Proposition 52K2240

Projet de loi relatif à l'indemnisation des dommages résultant de soins de santé (I).

General information ¶

Submitted by

CD&V Leterme Ⅱ

Submission date

Nov. 12, 2009

Official page

Visit

Status

Adopted

Requirement

Simple

Subjects

liability health care profession doctor medicine medical error damage damages insurance

Voting ¶

Voted to adopt

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

Abstained from voting

N-VA LDD FN VB

Party dissidents ¶

• Peter Luykx (CD&V) abstained from voting.

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Discussion ¶

March 4, 2010 | Plenary session (Chamber of representatives)

Full source

The rapporteur is Ms. Burgeon. Registered speakers are Mmes Avontroodt, Van Daele, Lambert, Smeyers, Fonck and MM. Bultinck and Otlet.

Mr. Speaker, I propose to suspend the session for a few minutes to allow Mrs. Burgeon to join us.

The Committee on Public Health has devoted seven of its sessions to the discussion of the bill that we are dealing with today, three of which were more specifically employed to hear experts and the various stakeholders.

Thus, experts in the French model, which is largely inspired by the project, were heard. They were followed by representatives of the providers of healthcare institutions. Finally, the committee heard insurers and patient representatives, including mutualities. Regarding the content of these hearings, I allow myself to refer to my written report.

Following the introductory exhibition made by the minister, my colleagues Fonck, Lejeune and Flahaux presented their proposals of law, respectively, initially attached to the bill. These texts aimed at compensation for victims of hepatitis C, HIV, and thalidomide victims. After submitting amendments aimed at introducing these issues in the bill, the aforementioned authors first withdrew their amendments acknowledging, on the one hand, the difficulty of introducing for some victims only the notion of retroactivity and, on the other hand, the budgetary uncertainties created by these amendments. The authors also requested that their proposals be excluded from the bill.

During the general discussion, the members first expressed their general appreciation for the bill. Thus, Ms Avontroodt expressed satisfaction with the establishment of a system of compensation for damages resulting from health care without the fault of the provider. She, however, was concerned that some experts feared that many judicial procedures would not be controlled by this project. She therefore asked the minister to provide guarantees that insurance will not, in the future, cost the health care actors more.

by Mr. Bultinckx recalled the inapplicability of the 2007 law due to legal difficulties, but also due to the risk of leading to too defensive medicine and an inability to control costs.

I personally intervened to essentially remind the urgency of adopting such a project, the patient of which is at the heart, a project that also provides a response to the legitimate concerns of healthcare providers.

by Mr. Flahaux recalled that the two stumbling stones in this case were, on the one hand, the maintenance or abolition of civil liability and, on the other hand, the financing of the system.

He cited the nine strength lines of the project which, according to him, are as follows: the two-way approach more respecting the rights of patients; the maintenance of the common law on liability that avoids disresponsibility of service providers; the intervention of national solidarity in case of therapeutic disability; the compensation for only consequent damages in the absence of responsibility; a large accessibility of the Fund; the encouragement of amicable settlement; the rapid and efficient processing of applications by the Fund; the stabilization of insurance premiums for care providers; the guarantee for victims of effective compensation.

Ms. Fonck called for a rapid operationalization of the Fund. Mrs Gerkens, on the other hand, welcomed the new arrangement favorably.

by Mr. Goutry highlighted the following six positive elements: the establishment of a compensation for damages resulting from accidents without responsibility and without fault; the establishment of a double path; the full reparation by the Fund of a damage; the free for the patient of the procedure before the Fund; the prompt compensation; the functions of mediation, reporting and registration of the Fund.

Van Broeckhoven recalled that the system proposed in 2007 demonstrated its inapplicability, in particular for budgetary reasons. He also called for a follow-up of the legislation.

Finally, Ms. Smeyers expressed doubts about the constitutionality of certain aspects of the projected system and announced the abstention of her group.

As regards the more specific observations, Mmes della Faille, Fonck, Gerkens, Van Broeckhoven and M. Goutry questioned the definition of reparable damage and the possibility of introducing a notion of probability or probability. The Minister, however, considered that the definition adopted was sufficiently precise and that it should be read in conjunction with the explanations provided in the commentary of the articles.

by MM. Bultinck and Goutry wanted to know whether rest and care homes (MRS) and elderly rest homes (MRPA) fall within the scope of the law. The Minister replied that the MRSs fall within the competence of the federal state and were therefore covered by the bill, as opposed to the MRPAs, which, in turn, depend on the Communities. However, the law will apply as soon as a healthcare provider has intervened, whether it is a MRS or MRPA.

Many interventions targeted nosocomial infections. The minister clarified that the project submitted these infections to the general scheme of compensation: if a fault is demonstrated, it is the provider’s insurer who compensates; if it is an injury, the Fund will compensate.

by Mr. Flahaux and Mmes della Faille, Fonck and Gerkens have ⁇ intervened on the problem of the exclusion from the scope of the law of care services performed for a non-refundable aesthetic purpose.

The speakers joined the option taken not to intervene national solidarity in the framework of purely aesthetic services without any medical justification. However, Ms. Gerkens noted that it was of particular importance on this point to inform the patient very clearly and very thoroughly.

Many questions have arisen regarding liability for defective products. The Minister noted that the law of 25 February 1991 on liability for defective products, which organizes a specific and victim-favorable liability scheme, covers damages that may result from a product used as part of a care provision.

Regarding the obviously insufficient offers of the insurer, my colleagues Flahaux, Fonck and Goutry recalled that the French system provides for a set of sanctions that dissuade insurance companies from making clearly indecent compensation offers. A majority amendment was submitted to supplement the bill.

Many other questions have arisen regarding the applicable gravity thresholds, the refractable presumption of the causal link, the proceedings before the Fund and the absence of insurance obligation.

In order not to be too long, I refer to these points in my written report. I will do the same for the discussion of the articles.

Finally, the text being discussed was submitted to a second reading during the meeting of 23 February. Some legal changes have been made. The bill was approved by nine votes and three abstentions.

I would like to take the floor to congratulate the two secretaries of the committee for the excellent work done in the drafting of the report. This report was not fully transcribed from another committee, but each of the themes was re-examined. I confess to you, even if only for retouching the report, that it was a titan’s work. We can thank them for the extraordinary work they have done.

Mrs. Speaker, Mrs. Minister, colleagues, when I stand here on the tribune, that gives a déjà vu feeling because I have stood here three times for a law on the no fault. Let us hope that three times is shipping law and that we will soon be able to pass a definitively improved law.

I have expressed my hope and faith in this project.

Why are we here, colleagues? It turned out that the previous design was rushwork. Mr. Bonte, this was also the case when we still shared the same opinion or had to share. We have already stood here at that time. Mr. Bonte, I’m always happy that you keep the schwung in it.

This actually brings me to the basic pillar. Why do we have a no-fault law? Under Verhofstadt I we have been able to lay the basis for this. That basis was formed by, on the one hand, protecting the patients and, on the other hand, guaranteeing insuredness. The premiums of healthcare providers and institutions swinged the pan out and some disciplines could only subscribe to insurance if high premiums. The protection of patients was ultimately compromised.

The basis for the no fault law is found in our desire not to be caught up in U.S. states and to counter a disorientation of the medical-legal. The lawyers in the hall may like this less, but this was the entrance gate anyway.

Colleagues, this law rightly pays much attention to something useful, something with a short procedure and something to which much less attention is paid. I regret this last one, but we have already discussed this, Mrs. Minister. I hope you will have sufficient tools to monitor this law.

So that we do not evolve towards more processes rather than towards fewer processes.

The big difference is that we have moved back from a one-track policy to a two-track policy. Open Vld may find itself in the protection of everyone’s rights but there is the risk that there is still an inflation of legal cases possible.

The Committee organised hearings. I would like to thank our reporter who has done this very extensively. From those hearings, and especially when the lawyers come to the tribune, you hear very often that there could still be traps in the law. These pitfalls have gained attention during the discussion, Mrs. Minister, and where you have been able to adequately answer some of them.

The biggest trap is of course the definition. The first judge who reads the report will be able to determine that this definition has been discussed. What is the definition of abnormal damage? This will, in my opinion, be demonstrated by the case-law.

A second trap concerns – we can understand it because in reality it is – the difference between a RVT bed and a ROB bed. Who will tell in which bed who will be cared for? Here too, I think, Mrs. Minister, that this will need to be monitored in a very concrete and pragmatic way so that patients who accidentally lie in a ROB bed of a RVT and have not yet ended up in a RVT bed because there is no place, but still suffered that damage. The monitoring should ensure that these people do not become the victim because they happen to not be in the right bed.

Then there is the question concerning aesthetic surgery performed by recognised doctors, who are therefore trained and must work according to the booklet and therefore do not make mistakes. If such patients get a hospital infection, there may be a problem for them. I believe that there will also be jurisprudence on this.

We have come to my horse, Mrs. Minister. We discussed this very openly. Patients treated in non-conventional ways are also eligible for this no fault insurance, while, of course, evidence-based concerns are not provided in the same way. You said that we are condemned and must implement the 1999 law. You have also said that you will do so and all the traps that may still emerge in order to enforce this law will have to be taken step by step. This also remains a focus point.

Then, of course, there is the problem with the composition. I remember the heroic discussions about the board of directors and who will ultimately judge whether or not to be eligible for a no fault insurance coverage.

Here too, an amendment has added a number of experts to the Board of Directors so that, in my opinion, the first basis for an objective approach can be set.

The accompaniment of the victims, Mrs. Minister, has also attracted the attention of many of us. The fact that victims can turn to the Fund for advice is ⁇ a tool for the victims, but we will have to wait to see how many victims will turn to the Fund and how much expertise will be able to build there. I think it is ⁇ useful to involve the people in the field, both of the private insurance companies and of the insurers.

You have been very transparent and clear about affordability, Mrs. Minister. You said what is in the budget: 5 million euros and 12 million euros, next year. We will evaluate it and maybe we will be able to experience the first year and see with you and with the colleagues in the committee where it brings us.

Finally, Mr. Speaker, Mrs. Minister, colleagues, I think that we are ⁇ taking a good step towards the protection of the patients, who are ultimately the victims of no fault. No fault is the most important concept that we emphasize here. The legislation meets a need. We expect legislation, no matter how complex it is, to be applied in a simple way for patients and to reduce the skepticism among doctors. There should be no false expectations, but fair legislation for patients who are victims. That word is not in question. A victim is a victim of a no fault. The law applies both to the providers, the patients and the government. We will therefore approve and follow this law with conviction.

Mr. Speaker, Ladies Ministers, Ladies and Gentlemen, the bill we are discussing today is indeed the successor to the law of 15 May 2007 on compensation for damage caused by health care.

The 2007 law never entered into force because there were problems with its implementation, but also because of the lack of political consensus. Our group was in the opposition at the time. We opposed that legislation at the time, especially because the medical errors were actually immunized by that legislation.

The current bill, which is based on the French system that aims at a two-track policy, largely responds to our previous objections. For our group it is important that the compensation for damages will come, regardless of whether or not the healthcare provider made a mistake. I think it is especially important that victims of accidental injury or misfortune will also be compensated.

A second improvement according to CD&V is that the patient, the victim, continues to have the opportunity to turn to the court. He will not have to choose between the Fund or the court, but can walk both tracks.

A third major improvement is that the Fund will fully compensate for the damage. This means that there are no longer any franchises or ceilings. However, there is one important condition for compensation, and that is that the damage reaches a high degree of seriousness, and indeed that will be an important point of discussion that will probably require jurisprudence.

What we also find ⁇ positive is that the procedure through the Fund is free for the victim, and that there is also a quick compensation. So, when it would prove that there is a medical error, but if the insurer disputes that error, then the Fund will also immediately compensate the victim and later charge those costs to the insurer. Even if healthcare providers do not have insurance, victims can go to the Fund. This is ⁇ important.

Finally, a fifth element that we consider very important is not only the mediation function of the Fund in case of dispute, but also the reporting function. The fact that there will be registration will also be politically useful in improving the prevention of medical treatments.

I would like to join the rapporteur and colleague Avontroodt when she said that the discussion in the committee was conducted in a very constructive manner between all parties. A lot of amendments have been discussed and accepted, including many under the impetus of our group. We can really support this proposal.

That does not mean that we also have a number of concerns, which we would like to pay attention to. First and foremost, we fear the flooding of the Fund. It is good that the procedure is free of charge, but this means that a lot of people will make a request for reimbursement through this channel. It is ⁇ important that that large demand, in itself positive, will not lead to a suspension of what is intended, namely a quick handling of the files. Therefore, it is especially important that there will be sufficient staff for all those applications and to do the guidance of the people. It is especially important that this works well from the start of the Fund, because otherwise many people who put their hopes on it will be ⁇ disappointed.

Patient expectations are high: this compensation has been discussed for a long time. That is why we believe that it is also so important to communicate very well with the patients, so that there are no false expectations created, for example in people who have suffered a small damage and think they can appeal to it. Communication at the start is especially important, especially to put that limitation to serious damage in the paint.

The Fund will be financed through the administrative costs of the RIZIV. Mr. Minister, you have been ⁇ transparent about the planned amounts. In 2010 you provide 5 million euros and in 2011 12 million euros. We asked in the committee whether this would be sufficient, when both the reimbursement of costs and the operation and the staff all should come from those budgets. Therefore, a good follow-up of in the beginning is absolutely necessary.

We share the concern of colleague Avontroodt regarding the various applications of this law on the rest homes or ROBs on the one hand and the rest and care homes or RVTs on the other. Those RVTs fall within the scope of this law and the ROBs do not. That is very difficult if you know that there are also people with a RVT profile in a ROB bed. Explain this to the patients. It is only a question of whether this will survive the test of the principle of equality.

We will also vote on this with conviction and follow this closely. I would like to conclude by yet again urging to make the Fund operational and to have the implementing decisions ready as soon as the law comes into force, so that the Fund can take a good start in the interests of patients who are victims of this serious medical injury.

For several years, the traditional system of civil liability applied to damages resulting from health care services was not satisfactory for none of the parties concerned.

We have witnessed long, laborious, uncertain and above all expensive proceedings before overloaded courts. These procedures could sometimes take fifteen or twenty years.

This was not satisfying for patients who had no other option to be compensated than to seek at any cost a fault that would have been committed by the family doctor, by the specialist or simply at the hospital. This was also not satisfactory for care providers who exercised their practice with fear of a trial and the professional or insurance consequences that could result.

In short, it was necessary to act under the penalty of seeing medicine judicialise, seeing doctors reject risky cases and our health care system divide between caregivers and patients.

A first attempt was made in 2007, we voted a text here. Certainly, it did not come into force, but it had the merit of laying the foundation for the discussion on compensation for damages resulting from health care services within the framework of a no fault system. This innovative reflection became urgent because, I recall, the number of cases of damages and interest for medical errors only increased and the conclusions drawn from these cases most often left a very bitter taste for both patients and healthcare providers.

The legislative options that were taken at the time, in the light of the experience – well-rounded now – of our French friends, appeared inadequate. That is why Ms. Minister submits this bill to us today, which I hope will be voted, as it ⁇ constitutes a major step forward in terms of patient rights.

In general, this text guarantees two ways of recourse to victim patients. One before the Fund established by this law, the other before the courts.

The bill allows victims to quickly know if their damage deserves compensation. In addition, it allows full compensation, therefore without a ceiling or franchise. It also offers the victim the opportunity to be supported and to receive an objective opinion on a compensation proposal made by a service provider or his insurance under an amicable negotiation.

Victims can also be compensated in the event of therapeutic damage. It is national solidarity that will intervene in this case.

Thanks to the proposed system, the victim will be able to get compensation especially quickly. In case of disagreement on the liability and the amount of compensation proposed by the provider or his insurance company, the Fund will compensate the victim itself, which will not have long years of proceedings to endure. This should clearly encourage patients to follow this path rather than the judicial option.

If this text provides a very clear answer to the suffering of patients who are victims of a health care provision, I believe I can say that the bill is the result of a balanced and almost perfect text. Balanced, it has been widely worked in consultation with healthcare providers, patients, hospitals, mutual and insurance companies. The proposal of the Board of Directors of the Fund is also a reflection of this.

In this regard, I would like to make a correction, because I read in the press that it would be the management committee that would decide whether or not the doctor has committed a mistake and that mutualities would occupy a leading place there. I would like to correct this misperception, insofar as it is wrong to say that the board of directors would analyze individual files and that one part would be better represented than another. As I said, the project is balanced. Thanks to an amendment that we submitted to the committee, the presence of care providers was strengthened by the addition of a hygienist doctor. We also ensured that this committee has all the necessary expertise by joining it with two professors – or lecturers – specializing in medical law.

In addition to patients, care providers are also winners. Indeed, this bill ⁇ encourages and will encourage in the future the use of amicable procedures.

The text that is proposed to us is also very rational, because it has been conscientiously budgeted, in particular by the KCE, instance that cannot be accused of lightness, I think.

It is now the implementation of the Fund. The Health Commission has been able to avoid debates on practical cases that should or should not give rise to compensation. In fact, it is important that the Fund itself gradually makes its own case-law. The legislator, however, retains all his freedom and, above all, his responsibility to redirect the shot if necessary. Indeed, in amendments submitted in a committee by a majority, it is also provided that the annual report on the activities of the Fund shall be transmitted to Parliament.

Mr. Speaker, Mrs. Minister, dear colleagues, in conclusion, I would say that the Socialist Group is obviously delighted to vote today on this capital text, text awaited for so many years by patients and practitioners. We will, of course, be attentive to its implementation which we want as quickly as possible. This text will inevitably create many expectations; it will then be up to all of us to avoid any frustration and disappointment.

Mr. Speaker, Mrs. Minister, as the first speaker on behalf of an opposition faction, I have no problem with recognizing from the Flemish Interest Faction – that may happen – that serious and solid parliamentary work is still being carried out in the Chamber, with respect for the opposition. I would like to expressly emphasize this. The draft law is the beautiful exception to the bad habits that sometimes exist in our House.

We have quietly and reliably taken our time to deliver good parliamentary work, with sufficient hearings. Indeed, the majority has taken into account a number of aspirations of the opposition. A number of majority amendments indeed met what colleagues from the opposition asked. In that sense, we were also very constructive from the opposition, because, indeed, it was rightly understood that the dossier had already been drawn too long, and we had to bring it to a good end, beyond the boundaries of majority and opposition.

Mrs. Minister, it is indeed all about the problem of medical errors and the evolution towards the legalization of medical errors. If we do not fundamentally intervene with a draft that concretizes something in this regard, we threaten to end up in U.S. states, with which some insurance companies can earn rough money by organizing or not organizing claims. In the end, that may not be the intention.

Mrs. Minister, we acknowledge very explicitly from our group that the two drafts have the merit of being finally submitted, though – and this must nevertheless be repeated again, Mrs. Minister – because the dossier has been drawn for a very long time. I remind you of the Law on Patient Rights of 22 August 2002, whose draft that will pass today was to be the famous counterpart. It has therefore been too long to wait for itself to eventually meet the rightful care of all kinds of healthcare providers, who had to establish that, on the one hand, we approved the law on the rights of patients, but on the other hand threatened to strike a shortage by not meeting their rightful aspirations, if we did not bring a parliamentary initiative to a good end. In that sense, it is good that we finally concrete something and come to an end in the matter.

The work has taken a long time. We have already adopted a draft at the end of the previous legislature, in 2007, eventually very quickly, at a moment, and we have to find that it was inapplicable, because at the end it gave a number of legal and other problems, which we now have to remedy in part. With this project, this has been successfully accomplished.

I have no problem with saying from our corner that the design contains a number of positive elements. The introduction of compensation for damage caused by accidents without liability and without error is such a positive element for us.

Contrary to the 2007 draft, the restoration of the double track has been looked a little south, so that the patient, whether or not victim of a medical error, is now given the choice of whether to step into the Fund or to enter a legal procedure, which sometimes threatens to attract for a long time.

We also consider positive the fact that the Fund, according to the plans, intends to reimburse the total damage suffered, as well as the fact that the procedure at the Fund is free.

I would like to return to a few details, Mrs. Minister. I do not have any ambition to deal with the proper work of the committee.

A first element to which I would like to return is the entire problem of the medical errors in RVTs and ROBs. As planned now, only medical errors occurring in RVTs will be covered by the scheme. I can understand this with certainty, because in the case we are faced with a problem of competence: the ROBs belong clearly to the Communities, while the RVTs fall partly under federal competence. We will have to ensure that in the long run we do not involuntarily introduce any discrimination between these two types of patients.

A second element that I would like to remind you, Mrs. Minister, is the whole problem of communication. I think that will be of great importance in the coming weeks. After all, we must not create false expectations among the patients, the victims of medical errors, as if with the two-facing designs we solve all problems.

In that sense, Mrs. Minister, I would like to touch a moment on your concrete stand against the comparison with the draft of 2007? Your predecessor, then Minister Demotte, said that the ambition was to resolve 70% of disputes with that previous draft. I would like to know from your response later your ambition on this subject. How many cases do you intend to resolve with the design, without creating false expectations in the potential victims of medical errors?

A third element to which I would like to return, Mrs. Minister, is the funding of the Fund. The colleagues who followed the file know that the Federal Knowledge Centre for Healthcare has estimated the cost of more than 5 million euros for the current year 2010 and more than 12,5 million euros for 2011.

So the crucial question remains, Mrs. Minister, what we will do after those two years. We now have a budget for 2010, the current year, and for 2011. What guarantees do we have that there will also be sufficient funding for the coming years, so that we do not fall into the typical budget marshmallow? Can you give us, the patients, the victims of medical errors, any minimum guarantee that sufficient budgetary resources will also be allocated in the future?

We now know that, unlike in the 2007 draft, the financing is made exclusively through the administrative costs of the RIZIV. As for the Medical Corps and, in the case of expansion, the Medical Corps, we also want the guarantee that it may not be the intention to shift with partial budgets sooner or later. Certainly given some scepticism in the physician corps, there is the fear that there could be pushed with sub-budgets that, in their respects, went to the physician corps itself. I would also like to have your answer to that second critical question.

Mrs. Minister, when I talk about the composition of the Fund, you know very well that this has been discussed in the committee, partly based on a number of elements. On the one hand, it was about the politically coloured composition, which, as it now appears, carries the risk that when the fund administrators are appointed, the quality will not precede political balances. Let us hope that you will soon be able to convince us with the KBs to perform the opposite. Mrs. Minister, for our group, it remains sensitive that one chooses a paritary-composed fund according to poor federal tradition with 50 % Dutch-speaking and 50 % French-speaking.

A closing element that I would like to point out for a moment is the concern of the whole physician corps that we should succeed with the present drafts in order not to increase the insurance premiums that the doctors and paramedics must pay. For some part, much depends on it. The doctors and paramedics really expect us to do something about this with the design. Otherwise, we will miss for some of the designs what we have considered. That can really not be the intention.

In a brief presentation, I have clearly cited the positive elements. I have also tried to highlight some remaining pain points. However, I repeat very explicitly that the great merit of the design is that it is finally there now. We finally have the counterpart of the Patient Rights Act. As part of our group, we are very pleased that the file has already been handled. For us, however, the design is not perfect yet. We will later demonstrate this also through our positive critical vote behavior.

Mr. Speaker, Mrs. Minister, dear colleagues, many countries have put in place, although to a varying extent, a regime to allow patients to obtain compensation for their damages more easily.

While some have chosen to simply encourage the parties to reach an amicable agreement, sometimes through recourse to recognised extrajudicial instances, others have purely and simply established a system of automatic compensation for all damages, such as in the Scandinavian countries.

In Belgium, since the Act of 22 August 2002 on Patient Rights, we have claimed the need to obtain a law on medical liability. Indeed, with increasingly sophisticated acts of medical technique, increasingly heavy judicial procedures and an increasingly demanding social context, it was necessary to create in our legal arsenal a new notion, that of liability without fault.

This reflection has suffered many peripeties for ten years. The two central issues in this case were, on the one hand, the maintenance or abolition of civil liability and, on the other hand, the financing of the system. The law of 15 May 2007, called the Single Way, has always been a problem for us, as it abolished civil liability. There was therefore only one possible remedy for the victim, the Fund, and all damages were covered.

Sure, it was a single checkpoint and uniform risk coverage, but the disadvantages were also appealing: a necessarily limited repair, even if there was a fault, a disresponsibility of healthcare providers, the risk of favouring dubious practices and a certain distortion between the criminal who, he, was ⁇ ined and the civil who, he, was removed.

By giving the victim the free choice to claim damages either before the Fund or before the judge, the return to a two-way system, with the maintenance of civil liability, appears to us more respectful of the rights of the patient.

The MR had also concretized this other vision in a bill submitted in January 2003. Of course, if there is contestation of the amicable procedure, the victim will always be able to appeal to the judge. There is, therefore, a two-way resort.

The second question concerned the financing of the system.

What budget ? Who would pay? The community, the doctors, the patients? The ultimately chosen option is a state funding through an annual amount covering INAMI’s administrative costs. The bill under consideration has a cost estimated by the KCE at €19.4 million in cruise speed. In the first year, the cost is expected to be around 5.3 million, taking into account the expenses related to the establishment of the Fund and 12.5 million are expected in 2011. However, it is important to note that nothing has been decided for the following years. The system will be evaluated and adjusted if necessary.

The project under consideration presents the following advantages: the intervention of national solidarity in the event of an unresponsible medical accident, the accessibility, the fact of avoiding as much as possible the recourse to the judge and promoting amicable settlements. Furthermore, the method is quick and effective to obtain the Fund’s opinion and, if necessary, compensation. It guarantees patients victims of a medical accident effective compensation for the damage suffered, regardless of whether or not the responsibility of the healthcare provider is engaged.

However, the expert hearings organized by the committee show a few remarks that we would like to clarify. The first was about the insurance obligation. The project does not provide for the obligation of insurance for doctors, which still causes their dissatisfaction and which has caused many reactions during the hearings. There is also no provision granting doctors a right to be assured by the intervention of a pricing office. However, for memory, it is the Code of Ethics of Doctors that provides for the obligation for doctors to cover their professional responsibility. The Order of Doctors will therefore be requested to obtain a state of the place on compliance with this obligation. Furthermore, we maintain that an evaluation is planned on this point and that, if necessary, we may return to this aspect if the evaluation did not give us satisfaction.

The second note concerns the coverage or not of aesthetic surgeries. It was decided to cover only damages caused by benefits reimbursable by the health insurance, which does not prevent an appeal before the courts if there would be a fault in the head of a service provider. We support this restriction for several reasons. First, the aesthetic is not covered by the health-invalidity insurance. Aesthetic disadvantages are difficult to appreciate: what are the standards in the matter, who can judge the normality of an aesthetic disadvantage? Is the failure of an aesthetic service a criterion of abnormality? It was therefore not appropriate at this stage to charge the national solidarity the compensation for benefits which are of pure aesthetic nature, except when they are reparative.

Third note: the composition of the Board of Directors of the Fund.

The initial composition of the Fund posed problems with regard to the professionalization, independence and impartiality of its members in the field of decision-making and/or case assessment. We also regret the lack of representation of doctors in the board of directors. Two majority amendments allowed us to join the text by adding two professors specializing in medical law as well as a doctor specializing in hospital hygiene.

The fourth note concerns the free procedure before the Fund.

We hope that there will be no instrumentalization of the device through this free of charge. If the assessment of the law demonstrated the contrary, there would of course be a point of placing labels on this situation.

Finally, we still wanted to emphasize communication towards patients. The hearings have sufficiently insisted on this point and of course we should not create false expectations in the patient’s head by making them believe that from now on everything can be compensated.

Let me say a word more about the bills that were attached to this debate and which concerned the compensation of patients victims of contamination with the hepatitis virus or HIV following a transfusion accident or persons who suffered damage caused by Thalidomide before 31 December 1965. We remind you that this debate remains more than ever on the agenda of our commission, as the Minister has committed to it. We will conclude this debate at the end of the study commissioned by the KCE on this point.

In conclusion, Mr. Speaker, Mrs. Minister, Dear colleagues, the MR Group will support this text because we are convinced that victims of health benefits will be quickly and properly compensated without having to endure long and costly legal proceedings.

Mr. Speaker, Mrs. Minister, colleagues, although our group supports the starting point of this bill, namely to ensure that people do not have to go through years of judicial proceedings before obtaining compensation, we still have some uncertainties that can make the application of the bill difficult. One of them is the funding of the Fund, which is determined annually by the Council of Ministers. It is our group and certain groups discussed during the hearings that it is not clear what the consequences of this may be. Can persons who correctly apply in this way really be sure that they will also be paid an effective compensation? That is my first concern.

My second consideration concerns the procedure for the Fund. It is a very complicated procedure. We urge the Minister to accompany the entry into force with a very clear information campaign to prevent people from finding their way to the Fund and to ensure that it is clear in advance in which cases the Fund can pay damages and in which cases not.

Another uncertainty — I’ve heard it here today — is the definition of medical accident without liability, the basis of the bill. Both the State Council and several legal experts have noted that the definition, as defined in the draft law, can be interpreted in such a way that it refers to accidents in which medical responsibility actually plays. Furthermore, the definition is so broad that even matters not directly related to the accident could be eligible for compensation.

The Minister replied in the committee that the definition was deliberately kept so broad to give the Fund the opportunity to develop its own jurisprudence, but that is what we think is the shoe. The Board of Directors, which is responsible for formulating the remuneration policy of the Fund, is a politically composed body and this composition does not, in our view, provide sufficient guarantees that the members have the relevant knowledge to carry out the task assigned to them. For this reason, together with Mr. Bultinck, I supported the amendment that advocates a less political composition, with more experts, in order to counter political interference and destruction.

Because of the patient’s interest, we follow the government’s reasoning that a new procedure is necessary. Given the reasons mentioned above, we believe that there are sufficient elements available to conclude that the present bill is not the correct way to regulate this innocent compensation.

Our group will abstain or, as Mr. Bultinck calls it, be positively critical.

First of all, I would like to thank the rapporteur. I will also join his thanks for the services that have made an excellent report in a matter that is not simple.

Would you dare to say, “Finally, it’s done!”? History encourages me to be cautious because a text had already been voted without being applied. So let’s wait for the day J, the day that this law will finally be applied!

The expectations of victims and care providers are high with regard to this Compensation Fund.

Would you remember the year 1992? Some colleagues, including Ms. Avontroodt or Mr. Otlet, mentioned some dates but it was, in fact, in 1992 that the interuniversity groups started this work. The first bills were submitted.

What belongs to Caesar must be returned to Caesar. He is no longer part of our group today, because he was called to other missions, but it was Benoît Drèze, for the CDH, who had deposited the very first text concerning the Compensation Fund. That is 18 years. This timeframe is a beautiful illustration of the patience that sometimes needs to be shown in order to see certain cases succeed, on the political level in general and at the level of parliament in particular.

I would like to emphasize the three points that I think are the most important at the level of achievements of this law. I will then refer to the issues that were discussed in the committee. Finally, I will address the vigilance that will need to be shown in the future.

The three most important achievements for patients, for victims are, first and foremost, to have enabled a two-way system: solidarity and the maintenance of common law. The CDH had previously supported it. During the voting of this law, Mr. Demotte has already insisted on this two-way system.

The second acquisition is the full compensation without a ceiling or franchise. There is indeed a limitation of size: the thresholds of gravity; I will return to it.

Finally, the third achievement, accessibility, is ⁇ positive. Indeed, the burden of proof is ⁇ heavy on the victims; however, the instruction of the file would be permitted in the case of health and damage. This would be a major role for victims given the free of charge of this instruction and the function of mediation.

The work was important. Several positive advances can be noted: first and foremost, maximum safety for patients and victims, in particular in terms of modified deadlines; the suspension of prescription during friendly negotiations; the new composition with the addition of a hygienist doctor and lawyers.

Another advance is to avoid abuse by insurers offering an insufficient offer to the victim, knowing that the Fund is responsible for addressing the deficiency.

Mrs. Minister, dear colleagues, it is not because it has had to wait for 18 years this bill, which will soon – I hope – become a law, that it no longer deserves a particular vigilance on the part of politics. Indeed, various points deserve special attention, or even some new changes in the future.

There should be continued vigilance over the operation of this Fund. Some have recalled just recently, and I join them, that this point is crucial for patients.

Gravity thresholds are also an important element. They are very high and, as a result, many victims will be excluded. According to patient representatives, including associations and mutual associations, ⁇ 90 percent of victims of therapeutic disorders will be excluded given the adopted gravity thresholds.

Of course, these thresholds were held for budgetary reasons. At the same time, it seems to me primary that these limits of the Fund’s intervention are communicated unambiguously. Otherwise, it would give patients false hopes. I hope that in the future we can lower these thresholds. Everyone will recognize today that they are all but too low.

We will also have to be vigilant about the definition that has been taken of abnormal damage, in the sense that it is defined as “should not have occurred.” Legal opinions converge, as we heard during the hearings. The question remains whether a definition based on a high degree of probability should not be preferred subsequently.

We will also have to pay attention to the service providers. A jurisprudence will be built, but neither should the protests fire against them. This would then lead to an increase in liability insurance premiums and a multiplication of judicial remedies. Furthermore, Mrs. Minister, if a judge concludes that it is neither an illness nor a real fault, what will be the fate reserved for patients by the Fund?

Finally, we will have to be careful on the political level. We will never say enough: it is essential that people are compensated when they are in some way victims of fatality. But the recording of the data will also allow you to influence in advance on therapeutic accidents and accidents. Even more than the Compensation Fund, it will be a significant added value for the victims.

I will conclude by telling you that the CDH will support this law because we are convinced that it is well-founded for the victims. Furthermore, I hope this will not be a missed opportunity for those who are great forgotten victims. I think more specifically of those for whom the damage is clearly established: Thalidomide and Softenon victims, but also people who contracted the hepatitis C virus after a blood transfusion or blood derivative.

They are now highly discriminated. In fact, people who contracted another virus, in particular AIDS, as a result of a blood product transfusion, already benefit from compensation for several years. We cannot remain blind or myopic to this discriminatory situation.

The amendments I submitted were not followed. I hope that in the future, we will be able to make the advancements that the CDH ⁇ respects. Mr. Minister, you have made commitments yourself and you can count on us to have unparalleled vigilance so that they are fulfilled.

Mr. Speaker, Mrs. Minister, Mr. Minister, Dear colleagues, we were looking forward to a version that could become concrete and organize a Compensation Fund for victims of therapeutic disorders. It became unbearable that victims of medical errors had to wait years and fight against insurance companies or actors who did not want to recognize their responsibility before obtaining the compensation they are entitled to.

In 2007, a draft was presented quickly, while bill proposals were on the table and we could have taken the time for a real debate and draft a law. Political realities are such that in 2007, a bill was passed that proved inapplicable. The work had to be restarted.

Ecologically green! will support the project that is submitted to us today, while noting that particular attention will need to be paid to certain details but also to several important elements that have been raised in the committee, during the review of the project. Some aspects will require an assessment, while others will require additional arrangements.

We will support this project because the victim of a therapeutic illness can be directly taken into account and benefit from compensation. The determination of liability, the amount and the manner of compensation will be the subject of discussions and negotiations which will take place without having to suffer the waiting times and the related complexities.

Furthermore, this project reintroduces the possibility of using both ways depending on what the person considers most appropriate for them: the Fund path or the judicial path.

One element will require special attention and evaluation, namely the disability threshold that entitles to the Fund’s intervention. It is apparently relatively high compared to the number of victims of therapeutic illnesses.

Our position is therefore to approve this project in a first phase. A fixed budget package is provided for its implementation. It will be necessary to carry out assessments and, ⁇ , to improve and lower this threshold in order to be able to cover the majority of accidents or disasters that occur.

The wording contained in the project basically refers to occupational incapacity. However, it would be interesting to take into account the incapacities of everyday life, household life, school life. In this regard, it will also be about correctly identifying victims, how and where the problems manifest and the specificity of the aid that people need as a result of therapeutic errors that would not harm their work, because they do not work, but because they also deserve to be taken into account through the Compensation Fund.

Given these elements that have been discussed, the intention is to number cases, evaluate them and make improvements.

Another point makes us trouble in the formulation, but again, we consider being facing a first step: this is all about nosocomial diseases. Will they be considered mistakes that shouldn’t happen? From there, how will responsibility be determined knowing that medical practices and acts involve more risks than others?

It will include listing the damage suffered by patients victims of nosocomial diseases and assessing, on the one hand, what this means for them and, on the other hand, how healthcare providers, the Fund and hospitals assume their responsibilities.

One of our concerns is the ability to reimburse amounts advanced by the Fund by a healthcare provider or institution when their liability has been recognized. If the provisions provided, the constraints imposed on the Fund do not allow to recover this money, this Fund will be quickly bankrupt, hence the need to follow the process and to evaluate how each assumes its responsibilities. In any case, the patient should not be hurt.

Furthermore, in our opinion, one fundamental element is lacking compared to the 2007 project: the obligation of insurance imposed on healthcare providers.

In this regard, with the exception of the representatives of the insurance companies, all stakeholders advocated this obligation. Nevertheless, it is apparently not obvious to organize it, control it and guarantee everyone’s access and right to this insurance.

Mr. Minister, you said that you are launching a working group to reflect on this question and find answers. Ecologically green! He will continue to reflect on this issue. The track we are still considering and considering is to link the approval of healthcare providers to the subscription of civil liability insurance, which would help verify that they are well insured.

Unfortunately, nothing is so simple. It will also be necessary to ensure that the amounts of insurance and the acts covered by such insurance leave the physicians the latitude to make the choices necessary for the exercise of their profession and to take into account the needs of patients. Furthermore, the various complexities of the different disciplines provided by these care providers will also have to be taken into account.

In view of the commitments you have made in the committee, in view of the fact that additional and parallel provisions can be filed, which we will contribute to, to complement the arrangement established by this law, we will approve the project. We regret that some of the amendments we had submitted were rejected while they seemed to meet your concerns, Mrs. Minister, according to what we heard in the discussions in the committee and in your responses. They will be reintroduced within a short period of time. Work timelines and majority-opposition relations sometimes make things complicated, as do majority agreements that can hinder changes.

I would like to emphasize a last important point, the information of the population. Many believe that there is already a Compensation Fund and not many journalists believe that too. I remember reporting to one or another that we were working on a Therapeutic Disorder Compensation Fund, in general indifference, while this is an important topic for citizens, and I was answered that it had existed for a long time. Information work will be necessary. The press will not be enough: we know that we do not read enough newspapers. Given the cases that will not be concerned or the steps to be taken by patients, this information must be provided by hospitals, by all places where a Belgian citizen will be in contact with a healthcare professional, collectively or individually. It will be necessary to provide the financial, human and strategic resources to reach as many people as possible.

The last point concerns taking into account the victims of Softenon, infusion victims who have caught hepatitis C. We talked about it in the committee and these are two very important issues to which we are all sensitive and to which we all want to provide an answer. It was difficult to answer this bill because we cannot compensate victims through this Fund with a retroactive effect for certain people, certain diseases or medical errors that we know well.

It is really necessary to create a specific Compensation Fund for people who have been infected or victims of medical errors and who do not fall within the scope of the current Fund. We must take responsibility for the past.

Mr. Minister, you have pledged to work on this aspect and to ask the KCE to assess the number of these persons and the cost of the commitments that we could take towards them. We will support you in the implementation of this system. We need to relieve the suffering of those people who have probably felt forgotten for years. These people may tend to believe that they are affected by this Medical Error Compensation Fund. But these mistakes have occurred before, and therefore it is another fund that will have to compensate them.

Mr. Speaker, dear colleagues, you have a happy woman in front of you, both privately and in my capacity as Minister of Public Health.

Like all who have expressed themselves today, I know how much this project is expected by victims of mistakes or medical accidents.

Ms. Nyssens knows that in judicial proceedings, which last for years – a period of ten years being common in this matter – victims of medical problems must fight against insurance companies, with expertise and counter-expertise that eventually add violence to the problems they experience on a daily basis.

We had to act therefore. I am pleased that as a result of the work carried out within the government and in the parliament with the consideration of amendments, we obtained a very broad consensus. This law can be applied in the short term.

I would like to thank the rapporteur for the work done and the services rendered and I would like to give a few indications to the various stakeholders. Madame Avontroodt, this report is indeed very important, in particular by the case-law that will necessarily have to clarify certain terms of the law. In the framework of the work, for example, we have specified, in a very punctual manner, in which places the law would be able to apply. I think in particular of the question of rest houses and rest and care houses, the beds that depend on the federal or the Regions. You know, in Belgium, nothing is simple in this matter! All this is clearly stated in the report of our work.

We also explained why there was exclusion of the benefits of aesthetic care. The chairwoman of the committee told me that the work would anyway be started in the health committee as regards the framework relating to aesthetic benefits. I would like to point out to you in this regard that the only thing excluded is the compensation for the therapeutic delay following the provision of purely aesthetic care. The victim of a fault can, of course, always turn against the provider. This is obvious! I wanted to remind him.

What do we cover or exclude from liability for defective products? There is already a law in this area. It seems to me that it gives full satisfaction. We also explained in the report why we do not provide for a presumption of a causal link between the provision of care and the damage.

Yes, Mrs. Avontroodt, the work of the committee and all the clarifications of the report will be important for the case-law.

Mrs. Van Daele, the case has evolved well. Therefore, we must pay attention to the bottling. It is true that when the arrangements provided by the law are implemented, we will have to be prepared: it will be necessary for the Fund to have the necessary personnel to accommodate all beneficiaries. The application applies to victims on the day of the publication of the law. Thus, between the time of application of the law and the time when the Fund receives requests, a certain period of time will occur during which an influx of requests may occur. Therefore, it will be necessary to be very careful to avoid any traffic jams that are unfavorable to the victims.

Madame Lambert, you are right to point out that the current ordinary regime of civil liability is inadequate for medical risk: it was necessary to invent this new system, quite special, which we still lacked in Belgium. The explanations, especially legal, given in the committee will allow to open up this new pillar of social security.

Mr. Bultinck and others, you ask me about sufficient funding and you are right. You have seen how accurate I have been about the increase in power of the resources necessary for the functioning of the Fund. The federal government has already planned a budget for 2010 and 2011. It is obvious that the Parliament does not accept that a Minister of Health, whatever he is, wastes the funds at the expense of the Fund, thus at the expense of the victims.

Mr. Otlet and Mrs. Gerkens, you are right in talking about this problem of insured default in the providers.

This is a real problem. I would like to have a short-term implementation of this insurance obligation. The report explains why this was not possible through this bill, but we will work on it with providers and insurance companies. However, this task will be a bit complicated, for the reasons I have given in the commission.

That said, I use this to refer to the role that the Fund can play as a rescue network for victims of non-insured service providers. Indeed, the Fund may intervene in their place and be subrogated in their rights by turning against the provider who is not insured on an individual basis. Fortunately, this phenomenon is not common.

I would like to thank Mrs. Smeyers. I know, in discussing this with her in commission, that she would have wanted some adjustments to the law. But we could not follow it in this regard, and the report will show very precisely why. Thank you for your constructive criticism.

In answer to Ms. Fonck, I will tell her that I hear her calls for vigilance. Of course, the new law will need to be evaluated on all the points it cited. Like Ms. Gerkens, she spoke of thalidomide and blood transfusions victims who have contracted hepatitis C or AIDS and who are not covered by the provisions of the AIDS Compensation Fund. As I explained in the committee, it was impossible to provide for everything within the framework of this law, which does not concern medicines but victims of therapeutic errors, after the publication of the said law.

That being said, I have made commitments that I will keep. This is how the Centre of Expertise, the Kenniscentrum, was commissioned for blood transfusion victims of an urgent study. He hopes to deliver his conclusions by June 2010.

It has references, especially in France where, after a certain time of operation, this Compensation Fund has received the additional mission to meet the problem of the victims of hepatitis C and the AIDS virus. Depending on the outcome of this study, a request will be submitted during the preparation of the 2011 budget.

As for the victims of thalidomide, I am in negotiation with them. I met them again last Tuesday. I hope to make a proposal to the government and to make them a proposal in the very short term.

Mrs Gerkens, I will be clear about nosocomial diseases. These are of course taken into account. Let there be no worries about this! It was really a necessity under pain to see this law lose interest.

You are right when it comes to information. We will have to be very precise and not rely on a punctual information given by the media on the occasion of the outcome of the law, but go to meet patients, in hospitals, etc. To keep them aware of the existence of this Fund.

In terms of timing, these two bills will be considered in the Senate. We are in the process of examining the implementation decisions. My hope is that this Fund can collect the first requests from patients as early as next September.

I would like to thank you for the very positive work done in the committee.