Proposition 53K2600

Projet de loi portant des dispositions diverses en matière de santé (I).

General information ¶

Submitted by

PS | SP the Di Rupo government

Submission date

Jan. 10, 2013

Official page

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Status

Adopted

Requirement

Simple

Subjects

supplementary pension budget bio-ethics blood transfusion cytology protection of privacy electronic signature financial management database emergency medical treatment medicinal product information network computer system health costs medical device medical error medical data medical research organ transplant public administration experiment on humans advertising mutual assistance scheme statistics sample survey dental medicine indemnification public health midwife scientific research alternative medicine medical institution health insurance

Voting ¶

Voted to adopt

Groen CD&V Vooruit Ecolo LE PS | SP Open Vld MR

Abstained from voting

∉ N-VA LDD VB

Party dissidents ¶

• Bernard Clerfayt (MR) abstained from voting.
• Olivier Maingain (MR) abstained from voting.
• Damien Thiéry (MR) abstained from voting.

Contact form ¶

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Discussion ¶

Feb. 28, 2013 | Plenary session (Chamber of representatives)

Full source

It is a draft law with many different provisions. It would be an uninitiated matter to discuss all of them here. Therefore, I refer to the written report.

Mr. Speaker, Mrs. Minister, dear colleagues, I would like to return only to three topics addressed in the bill concerning various health provisions: the Medical Accident Fund, biobanks and unconventional practices.

The Medical Accident Fund has been in operation since September last year and has since dealt with the files relating to compensation for damage resulting from health care; I remind you that we remain within the no-fault principle. Everything seems to work, which is very satisfying.

The recipes of this success are simple: the Fund must be known to the public, it must offer the best expertise in the field and, above all, it must carry out its legal missions with complete independence.

In order to guarantee this latter point, the law of 31 March 2010 establishing the Fund had initially established it as an organization of public interest. However, in order to allow the Fund to start its task as soon as possible and thus provide a clear response to people suffering for many years sometimes, it was decided to integrate it into the INAMI and constitute a special service within the institution.

This decision will enable the Fund to dispose of all useful and necessary means to effectively carry out its legal tasks and thus respond quickly and professionally to the distress of those who contact it. We approve of this provision in particular as all precautions regarding independence regarding the members of the Management Committee of the Fund have been taken.

We will have the opportunity to evaluate the work of the Fund within a few months. We strongly hope that those who will address it will be satisfied with the work done.

I now go to the biobanks and the experimentation on humans. Regulations evolve as research activities develop in this area. The issue is complex, and it will remain. The option chosen by the Minister allows to offer a legal framework for these structures, a legal framework that, while guaranteeing the strict observance of ethical rules enacted in the matter, nevertheless allows to stimulate scientific research and thus support the development of hyper-specialized industrial poles. This regulation has been developed in consultation with all relevant environments. We hope that through this, Belgium will occupy a place of choice in this extremely advanced field of innovation and scientific research.

Finally, I would like to return to the unconventional practices. The Minister’s will is to offer patients as well as professionals concerned the effectiveness of a legal framework drawn almost fifteen years ago. This will must be supported and fiercely defended. This gap in our health care system has only lasted too long. More and more people turn to these practices, more and more professionals offer them without the slightest control of the competent authorities. This is obviously not satisfactory.

So yes, we are well aware that this is a difficult matter where the sharing of skills between service providers sometimes makes teeth grind but action is needed; it is more than time. Our group is well aware that the Minister will be interested in drawing up the guidelines for the effectiveness of this law, to fully involve the Parliament. His working method that tends to reconcile efficiency but also coordination and respect for parliamentary work has been successfully tested for the case of surgery and aesthetic medicine that we are currently examining.

The same will happen with these unconventional practices.

I call on my colleagues to show confidence in our Minister of Health, who has never lacked loyalty to our commission. I still urge today the Chairperson of the Commission, Mrs. Detiège, that the start of the hearing work, which we agreed upon when drawing up the timetable of our work, be promptly scheduled. I thank him already.

Mr. Speaker, I would like to answer the question of Mrs. Lambert which was addressed to me as Chairman of the Commission.

Indeed, the members who were present in the committee during the discussion of the draft law containing various provisions have said that it would not be bad to organize a debate or at least a hearing.

I think this is indeed a necessity, given the importance and the many responses we have received from the sector.

I therefore propose that before the Easter holidays in the committee a whole day be devoted to homeopathy, acupuncture, chiropractic and osteopathy, as well as to the Knowledge Centre and the dean of the universities in order to get good feedback from the various organizations.

I think the idea is excellent. Even if I work by royal decree, since this is the required legal framework, I will do so with parliament. It is very interesting in this context that, in the case of unconventional practices, Parliament can hear both academic representatives and deans of medical faculties, who request to be heard, and professional associations. This will enlighten the Parliament and will help to enlighten me too.

Subsequently, I will regularly keep Parliament informed of the progress of my work. From now on, I can tell you that I do not intend to deal with the four practices at the same time, but rather try to approach them one after the other. I will begin to bring a regulatory framework to a new practice when the previous has found a favorable outcome.

Mr. Speaker, Mrs. Minister, colleagues, as is the case with laws containing various provisions, this draft also covers a lot of themes. Certainly some of these topics are difficult for us. Others a little less.

For example, our group considers it a good thing that more work is done on electronic communication between healthcare providers and the strengthening of the eHealth Platform. The resulting efficiency gains can result in significant cost savings in the long run. More importantly, hopefully, we can reduce the administrative burden that healthcare providers face too often.

Furthermore, the possibility of extensive data recording and the extension of the use of the permanent sample should enable the health policy to be further supported. Today, too often, there is a lack of accurate data to estimate the impact of the policies carried out. This is also a form of efficiency gain.

We are less happy with the proposed integration of the Medical Accident Fund into the structure of the RIZIV. Your explanation for this integration, Mrs. Minister, has always been the anticipated efficiency gains, but you do not give any figures. You also do not have data showing that integration into the RIZIV is more beneficial than integration into the Public Health FOD. This last track seems to us more logical, as medical accidents are much more closely linked to public health insurance than to health insurance. Furthermore, you could have avoided the need to divide the legislation on this subject, which does not benefit the clarity.

The last point of criticism I would like to point out is the financial responsibility of the health funds. With the changes you propose, this system can be adjusted within the RIZIV committees and no longer needs to be done through a royal decree.

For a system with which the health funds have been able to build up more than half a billion euros of reserves in recent years, it seems obvious to our party that the greatest possible transparency is guaranteed. With what you propose, this is no longer the case. This does not seem to be a good evolution.

In short, there are good and less good things in this bill. Our group will therefore abstain from voting.

I want to clarify something. For the Service Fund for Medical Accidents there is an administrative integration. However, the Fund will remain autonomous.

Therefore, it is an administrative integration into the RIZIV, but the fund remains independent.

Mr. Speaker, Mr. Minister, we will vote on this bill even though we have made some criticisms in the committee. I think in particular of the negative vote on one of the articles. Therefore, I would like to return to a few reflections on this bill.

It includes a whole series of provisions, sometimes of pure form and toileting. However, some changes are somewhat more fundamental, as they affect medical practice and aim to provide answers to problems raised by the State Council or the European Court of Justice.

I will just mention a few measures. First, Article 2 introduces a provision allowing the King to subordinate the reimbursement of health benefits to the recording of data relating to them. This can be interpreted in a very broad sense. We will therefore be attentive to how this will be executed. We find that there are still many unknowns in the implementation of this article. Therefore, we do not know what benefits will be targeted. Likewise, what will be the proposed recording and by what means? We fear that, by the purposes of this, we tend once again toward a medicine focused primarily on the administrative, while we attach more importance to the care provided to patients. Here again, we can fear an administrative burden on healthcare providers, inherent in the implementation of this measure. However, we believe that we should seek to ease, as far as possible, this burden.

I am moving to Article 14 following judgments of the Court of Justice of the European Communities stating that the prohibition of advertising for care providers is likely to impede or make less attractive the exercise of the fundamental freedoms guaranteed by the Treaty. As mentioned in the commission, any advertising will not necessarily be allowed, since different legislations exist in this area – fortunately, in addition – to impose limits. However, we share the finding that the regulation remains too scattered and that there would probably be a need to group all the legislation on advertising to make it more readable.

I come back to Article 22, which aims to provide for dental benefits that the King may determine parameters to limit the number of benefits that can be taken into account from compulsory insurance during a specified reference period. It is true that it appears that a small number of dentistry providers perform services in completely unrealistic proportions, in the sense that it appears impossible to do such a number of services within a specified timeframe without losing quality or by applying correct rules on nomenclature.

It is clear that in many cases it is fraud, and therefore I strongly support any measures to remedy it, to combat fraudsters that lead to unfair competition in the sector, which is more. I wonder, however, why the Medical Assessment and Control Service was or is not able to punish outsiders. Why has this bias not been used to eradicate this fraud earlier? I have questions about the effectiveness of the control service in this area.

The provisions of Articles 27 to 44 relate to the Medical Accident Fund and aim to ⁇ the integration of the Fund into the INAMI. We endorse these provisions without reservation, but we regret that it took three years after the passing of the law to reach its actual implementation.

However, I would like to clarify that the Fund does not wait for its administrative integration to function! For now, the files are subject to examination, medical expertise and even decision proposals. This is obviously launched!

I would like to conclude with Article 128 which I have not been able to support during the work in the committee. This article aims to exclude from parliamentary control the implementation of the law of 29 April 1999 relating to unconventional practices, so-called Colla law. As a parliamentary in the soul, I always find it difficult to remove a prerogative from parliament.

The role of parliamentarians is not to limit their power and action and if this article had been inserted into the Colla Act, it was not in vain. The reasons were serious and, in my opinion, did not disappear.

In fact, the procedure provided for in Article 4, paragraph 2 of the aforementioned law provided that "royal decrees cannot produce their effects unless they have been confirmed by law before the end of the sixth month following their publication in the Belgian Moniteur."

For me, this procedure retains all its actuality. In fact, this arrangement aims to ensure that Parliament will never be separated from discussions on the matter. I’m not saying it will be, but in the present case, it could not be. It was important to maintain this provision. Indeed, it remains necessary to ensure that no minister can make a royal decree that would not receive the approval of a parliamentary majority on this extremely delicate issue. Therefore, this lock seemed to me essential: by its very existence, it guaranteed the intervention of parliament; abrogating this arrangement constitutes, in my opinion, an error.

Therefore, I could not vote in favour of this article 128.

Here, Mr. Speaker, Mr. Minister, Ladies and Gentlemen, are the various remarks I wanted to make during this debate. Of course, we will vote on the whole of this bill.

I would like to respond to this last speech. and Bacquelaine.

I believe in the need for a real power of parliament, but not a power of blessing yes-yes. The law stipulated that the parliament, within six months following the adoption of the royal decree, would say yes or no. He can’t change, he can’t do anything, just take or reject!

It is much better to work forward, with Parliament, to reach a consensus on what unconventional practices will become.

Mr. President, what Ms. Minister evokes here is not the blessed yes-yes, it is the blessed yes-no!

In fact, this is not exactly what it is about. It is not for parliament to say yes or no after the arrests. The introduction of this type of lock, already applied in other subjects, allows everything to be discussed before the royal decrees are taken.

Which Materials ? This is not a special arrest.

Let us be of good faith.

This type of article makes it possible to ensure that the content of the royal decrees is discussed in a parliamentary committee before they are taken. This is the purpose of this type of lock. It’s not about waiting for nothing to happen. No minister will be unconscious, ⁇ not you with your wonderful experience. You will not suddenly take royal decrees of which you know that, by a dry blow, they could be cancelled if the parliament does not confirm them. You will not take that risk. Instead, it encourages you to come and discuss it in the committee.

Here, we rely solely on your good faith. So much better! As long as you are there, it will probably be, but I don’t know who will replace you someday, if you are replaceable!

Everything will be noted, Mr. Bacquelaine!

I wonder, therefore, whether at some point we will not be confronted with royal decrees taken lightly by a minister X or Y on such a sensitive subject without the parliament being able to give its opinion on the matter. It is a pity!

The royal decrees we are talking about are royal decrees deliberated in Council of Ministers.

Mr. Speaker, I would like to intervene for a moment and join a comment by Mr. Bacquelaine. Of course, in the law containing various provisions there are a number of good elements and provisions.

As I have already said in the committee, I am primarily opposed to the article which limits the number of performance of dentists. I understand that they want to deal with fraudsters and I absolutely do not oppose dealing with fraud. However, there are not yet twenty fraudsters who are trying to deal with this, people who are known. I find it regrettable that therefore an article is introduced which aims to restrict the freedom of the dentist, a free profession. It is also unclear how far this restriction will continue in the future. This creates a dangerous precedent. There are other ways to address these fraudulent practices. Therefore, it is not necessary to undermine the freedom of profession.

As the last speaker in this debate, I would like to ask you another question. In the framework of the Health Act, we had the discussion about the reference amounts in hospitals. In this design, you provide an extension. You know that, according to the government agreement, we are in favour of extending the reference amounts, both for the care period and for the daily hospitalization. A few weeks ago, during the discussion in the committee, you said that you were in the final phase. You had the necessary royal decrees in this regard prepared. What about the carens period and the daily hospitalization? Can or cannot they be included in the reference amounts? When I see the movements, I think this will be soon.

The [...]

Mr. Minister, we are going to record the question of Mrs. Muylle. Ms. Schyns wants to intervene again.

It is soon, I think.

I can’t tell you exactly how long, but I’ll tell you later.

Mr. Speaker, I want to say something about one point.

Mr. Bacquelaine, I would like to note the following about your argument on the KB with regard to the powers. I understand part of your argument, but it is also up to the Minister to take the necessary initiatives in the coming weeks, both around the recognition of clinical psychologists and around the recognition of the unconventional professions.

In fact, Mr. Bacquelaine, I have only heard of you on this matter when it comes to procedures. I hope that you will be as constructive and active as we will find real solutions in the working groups in the coming weeks to gain recognition. There is a 1999 law by then-Minister Colla, but today, more than fifteen years later, it has not yet been implemented.

Today there are four unconventional professions, of which we know that they are visited annually by tens of thousands of patients. I am really concerned because patients have a right to quality. There must be recognition; we must dare to conduct that debate. I hope that you will not only conduct this debate from the doctors’ point of view, but will look at it more broadly.

I also hope that the Minister can take the necessary initiatives as soon as possible, so that the committee, whether or not with full authority-KBs, can fully work to come to good legislation and good implementation decisions of a law that has been in place for fifteen years.

Mr. Speaker, with regard to the first question, I think that the KB has already been published, or that it will happen in the course of the coming days.

I will limit myself to three points.

The first is e-Health. Obviously, we are for the development of this computer network that allows the secure exchange of data in order to optimize the continuity of health care services and the safety of the patient.

Nevertheless, whenever this file came to the table, we insisted on the confidentiality of so-called sensitive data; I mean more specifically the obligation of registration provided in the bill. It will therefore be necessary to take care of how to implement this obligation in relation to the data recorded, the protection of the file, the persons authorized to consult it, the possibility to cross this file with other data, as well as to be attentive to the workload for the persons responsible for the data encoding. I had ⁇ this in the committee and you answered me that you would be especially attentive to it; I wanted to remind you.

The second point concerns biobanks: they also raise ethical questions. It is well known how important it is to make human material available to researchers, to increase the number of available data, especially when research involves a rare disease, thus to have maximum availability of samples.

Ethical issues include the respect for the confidentiality of personal data relating to samples, the purposes of scientific research in which the samples are used or the remuneration of donors. We therefore find it really important – and you confirmed it to us in the committee – that, in delicate cases such as this one, all relevant sectors (academic and pharmaceutical) be concerted to consider the different issues of the establishment of biobanks structures.

My last point has already been widely addressed: unconventional practices. We voted for this famous article 128, aimed at removing a confirmation by parliament, because we feel that we need to move forward on this matter and that we have decided to work in confidence with the minister.

Why is it important to move forward? Mrs. Muylle just said: the interest in these unconventional practices is growing, which testifies to the evolution of a society. We cannot always be late on the field.

We thank the Minister for the concertation she has planned and is already organizing with the President since she has just confirmed our hearings.