Cord blood stem cells (debate) 
President
The next item is the Commission statement on cord blood stem cells.
John Dalli
Member of the Commission. - Mr President, honourable Members, scientific advances over recent decades have contributed to an increase in the use of cord blood stem cells in medicines. The use of such cells has led to positive results in treating patients with blood disorders such as leukaemia.
In future, cord blood stem cells could possibly be used to treat other conditions, in particular, genetic diseases. Similarly, adult stem cells are also showing promising potential. However, research still needs to bring proof of such potential benefits for both kinds of stem cells. The transplantation of substances of human origin, including cells, carries risks of disease transmission and that is why there is a European legal framework in place to ensure the quality and safety of human tissues and cells throughout the Union.
However, let me make this very clear: Member States alone decide whether and how to use cord blood stem cells. The EU has no competence to harmonise the use of cells. The Tissues and Cells Directive explicitly mentions that the EU should not interfere with national decisions concerning the use or non-use of any specific type of human cells. If, however, a Member State decides to use cord blood cells, then it must fulfil the directive's requirements on quality and safety, protect public health and guarantee respect for fundamental rights.
I agree with you that it is important to provide accurate and objective information to citizens about the advantages and limitations of the use of cord blood stem cells. Providing such information is, again, the competence of the Member States. The Commission encourages Member States to take such action and some have indeed already done so.
Finally, I can reassure you that the Commission regularly monitors the transposition and implementation of the Tissues and Cells Directive. In fact, the Commission adopted a communication on the application of the directive, which was sent to Parliament in January 2010.
Peter Liese
on behalf of the PPE Group. - (DE) Mr President, Commissioner, it is good to see that, even at this late hour, you are taking the time to join the debate in this House on this important issue. Ladies and gentlemen, stem cell research offers great opportunities for patients to whom we are unable to offer adequate help at the moment. In this field, much is not yet beyond the stage of fundamental research and still uncertain, but there are still over 70 diseases for which help can be offered to the patients in question in one way or another through adult stem cells and cord blood cells.
The cord blood cells are currently predominantly used for allogeneic transplants, in other words, the cord blood can be used to help children - from whom this blood does not derive - with conditions such as leukaemia. There are also autologous therapy techniques, however, where the child from whom the cord blood is obtained can already benefit from this today in a small number of narrowly restricted areas. I am therefore of the opinion that policy must be oriented in such a way that, within the scope of our competences, above all, support is given to public cord blood banks. We can encourage it; we cannot dictate it. That said, we should also not prohibit autologous treatment and the relevant measures. Ultimately, the parents should decide this themselves, but State policy should inform them about the chances and risks.
We need clear standards for quality and safety. We must be constantly vigilant, in this connection, that cells are not offered that are no longer useable at the point of use due to a failure to adhere to quality and safety standards. We need to prioritise research in this field, as it is clear that research of this kind is something very close to the patients. Moreover, we must ensure that parents are able to decide that the cord blood should not simply be thrown away, as it may possibly be valuable in future for other children, or even for their own child. We should organise ourselves with that in mind, within the sphere of our competences, as I say, but there is much that we can already do in this area.
Frédérique Ries
Mr President, Commissioner, ladies and gentlemen, I, too, wish to thank my co-authors and, in particular, Mr Liese, who spoke just now, and Mr Peterle, for this very satisfactory initiative on the donation of cord blood - a donation of life, then - which has enabled extraordinary and significant medical advances to be made over the last 20 years thanks to the transplantation of its plentiful supply of stem cells. They are used today in the treatment of more than 80 diseases, and especially of cancers - brain cancer, blood cancer, leukaemia, lymphoma - anaemia, autoimmune diseases, certain rare diseases, and the list keeps on growing.
Despite this, just 1% of this cord blood, which is so full of possibility and promise, is preserved in Europe, 1% of more than 15 million births per year. In addition, there are huge differences between countries: 7 000 registered donations in Belgium, and 7 000 in France, even though its population is six times that of its neighbour to the north.
We therefore call on the Commission to launch, in conjunction, of course, with the 27 Member States - as the Commissioner mentioned - an information campaign aimed at parents-to-be, so that these donations become a reality, if not a necessity. Well-informed mothers in Europe will clearly want to give life twice.
That is why I, and why we, think it is crucial, over and above the uniform transposition of this 2004 directive on the quality and safety of tissues and cells, which has already been mentioned, and which is the subject of our second question, that Europe strongly encourages the Member States to simplify their maternity hospital accreditation procedures and systems. The number of maternity hospitals authorised to preserve and store cord blood is still too small, and the figures prove it. We can no longer allow the passionate debate - which we are not here to resolve - and controversy surrounding the purpose and use of this blood - whether it ends up in public or private blood banks - to actually stop us from talking about this technique, and this is the appeal launched by Professor Eliane Gluckman, who has dedicated her entire career to making the donation of cord blood a donation of life.
Margrete Auken
Mr President, of course, I too agree with what has been said with regard to the importance of us building up these cord blood cell banks for both research and treatment. These stem cells are easy to get hold of if someone is prepared to do it, and I personally do not believe that this should even be treated as a transplant matter. In fact, I believe we should simply be able to take these cells and that parents should be able to oppose this, but they should not need to give their consent. I think that this aspect is less important.
I do, however, think it is important that - in addition to the safety measures that Mr Liese and others drew attention to - we remember that we still do not know very much about the possibilities for development in this field. It is therefore important for us to have these banks. I believe, first and foremost, that these banks should, of course, be public, as they are something that we should be able to use for everyone. By far the largest area of application will be the treatment of other people. However, it is also important that we draw attention to the fact that there are pitfalls here. We have seen cases of attempts being made to get parents to pay a kind of security for their child by having a 'reserve store' for the child placed in a bank. Doing so is to pay unnecessarily.
It is quite rare for someone to need to have their own child treated in this way, and I firmly believe that these banks should be established primarily for the purpose of general research and general treatment. That should be the opening that we aim for. I feel that we could almost be deceiving parents if they believe that they will be able to invest a great deal in the protection of their own child. They should invest cord blood for the protection of the public in general and I very much hope that we will be able to make this more widely available. It is a shame that such an important substance that we have available to us right now simply goes to waste because too little attention is paid to it.
Marisa Matias
Mr President, Commissioner, I would also like to say that I feel that this issue is too important for us to continue to live the lie that we have been living in Europe. It is a lie or a false promise, whichever you want to call it, as we have been continuing to operate particularly in the area of stem cell collection from umbilical cords based on misleading information.
As we well know and as has already been mentioned, in Europe, the collection of stem cells from umbilical cords barely reaches 1%. However, we also know that their potential for treating illnesses may be endless - illnesses such as those that have already been mentioned: cancer, Alzheimer's and rare diseases. The possibilities are immense.
However, what we have allowed to happen is that a series of private cell banks have been set up and parents have been told that they can store their children's cells when they are born, which can then be used to treat them in the future if necessary.
I think that we need to be much more responsible than this, as the probability of guaranteeing that this will happen is very low, as we all know. This false promise that is being sold to parents costs money. In Portugal, for example, this false promise costs three and a half times the minimum monthly wage.
The solution, then, is clearly to create public stem cell banks, as it is only with public banks that we can guarantee equality of use, equality of access, effective medical treatment and more research that is equal for all and not just treating stem cells as some sort of commodity or a business which is expanding, but is only for the privileged few.
I therefore feel that solidarity, common sense and impartial information are ultimately not things that can be classified as an extra demand. We do not have the power to impose, but we have the power to promote. This is within our capabilities, and I think that we need to do it in the name of equality.
Alojz Peterle.
(SL) Mr President, Commissioner, I am pleased that you are giving attention to our question. What we are doing together is, in my opinion, achieving proximity, or greater proximity to citizens.
I was once rapporteur for the approval of hydrogen-powered motor vehicles and I believe that we need to pay at least as much attention to cord blood stem cells. Indeed, you have said yourself that you were positively impressed by this fact, which is a source of excitement not only for those who are ill or for parents, but also for researchers, who are finding an increasing number of areas of application.
What you said about the European Commission encouraging Member States to take measures in this respect is very important. It really seems to be the case that what we largely see as waste today could later become a source of our or someone else's health.
In this context, I believe that we need a strategy. We need to know what we are encouraging, what information we are giving to parents and other people and, of course, what research we are doing. I am confident that we have a great opportunity here to prove to people that we are on their side and that we are supporting the right way forward.
Antonio Cancian
(IT) Mr President, Commissioner, ladies and gentlemen, although we are dealing with it at a late hour, I believe that what we have here is an important argument that should be highly valued, because the therapeutic use of stem cells from the umbilical cord should be upheld, just as initiatives and information campaigns aimed at making the possibility of donating stem cells more widespread should be encouraged and promoted at every level, all the more so at the European level.
You have just maintained that all this is not within the competence of Europe. However, could the transposition of Directive 2004/23/EC not define quality and safety standards for the donation, testing, preservation and distribution of the selfsame cells?
It is, in any case, necessary to ensure that the diverse national legislation be applied coherently over the different European countries to guarantee that all European patients and parents have the same rights and are subject to identical rules.
It is particularly important that cord blood be preserved in public banks at the national and European level, so that it can be efficaciously given to all patients who really need it, thus preventing death and trying to ensure the same rights for everyone.
Seán Kelly
Mr President, during the last election in Ireland, embryo stem cell research was a hugely controversial topic. This time, medicine is scarcely being mentioned as the elections take place. Obviously, the economy has taken centre stage, but also medical science has moved on considerably. We are very fortunate with the quality of medical research we have in various institutions throughout the European Union, and also with the quality of medical practitioners.
Cord blood stem cells are one example of where progress has been made. It has been said that this research has the potential to help deal with 70 to 80 diseases. That is something that we should encourage, and therefore it is important that this type of research and facility be made available - obviously within ethical constraints. As you pointed out, Commissioner, much of this will depend on the Member States themselves, in terms both of application, in particular, and also of follow-up in due course.
Nicole Sinclaire
Mr President, as many of my colleagues have already commented, this is an incredibly important debate and an issue that needs to be debated not just here in this Chamber within the European Union, but in as far spread a way as possible. It is an issue on which I myself have yet to come down on one side of or the other. I keep swinging between the two: on the one hand, there is my Catholic upbringing, and on the other, modern science and the benefits this can bring.
That said, for the first time probably ever, I am going to commend a Commissioner. What he said was absolutely correct: this should be left in the hands of the Member States. The cultural and religious differences among the European Union should be respected, and under no circumstances should this matter be taken out of the hands of the Member States.
Miroslav Mikolášik
(SK) Mr President, I would like to talk about the issue of collecting and storing cord blood, which is a major source of stem cells. Through the collection of cord blood at birth, which, in the past, used to be discarded with the placenta, we can obtain a significant source of undifferentiated stem cells without causing discomfort to the mother or child, and these can be modulated and used successfully at any time in the future to treat leukaemia and at least 70 other conditions. I would like to ask why it is that in Europe, we collect less than 1% of stem cells at birth, and I would like, of course, to agree with the Commissioner, who says that it is mainly up to Member States to regulate this, although the Commission, along with the Member States, could surely help to improve the provision of information to parents concerning the advantages of stem cells, in light of progress in stem cell therapy and regenerative medicine. I say this as a former rapporteur for the directive on advanced therapies.
Brian Crowley
Mr President, I, too, would like to thank the Commissioner for his contribution to this debate.
However, because of the concerns that have been raised, maybe one solution could be that the national registry of blood banks could be used as the registrar, the resource, for maintaining the cord stem cells for future use. This would overcome some of the problems and difficulties some of my colleagues have already mentioned with regard to the cost of storage.
As well as that, we already have a system in place within the existing national blood banks that can regulate and control the quality of that supply. That could be a good way of overcoming some of the difficulties. I, like many colleagues, believe that the use of stem cells has a huge potential for future disease treatments.
However, we must also be cautious about giving false hope, because too often we have heard, not just with stem cells but also with biotechnology in other areas, of people being given false hope. We need core scientific values and core scientific research to ensure that the results that are being proclaimed can actually be delivered.
John Dalli
Member of the Commission. - Mr President, clearly, there is a general appreciation of the progress that has been made in the application of stem cells for therapeutic purposes. We agree that this needs to be encouraged.
The issues as raised by the honourable Members are firstly on information and secondly on storage.
As far as information is concerned, it is important - as we all agree - to provide accurate and objective information to parents and to the general public about the advantages and limitations of the use of stem cells, including cord blood stem cells. Providing such information is the competence of the Member States, which sometimes vary in opinion and policy regarding the advantages and limitations, as well as the uses, of stem cells. Many Member States already have in place information campaigns and other information activities. The Commission encourages Member States to take such actions.
As to storage, we know that private firms already offer parents the service of storing cord blood cells. However, several Member States have established public cord blood banks based on altruistic and voluntary cord blood donation.
EU law on tissues and cells regulates all tissue establishments, whether public or private. It specifies principles of voluntary and unpaid donation, anonymity, altruism of the donor and solidarity between donor and recipient. In 2004, the European Group on Ethics recommended public storage of cord blood banks to ensure solidarity access to all patients in need.
President
The debate is closed.
Written statements (Rule 149)
Elena Oana Antonescu
The value of the global market for cord blood stem cells was approximately EUR 3.34 billion in 2010. Future projections, based on an annual growth rate of roughly 27% in the coming years, indicate that this figure will reach EUR 11 billion by 2015. At a time when stem cells seem to be the new 'El Dorado' in medical research, many researchers are in a hurry to move into this niche area without ensuring that they achieve all the quality and safety standards required for these procedures. I think that the Commission must step up its efforts in terms of informing patients and medical staff about the benefits of extracting cord blood stem cells. However, it must also make a special effort to ensure that the minimum quality and safety standards for donating, acquiring, testing, processing, keeping, storing and distributing human cells and tissue are, and will be, complied with in all Member States.
Anna Záborská
We have heard from Commissioner Dalli the very cautious position of the European Commission regarding research on stem cells from cord blood. This is hardly surprising. The Commission proposed and pushed through in the Seventh Framework Programme an enormous package of support for contentious stem cell research and is afraid to admit that this research failed to fulfil expectations. Moreover, it is now clear that the research on stem cells obtained from the bodies of unborn children did not produce anything like the results from research on cells obtained from cord blood. Until recently, this blood was regarded as biological waste. In light of the latest reports of successful experiments and even treatments using stem cells from cord blood, how can the Commission defend the morally unacceptable production of human embryos for research purposes? Also, why has Commissioner Dalli not presented us today with a concrete plan for the Commission to increase the percentage of cord blood collected at birth, instead of a meaningless opinion? I hope it is because his staff are still hard at work on such a plan. I assume that the Commission will propose a mechanism in the plan which will relieve parents of the burden of paying for the collection and subsequent storage of cord blood. I also expect that the plan will include a reassessment of priorities in the area of stem cell research.
