Proposition 53K2158

Projet de loi modifiant la loi du 13 juin 1986 sur le prélèvement et la transplantation d'organes et la loi du 19 décembre 2008 relative à l'obtention et à l'utilisation de matériel corporel humain destiné à des applications médicales humaines ou à des fins de recherche scientifique.

General information ¶

Submitted by

PS | SP the Di Rupo government

Submission date

April 19, 2012

Official page

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Status

Adopted

Requirement

Simple

Subjects

EC Directive organ transplant public health

Voting ¶

Voted to adopt

Groen CD&V Vooruit Ecolo LE PS | SP ∉ Open Vld N-VA LDD MR VB

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Discussion ¶

May 31, 2012 | Plenary session (Chamber of representatives)

Full source

Mrs Burgeon, the rapporteur, refers to her written report.

Generally speaking, this bill is a good thing. This is the transposition into law of a 2010 European Directive. It is based, in some aspects, on the work of the Bioethics Advisory Committee, but also on recommendations made by medical academies.

This bill corresponds, in some way, to current quality standards, both in terms of organ sampling and organ transplantation. It will not fundamentally change the very good operation of the transplant in Belgium within Eurotransplant, which we can be proud of. It will enable increased controls, better traceability of organs with all the positive elements resulting from it, including the fight against organ trafficking and transplant tourism.

Another positive point should be highlighted. Thus, for deceased donors, the implicit consent is confirmed. Therefore, it will be necessary to consult the National Register and inform relatives of any possible opposition expressed by the donor himself before his death and not by his family. I think this is an excellent thing.

There is also the whole aspect related to the strengthening of consent criteria and, in particular, with regard to living donors whose objective is to strengthen the safeguards surrounding organ harvesting in minors and in persons who are no longer able to express their will.

These elements have been put on the table several times by the transplants themselves. This issue has been widely discussed in the Bioethics Committee. These points were also ⁇ expensive to us, which is why I submitted a bill in this direction.

That said, the draft under consideration goes beyond a mere transposition of the EU directive at the level of the particular points that are taken back.

Dear colleagues, as I have already said in a committee to Ms. Minister, we should be ⁇ vigilant because this should not become a barrier to the practice of transplantation in Belgium. I think here in particular of the transplant coordinators, although the minister was very clear in the commission. She pledged to ensure that there is no change in the existing situation and made clear that coordinators should not necessarily be doctors. It also pledged not to amend the royal decree that regulates this point.

I have two questions, but I do not ask you to answer. Since the Minister of Health cannot be present today, I will address him an oral question.

My first question concerns the fact that this measure could undermine some existing transplant programmes, including the Living donor exchange program. I will return to the committee. My second question concerns organ harvesting on a stopped heart.

I will conclude, Mr. Speaker, by insisting on the fact that it is always necessary, in the field of transplantation, to be able to project ourselves into the future and again and again to try to lift the maximum of brakes that can persist. There are more. There are first because the transplant is, in itself, a victim of its success. There is a growing imbalance between supply and demand. Today, with the prolongation of life, more and more patients are waiting for transplant compared to the number of potential donors.

Furthermore, in future challenges, it is worth asking how to lift brakes that persist. This has been discussed in the committee; so I will not return to all the elements. I quote one for example: the fact that some medical costs remain to be borne by the donor in the event of a living donation. We cannot rely on the solidarity and altruism of the living donor. It seems to me that society, the State must be able to make new advances so that there are no remaining costs to be borne by the donor, or even that there is an intervention to cover the stop of work when the living donor is a worker, regardless of his status.

This is clearly a positive progress. I think others will have to follow in the future. In particular, I will return to some points in the committee. I’m not going to bother Mr. De Block here.

Mr. Speaker, Mrs. Minister, dear colleagues, if our country is an exception at European level by recording a rate of donations twice as high as the other Member States, 1,174 patients were, in December last year, in anxious waiting for a transplant.

Therefore, the general mobilization must remain. Awareness of citizens should be a priority. Hence the importance of national campaigns like Beldonor.be. Indeed, the challenge is more of the order of citizen awareness than of the legislative order. As I said earlier, Belgium has legislation in this area where the only barriers to donation are those that are ethically and medically justified.

Thanks to the principle of opt-out, the potential reserve of organs is as wide as possible and, thanks to the awareness-raising campaigns conducted by public authorities and relayed by the media – I thank them – the number of opposition statements registered with municipal administrations has decreased since 2005 and currently concerns no more than 188 208 people.

The proposed bill therefore aims to bring our legislation in line with new European obligations aimed at harmonising the quality and safety standards for organ collection, transportation and use. We must hope – but here again, Belgium is a pioneer as an active member of the Eurotransplant program – that European collaboration progresses and that other Member States take advantage of our experience to advance their legislation in order to address this growing shortage of organ donation, while ensuring irreproachable practices.

As a result of the European Directive, some new provisions appear to me to be ⁇ important. These include, for example, registration, traceability of donors, recipients and organs. I also maintain the obligation of a lifetime medical follow-up of living donors.

The implementation of such a arrangement may be able to encourage this type of donations, as well as the establishment, which I wish effective as soon as possible, of the framework of financial compensation because the challenge in this matter lies in the constant increase in the number of living donors.

The bill also improves the legibility and consistency of the 1986 Act and, above all, strengthens certain ethical aspects. This includes, for example, the guarantee of anonymity but also and above all the absolute protection of minors under the age of twelve and of persons deemed incapable of expressing their will due to their mental state. By thus modifying our legislation which, on this point, was contrary to the Convention on the Rights of Persons with Disabilities, our country now offers maximum protection to any person whose age or mental state does not allow for a free and informed choice. This is of course primary. Also, taking advantage of this transposition of a directive whose obligations in terms of safety, quality of sampling, transplantation and transport of organs were already mostly applied, the bill makes progress our legislation on the ethical level, and this is fundamental even though the practice in Belgium has been irreproachable for a long time.

Mr. Speaker, dear colleagues, the bill that is submitted to us today is not anodine because, as in all ethical files, it touches on important principles that are dear to us, which belong to respect for the person. I think in particular of the non-commercialization of the human body, of taking into account the will of the patient, of the quality treatment of the human organs, of the protection of the most vulnerable persons, of the respect for the privacy of the patients. This project also responds to a directive and a request from Europe. The EU Directive must be transposed by 27 August 2012. On 7 July 2010, the European Parliament and the Council of the European Union adopted the Directive on quality and safety standards for human organs intended for transplantation.

It aims to establish common quality and safety standards in the European Union for the collection, transport and use of organs. We are, of course, in favor of this type of harmonisation, of which all patients across the European Union will be the beneficiaries.

Another advantage, this bill, which thus inserts in the Belgian law of 13 June 1986 this extremely pushed normative framework, has a very broad scope of application. It covers all stages of the chain, from donation to transplantation. The risks, whatever they are, will be reduced and the chances of successful organ transplants will be increased.

The new quality and safety guarantees introduced by this project must be highlighted, first of all, an assessment and selection of donors by an independent physician, based on a characterization of donors and organs. Next, a reinforcement and traceability of organs taken, assigned and transplanted from donor to recipient, including a system for reporting and managing serious adverse events and serious adverse reactions that are observed during or after the transplant.

Another important element in our view is that it offers real protection to living donors, both minors and adults, who are unable to express their will for whatever reason and not only because of their mental state. Indeed, no more levy is permitted on a person who is unable to express his own will. We have already submitted a bill in this regard to the Senate.

Furthermore, this project also meets the objective of a bill that I myself submitted here with Damien Thiéry, which aims to remove the possibility of automatically revoking the consent – but not the opposition – given by the representatives of the minor, once his majority has reached. This will allow for a greater number of donors. This consent may only be expressed by yourself and not by the parents or guardian of the minor. This objective is achieved by Article 21 of the project.

Finally, this project was developed on the basis of several important opinions, which were taken into account. I think of the National Bioethics Committee, the Commission for the Protection of Privacy and the Council of State.

It was therefore drafted with all the prudence and rigour necessary for such legislation.

For all these reasons, my group will of course support this bill.

The draft law transposes the Directive of 7 July 2010 on quality and safety standards for human organs intended for transplantation.

Reducing risks, maximizing the benefits of transplants, respecting human dignity, developing all necessary data and harmonising mechanisms at European level are objectives that Ecolo-Groen Group can support.

Let me talk about the situation in Belgium. The reading of some figures is impressive; Ms. Burgeon cited them. Today, the waiting list includes 1,174 names of people, the vast majority of whom (837) are waiting for a kidney transplant. Of course, the number of donors is increasing in 2011, but does not exceed 321. This makes it possible to measure the importance of the unsatisfied demand.

More than 100 people on the waiting list died in 2009, according to figures from the Academy of Medicine.

The number of people who declared their consent to organ donation has increased significantly: 30,000 citizens had registered their positive will in 2005 compared to 133,000 today. That’s fine, but given the impressive figure of 288,000 citizens opposing the hypothesis of organ donation, there is still work to be done. The rejection rate of families is 15%.

Thus, these few figures allow to clear the situation and indicate that, although Belgium occupies a place at the top of the countries whose rate of donors is the largest proportionally to the population and is cited by the Academy of Medicine in the top 3 worldwide, given the advances of medicine and demand that exceeds supply, we must nevertheless continue to look for how to improve the possibility of donations and, simultaneously, maintain it in an absolutely non-market perspective.

Some relatively serious problems have arisen for a near-champion country, if I can express myself so. Thus, organ harvesting from incapable persons was possible following a law passed in 2007, with the consent of the legal representative. This provision was contrary to the Convention on Human Rights. It is very important that we remove this provision today.

In addition, the problem of non-covering costs for the living donor had to be addressed. It cited figures of 1,300 euros that were reimbursed for transactions up to 14,000 euros. Finally, there was a lack of data or a certain lack of coordination of the data.

The existence of a register seems to me absolutely indispensable; it was surprising that it did not exist before. I am pleased to know that it becomes legally mandatory, as well as other advances made by this law.

We especially appreciate, in this bill implementing the European directive, this register of identification for living donors that will ensure the safety of organ donation for recipients and will allow to quickly find a donor, to act faster and in a coordinated way. Furthermore, the protection granted to persons unable to express their will and to children under the age of 12 is very important for us; therefore it is excluded from taking their organs. We appreciate the accompaniment, cost coverage and compensation for living donors.

This last point, which is valuable in this new law, is, at the same time, the one that continues to ask questions. Indeed, for living donors, the question is what will be the limit between the refund, the necessary compensation for the discomforts suffered for the donation made (physical problems, school absence, professional absence) and a financial advantage that could constitute an incentive and would give a commercial character to this approach.

This is a difficult balance to find. I hope that we can go back and discuss it together so that this accompaniment remains fully legitimate, avoiding penalties for the donor.

I also take the issue of the protection of the donor’s employment. How to protect the employment of the donor who will be absent, ⁇ , for several months? Is it possible to protect him and find compensation so that he is not without income at that time? What about students who are at risk of missing a year of study, training?

How can we generate more positive statements about organ donation in the event of death? How can we encourage this positive record that makes things easier, while organ donation is possible even without this statement? This statement should be encouraged.

The ideal solution has not yet been found. I know that the N-VA made proposals, wondering to what extent it was not possible to make a statement to its general physician. We also talked about the registration of an eHealth statement. There too, it will be necessary to find a balance between the ease and encouragement to make this statement and the protection of the person against acts committed under pressure or in a too singular dialogue. This approach must remain a little public where the initiative of the person is objectivized and officialized correctly.

The two remaining points are, therefore, on the one hand, the accompaniment of living donors and the concern to compensate their donation properly and, on the other hand, the question of encouraging positive statements, in order to better respond to demand.

Unfortunately, I was unable to follow the discussion of this interesting draft. It was long anticipated and has now come: this is an important step forward in the regulation of organ donation.

It was discussed for a long time and in practice there was increasing demand for it. Given the longer life expectancy, the smaller number of people who die prematurely and the increasingly sophisticated transplant techniques with increasing likelihood of succeeding, this is an important step towards better health policy.