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Procedure : 2005/0227(COD)
Document stages in plenary
Document selected : A6-0031/2007

Texts tabled :

A6-0031/2007

Debates :

PV 23/04/2007 - 17
CRE 23/04/2007 - 17

Votes :

PV 25/04/2007 - 11.1
CRE 25/04/2007 - 11.1
Explanations of votes

Texts adopted :

P6_TA(2007)0144

Debates
Monday, 23 April 2007 - Strasbourg OJ edition

17. Advanced therapy medicinal products (debate)
PV
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  President. The next item is the report by Mr Mikolášik on behalf of the Committee on the Environment, Public Health and Food Safety on the proposal for a regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 [COM(2005)0567 C6-0401/2005 2005/0227(COD)] (A6-0031/2007).

 
  
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  Günter Verheugen, Vice-President of the Commission. (DE) Mr President, honourable Members, I am very glad that we are able today to talk about the regulation on medicinal products for advanced therapies, which has been long awaited, and is of enormous importance to innumerable sick people in Europe, to many of whom these new therapies offer hope of new and life-saving treatment. I am not talking here about the common cold, but about such conditions as cancer, Parkinson’s disease, AIDS, and other dreadful scourges. So far, no single legal framework has been put in place, with the consequence that many patients are not in a position to benefit from the treatments that are available, or they end up being prescribed medications that are not safe. By means of this regulation, we are preparing the way for easier and safer access to the ones that will save their lives.

The proposal is also of great importance for Europe as a centre for research. With things as they stand at present, European researchers and manufacturers – who are often small and medium-sized enterprises – can neither grow nor hold their own in international competition.

Let me now say something about the legislative process. While it is self-evidently a matter for your House as to how the procedure is handled, I would, however, ask you to bear with me as I appeal to you to come to a decision and to refrain from dragging the process out any longer, in view of the need to create unambiguous conditions for these innovative therapies, for which people have been waiting for so long, and it is for that reason that I am all the more pleased that three groups have put forward a comprehensive compromise package that will make a speedy agreement of that sort possible.

I am able to say, on behalf of the Commission, that we are able to endorse this package as a whole without any changes needing to be made, and I believe that the Council Presidency, too – although we have yet to hear it say so – is persuaded that the Council will be able to adopt the package as it stands.

I am perfectly well aware that we are dealing here with a particularly tricky topic, and we must be especially sensitive when considering ethical issues as important as this one, and so let me once again make it clear that our sole intention, with this regulation, is to ensure that patients get safe and effective medicines. There is no other objective in mind.

The fact is that the regulation does not actually lay down whether or not medicines are ethically acceptable, and in this respect, we are abiding strictly by the subsidiarity principle, for ethical matters are reserved to the Member States, and we, in the European Union, cannot end up in a situation in which one of them can impose its ethical convictions on another; that is not on. The only thing that is workable is that we leave the ethical issues to the Member States, for that is what we have always done. There is nothing new about it; that is a policy that has been clearly established for many years, and there are many examples of it.

It follows, then, that the proposal neither compels the licensing of ethically problematic technologies at national level nor prohibits them from being used throughout Europe; the proposal goes no further than respecting decisions taken at national level. The important principle that donations of organs and tissue must be voluntary and unpaid applies as a matter of course, and is already enshrined in other legal acts. Reiterating it in this proposal would therefore be superfluous.

What we should do, whatever happens, is lay down common safety standards for such products. I do not think there is any argument by which we might justify acceptance of a standard of protection that varied from one Member State to another, which – among other things – would result only in patients and their various diseases travelling the length and breadth of Europe.

Despite the amendments proposed by the Committee on Legal Affairs, then, we should not remove ethically problematic products – those derived from embryonic stem cells, for example – from the scope of the regulation.

Let me say once more – and I do so in all seriousness – that today presents us with a unique political opportunity to adopt a regulation for which sick people in Europe, and the European medicines industry, have been waiting for a long time. It is because this is an opportunity that we cannot allow ourselves to miss that I ask all the Members of the European Parliament to endorse the compromise package submitted by Mrs Roth-Behrendt, Mrs Ries and Mr Adamo on behalf of their groups, and to reject other motions. If this regulation is adopted, it will promote innovation, make our research and industry more competitive, and, above all, help to save lives and deliver people from grave suffering; all these things you can bring to pass by endorsing this package.

 
  
  

IN THE CHAIR: MR SIWIEC
Vice-President

 
  
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  Miroslav Mikolášik (PPE-DE), rapporteur. Mr President, I should like to address you today as the rapporteur on the proposal for a regulation on advanced therapy medicinal products. Furthermore, as a medical doctor, I should like to address the progress in medicine of highly specific medicinal products emerging onto the European market to treat patients with the diseases enumerated by the Commissioner.

I should like to seize this opportunity to thank the Commission for its proposal. The time has come to treat patients with products which are safe, efficient and based on non-controversial grounds.

Since the beginning of 2006, the European Parliament has been working hard on this proposal with the Committee on the Environment, Public Health and Food Safety, the Committee on Industry, Research and Energy and the Committee on Legal Affairs. The final report was adopted by a large majority. There is a broad consensus within Parliament that the report by the Committee on the Environment, as presented for the vote in this House, is excellent. All stakeholders, representatives of both the bioindustry and of patient groups welcomed it after its adoption last January.

Last week three Members of Parliament, on behalf of their political groups – Socialists, Liberals and GUE – tabled a number of amendments presented as a so-called compromise with the Council and the Commission. This individual action was undertaken without the knowledge of the rapporteur.

I would like to underline that no agreement was reached with the other two institutions at the end of the informal trialogue that took place last month. Ninety per cent of these amendments are a copy-and-paste of the committee report with cosmetic changes. The most relevant are the 10%. These amendments concerning the more sensitive political issues are the result of an individual initiative of three of our colleagues. As they mentioned in their letter last week, the interinstitutional agreement has not been finalised. Furthermore, many of the amendments presented in the package do not have the support of the committee responsible, the other two committees nor of the rapporteur. Therefore, I should like to urge all my colleagues to support the responsible report by the Committee on the Environment in the vote on Wednesday.

In order to speed up the legislative procedure, the informal trialogue with the Council and the Commission took place last month. The three meetings showed discrepancies. From a substantial point of view, several politically sensitive questions have not been solved. From the point of view of procedure, the question was raised of the two amendments tabled by the Committee on Legal Affairs which were directly incorporated into the report under the enhanced cooperation procedure. As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, colleagues from the two other institutions and some shadow rapporteurs refused to consider these amendments in the light of the first reading agreement. Apparently, enhanced cooperation is respected only when it suits certain colleagues. It is welcomed in files such as REACH, but as far as advanced therapies are concerned. Some go even further and misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic.

I would like to raise one aspect of the proposal which still worries me: the principle of subsidiarity. In its fully harmonising proposal, the Commission introduces an op-out for Member States to apply their restrictive national legislation concerning certain contentious products. In practice, this would mean that certain products would not have access to the market of all Member States. Following the opinion of our Legal Service, this provision presents serious problems of incompatibility with the legal bases and could therefore be annulled by the European Court of Justice. If this is the case, this regulation would become a fully-harmonising measure for all products including those prohibited in some Member States. Here, the two amendments from the Committee on Legal Affairs bring legal certainty by excluding from the scope products containing or derived from embryonic stem cells.

As rapporteur, I have to respect the diversity of 27 sets of legislation relating to embryonic stem cell research, from the complete freedom of research to the prohibition of killing embryos for research purposes. If we do not support the amendments from the Committee on Legal Affairs, this regulation would de facto promote the development of products derived from embryonic stem cells, although this might be considered as ethically unacceptable by citizens and Member States.

As an elected representative of this House, I have the responsibility to listen to all opinions, to marry positions and to propose to our citizens a text which can be considered as modern, progressive and respecting universal principles and values such as human dignity. I welcome the tone of the recent Berlin Declaration regarding European values, as well as the programme of the President of the European Parliament, who stated that the question of human dignity is at the core of his and of our approach when voting on European legislation.

 
  
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  Giles Chichester (PPE-DE), draftsman of the opinion of the Committee on Industry, Research and Energy. Mr President, Commissioner, first of all I should like to thank the Commissioner for his remarks about this proposal and report. I warmly support them.

I should also like to state quite clearly that my committee, the Committee on Industry, Research and Energy, supports this proposal and hopes that it will go forward smoothly. So we share that objective.

Next I would like to remind colleagues that the interest groups – the patient groups who are most likely to be affected by this measure and to benefit from it – strongly support the measure. I regularly see reports in the press of exciting new therapies and developments in this field, but usually they are in the USA and not in Europe, which is to our loss.

I would like to congratulate the rapporteur for his work, but I have to respectfully disagree with him with regard to the two amendments from the Committee on Legal Affairs which seemed to me, and to many on my committee, to be pushing in exactly the opposite, retrogressive direction to that of this proposal. So I join in supporting the compromise package which has been put forward, particularly by my distinguished colleague Mrs Roth-Behrendt, not least because independent observers tell me that this package is in line with the ITRE Committee’s position. So naturally I support it.

(Interjection from Mrs Breyer: ‘Are you speaking for the committee or on your own behalf?’)

I am speaking for the committee, Madam; I am speaking in my turn, and you should wait for yours.

I would like to remind everybody that the world around us is changing technologically, socially (although manners may not be changing), scientifically, and, as we can see in this report, biomedically. We must not deny the patients of the future the therapies of tomorrow.

 
  
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  Hiltrud Breyer (Verts/ALE), draftsman of the opinion of the Committee on Legal Affairs and the Internal Market. – (DE) Mr President, before I speak for the committee, I should like to point out an error to Commissioner Verheugen. I think it is improper that he should give the impression that those who tabled the compromise had made sure it would make rapid progress; the very opposite was the case, for it was those individuals who put forward the compromise who voted ‘no’ in the first vote in the committee.

Now, though, for what I have to say on behalf of the committee. The Rules of Procedure give the committee a most prominent role in the treatment of ethical issues, and I trust that everyone here accepts that – not just the Council and the Commission, but also many Members of this House, none of whom, I hope, are seeking to deny the members of the Committee on Legal Affairs their authority in matters of law. We have considered this report in very great depth and adopted a multitude of amendments, two of which in particular – I am referring to Amendments 3 and 17 – were referred directly to the plenary in accordance with the enhanced procedure and are extremely important.

The committee calls for the reference to embryonic stem cells to be deleted, but why? As you know, the Court of Justice’s interpretation of Article 95 is that a fully harmonised measure must not allow derogations for Member States, so, it being a matter of doubt as to whether the article would stand up to the Court’s scrutiny, the committee has therefore proposed a precise wording supplementary to Article 28; that alone makes for legal certainty and clarity and is, most important of all, capable of standing up in the European Court of Justice.

 
  
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  John Bowis, on behalf of the PPE-DE Group. – Mr President, as the Commissioner has said, it is an exciting time in medical research. We are on the verge of new breakthroughs, and the root for these is the development of advanced therapies, using gene and cell therapies and tissue engineering.

Gene therapy and somatic cell therapy products are already being clinically tested. Some of the tissue engineering products are already with us. This proposal is there to ensure that we deal with a complex issue in a sensible and universal way, through central authorisation so that we can pool scarce expertise at Community level, ensure the highest standards of patient safety across the EU and enable access to the European market and thus to all patients. That is what it is all about and on that basis, I welcome my honourable friend’s report and congratulate him on the work that he did, not only in bringing the report through our Committee on the Environment, Public Health and Food Safety but in the subsequent work he has done negotiating with the Presidency in the trialogue. We needed to look at various issues: the hospital issue, the small and medium enterprise issue, the medical devices issue. Of course, with this comes a number of ethical issues and those are important. However, my belief is that the EU’s job is to guarantee safety and efficacy, and Member States should take the ethical decisions.

I believe that is where we will conclude on this important measure. We now have to look very carefully at the options before us in the votes on Wednesday to make sure that we take something through which has the wholehearted support of this House.

 
  
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  Dagmar Roth-Behrendt, on behalf of the PSE Group. – (DE) Mr President, I shall say just two sentences about the substance of the matter in hand – with which all of us present here are familiar – and would then like to say something about the procedure.

Thousands of patients right across the European Union are waiting in desperation for new kinds of therapy that might alleviate their suffering or even save their lives. To all those who think certain categories of therapy have to be excluded, in whatever country and with whatever laws being in force, I say, once more, here and now, what I said in the committee, and yes, I do mean it: you are cynical, you are irresponsible, and you should be ashamed of yourselves; now take your ideas and put them to the patients – face to face. Mrs Breyer is not squeamish either, so you can say it to her as well.

I should now like to say something about the procedure.

I will do this in English so that Mr Mikolášik will understand me directly. Mr Mikolášik spoke about tabling amendments without the knowledge of the rapporteur. It is not necessarily usual that one clears it with the rapporteur, Mr Mikolášik. I would have loved to do that with you, but you stopped cooperating at an early stage in the trialogues.

I want to read out what we – Mrs Ries, Mr Adamou and others here – did, so that everybody is clear.

We tabled a package of 75 amendments. 32 are exactly identical to the amendments from the committee; 18 amendments are slight linguistic changes; 10 amendments are working on a compromise which you and I already agreed on before you stopped cooperating, and 15 amendments are linguistic or legal concerns. That is the situation we are in at the moment.

I now want to add something concerning what you said before on the interinstitutional agreement. I think we should just have a result as soon as possible. Mr Mikolášik, you also said that we should have a first-reading agreement. I agree, because thousands of people are waiting for it.

I am very grateful to the Commission and to the Council, who really supported us in reaching a result. From my point of view, they have come as close to Parliament’s positions as they could – going further than I have seen before and further than I expected them to go.

Naturally, Mr Mikolášik, we compromised, you compromised and I compromised. In fact I made a compromise as regards your group’s position on hospital exemptions and other things, because I thought, as some of you think, we should have a strong, safe regulation which makes sure that patients get the best scientific support and the best therapies in safe surroundings.

As regards the so-called ‘ethical’ amendments, yes, Member States who want to ban the use of foetal stem cells should be allowed to do so, and, Mrs Breyer, everybody who says that the Court of Justice would deny that and would put it under Article 95 is either not knowledgeable – which you are not – and then giving the wrong impression, I am afraid. If you read Article 30 of the Treaty, you are exactly sure that it says that public morality is always a reason to make sure that a Member State can ban something. And that is what happened in the past. That is what is happening at the moment in the European Union. We have always said that those Member States who allow research on it could continue.

However, the patients also deserve the right to have the safest, best products available, and that is why I tabled an amendment on subsidiarity, to make sure of that again. That amendment is in the package. It says that every Member State which thinks a product should not even be produced there, nor marketed, should be allowed to ban it. In other Member States, the patients should have the freedom to obtain it. That is what we are here for.

 
  
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  Frédérique Ries, on behalf of the ALDE Group.(FR) Mr President, Commissioner, Secretary of State, given that the rapporteur has already done so at length, I do not wish to launch into a detailed description of advanced therapies. I shall merely reiterate the point that this is an extremely promising area of research and medicine, offering real solutions for people with third-degree burns, patients suffering from venous ulcers, diabetes, hereditary diseases and cardiovascular diseases, offering hope, too, for Parkinson’s disease and Alzheimer’s disease, and offering a solution finally, one day perhaps, to the tragic shortage of organs, which results in the deaths each year in Europe of thousands of patients awaiting donations.

In other words, there are countless numbers of patients – millions of them – who are awaiting this regulation. It is not just patients who are awaiting it, but businesses in this sector, too, for, quite apart from the quality, safety and effectiveness of the products, quite apart from the need to make them accessible to everyone, without discrimination, the idea here, with this text, as the Commissioner pointed out, is also that we stimulate research and innovation. Well, on three occasions already, those seeking to impose on us their vision of ethics and morality – and the rapporteur is one of them – have delayed and are still delaying the adoption of this regulation: in committee, in the informal trialogue – as my fellow Member, Mrs Roth-Behrendt pointed out just now – and perhaps again on Wednesday, I fear, with a request for referral of the report.

At the heart of the controversy and the deadlock are medicines made from embryonic or foetal stem cells, which the rapporteur wants to exclude from the centralised procedure and thus leave outside the scope of this legislation. Things must be made clear, as clear as our Amendment 62, which is in the package, and validated by the legal services of the three institutions, I should also like to point out: the Member States and they alone will decide which research and which products will be available on their territory. Nothing will be imposed on them that contravenes their national legislation on ethical matters. That is indeed, I believe, the definition of subsidiarity, and those who intend, in the name of subsidiarity – it is quite a feat, after all – to ban these products throughout Europe and prevent countries that want them from making progress, puzzle me. For that reason, I formally reject Amendments 3 and 17 tabled by the Committee on Legal Affairs, together with the package of amendments endorsed by Mr Gargani and others.

Ladies and gentlemen, the choice is simple, after all. Our credibility is at stake here, as is, I would say in passing, the consistency of our work and of our decisions. I would remind you that, last June, we were authorising the funding of research into embryonic stem cells in the seventh framework programme for research. I urge you today to support this compromise package tabled by the Socialist Group in the European Parliament, the Group of the Alliance of Liberals and Democrats for Europe and the Confederal Group of the European United Left/European United Left. Something that has not yet been said is that this package also has the support of a number of MEPs from the Group of the European People’s Party (Christian Democrats) and European Democrats and, contrary to what was explained by the rapporteur, it is accepted by the Commission and by the Council. This package solves all of the technical issues; it is a compromise that makes it clear that it is not Europe’s role to legislate on ethics, because, ladies and gentlemen, if the next few years are to be characterised by all manner of revolutions, it is up to us to give meaning to them, and to offer hope, not destroy it.

 
  
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  Konrad Szymański, on behalf of the UEN Group. (PL) Mr President, despite the tremendous efforts made by Mr Mikolášik, the rapporteur, there may be significant weaknesses in our position on advanced therapies. If the ethical amendments package is not supported, adequate guarantees will not be provided for countries that do not wish to destroy human life for therapeutic purposes. Guarantees for human dignity may also be lacking. Human dignity is currently under threat from the commercialisation of the human body, interference with the individual’s genetic heritage and the possibility of creating animal-human hybrids.

Europe is right to set human rights standards for the world, even though this sometimes seems a hopeless task. The question arises as to why we adopt such a passive stance with regard to biotechnology and advanced therapies? We may be forced to give in twice. Without a clear ban on the commercialisation of the human body we risk being forced to give in to the market, which will handle trade in cells. Without a clear ban on interfering with an individual’s genetic heritage we risk being forced to give in to a cruel, eugenic and inhuman philosophy. Such a philosophy always gives precedence to the quality of life over its inalienable value and dignity. We should be ashamed that Asia is now setting standards for the European Union in this area. The legislation in question cannot be endorsed without the ethical amendments package.

 
  
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  Hiltrud Breyer, on behalf of the Verts/ALE Group. – (DE) Mr President, the vote, the day after tomorrow, will put to the test how seriously we take the Berlin Declaration, which had a lot to say about values, and of whether we are willing to express those values in European law, or whether they are only empty words and a waste of paper.

There are three principles that we see as indispensable. One is that the human body should not be exploited for commercial gain, and I have to tell Commissioner Verheugen that this is not laid down elsewhere; nowhere, in fact, is this principle laid down and made binding in law. I am amazed at the aggressiveness with which some seek to prevent it from being so.

Secondly, we do not want any interference in human beings’ genetic identity: we do not want tailor-made human beings. Not only is that laid down in the Charter of Fundamental Rights, but it is also present in the bio-patent directive. We do not want the choice of treatment to be determined by people’s wallets any more than we want, in the future, modifications of genetic material that would no longer be reversible.

Nor do we want monsters and hybrids; what we want is for these things to be quite explicitly banned. Were this House to unite against these three ethical principles, it would send a devastating message and would, indeed, in moral terms, represent a breach in the dam.

Since it is intolerable that naïve hopes and false promise of cures for conditions with which embryo therapies have next to nothing to do should be used as a means of sending this House down slippery ethical slopes, we must instead send out a clear signal for European values and ensure that …

(The President cut off the speaker)

 
  
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  Adamos Adamou, on behalf of the GUE/NGL Group.(EL) Mr President, Commissioner, I too should like to take my turn in emphasising that the purpose of this proposal is not to harmonise questions of ethics or morals; it is for the national competence of the Member States to be respected as regards whether or not sensitive products are used.

Such decisions must be taken on the basis of the principle of subsidiarity and must remain within the national competence of each Member State. The personal, moral and ethical views of each of us must not conflict with this approach, especially as each Member State will be responsible for deciding which type of products it will allow to be imported and which not. The crucial question is whether or not we agree that Europe should decide which products we shall market and which we must ban. My answer is no.

Let me now remind you of the package of amendments – Amendments 82 to 156 – which also reflects the six months of consultations and attempts to reach a compromise with the Council and the European Commission. Our objective is to reach a compromise at first reading, which is what is wanted by most of the associations of patients whose lives, in many cases, depend on a leading edge medicinal product. In short, the immediate application of the regulation would mean easier, faster and safer therapies for European patients. Europe needs this regulation and it needs it now.

 
  
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  Johannes Blokland, on behalf of the IND/DEM Group. (NL) Mr President, imagine someone who is in financial difficulty and who is racking their brains to find a way of making ends meet. They decide to sell tissue and cells of their body for payment in order to eke out a living. This situation is conceivable if we exclude the ban on the commercialisation of the human body from the scope of this regulation. I would argue in favour of backing the amendment in this respect, not least to remain in line with the Oviedo Treaty and the EU Charter of Fundamental Rights.

I am also extremely anxious about the technical scope in the area of medicinal products modifying the human germ line as well as those derived from human-animal hybrids, as these techniques greatly affect human dignity. Moreover, there are major differences in opinion among the various Member States. I therefore hope that we can keep these products outside the scope of this regulation out of continued respect for the dignity of the human body and for the choices of the individual Member States. We would, in my view, also reinforce the principle of subsidiarity by keeping these products outside of the regulation’s scope. Since the regulation's legal basis is Article 95, which deals with the internal market, it appears possible, as the proposal is worded at the moment, for legal entities to bring charges before the Court against a national ban on medicinal products that are authorised at European level and to win their case. This is something that must be avoided.

 
  
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  Françoise Grossetête (PPE-DE).(FR) Mr President, this evening we are debating a particularly important advance, which should enable future generations to benefit from high-technology medical treatments. European patients therefore need to be able to have access to these revolutionary products, on a non-discriminatory basis, because of the potential that they offer. It is also important to guarantee that these products are safe and effective.

The fact is that, without Community legislation, the situation varies from one country to another and is unfair for patients: some have access to products, when others have to go without. As you yourself said, Commissioner, in a situation such as this, there will be medical tourism. Therefore, if we are to overcome these obstacles, we need a clear, strict, framework encouraging investment and the growth of the biotech industry in Europe.

The technical section is therefore totally pointless in this context since, on account of subsidiarity, each Member State has the freedom to decide whether or not to ban this type of cell technology on its national market.

I particularly support the technical package that Mrs Roth-Behrendt has tabled in the form of amendments and that takes up all of the points of agreement that were reached during the various informal trialogues with the Council and the Commission. I truly hope that we vote in favour of this technical package because, by doing so, we will be able to reach an agreement at first reading and to fulfil patients’ expectations quicker.

I absolutely regret Amendments 3 and 17 tabled by the Committee on Legal Affairs. They simply prohibit any form of centralised authorisation for advanced therapy medicinal products derived from embryonic stem cells. I should like to point out that the aim of this text is to guarantee the safety of new therapies, while facilitating research and development and the authorisation of products derived from these advanced therapies. Amendments 3 and 17 put patients’ safety in real danger by excluding certain products from the very strict public heath requirements laid down by the regulation.

When patients’ safety is at stake, any form of discrimination is unacceptable. The implementation of a European technical framework, which patients and the industry have been awaiting for several years now, must not serve as a pretext for imposing any particular ideological point of view.

 
  
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  Proinsias De Rossa (PSE). – Mr President, I would like to thank those Members who participated in the detailed processing of this regulation. It is extremely important that issues as sensitive and complex as this are dealt with under the codecision procedure. It reassures our citizens, whose national parliaments cannot vary a regulation, to see their MEPs engaged in preparing balanced and effective legislation which seeks to enhance their lives.

The therapies which this regulation seeks to deal with have great potential for treating cancer, Alzheimer’s and Parkinson’s disease. Regrettably, and not unexpectedly, some reactionary elements are falsely claiming that this proposal overrides Member States’ rights on ethical issues. They want to exclude products derived from embryonic stem cells from the scope of this regulation. The effect of doing so would be to leave such products unregulated in many parts of Europe as regards their safety, quality and efficacy.

Contrary to these wild claims, the regulation does not circumscribe a Member State’s right to refuse to countenance embryo, stem-cell-based therapies. Indeed I would deplore such a ban by any Member State. This regulation is about saving life and about enhancing the quality of life, not its destruction – as is being claimed by some in this House tonight. We owe it to tens of thousands of patients and their families to do everything we can to encourage and make available the most advanced treatments for some of the most intractable illnesses facing our societies today. We also need to guarantee insofar as we can that they are safe and of the highest quality and that they actually work. This is what this regulation seeks to do.

I fully support the PSE Group’s position and call on all Members – and indeed I would particularly call on all my Irish colleagues – to support this regulation.

 
  
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  Marios Matsakis (ALDE). – Mr President, the regulation of tissue engineering products is both a necessity and an inevitability in the present era of rapid biotechnological advances. Such advances offer a potential cure for hitherto incurable diseases. But, as on many occasions in the past, one of the main obstacles to medical progress is not scientific limitations, but pseudo-ethical dogma born out of religious misunderstandings of God’s real wishes for mankind.

Such misconceptions have sadly changed very little since the Dark Ages’ comprehension of the physical world. Accordingly, in these legislative discussions, we have again heard heated ethical disagreements and calls for the prohibition of anything to do with human embryonic stem cells, hybrid chimeras and payment for human tissue. I ask you, colleagues, what is ethically wrong in using an animal ovary into which human genetic material is inserted in order to produce a certain human chemical and save someone’s life? What is ethically wrong with a unique human tissue being obtained from a donor in return for payment in order to use it in the treatment of a child’s cancer? After all, what is less ethical: to use embryonic stem cells or hybrid chimeras and to allow payment, or to let a child to die?

 
  
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  Urszula Krupa (IND/DEM). – (PL) (text missing) and advances in biotechnology and biomedicine lead to the development of therapies described as advanced, including gene therapy, somatic cell therapy and genetic engineering, all of which should aim at preventing disease and improving the state of human health. What has happened, however, is that experimental technology has been used to create animal-human hybrids and chimeras. It has also been applied in cloning and in experiments to change the genetic heritage of individuals. Techniques of this nature infringe ethical principles, and they are also problematic from a medical point of view. They can cause side effects as they have a negative impact on health and they lead to the commercialisation of the human body.

The situation is aggravated by the intense competition between medical and pharmaceutical concerns. It is not the first time this has led to the production of medicines or the use of D therapies with dramatic side effects.

Rejection of the amendments banning immoral practices reveals the irresponsibility of people who endanger the health and even the life of those they should be helping by condoning disregard for human dignity. At the same time, solutions at European level can be a way of forcing acceptance by those who do not agree with infringing moral principles. This amounts to a distortion of values and to putting the brakes on scientific research that complies with the principles of respect for human dignity.

 
  
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  Peter Liese (PPE-DE).(DE) Mr President, Commissioner, Mr President-in-Office of the Council, ladies and gentlemen, we should be clear in our own minds about the fact that all those who have given their attention to this regulation want to help patients; Mr Mikolášik is a doctor, and so am I. Even though we may take a different line on some amendments, you should not take that as indicating any opposition to helping the sick. Speaking personally, I do agree with Mr Mikolášik and with the amendments from the Committee on Legal Affairs and the Internal Market that have now been brought back in by Mr Gargani, Mr Morillon, Mrs Auken and others, which – and this is something you need to know, too – represent the position taken by the overwhelming majority of the Group of the European People’s Party (Christian Democrats) and European Democrats, as determined by a vote we took last Wednesday.

I would like to turn to a subject that has not featured in this debate so far, but is very important if we want to know how we can create the right conditions for the companies that want to help patients. There is at present a whole array of small and medium-sized enterprises that are already carrying out treatments in hospitals, whether the people treated are in-patients or outpatients. Quite some time ago, these firms came to me and told me that, if the regulation goes through unamended and without easier arrangements for small and medium-sized businesses under national licensing schemes, they would no longer be able to offer those services.

That, rather than this or that promise of miracle cures, is what we need to bear in mind – the real live businesses that are there today helping patients and who say that the proposal for a Commission regulation is not as good as it is made out to be. Nor does the so-called compromise package offer the small and medium-sized businesses a proper solution for their problem.

Amendment 127 provides for SMEs working in tandem with a hospital to be exempted from the requirement for a European license. SMEs working outside hospitals, though, and facing fewer risks, are obliged to go to London to get their licences, incurring many charges and having a complicated process to go through. As one Member of this House always says, there are times when consensus becomes nonsensical, and this is one of them, thanks to those who cobbled together this so-called compromise.

Commissioner Verheugen said that we are not talking about ethics. He went on to say that the principle that the human body must not become a commodity has been complied with. What now, then? Are we going to talk about it or are we not? If the principle has been taken into account, then a European regulation on the subject exists, and, that being so, we have to examine whether or not it is any good. Having been a rapporteur on this, I know that this House wanted more stringent regulation, but, back then, the Commission said no, citing the legal basis. The legal basis has now changed, and so you ought at the least to think up a proper justification, rather than simply saying that the matter has been taken care of.

We need this regulation; I am all for us getting it, and have been so for the past five years. For three of them, it was on ice in the Commission – not, admittedly, on Commissioner Verheugen’s watch, but the Commission does nevertheless bear responsibility for this three-year delay. Mrs Roth-Behrendt, Mrs Ries and others bear responsibility for another six months’ delay, having rejected the report back in September. Now you are giving us another month in which this House has to talk the matter through in proper parliamentary fashion.

(The President cut off the speaker)

 
  
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  Jorgo Chatzimarkakis (ALDE).(DE) Mr President, Commissioner, Mr President-in-Office of the Council, ladies and gentlemen, the regulation we are discussing today is indeed urgent and of particular importance, dealing as it does with advanced therapies, across-the-board quality standards, the more rapid availability of high-quality products, and, ultimately, the competitiveness of European businesses.

I therefore want to congratulate those Members who had a hand in putting together the compromises; that was the right thing to do, and it was done at the right time. I, too, find this or that part of it indigestible, particularly those that have to do with small and medium-sized enterprises, which the compromise package rather tends to disregard, but this is one of those times when we all have to make a superhuman effort for the sake of coherence, in order that we might achieve uniformity of regulation, and, not least with the Seventh Research Framework Programme in mind. To be sure, this does have to do with ethics, but it is also about the way in which different ethical standards collide and the challenge that that presents us with. At the end of the day, though, it is about people, and they should come first.

What we are fighting about is the prevention of suffering, and that is why I should like to congratulate the Presidency of the Council, for I know, Mr Schroeder, that you too have done the seemingly impossible, and that is why I find so much of the hysteria, indulged in by the Greens in particular, quite incomprehensible.

 
  
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  Kathy Sinnott (IND/DEM). – Mr President, last month the Ukrainian Prime Minister came to the European Parliament. In a discussion in committee, I asked him about the trade in human body parts, especially of infants before and after birth. The Prime Minister acknowledged this gruesome trade and called it painful. He reminded me that it also included embryos. He said the problem was not only Ukrainian sellers but also the wealthy international buyers

He asked for our help to end this form of human trafficking. Our help. Tomorrow’s vote will determine whether we have any help to give. If we uphold the ban on commercialisation and if we exclude human embryos from the scope of this directive, then we will be able to do something about the wealthy buyers within the EU. If, however, we give the green light to commercialisation and destruction of embryos, not only will we be unable to help Ukraine with the buyers who keep the trade alive, but we will also cause the same painful situation in the EU, whereby those who are desperate for money are exploited for their body parts to benefit those who are rich enough to pay for them.

 
  
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  Antonios Trakatellis (PPE-DE).(EL) Mr President, this regulation is needed and it is needed quickly, because medicine has advanced, progress is being made and there are also high hopes of innovative therapies.

I do not think that anything should be exempted. Everything must be included in this regulation and the reason is very simple and very practical: does anyone believe that, if in the European Union we ban the licensing of certain innovative therapies which have been approved elsewhere, the citizens of Europe will not go and find these therapies? I, of course, much prefer central licensing. The only thing that I personally am calling for at the moment – and I think that the regulation covers this – is a strict scientific evaluation of these innovative therapies and full safety. Apart from that, if we fragment and stop licensing by each Member State, just imagine what will happen in the European Union. We shall have Member States which will have allowed it and Member States which will not have allowed it.

Moreover, as many speakers said, no one is prohibiting any Member State from allowing or banning something which has been licensed. Consequently, I do not understand why there is all this debate, when the world is waiting for new therapies, when there are chronic illnesses and when patients' hopes are very high. I do not think that we should be the obstacle to a future cure for Parkinson's disease, diabetes, certain types of cancer and so on.

I therefore think that we should go ahead and vote for the regulation, as tabled by the Committee on the Environment, Public Health and Food Safety and, of course, I am against the two amendments by the Committee on Legal Affairs.

 
  
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  Péter Olajos (PPE-DE). (HU) Every time we begin talking about advanced therapy medicinal products, stem cell or embryonic cell therapies, or embryo research or organ transplantation, vehement debate inevitably ensues. Our points of view differ widely, regardless of age, sex, nationality or political convictions, a sure sign of the complexity of the question.

It is no small undertaking to have decided to draw up a piece of legislation that seeks to provide a unified regulation of this border area between ethics and science. For these therapies and medicines increasingly represent life and death. By using, or by not using them, either way we are making decisions about human lives. Advanced therapy means life for many thousands of European citizens. It is the last ray of hope offering the prospect of a healthier, fuller life.

In the developing world, however, it can mean death, since the illegal trade in organs is already causing the maiming and death of thousands of people. At the same time, our goal cannot be to stop the development of technology. What can, however, be our goal is to find answers to the moral and ethical questions raised by technical advances. We need the current legislation to point the way, to help ensure that technical development means an affirmation of life. This is not a question of the struggle between good and evil, but of what is technically possible and yet ethically permissible.

I owe Mr Mikolašik and my other colleagues gratitude for the fine compromise they have prepared, and trust that the legislation to be brought into effect by our votes will be on the side of life.

 
  
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  John Purvis (PPE-DE). – Mr President, there are many European families with members suffering from serious diseases. There are also many medical researchers and therapists with the means to help those patients, and they are all waiting for this important piece of legislation. It will provide the common legislative framework which will make these innovative therapies more readily, more widely and more safely available. It is urgently required, it will be of great benefit and there is no reason for delaying its implementation by loading it with unnecessary ethical provisos and carve-outs that are impossible to agree with the Council.

It has been firmly established that ethical restrictions are properly within the power of individual Member States if they wish to limit or forbid. Subsidiarity is the essential rule. But there is every reason to have a European standard for regulating the safe use of such therapies where they are used. So I ask my colleagues, and particularly my good friend the rapporteur, to let this vitally important piece of legislation proceed this week, so that agreement with the Council can be reached.

Many of our less fortunate fellow Europeans will thank us when this legislation comes into effect, but they will have great difficulty understanding if it is further delayed, emasculated or stopped altogether by this Parliament. This is one of those occasions when it is really important for us to exercise our powers carefully and responsibly and let this matter be finalised.

 
  
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  Carlo Casini (PPE-DE).(IT) Mr President, ladies and gentlemen, I can say that I agree with the rapporteur and therefore am also in favour of the two points included in Amendments 3 and 17, in line with the opinion of the Committee on Legal Affairs, as well as all the amendments proposed by that committee.

Someone said that they did not understand why this debate was so heated. It is heated because it has to answer two important questions. The first one is, 'Does the end justify the means?' I recall that in Article 2 of the Oviedo Convention on bioethics we wrote that the interests and welfare of the human being shall prevail over the sole interest of society or science. The first question is therefore as follows: ‘In view of the fact that science is capable of crossing new boundaries, should we always do what science tells us? Does the fact that something can be done make it right, or is there an ethical rule to say whether it is right?’

The second question is as follows: ‘The human being takes precedence, but what is a human being?’ We can no longer ignore this question, which is of momentous, planetary importance, because the whole human rights doctrine, from which everyone claims to draw inspiration, turns on this one point: ‘What is a human being?’ When we talk about embryos, we need to answer the question of whether an embryo is a human being or not. This is not merely an ethical question, but rather a legal and political one, even more than it is an ethical one. It is not a quibble, either, but a serious question, and it should at least make us hesitate for a moment when we come to vote.

Since we have already decided that the Member States can do as they see fit, I do not see why a different view of things should be imposed on them through a European regulation. At any rate, I hope my speech will make my fellow Members think carefully about a complex issue that involves human beings – not just those human beings who are hoping for new kinds of treatment, but also those whose bodies and very lives might be sacrificed for the sake of others.

 
  
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  Bogusław Sonik (PPE-DE). – (PL) Mr President, essentially, the draft we are debating concerns the introduction of a centralised procedure whereby the European Agency for the Evaluation of Medicinal Products could issue authorisation for the marketing of advanced therapy medicinal products. The European Commission also wishes to ensure financial support for the firms manufacturing these products.

These proposals are worthy of support, or rather, they would be worthy of support if it were not for the fact that products that could be developed using controversial technologies have been included amongst advanced therapy products. I refer to products created using human embryos, or developed from animal-human hybrids or chimeras, and also to pharmaceuticals that change the genetic heritage of human beings.

Several European Union Member States such as Germany do not allow products developed using unethical methods onto their markets. The Commission’s proposal contains an exclusion which would allow these states to opt out of the principle of a common market in the case of these controversial products. It is now being stated that there is a legal error affecting both the draft currently under debate and the 2001 directive. Supporters of that view argue that pursuant to Article 95 of the Treaty, which aims at full harmonisation of the market, citing it as a legal basis for a draft regulation on advanced therapy products implies creating an open European market for these products.

The European Parliament therefore found itself in a situation in which it had to choose between going along with the European Commission’s draft or exercising caution and not condoning controversial experiments. Members of Parliament’s Committee on Legal Affairs were opposed to the idea of including unethical products in the regulation, arguing that regardless of Member States’ rights and despite rapid progress in certain areas no compromises concerning human rights can be permitted. They maintained that the principles banning the use of the human body for commercial purposes must be upheld, and that creating animal-human hybrids or chimeras amounts to an infringement of the principle of human integrity and an affront to human dignity.

 
  
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  Klaus Theo Schröder, President-in-Office of the Council. (DE) Mr President, honourable Members, you will, on Wednesday, be voting on the regulation on medicinal products for advanced therapies, which has since early 2006 been promoted initially by the Austrian Presidency of the Council and then by its Finnish counterparts, and we have, since the beginning of this year, done everything in our power to bring about agreement without delay. The regulation aims, in the highly-innovative and extremely important area of medicine production, to protect all the patients who need those medical products, and to do so by means of quality standards that are uniform across Europe. The need for high-quality products for everyone in Europe means that it is true to say, as some of you have, that what is on the agenda today is in fact life itself, improved quality of life and the chance of new life. What is also on the agenda, and not least in importance, is the competitiveness of the European biotechnology sector.

In negotiations on the regulation in the Council working party, aimed not least at achieving agreement with your House, it has proved possible, over recent weeks, to make decisive progress, and it is on these negotiations, which take into consideration a very large number of amendments drafted by experts and submitted by the lead committees, that the prospects for a good compromise, and also a rapid agreement between the Council and Parliament, depended, and still do depend; as the negotiations currently stand, agreement is possible on the basis of that which is to be the subject of Wednesday’s vote. The rapporteur has submitted a parcel of amendments, and the Socialist Group in the European Parliament, the Group of the Alliance of Liberals and Democrats for Europe, and the Group of the European United Left have drafted their own sets of them. Both packages draw to the fullest possible extent on the debate in the Committee on the Environment, Public Health and Food Safety and on the amendments drafted by it, and are therefore close to one another, although it is clear that it is the package produced by the shadow rapporteurs of the named groups on which agreement is possible at Council level.

However great our differences in debate, it strikes me as essential that it be stressed that what this is all, primarily, about is the quality and safety of these new and advanced therapeutic products. Clear though it is that ethical considerations have a part to play in these deliberations, there has, ever since the cells and tissues directive was resolved upon, been agreement to the effect that we in Europe see ethics as subject to subsidiarity and hence as something for which the Member States bear responsibility, and it is for this reason that two ethically-motivated amendments proposed by your House’s Committee on Legal Affairs could not be agreed to by the Council working party and would represent a definite obstacle to agreement between the Council and your House. The German Presidency strongly asks you to bear this in mind when the time comes for you to vote.

Application of the subsidiarity principle ensures that national legislation – and I would draw Mrs Breyer’s attention to the example of stem cells – is not touched by the regulation. It is not we who have stated that, but rather the Committee on Legal Affairs of your own House that has made that clear, so that, for example, my own country’s legislation on stem cells is not affected, while, on the other hand, the regulation gives all the others the highest possible degree of certainty.

Certain among you have – and quite rightly – had comments to make on the ethical framework, with warnings as to what might come to pass. I certainly share your misgivings, and I am quite sure that the Member States are taking them into account already; moreover, I know of no doctors in this Europe of ours who would do the things that some of you have so graphically described today. In view of the importance of the document you have to vote on, which touches upon the future of many patients in this Europe of ours, the German Presidency has a great interest in concluding this legislative process as successfully and speedily as possible. We have a great opportunity to show the public how we are, in a very important field, capable of being very purposeful and consistent in working towards adding European value, and our sense of ethical responsibility leaves us no alternative to a rapid and necessary decision that will be a basis for quality products of high value.

We therefore strongly urge you, whatever misgivings some of you may have, to perhaps put these to the backs of your minds in view of the vital and higher objective of getting this regulation in place without delay. For that, we – and in that I include the citizens of Europe and the patients – would owe you the utmost gratitude.

 
  
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  Günter Verheugen, Vice-President of the Commission. (DE) Mr President, honourable Members, if, if in a community of twenty-seven states, there is no consensus on an ethical issue – such as is the case in this instance – then the only way in which civilised people can deal with this state of affairs is with tolerance and respect, for we have to tolerate and respect the views of others.

I might add that it is also a fact of life for all of us that, while we do well to pay attention to what our consciences tell us, we cannot make that a yardstick for the conduct of others. On this issue, for example, my conscience tells me that I could not take upon myself the responsibility not only for leaving this new medical sector in a legal no-man’s land, but also for putting it in a situation in which – in certain parts of Europe at any rate – everything would be possible, with no legal bounds set and no stipulations as to quality. That, then, is why my conscience tells me that we need this regulation.

My conscience also tells me that I could not take upon myself the responsibility for saying, to a sick person at death’s door, ‘here is a medicine that could help you, but there were some ideological objections to it, and so we are not allowed to use it.’ My conscience tells me that I do not have the right to do that, and that is why I say to you that the only way in which we can handle this issue is to do as is suggested here, that is to say, to allow those with ethical objections to act accordingly and to allow those without them to do whatever they want to do within the bounds of that which will be permitted by the regulation, which – heaven knows – will not allow everything.

Let me now say something about some of the arguments that have been adduced today. As regards the principle that the human body should not be exploited for commercial gain, I would say, yes, that is indispensable, and you will find nobody who is more in agreement with that than I am. This principle is already firmly enshrined in the directive on human tissues and cells. The anonymity of donors and recipients, and the altruism of donors, are European principles that must be adhered to, and that is certainly true in this context and is something about which nobody can be in any doubt.

It has been said that the Commission proposal is ambiguous, that it is, so to speak, not watertight when it comes to the issue of national prohibitions and their remaining in place, but the representative of the Presidency has already given the answer that needed to be given to that, and all I can do is confirm it. The changes needed in order to take account of the objections raised by your House’s legal service are contained in the compromise package, which, as I have already said, the Commission supports, and I want to repeat what Mr Schroeder said, namely that your House’s legal service has explicitly stated that these amendments resolve the problem, and that it welcomes that.

I would like to make it plain that it is a misreading of the Treaty to say that Article 95 – the internal market article, that is – would not guarantee that no products would be licensed that a Member State did not want to see licensed. On this point, the internal market rules are as clear as daylight: every Member State has, at all times, the right to refuse to allow a specific product onto its market on ethical grounds or by reason of public morals; about that there is no doubt. Since we can be certain about the case law, about its practical implications, and about the legal basis afforded by the Treaty on European Union, you really do not have anything to worry about on this score.

Finally, the technical package has been described as inadequate, and to that I have to say that the Council and the Commission really have been extremely willing to make compromises in order to get this dossier wrapped up early. We did indeed accept the great majority of your House’s amendments, particularly as regards small and medium-sized enterprises, in the form, for example, of reductions in charges and derogations from central licensing; all that is in there. That which is in this proposal for legislation goes well beyond what we did earlier, for the Commission has already enacted its own regulation allowing small and medium-sized businesses going through the approval process a reduction in costs of up to 90%, and here too, or so I believe, everything that could be done has been.

So, then, let me ask you again to consider whether it is not indeed really high time that this debate were brought to a proper end, with a good outcome for those researching in this field, because they want to help people, and a good outcome for those who depend on these medicines for dear life.

(Applause)

 
  
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  President. The debate is closed.

The vote will take place on Wednesday at 12 noon.

Written statement (Article 142)

 
  
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  Zita Pleštinská (PPE-DE), in writing. – (SK) We live today in a world of incredible technical progress. But despite the advances that medicine has made, modern diseases still inspire fear. The use of progressive treatments, including gene- and cell-based therapies as well as tissue engineering, are innovative developments that give great hope to patients.

There is no doubt about the huge potential of advanced medical therapies when it comes to providing revolutionary cures for serious conditions such as cancer, Parkinson’s disease and skin burns, and therefore I welcome the regulation of the European Commission aimed at harmonising procedures in this field across the EU, and ensuring that sufferers have safe cures for these serious ailments.

The elimination of barriers on the European market will give patients greater access to existing cures through the Europe-wide licensing of these products.

However, in order to maintain the underlying principles of the internal market and in the interest of its proper functioning, as well as to secure the legal bases, this regulation should apply only to cell-based products that may in the near future be actually introduced on the market and which do not arouse controversy.

For this reason it is quite unacceptable to ignore the position of the Committee on Legal Affairs, which is the main body responsible for ethical issues in new technologies in the European Parliament.

Finally I would like to congratulate rapporteur Mikolášik and thank him for his principled position on ethical matters and for his personal integrity based on the Oviedo Agreement and the Charter of Fundamental Rights.

 
Last updated: 6 July 2007Legal notice