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Procedure : 2008/0218(CNS)
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PV 23/04/2009 - 5
CRE 23/04/2009 - 5

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PV 23/04/2009 - 8.14
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Verbatim report of proceedings
Thursday, 23 April 2009 - Strasbourg OJ edition

5. Rare diseases (debate)
Video of the speeches

  President. – The next item is the report (A6-0231/2009) by Mr Trakatellis, on behalf of the Committee on the Environment, Public Health and Food Safety, on the proposal for a Council recommendation on a European action in the field of rare diseases (COM(2008)0726 – C6-0455/2008 – 2008/0218(CNS)).


  Antonios Trakatellis, rapporteur. (EL) Mr President, this Council recommendation is very timely, because concerted action in the field of rare diseases is an absolute necessity, both at European Union level and at national level.

Although the incidence for each rare disease is very low, millions of people are affected in the European Union because these diseases are measured in thousands. However, the proposal as received by Parliament was insufficient in its current state and it was not possible to produce a viable programme out of it. This is because it does not describe, at least in general terms, both the necessary funding by the European Union and the cofinancing by Member States or other organisations.

Thus it is not possible to promote certain essential aspects on rare diseases, namely the creation of networks of centres of expertise, cataloguing of diseases, collection of data, the special research required and so forth. The text asks for an implementation proposal from the Commission five years after the adoption, which is a long period during which nothing can be done in practice as there is no funding provided.

Therefore, as rapporteur, I propose that the Commission be asked to provide the implementation proposal at the latest by the end of 2012, since by this date the required data from Member States on expert centres and expertise on rare diseases will be at hand.

In this implementation proposal, specific mention should be made for funding and cofinancing in the following areas:

Firstly, the collection of epidemiological data and compiling a catalogue of rare diseases, as this is necessary in order to have a clear picture of the field of these diseases in the European Union.

Secondly, the formation of relevant networks.

Thirdly, the creation, in addition to existing expert centres, of new centres in Member States which lack such centres, the creation of special training courses in the existing centres for professionals to acquire the necessary expertise, the mobilisation of experts and professionals in order to create the necessary conditions for advancing existing knowledge and for research on diagnostic tools and tests on rare diseases and especially on genetic ones.

We should be viewing this Council recommendation as a roadmap to create helpful conditions in the field of rare diseases. We should also understand that it is of a general nature, but I would like to stress once more that, in order to be efficiently and successfully applied, the proposal needs to be more precise and to make provision for a specific timetable and funding.

An important aspect in combating rare diseases is patient mobility. This has already been examined in the Bowis report and I believe that patient mobility is absolutely justified here, because there are no special centres or experts able to undertake the treatment of patients in all the Member States. Consequently, it is absolutely vital here to make provision for patient mobility and for mobility of professionals, so that some can obtain expertise and others can pass on their experience.

Finally, I should say that, for rare genetic diseases, research and innovation are absolutely necessary in order to increase the number of diagnostic tests.

Most of the report concerns treatment, diagnosis, the acquisition of expertise and the creation of centres and networks. One point also concerns prevention. Prevention of genetic diseases is possible nowadays through a combination of in vitro fertilisation and pre-implantation tests. Because it is a recommendation, it is not binding on the Member States. The report states that it will only be carried out in the Member States whose legislation so allows and by the free will and choice of the persons who wish to follow this genetic advice and, therefore, I do not see that it clashes with the principle of subsidiarity as regards existing data.


  Daniela Filipiová , President-in-Office of the Council. – (CS) Commissioner, ladies and gentlemen, rare diseases are dangerous and very complex diseases that threaten life or cause chronic invalidity. Despite their low prevalence the number of patients in the EU with these diseases is relatively high, and joint action is therefore necessary at an EU level. These are also reasons why the area of rare diseases is an EU health strategy priority.

The Czech Presidency believes that after the Council adopts the draft proposal on European action in the area of rare diseases there will be significant advances and improvements in the diagnosis of rare diseases, which is currently problematic due to the nature of rare diseases. Conditions will also improve for a much-needed sharing of expertise and experience in this area.

Due also to these reasons the Czech Presidency has taken an active approach in negotiating the draft, carrying forward the work of the French Presidency and the discussions at the EPSCO Council in December 2008.

I believe that the European Parliament and the Council share similar views on this matter. The initiative is necessary as it should improve the current situation for millions of patients suffering from these diseases and it should lead to an improvement in their chances of receiving adequate care and comprehensible information.

This should be achieved, for example, through the creation of common definitions of rare diseases, further development of EU activities based on the Orphanet network, coordination of European research including cooperation with third countries, the creation and support of centres of expertise and the development of European reference networks for rare diseases. The Council also recognises the key role played by independent patients’ organisations in developing and implementing national policies in the area of rare diseases.

The Czech Presidency is at present completing negotiations on the draft proposal in the working bodies of the Council and it will try to get it accepted by the EPSCO Council in June this year. However, due to the importance of this issue the Council has decided to consult the European Parliament also in this case, and it will carefully consider Parliament’s opinion.

I would like to end by once again thanking everyone who took part in preparing the European Parliament report and particularly the rapporteur Antonios Trakatellis for drawing it up.


  Androulla Vassiliou, Member of the Commission. (EL) Mr President, I should like to thank all the honourable Members who were involved in the work by Parliament on the proposal for a Council recommendation in the field of rare diseases.

I should like, in particular, to thank the rapporteur, Rector Antonios Trakatellis, for coordinating the discussions and, of course, for his report.

Rare diseases, which individually affect a very small number of people and the majority of which are genetic diseases, can lead to death or chronic disability. However, even though the incidence of each individual rare disease may be very low, as a whole these diseases affect approximately 6% of the total population of the European Union in some aspect of their lives.

This means that, in the European Union, between 29 and 36 million people are affected or are likely to be affected by a rare disease. However, because each disease is rare, it is impossible for each Member State to have the expertise needed to diagnose it and treat the patients. This is therefore an excellent example in the health sector where Europe can add particular value, which is why the Commission has approved the strategic action.

The European strategy is supplemented by the proposal for a Council recommendation on action within the Member States. The aim of this draft recommendation is to help Member States deal with rare diseases more effectively, more efficiently and more globally. One important sector for action is in collecting expertise via the European reference networks. These networks can add value to action by the Member States on rare diseases and in other cases. They can also facilitate the exchange of know-how and expertise and, where necessary, direct patients as to where they should go when this expertise cannot reach them.

The Commission’s proposal for a directive on patients’ rights to cross-border healthcare includes special provisions to support patient mobility and provide a legal framework for the European reference networks.

There are still many ways in which European action can support the Member States in combating rare diseases, such as by improved identification and recognition of diseases, by supporting research into rare diseases and with mechanisms such as regulation of orphan medicinal products.

My thanks therefore to Parliament for its support on the broad spectrum of issues covered by this report. I await your debate with a great deal of interest.


  Françoise Grossetête, draftsman of the opinion of the Committee on Industry, Research and Energy.(FR) Mr President, patients affected by rare diseases suffer misdiagnoses and, often, receive no treatment.

The rarity of these diseases creates challenges both from a scientific and an economic viewpoint. Now, having been the rapporteur on the regulation on orphan medicinal products, ten years ago, I know how these patients are too few to be a local or regional issue and how, on the other hand, the diseases are too numerous to be taught to health professionals. Expertise is therefore rare.

The response, of necessity, involves Europe, and our Committee on Industry, Research and Energy supports Mr Trakatellis in his desire to strengthen research and prevention. How can we deny, for example, a couple whose two children are affected by cystic fibrosis and who wish to have a third child, advances in research to prevent the latter being affected by the same disease? This is why patients need more coordination, more safety and more clarity. These are essential issues that meet Europe’s citizens’ expectations of a Europe for health.


  Peter Liese, on behalf of the PPE-DE Group. – (DE) Mr President, Commissioner, helping patients who suffer from rare diseases has long been a major concern of the European Parliament. Patients who suffer from rare diseases – this has been said – need European support. National efforts in this area do not suffice. Because these diseases are so rare, there are not centres and experts for them in every Member State. For research – and this is a very important point – you need a certain number of patients for the disease to be researched at all and for it to be possible to develop new therapies. The same applies to the development of new drugs. Mrs Grossetête talked of the Regulation on orphan medicinal products, which is very important.

The Commission’s initiative, Commissioner, is also very important. We in the Group of the European People’s Party (Christian Democrats) and European Democrats support you wholeheartedly on this and we also support the many improvements that have been made by Mr Trakatellis in this report. I have to say, however, on behalf of my group, that there is one amendment in Mr Trakatellis’s report that goes against this fundamental aim of helping patients.

Amendment 15 talks of how genetic diseases should be avoided and eradicated through measures such as genetic counselling and the selection of embryos. This wording has shocked many people, and not only the ethics experts and the representatives of disabled groups, but scientists, too. The European Society of Human Genetics is calling on us to reject Amendment 15. They are making comparisons with the eugenics of the first half of the last century.

Politics should not exert pressure. Genetic counselling, likewise, should not be dominated by a political goal. We should therefore reject Amendment 15. We should vote in favour of this report – provided that Amendment 15 is rejected – as it is a sound report. Otherwise, it will be highly problematic. We should be helping people with rare diseases, not giving them the feeling that they are actually surplus to requirements.


  Dorette Corbey, on behalf of the PSE Group. – (NL) I am grateful to Mr Trakatellis for his fine report. If there is one area where cooperation in Europe is useful and provides added value, it is certainly the area of rare diseases. In the case of rare metabolic diseases, muscular diseases and also rare forms of cancer, it is practical and useful to work together in order to exchange information on treatment techniques and to join forces. These are all very important. The information must also be made accessible, and the Trakatellis report provides for all these matters.

I would like to draw your attention to three matters. First, patients must have a voice in Europe. In recent years we have seen increasingly well organised patient groups that also know their way around Europe, around Brussels. That is all very important and informative for politicians, for many of these rare diseases are, logically, largely unknown. It is good, therefore, to determine how these patient organisations are financed, and it is extremely important to ensure that these organisations are financed independently and are not solely dependent on the pharmaceutical industry. That is why I am arguing in favour of financing for these patient organisations.

Secondly, the development of medicines for rare diseases, the so-called orphan medicinal products, is of crucial importance. That is why we have directives, but it would be good to devote some attention to seeing whether this is actually working well.

Thirdly, this is a controversial subject that has also been tackled by Mr Liese. Many rare diseases are hereditary. Research and embryo selection can prevent much suffering, but it is important that the Member States retain the power to decide as to the eventual treatments such as pre-implementation and embryo selection. We support Amendment 15, but we wish to delete the reference to the eradication of illnesses. That term summons up very unpleasant associations, as Mr Liese has already said. We also consider it important for the treatments to be voluntary and that they should take place within the boundaries established by national governments. If these conditions are met, we are in favour of the amendment and call on everyone to support it, but the reference to the eradication of illnesses should be deleted. Under these conditions, we can agree fully with the report and are enthusiastic about the work of Mr Trakatellis. Thank you for your attention.


  Frédérique Ries, on behalf of the ALDE Group.(FR) Mr President, I would like to thank our rapporteur, Mr Trakatellis, and to apologise for my late arrival in this debate, whilst welcoming the group of visitors, who are the reason for my slightly late arrival.

During a hearing on rare diseases that I organised in Parliament last year with Eurordis – the European patients’ association – I pointed out that it was up to us, that it was up to Europe, to place the bar very high for these patients who are pinning all their hopes on research, and this is what our rapporteur has done here by considerably enhancing the Commission’s text.

The small number of patients involved in each country and the fragmentation of knowledge across the Union make rare diseases the example par excellence for which concerted action at European level is an absolute necessity. Our unanimous desire is to have better knowledge of these diseases, to improve their diagnosis and their treatment and to give better care to patients and their families.

There remain, of course, the questions of the timetable and funding. Various options are available, and we are exploring them. Besides the funds granted by the European Union or by the States, it is also useful to find other sources of funding. One option that is working well in many Member States is public-private partnership.

I would be annoyed with myself if I did not mention here the considerable financial support also provided by citizens’ actions: the Téléthon in France and Télévie in French-speaking Belgium. The latter has allowed no more and no less than a doubling of the budget for scientific research – a miserly budget, I might say in passing: EUR 13 per year per citizen, compared with EUR 50 in France and EUR 57 in Germany, to take but two examples.

I shall conclude, Mr President. Millions of patients in Europe are watching us. The will is there. It is up to us to ensure that this is more than just a catalogue of good intentions. Just one more thing: the Group of the Alliance of Liberals and Democrats for Europe supports Amendment 15.


  Hiltrud Breyer, on behalf of the Verts/ALE Group. – (DE) Mr President, ladies and gentlemen, it goes without saying that we support helping people with rare diseases. That said, Amendment 15 is completely unacceptable from an ethical point of view.

There must never again be a debate in Europe about whose life is worth living and whose not. There must be no political and social pressure on parents in Europe to consciously decide against having a disabled child. The selection of embryos would represent an opening of the ethical floodgates. For that reason we must reject this amendment. It is not enough just to remove the word ‘eradicate’, which is actually, it is sad to say, in line with fascist language use. Doing so would mean that we would still be faced with the selection of embryos. It would be insufferable if this amendment and its idea of selecting embryos were to become a stepping stone to a new ethics in Europe.

We must stand up resolutely against genetic discrimination. Amendment 15 must therefore be rejected in its entirety. Otherwise, our group will, unfortunately, be forced to come out against this report even though the rest of it is highly positive.


  Philip Claeys (NI). (NL) The Trakatellis report refers to a number of shortcomings in the Council’s recommendations, and these observations are, in my opinion, correct. I, too, am convinced, by the way, that a coordinated approach by the European Union in the area of rare diseases is necessary. Yet neither the recommendation nor the report mentions the aspect of rare diseases that are coming in from the developing world.

Thus, for instance, we are seeing the return of tuberculosis, a disease that, until recently, had completely, or nearly completely disappeared from Europe and that is now being imported again through mass migration. Here, too, therefore, urgent action is needed in the form of specifying risk areas, exchanging information, conducting spot checks where the Community’s external borders are crossed, etc. It is naturally of the greatest importance that public health policy should be given primacy over political correctness.


  Christa Klaß (PPE-DE).(DE) Mr President, Commissioner, ladies and gentlemen, we are aiming to work together to attain the best conditions for the provision of health care in Europe. Especially in rural areas of the European Union close to national borders – such as my home in the greater cross-border region between Germany, Belgium, Luxembourg and France – the advancement of patient mobility, which we were just debating, is a particularly important building block for improving the provision of health care and making it more efficient. In everything we do, however, we must adhere to and retain the ethical standards of the Member States. This applies to DNA analysis just as it does to artificial insemination, and it also applies to rare diseases, the subject of Mr Trakatellis’s report. Rare diseases need a stronger political framework in order to improve research and treatment, as companies prefer to invest in large markets.

In fighting for people’s health we must not seek to eradicate rare diseases by, for example, selecting embryos. The matter at hand here, after all, is healing people. This one element represents a complete wrong turn for a report that otherwise takes a sound approach, and it is a turn that is morally perilous. In Amendment 15, it is not healing that is the focus, but selection. Who is to decide which life is worth living? Do we believe that prevention means preventing life? I do not think so. In my own country, and many other Member States besides, pre-implantation diagnosis is prohibited, and for good reason. That official European documents can use terms such as eradication and the selection of healthy embryos unabashedly is something that I find shocking and contrary to our stated goal of the acknowledgement and integration of those with disabilities and diseases into our society.

I ask you all to vote against Amendment 15 as a matter of imperative importance so that what is otherwise such a sound report by Mr Trakatellis will also be able to obtain a good majority.


  Siiri Oviir (ALDE).(ET) I find that coordinated actions at the level of the European Union and the Member States in the area of rare diseases are absolutely crucial. I support the rapporteur’s position that this recommendation by the Council and the plan of action in its present form are insufficient, and that it is not possible to create a functioning programme in the European Union on that basis. There are no specific recommendations and definite deadlines for implementation.

It will definitely not be possible to achieve a breakthrough in this area without efforts and funding from the European Union and Member States. I believe that rare diseases must undoubtedly receive special attention, and we must consider the specific needs of those several million citizens, to make it possible to guarantee them a dignified life in future. I do not concur with the claim by the previous speaker, Mr Claeys, that tuberculosis comes into Member States from third countries. I do not agree with that. Tuberculosis comes from poverty and homelessness, and in Member States with lower standards of living this disease is common today.


  Daniela Filipiová, President-in-Office of the Council. – (CS) Ladies and gentlemen, I would like to thank all MEPs for their comments, suggestions and observations. I was delighted to hear that in principle the opinions of the European Parliament and Council coincide over this issue. Of course, I cannot but agree with the rapporteur Mr Trakatellis’s assertion that the draft applies to diseases which may be rare but which afflict thousands of people. I think it is important to say that in this area better coordination and cooperation between the Member States can deliver benefits for patients due to the specialised centres where financial benefits may accrue through the economies of scale that Commissioner Vassiliou has just been talking about. The Council will of course carefully consider all amendment proposals from the European Parliament and based on this will assess their inclusion in the final version of the draft proposal.


  Androulla Vassiliou, Member of the Commission. (EL) Mr President, ladies and gentlemen, today’s debate demonstrated the high level of interest in this important sector of public health.

European action in the field of rare diseases is an issue which has obtained general consent in all the institutions and I am grateful for Parliament’s support for this initiative.

Rare diseases are incontrovertibly recognised as a public health sector to which 27 different national approaches would be inadequate and inefficient. This recommendation will allow us to address the particular problems associated with rare diseases and to try to improve the lives of people affected by them. In addition to the patients themselves, this action will also affect their relatives and friends.

We shall achieve this in large part by recommending to the Member States that they develop plans and strategies on rare diseases and by creating European reference networks.

As regards Rector Trakatellis’s proposal that we prepare and present a report on the results of the recommendation by the end of 2012, we have no objection and shall bear it in mind.

Allow me now to turn to two or three references which were made by the honourable Members. First of all let me refer to Amendment 15 and to say that I wish to stress that ethical issues are outside the competence of the EU. This is particularly the case in this instance, due to legal differences in the Member States with regard to screening and the ethical choices that have to be made on the basis of that information.

There was reference to the need for funding. Funding for the treatment of rare diseases is for Member States to consider. The Commission hopes that these proposals will help to support the importance of such investment, as well as helping to make best possible use of the funds that are available through European cooperation.

Regarding additional Community funding, the limits on the current health programme are due to the overall financial perspective set by Parliament and the Council. If Parliament feels that more Community funding is needed for rare diseases, then Parliament must address these through the budgetary procedures.

Reference was made also by Mrs Corbey on the help we need to give patients’ groups. The Commission agrees with the importance of patients’ groups. We work closely with them and in particular with Eurordis. I recently hosted the launch of a book providing 12 000 patients’ testimonials. That engagement of citizens is a vital part of work in this area.

(EL) Mr President, I should like to close by pointing out that, with improved access for patients to specialist healthcare, with support for research and development of effective treatment and with cross-border cooperation, we hope that patients will find the specialists they need more easily.


  Antonios Trakatellis, rapporteur. (EL) Mr President, I am most grateful to my fellow Members for their comments, to the Council for its comments and to Commissioner Vassiliou for her speech. She demonstrated that she is very open-minded and prepared at least to adopt the amendment in which we call on the Commission to table a proposal by the end of 2012, so that we can proceed quickly in the field of rare diseases in Europe.


  President. − The debate is closed.

The vote will take place in a few minutes.

Written statements (Rule 142)


  Carlo Casini (PPE-DE) , in writing. – (IT) The prevention and treatment of any disease, including rare diseases, requires the utmost commitment of the public institutions, but treatment and prevention cannot come at the extremely high cost of sacrificing the life of any human beings, even if for the benefit of others. That would be fundamentally at odds with the spirit of the European Union, which was founded on the recognition of the equal dignity of members of the human family. Genetic diagnosis of embryos to choose the best and healthy ones while killing the others is unacceptable discrimination against humans. Some Member States allow it, but the European Union absolutely cannot encourage either laws or practices that allow it.

For this reason, notwithstanding my unwavering desire to fight every disease, I am opposed to a text whose worthy parts stand in contrast to the seriously negative content of Article 4, as it would be amended by Amendment 15.



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