President. − The next item is the report by Adamos Adamou, on behalf of the Committee on the Environment, Public Health and Food Safety, on organ donation and transplantation: Policy actions at EU level (2007/2210(INI)) (A6-0090/2008).
Adamos Adamou, rapporteur. − (EL) Mr President, Commissioner, ladies and gentlemen, let me first thank the European Commission for its communication and the excellent cooperation we have had together. I should also like to thank all my colleagues, particularly the shadow rapporteurs, for the very difficult work we have done together to reach the compromise amendments which have been unanimously adopted.
The main issues the Commission deals with in its communication and which I have been dealing with as rapporteur are: transplant risks and safety, for instance the transmission of diseases, the organ shortage and illegal organ trafficking. Permit me to talk about each of these in turn.
With regard to quality and safety, when organs are used in therapy diseases risk being transmitted to the recipient. Donor testing is therefore important to minimise the risks to the recipient. Donors must be screened to establish whether or not there is a risk of any disease being transmitted. To establish a standard of donor safety, a minimum set of examinations should be performed. We must point out, however, that there is no consensus today between the Member States on these tests.
The severe shortage of organ donors remains the main challenge facing Member States in organ transplantation. Growing waiting lists are a serious problem. The establishment of an efficient system to identify those who might become organ donors on their death, provided, of course, that all the mandatory consent requirements in Member States have been met, is thus a key element in fighting organ shortage.
Another important option to increase the number of donors is the possible promotion of altruistic donations from living people. Careful consideration is also required of those potential donors who would not normally be considered ideal candidates, known of course, as expanded donors. For example a transplant could be allowed from one HIV-positive patient to other.
Now, with regard to trafficking in organs, Commissioner, everyone knows that organ trafficking takes place. We all know that rich tourists from the West exploit the economic needs of people from the poorest countries. We have all heard that there are price lists of organs, that there is a black market in organs, particularly in countries of the Far East, such as India, Pakistan and China, and that these things are even happening in the enlarged Europe. I therefore endorse Amendment 7 to paragraph 57 by my fellow Members Mrs Brepoels, Mr Liese and Mr Bowis, on behalf of the Group of the European People’s Party (Christian Democrats) and European Democrats, and it is important to improve the control of cases of organ trafficking so that we may, finally, draw the necessary conclusions.
At the same time, I would like to stress that altruism must constitute the main element of organ donation and transplantation. The economic terminology used in the Commission’s communication is therefore not adequate, in particular from the viewpoint of the principle of non-commercialisation of the human body. This is also the reason why I could not support Amendment 2 to paragraph 38 by Mr Martin and Mr Matsakis. Of course, following my detailed talks with Mr Matsakis, he – as he will explain to you himself – intends to withdraw it and will submit another oral amendment, tomorrow, which I support.
I consider, however, as I have said before, that organs should not be treated as a commodity of the internal market and, consequently, I would not agree with the removal of this addition. Besides, the principle of non-commercialisation of the human body is expressly stated in Article 3(2) of the Charter of Fundamental Rights of the European Union.
Ladies and gentlemen, I do not have any more time because the four minutes are up. I intend to continue in my conclusion, when I speak again following your remarks.
Androulla Vassiliou, Member of the Commission. − (EL) Mr President, ladies and gentlemen, let me first congratulate Mr Adamou on the excellent report he has prepared on organ donation and transplantation. I am particularly pleased that the report supports the Commission’s view that action on the donation and transplantation of organs must focus on: firstly, improving the quality and safety of organs; secondly, increasing the availability of organs; and thirdly, making transplants safe.
Ensuring high quality and safety standards in human organs is a benefit to everyone. We know that a number of organs are exchanged between EU Member States. At present, there is a lack of common quality and safety standards in the procurement of human organs and, therefore, meeting this need is very important.
It provides not only a comparable safety standard to apply across the EU, but also leads to a feeling of security and solidarity in the transplantation system.
The Commission plans to propose a legislative framework on the basic safety and quality principles in relation to the donation and procurement of human organs.
These requirements will be broad and flexible, to maximise the number of transplantations taking place. After all, this is all about saving lives. We must keep uppermost in our minds the fact that there are 50 000 people on organ waiting lists across Europe at this point.
Increasing organ availability requires raising public awareness of the issue. Citizens need to know that transplantation systems are safe and reliable. Otherwise they will not consent to donation.
We already have some good examples in Member States where the addition of transplant coordinators, for example, has had a positive impact on donation rates. The Commission intends to propose an action plan with 10 priority actions to meet the challenges of organ donation and transplantation in the EU. The Commission recognises the importance of fighting organ trafficking as reflected in the communication on organ donation and transplantation.
I also noted Dr Adamou’s comments and will seriously consider them. His report makes it clear that we should look very carefully at how we intend to respond to the menace of organ trafficking in the EU.
The Commission will monitor the situation in collaboration with our international partners, the Council of Europe and the World Health Organisation. We shall also support Interpol in order to continue with the monitoring of this problem.
Moreover, I believe that by increasing organ availability in the European Union, we shall indirectly fight transplant tourism and trafficking of organs.
In addition, organ trafficking will be included in this year’s Commission report on an EU action plan on trafficking in human beings.
Edit Bauer, Draftsman of the opinion of the Committee on Civil Liberties, Justice and Home Affairs. − Mr President, organ donation and transplantation is a sensitive and important issue, where good legislation, together with good practice, might save thousands of human lives on a yearly basis. Issues on the fragile line between life and death are really sensitive. It is hard to help with legislation, but it is easy to harm. That is why it is profoundly important to respect good practices in the Member States.
On the other hand, it is vitally necessary to discover all those practices which cause lack of trust and transparency in managing waiting lists or lead to scandalous cases of misused loopholes in legislation.
I would like to point out three topics in the opinion of the Committee on Civil Liberties, Justice and Home Affairs. First, living donors are mainly unrelated. In this regard, legal procedures should minimise the possibility of illicit organ selling. The question of reimbursement of the social costs of donors is still awaiting a suitable solution.
Secondly, in those cases where international cooperation is included in the transplantation process, legislation should ensure rules as clear as those within Member States. Transplantation tourism raises new questions, as the Commissioner mentioned. How should we handle such cases?
Thirdly, international cooperation in detecting cases of organ trafficking should be more organised and more serious, because hidden trafficking and its consequences can destroy the hopes of thousands of patients waiting for life-saving organs. On the other hand, European legislation on trafficking in human beings should also include organ selling and trafficking, even if it is still hidden but becoming an increasing global problem.
I would like to congratulate the rapporteur and also the shadow rapporteurs and thank them for good cooperation.
Frieda Brepoels, on behalf of the PPE-DE Group. – (NL) Mr President, Commissioner, organ transplants do indeed save human lives in Europe every day. Sadly, a shortage of donors means that thousands of Europeans die every year whilst still on the waiting list. The challenge is how to increase donor numbers safely. As shadow rapporteur for the Group of the European People’s Party and European Democrats I am very happy today to see Parliament wholeheartedly endorsing the Commission's initiative and acknowledging that Europe can play an essential role here.
Organ donation and transplantation is a highly complex and emotive subject, as other speakers have said, and views on it vary widely in the Member States. Whilst working on the report I myself talked to quite a few doctors, patients and organisations. The hearing we held and the study visit to Spain also provided us with interesting insights, and I must thank the rapporteur very sincerely today for having incorporated all our contributions into his report.
Four points. One, we must above all take care to ensure that the directive on quality and safety, put forward by the Commission, is sufficiently flexible and does not create additional administrative burdens or even a decrease in the number of organs available. In our view it must be the doctor who ultimately decides on quality and safety. To guarantee quality and safety we also ask that Member States monitor and evaluate post-transplantation and post-donation results. Since data comparability between Member States is very important here, we might perhaps think about having a common methodology for analysing the data.
Two, we think the most essential factor in recruiting more donors, even more important than legislation, is the way in which the donation system is organised. We would thus like to see hospitals deploying more staff to identify potential donors, but also to counsel and assist the next of kin. In countries that use transplant coordinators of this kind, the number of donors rises.
Three, this also demonstrates how crucially important it is to exchange good practice among Member States. The European Union can easily foster this. It is also important that hospitals publicise the positive results of transplantation and be proactive in their dealings with the media.
Four, we think it is very important to consider living donors as well as post-mortem donors. And we would like to see living donors not being discriminated again, by insurance companies for example.
Lastly, organ donation must remain a strictly non-commercial, altruistic and voluntary process. Any payments made must in our view be only for the expense and inconvenience of donating. The Commission, together with Member States, must be far more proactive in countering the sale and trafficking of organs and transplant tourism. Traceability is very important here and Europol too must monitor things better and identify cases of organ selling and/or trafficking.
I am certain that Parliament, through this report, is sending out a very balanced and firm signal, and I urge the House to vote in favour of the report tomorrow.
María Sornosa Martínez, on behalf of the PSE Group. – (ES) Mr President, Commissioner, I look forward to the forthcoming proposal for a directive from the Commission which will establish quality and safety standards for the donation and procurement of organs throughout the European Union.
In the interests of transparency in this process, I would like to say that as Socialists we support the measures aimed at protecting donors and ensuring that organ donation is made altruistically and voluntarily, ruling out any payment other than strict compensation for the expense and inconvenience involved in making the donation.
The forthcoming legislative framework should not create an excessive administrative burden for the Member States, nor jeopardise the use of existing good practices.
As for the practical process as such, I would like to point out that a few very stringent quality standards should not increase costs and in particular they should not reduce the number of organs available for transplant. Clearly, measures should not be adopted if they prevent organs from being transplanted, which would currently be regarded as acceptable, because what we are trying to do is to save human beings and ensure that human life is as comfortable as possible for the sick.
Unfortunately, the excellent results obtained from transplants, in terms of increased lifespan and improved quality of life, have increased demand for this form of treatment.
I come from Spain, a country which is a world leader in organ donation and transplantation. If we have managed to achieve this worthy ranking it is doubtless due to the existence of a National Transplant Organisation which coordinates all the teams of professionals in the relevant hospitals, each of which has its own transplant coordinator, a medical professional who coordinates the entire team and the process leading up to the donation.
I hope that the proposed legislation from the European Commission will take this type of model into account since it is proving so successful.
Finally, I would like to emphasise the desirability of including a reference to the need to involve citizens from third countries, with different cultures and religions, in the donation culture, by means of specific awareness measures, campaigns in their native language, cultural mediators etc., and of calling on States to combat trafficking wholeheartedly by adopting criminal liability measures against European citizens who pursue health tourism with a view to obtaining organs in third countries.
It only remains for me to thank the rapporteur, and all the rapporteurs not mentioned individually, because it has been very easy working together and reaching agreement.
Jules Maaten, on behalf of the ALDE Group. – (NL) Mr President, I am trying to put myself in the position of the parents of a three-year-old girl diagnosed with a heart defect, for whom a three-year-old donor heart – not easy to find – was not available in her own country. In another European country one might well be available, but that country was not interested in cooperating with the rest of Europe. In that case I would be demanding action from Europe. And there is good reason why European action is needed. We currently have 400 000 people on a waiting list for organs in Europe and about ten of these will die every day because there is a shortage of donor organs.
Regarding safety and quality criteria, the excellent Adamou report rightly warns against any further bureaucratic burden being imposed by legislation from Brussels. And the proposed legislation – I am glad that the Commissioner has just given it his blessing – certainly must not add to the red tape. If there is one sector that is vulnerable to red tape, it is this one. I was also very happy to hear you say just now that you want to open the way for as many transplants as possible and do not want to restrict the numbers. I think that is an important principle.
We do need guarantees of closer cooperation between Member States. Cross-border cooperation means that the transplantation process is handled by hospitals and doctors who are governed by different legal systems. Last year, former Commissioner for Health Markos Kyprianou argued for the introduction of a European donor card. And Cyprus, as we know, Mr Adamou, Mrs Vassiliou, is a fount of wisdom. This card, whether or not it is combined with the European health insurance card, can ensure that organs which become available are used as efficiently as possible. Eurobarometer surveys show that 81% of Europeans back the use of an organ donor card, but only 12% of them actually carry one. The Adamou report calls for a voluntary European donor card and so I would like to take this opportunity to urge the Commissioner to put forward legislation by the end of the year to introduce a card of this kind to complement national cards.
Margrete Auken, on behalf of the Verts/ALE Group. – (DA) Mr President, I would like to thank Mr Adamou for a very good report and excellent cooperation during the preparation of this report up to now. We need more organs – we are certainly in agreement over that. However, it is important that this takes place in a proper manner. Cooperation is good, and I personally believe that proper information is needed, better information, so that people will feel comfortable about being organ donors. As a result, people will know that everything will be done with respect, and this also applies to the next of kin, who are of course facing the most desperate situation of their lives, and people can also be secure in the knowledge that their relatives will be taken good care of. If this makes it is possible for them to discuss the matter with each other, then something good will come of it.
However, under no circumstances should the need for organs lead to the commercialisation of the process. I believe that everyone is very pleased and in agreement that this issue is now to be addressed and we are going to tackle the trafficking that is taking place. It is unacceptable that we have not involved Europol sufficiently, because it is really a criminal matter. Even in places where it is not illegal, it is of course criminal that poor people are being persuaded to sell their kidneys in order to support their families.
Finally, allow me to emphasise how many assurances we will have to give; we will need to be aware of this, as we will be subject to immense pressure. For example, I feel that a formulation such as people are dying ‘as a result of the chronic shortage of organs’ is poisonous. People are dying because they are ill. In addition, we will never have enough organs. There are some people who are fortunate enough to receive an organ and whose lives are saved as a result. Being able to achieve more cases like this is why we have to adopt this report. However, we will never be in a situation where we have enough organs. Even if we abolished all speed limits throughout Europe, it would not be enough.
IN THE CHAIR: MR BIELAN Vice-President
Jiří Maštálka, on behalf of the GUE/NGL Group. – (CS) Mr President, ladies and gentlemen, first of all I would like to congratulate, as a physician and a Member of this House, my colleague Mr Adamos Adamou on his excellent work on this report. The issues of organ transplantation and donation can sometimes cause controversy and the reasons are evident: on the one hand, we have to take ethical issues into account, while on the other hand we should not allow medical progress to come to a stop, thereby restricting or hampering our ability to help people.
I welcome the fact that the report is based on the pillars that I value. The first of these is the legal instruments: they have to guarantee that organ donation will continue to be voluntary rather than a commercial activity. It will be good to have standards but these standards must not affect implementation and options in the individual Member States. The second pillar relates to cooperation between the Member States, which is essential, as in many other areas. The third pillar relates to the fact that no measures can be taken without the cooperation of the citizens. I therefore welcome the measures to ensure greater public awareness and transparency. The common goal, which is evident in the report, is to eliminate illegal trafficking at all costs. Mr Adamou’s report certainly paves the way for this.
Urszula Krupa, on behalf of the IND/DEM Group. – (PL) Mr President, the noble objectives of the Commission’s Communication on organ donation and transplantation and policy actions at EU level, as well as Mr Adamou’s report, which stresses that organ donation is a gift and that it is important to respect and protect the freedom to donate or not to donate organs for transplantation, are insufficient.
Similarly, the regulations providing for the introduction of a European organ donor card will be insufficient if all the amendments concerning guidance by ethical and moral principles contained in the European Parliament documents are rejected. Lack of moral principles and of their use in legislation leads to loss of our societies’ moral health and to various abuses in all areas of social life, including science and medicine.
In addition to the spread of liberalism and commercialism, vast social differences are a cause of the trade in organs and of other abuses. There are very rich people who can buy anything, including organs for transplantation. There are also those who are destitute. They may donate their organs as a last resort or under duress, and thus reduce their chances for good health and survival.
This state of affairs will not be changed by assurances about equal opportunities and equal access to health services. There is a requirement for real social protection and for statutory protection of human health and life.
Irena Belohorská (NI). - (SK) Ladies and gentlemen, I, too, would like to congratulate Dr Adamos Adamou on this report, which was adopted unanimously by the Committee on the Environment, Public Health and Food Safety. Not a single Member voted against it; nor did anyone oppose it any of the committees that were asked for their opinion. That this unique level of consensus was achieved is also due to the frequent and long debates on this report organised by the rapporteur, and I would like to thank him for that.
Our task in the area of organ transplantation is twofold. On the one hand, we want to help people for whom transplantation offers the only possibility of staying alive, and on the other hand, it is our duty to prevent organ trafficking, which is one of the most serious criminal acts. We know that trade in organs is at present particularly active in the poorer parts of the world, where organ donation is providing the poor with the only possibility of survival.
I therefore find it shocking that in today’s European Union, based on values, morals and ethics, some people are asking for this trade to be legalised. Since there is a vast difference between the supply of organs – from either live or deceased donors – and the demand for organs, it is important to increase the number of donors.
In the Health Programme 2008-2013 the Commission includes evaluation of post-transplant results among its health safety priorities, which means that grants can be awarded for these purposes. Although I very much welcome the possibility of financing projects from grants, I have a few reservations.
I know that this debate is not about the Health Programme 2008-2013 but I must emphasise the following aspect. As far as the projects concerned, I was surprised at the mathematical discrepancy between the number of projects approved and the number of projects completed: in 2004, 72 projects were approved and 9 were completed; in 2005, 61 projects were approved and 7 were completed; in 2006, 87 projects were approved and not a single one was completed; and in 2007, 6 projects were approved and none was completed. Are there any mechanisms available to verify the effectiveness of the projects cofinanced by the European Union?
Glenis Willmott (PSE). - Mr President, the use of human organs for transplantation has increased steadily over the past decades. Organ transplantation is now the most cost-effective treatment for end-stage renal failure. For end-stage failure of organs such as the liver, lung and heart, it is the only available treatment.
Transplants are one of the most miraculous achievements of modern medicine, but less than 25% of the UK population are registered organ donors. Last year, around 2 400 people in the UK benefited from an organ transplant, but more than a thousand die every year whilst waiting for such a transplant.
Organ shortage is a common dilemma in all European countries, and there is clearly a need to improve the system supporting organ donation across the EU. Therefore, I warmly welcome this report, and I especially welcome the expanded section on organ trafficking.
A lack of donors has resulted in an exponential growth in transplant tourism to the world’s developing nations. The international black market in organs is attracting people in search of a kidney or other organ, and people living in abject poverty or other vulnerable circumstances are being exploited. They have become a spare parts inventory for the sick. However, when illegal organs transplants are practised, safety is often ignored and the lives of both donor and recipient are put at risk. British newspapers have already exposed several macabre websites aimed at so-called ‘transplant tourists’, including the offer of kidneys from executed prisoners in China.
We should not view this as a distant crime. Several European nations have also become embroiled in the transplant trade, including Moldova, Serbia, Turkey and Russia. Governments across Europe must do more to prevent this shameful crime, so I would like to congratulate Mr Amadou on what is a wide-ranging and thoughtful report.
Marios Matsakis (ALDE). - Mr President, I wish to congratulate the rapporteur on his truly excellent report.
Allow me to take this opportunity to raise an important but highly controversial issue, which, although not the subject of decision presently, nevertheless needs to be addressed at some stage: this is the concept of presumed consent. Most potential donors’ organs never become available, because the system of obtaining the consent of the donor in life, or of his or her relatives, can never function to such an efficient degree so as to overcome the constraints of narrow time limitations, the sensitive psychosociological manifestations of bereavement and the complex technicalities of organ harvesting and transportation.
The answer to this problem of organ availability is decidedly to presume that all dead people are donors unless this is specifically objected to in time by a close relative or by the donor when alive. I know that this is not easy for legislators to accept, but I hope that this will cause some serious and mature thinking in the future, based on realism and bearing in mind the enormous number of lives that could be saved if such a system were put into effect.
Hiltrud Breyer (Verts/ALE) . – (DE) Mr President, ladies and gentlemen, Mr Adamou, we know that demand for organs outstrips supply. We also know, however, that the only way to increase supply is to secure the principle of non-commercialisation. So there can be no trade in organs, and we cannot permit expense allowances and reimbursement of costs to turn into covert forms of payment.
The problem of organ trafficking is not taken seriously in the European Union. I am pleased to hear from the Commissioner that organ trafficking is to be included at last in the report on trafficking in human beings. However, what happens if a European citizen comes, with an organ, from a third country such as the Philippines? No doctor or hospital will query the origin of the organ. The European citizen will not be required to prove that it did not come from trafficking. That is why we need traceability if we are to eliminate organ trafficking effectively. It is here that the European Union has a big responsibility because we cannot permit a situation where people in China, Ukraine or other countries have to live in fear of an organ mafia.
It is tragic that poverty and desperation should drive people to sell their organs. It is equally tragic, of course, that people should have to die because there are too few organs available for transplants, but we do need to consider both sides of the coin.
Kathy Sinnott (IND/DEM). - Mr President, to be reprieved from death and disease through the gift of an organ is a wonderful thing, but we have a shortage of organs. Adult stem cells are a promising development, worthy of mention. Many people who would otherwise have needed a transplant are being taken off the list, as their own stem cells are being used to repair their damaged organs. Also, in a research setting, new organs have been made for animals, using their own stem cells. Such replacement organs do not present rejection problems for the recipient.
I would like to thank the rapporteur for supporting the amendments on equality in organ donation for people with disabilities. Research by the Disability Rights Commission suggests that people with disabilities are four times more likely to die from a treatable disease, with organ failure being one of these conditions. We must fight such institutionalised discrimination and ensure fair, free and equitable access to organ donation for all.
I also want to congratulate Mr Derek Rowe and all those at Irish Air Ambulance who, despite receiving no support from the Irish Government, will finally have the first air ambulance operational in Ireland by the end of the year. They have based it on the Cornwall Air Ambulance. The very first mission of the Cornwall Air Ambulance involved a person who had drowned and donated four of their organs – organs that would have been lost without an air ambulance.
Maciej Marian Giertych (NI). - (PL) Mr President, transplantology is suffering from a shortage of organs. Demand is high and therefore big money is involved. Where there is big money, abuses will be found. Consequently a new kind of crime emerges. There are examples of purchases from poor donors – for a few pennies kidneys can be bought for transplantation. We hear of organs being harvested from executed persons, whose permission has not been sought. We hear of potential donors being kidnapped and killed so that organs can be obtained. There are cases of death being accelerated to harvest organs. This is what I wish to address.
Since transplantology emerged, the definition of death has changed. A criterion of brain death emerged – defined for the first time in 1968 in Boston. It is known as the Harvard Criterion. Since then new criteria of brain death has emerged, each successive one being less restrictive. Cessation of brain activity does not amount to an observation. It is a prognosis. To verify it, the life-support machine is disconnected, and that in itself can cause death. Sometimes the assistance of anaesthetists is enlisted to obtain the organs of the allegedly dead, so that harvesting of a dead body is painless.
What is needed is a stricter, not more liberal, definition of death. Taking of one life to save another is not acceptable.
Harald Ettl (PSE) . – (DE) Mr President, if we want a joined-up health policy, then the call to the Commission to table a proposal for a directive on organ donation and transplantation is a timely one. The extremely short supply of organs, which persists in some Member States, means that many patients there are on waiting lists for years, and many of them die. If we had just 20-30 dead and live donors per million head of population, the European Union would have a good supply of organs.
Achieving that depends, however, on transplant laws that provide in principle for the removal of organs after death, unless the person concerned has left instructions to the contrary. Only Member States with this type of legislation – and there are currently 11 of them – can hope to resolve the problem fairly at European level. Article 38, or rather the proposed amendment to it, is at odds with such a solution. In Austria, although the principle of organ removal is enshrined in law, an intensive-care specialist with psychological training will also discuss the procedure with the family of the deceased donor, and this system has been very successful. If the relatives oppose the organ removal, then their view will be respected.
Other approaches – such as that taken in Austria’s largest neighbouring country – lead to major difficulties with organ supply and thus turn the whole thing into a European problem. A functional system of obtaining organs depends on having the same set of rules throughout Europe and on arrangements for organ distribution that are transparent and fair and can be supervised at national level. Any approach that fails to put these elements in place will be a capricious waste of time and, at worst, will generate a dubious form of business for poor and mainly non-European countries.
I know what I am talking about because, as Health Minister in Austria, I was responsible for this issue and our experience with it today is positive. The proposal now before this House does not go far enough to resolve the problem at European level. I expect and hope for more from you, Commissioner!
Johannes Blokland (IND/DEM). - (NL) Mr President, previous speakers have already made the point that organ donation is an emotive subject. It is also a subject which in my view ought largely to be dealt with at Member State level. But a European approach may make sense, chiefly when it comes to quality criteria and information-sharing. We need to take a tough line on illegal organ trafficking. Mr Adamou’s own-initiative report makes a significant contribution here and I thank him for it.
Some members have advocated the introduction of an ‘opting out’ system, but I have grave reservations about that. We cannot force anyone to make a choice about organ donation when the sector itself has not yet weighed the issues clearly and responsibly. I am glad that the resolution now before us makes this point a matter for the Member States.
Lastly, I endorse the amendments tabled by Mrs Sinnot, Messrs Liese and Bowis and others regarding the proven benefits of using adult stem cells.
Anne Ferreira (PSE). - (FR) Mr President, Commissioner, I should first like to congratulate Mr Adamou on his work.
If one of the objectives of this report is to break down the barriers to organ donation and to ensure the safety of organ transplantation, the first problem clearly concerns self-sufficiency within each Member State and within the European Union. Organ shortage is a problem facing all the Member States to varying degrees. Whilst this situation, which has tragic consequences for people who are waiting for an organ transplant, may be one of the causes of organ trafficking, it is not the only one. It appears that the root cause of trafficking in human organs is their market value.
To remedy this situation, at least within the European Union, organ donation must be guided by three basic principles: it must be unpaid, voluntary and anonymous. If commercialisation of human organs is not possible, then trafficking will be more difficult. In an attempt to resolve this fundamental problem of organ shortage, as highlighted in the report, it is necessary not only to conduct effective public awareness campaigns but also to raise awareness among potential donors. Some Member States are already leading the way on this issue.
It should be noted that, in the case of the donation of blood, which is also in short supply in Europe, several years ago now, we called on every Member State to conduct blood donation campaigns. What was the outcome of this request? Can we build on this experience and extend it, and possibly improve it, to include organ donation?
Nevertheless, I would like to emphasise a couple of points which worry me: firstly, the donor card is not fit for purpose, and, secondly, the issue of the living donor needs to be regulated more effectively. These two points highlight the central role to be played by doctors and surgeons.
Finally, the report refers to the various possibilities of treatment available using adult stem cells. I should also like to mention the opportunities offered by the use of umbilical cord blood stem cells in the treatment of blood cancer, as a substitute for bone marrow transplants. Let us not dismiss this approach. I already mentioned it at your hearing, Commissioner.
Hélène Goudin (IND/DEM). - (SV) Mr President, the question of organ donation is an ethically sensitive issue and must be guided by national values. Cooperation across national borders can take place in order to ensure quality and safety, but the choice of whether to donate or receive organs must be the choice of the individual or his or her family. This choice often has its roots in a cultural context.
The proposed European donor card is inappropriate, as rules on consent, allocation and organisational structure differ from one Member State to the next. Health is and should remain a national issue. Nevertheless, the Swedish June List is in favour of voluntary exchange of organs and expertise among the existing organisations in Member States.
Parliament’s proposed measures to encourage debate on organ donation, on national transplant hotlines, positive media exposure for organ donation and educating sports stars may possibly be justified, but these initiatives must be decided by the Member States themselves on the basis of the prevailing social climate in the respective country.
Anna Záborská (PPE-DE). - (SK) I would like to extend my heartfelt congratulations to my fellow Member Mr Adamou. Because of the shortage of organs, some people are quick to use criminal methods. They have turned concern for human beings into lucrative trade in human organs, and children are the group most at risk.
Two weeks ago I made an appeal in Slovakia, and now I am appealing to the European Parliament and the European Commission, for an intensive campaign to increase parents’ awareness of the dangers threatening their children. We must launch a pan-European campaign entitled ‘Do you know where your child is now?’.
This campaign should increase parents’ sense of responsibility for their children. We need to take this issue very seriously and the European Union must adopt measures to tackle the transnational nature of the illegal trade in human organs.
Gyula Hegyi (PSE). - (HU) An unreasonably large number of people die or suffer because there is no organ available in time for transplantation. But many people do not consider use of their organs after death an ethical problem, if they know that this can be done, but because of inadequate information they do not donate their organs. Naturally everyone must make their own decision, and no one can overrule them or force them. It is important, however, that citizens in our various countries understand that, with different rules in different Member States, if they do not make provision for donating their organs, some countries will permit transplantation while others do not. I welcome the European Parliament’s proposal for a legal representative to decide on the use of organs after death if the deceased person has made no other provision. The illegal trade in organs is a most loathsome crime associated with organ transplants. Robust action must be taken against it, and, especially when those who are termed allies of the west pursue it, covering up these crimes would be a collective shame.
Siiri Oviir (ALDE). - (ET) Organ transplants must take place quickly. No more than a couple of hours must elapse between removal and transplantation. Therefore public awareness and public opinion play an important role in increasing organ donation.
Organ donation and transplantation are medical procedures, and in order for them to be further developed there must be full public involvement and greater public awareness. The most effective means of increasing public readiness would appear to be improving knowledge of transplant issues among the public and the media. This must be the first step.
Secondly, I would like to emphasise that, given that there is currently no European coordination of organ exchange, making an improvement in that area is very important, specifically with regard to coordination of the system for organ exchange such as it currently exists between the Member States, for example through a European donor card or a European hotline.
Sylwester Chruszcz (NI). - (PL) Mr President, I see that in general we all agree that organ transplants must not be a commercial activity. Any commercial utilisation of organs is simply unethical and contrary to basic human values. Huge demand for organs for transplantation may lead to pathology or, indeed, crime. All of Europe was recently appalled by those parts of Carla Del Ponte’s book where she spoke of Albanian terrorists who used Serbian citizens from Kosovo for commercial transplantation. This is the issue that the European Parliament and the Member States should address. I believe that the informed consent of the donor must always be a basis for donation and for transplantation of organs. There is a need to secure such a solution which must be the norm in Europe.
Péter Olajos (PPE-DE). - (HU) Thank you, Mr President. Ladies and gentlemen, perhaps not everyone knows that the first organ transplant in the world was performed in Vienna in 1902 by a person of Hungarian origin, Imre Ulmann. This particular link with the Austrian capital has existed since then, and so strongly that, even though personnel and technical resources are roughly the same, Hungarian lung transplants are still carried out in Vienna. And why not? It costs three times as much and even then the number of patients is even limited. There is no doubt but that transplant coordinators have to be appointed in the intensive care units of European hospitals. The number of these in Hungary is at present precisely zero, while Spain reportedly has 156. As regards heart transplants, my own country has outstanding results, performing well in international comparisons, but we are at the bottom of the list in Europe. The reason is the lack of donors, lack of equipment, air travel, and the human resources required. Hopefully this report will help to address these anomalies since the problem lies not in our hearts but in our minds. Thank you, and I propose that the report be adopted.
Catherine Stihler (PSE). - Mr President, I should like to thank the rapporteur for his report.
Tonight, there are 700 people in Scotland waiting for an organ transplant: that is 700 families waiting for calls that could guarantee their loved ones’ survival.
The need for consensus on this sensitive subject is essential, and it is a sad day when Member States cannot agree on this. I would like the system of organ donation to be, as Mr Matsakis has said, a system into which everyone has opted in to donate, unless they have requested to opt out. That would help with the supply side, particularly for the young and those from an ethnic minority, where shortages are most acute. Such a system would help save European lives. While I welcome the Commission’s action plan, let us make sure that it is not too little, too late.
Androula Vassiliou, Member of the Commission. − Mr President, this has been a very interesting and lively debate and no wonder, given the seriousness and importance of this problem.
Now, a lot of issues have been raised. I will try to comment on some of them. Non-commercialisation of organs is a very important issue and I believe, and agree, that organ donation should be done on an altruistic and voluntary basis. That is why, of course, donor cards should be voluntary, and the same applies to the European donor card, which we intend to introduce in our action plan.
Good practices exist in some Member States and these good practices should be shared with other Member States for the benefit of all. The Commission’s directive on quality and safety will, I assure you, be flexible enough not to affect donation whilst ensuring basic requirements throughout the European Union. I also want to confirm that traceability will be included in the directive.
Consent for donation is a particularly sensitive issue, which needs to take into account local and cultural attitudes to donation and transplantation. I wish to point out, on this point, that national authorities are responsible for deciding the legal requirements and practices regarding donation consent in their own Member State and for ensuring that their citizens are aware of their rights in this area.
I would like to say that the use of stem cells from cord blood has proved to be useful for the treatment of some malignant diseases, such as cancer. The Commission supports the development of cord blood banks and the use of this technology.
I also think that it is very important that we raise awareness among European citizens, so that we encourage the increase of both live donations and donations after death, because, in this way, we shall also – as I said in the beginning – indirectly fight trafficking. In order to prevent transplant tourism, I think it is very important that citizens should be made aware of both the dangers regarding the safety and security of organs and the ethical questions that may arise. As we know, in many third countries, very poor and vulnerable people are being exploited for the purpose of organ extraction.
Finally, honourable Members, I would like to thank you once again for providing us with such a constructive report. In particular, I want to stress the fundamental aim of saving lives, whilst recognising the important scientific advances in organ donation.
I therefore look forward to continuing our close and constructive collaboration and presenting the Commission’s proposal to this House later this year.
Adamos Adamou, rapporteur. − (EL) Mr President, let me thank all those who have spoken on this particularly sensitive subject and allow me to make some comments.
Mr Maaten and others spoke about the European donor card, which we have adopted as an addition to what is provided in Member States. Mr Maaten quoted some correct figures: 80% of citizens surveyed were in favour, but only 12% have a donor card. However, another statistic should give us cause for concern: of those who had a donor card when the time came for them to become donors, 50% did not donate their organs because their families refused. There are thus problems that we cannot be sure will be solved with a European donor card.
As for the point raised by Mr Matsakis about ‘presumed consent’, this is a matter for the Member States. According to my fellow Member who spoke about Scotland, presumed consent solves the problem. It is up to the Member States to decide whether to adopt such a measure. We should not forget the principle of subsidiarity. In this case, we must see which systems have succeeded, so that we can exchange experience and procedures, as in the case of Spain, to which Mrs Sornosa Martínez has referred. Why do we not have in different hospitals coordinators, specialised doctors and nurses, able to recognise potential donors so that transplants can go ahead and we can thus increase the availability of organs? Mrs Auken, who is not here at the moment, has said that we will never be able to fill the shortfall in organ donation. As a doctor and a scientist, my answer is that perhaps I will not live to see the day, or future generations will, but in the decades to come we will be able to make the organ we want from the cells of the individual who needs it, maybe from his skin or from elsewhere.
Commissioner, you spoke about umbilical cord blood cells and about their storage. Now let me point out that we really must not let them fall into the hands of private firms operating for profit. In my country, Cyprus, the Karaiskakio Foundation provides this service free of charge. There are also three private firms charging parents to store umbilical cord blood cells. These cells are also precursor and stem cells; they are very valuable, as you know.
What can I say about the reference made to trade? My fellow Member referred to the report by Carla Del Ponte. I expected to see this report earlier, to be honest. Naturally, it is yet more proof that trafficking is also taking place in the enlarged Europe.
I thank all of you once again. I think that the time has now come for us as European citizens to take action. We must mobilise, coordinate, raise the awareness of those around us and set a good example: we must become organ donors ourselves.
President. − The debate is closed.
The vote will take place on Tuesday, 22 April 2008.
Written statements (Rule 142)
Slavi Binev (NI), in writing. – (BG) This is to express my deep satisfaction with Mr. Adamou’s report. I support the opinion that to reduce the shortage of organs is the main challenge EU Member States face in terms of organ transplantation.
On 9/04/2008 my colleagues from the ATAKA Party Dimitar Stoyanov and Desislav Chukolov and I submitted a written declaration in support of informed consent for organ, tissue and cell donation in Bulgaria in which we called upon the European Commission to come up with a proposal on the quality and safety of organ donation. The introduction of a European donor card as a supplement to existing national systems will contribute for the rapid identification of donors and thus increase the availability of necessary transplant material. Public awareness about organ donation and transplantation and the introduction of uniform EU legislation and strict criminal prosecution measures against those engaged in organ trafficking, including against medical staff, will serve as safeguards for donation procedures and informed consent.
Once again I congratulate you on your report, sir.
Titus Corlăţean (PSE), in writing. – (RO) Support for the proposal of a European Parliament resolution on policy actions at the European Union level on organ donation and transplantation.
I request that the European Commission propose a more comprehensive directive that would set quality and safety requirements for the donation and transport of organs in the European Union. This directive would also provide methods of preventing potential abuse.
The new legislative act should supplement and strengthen the Member States’ efforts to improve the present situation, imposing lines of conduct at a European level, by taking into account the progress in medicine.
I insist on Member State involvement, including the Member State I come from, Romania, in educating citizens by presenting the advantages of organ donation and acknowledging the fact that organ donation and transplantation mean lives saved.
I also support the involvement of the European Commission in organizing public debates together with the relevant European non-governmental organizations, in order to identify the best solutions, both as regards the communication campaign and the turning to account of the Member States’ experience and good practice.
The response speed is essential in such cases. Better organization of the medical system at a national level is necessary, as well as making paramedics sensitive to such emergencies
Neena Gill (PSE), in writing. – This is a crucial report and a real opportunity to save lives. Chronic shortages of organs across Europe are causing 60 000 unnecessary deaths.
Therefore, urgent action is needed:
1. Removal of restrictions in organ donation and increased cooperation across Member States and the number of quality safe organs available for transplantation. What is required is a Commission directive that adds value and sets common EU-wide quality and safety standards which complement existing arrangements in Member States.
2. Encourage Member States to adopt a system of ‘opting out’ rather than ‘opting in’ to organ donation. This would enable greater awareness of shortages, and would allow more people to actively consider their position on the issue.
3. I fully support the emphasis in this report on illegal trafficking of organs. I am especially concerned that it is often the poorest who are targeted for donating organs. We must end this cruel exploitation of poverty and protect the innocent victims who are tricked into losing their organs. This is not just a problem in developing countries but also in eastern Europe. I want to see strong measures put in place through Europol and Interpol to curb this illegal trade.
Katalin Lévai (PSE), in writing. – (HU) I welcome Mr Adamos Adamou’s report on organ donation and the trade in organs. Even though technical expertise in this area is unfortunately often at very different levels in the Member States, the use of human organs for transplantation has increased dramatically in recent decades. There are around 40 000 people on waiting lists in western Europe, and as a result of this the trade in organs, as a form of livelihood, is flourishing in the poorer areas of eastern European countries.
The European donor card represents a good solution to the legal issues of donation, but more robust measures need to be applied to trafficking and trading in organs. Given that, despite isolated attempts, there is no easy-to-use record system for organs available for transplantation even at national level, it is important to introduce a certificate, similar to the Schengen system, accessible on the Internet, valid throughout the whole Union, supported by medical opinion and a single Union transplantation database. Certified establishments engaged in the legal transplantation of human organs would have this life-giving information available instantly and could set up bipartite agreements, while the poor and vulnerable would be protected from becoming victims of organ trafficking.
The creation of a database is an absolute necessity so that organs available in several countries can be used, and it is therefore vital that the Member States discontinue legislation prohibiting this.
It is also important that organ donation remains strictly ‘non-commercial’ but the conditions under which financial compensation can be offered must be defined.
Joseph Muscat (PSE), in writing. – (MT) Any lack of or delay in action in the sector of organ donation costs lives that could be saved.
As Europeans we have a lot to learn from one another. Moreover, countries with experience and infrastructure in this sector can help other countries, like Malta, that may not have the critical mass, especially in cases of rare conditions.
Recently the Maltese and Gozitan people were moved by the case of Jamie Zammit. Jamie is having problems finding a donor to save him from a condition known as Fanconi anaemia because in Malta we do not currently have a register of bone marrow donors.
The Maltese Government has now announced that it is going to set up such a register. This is good news. However, in order to set it up, we require the specialised procedure of HLA typing, which does not yet exist in Malta, and we also need long-term training in other countries so that this can be introduced.
I am appealing that, out of European solidarity, Malta is given all the help it needs, particularly until this system is set up in our country, so that we can save as many innocent lives as possible.
Daciana Octavia Sârbu (PSE), in writing. – (RO) The penury of organs, which has led to the rapid development of mercantilism and tourism in organs, represents an essential health problem the European Union is dealing with. Organ trafficking is caused by a combination of factors such as poverty, corruption and criminality, a reason why the countries of Eastern Europe are the most exposed to this phenomenon. In order to prevent this "transplantation tourism”, the report of the Committee on the Environment requests that organ donation be performed altruistically and voluntary, without becoming a source of profit for the donors. Member States should take action to protect the poorest and more vulnerable donors so that they do not become victims of organ trafficking.
Nevertheless, there are considerable difference between the EU Member States as regards the ways in which they organize donation and transplantation activity, the community of donors and the sources of organ procurement. For instance, the low number of donors in Romania is due to the absence of an efficient system for identifying donors and doctors prepared to coordinate the organization of transplantation. For this reason, the European average for the number of donors is 20, and in Romania, only 0.5. We need adequate technical and logistics infrastructures, as well as psychological and organizational support to reduce the differences between demand and offer.
Richard Seeber (PPE-DE), in writing. – (DE) Today, almost a thousand patients are registered for transplants in Austria. Unfortunately not all these seriously ill patients will get the transplant that may save them.
Every year some 150 patients die while awaiting a transplant because of the very limited number of available donor organs. Organ shortage is a major challenge facing Europe. That is why we need a directive on the quality and safety of organ donations. Equally, however, we need cooperation between Member States and an exchange of good practice. There are, currently, considerable differences within Europe in the number of organ donations and in the transplant quota. Cooperation among Member States should focus on discovering the most efficient systems, exchanging experience and promoting well-established procedures. Member States must learn from one another.
I am convinced that live donation should always remain complementary to post-mortem donation. Moreover, it is important for donations to remain voluntary and unpaid. Transfers of money between donor and recipient are unacceptable. The Commission and the Member States must take measures to combat transplant tourism and the illegal trade in organs more effectively.