Proposition 52K1409

Projet de loi relatif 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

The Senate

Submission date

June 24, 2008

Official page

Visit

Status

Adopted

Requirement

Simple

Subjects

bio-ethics marketing cytology medical research organ transplant scientific research

Voting ¶

Voted to adopt

CD&V LE PS | SP Open Vld N-VA LDD MR

Abstained from voting

Groen Vooruit Ecolo FN VB

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Discussion ¶

Dec. 4, 2008 | Plenary session (Chamber of representatives)

Full source

Mr. Speaker, ladies and gentlemen, dear colleagues, today we have the opportunity to address an important topic: it covers many areas, some sensitive such as ethics, but also the problem of scientific research, the problem of the economy and even the problem of equal opportunities.

In the Committee on Public Health and Environment, we had a very rich and constructive debate. As the rapporteur and on behalf of the two co-chairs of this committee, I would like to thank Mrs. Minister, but I would have preferred her to be present since she is the minister specialized in this matter. I wanted to compliment her for her openness of mind, her voluntarism and even her “flexibility,” according to the term she recently used about another case.

I would also point out that the commission has worked beyond political labels, with height, depth and rapidity.

However, in this case, we showed ourselves very bad students of the European class. Indeed, we still operate today under the cut of the 1986 law on organ transplants – which does not exactly concern the problem of the day – the 1988 Royal Decree on tissue banks, and the 2002 Royal Decree, repealed by the State Council in 2005, on human tissue.

Since then, the European Union has taken the bull by the horns: at the end of the 1990s, various proposals were submitted; they resulted in a proposal by the European Commission in 2002 to result, in 2004, in a directive of the European Parliament and of the European Council dated 31 March 2004.

But we had the obligation to transpose this European directive by April 2006. Dear colleagues, I draw your attention to this already significant delay of two and a half years, while the process is not yet completed. Our transposition has yet to go through the royal signature, and then through its publication.

In addition, there are also all the royal decrees that I will discuss in a few minutes as they are intrinsically linked to the law.

That said, this is an extremely important and urgent matter since the transplantation of human cells and tissues is a growing field of medicine that makes it possible to treat previously incurable diseases. The quality and safety of the substances concerned should therefore be ensured in order, in particular, to prevent the transmission of diseases.

Furthermore, the availability of human cells and tissues used for therapeutic purposes depends on citizens who are willing to donate them. We have experienced the same kind of situation for organ donation. At this point, I would like to clarify that Belgium is considered a good student at the European level.

The process at the level of Belgium has been ⁇ lengthy since, during the previous legislature, several bills were submitted to the Senate and failed.

During the current legislature, a preliminary bill was submitted to the Council of Ministers, which adopted it on 25 April 2008. It was also submitted to the State Council, which gave its opinion on 13 May. It is this preliminary bill that was transmitted to the Senate and which was the subject of a new common bill of the five groups of the majority.

This initiative had the merit of unlocking the file. But whoever says compromise, says bad cut. The Health Commission expressed itself unanimously to say that the draft law of which issue still raised many questions and that many points were improved.

On July 18, last year, the Senate approved this bill largely inspired – I have already pointed out – by the government bill.

I recall that the bill, which is submitted to us today, aims to regulate in a legal and comprehensive way the various operations performed with human body material and intended for human applications or for scientific research purposes.

This draft takes into account the applicable directives in the field whose final date for transposition was – I repeat – 7 April 2006.

When the bill was submitted for consideration to the Public Health Committee, the question of whether or not hearing would be held arose.

There were two opposing attitudes. According to the first, due to the hearings that had been organized in the Senate and in a concern of speed, there was no need to organize new ones. On the other hand, some elements deserved to be taken back and new elements had also appeared. Recall that in the French Senate, Ms. Marie-Thérèse Hermange has just produced a report on the subject. This issue is constantly evolving. That is why the committee finally decided to hold a few hearings, limiting their number to six, which brought clarification. For my part, and like other new parliamentarians, I highly appreciated these meetings.

Since the minister joined us, I will tell her that the commission appreciated her collaboration and her openness of mind, as well as her flexibility. The purpose of the hearings is to inform parliamentarians about new elements, gaps, etc. And indeed, they made light on some elements thanks to the audited people. They were relatively important personalities. What we have been told in particular, as the minister knows and assumes, is that the bill in question goes beyond the subject of the directive, its scope being wider. In fact, it covers not only cells and tissues but also all other human body materials, including substances extracted from them (thus embryos and fetuses), as well as the use for scientific research purposes, which was not regulated by the Directive.

The rules are also stricter. In particular, the human body material bank can only be operated by a recognised hospital or by a university coupled with a medical faculty. This goes further than the Directive.

Furthermore, it was also mentioned the fact that once the project is adopted, the biobanque will not be able to obtain directly from human body material: it will have to call on a bank of human body material, only authorized to do so.

This relationship of dependency makes the situation relatively complex and the fact that many provisions – many parliamentarians have come back on this – require royal enforcement decrees, especially those relating to biobanks, generates just as much legal uncertainty. I would like to say that the Minister promised to involve the Health Committee in the preparation or discussion of the resolutions, in any case those that will be discussed in the Council of Ministers.

We also heard a French researcher who highlighted the fact that stem cells are of essential utility for the treatment of patients and for certain biotechnological applications.

I would like to make a small reminder for the Room because it is true that it is an unusual topic. Stem cells taken from adults consist of fat, skin, bone marrow and tissues of organs. These cells, however, are less easily accessible than placental blood or cord blood. Extracting these cells from this material is more ethically acceptable and more acceptable. In addition, they are available at every birth, or 130 million in Europe each year. They are immune-naive because they are not yet exposed to the influences of the external environment. Four perspectives are offered by these cells: obstetrics, hematology, oncology, generative medicine. This is an important point that was also highlighted during these hearings.

The problem of two co-existing opposing models was also at the heart of the commission’s debates: that of a public bank (allogenic conservation) and that of a private bank (autologous family conservation). Between the two, there is a mixed model, which the bill has partially retained, that of solidary family preservation within a public-private partnership.

Regardless of the preferred model, the main thing is to guarantee the sampling and preservation of cord blood. The abandonment of bio-resources – this was essential in the discussion – is not compatible with the public health imperative.

We have also heard a series of legal comments from Professor Herman Nys calling for a better definition of the scope, a greater care to be given to the applicable rules, respect for the rights of minors and disabled persons, and realistic tasks for opinion committees. There, the minister promised that, through the royal decrees, she would pay attention to these elements.

It is also necessary to highlight the problem of taxation after death on the legal level. It is true that Article 12 of the bill sufficiently extends the scope of the absence of objection regime of the Act of 13 June 1986 on the collection and transplantation of organs. Currently, the scope is limited to sampling for transplant for therapeutic purposes. Article 12 of the bill that is submitted to you extends this regime to scientific research applications. It should be avoided that as a result of this enlargement, a much larger number of people oppose the removal of their organs after their death.

We also had other hearings about the problem of diabetes which is a very important point! Type 1 diabetes appears frequently at an increasingly young age. However, this diabetes is an infection that constitutes a constant burden in the life of the patient, in particular due to diets. In this context, cord blood therapy is of great interest. Therefore, autologous use of cord blood in children with type 1 diabetes should be decisive in the treatment of this condition.

We also heard representatives of private companies who expressed their fears to us. Indeed, while they are already recognized and have accreditations in other countries, this is still not the case in the head of the Belgian authorities. Everyone has pointed out that information is extremely important, as is the case with organ donation. We have already talked about this in particular with Katia della Faille; parents should be much better informed. Currently, 99% of stem cells are abandoned. I insist on this fundamental and vital element!

As I mentioned earlier, it must be remembered that this is an ethical and ⁇ sensitive area on the economic level. While there is a need to stimulate medical research and applications, it is also true that there are also important economic issues. Ms. Bron, a professor of hematology at ULB, made us ⁇ aware of this, as abuses have been found in other countries with uncontrolled human body materials that have already been sold.

Then we had a very constructive exchange with the members of the committee. I would like to highlight, in particular, the intervention of Ms. Yolande Avontroodt.

She wants to know whether the draft, if adopted unchanged, will immediately give rise to legal proceedings.

It also asks about the possible limitations that the bill may impose on the development of scientific research, especially in Flanders.

His colleague, Christine Van Broeckhoven, wants to know why private cord blood banks are needed. This is really the big gap within the commission. He asks if it is because public authorities do not take their responsibilities. She also asks whether paid private cord blood banks mean that children whose parents are unable to pay have no future.

by Mr. Bultinck notes that the six people who were heard in the committee agreed that the bill should still be corrected and modified.

Ms. Thérèse Snoy et d’Oppuers investigates the difference between the use of cord blood intended for autologous and allogenic use.

Ms. Lambert reminds that Member States are obliged to transpose EU directives. I’ve just said how late we were in this matter for this bill. Directives are not intended to harmonise national regulations and Member States are free to develop more stringent and restrictive rules.

In the general discussion, Ms. della Faille notes that the bill does not offer any legal certainty and that it is especially the research sector that raises many questions about the text under consideration. She also insists in hoping that all patients have the guarantee of being able to preserve cells in all hospitals, both for autologous and allogenic uses.

His colleague, Ms. Van Broeckhoven, has a lot of difficulty accepting the regulation in project. He believes the bill complicates things. On the one hand, this complication is attributable to the expansion of the scope of the law to blood, organs and embryos. On the other hand, it is the result of the mixture of the regulation on tissues and cells intended for human application and the conservation regulation for scientific research.

Although Ms. Thérèse Snoy et d’Oppuers supports the principle rooted in the law – this was also recalled by her colleague Tinne Van der Straeten – according to which human body material is not commerciable, she specifies that the bill is not yet going far enough on this point. The exceptions it provides are not clear enough and clear enough, she said.

I make my own speech. Mrs Avontroodt points out that the bill may have no negligible consequences for scientific research. She emphasizes that, in the field of cell therapy, research is still in its early stages and offers very promising prospects.

However, the hearings show that experts believe that the adoption of the legal framework for the examination would result in Belgium no longer being able to participate in a study on the therapeutic possibilities for juvenile type 1 diabetes, which I mentioned recently. The law would have pernicious effects.

Ms Avontroodt also wants to analyze the ethical aspects of regulation. She agrees with the Minister that there must be quality standards and that regulation is necessary for tracking. No one disputes this, but there are also other concerns that one cannot lose sight of and which relate to ethical aspects. The speaker cites the example of mothers who should not be able to be prohibited from keeping cord blood if they also subscribe to the principle of solidarity.

Finally, she stresses that she feels that the bill does not introduce a framework regulation, but an ad hoc regulation, which will quickly be overtaken by scientific developments. She proposes – and I believe that this is one of the important points that helped raise many objections within the committee – that the law be subjected to an evaluation no later than one year after its entry into force. I would like to say that the Minister was very open to this proposal for the evaluation of the law.

Ms Van der Straeten praises the merits of the texts adopted by the Senate and welcomes that the draft text takes as its starting point the principle of solidarity and the priority position of public banks.

However, it adheres to the opinion of the previous speaker concerning the multitude of delegations granted to the executive power; this is the problem of royal decrees that I have already mentioned.

Ms Salvi, on the basis of the principle of solidarity, is in favor of the principle of a single bank of cord blood accessible to all.

by Mr. Otlet believes it is very important that the freedom of the patient is respected.

by Mr. Luc Goutry acknowledges the difficulty for the non-specialist to understand the text of the bill, although the underlying purpose is clear. If the mixed model seems to be the most effective, it is provided that the rights and obligations of each are clearly defined.

The collection, storage and processing of human body material does not escape this conclusion. Public control over these operations must continue to avoid any abuse. The ethical nature of the discussion cannot be ignored.

Over-protection should also be avoided; the EU framework already provides effective coverage against the majority of known risks. Why then go further in the bill by establishing a sui generis system in Belgium. This system very much resembles a compromise to the Belgian with the dose of complexization and overprotection that such compromises generate.

Finally, the speaker recalls having actively participated in the discussion on ethical committees under the 2004 Law on Experiments on Human Persons. In practice, these committees are already overloaded and the quality of their opinions is thus compromised. But the draft law is strict: it entrusts the committees with extensive powers. Is it not too strict? The implicit question was as follows: what will be the actual possibility for these committees to give opinions when they already have trouble with previous legislation?

The European Commission will initiate an infringement procedure before the Court of Justice of the European Communities if Belgium does not publish the law transposing the European Directive by the end of the year. I recall that the bill provides that it will be published for July 14, 2009, which was the subject of a question: why this date that does not correspond to anything in particular, at least in us?

It also recalls the five structures that may intervene within the framework of the law: the hospital, the bank of human body material, the intermediate structure which is the grouping pursuing a profit or non-profit purpose and which serves as a link between the public and the private, the production establishment and the biobanque which is the new structure intended to support human body material for scientific research and which must be approved.

This biobanque can be operated by a hospital or university but also, which has caused debate in the commission, by a private company, for example pharmaceutical. The purpose of the activities of this biobanque must be the subject of an opinion of the Ethics Committee. However, confidentiality and traceability are guaranteed and each biobank will keep a record of the nature of the preserved human body material. Their inspection will be entrusted to the Federal Agency for Medicines and Health Products.

However, the Minister acknowledges that the scope of the bill is wider than that of the aforementioned directive. In fact, the draft supplements the legal disposal of the 1986 Act on Organ Proliferation and Transplantation and that of the Act of 5 July 1994 on Blood and Blood Derivatives of Human Origin.

Any material of the human body, which does not fall within the scope of any of these two laws, is now included in that of the project, with the exception of the materials referred to in article 3 and which have also been the subject of a debate which I will call "technical". Additional protections are also provided for donor consent and ethical compliance.

A number of amendments were submitted to the committee. With the exception of two technical amendments concerning the linguistic "toiletage" of the Dutch text that were adopted unanimously, all amendments were rejected and the overall text was adopted by 11 votes for and 4 abstentions.

Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Flahaux, I am pleased to share the position of my group. Indeed, from the beginning of his report, he indicates that all groups have noted the fact that the proposed law was poorly strapped, like a badly strapped cottage, according to the term used. However, the Socialist Party has never expressed itself in this way during the commission. I wanted to clarify this from the beginning.

The bill we are discussing has a particular genesis.

First, it is a preliminary bill drawn up within the government and approved in first reading by the Council of Ministers. It also served as a basic compromise to the text proposed today. It was subsequently submitted to the Senate in the form of a majority proposal, the first signer of which is our colleague Senator, Mr. and Vankrunkelsven. This proposal, which was voted in the Senate in July last year, has thus reached the House.

The debates were lengthy, as you realized from the report, among other things because of new hearings that took place in order to give broad light to the members of the committee.

With regard to the subject of this text, we can say that it does not merely transpose EU directives. It also intends to provide a comprehensive response, through a detailed device, to situations that already exist in our country in terms of obtaining, collecting, processing and using human body material.

The problem is therefore double and ⁇ far from being obvious to solve. It is necessary, on the one hand, to ensure sufficient control of the use of this human material, which implies for my group to entrust it to a large extent to public authorities, and, on the other hand, it is also a matter of not preventing scientific research and the development of new therapies using this material, which can effectively contain a promise for the medicine of tomorrow.

The legislation presented today allows, in my opinion, to preserve, or even to stimulate this research, ⁇ under a certain control, otherwise indispensable. This control must be as intense as it is now applied to embryonic research or blood control.

A series of operations are therefore reserved for hospitals and universities, and this is very well so. It is indeed indispensable to provide for high standards of quality and safety, traceability as well, to provide for information and consent requirements of the patient, i.e. the donor. We are not talking here about apples and pears, but about human substances, delicate substances and this, both at the biological and ethical level.

This control, in addition to quality control, must therefore also be examined from an ethical point of view. We strongly support the various interventions provided for by the legislation in the area of ethics committee, mandatory approval. It is important to strictly observe the ethical principles. This is why a bank of cells and tissues must remain linked to a hospital or university.

With regard to advertising, we also support 100% the will to prohibit it purely and simply without any derogation.

The proposed text thus strictly encompasses private banks that, today, mainly run through advertising for delayed, autologous, non-therapeutic use. There is a very strong financial market. It is therefore necessary to regulate. In recent years, we have seen the development of practices in some private centers that encouraged, against remuneration of course, young mothers to store cord blood for a hypothetical future use. In addition to the disturbing monetary aspect, there is also the question of the actual usefulness of the process and therefore the role played by certain structures, which "sell the uncertain and the unknown". The text addresses the issues related to advertising and those that could result in material benefits.

Mr. Speaker, I would like to react to what Mrs. Lambert says here.

First, I did not hear that during the debate. I have not heard the Minister in those terms defend what she says now. She apparently did not listen properly to all the experts we heard in the Chamber Committee. When she speaks about unsafe use of stem cells, that is absolutely not evidence-based. I think that both Professor Rooman and the international experts, as colleague Flahaux has pointed out, have very clearly demonstrated that it is evidence-based and within a few years.

Mrs Lambert, I therefore leave that to your responsibility, when you here state that there is a totally unsafe use. That was absolutely not the tone, and that is not scientific; no professor has said that in the Chamber. I would like to comment on this for a moment, Mr. President.

Dear colleague, I hear well your intervention but I do not here make a report of what was said and what I heard in the Health Committee, I relay a position of my group in relation to the problem raised. So let me express the feelings and sensitivity of my group!

The bill also lays as a principle the general prohibition of collection and storage for delayed use, autologue or allogene, for a particular and identified recipient. For my group, this is an essential element. The prohibition, which, under certain very precise conditions, can be eased, seems to me quite balanced.

The authors added one element that I would like to emphasize, that of solidarity, namely the accessibility to all of these stocks if necessary. My group would like to especially welcome this aspect of the proposed law because it is of course important that every citizen can access all available medical resources. Our health care system is based on this principle of solidarity. Everyone is entitled to the best therapies. This principle, which today applies to blood donation, poses no difficulties. Why would it be different for this human body material? How else can one dare to imagine a system that would allow people to jealously keep their precious cells “in case”, while a patient, somewhere, needs them greatly for his survival? I will be perfectly clear on the subject: for my group, it is not conceivable to allow such a model to function where the private would supplant the public, where solidarity would be challenged by selfishness.

Mr Flahaux, we are listening to you!

Madame Lambert, it is me who gives the word!

Mr. Speaker, we do not only want to deal with personal aspects but we also want to take you the presidency!

I am surprised because we had very serene discussions. However, I have the impression that Mrs. Lambert speaks at this tribune differently than at these. Are there hidden media? Previously, she had already told us that the Socialist group had not issued a state of mind. I thought the minister was a socialist because she herself said there was a problem in clarifying the bill. She acknowledged it and said that she would take this into account for royal decrees and for revision after review of the law. She therefore showed a great openness of mind and she even specified “toward democratic groups.” I thank him very much!

Finally, Madame Lambert, you are putting a little bit of a bump on this. I’m also surprised to hear you say, “I don’t see why we could keep these organs, even if only in part.” I imagine that, in the same way, you will also have offered to share your bank account with your neighbor!

First of all, please accept my apologies.

Mr. Flahaux, I remember very well the discussions in the committee as well as the time when some members talked about the possibility of possibly keeping a percentage for private purposes. I then spoke very clearly, saying that, for us, this was not the case! I even mentioned at the time the donation of blood that I just referred to. I believe, therefore, that I have been explained in the same way at the level of the commission in relation to attempts which I call at a given time "drives" and in relation to a central bank of human material, as is done for blood donations that do not pose a problem.

In conclusion, Mr. Speaker, the text is a good balance both in terms of safety for patients and the ethical aspect of the problem, without however hindering the promotion of biomedical research.

Like you, Mr Flahaux, I note that enforcement orders will ⁇ play a crucial role for the effective application of this legislation. We will all pay attention to it, and my group in particular, as we will make sure that the fundamental principles that I have just recalled in my speech, which are the principles of solidarity – basic principles of our public health – are not undermined by merchant interests or too egocentric interests.

Mr. Speaker, Mrs. Minister, colleagues, I do not say that my enthusiasm was great, up to the report of colleague Flahaux. I don’t even say that my enthusiasm is very low. I regret the unilateral interpretation made here by Mrs Lambert on behalf of her group, on behalf of the coalition, on behalf of the PS on the agreement reached.

Mrs. Minister, you have always said and have continued to maintain in a very open stance that this is a compromise text. Ms. Van Broeckhoven and other colleagues have finally signed up for a compromise, an acceptable compromise, across all banks. That was the result that you, Mrs. Minister, had achieved.

I can also give a one-sided interpretation. I can also come here on behalf of my group to say and come to say that we are absolutely in favour of retaining that autologous retention exclusively. We did not do that, Mr. Goutry. It is an ethical issue. I have said so too. I believe that this right cannot be denied. However, I also dare to reassure you that the compromise as it was proposed during the debate and in the responses of the Minister implies even greater solidarity.

Both Professor Forraz and Professor Rooman have demonstrated this very clearly with international examples, with international applications now enabling it to save diabetic children and to give diabetic children a life where they are not insulin-dependent.

Mr. Goutry, if you had been there, you would not have been there during the hearing, unless I am mistaken, you would have said, with your knowledge of industry affairs, that this is an application that is needed.

When we are read by colleagues, we have to react. If the colleagues even judge us about our presence, then we all need to start keeping records and then we will also remind you of it at a suitable time. However, this is not relevant now.

I think we should not let the debate from the beginning disappear. Everyone speaks for his group and each has the right to express his opinion. I will do it later, on behalf of our group and in my own name, but we should not make it more difficult. The compromise consists in that, if medical necessities prove to exist and a medical necessity retention must be made, that this can and will happen.

For the rest, we must be solidary. There is no doubt about the way blood and plasma banks are now being built, but if we do not ethically monitor or guide it, then commercialization is possible and then it could be that everyone gets their own safe or drawer. That is why we say that we must solidarely, for all, make things available. There must be equal access for all people, but if it is medically necessary, then there must be a detention to be possible to help themselves. This is quite obvious. I do not hear any contradiction in that.

This is of course the essence of the debate. Why do I not look at my text, which I have prepared very well and beautifully? Since you would have determined that the word and the statement of Mrs. Lambert “l’usage hypothétique” were completely undermined, if you have listened to the professors and the scientists and if you have heard the reports, both of Professor Forraz and of Professor Rooman.

Mrs Avontroodt, Mrs van Broeckhoven asks for the word.

Mr. President, Mrs. Avontroodt, I would like to intervene in this discussion. I started the first general discussion with a question. I have added that this is a philosophical and controversial question. I asked why there should be private initiatives in addition to public initiatives.

I immediately subsequently pointed out that this is a decision of the government and that the government plays an important role in it. Why do I say that? If we look to the future and think of scientific research, we can expect that in the future, through cell and tissue therapy, various diseases that today cannot be cured or treated can be cured. Think, for example, of brain diseases, such as Parkinson’s disease – which is already quite close – but also of forms of dementia, such as Alzheimer’s dementia.

If we were to live in an ideal world, today we would have to record the umbilical cord blood for the future of every child born. The government has finally decided that this is currently only possible for diseases where cell or tissue therapy has already been proven to be appropriate.

The government has imposed this restriction. In this way, the government excludes the possibilities of the future. According to the government and government parties, this is a compromise. That is not to say that this is a good compromise, but it is a compromise between what we can today and what we may be able in the future. This is the private initiative. I think it is important that we try to keep these two things a little apart and that this therefore does not per definition have to do with abuse, private banks. This is not a criticism of you: it was actually intended to summarize the whole discussion here. That was actually my intention.

I think we can thank Professor Van Broeckhoven in this very heartfelt for her contribution to the committee and her expertise in this area. Thank you, Mrs. Professor Van Broeckhoven.(applause)

I will not repeat everything. Of course, the part of transposing that European directive has two big legs. One foot is everything, the contentieux I would dare to say, with regard to science policy. The other part relates to what we have already partially and somewhat unwillingly continued in order to clearly frame the debate.

The fact that that European directive has been transposed too late has, of course, to do with the way we have dealt with it. Everyone knows that the Netherlands has no fine because it has decided immediately and in a very simple way to transpose the European directive. The final point is near. They are in the rule, they have no fine and the European directive has been transposed.

Does this mean that we do not find it necessary to regulate quality control or that there is a regulation to treat body material, tissues and cells, not as ordinary goods? and no. Indeed, we believe that quality requirements are needed, a regulation is needed, permission is needed, and that regulation is needed to prevent abuse, including for trade abuses that could be created in body material.

Nevertheless, Mr. Speaker, I would like to emphasize the science, the mortgage in the scientific world, and the life-size questions that we also have in the business world. You know, colleagues, that we would never ⁇ the Lisbon objectives on investment in scientific research if the private sector was not involved.

You know that the Flemish government has made enormous efforts to support the world of biotechnology. You also know – I think all members of parliament are well informed about this – that some companies speak of relocalization if one could no longer carry out this or that activity. In particular, I look at making this law very restrictive for the use of material, only for autologe applications. This raises questions as to whether for scientific research one should always return to the hospital or to the place where material is tested. I am convinced that Professor Van Broeckhoven and other colleagues can say even more about this.

As Open Vld, we are absolutely concerned that we would mortgage our knowledge economy by doing so. This is a different type of mortgage than the one mentioned earlier. It is not the industry that has problems with this. Rather, we should give incentives to biotech companies and the industry to encourage their highly educated people to stay here, to counter the brainstrain and to actually do braining. In the previous legislature, serious efforts were made for this. Reductions and incentives have been given to the strictly scientific staff. It would be regrettable if a conversion, which could be interpreted as being very strict in the scientific world, would underestimate it or if that conversion would cause a competitive disadvantage. We live in a competitive world in the field of the knowledge economy. Knowledge is our most important raw material. Therefore, we must continue to support this sector rather than fool them.

The Minister has repeatedly stated in the committee that it is not intended that the scientific world and its companies would suffer disadvantage. Nevertheless, there remains a risk of overlapping, double legislation with conflicting requirements. I hope that the uncertainty that remains in certain areas will be removed in the royal decrees, so as to avoid legal uncertainty and competitive disadvantage, both for the scientists and for the private companies – I am not shy to say so – that invest in biotechnology, development and research.

Finally, Mr. Speaker, I would like to pay some attention to the Flemish research institutions that are effectively engaged in research. That may not be profitable, but they are effectively engaged in pure research. The extension to the generic consent, with which the Minister has agreed, is a positive contribution. This shows the government that it can make compromises that can lead to a win-win situation.

My colleague will explain the other aspect in detail.

Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker, Mr. Speaker. As announced by Ms. Avondroodt, I will limit my presentation to the ethical aspect of the present bill.

I explain myself more closely. In principle, the bill prohibits the storage of body material for personal use. However, there are two exceptions. The first exception stipulates that the storage of body material for autologous use is allowed if the person concerned at the time of removal presents a scientifically proven risk of a disease for which the usefulness of autologous use has been scientifically proven.

As Mr Flahaux noted, in particular Professor Rooman objected to the aforementioned provision. Professor Rooman is affiliated with the Diabetic Center of the University Hospital Antwerp. He rightly argues that many pathologies for which autologous cell therapy could be a solution, are impossible to identify at birth. Medicine is a science that is constantly developing.

Contrary to what Mrs. Lambert thinks, we believe that the use of stem cells can sometimes lead to the next, medical revolution.

During the hearing, the professor well outlined all the possibilities that cell therapy for diabetes in children could offer. After all, it turns out that only 5 to 10% of patients with diabetes come from a higher risk group, especially children whose father, mother, sister or brother has diabetes.

Ladies and gentlemen, with the present design, you should realize that 90 to 95% of patients who will eventually develop type 1 diabetes will never be able to store stem cells for autologous use.

The following gaps in the committee were also addressed. Nowhere in the present law we find for the banks of human body material the obligation to store stem cells for the aforementioned group of patients. Not every maternity in our country belongs to a hospital that has the resources to take advantage of a bank with human body material. In August 2008, there were only four banks, which also retain stem cells from umbilical cord blood.

Mr. Speaker, Mrs. Minister, colleagues, I wonder where solidarity is here. Our group believes that all patients should have the assurance that in every hospital they have the ability to preserve the cells.

I now come to the second exception. Storage for autologous use is also exceptionally permitted if the body material for therapeutic use remains available by third parties.

The aforementioned exception is, of course, very positive. It offers opportunities and stands for solidarity, which, of course, we can only welcome.

Open Vld connects these opportunities with one condition. Stem cells must be allowed to be divided ex vivo.

In the committee there was also an ethical discussion that constituted a denial of what is scientifically possible. Under the guise of the principle of solidarity, many have rejected the sharing of stem cells a priori. However, we believe that cell sharing as a scientific technique can reconcile the interests of stem cell donors and potential third-party users. The patient who does not find appropriate stem cells in the public bank can then resort to cells, deposited by a donor at a private bank. In addition, in that case, the donor himself still keeps sufficient stem cells at his disposal in order, if necessary, to use them later. This increases the availability of stem cells for everyone.

I therefore hope that the implementing decisions will allow the division of the stem cells, in order to ⁇ a greater number of stem cells. Only then will we be able to speak of true solidarity.

Mr. Speaker, Mrs. Minister, dear colleagues, the majority in the committee has voted for the present text. We realize that this text is far from perfect, but during the discussion of the law in the committee it was clear that this draft was the only feasible one. Many of them still need to be regulated through implementing decisions. Our group therefore hopes that the implementing decisions will be able to limit the possible negative impact of this law.

Open Vld also hopes that common sense will triumph and that we will be able to choose to collect as much body material as possible. Only in this way will we provide sufficient opportunities for scientific research and provide more opportunities for recovery for our patients.

We propose that the law be reviewed within three years. If then it turns out that Belgium has built up a backdrop or threatens to lose its competitive position by that law, then we hope that we will indeed have the political courage to revise the law in the appropriate way.

After listening to my colleagues in the committee, I would like to express two regrets. First of all, the regret that this law could not be the subject of a single amendment because, Mr. Flahaux recalled that we accuse a two-year delay in the implementation of the directive. Indeed, the majority had decided that we could not amend anything, while obviously this text deserved it.

Then, I regret the differences in interpretation between the different parties of the majority regarding this text. by Mr. Flahaux spoke of a poorly cut cotta; with a very good word, he reflected the discussions of the commission. No amendment – meaningful and formal – could be accepted, while many paragraphs of the text were confusing. In other words, the report of Mr. Flahaux was long, so the possibilities of amending the text were null.

This law is of great importance to us. Both in the Senate and in the House, we paid the greatest attention to this. In the Senate, it was my colleague, Isabelle Durant, who worked on this project in an attempt to amend it; some amendments have also been accepted.

Given the essential and intimate nature of the subject of this law, we are in the field of ethics. For us, environmentalists, human cells and tissues cannot be considered as material. My first comment is about the term. This term "human body material" is not the term of the European Directive. One of our first amendments was to ask to change this term "material" which we find unworthy and not in accordance with human dignity. In our view, these human cells and tissues cannot give rise to commercial operations or privatization.

Their use must remain within the framework of a non-profit, in a logic of respect for human dignity and solidarity in the service of public health of future generations. These tissues and cells must remain accessible to all. In this regard, we join the memorandum of university hospital directors calling for the maintenance of the Belgian non-profit framework. According to them, a privatized use of these fabrics would present risks of several kinds, the most important of which are, in my opinion, the compromise of free donation and the export of the most profitable cells and tissues to countries that offer the highest prices.

We must recognize that the bill, which is presented to us and which has already been improved by the Senate, has the merit of providing a framework for the collection and storage practices already in progress. It gives – it must also be acknowledged – the priority to the use of these tissues and cells for the benefit of the community.

However, the text has several shortcomings. These have been raised by the experts present at the hearings and, more recently, by my colleagues from the various majority parties, which is at least worrying.

I would like to address some of these shortcomings. First, there is the question of the multitude of delegations granted to the executive power. Thus, the fact that the bill provides that different matters will be settled by royal decree is obviously normal, except when it comes to essential or basic items. This is ⁇ the case in Article 3 and Article 4, where the delegation to the King concerns the essential principles of the law, the very scope of its application as well as the framework within which tissues and cells may be taken. After the affirmation of a principle, it is stipulated in a second paragraph that the King may decide exceptions to the prescribed prescriptions.

Finally, we were able to find that some paragraphs were written in such a way that the types of tissue in question were not clearly defined (cf. Article 3, second paragraph). You know that there has been a discussion on this. It is embarrassing that an article relating to the scope of the law may cause confusion.

In addition, an expert drew attention to the fact that the protection of minors and so-called "incapable" persons is not sufficiently guaranteed. But I will let my colleague Tinne Van der Straeten speak on this point.

Finally, I come to the point on which I would like to emphasize more in response to the remarks made by my colleague Katia della Faille on the issue of the deferred use of stem tissues and cells.

This is obviously something that has touched us all and that has been the subject of a debate, I recognize it, extremely interesting during which our oppositions to basic political principles have found themselves.

Article 8, §1, paragraph 1, 4° of the bill prohibits the collection and storage of human bodily material. Mrs Lambert said: a ban on autologous use has been introduced with one exception, that of proven predisposition to a disease for which this delayed use would be useful and scientifically proven. We fully agree on this point. However, there is a second exception and this is where the bât hurts: this is the famous §b. This exception reopens the door and does not correspond at all with what you said. I quote it: "or if the human body material remains available for a therapeutic use for a third." This reopens the door that was closed in the previous paragraph.

I then quoted Professor Nys, not because he agreed with us, but because he had highlighted the confusion in the text. He says that "the formulation of this second exception is problematic. This exception does not concern a deferred use within the meaning of Article 2, namely any deferred use within the time that is intended for a specific recipient. The exception to the prohibition of deferred use referred to in point (b). It’s about a third.” Either it is an identified third party and in this case it falls back into the first exception or it is not an identified third party and in this case it should not be an exception to the prohibition of delayed use. Because of this formulation, Professor Nys, indicates that the aim pursued, namely the sampling and storage of cord blood in order to use it on unidentified third parties, cannot be achieved. The text is confusing.

For us, in addition to the confusion in writing, this paragraph opens the doors to autologue delayed use and to fabric marketing practices. This is especially true of cordon blood.

Today, in maternity homes, the company Cryo-Save addresses in these terms to future mothers, I quote: "In the near or distant future, if you consent to store cord blood, your child will have at his disposal their own stem cells that, with their enormous vitality, may constitute the key to a number of treatments."

Parents are asked to pay 1,895 euros to entrust Cryo-Save with the drawing of cord blood. We do not agree! We do not agree with the advertising that is made by Cryo-Save but also with the practice. For us, this is a question of ethics and solidarity. Not only advertising but also the practice of autologous use should be prohibited, with the exception for the predisposition of a child to a genetic disease.

I will therefore re-submit an amendment, co-signed by Mrs Van Broeckhoven, because, for us, this point b. Article 8 is a source of confusion, openings and too wide derogations from the prohibition of autologous use.

Generally speaking, we consider that this bill is going in the right direction. We do not challenge its necessity, but we think there is too much ambiguity, too much confusion and we will abstain.

Mr. Speaker, colleagues, Mrs. Minister, I would also like to intervene on this bill concerning the acquisition and use of human body material for the purpose of medical application on the one hand and scientific research on the other.

I know that we have had a very extensive discussion in the Public Health Committee for two days. I think this was also very important. This was a discussion held in the committee. It is, in my opinion, important that the position of our group be expressed also during the plenary session. Since we have been very critically discussing for two days, it is impossible to summarize that whole discussion. It is also not necessary. What I want to try is to demonstrate that the origin of this bill has a history that makes it a very complex given that gives rise to a lot of discussion and criticism unless some concerns can be removed when drafting the implementing decisions, as you have often promised during the discussions. It is also true that I was cautious after the second day of discussions. In the end, together with the other colleagues, I did not immediately approve the bill, but I proposed an abstinence. We will abstain from voting today.

The draft law is called the draft law for cells and tissues. By “us” I mean not only some politicians who have been actively engaged in this, but also the scientists. For those who don’t know, I’m a basic scientist and I work with cells and tissues. Cells and tissues also come from the European directive. In principle it is true that the essence of this bill is the transposition of the European Directive of 31 March 2004 into Belgian law. This European Directive is actually a rather simple directive addressing a specific concern, namely, the quality and safety of cells and tissues transplanted in humans.

What the European directives insisted on was a uniform standardization of these quality and safety standards and a very clear traceability. This is what the European Directive essentially meant.

The present draft law should in principle provide for a correct transposition of that European directive into Belgian legislation as regards cells and tissues.

As Mr. Flahaux said, it is an important bill. I have to congratulate him. I found his report extensive, which was very good. The report will also be very important for the continuation of this draft law.

This is a very important bill. Cells and tissues do not really belong to the normal standard matter that is treated in the Chamber. Such things are not often treated in the Room. It is rather a proposal that fits into an ethical discussion. It was first discussed in the Senate.

It can be seen that few colleagues are interested in it. That is very unfortunate for them. They are on average somewhat older – I apologize for the younger members – and would use those cells and tissues somewhat earlier. Maybe they’re listening in the cafeteria.

The bill provides for a legal framework for the donation, acquisition, testing, processing, storage and distribution of human body material, cells and tissues.

It is about the application of these cells and tissues on humans in the context of medical treatments. It is cell and tissue therapy. It is also about the application of cells and tissues in the scientific basic research, where one wants to gain more knowledge about potential new therapies for cells and tissues. It is also about derivative products, where we then think more in the context of the medicinal products or possibly the therapies that can be applied to humans.

This is a complex given. This means that various actors are involved. There are the politicians, whom we have already heard here, and a few of whom will speak on behalf of their group. There are the doctors who work within the framework of therapeutic action towards the patient. There is the industry, the biotechnology, the economic tissue, where one begins to work out of cells and tissues on those derivative products and new therapies for patients. There are the basic scientists who want to use the cells and tissues to acquire new knowledge.

There are also ethics. After all, it is about man and when it comes to man, there are of course many ethical guidelines involved. I have not listed them all yet, of course.

The discussion on cells and tissue was held for the first time in the Senate, based on four bills submitted. In the Senate, at least in the first phase, there was a concern about umbilical cord blood and umbilical cord blood banks.

I would like to point out that this bill is not just about umbilical cord blood. It goes far beyond umbilical cord blood banks. The Senate has also bowed over the commercial use of cells and tissue. There is a lot of concern about the expression. Often this concern comes back in the various interventions of politicians. Again, it’s not just about private tissue banks. This bill goes much further. I will return to this in the course of my speech.

The entire discussion on umbilical cord blood banks was linked to the transposition of the European Directive, which is more about cells and tissues in a broader context and which is about quality and safety. We have worked very hard in the Senate. There have been several hearings there and I think we should respect our Senate colleagues who have spent so much work on it. The texts of all those hearings have come to us and we have been able to see them all. We were able to use it.

The government, in particular the minister, prepared a preliminary draft law in the spring of 2008 that should summarize the whole. That preliminary draft formed the basis for this new bill. According to the Minister, the new bill is a synthesis of the submitted bills and of the preliminary draft.

At that point, we had already the merger of two very complex substances. At that time, the entire bill was created and the complexity was created. Then the discussions also arose. First, of course, there were discussions in the Senate and later in the Chamber.

According to the government, according to the minister, this bill is a consensus between parliament and government. That consensus bill came to us after it was approved in the Senate, on 18 July 2008. It was sent to the Chamber on July 25, 2008, and it came to us at the table just before the summer holiday. That means that we only started the discussions at the beginning of the parliamentary year, say in October. This was on the agenda of the Public Health Committee. There were several other legislative proposals on the agenda, and we discussed them during the work of the committee.

There was the first discussion about the bill on cells and tissue. It was already clear that there was a lot of criticism and comments among the different factions – especially the opposition, of course, but that is normal.

I also remember the Minister’s explanation at that time about the history of that bill. He then said it was a compromise. I also remember that I have responded to it and that I have called it. However, a compromise proposal is not by definition a good proposal.

The reason I remind you of this, Mrs. Minister, is because at the time when the agenda of the Committee on Public Health was discussed, we had a discussion about whether or not we would organize a hearing in the Chamber. Thus began the discussion. I will not go into detail, but I remember that I, the first, and colleagues from the opposition immediately said that we should be given the opportunity in the House to discuss a bill, even if it was already approved in the Senate. That was said then.

We, as Chamber Members, demanded to be allowed to make a contribution, because we also had something to say. That happened at that time. Eventually, we reached an agreement on the hearing. The Minister agreed. I think there was no other choice either.

With the bill, I wanted to do the following for our group. There is a draft law and I would like to test it to the reality. There is a whole set of regulations. I have proposed to test the bill, on the one hand, on what is happening today in scientific research and, on the other hand, on the ethical standards that are currently common. We immediately indicated that in our group we consider scientific research important. That’s because I’m a scientist. In addition, we wanted to see the ethical aspects of the bill reviewed again by someone who is trained not only in biomedical ethics, but also in law.

There were two speakers. The first was René Custers of the Flemish Institute of Biotechnology. He is what in English is called a regulatory officer. That simply means that he must translate all that regulation, which is drafted, among other things, in the Federal Parliament, into practice. In other words, the VIB is a research institution. In that research institute, more than 1,000 scientists work with cells and tissues almost daily. That means that someone like René Custers should examine whether what is proposed here can be applied in practice. He said some positive things. The Minister has heard this too. However, he also made some very concrete things.

The decision of his presentation was that the scientific research would be better clarified from that bill. This was not originally included in the European Directive. That was of course very drastic. That was his proposal. He also spoke very specifically about the biobank. I will return to that later.

The second speaker was Professor Herman Nys of the Catholic University of Leuven. Everyone has read his exhibition. He has made a thorough written report with more than 40 criticisms and potential corrections to the bill. He highlighted some of them in his speech. He is an authority in that domain. It was very clear that some ethical aspects and some provisions in the bill could get a legal tail.

We discussed further. It was not easy that day. There was a hearing. We only had half a day left. We had criticisms from the beginning. After the discussions of the experts, we had a whole series of criticisms, which were made by our experts. We then asked, I asked, and the colleagues from the opposition agreed, to challenge the session to give us the opportunity to translate that into amendments.

We discussed over and over again. Mr. Goutry was chairman. By the way, he did this very well. We finally started the general discussion. The next thing happened then. Time has helped us a little. Time has ensured that we have no longer been able to start the article-based discussion. This proves that there were an enormous number of comments, very constructive comments from the various factions, of course mainly from the opposition. We needed that time to submit amendments.

During these two days, we have worked very hard. Before I come back to one point that I’m going to add anyway – I’m not going to add them all, I want to say the following. You know the outcome of those two days. You know that my group in the Senate abstained. You also know that I abstained for my group in the Public Health Committee. We are not opposed to your design. We have given you the advantage of doubt. That was the message from our group.

We have given you the advantage of doubt for the following reason.

Mr. Speaker, Mrs. Van Broeckhoven, all taken together, there is one thing to regret, namely that you could not be in the Chamber and in the Senate at the same time. After all, the truth is also that the bill, which was a bill in the Senate, has been complicated by, among other things, bills on the umbilical cord blood bank submitted in 2005 by the sp.a. group.

This has made the debate so troubled, complicated, complicated that we have no longer come to a good discussion about the conversion in itself. Therefore, in the discussion, I was always a little surprised at your position. After all, I think that your knowledge is greater than that of your colleagues in the Senate and because I think that it is precisely because of the restrictive attitude of your colleagues in the Senate that this has become difficult.

If you had also been in the Senate, then the debate would have been better and then you would undoubtedly have voted for.

Mr. Goutry, I am pleased that you said that our amendments have led to discussion. I just wanted to get there. I think there is no contradiction between what I said in the Public Health Committee and what my group said in the Senate. Let me clarify that. I just wanted to get there.

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