President. – The next item is the joint debate on:

– the report by Mr Mikolášik, on behalf of the Committee on the Environment, Public Health and Food Safety, on the proposal for a directive of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation (COM(2008)0818 - C6-0480/2008 - 2008/0238(COD)) (A7-0106/2010), and

– the report by Mr Perello Rodriguez, on behalf of the Committee on the Environment, Public Health and Food Safety, on the Commission Communication: Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States (2009/2104(INI)) (A7-0103/2010).

  Miroslav Mikolášik, rapporteur. – (SK) I am delighted to have this unique opportunity to appear before you today and to talk about the progress we have achieved in the negotiations in Parliament, and also in the subsequent trialogue on this very important topic of organ donations and transplants.

I personally consider this bill to be enormously important, not only as the chief rapporteur, but also as a doctor. I firmly believe that this new directive fundamentally addresses the greatest challenge we currently face in the process of organ donations and transplants, which is the shortage of organs faced by patients who are waiting for them.

In the context of providing the best health protection for European Union citizens, our goal is to ensure that human organs designated for transplantation are safe and of a high quality.

The Committee on the Environment, Public Health and Food Safety voted on the draft report on 16 March, when it was adopted by a clear majority in the context of the rapporteur’s recommendations. Subsequently, we completed three intensive interinstitutional trialogues involving Parliament, the Commission and the Council, under the leadership of the Spanish Presidency.

I would especially like to highlight the following points, which were key to our discussion.

First, the principles applying to organ donation.

Voluntary and payment-free donation is a fundamental principle which must not be challenged in any way or under any circumstances. The altruistic nature of donation must be preserved so that we can prevent any form of commercialisation or financial motivation of donors. At the same time, the greatest possible protection must be ensured for living donors. Here, I would like to mention the lively discussion provoked by the topic of organ donation by living donors. On the one hand, this method remains complementary to the acquisition of organs from dead donors but, on the other, it is an alternative with remarkable potential.

Of course, it is not our intention to prevent progress in this area, but we must ensure that the donation of organs by living donors who do not have a genetic or family connection with the recipient is always voluntary and payment free. The principle of non-payment does not apply to cases of so-called compensation, where a living donor may receive a contribution in line with the expenditure related to donation. However, Member States must precisely define the conditions under which such contributions can be made, so that we can avoid any kind of financial incentive or profit for potential donors.

Other important matters in the context of principles include allocation criteria – ensuring that organs are not taken from a person before the legal acknowledgement of death, and the fully-informed consent of the donor. We defended these in the introductory parts of the provision known as the recitals.

The second principle includes traceability, protection of personal data and confidentiality. Member States must ensure that all organs which are taken, allocated and transplanted on their territory can be traced from the donor to the recipient and back again. This concept has replaced the original proposal for anonymity, which is inimical to the safety of the process. Personal data must remain confidential.

The third principle is the framework for quality and safety. We expressed clear agreement that Member States should set up a national framework which will set out all stages of the process organisationally, from donation to transplantation. The Member States will subsequently inform the Commission about the activities and results achieved in the context of fulfilling this regulation within three years of it entering into effect. Here, we are expecting great progress, especially in the case of countries where the system is not sufficiently well developed and which may significantly increase the number of transplants through the adoption of appropriate systemic measures.

I would especially like to underline the role of the transplant coordinator or coordination team, the importance of which is beyond question. It has proved its worth in many countries where operations run smoothly.

I would like to end by mentioning criteria such as the organisation and performance of collections, the specification of roles for competent authorities, the involvement of third countries, the swapping of organs with third countries and the safety of the process. We approved the so-called delegated acts under provisions based on the Treaty of Lisbon (I will finish shortly).

Finally, I would like to emphasise how hugely important it is to increase public awareness, and I would therefore like to call on the Commission to encourage the Member States to promote organ donation via special programmes. I would like to thank everyone who contributed to the successful course of the negotiations, and especially to applaud the efficient and constructive approach of the Spanish Presidency.

  Andrés Perelló Rodríguez, rapporteur. – (ES) Madam President, Mrs Jiménez García-Herrera, Commissioner, it is 43 years since Dr Christiaan Barnard said the sentence ‘Jesus, dit kan werk’, which in Afrikaans means ‘Jesus, this is going to work’, as he watched in disbelief as the heart he had just transplanted was beating. In that time, it has become common practice to transplant a useful organ from a person who no longer needs it to another who needs it in order to live.

It is, however, also true that this has not yet prevented 56 000 Europeans from being on the waiting list, and has not prevented the possibility that 12 of those people will have died by the end of this debate because they do not have the organ that they need. Therein lies the challenge for Parliament which, in this plenary sitting, has to adopt both the directive, which was explained so well by Dr Mikolášik, and also the action plan.

There is no doubt that we need to offer clear and efficient channels of support for the European public so that no European dies due to a lack of organs as a result of shortcomings in the transplant system.

Europeans living longer, a reduction in traffic accidents and advances in science are, of course, to be celebrated, but they also mean that more organs need to be available as there are more people who need them.

The response from Europeans when they are asked whether they are willing to donate organs in order to save the life of a fellow citizen is very strong and very positive. The reason that this is often not directly reflected in the number of transplants carried out in each country is undoubtedly because we need to improve essential aspects of our transplant system such as coordination, information, professional training and educating the public on this issue.

In some countries, we have examples that show that when coordination and training are at optimum level, the number of transplants per million people increases. If you will allow me, I will quote the example of Spain, where a model has been established that must be used as a benchmark.

In addition to the guarantees of quality and safety in transplants and the complementary, free and voluntary nature of transplants from living donors established by the directive, there are the recommendations established by the action plan on the need for continuous training for professionals, and for society to be provided with information and education on this issue, without which it is difficult to work.

All of this forms the basis for optimising what we could call a harmonised European transplant system shared by all the Member States as an instrument for achieving the objective that we have set ourselves. Our objective is simply to reach the point where no European dies because he lacks an organ that he needs in order to live due to systems that have not been perfected.

In 21st century Europe, we cannot allow a lack of coordination or of optimised systems to cause an organ to be lost so that another European cannot benefit from it. This is what the adoption of this directive and action plan is achieving, which is the result of hard work.

I would like to take this opportunity to highlight the willingness and cooperation shown by both the rapporteurs – in this case Mr Mikolášik – and the shadow rapporteurs. I would also like to highlight the major impetus that the Spanish Presidency – represented by the Spanish Ministry of Health and Dr Matesanz, as Director of the Spanish National Transplant Organisation – have given to this directive and to the action plan, because we have been able to count on them at all times.

I would like to stress that those who have worked so hard deserve our thanks and ask you to repay them by unanimously adopting this report. As a Member, I am thankful for the work that has been done, and as a European I am thankful that this step is being taken to save the lives of all the citizens of the Union who might need it at any time.

  Trinidad Jiménez García-Herrera, President-in-Office of the Council. – (ES) Madam President, Commissioner, ladies and gentlemen, I am delighted to be appearing before Parliament’s plenary sitting to take part in the joint debate on organ donation and transplantation.

This is certainly an important debate, firstly because it has a direct impact on people’s lives and on the health of thousands of Europeans. In this respect, I would like to remind you that, despite the constant increase in the number of donations and transplantations in recent years, it is estimated that currently there are 56 000 patients in the European Union on the waiting list for the right organ, and many of them die before receiving it.

Secondly, it is an important debate because it enables us to enhance the generosity and solidarity of our society. Allow me to give you an example: currently in the European Union, there are 18 donors for every million inhabitants. If we were able to increase this figure to equal the highest figures, such as 34 in Spain or more than 30 in Portugal, 20 000 more lives would be saved in Europe.

Likewise, promoting organ donation by living donors across the European Union to the levels in Scandinavian countries, the United Kingdom and the Netherlands would free a further 2 000 people from dialysis every year. We should never forget, ladies and gentlemen, that without donors, there can be no transplants.

The debate this afternoon is going to enable us to give a definitive boost to the launch of a common Union strategy for achieving the best structure in the world for organ donation and transplantation. Moreover, Article 168 of the recent Treaty of Lisbon gives us the opportunity to create this common, high quality and safe framework for the process of donation and transplantation.

We now have two important Commission initiatives on this, which were presented in 2008, and on which the Council, along with Parliament, has worked very hard and very generously in recent months.

The first is the proposal for a directive regulating the quality and safety aspects of organs intended for transplantation. As I said, this directive establishes a common legal framework which must enable us to limit certain risks in all the stages of the process of using organs for treatment, from donation to transplantation. This involves guaranteeing the quality and safety of the organs but also protecting donors and recipients by appointing the competent authorities.

Secondly, we also have an action plan that helps to strengthen cooperation between the Member States, the objectives of which are threefold: first, to increase the availability of organs; second, to improve efficiency and accessibility to the transplant system; and third, to improve quality and safety.

Ladies and gentlemen, these two initiatives give us a common framework, which is a European framework that incorporates not only the best shared elements, but also the best of good organisational and welfare practice that the different Member States have been building up in this field. In other words, it is a framework based on quality, security and innovation.

We are doing so by establishing a European model for donation and transplantation around values and principles that we all share: solidarity, fairness and cohesion, which are the symbols of the Union’s identity. This will help to achieve self-sufficiency in organ donation and therefore to combat transplant tourism.

I am sure you will agree with me that the entry into force of this directive and Parliament’s support for the action plan will, in themselves, boost the exchange of organs between the Member States and promote donation.

Firstly, we are establishing an EU framework to give Europeans equal access to health in general and to transplant treatment in particular. Secondly, this more efficient Union framework will directly benefit patients who, due to their characteristics, have a smaller chance of finding an organ that suits their needs. As a result, there will be a reduction in the number of organs wasted due to the absence of a suitable recipient in a particular geographical area.

Ladies and gentlemen, before I conclude, the Spanish Presidency would like to thank the Czech and Swedish presidencies for the work that they did in beginning the negotiations in 2009, creating the circumstances for significant progress thanks to the cooperation of the Member States and the Commission.

The Spanish Presidency would also like to thank Parliament for its hard work and particularly the rapporteurs, Mr Mikolášik and Mr Perello, for the work that they have done to promote the necessary agreement and consensus.

It is through the joint work of all the Union’s institutions that we have to reach an agreement that will enable us to launch a European service which, on the one hand, will give 500 million people the best guarantees of quality and safety and, on the other, will promote equal access to the treatment on which so many lives depend every year, and also the solidarity of our society. Let us enhance what the European Union means today.

  John Dalli, Member of the Commission. – Madam President, 56 000 Europeans are waiting for an organ transplant in Europe; for many of these people, a successful transplant is a matter of life and death. This is why we are here today: to ensure high quality and safe organ transplantation across Europe. This is what the Commission’s proposal for a directive and the action plan are about. I would like to thank the rapporteur, Dr Mikolášik, and the shadow rapporteurs for their excellent work on the proposed directive on the quality and safety of organs. I would also like to thank Mr Perello Rodriguez for his supportive own-initiative report on the action plan on organ donation and transplantation.

Let me recall that the key objectives of these two initiatives are to improve quality and safety for human organs for transplantation, to increase organ availability and to make transplantation systems more efficient and accessible. The proposal for a directive sets the legal framework for quality and safety requirements, and the action plan focuses on increasing the availability of organs, and the efficiency of transportation systems.

The six-year action plan sets out 10 priority actions to reinforce cooperation between Member States through joint actions and the sharing of best practices. I note the wishes of Parliament to include in the action plan activities which could not become legal obligations in the directive under Article 168 of the treaty, in particular, regarding criteria for allocating organs, recording the wishes of potential donors and issues related to medical practices. The Commission is willing to support the Member States in addressing these issues of importance to Parliament.

With regard to the directive, I am very pleased that we are now close to a first-reading agreement following swift and constructive dialogue between Parliament, the Commission and the Council. I believe that this is the first agreement to be reached at first reading since the entry into force of the Lisbon Treaty.

I am convinced that the text with the amendments proposed includes Parliament’s key concerns as set out in Dr Mikolášik’s report. Allow me to comment on a few specific issues.

I strongly support strengthening the principles of voluntary and unpaid donation, which are essential for ensuring the quality and safety of organs. I also welcome clarification that the principle of non-payment shall not prevent living donors from receiving compensation, provided that this is strictly limited to covering the expenses and loss of income related to the donation. I fully share Parliament’s concern as regards combating organ trafficking. However, the scope of the proposal is limited to quality and safety as stipulated in the public health article of the treaty. In this context, I welcome the text stating that the directive will indirectly contribute to combating organ trafficking, for example, through the authorisation of transplantation centres, the establishment of conditions of procurement and systems of traceability of organs.

I also understand Parliament’s concern about transparent, non-discriminatory and scientific criteria for organ allocation. Although the matter falls outside the EU’s sphere of responsibility, I can accept the inclusion of this principle in a recital. I also welcome the fact that the text proposed recognises that living donation coexists with deceased donation in most Member States. Living donation increases the number of available organs and I welcome the text strengthening the efforts to protect living donors as a means to guarantee quality and safety of organs for transplantation.

Moving on, as regards the provisions dealing with consent systems and certification of death, these issues are governed by national law. However, in the spirit of compromise, the Commission can accept the additional clarifications proposed. I also note Parliament’s wish to include in the action plan activities which cannot be covered by the directive, in particular, regarding criteria for allocating organs, recording the wishes of potential donors and issues relating to medical practices. The Commission is willing to support the Member States to address these issues.

Let me also raise another issue: adopting a law is the first step. What really matters is that the law is implemented. This is why the Commission insists that Member States report how they transpose directives into national law: the ‘correlation tables’. Parliament has always supported this. I regret that, for the very first time, Parliament does not support inclusion in the directive of the obligation for Member States to report on transposition.

Finally, several amendments align the proposals to the comitology provisions of the Lisbon Treaty. I welcome the possibility granted to the Commission to adopt, in clearly defined cases, delegated acts under the urgency procedure in this regard. I declare that the European Commission undertakes to keep the European Parliament and the Council fully informed on the possibility of a delegated act being adopted under the urgency procedure. As soon as the Commission services foresee that a delegated act might be adopted under the urgency procedure, they will informally warn the secretariats of the European Parliament and the Council.

I also declare on behalf of the Commission that the provisions of this directive shall be without prejudice to any future position of the institutions as regards the implementation of Article 290 of the Treaty on the Functioning of the European Union, or individual legislative acts containing such provisions.

To conclude, let me state that the Commission is prepared to support the compromise package.

  Cecilia Wikström, rapporteur for the opinion of the Committee on Legal Affairs. – (SV) Madam President, I would like to begin by thanking Mr Mikolášik for such excellent and very constructive cooperation on this important report.

There are many challenges in the area of the donation and transplantation of human organs. We have a responsibility and must live up to the expectations of the great number of people on the waiting lists who live in uncertainty from one day to the next, as they await the new life that a new organ can bring. The line between life and death does not come any clearer than this.

The tasks of the European Parliament also include conducting a determined battle against the despicable trade in human organs. That is also something that we are doing. By laying down clear ethical and safety rules, we can better ensure people’s self-evident right to their body, their integrity and their self-determination. I am pleased that the views advanced by the Committee on Legal Affairs have been taken account of.

It is hard to paint a finer picture of our common purpose than that of safeguarding people’s lives in our various Member States. This report portrays that picture very clearly.

  Eva Lichtenberger, rapporteur for the opinion of the Committee on Legal Affairs. – (DE) Madam President, ladies and gentlemen, yes, it is true, this is a question of life and death. That is precisely the reason why this debate is quite so emotionally charged.

There are completely different systems for organ transplantation in the different countries of Europe and for how people give their consent or non-consent, whether people’s own organs may be used or whether family members can consent to a transplant. In future, under this report, those countries with very restrictive systems ought to take a very close look at the examples of other countries in order also to observe the positive effects. Since, when so many people are waiting for transplants, that must be a signal to us, not only to create more opportunities and greater accessibility, but also to guarantee quality, safety and accessibility. That would also provide an important tool to combat the trading of organs – a truly ignoble activity – and make possible the better regulation of living transplants, which really must take place without payment.

  Peter Liese , on behalf of the PPE Group. – (DE) Madam President, Mrs Jiménez García-Herrera, Commissioner, ladies and gentlemen, the Spanish are the champions of Europe at football, most people know that, and it is nice, but it is not as important as the fact that the Spanish are also the champions of Europe when it comes to organ transplantation.

The key to the Spanish model, we should all understand this quite clearly, is the organisation in the hospitals. In other European countries organs, I am sorry to say, are lost, not because the family members were unwilling to give consent, or because the victim does not have a donor card or had stated that they did not want to donate their organs, but, for most organs in Europe that are lost, it is quite simply due to the fact that the doctors do not have enough time to deal with this matter.

Spain has organised this much better with its transplant coordinators. Wherever this system is adopted, more people can be saved and more people can live a healthy life without having to suffer dialysis and other difficult experiences. That is why we should really press home this point in the Perello report to the Member States.

The directive deals, above all, with quality and safety, but also with the effects on people who are waiting for organs. This is because, at present, an organ in one Member State may not be used because no matching recipient can be found fast enough. If we have common quality and safety standards, we can also improve cross-border organ exchange in order to help people. That means that this, too, is an important point.

Another very important element in the directive is that we must combat the trade in organs. This is a subject that we must not simply ignore. For that reason, a few other Members and I have also invited an expert who has investigated organ trading and the deliberate killing of people in China for organs to transplant to come and speak to us tomorrow. I would ask all my fellow Members to also take an interest in this topic.

With the directive and the action plan, we have sent a clear signal. Voluntary and unpaid donation is laid down in a legally binding way and I would like to thank everyone who has helped us to achieve these goals.

  Karin Kadenbach, on behalf of the S&D Group. – (DE) Madam President, Mrs Jiménez García-Herrera, Commissioner, ladies and gentlemen, I, too, would like to agree with the preceding speakers and open with the words ‘life is beautiful’. This is a sentence I hear again and again from a former colleague of mine, Vice-Governor Ernst Höger, who suffered a serious heart condition as a result of a tick bite but had the good fortune, in December 2004, to benefit from a matching heart donation. Ernst Höger is still alive and kicking, he walks among us, full of life and full of energy and he tells us that ‘life is beautiful’.

We have heard the figures today: 55-60 000 Europeans are waiting for the opportunity to be able to tell us in future, like Ernst Höger, that ‘life is beautiful’. Twelve of them are lost to us every day because our systems have simply not progressed to the stage where we can get the organs to the people who need them from another location where they become available in time. That is why it is our task to put that into practice. I believe that this action plan is something really important, that we must ensure the security of organ donations and transplants, that we must also give the living donors, who we also need just as much – I say that thinking purely of the many dialysis patients – the certainty of the best medical standard, and that we must be absolutely vehement in our fight against any trade in organs – in other words, voluntary and unpaid donation is the absolutely essential thing.

We must guarantee the consent of donors. We must develop Europe’s systems so that we can close the major gap between the one donation per million citizens in many Member States and the nearly 40 donations per million in Spain, our European champions. We should aim, together with our national health care systems, to implement these action plans as soon as possible and to guarantee the highest standard so that the 55 000 who are currently waiting can say that ‘life is beautiful’.

  Frédérique Ries, on behalf of the ALDE Group. – (FR) Madam President, tomorrow we are expecting to have this directive on organ donation and transplantation, which is essential. In Europe, some 60 000 patients awaiting a heart, lung, liver or kidney have been waiting for this law for years. Twelve of them die every day because they have waited too long.

Like those who spoke earlier, I would like to stress the excellent result that we have achieved, which would not have been possible without cooperation between our rapporteurs, Mr Perello Rodriguez and Mr Mikolášik, the shadow rapporteurs, of whom I am one, and the Spanish Presidency. I would like to take this opportunity to praise Dr Matesanz, who was our excellent guide during our visit to Madrid.

Let us not mistake the objective here. The main priority is indeed to increase the number of organ donations in Europe and, therefore, of course, at the same time, to make European men and women more aware of donation, as the disparities speak for themselves, they are quite blatant: there are 34 deceased donors per million inhabitants in Spain, 27 in my country, Belgium, and just one single donor in Romania. Therefore, we also have to educate people about this issue of donation; enable potential donors to access information; break down administrative barriers, which is essential; establish throughout the 27 Member States a national authority in charge of controlling the quality and safety of organs, from extraction from the donor to transplantation; and then also inspire – as has been said – better examples of organisation, such as exist, once again, in Spain, where progress is linked to a kind of early warning system, a constant warning throughout the chain, from the death of the donor to transplantation.

Our directive’s compromise, our famous Amendment 106, which sums up all our efforts, sends out the right message to patients, the message of hope, by authorising – and this was sometimes at the end of very in-depth discussions – the use of a non-optimal organ in cases of extreme urgency, especially by encouraging living donations, where this is possible of course. Here I am essentially talking about kidney or liver donations, donations which are necessary, which are fast expanding, which are encouraged by practitioners and specialists, and which, at the moment, still only account, on average, for 5% of donations.

Do more and cooperate more: that is the rationale behind the action plan that has been guided by Mr Perello Rodriguez. One example is my proposal for online enrolment in a register, in a national or a European donor register, with the idea of adding a reference to a person’s identity card or driving licence identifying him as a donor and therefore allowing matters to proceed more swiftly, where necessary.

I would just like to sum up for a second by saying that we have done an excellent job and that we preferred the ethics of hope to the ethics of prohibition.

  Satu Hassi, on behalf of the Verts/ALE Group. – (FI) Madam President, ladies and gentlemen, my thanks go to Mr Mikolášik and Mr Perello Rodriguez for their quite excellent work. The hardest question in the talks related to living donors. On the one hand, there are long patient waiting lists for a kidney transplant and, on the other, there is the need to protect living donors and prevent the illegal trade in organs and the extreme exploitation of poor people that is associated with it.

We did not achieve the sort of good result that we in the Group of the Greens/European Free Alliance would have liked. The safest solution as far as the human rights of donors are concerned would be to insist that Member States impose a strict national system to prevent the illegal trade in organs, if donations from living persons are to be allowed outside the sphere of family members and close relations. Although the legislative text negotiated is rather less robust in its objectives, I hope that all the EU countries will take strict measures to weed out the illegal organ trade. According to the Council of Europe, 5-10% of transplanted kidneys come from the illegal trade in organs, and that means thousands of victims a year. Voluntary donations that are free of charge are also the safest option, even for the recipients of organs.

There can be no crimes associated with the trade in organs unless there are middlemen and the demand. It has been appalling to read reports about how organs are bought in poor countries in regions such as Africa, Asia and even eastern Europe. The most shocking have been the reports that describe people actually being killed. For example, Australian organ transplant surgeons have condemned the practice in China of killing prisoners for their organs. We in Europe must do all we can to avoid creating a market for this kind of criminality.

  Marisa Matias, on behalf of the GUE/NGL Group. – (PT) Madam President, Commissioner, Mrs Jiménez, the lack of organs for transplantation is a major problem. It has already been referred to several times and it is a major problem that is raising questions for us, both about public health and about associated matters, such as the strengthening of the grey market and of organ trafficking; this last is in no way good for our health systems or our citizens. We must therefore fight this crime, and one way of doing so that seems more than important and more than relevant to me is through legislation and proposals such as those that we are discussing here today. That is why I want to focus on the most important issues raised by these two proposals.

The system that we have had up to now is one with enormous inequalities, because it lacks these two proposals. Inequalities between Member States, inequalities between existing systems, inequalities in access to organs, inequalities between members of the public: I believe that we cannot put up with these inequalities. It is therefore important to reduce them further and these proposals seek to do exactly that. Nonetheless, I think that a European system that maintains some of the specificities of some countries, so that they are not obliged to have more restrictive systems, is the response to this problem. The work that has been carried out by the rapporteurs, Mr Mikolášik and Mr Perello Rodriguez, is extremely important and contributes to solving the problem that we are facing.

If we are talking about proposals that are based on, and supported by, issues such as donation, volunteering, gratuitousness, confidentiality, safeguarding of data, traceability, accountability – and here I think that Parliament’s interest in helping until the patient recovers and not just in donating is important – and cooperation between Member States, we are on the right track.

However, in relation to donations between living people, I must just mention that I am pleased that this enlargement with rights has been included. Obviously guaranteeing all rights and all conditions, but it is very important to have gone beyond the restricted circle of the conventional family because, if not, that would be another way for us to have other forms of inequality. Therefore, promoting donation as the main source of transplantation, as well as protecting the data and security of patients, seems to me to be more than enough reason for us to all be together this morning and vote in favour of these two proposals that are extremely important for the European Union.

  Anna Rosbach, on behalf of the EFD Group. – (DA) Madam President, I hope that no one here ever needs to make use of this directive. Twenty seven EU countries means 27 different sets of regulations plus people from countries outside the Union who have been illegally let in and who, because they are poor, are willing to donate a kidney for very little money. Unfortunately, in recent years, we have seen a number of examples of botched work that has affected both patients and donors. We therefore need coordination at EU level and, of course, we must ensure that both recipient and donor receive the best possible treatment. In a couple of EU Member States, you are born a donor, whereas in most countries, you can only donate by making an active personal decision to do so. Thus, we are in a situation where we have 27 different statutory regulations and insurance schemes, which does not exactly promote opportunities for cooperation.

It is an extremely complicated subject that we are talking about, because we must also ensure that the quality of organs is a top priority. For health reasons alone, it is important for us to take up the issue of illegal donation, as we often do not know the donor and hence, his or her state of health. It would be very unfortunate if we were to end up with kidneys, hearts and other organs coming from donors with contagious diseases, infections, leukaemia or worse. We therefore need to screen the organs concerned before they are used. We need to be sure that interventions are carried out safely, in other words, that the personnel responsible for the operation itself are well trained in their field and that the highest level of monitoring is carried out.

  Pilar Ayuso (PPE). – (ES) Madam President, Commissioner, Mrs Jiménez García-Herrera, I would first of all like to highlight the work done by the rapporteurs – Mr Mikolášik and Mr Perello – and all the work that they have done to reach the best possible compromise for a transplant policy in the European Union.

I would also like to highlight the contribution made by the Spanish Presidency and by Dr Matesanz, the Director of the Spanish National Transplant Organisation, because Spain is currently the world leader in terms of donations, with 34.4 for every million inhabitants. This is solely due to the constant improvement in organisation and to the measures that have been taken to raise awareness among the population about organ donation.

We need to achieve this for the whole of the European Union: increase the number of donations, ensure that all transplants are done to the same quality standards, and also promote cooperation between all the Member States.

We also need to ensure that every donation is voluntary and not rewarded, with the exceptions listed by Commissioner Dalli, in order to combat organ trafficking, which is entirely linked to a scarcity of organs. The action plan can contribute to this by helping to solve the shortage of organs and improving public access to transplants.

The solution that has been reached for living donors is very important, as we cannot forget that living donations are complementary and have been shown to be effective even if there is no genetic relationship between the donor and the recipient.

  Gilles Pargneaux (S&D). – (FR) Madam President, Commissioner, to encourage, coordinate and supervise organ donation: those are our objectives, and that is why it is very important that we be gathered together here to enable the development of organ donation and transplantation in Europe.

Currently, 60 000 people – European men and women – are awaiting transplants in Europe and, according to our estimates, 12 people die every day for want of a transplant, because, while 81% of Europeans say they are in favour of organ donor cards, only 12% possess one. It is, therefore, first of all, a question of harmonising practices by following the example of Spain, the star pupil of the 27. Organ donation rates vary considerably from one country to another. It is therefore a question of harmonisation.

As you indicated earlier, Commissioner, the challenge is also to create a European network of organ donors, which would allow us to better satisfy the needs of European citizens.

It is also a question of improving cooperation among all the Member States. We must ensure that we can establish national authorities that will be responsible for controlling organ quality and safety, from extraction from the donor to transplantation. For example, in France, a person waiting for a liver transplant could thus receive a compatible organ from Germany or Italy, knowing that minimum common standards are applied throughout Europe.

It is also a matter of reaffirming, as has been indicated, the free and voluntary nature of donation as a more effective way of combating organ trafficking and transplantation tourism and thus, of stopping rich patients from going abroad – to China, for example – to receive a transplant.

Finally, I welcome the action plan aimed at developing transplants in Europe, on which we will also vote today, and I am delighted with the work of the rapporteurs and, in particular, with the report by Mr Perello Rodriguez.

  Miroslav Ouzký, on behalf of the ECR Group. – (CS) I would first like to express my astonishment that a representative of my group has been interrupted in the introductory part of a speech on behalf of the group. It was clearly just an error of some kind.

In my speech, I would like to praise the work of both rapporteurs, which I consider to be very valuable. If there is one area in health care and public health that is genuinely European, then it is surely transplants. This standard is a logical and very welcome step. I would also like to applaud the rapporteurs for leaving out the ethical element, which will naturally fall within the scope of the Member States. As has already been said here, there is a different approach and, in my own country, for example, we use the previously mentioned principle of assumed consent. Some countries, on the other hand, require explicit consent.

In my opinion, this is a foundation stone which can improve and expand the scope of the existing Intertransplant, and if it has been said here that this is clearly the first standard that can be adopted at first reading following adoption of the Treaty of Lisbon, then I am pleased about that. However, I am even more pleased that this is a topic which is genuinely European. I value that highly.

  President. – As far as the list of speakers is concerned, the cause is being looked into.

  Oreste Rossi (EFD). – (IT) Madam President, ladies and gentlemen, increasing the availability of organs, improving their quality and access to them and making the public more aware of these issues: these are the demands of the European Parliamentary Committee on the Environment, Public Health and Food Safety in order to reduce the waiting lists for transplants.

We therefore need to promote biotechnological research and organ circulation within the European Union, but we also need to introduce a European donor card, prevent transplant tourism, and strengthen our opposition to the illegal trafficking of organs, by imposing strict penalties upon those responsible. In order to avoid illegal practices, living donations must be considered only as a last resort, when there are no other possible options, such as post-mortem donation. The living donor must not receive remuneration of any kind, other than compensation to cover inconveniences following the operation, to be determined by national regulations.

Member States should also approve or maintain strict legal measures over transplants and living donors who are not blood relatives, in order to make the system transparent and to rule out the possibility of illicit organ sales or forced donations. They must also ensure the reimbursement of social costs for living donors and protect them against discrimination, especially by insurance systems.

Parliament emphasises, however, that living donations must be considered complementary to donations after death. Organ donation must remain strictly non-commercial, supporting the measures aimed at protecting donors and ensuring that organ donation occurs on a voluntary basis, for altruistic reasons.

  President. – Mr Ouzký, many thanks once again for bringing this to our attention. We have looked into it. It was a problem in the allocation caused by the computer system. You will thus be listed in the minutes as the speaker for your group. I hope that this resolves the issue. Thank you for pointing it out.

  Elisabetta Gardini (PPE). – (IT) Madam President, ladies and gentlemen, Commissioner, today we find ourselves discussing organ transplants, which is, without doubt, one of the most positive aspects of progress in the sphere of health, but which also opens up a series of problems concerning the rights of the donor and the patient, which must be dealt with on ethical, social, legal and economic levels.

It is a question of embarking on a virtuous path that addresses the serious imbalance between the need for and the quantity of organs available, without damaging the principle of free, voluntary donation. The aim must be that of preventing all forms of commercialisation and illegal trafficking, ensuring the quality and safety of organs destined for transplants and introducing measures that combine confidentiality and traceability. It goes without saying that, in the context of cross-border exchanges and significant differences between the transplant systems used in different Member States, these objectives can only be reached by promoting coordination and cooperation.

On this note, I think it is very important to establish a European database and to adopt common quality and safety standards. We must, however, be careful not to introduce pointlessly rigid rules or create further bureaucratic burdens which compromise a process that is currently taking place correctly and efficiently. This would not only fly in the face of our aims …

(The President cut off the speaker)

  Kristian Vigenin (S&D). – (BG) Madam President, Commissioner, ladies and gentlemen, we are discussing a topic which, by its very nature, directly affects a limited number of people, compared to other issues which are important to health care in the European Union. On the other hand, it is a subject of heightened interest for two basic reasons. The first reason is that transplants are perceived as a crowning achievement of modern medicine. The second reason is that, in practice, all citizens are potential donors, which raises many questions of a different nature.

In addition, I want to emphasise that human life is priceless and that every conceivable effort must be made to save such a life. Statistics show that the situation differs greatly among the various Member States. In some countries, a good structure has been set up across the whole chain, whereas in other countries, health care systems are experiencing enormous difficulties and transplants are more likely to come under the heading of ‘exotic medicine’. Patients requiring transplants in these countries are forced to resort to transplant tourism, clearly aware of the high risk involved and that they are infringing the law and ethics as their life is often saved at the cost of another life taken or destroyed through violence.

It is important to avoid the commercialisation of organ donation and to guarantee that the donation of organs from live donors is completely free, while obviously ensuring the provision of all the necessary care and compensation for loss of earnings. It is particularly important to set up a transparent system for monitoring organs within the European Union, including after transplantation as well.

I believe that the proposed directive will improve access to organs for European citizens requiring a transplant, increase trust in the donor system and encourage the exchange of good practices which can be applied at supranational level.

  Marina Yannakoudakis (ECR). – Madam President, we all support directives that help save lives, and I would like to congratulate the rapporteur on his work with a report that seems simple in principle but is, in fact, complicated in detail.

In the area of post-mortem donations, there are issues of a delicate nature to be addressed, such as ethics, the deceased family’s positioning, the question of whether donor cards should be compulsory and, indeed, whether there should be a European donor card. All these areas need to be treated with respect as there is no right or wrong approach.

The area of living donations has been the most challenging. There is an important red line that cannot be crossed and this line ensures that living donations can be made freely and with no financial gain.

The directive has achieved the balance between ensuring a good quality of post mortem donations, while recognising the need for living donations. Its strength is in its recognition that post-mortem donations alone cannot achieve the supply of organs needed and therefore has set up controls and guidelines to ensure that when living donations are made, they are done in a correct manner, protecting both donor and recipient and ensuring that it is done on a free and voluntary basis.

(The President cut off the speaker)

  Horst Schnellhardt (PPE). – (DE) Madam President, Commissioner, ladies and gentlemen, I, myself, have a staff member who was reliant on an organ transplant. I have seen how pleased he was that he was able to benefit from this. However, I also saw how he waited and how his quality of life was restricted. It is therefore important that we adopt this proposal now. A thousand patients still die in Germany every year – and this is a fact – because no organ is available, and it is therefore important to rectify this shortcoming and to guarantee quality. There is a high social relevance to this.

In Europe, we have the best conditions to be able to achieve a significant improvement, thanks to the existence of the internal market and the European institutions. Let us make use of those conditions. I am very pleased that we have stipulated in the directive that donations must be voluntary and unpaid, thus ensuring that human dignity is maintained.

As far as the fall in donors is concerned, I would like to ask the Commission – it has already proven this several times – to generate a culture of discussion and information in Europe so that acceptance amongst citizens is reinforced. I really do not believe that we need to harmonise the differing systems. What we need to do is coordinate them and I think that the appointment of a transplant coordinator in hospitals is an important step.

(The President cut off the speaker)

  António Fernando Correia De Campos (S&D). – (PT) Madam President, Mrs Jiménez, Commissioner, the ability to replace deteriorated human organs with those of another person, preventing it from being rejected, is one of the great successes of contemporary medicine. European benchmarking shows differences. It shows that average countries like Portugal do very well in such comparisons and that larger countries such as Spain are today recognised as leaders in terms of organisation and best practices.

There are some principles and practices to be safeguarded. First, the strengthening of any scientific knowledge and information that leads increasing numbers of donors to donate whilst alive and making post mortem donation general. Second, the banning of commercial donations not only in the Member States but outside them too, banning transplant tourism and fighting organ trafficking. Third, the proactive promotion of donation in hospitals as a way of overcoming shortages.

Lastly, Madam President, guaranteeing equal access to transplants for all those who need and qualify for one under harmonised clinical criteria, obeying the principle of universal access to health: a paradigm of social Europe of which we are proud. Congratulations to the rapporteurs on their work.

  James Nicholson (ECR). – Madam President, first of all, I would like to thank both rapporteurs, who have worked very hard on these reports and have produced between them an excellent body of work and, within, a real plan for organ donation and transplantation throughout Europe.

We are all well aware of the figures – thousands of people across Europe require organ transplants every year. In light of this, I am glad to see that we are going to make concerted efforts to boost the numbers of organ-donor registers by encouraging different forms of registration schemes and strengthening our cross-border cooperation so that the best matches between donors and recipients can be made. For me, the key issue is raising awareness and I believe these reports will help achieve this.

Can I also say that I am glad to see that we have highlighted in these reports the key principles that organ donation should always be altruistic, voluntary and unpaid. This is important if we are to encourage people to donate and ensure the quality and safety of the system as a whole. Many lives have been saved. Many more can be. I commend this report.

  Theodoros Skylakakis (PPE). – (EL) Madam President, the directive we are debating today will concern more and more people over coming years, as medical technology and genetics progress. We literally cannot forecast today the number of transplants that will, at some point, be covered by this directive, which may become much more important than we imagine.

That is why it is very good that the text has solid foundations based on altruism and voluntary donation and requires the Member States to adopt very strict procedures for the whole endeavour. However, one drawback of the compromise on which we will be called to vote is that it waters down controls in comparison with the text we initially voted on, saying that there will either be a control or an ‘audit’, whereas the initial text made provision both for control and evaluation of organisations which will carry out transplants and provide organs. This is a weakness and I hope and believe that it is not serious. However, I consider that it is important to point it out, because transparency is the key to the issue of transplants.

  Zbigniew Ziobro (ECR). – (PL) Madam President, transplantation and transplantology need our strong support and, as a matter of priority, they need better organisation and coordination as part of health care services. However, it is also extremely important to increase the trust of society in this branch of medicine, especially because every so often, news comes to the attention of public opinion in Europe about a variety of irregularities, including the illegal trafficking of organs from unknown sources.

As Public Prosecutor General in Poland, I supervised an investigation in which a series of irregularities in obtaining organs was found, including illegal payments made to doctors, which motivated them to look for information about donors with suspected brain death. For supplying information about a single donor, doctors in Poland could earn more than one month’s salary.

In the matter of transplantation, society must be sure that everything is being done in accordance with the law, transparently and without any hidden interests, and that this noble medical procedure is not being used as a cover for considerations other than that of saving human life. Trust is absolutely essential.

  Françoise Grossetête (PPE). – (FR) Madam President, Minister, Commissioner, today we are having a debate that clearly shows that the evidence is alarming and that, in order to rise to this challenge, we must strengthen the cross-border exchange of organs so as to make the link between donors and receivers. It also shows that, given the length of waiting lists, the absence of such action will mean that there is very little chance of patients receiving the organs they need.

Common binding standards on the quality and safety of donations in the 27 Member States absolutely must be adopted in order to improve cross-border exchanges and to increase donation rates. That is why a European framework on the issue is required.

Of course, we must be extremely vigilant as regards the issue of illegal organ trafficking. All measures must be implemented to combat mafia-style networks and transplantation tourism. However, care must be taken not to hinder donations from living donors, which must be a matter of free and informed choice. We must guarantee the principle of free transplants and prevent any pressure from being put on potential donors.

We must therefore encourage those patients who want to freely give their organs to save lives, because the risks of rejection during these transplants are significantly lower than in cases where the organs come from deceased donors.

I would also like to warn those who, for ethical reasons, would like to limit organ donations from living donors in Europe, by arguing that there are risks of trafficking. The donation of organs from living donors must, above all, be very strictly regulated, and that is the only solution.

  David Casa (PPE). – (MT) Madam President, as the Commissioner mentioned, there are around 56 000 persons awaiting organ transplant surgery within the European Union. Many of these cases, as has already been said, can mean the difference between life and death and therefore, I believe that these are important developments that merit further discussion. The measures will not directly add to the number of organs to be transplanted, yet the implementation of common practices within the Member States should increase the level of trust and reliability between these countries which, in turn, will lead to an increase in organ donations both within and amongst countries.

Some of the problems mentioned in the report, such as organ trafficking, cannot be directly addressed. However, I appreciate the rapporteur’s efforts in increasing awareness on this issue and I hope that these are annexed to the final document in a non-binding manner. To conclude, I would like to congratulate Commissioner Dalli and the rapporteurs for the good work carried out on this sensitive topic.

  Daciana Octavia Sârbu (S&D). – (RO) Transplants and organ donation save and prolong the lives of thousands of European citizens every year. It is unfortunate that thousands of other patients die while waiting for a transplant, even though there are compatible donors available in the European Union. This is a difficult and controversial issue which raises important questions. Parliament confirms through this report a common viewpoint, which is that any commercial element in this process which may lead to the sale and purchase of organs is illegal.

It is vital for us to approve and implement an effective system as quickly as possible, not only because we will save patients’ lives, but also because such a system will reduce the request for organs which, otherwise, will be obtained illegally for profit and even against the donors’ will.

  Izaskun Bilbao Barandica (ALDE). – (ES) Madam President, I would like to congratulate everyone on this initiative, because it means improving the life expectancy of many people and making solidarity and fraternity into something more than just words.

The Basque Country – Euskadi – has the world record for organ donation. In 2009, we had a rate of 38.5 donations for every million inhabitants. This means that every year, we carry out 60 kidney transplants and 30 liver transplants for every million inhabitants. In the United States, the figures are 54.7 and 21.4; in Europe, they are 35.1 and 13.4; and in Spain they are 48.8 and 24.6.

This success is due to the protocol used in hospitals in order to secure donations and a process of organisation and awareness raising, which are the two ideas that we need to support. It is also due to the work begun in 1986 with the creation of the regional transplant coordination system: another example of how the regions can make their contribution to Europe.

  Frieda Brepoels (Verts/ALE). – (NL) Approximately two years ago, the European Parliament adopted the Adamou report by an overwhelming majority. The report discussed the policies at EU level in the field of organ donation and transplantation for the first time. It was my very great pleasure to cooperate on this as one of the shadow rapporteurs.

Today, I note to my great satisfaction that the rapporteur, Mr Mikolášik, and his shadow rapporteurs, have done a splendid job and, even in this short period of time, have succeeded in achieving an agreement with the Council at first reading. For the most part, the key points of the report from two years ago have been incorporated and built upon. I hope, therefore, that this directive and action plan will result in an increase in the number of organ donors in the European Union, so that patients no longer need to end up on waiting lists.

  Krisztina Morvai (NI). – Madam President, I would like to have some guidance from the rapporteur on two issues. One is the issue of the ‘presumption of consent’ system and the ‘presumption of the lack of consent’ system. As I understand it, these two systems still coexist in Member States. In one system, it is presumed that the deceased donor would have consented to the transplantation. It seems to be quite obvious that this is a much more effective system from the point of view of the number of transplantations made available. Should it not be recommended to every Member State to use the presumption of consent system?

The other thing is anonymity versus traceability. There seems to be a kind of controversy between the two. What are the issues here? What is anonymity and traceability?

  Alf Svensson (PPE). – (SV) Madam President, around 95% of us say that we would want an organ transplant if it would extend our life. No more than roughly half of us are prepared to donate organs, however. We therefore need to influence public opinion in this area.

Can coordination be improved? Absolutely. A heart that is removed from the body of a person who has died is viable for only four hours. That is how it was. Today, however, it is viable for up to 24 hours if we decide to utilise the modern medical technology that has been developed for transplantation.

We also now have medical knowledge that enables us to ‘cleanse’ or recondition lungs, to put it simply – so that they can be used for transplantation in ways that were inconceivable in the past. It is a known fact that the lungs live on for two hours after death has occurred.

Let us push for factual knowledge to be exploited in practice. I believe it is a basic prerequisite if this coordination is to become a reality and not just something that we talk about.

  Janusz Władysław Zemke (S&D). – (PL) Thank you very much for giving me the opportunity to speak. I would like to come back to what is, in my opinion, a fundamental matter.

In different Member States of the European Union, very different methods are used for identifying potential donors. In some countries, written consent is required from a potential donor, while in other countries, it is assumed that if there is no objection, an organ can be taken from that donor. These measures do, of course, have a fundamental influence on the number of donors. In relation to this, I would like to ask the representative of the European Commission if the Commission should not support more actively the second solution, where written consent is not required? A situation in which organs can be taken from those who did not express their objection to this would be enough to create a radical increase in the number of donors.

  Angelika Werthmann (NI). – (DE) Madam President, ladies and gentlemen, more than 55 000 patients are on waiting lists for an organ transplant. Nearly 10 people a day die whilst waiting.

Organ transplantation – yes, of course, but truly only voluntarily, with a declaration of consent and without payment, in order to be able to counter the illegal trade in organs and, of course, based on the highest possible quality and safety for those involved.

  Elżbieta Katarzyna Łukacijewska (PPE). – (PL) I am pleased that the question of organ donation and transplantation is a priority for the Spanish Presidency, because it can be said that this is a matter of life and death. Despite the fact that every year, the number of transplants rises, the number of those waiting for a transplant is not falling.

In spite of growing social awareness, a huge disproportion is noticeable between Member States in terms of donation and transplantology. Therefore, besides establishing a European model for donation and transplantation which will use the best practices and solutions, it is very important to improve social awareness and acceptance. This is why I am pleased that the model for the proposed measures is Spain, which has achieved the best effects, both in terms of numbers of donors and numbers of transplants performed, but also in gaining huge social support for the idea of organ transplantation and donation.

  Ricardo Cortés Lastra (S&D). – (ES) Madam President, Mrs Jiménez García-Herrera, allow me to start by telling you that I come from Cantabria, a small region of Spain with a rate of 61 donations per million inhabitants, the highest in Spain and in Europe. I would like to congratulate Mr Perello and Mr Mikolášik on this report and for supporting this proposal for a directive that has come as a response to the scarcity of organs in the European Union.

The success of the Spanish case is a model that can be useful to the rest of the European Union with elements such as the competent national authorities, traceability of organs and living donors.

I would also like to congratulate the Spanish Presidency on its firm support for this issue as one of its priorities.

Lades and gentlemen, as you are aware, nearly 56 000 patients are currently on the waiting lists. Donation rates and the availability of organs vary considerably between European countries. The lack of organs is a key factor affecting transplant programmes. The good practice that can be achieved produces much greater benefits in some Member States than in others. For this reason – I will now conclude – the adoption of this report is essential for improving this situation in all the Member States

  Salvatore Iacolino (PPE). – (IT) Madam President, Mrs Jiménez García-Herrera, Commissioner, ladies and gentlemen, these days, people are often denied the right to have a transplant. The denial of this right is perhaps the most problematic condition as far as social welfare is concerned, not least on account of its psychological consequences, and yet there remains a chronic discrepancy between the number of people on the waiting list and the number of patients who receive a transplant. Moreover, the donation procedure is very sensitive with regard to health and legal issues, and is often weakened by procedures that are generally cumbersome and slow, when instead we should be reinforcing the welfare response.

The European Union must therefore commit to ensuring real solidarity and voluntary action that does not make the procedures any less rigorous, by improving the professional nature and the culture of donation itself. Adopting common quality standards is therefore a definite step forwards, which must be viewed favourably as part of a goal to which the World Health Organisation can contribute further.

  Karin Kadenbach (S&D). – (DE) Madam President, I have followed this debate very closely. Words draw pictures in people’s minds. Today, we have repeatedly heard about the illegal trade in organs – about an illegal activity and about trade. I believe that this directive quite clearly states that the trade in organs is itself an illegal activity. We must not send out the signal that trade in organs could be legal in some circumstances.

I would ask Members to emphasise, including when dealing with the media, that we want organ donation, in other words, an activity where one party has a will to help someone to live longer but there is no payback except for gratitude. Thus, there cannot be any illegal trade in organs because no trade in organs is allowed. There is only organ donation.

  Trinidad Jiménez García-Herrera, President-in-Office of the Council. – (ES) Madam President, Commissioner, ladies and gentlemen, I would like to thank all of the political groups and everyone who has spoken for the support and the constructive tone of their speeches. I would also like to express my satisfaction, because with this agreement that we are achieving here today, in this debate, we are concluding a process.

In addition to the difficulty of legislating on technical aspects that could vary as science progresses, we have had to tackle the practical difficulties of applying the Treaty of Lisbon in this six month term. The Spanish Presidency would therefore very sincerely like to thank all the European institutions – Parliament, the Commission and the Council – and all the Member States for their cooperation in completing this exercise. It has been an exercise involving, firstly, flexibility and adaptation and, secondly, responsibility and a desire for consensus, which has been expressed this afternoon.

Ladies and gentlemen, we have succeeded in making the Union more effective and relevant to the public, and we should be pleased with this. However, as you are aware, the work does not end with the adoption of this directive. On the contrary: we need to continue to work towards ensuring that the spirit of protecting public health that we have sought and achieved is maintained when it is transposed.

We need to continue to work to generate more solidarity and maintain the social value desired by everyone who has been involved in creating and launching this directive. We also have a great deal of work left to do in the context of the action plan, which offers us a unique opportunity for continuous learning, adaptation and improvement.

Thank you once again to all the parliamentary groups for their support, their tone and their constructive attitude. Together, we are going to achieve this. We have already achieved it.

  John Dalli, Member of the Commission. – Madam President, following the very good collaboration between the Commission, Parliament and Council, I am convinced that we have now reached agreement on all the key issues. I would like to again congratulate and thank Dr Mikolášik and Mr Perello Rodriguez for their contribution.

I believe that by ensuring high quality and safety standards for human organs, the proposed directive will be of great benefit to European patients. The directive will provide a comparable safety standard across the Union and increased trust in transplantation systems. I am convinced that the proposed directive strikes the right balance between citizens’ data protection and organ traceability, and indirectly contributes to the fight against organ trafficking.

This is not the solution to all the problems in the area of organ transplantation; this directive provides the framework, clarifies the boundaries of responsibilities and sets some standards. However, more needs to be done in the area of organising our hospitals, collecting and disseminating information, proper characterisation of organs and action against illegal trafficking. In the latter context, traceability will go some way to redress this, but this depends on the enforcement exercised in Member States.

Member States are being given a great deal of flexibility, and we hope that all Member States will give this issue the importance it deserves. The competent authorities that they need to set up should be adequately equipped and resourced to ensure proper data collection and control, traceability, supervised standards, characterisation of organs and in transplantation and to conduct effective vigilance to report adverse events and reactions which will help all of us to minimise risk in the future.

President, Minister-in-Office of the Council, honourable Members, from the contributions of the honourable Members during this debate, it is evident that the compromise text which is on the table today responds to everybody’s concerns. Thank you for your input, your cooperation and your support.

Analytical Table of the Amendments on the Proposal for a European Parliament and Council Directive on standards of quality and safety of human organs intended for transplantation

(COM(2008)0818 – C6-0480/2008 – 2008/0238(COD))

Rapporteur: Mr Miroslav Mikolášik (PPE)

Amendments:

Directly acceptable: amendment 106 (Text as a whole, Block No 1, compromise amendment). The Commission is in favour of the adoption of the compromise text by the colegislators

  Miroslav Mikolášik, rapporteur. – (SK) I would like to thank you for your contributions to this discussion and to express the firm belief, which I think we all shared during the negotiations, that this directive goes beyond political controversy, because it is about people, about patients and about saving lives.

In my opinion, more organs and more successfully cured patients will mean that more people return to a full life, to their families and to new jobs or back to existing jobs, making a fundamental change to their quality of life.

Openness, accessibility, safety, quality, availability, altruism, more living donors, payment-free and voluntary donation – these are the principles we have all incorporated into this directive.

I believe that this directive will also provide more organs, thanks to better cooperation and cross-border swaps between individual countries, and that it will link EU Member States together in a new and fundamental way.

Through this directive, I believe we will all contribute something that we resolved upon at the outset: more consensus, more love, more cooperation and especially more happy patients.

  Andrés Perello Rodríguez, rapporteur. – (ES) Madam President, the fact that, during the difficult crisis period that Europe and the world are going through at the moment, Parliament has been able to adopt the first directive since the entry into force of the Treaty of Lisbon at first reading says a great deal about this House’s sensitivity. It also increases confidence in democratic institutions and shows that the Members of this House want to move forward and make progress at the same pace as science and with the same level of willingness and strength of solidarity as European society.

I do not know if we have done everything too well or if we could have done something more, but I do want to clear up any doubts that may have arisen. What I am sure about is that if we fulfil everything that we are going to adopt in this House, we will be giving people longer lives and preventing any organ trafficking crimes from being committed in the Union. These crimes may be committed anywhere else in the world, but that is absolutely not the case in the European Union.

Therefore, if, as a result of any speech, any of these doubts has remained in anyone’s mind, as fellow Members have said, I want to clear them up. That was not our task. We have tried to respect everyone’s conscience, the measures of ethics and morality, without losing sight of the fundamental objective: that not a single European should be left without the transplant they need to live, because we can achieve more transplants, and therefore less organ trafficking.

Therefore – and I will conclude now – I do not know if we have succeeded in saving everyone’s conscience with the work we have done, but I am totally convinced that we are going to save many lives. That was our task and that is what we have done.

  President. – The joint debate is closed.

The vote will take place on Wednesday, 19 May 2010.

(The sitting was suspended at 16.25 and resumed at 16.30)

Written statements (Rule 149)

  Jim Higgins (PPE), in writing. – I welcome the new legislation to regulate quality and safety standards of organ donation in the EU. In particular, the introduction of practical measures to help ensure that live saving organs are not wasted, such as the creation of a pan European organ database. The new law will save many lives and optimise the organs donated by allowing Member States to share organs. Before this legislation, if there was no suitable recipient in a particular Member State, the organ went unused. Now, the organ can be given to one of the 56 000 EU citizens awaiting transplants. This regulation constitutes an important framework which needs to be developed upon by the respective Member States. With reference to Ireland, we need an independent body to monitor the transplantation and harvesting of donated organs. At present, Ireland and Malta are the only two countries in EU without a national transplant authority to maximise organ usage. In order to eliminate transplant patient waiting lists, one of the primary aims of the resolution, we need to raise the profile of organ donation among EU citizens – in Ireland, this could be done by the introduction of a government supported awareness programme.

IN THE CHAIR: MRS ANGELILLI
Vice-President