Verbatim report of proceedings

Wednesday, 1 April 1998 - Strasbourg

12. Suitability of blood donors

  President . – The next item is the report (A4‐0112/98) by Mr Cabrol on behalf of the Committee on the Environment, Public Health and Consumer Protection on the proposal for a Council Recommendation on the suitability of blood and plasma donors and the screening of donated blood in the European Community (COM(97)0605 – C4‐0027/98‐97/0315(CNS))

  Cabrol (UPE), rapporteur. – (FR) Madam President, ladies and gentlemen, the current Council recommendation applies essentially to the first section of the previous Commission communication which related to blood safety and self‐sufficiency in the Union, for which I was rapporteur. This first section is devoted to the safety of transfusions and more particularly to the two primary conditions of this safety: donor suitability and screening of donated blood. Self‐sufficiency is mentioned incidentally, when it is a question of volumes of blood donations.

Firstly with regard to donor suitability, the Council wishes to have exhaustive information on these donors, whose gift is clearly a generous one – this needs to be underlined as we are asking, in Amendment Nos 14 and 18, for the application of the principle of voluntary donations – but it is not without consequence for the donor or for future potential recipients of transfusions. This information must be encouraged – this is the objective of Amendment Nos 1 and 5 – in order to gain a better understanding of, and cooperation from, potential donors.

In order to find a donor who is at the origin of a contaminated donation, it is important to set up a register to include the name of the collection centre and precise identification of the donor in the form of a code number which would guarantee confidentiality of information. It seems essential to us that statistics should be held centrally on a single register within the Union, with a unique identification code enabling precise traceability. This is covered by Amendment Nos 8 and 11.

To reduce as far as possible the harmful consequences that a donation could have on either the donor himself or on possible recipients, the Council is proposing a detailed questionnaire on donor criteria. This questionnaire is in response to the demands of Parliament itself in its previous resolution on blood safety. There are three points in this questionnaire worth drawing your attention to. The first relates to risks connected with journeys outside of the European Union. Of course, many illnesses only exist and can only be caught in some countries, for example, malaria. Nevertheless, it would be useless to discriminate in this matter and to exclude certain third countries such as North America, where some illnesses are, nevertheless, endemic. This is the objective of Amendment No 20 which corrects the original text in this sense.

The second point relates to sexual activity. Wherever there is sexual activity, absolutely wherever, in no matter what country, even in the European Union, there is also the risk of contracting sexually transmitted diseases. This is why we recommend voting against the two points in the Council"s questionnaire which mention sexual activity. The first is aimed at Africa, we do not want this included, and the second is aimed at countries other than in Africa, for the same reason we do not want this included. This removal would render Amendment No 21 null and void.

The third point relates to homosexual practices between men. These practices still carry very high risks, the rectum holding up much less well to the virus than some other mucous membranes. We therefore reject Amendment No 29, which would limit the danger to high risk male homosexual relations, as if no other male homosexual relations carried a danger. I repeat that, medically, all male homosexual relations carry risks, very considerable risks. The exclusion of donors on the basis of these criteria could be definitive or temporary, depending on the case and the illness. But in any case, absolute confidentiality must be guaranteed in order to respect the rights of donors and to maintain the generosity of the general public. Amendment No 10 is intended in this direction.

Full and specific tests must be carried out on donated blood and plasma and we must be continually informed of the existence and validity of new viral markers. This is the intended direction of Amendment Nos 7, 9 and 13. But these tests only show positive after a certain period of time in the contaminated donor, a period during which antibodies are produced yet during which the antibodies are still not sufficient to be detected by the tests. This is where the need for a questionnaire comes in, as it is the only way of removing these high risk donors during this period. Finally, the Council makes recommendations on the volume of blood to be taken from donors, and the frequency of donations. The standards advocated by the Council seem a little too high to us and we would rather recommend those of the Council of Europe. This is covered by Amendment Nos 24 and 25.

In conclusion, Madam President, Commissioner, ladies and gentlemen, apart from the important questions we have raised, we advocate voting for this recommendation and our amendments. This text will undoubtedly contribute to greater safety in blood transfusions which, without reducing the risk to zero, will enable patients within the European Union to benefit from the lifesaving support of a blood transfusion when they need to.

  Whitehead (PSE). – Madam President, I support and, indeed, salute Mr Cabrol for the breadth of experience, knowledge and compassion that he has always brought to this subject.

I am speaking on behalf of our shadow rapporteur for the Group of the Party of European Socialists, Mr Needle, who cannot be with us, courtesy of Air France, who have done their best this week to make this a shadow Parliament.

All of us here want to see a speedy passage for this Council recommendation. my group is concerned that the proposal before us has no binding force. We look to the Council of Health Ministers on 30 April. In Amendment No 17 we call on the Member States to work together and with the Commission on binding legislation by the end of this year, and certainly no later than 1999.

The Commissioner will know of the concern in my country, and probably in his also, at the danger, however remote, posed by new variant CJD in the matter of blood plasma products. We are deeply concerned that there should be a field of safety and of common practices throughout the European Union in the matter of blood products and their safety. My own view, and that of my group, on this is that, whilst the emphasis put on donor selection and the appropriate testing of donations is fairly adequate – and it has been outlined by Mr Cabrol in his remarks – we still need to look very carefully at the monitoring of recipients of blood transfusions. We need to be certain that throughout the Community the same measures are in effect, the same points of contact are available and information is wisely considered, assessed and shared.

One thing that concerns my group very greatly is the issue of voluntary donations, and here I agree with Mr Cabrol. It seems to me wrong that we should be legislating here on the basis that there is not a marked distinction between voluntary donations and paid donations. We may be a single market but there is not a market in blood: there is a community in blood. We are in the most literal sense blood brothers and blood sisters.

The book that has most influenced my life is that by Professor Richard Titmus called ‚The Gift Relationship’, which sets out how much the principle of altruism relates to the giving of blood. We should do nothing in the course of this legislation that makes it harder for people to offer this most precious of donations. But we should also do nothing that makes it harder for us to trace those who, for whatever reason, might spread an infection and endanger others. We are wholly in support of Amendments Nos 1, 3 and 18, tabled by Mr Cabrol, and those on the issue of voluntary donation, which have been tabled by my group.

One last word on Amendment No 29: we need to draw a distinction between unsafe practices between men and any sexual practices between men. There are many unsafe sexual practices between the sexes, as well as between men, and we should not stigmatize the entire gay community in what we say tonight.

  Valverde López (PPE). – (ES) Madam President, I think we all agree that this proposal is aimed at establishing a Community strategy to improve confidence in the safety of the blood transfusion process. And it is not a new proposal, since we already have an excellent directive from 1989, which provided for quality, security and effectiveness in terms of medical products derived from plasma. However, we must not forget that the Convention on European Pharmacopoeia, with an excellent technical monograph, has also been ratified. Therefore, this proposal contributes by giving more security to the entire process. For that reason we give our full support to Professor Cabrol"s report, to which he has imparted the best of his knowledge and professional authority. However, the Committee on the Environment, Public Health and Consumer Protection has approved several amendments to which I would like to draw the attention of the European Commission since, if they are approved, they would actually distort the proposal and the Community law which is currently in force.

I will look firstly at the reference to the Council of Europe"s recommendation. It is not that I disagree with it, but there is an accepted Court of Justice doctrine that we should not make cross‐references since they are based on different legislation and we would therefore lose legal security.

Secondly, Amendment No 14 refers to the establishment of the legal principle of voluntary and unpaid donations of blood or plasma. But talking about the legal principle seems to me to be truly absurd. As a political objective we should move towards self‐sufficiency, but establishing a legal principle, if we realize what we are talking about, is unacceptable. Maybe I should explain in this Parliament that the Community institutions all agree that every policy should be directed towards achieving full employment. But establishing the legal principle of full employment in the European Union would be truly absurd, despite the fact that we all want to see this objective realized. Confusing a political orientation of an ethical nature with a legal principle is a legal aberration which should not be brought about by any report from this Parliament. I would draw the attention of the European Commission to this question so that, although it is proposed here, it acts as a sort of filter, it carries out a reasonable job – as the European Commission usually does – and does away with this reference.

In the same way, I cannot accept the attempt to apply the same principles and demands to blood and products derived from it. I would not need to provide any example here but blood does in fact undergo a determined treatment, while derived products are treated completely differently. I trust in the European Commission"s good judgement to ensure that these amendments tabled by the Committee on the Environment are properly done away with and that they are not taken into account. The original proposal would be thus much better with the amendments tabled, which are also original, from Professor Cabrol.

  Kestelijn‐Sierens (ELDR). – (NL) Madam President, ladies and gentlemen, Commissioner, the safety of donated blood is a matter of life and death. That is why the Group of the European Liberal Democrat and Reform Party supports the request by the rapporteur for binding legislation towards the end of next year on blood products, donated blood and blood plasma. On behalf of my group, and of my colleague Mr Eisma who is not able to be present here tonight, I would like to draw attention to the following points. First of all, we wish to underline that blood should be donated on a voluntary basis, and that donating blood should therefore be unpaid. It is vital that the principles recommended by the World Health Organization, namely that donations should be unpaid, voluntary and anonymous, are implemented by the Member States in cases of medical intervention to the human body. This has not been expressed clearly enough in the proposal, which is why we fully support Amendment Nos 14 and 18 which deal with this issue in greater depth.

Moreover, we consider it extremely important for health reasons that the amount of blood a donor is allowed to give per session is reduced from 800 to 650 millilitres.

Finally, we do not wish to refuse people giving blood purely on the basis of their sexual orientation. We think it is essential that all applicant donors are fully aware of the risk that donated blood and plasma can transmit contagious diseases. But it would be a form of discrimination to exclude a priori all homosexuals. Homosexuals might only pose a risk when they engage in unsafe sexual practices. I ask you to support the Liberal Group"s Amendment No 29 which deals with this subject, and consequently not to consider this group amongst the excluded groups in Appendix 5.

  Marset Campos (GUE/NGL). – (ES) Madam President, Commissioner, our group is in complete agreement with Professor Cabrol"s report on the Council"s proposal on the suitability of blood and plasma donors. We also agree with the amendments tabled by the Committee on the Environment, Public Health and Consumer Protection.

We would like to highlight three issues which have been sufficiently discussed: confidentiality and respect for donors, regardless of any stigma; the need to create a central identification service in Europe – as already pointed out in other epidemiological reports; and the adoption of all the precautions necessary to avoid the transmission of diseases or new risks.

Nevertheless, there are other aspects which we would like to underline. Firstly, the maximum quantity to be donated should be the same, independent of weight, since volume of blood and body mass are two different things, and there is no direct relation between the two quantities. Secondly, in our view, it is very important that donations are voluntary since we must remember that AIDS in fact originated in North America due to the abuse of trade in blood from Haiti.

  Pradier (ARE). – (FR) Madam President, faced with the dangers of using blood and blood products, one necessity alone should guide all our actions and attitudes: the safety of the sick and wounded. This is based on two factors: the competence of the doctor providing the transfusion and the quality of the transfused product.

To treat the issue lightly, or to content oneself with an approximation on the subject is a criminal attitude which has already causes dozens and dozens of deaths, not only in France, I am told.

However, the text proposed to us by the Commission seems to contain, alongside sound demands, some outrageous remarks which I was surprised had got this far without being noticed. The fact that it is considered far more dangerous to have a sexual encounter in Pretoria than in Bangkok leaves me truly confused. On the other hand, it is a little ridiculous to make no mention of whether sexual relations are protected or not, whilst male homosexuality is rejected as a whole regardless of the methods practised when it relates to blood donations.

On the other hand, it seems inappropriate to become alarmed when the possibility of setting up a circle of transfusion centres or of tying them into a central body is considered, for in each of our countries national blood transfusion centres collect perfectly confidential statistics, which are coded and permit traceability.

I would like to indicate finally, Madam President, that the centralization of information at European level would seem to be as safe as that at national level – I say that for the benefit of certain worried people, particularly in my country where, as everyone knows, harmful political forces are developing.

  Blokland (I‐EDN). – (NL) Madam President, it is impossible to imagine modern medicine without blood donation. It saves lives. Yet there will also be risks attached to transfusions. These risks should be limited as far as possible, and that is what this proposal aims to do. Thankfully, we do not need to reinvent the wheel in Europe as far as blood screening is concerned. Much important work has been carried out by the Council of Europe. A reference to the recommendations made by the Council of Europe is therefore in order, and I wholeheartedly endorse Amendment No 1. But there are two things I would like to draw your attention to. Firstly, I believe that in principle, donations must remain voluntary. A paid donation is essentially no longer a real donation, because a quid pro quo in the shape of money is expected. This is a step back. Neither for the donor, nor for safety is it desirable that blood or blood products are donated for money. There will be an increased chance of less safe donors coming forward, and the aspect of solidarity with one"s fellow human beings will be lost.

Secondly, I would like to add a little explanation to the amendments I have tabled. In my amendments I point to the ISBT 128 system for the identification of donated blood. ISBT stands for International Society for Blood Transfusion. It is a recognized body in the world of blood transfusion. The system I have just referred to amounts to a standardized, personal identification code which is allocated to each blood donation. This system is recognized by the United States, Canada, and a number of European countries. It would be obvious to choose this as the general standard for Europe.

Lastly, I would like to say something about safety. I see the enclosed survey as an extremely important selection mechanism for donors. The questions about sexual behaviour may come across as a little inappropriate, but we all know that certain types of sexual behaviour are more dangerous than others. As long as the responses are well protected, this should not present any problems. The safety of the people at the receiving end is more important in this case.

Finally, a word of thanks to the rapporteur, Mr Cabrol. It is an excellent report.

  Flynn, Member of the Commission. – Madam President, I ask for your indulgence in advance because I wish to take a few moments longer than anticipated as I want to deal with a lot of the amendments which are extremely important for blood and blood safety in the Community.

Parliament has voiced its concern in several reports and resolutions about the safety of blood and blood products and the attainment of self‐sufficiency in the Community, and the Commission welcomes the committee's report this evening. Parliament has noted that the recommendation is a logical sequel to the Commission's communication presented on blood safety and selfsufficiency. It correctly pointed out that only the first two activities, that is donor suitability and screening of donations, were addressed. These are the very first two phases in the blood transfusion chain. The Commission considers it sensible first to focus on them. But I can assure the honourable Members that steps are already under way to address the other identified activities in the development of the blood strategy.

I wish to thank Mr Cabrol for his contribution and also those others who have contributed this evening.

With regard to the amendments proposed by Parliament, the Commission is prepared to accept fully Amendments Nos 5, part b. of 13, and 23, and to accept partially Amendment No 2 – which requires some editing; No 9, the intention of which is acceptable but will require the establishment of common criteria for the parameters to be collected that are comparable throughout the Community; No 10, the wording of which will have to reflect the fact that much of current practice is experience – rather than evidence‐based – and efforts will need to be promoted to obtain good scientific evidence here; No 11: the intention here should be to have a unique coding system with relevant information communicated to all Member States and to the Commission and not a unique and common code; part of No 15: editing here too should reflect that although the risk is still theoretical, appropriate measures need to be taken to minimize any hazard associated with possible transmission of new variant CJD via blood components and manufactured plasma derivatives. The Commission proposed such measures in its prospective donor deferral criteria. Part of No 16: we have to reflect here the need for common parameters at Community level and for the collection of epidemiological data. Part of No 19: rewording is necessary here due to potential legal difficulties with the term ‚partner’, which must be linked to legal and administrative provisions in the Member States. Part of No 20: although acceptable from the aspect of travel outside the European Union, it goes beyond the Commission's intention of recommending Member States to pose certain questions and should, therefore, I suggest, be reformulated. Part of No 21, which exceeds the Commission's intention of proposing that Member States pose questions if they so wish. There are some additional amendments as well – Nos 27 and 28 – and that is dealt with under Amendment No 11; and No 29, which is acceptable. We would like to think a little further about the actual wording there.

The Commission finds the following amendments unacceptable. I would like to go through them very quickly. Amendment No 1: it is important to recall that in adopting Directive 89/381/EEC, which governs the placing on the market of medicinal products made from human blood and plasma, the Council agreed that Member States should encourage the voluntary and unpaid donations of blood and plasma as the starting material for the manufacture of medicinal products. There is, however, no definition of such donations in the directive, and significant differences exist among the Member States as to what it really means in practice. The definition of voluntary non‐remunerative donation adopted by the Council of Europe is much more restrictive than what applies in most Member States and strict adherence to it in the Community may have an adverse affect on supplies.

Amendment No 3. Because the Commission considers that measures to be introduced at Community level should take into account, in addition to those of the Council Europe, national and international standards, guidelines and recommendations including those of the WHO and our major partners such as those in the Food and Drug Administration of the United States. You must remember that considerable volumes of plasma and plasma products are used in the Community which originate in the United States. The Commission considers therefore that any reference to international standards should be as general as possible.

Amendment No 4 which is unacceptable as written because the concern is not at the risk of new variant CJD to blood products but the still theoretical risk, not yet scientifically proven, that new variant CJD could be transmitted by them. The use of plasma as an excipient in medicinal products coming from countries which have had no confirmed cases of new variant CJD is a recommended precautionary measure and the wording used of ‚imported blood between Member States’ is totally lacking in clarity, I suggest.

Amendment No 6 would only lead to some confusion and final medicinal products like plasma derivatives, derived from blood and plasma, can already move freely in the internal market, as long as they meet requirements of quality, safety and efficacy and therefore may be shared with other Member States. But the difficulty arises when labile components, for example red blood cells, platelets or plasma prior to fractionation, are prevented from being shared with other Member States.

Amendment No 7 is unacceptable as it implies that there are Member States that are not responsible for collecting blood and plasma, which of course is not the case in reality. The second amendment is also unacceptable because many donors do not wish to be in registers and we have to bear that in mind.

Amendment No 8 is similar to Amendment No 7 and while a common donor identification and registration system is certainly the ideal, donors themselves, on whom the entire blood transfusion chain is dependent, are reluctant to be even on national registers and a single donor identification and registration system common to all Member States contradicts the Commission proposal for a mutually compatible system.

Amendment No 13 is unacceptable because the Commission uses the word ‚blood’ in its generic sense. With regard to 9c, whether the plasma is recovered from a whole blood donation or is collected through the process of plasmapheresis, it is a sample of the donor's blood taken at the time of donation that is tested, not the plasma.

As far as Amendment No 14 is concerned, Directive 89/381 requires Member States to promote voluntary, unpaid donations for plasma used as source material for medicinal products. The exact wording must be maintained here.

Amendment No 17: first we oppose it because it is necessary to clarify what is meant by ‚blood products’. The labile components that do not come under Community legislation and the plasma‐derived products must adhere to existing pharmaceutical legislation in respect of quality, safety and efficacy.

Now with regard to the labile components, there is no legal basis for the Community to introduce binding legislation and Article 129 only provides for recommendations or incentive measures but excludes, of course, harmonization. In future harmonization legislation might be possible if and when the Amsterdam Treaty is ratified.

Amendment No 18: the definition of voluntary, non‐remunerated donation of the Council of Europe is more restrictive than the term ‚unpaid’ as used in Directive 89/381, and there are significant variations in the Member States as to what constitutes such donations.

Amendment No 24 regarding the proposed donation frequency stems from the implicit assumption by the authors that each and every donation is made at the maximum possible abstraction of blood volume.

In Amendment No 25, the whole purpose of course of automated plasmapheresis is to arrive at volumes that may exceed 15 litres but in a way that is safe for the donor.

Now finally may I take the opportunity to make a further comment on new variant CJD because Mr Whitehead brought it up specifically. For plasma‐derived products the issue of the assessment of risk of new variant CJD in blood is under very close scrutiny by the Committee of Proprietary Medicinal Products which advises the European Medicines Evaluation Agency in collaboration with the Spongiform Encephalopathy Advisory Committee.

The issue is also under discussion in the Scientific Advisory Committee on Medicinal Products. We are awaiting the advice of these bodies just now.

With regard to blood for transfusion there is no legal recourse, under Article 129, for us to take any action apart from non‐binding recommendations. As I said earlier, we have already done this. As Members will be aware, this is the first proposal for a Council recommendation from the Commission under Article 129 of the Treaty. The Commission took the decision that you should be fully consulted even though some Member States in the Council had some initial hesitation, given that there is no formal requirement to do so under Article 129. Mr Cabrol's report confirms to me that the Commission was right to do so. I want to put it on record for you, Mr Cabrol, and for your colleagues, that I will insist that you continue to be consulted on all future recommendations under Article 129. Parliament must have the opportunity to actively contribute to recommendations with a bearing on public health.

The Commission considers that this recommendation is a major step along the road to giving effect to the Community blood strategy that the Commission, the Council and the European Parliament helped to put in place in the years 1994 to 1996.

I regret the length of my reply, but this is a vitally important matter for all citizens of the European Union.

  President . – The debate is closed.

The vote will take place tomorrow at 12.00 noon.