacco on the basis of the texts deposited in the committee. I would like to repeat his answer. I hope your colleague has heard it. We abstained from the submitted amendments, including those of Ms. Fonck, whom she is re-electing today, because we wanted this collective work in committees to be truly organized.

Beyond this aspect, it is scandalous that in this month of June, the chapter "Compliance with the European Directive" of the draft law containing various health provisions is almost empty, while, for more than a year, we have the opportunity to work from proposals submitted by parliamentarians.

I therefore hope, and I say this to the members of the majority and to the minister, that we will be able to conclude before the parliamentary vacation and that we will be able to have the minister to carry out this work within the committee. For these various reasons, we will abstain from this text.

Mr. Speaker, Mrs. and Mr. Ministers, I will no longer return to the decisions of Dento-Mut, since I have taken advantage of the lively debate between the one and the other to give my opinion.

This bill contains several interesting provisions in terms of simplifying procedures or antibiotic uses for animals, although, since this part concerns you, Mr. Minister, it will be necessary to try to take into account the situation of motorway veterinarians.

A positive point is the faster entry into force of the authorisation for reimbursement for medicines. It would be good to set deadlines and compel ourselves, as a state, to respect them. For the pharmaceutical industry, this remains a weak point.

When it comes to pediatrics, we can highlight an interesting element. For pediatric conditions, it is known that 80% of medicines are used off-label; on this point, I recall that a KCE study was conducted. I can only advise the government to work on the KCE recommendations on off-label drugs. Both for children and for care providers, this is a matter that I think is important to finally move forward.

I will not return to a whole series of aspects already discussed in the committee. I have essentially two points to highlight and which pose a problem, in my opinion. First, I find it really unfortunate that the Minister of Health – and even more in bills like this one that are melting-pot projects with various provisions – again touches the financing of hospitals. In this regard, a series of decisions have been taken since the beginning of the legislature, even though the work on the reform of the financing of hospitals is ongoing and is not completed.

Subsequently, every two or three months, we have a negative impact with significant negative effects on hospital budgets. In the end, an opacity remains about where we are going and what will really be the funding mechanism for the hospitals of tomorrow.

I can only advise that we do not continue with this approach. We need to look at the reality of hospitals. I recall that the MAHA study shows that 40% of hospitals are in the red, despite professional management in budget terms. And I will take only one example, which I can not stop citing because it is quite caricatural: the minister has made the decision, in a bill, to remove purely and simply the articles of law that concern the financing of a competence that affects the hospital in a unique way – this is the case here for hemodialysis, peritoneal dialysis and extra-hospital dialysis – without providing other provisions instead. It is just the emptiness. We do not know, we discuss, we concert; it is true, the associations are concerted and a meeting has also taken place this morning. The logic would obviously want that in the same text, even though it is still various provisions, the articles on financing are removed and the new decisions and the way to fund appear, in a transparent manner. This is both good management and responsible and transparent management. This also allows hospitals and healthcare providers to see clearly with all the data.

The second issue that I am concerned with – you will doubt, dear colleagues in the Health Committee – is all about the approach to tobacco control. In this draft law containing various provisions, we transpose the European Directive but we do, in essence, only translate the mandatory position of the European directive by leaving aside everything that this directive allows the Member States and gives them as a freedom, to return it to later, or even forever. This is the law of the least effort. The position is ultra minimalist.

In this regard, dear colleagues, I would like to inform you of a series of new decisions that have just fallen into the new judicial and legal system.

For example, only for the month of May 2016, on 4 May 2016, the European Court of Justice confirmed the opinion issued by the Attorney General on 23 December 2015 and ruled that the European Tobacco Directive was consistent with EU legislation and that Member States could introduce neutral packages in the image of the United Kingdom, France and Ireland.

On May 19, 2016, the UK High Court of Justice issued a very detailed verdict, more than 300 pages, in which it rejects all the tobacco industry arguments regarding the neutral package. The tobacco industry’s arguments on the lack of effectiveness of this measure, on the respect of intellectual property or even on the increase of illegal trade, all these arguments of the tobacco industry are rejected purely and simply by the British High Court of Justice. These are arguments that must speak to you, dear colleagues, since these arguments, you used them, of course, relaying the tobacco lobby.

The British High Court of Justice also estimated that the billions claimed by the tobacco industry as damages were out of place, considering that smoking is the cause of real epidemics of various diseases. In Belgium alone, we record 20,000 premature deaths each year, not counting the large number of cancer patients – remember that tobacco is the leading cause of cancer – and a whole range of lung or cardiovascular diseases.

All these opinions agree with both the opinion of the Australian Constitutional Court, the French Constitutional Council of 21 January 2016 or, I said at the time, the European Court of Justice and the British High Court of Justice. All this to tell you that we could, no, we should have taken advantage of the transposition of the European Directive to also make significant advances in the fight against tobacco.

I advocate and I will continue to advocate that we can move forward on the establishment of the neutral package and on the removal of the remaining derogation on the prohibition of advertising. Mr. Minister, it has been more than a decade since Belgium ratified the World Health Organization convention to completely ban tobacco advertising and it is still not respected. We are very bad students in this area.

I also call for progress in the protection of minors against passive smoking in play areas and in vehicles.

Finally, I continue to advocate for e-cigarettes to be sold in pharmacies, as this would make it a real aid to quit smoking, rather than making it what it is today, namely a new doorway into the world of tobacco for young people.

I have submitted the amendments concerning the different aspects of tobacco that I have just mentioned. I can assure you that I will never stop deploying as much energy as possible in the fight against tobacco, in collaboration with tobacco experts and the Cancer Foundation. I have seen too many patients suffer and die from the effects of tobacco only to let go and not fight.

I would like to apologize to the Minister of Health. I had the opportunity to react directly about oral-dental care.

Regarding the important point mentioned by several speakers, I confirm the presence of Mrs. the Minister of Health, very soon, in a committee in order to discuss all the measures in the context of the fight against smoking.

Regardless of the a minima transcription that was acted in the committee and is proposed to you today, it is clear that the entire debate on the fight against smoking will take place. Ms. De Block indicates to me that she will request that a debate be put on the agenda in a public health committee very soon.

I come to the other more technical information elements, in particular concerning the arrangement, organization and articulation with the care path. Having regard to the provisions relating to the technical organization of the approval of medicinal products, the modalities for accelerating it, the Minister of Health also indicates to me that it will transmit the information to the commission.

I act, despite a number of points of divergence, the positive tone of some comments, the accelerations that you have wanted to emphasize in the recognition procedures as well as the overall positive tone of some abstinence intentions that have been announced to us.