Proposition 53K2577

Projet de loi réglementant les qualifications requises pour poser des actes de médecine esthétique non chirurgicale et de chirurgie esthétique.

General information ¶

Submitted by

The Senate

Submission date

Sept. 1, 2010

Official page

Visit

Status

Adopted

Requirement

Simple

Subjects

health care profession doctor medicine aesthetic surgery public health

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.
• Catherine Fonck (LE) abstained from voting.
• Peter Luykx (CD&V) abstained from voting.
• Olivier Maingain (MR) abstained from voting.
• Damien Thiéry (MR) abstained from voting.

Contact form ¶

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Discussion ¶

March 21, 2013 | Plenary session (Chamber of representatives)

Full source

Mr. Speaker, dear colleagues, our committee, after dealing with the section relating to the framework of advertising in the field of medicine and cosmetic surgery, began to examine the bill regulating the qualifications required to submit acts of non-surgical cosmetic medicine and cosmetic surgery. This project was accompanied by the Socialist Group’s bill aimed at framing and regulating the practice and advertising of surgery and aesthetic medicine.

The Minister of Health recalled in her introductory presentation that, given the absence of a legal framework surrounding the practice of medical aesthetics and the enthusiasm of people to resort to this type of intervention, it becomes urgent to take measures, on the one hand, to guarantee the good quality of our health care and, on the other, to protect patients.

Onkelinx said that this project from the Senate took almost five years to ⁇ and that it is the result of intense consultation with professionals in the sector. It makes a clear distinction between aesthetic non-surgical medicine and aesthetic surgery. It establishes a pyramidal system of qualification where each specialist is allowed to perform certain acts according to their competence. Finally, the project guarantees the patient complete and detailed information before any intervention. The protection of minor patients is also greatly improved.

All the speakers supported the bill in its objective. Ms Schyns thus highlighted her positive points such as the accompaniment of patients, the information of patients and especially of minors and the guaranteed evolution from regulation to techniques.

Some speakers insisted that the line between aesthetic surgery and aesthetic medicine is, however, not so obvious and that it also evolves according to medical techniques. The qualification of aesthetic for a treatment is not obvious.

Furthermore, as regards the scope of the text, the question of whether permanent makeup is intended has been raised. The Minister responded with a negative answer, understood that permanent makeup should be considered as a form of tattoo and is therefore governed by special regulatory provisions.

With regard to the creation of the new special professional title relating to physicians specializing in non-surgical aesthetic medicine, some members questioned the duration of the training and its content.

by Mr. Bacquelaine also wanted to draw attention to the fact that many general physicians will not wish to apply for this professional title even though they are trained in the discipline and that they work today to the greatest satisfaction of their patients.

To address this concern, an amendment was filed that allows, through transitional measures, to leave the possibility for general practitioners who can justify a certain experience to continue their practice in the field of aesthetics. The Minister signed this amendment.

In addition, Mr. Bacquelaine, Ms. Somers, Schyns and Detiège and myself have introduced an amendment allowing general practitioners who wish to specialize in non-surgical aesthetic medicine to continue to practice general medicine during the training and for the two years following obtaining the degree. At the end of these two years, the doctor will have to make the choice between the exclusive practice of general medicine or that of non-surgical aesthetic medicine. The Minister also supported this amendment.

Ms Van Gool questioned the precedent thus created by the law, namely the establishment of a medical niche for the exclusive benefit of a category of specialized physicians. The Minister responded that the drifts seen on the ground, which could put the health of patients at risk, fully justify the option taken.

Ms. Somers asked the Minister whether it was not appropriate to define through the Royal Decree the training that cosmetologists must undertake in order to be entitled to practice certain techniques of hair removal deemed invasive but also the techniques themselves. The Minister considered that the text as drafted, providing exceptions to the general prohibition, was sufficient.

All stakeholders welcomed the measures taken to enhance patient information. Several amendments were submitted, including one by Ms. Schyns and consorts who received the support of the minister. The latter amendment was intended to ease the administrative tasks of practitioners who, if they perform several identical acts in the same treatment, will only have to comply with the reporting obligation once.

For my part, I also requested clarifications on the reasons that motivated the imposition of the ceiling of 1 000 euros from which the cost assessment must be carried out. The Minister indicated that the acts thus aimed at and for which it is sometimes difficult to determine in advance, for example, the quantity of product needed, would fall within the scope of aesthetic surgery and not of aesthetic medicine. I wanted to make sure that attached costs such as hospital expenses would also be covered by the quote, which was confirmed.

Ms. De Bont, Snoy and Wouters questioned the composition of the Medical Aesthetics Council which does not guarantee, according to the speakers, the independence of the expertise.

Finally, we have been many to call on the Minister to quickly address the third aspect of the problem related to the management of the institutions in which these acts of surgery and aesthetic medicine can be placed. For my part, I recalled that my group’s bill, attached to the bill, also addressed this aspect of the problem. Ms. Detiège, on the other hand, indicated that this was within the competence of the Regions.

The entire bill was adopted by 10 votes for and 4 abstentions.

I would like to speak on behalf of my group.

As I have already pointed out, the Socialist group has long been concerned about the deviations found in the field of medical aesthetics. The quality of the care provided, the mercantilism of this practice, the vulnerability of patients using it are all elements that have prompted us, since 2007, to file a bill aimed at regulating the practice of aesthetic medicine and surgery.

Six years later, a regulation is about to come into being. As the practice is already well established on the ground, it took a lot of time, tact, perseverance to make everyone admit that it was necessary, in the name of the safety of patients and the quality of our health care, to regulate this so particular area of medicine.

The Ministry of Health has done an extraordinary job. She was able to put all the people involved around the table and find a consensus so that the quality of care and the protection of the patient prevail above everything else.

Given the heterogeneity of the acts concerned, the heterogeneity of the actors concerned, this concertation could not be simple. General doctors, doctors of various specialties, non-medical as well as cosmetologists were put around the table and all, in a constructive way I believe, contributed to the elaboration of this regulation.

The chosen pyramidal qualification system, which empowers care providers to perform specific acts according to their field of competence, is fully justified. This is the model we have chosen in our bill.

How can one admit that legally today, acts of medical aesthetics – including the heaviest acts of surgery – can be accomplished by anyone holding a doctorate in medicine? For example, today, an ophthalmologist can make breast prostheses. I think no one will find this normal, and at least not the Socialist group.

The bill in question, as well as the proposal we had submitted, regulates the information that will now be mandatory to be delivered by service providers to their patients. This is fundamental. Given the enthusiasm, or even the banalization of these acts, patients tend to lose sight of the risks associated.

These risks are not anodin and can have dramatic and lasting consequences. The patient’s health may be deteriorated, his body appearance, instead of being improved, ⁇ deteriorated. And this can happen despite all the skills of the doctor who sets the acts. It is therefore important to remind the patient of all this, to give him time to reflect so that his decision is, in the end, properly weighed.

To conclude, Mr. Speaker, dear colleagues, I would like to recall the desire of my group to see drawn up as soon as possible a regulatory framework relating to the required health standards applicable to the establishments in which these acts are made.

Today, it is unknown where these technical and even surgical acts are placed. There is no registration of these establishments, no minimum standards in matters of material organization, technical organization or in matters of taking care of persons during the intervention and during the subsequent hospitalization. This has to change and this construction must be the next step.

It is therefore not surprising that my group supports the bill and is looking forward to its soon-to-be adoption.

Mr. Speaker, dear colleagues, first of all, I would like to make it clear that our group is satisfied that work is being done on regulating the aesthetic medicine.

In the past, we were regularly confronted with all sorts of excesses that do not fit into our regular medicine. Thus, it is a good thing that a lot of emphasis is placed on proper and correct information to the patient. This should, by the way, apply to all interventions, whether they are of aesthetic nature or not. We can ⁇ support the strict conditions for performing interventions in minors patients.

Despite the fact that this bill covers some interesting parts, however, we fear that this will not immediately lead to an improvement in the quality of care. I will give an example. The draft law states that the choice of the doctor who may perform an aesthetic procedure will improve the quality. This is ⁇ a first step in the right direction, but this provision remains too limited for our party. The quality is determined not only by the doctor’s expertise but also by the experience of the nursing staff, the equipment of the premises and the hospitals where those interventions take place and so on. It is a missed opportunity for my group that these aspects are not addressed in the bill.

Another possible problem with the design is the division between aesthetic and non-esthetic medicine which, in our view, can be called fairly arbitrary. An intervention with a generally determined therapeutic benefit may be performed by any doctor. However, if this procedure has a purely aesthetic reason, only those doctors with the appropriate qualifications may perform it. In the first case there is no problem with the quality of patient safety, in the second case it is that there is if the wrong doctor performs the procedure. We fear that this division will lead to many problems. We have already asked some questions to the Minister on this subject, but this division could never be thoroughly answered. As far as I am concerned, it remains, therefore, very unclear how to ensure that therapeutic usefulness is not wrongly claimed for an intervention to escape the provisions of this law.

Dear colleagues, in summary, this bill, as far as our party is concerned, is a step in the right direction but there are still very important issues missing in order to really make a substantial contribution to the quality of the provided care. We will therefore abstain from voting on this bill.

Dear Chairman, Dear colleagues, the bill for voting was sent to us by the Senate. After the introduction of the ban on advertising for cosmetic procedures, this becomes a second important step. The Senate has, across the Party boundaries, developed a regulation concerning the required professional qualifications to be allowed to perform interventions of non-medical aesthetic medicine and aesthetic medicine.

The field of what I will easily call aesthetic medicine is much wider than plastic surgery, and has evolved tremendously in the last 20 years on the medical-technological level. In the last 10 years, it has even become a hype, and heavily mediated. This has advantages and disadvantages. On the one hand, it is openly discussed. She no longer belongs home in the world of the happy few or the BV’s. On the other hand, the pressure is increased to pursue certain beauty ideals, and one often forgets the medical aspects of the healing procedures. There are always risks associated. Complications can occur, and they are not miracle remedies that solve everything. Even an apparently harmless laser treatment can end badly.

Both plastic and reconstructive surgery and aesthetic psychiatry, for example after severe burns or birth defects, as well as the purely aesthetic non-medical interventions, for example removing old age symptoms, should be able to be performed in an equally quality manner.

This bill therefore introduces a new special vocational title, with a corresponding training: specialist in non-medical aesthetic medicine. It defines the fields of work of the various specialists: dentist, specialist in plastic, reconstructive, aesthetic psychiatry, dermatologist and so on.

Thus, a pyramid, a cascade system, a ranking of specialists is created. According to some, this constitutes a discrimination between healthcare providers and the general and aesthetic medicine. However, this distinction is motivated by past misprints and the concern to protect the patient. We all share that concern.

However, the professional group of doctors fell out of the boat here. To address this gap, Mr Bacquelaine explained two amendments.

Five years of legal practical experience is sufficient to be able to continue to carry out non-medical aesthetic medicine. The general practitioners who choose to pursue an additional training to become specialists in non-medical aesthetic medicine, the new BBT, may continue their profession of general practitioner during their training. These are two positive additions.

However, we have trouble with the regulation that general physicians may exercise both professions until only two years after obtaining that special professional title. After two years, they must choose between a general doctor or a specialist. CD&V has refrained from doing so because that prohibition of cumulation and that obligation of choice do not exist in other domains. We prefer to leave the ability to accumulate open unlimited in time.

I would like to refer to other examples where the cumulation of two disciplines within medicine is possible. A doctor who has studied the specialization youth and health care and from that discipline works in a consulting agency of Child and Family or in a CLB can quietly combine that work with a general practitioner practice. A doctor who has completed the training of general doctor and will continue to study occupational medicine over time can also continue to combine both.

For CD&V, in addition to the professional qualification, the second part of the design is very important. All patients should be treated in a respectful manner. Some television reports have questioned this point in recent years. Therefore, we are positive about the articles that define medicine in the KB no. 78 and amend the definition of health care in the Law of Patient Rights. From now on, interventions without a therapeutic purpose, intended solely to change the appearance, will also be counted within that scope of application. After all, every procedure can make a world of difference for the patient. Any intervention can be therapeutic and therapeutic.

In our view, the draft legislation gives proper attention to the protection of patients. The prior proper information on the technique, the risks, the nature of the product or the implant and the price is now legally anchored, as well as the protection of the minor and the introduction of a waiting period between the first consultation, which gives the information, and the execution of the procedure.

We have expressed our concern that we hope that doctors will not abuse this to escape their responsibility in the event of a complication.

With the present draft law, within the field of aesthetic medicine, certain limits are defined within which general physicians, beauty specialists and specialists or holders of the special professional title may perform aesthetic interventions, whether or not medical. Quality care and patient protection are the starting points. According to CD&V, there is a very good balance in this bill.

Mevrouw Van Gool, proficiat voor uw eerste tussenkomst in de plenary vergadering van de Kamer. (The Applause)

Mr. Speaker, my dear colleagues, the project presented to us today is part of the framework measures of medical aesthetics and aesthetic surgery, which we have been discussing for a few months. Indeed, we recently adopted a draft, first voted by the Senate at the instigation of Dominique Tilmans, on advertising relating to these two areas.

This project is somehow the second part of this issue, with a sector regulation aimed at framing the skills of practitioners, but also with the main motivation the preservation of interests and the protection of the patient.

The qualifications required to carry out the acts are, however, an extremely complex subject. I think it has been somewhat overwhelmed and that this project will most likely require adjustments in the coming months. Indeed, we will soon realize that many aspects of this bill will be extremely difficult to implement. This is a first step in the right direction, but it will quickly require improvement. Why Why ? Because it is always very delicate to create categories of acts that only a few doctors can practice according to their specialty.

We have always faced this difficulty, which we have solved mostly through the Code of Ethics. I recall that it limits the freedom of practice, even though it is based on essential principles of therapeutic freedom. It sets deontological restrictions on medical acts. Article 35, § b, provides in particular that "the doctor may not exceed his competence".

In article 141 of the same Code: "The doctor must be aware of the limits of his knowledge and possibilities. He can only act according to them.” If the doctor acts outside his competence, regardless of his specialization, his responsibility can always be challenged on the disciplinary level, but also criminal and/or civil.

It seems to me that this articulation, this structuring of medical responsibility on the deontological level has allowed, until now, to make sure that everyone practices in his sphere of competence and works according to the knowledge he has acquired during his course.

Here, we leave this way of conceiving therapeutic freedom. For the first time, a field of medicine is sweetened. I insist: this is the first time since time immemorial. This is, therefore, a complete paradigm shift that the commission has not always fully understood the importance, I think. I have drawn attention to this element and I repeat it today, because I believe that it should be included in the report and that it will determine a further review of this text.

Thus, the field of aesthetic medicine is sweetened by creating a new title: a physician specialist in non-surgical aesthetic medicine. Therefore, a pyramid scheme of qualifications is established, in some way restricting the therapeutic freedom of care providers, as currently practiced. Consequently, the domain will be expressly reserved while, until now, this reservation was made on a plane of the doctor’s conscience and deontology.

In my opinion, this is another type of organization that will make it necessary to rework this text in the future.

I wanted to introduce some amendments to this text to safeguard the essential, dare I say. Indeed, this text, as voted by the Senate, which appears to me to be sidering and which promises its disappearance without doubt, makes sure that an experienced doctor of 10, 15 or 20 years, who exceled in a certain practice, is suddenly banned from practice in this field, while it sometimes constitutes the essence of his activity.

We had never seen this! I don’t think there has been any retrograde in Belgian society since 1830. For one time, the Senate considered this smart. We have rectified and made sure that the skills and experience acquired by doctors over very long years are respected. These doctors may, if they can justify their competence and training, continue to practice the acts they previously practiced, notwithstanding the adoption of this new law.

It has also been allowed that doctors, at the time of their training in non-surgical aesthetic medicine, benefit from a time of reflection or motivation analysis for a certain number of years before definitively opting for one or the other specialization. I also think that for many of them it will be an extremely difficult decision to make because at present, aesthetic acts rarely constitute the majority of the practice of doctors. Non-Surgical Aesthetic Medicine is a part-time practice.

Two amendments were submitted to the committee. They improve this text and make it 'drinkable'. That is why I will vote for it, even though I admit that it will not be with great enthusiasm.

I am pleased that today we can vote on the draft law on aesthetic surgery.

After all, at that time I dreamed – I also said this in the committee – after I first wanted to become paracommando, to become a plastic surgeon. After all, I thought that I could then give a person who has been severely mutilated after a road accident a future again by operating him and making him beautiful again. I thought it was given a very noble.

In terms of plastic surgery, there are two problems. First, there is no legislation in Belgium that determines who can and who can not do an intervention. Second, there is a real wild growth, a phenomenon that has spread from other European countries and the United States.

After a working group in the Senate, on the initiative of Mrs. Temmerman and Mrs. Tilmans, had discussed the problem – for which I thanked them – the Chamber decided to work on a legal arrangement.

I am very pleased that today we clearly define qualifications for doctors who perform aesthetic procedures, because those were not there. Thus, there are finally conditions relating to required professional titles and training. Before this proposal, anyone could work in the field of plastic surgery. For example, a dentist – I didn’t believe it myself – who does breast enlargement after his hours or a beauty specialist who performs medical procedures under anesthesia, that can no longer after today.

Due to the lack of regulation, there has been a wild growth of unnecessary and dangerous interventions and knives can escape without punishment. Every so many weeks there is another incident in which an aesthetic procedure completely fails.

Ladies and gentlemen, this must stop. The interventions of plastic surgeons can have a major impact on the lives of patients. It is therefore important that they are done in a correct and safe way.

The design with stricter qualifications for doctors fits into a triple set of measures, which should regulate the sector.

A first step was the ban on advertising for beauty procedures, two years ago. Since August 2011, it has been banned in Belgium to promote plastic procedures. That drove the sputters out.

For example, in January of this year inspectors of Public Health entered the private clinic Clinica Aesthetica, because there the breast enlargements in the loads went through the purchase website Groupon. Medicine, even aesthetic, should not be a commercial product. It is therefore good that it is opposed in our country, unlike other countries, such as the Netherlands.

Following the prohibition on advertising and the qualification requirements finally approved today, the legislature should as soon as possible develop another scheme, namely a corresponding quality standards for private clinics and beauty institutes. For example, plastic surgeons can still choose where to perform an operation. This can be, for example, in a garage box, in rear rooms or on the edge of a swimming pool, where a botox party can be held. In such environments – I don’t have to explain this – there is no control over the procedure and the safety of the patient is often not guaranteed. These extra-wall rules will need to be drawn up in consultation with the Regions, as they are currently responsible for monitoring the quality standards in healthcare institutions.

Colleagues, we are pleased that we are making progress in the case and that the government has opened its eyes to the social reality of aesthetic surgery and intervenes. From now on, we can better prevent and punish abuses. By not putting out standards and rules, there has been a wild growth in the sector in recent years, allowing knives to escape that caused a lot of damage. We are ending this today.

Our group also largely agrees with the present bill, which protects the patient who must or wants to undergo aesthetic treatment. It is not an unnecessary luxury that standards are established to guarantee the quality of treatment and that the patient should be informed as best as possible. I would like to thank those who have invested a lot of time in bringing the draft law to a good end.

In doing so, I assume that the majority will support the bill today, but I regret that a few comments from my group, which could actually have improved the bill, were not taken into account.

First and foremost, the definition of non-medical aesthetic medicine contained in Article 2 cannot clearly infer whether permanent makeup, which is also used for the construction of the nipple cavity and scarring correction, also falls under the law and whether it can still be carried out by the specially trained beauty specialists. For permanent hair removal, which is usually also not a medical procedure, the design expressly states that beauty specialists who use a class 4 laser or a bright pulsating light for this purpose, and have received the appropriate training, may perform that operation.

Article 6 states that the King, after the advice of the Council for Medical Aesthetics, may specify the non-medical aesthetic medicine or the aesthetic medical interventions. However, that committee has yet to be established and it would then establish the list of non-medical aesthetic procedures.

It is indeed necessary to describe what is understood by aesthetic interventions. The distinction between aesthetic and curative interventions is, as several colleagues have already cited, not always so simple and that can lead to legal uncertainty for certain doctors. In this regard, among other things, colleague Bacquelaine also pointed out that the law will need to be amended very quickly.

In any case, the establishment of such a council is entirely contrary to the KB of 21 April 1983 laying down detailed rules for the recognition of physicians specialists and general practitioners. Even if the Council for Medical Aesthetics would only serve to advise the minister, as the minister replicated in the committee, then still the full recognition material for doctors-specialists and family doctors rests with the High Council and the Recognition Commission. In fact, they should advise the Minister on the matter. In addition, a law cannot change a KB. However, this happens regularly in this legislation and this was also cited by the Council of State.

In any case, according to the comments formulated in the committee in this regard, for the beauty specialists, the uncertainty is part of the course due to the express statement of the Minister that permanent makeup, considered as a form of tattoo without it being, is regulated by the specific treatment related to the tattoos. Therefore, it does not fall within the draft law submitted by the Senate.

With my amendment, I actually wanted to provide clarity in the draft law itself. In particular, I wanted to give the initiative to regulate the training that one must have received for this. This question comes from the industry itself. Per ⁇ the Flemish Parliament will provide a solution to this. This bill is a missed opportunity in this area.

Another improvement could have been made in Articles 17 and 19 regarding the information and consent of the patient. The obligation to provide clear information on all possible aspects of the aesthetic procedures before the patient gives his consent is an important advantage of this bill. However, the way in which this is addressed is, in my opinion, not efficient and completely out of time, in particular through the preparation of a written report that must be dated, signed by the patient and kept by the doctor, while doctors and dentists nowadays usually and increasingly only keep an electronic record of their patients.

It would have been better to provide the necessary documentation and a copy of the report to the patient so that he could readily consult at home, and to make a certified report of this in the patient dossier using a specially created RIZIV number. Amendments in this regard were also not heard.

This means that in this long-awaited bill regarding aesthetic treatments there are still a lot of beauty flaws. That is a pity, because it could be different. That is why my group will abstain in the vote on this bill.

I agree with many of my colleagues on what was said today. This bill is a step forward in protecting patients. However, there are still a lot of shadow areas, which will have to be settled in one way or another.

This project constitutes an advance because it protects the patient from possible deviations, this protection must remain a priority. This bill includes positive points, including the accompaniment of patients who want to resort to aesthetic medicine. Quality information must be provided. This requirement is especially reinforced for minors and this is essential. A period of reflection must be observed between the information and the execution of the act. It should also be noted that the formulation of the text allows a certain flexibility in the adaptation of legislation, in particular depending on the evolution of the techniques.

On the other hand, the shadow zones, also highlighted by Ms. Fonck and Mr. Bacquelaine, are the creation of categories of acts and the restrictive limitation of doctors with access to them.

Several royal decrees will need to be drawn up to enable the application of this law. I think in particular of the distinction between therapeutic acts and aesthetic acts. I also think about the training of cosmetologists who will have to deal with the acquisition of good practice gestures for hair removal techniques but above all for the safety of patients. Therefore, it will be necessary to be ⁇ careful in the preparation of these arrests to try to avoid the persistence of the shadow areas we have just talked about several times.

We supported the amendments submitted by Mr. supported and supported by the majority. We also submitted an amendment to ease the administrative burden facing professionals. In fact, when a patient undergoes a treatment that requires the repeated performance of the same act both at the level of the technique and the product, he will be able to limit himself to render one account rendered rather than several.

I repeat, we will be especially attentive to how the royal decrees will be drafted and how this text will be implemented and applied.