Intervention with members of the European Parliament 6 May 2008.

 

The International federation of Blood donor Organisation (also known as FIODS) – is the only international organisation representing voluntary blood donors at the international level, and our main goal is sufficiency of blood from safe donors to all patients in all countries of the world.

We also work to enhance safety of receiving patients and of donors. As volunteers we work for humanitarian reasons, but also to keep donor loyalty. Safety and sufficiency of supply depends on continued regular blood donation. Voluntary blood donors only come back to the blood centres if they have trust in the blood supply – and regular blood donation is the key to safety in all blood services.

We work to combat all commercial exploitation of blood and blood donors for reasons of safety  and for ethical reasons, but non-remunerated donation also enhances the respect for the blood supply, thereby increasing donor loyalty.

The IFBDO is independent of the pharmaceutical industry - unlike certain “patients organisations” which lobby for paid or compensated blood in Europe on behalf of their sponsoring industry. We work for a cause which we believe in. Most donors are modest about this and only want to help their fellow human beings – but we also have to “lobby” the European Union, because we see some very important challenges to what is still among the best and safest blood supplies in the world.

Since the Amsterdam treaty established EU competence in the field of blood, we have tried to influence European legislation in order to promote a safe blood supply to all European patients.

I am happy to note that over the years the European Institutions listen more and more to our views, and I take this meeting as a further step in this consultation.

We work for full sufficiency of blood from safe donors in all countries of the world. This is an enormous task – but it is possible as a number of European member states are in fact fully self sufficient in all blood products. (e.g. Finland, the Netherlands, Denmark, Belgium).

Most EU countries have opted for non-remunerated blood donation

This is recommend by the WHO and the Council of Europe, ISBT, the Red Cross and the IFBDO

• For safety reasons, as paid blood is less safe than donated blood.
• To enhance the respect for the donor and the blood supply (for frankly, who can respect a person who for a small sum of money wants to sell a part of his body?)
• For ethical reasons, as no one should be forced to sell a part of their body.

Non-remunerated donation is clearly in line with provisions in the Nice treaty (and new Lisbon treaty,) which forbids all profit making from the human body or parts of it.

Non-remuneration is also emphasized in the Directive 2002/98 from the Council and Parliament on Blood Safety, e.g. in Article 20, where all member states shall strive to obtain non remunerated blood donation, and in “Whereas 20” – which states, that modern blood services are based on non remuneration of donors and the absence of profit for blood establishments.

So far so good:
But unfortunately we have two competing systems in the European Union covering human blood contained in Directive (2001/83) on medicinal products and the later Directive on blood safety (2002/98). The administration of these directives lays within two different directorates in the European Commission (Inner market vs. SANCO) - and we really see this as the classical conflict between the Market Europe versus the Citizens Europe.

Non-remuneration as the basis of all blood products is NOT a question of religion, faith or ideals.

It is a very practical question: How do we best guarantee enough safe blood products to all patients in all 27 members states of the European Union?

All studies show, that a stable blood supply has to be build up over a long period of time. But some have jumped to the easy solutions: Pay the “donors” or import the products (often from paid “donors” also). Especially the private plasma fractionating industry is pushing for paid plasma “donation” and import of medicinal products from paid “donors. They push for an “inner market” solution, which allows for free import and commerce of plasma derivatives from paid blood.

But paying for blood is not a good long term solution! I would like to mention a recent study from Lithuania (published in Vox Sanguinis) that clearly shows that is it much safer to use unpaid donors than paid “donors” (The study was based on a uniform donor population with no geographical or other differences except that some donors accepted payment after the donation ….)

Paid blood is not as safe as unpaid blood, not even when used for plasma products. I know that the Commission has data on this from the plasma product industry which confirms my statement, but this information is kept as confidential with reference to the market-situation etc. I urge the Members of the European Parliament to ask for that information, and as a spokesperson for the blood donors, I think that we also have right to see such figures on blood safety..

May I add, that the European countries, which do have a stable and sufficient supply of blood, only use only non- remunerated donors and base their plasma derivatives on plasma from non-remunerated donors.

But speaking of plasma products we have a very strange system in Europe under Directive  2002/98. All plasma collection within the EU has to follow the rules in Directive 2002/98, which are very strict and more costly than the free-for-all system, we see outside Europe. The strict European rules (which we support) give rise to an unfair competition to European plasma products from plasma products imported from third countries.

A large import of plasma derivatives continues to countries such at the UK, Italy, Spain and Germany. This is not a healthy situation, especially since there is no real traceability from the third country donors to the European patients.

But even worse: Many European patients are still totally dependent on import of plasma products from the United States: The American Senate has already once temporarily stopped for export to Europe of vital immunoglobulines. This gave reason for panic in some European hospitals – and a rise in prices of plasma derivatives. We urge all European authorities to work for a sufficient supply from within Europe. It is totally unacceptable, that European patients depend on sudden changes in American policy for their life-saving provision of plasma derivatives.

Right now the FDA is hindering the licensing of new plasma collection centres in the US. Again the plasma price is going up, leading the commercial plasma-derivatives producers to look for paid donors in Eastern Europe and in the developing world. Depending on third country plasma collecting  is clearly not a good system for safety of products and sufficiency of supply in Europe.

In view of the overall wish for a safe and sufficient supply of blood products we urge the Commission to stop promoting the access to European hospitals of plasma products from paid (poor) donors in third countries.

We should always remember that blood products are effective in a treatment, because they have been developed within a human body. Very few blood products can be substituted by industrial products, so for many years to come there simply is no alternative to blood in the treatment of a large number of illnesses. Each year scientific research comes up with new properties in donor blood, which may eventually help new group of patients. This research into the properties in blood plasma is so very important for many groups of patients, and Europe must take part in it – and not leave this research to companies from third countries only.

Of course we must allow temporarily for the necessary import of products to European patients, but if we will, Europe can be self sufficient in all blood products. This demands a very minor investments in donor recruitment and retention, and luckily the Commission has taken a first small step by supporting the DOMAIN project for developing Donor Management, a project in which the IFBDO also takes part. .

Basically the IFBDO considers that donated blood is gift, which is not covered by the Inner Market rules. This view is supported in the Nice Treaty and in “whereas 20” of Directive 2002/98 .

Accordingly, the Commission should stop to demand that fractionation of European blood plasma is opened for public bidding. The blood donor has the property of any products from his blood until his gift has been transfused into another human being. The process between the donor and the patient is a service, rendered to the gift of blood. As we all know, a service within the medical field can, but does not have to be made open for commercial bids. We feel that the Commission should  stop to push for commercial bidding in this field, allowing for Australian, Swiss and American companies to undermine the European plasma fractionation, making us all dependent on research and development of new plasma products outside Europe.

So what do we want from you??

We would like to European Parliament and the European Commission to consider these goals:

That all 27 member states and the European Union becomes self sufficient in all blood products, including plasma derivatives, from voluntary non-remunerated blood donors.

That the European Union and it member states stop using paid or compensated blood – and that they stop pressing family members and relatives to give blood to specific patients.

To allow for the development of self sufficiency in all blood products, article 4, 2 of Directive 2002/98 allowing member states to stop for import of blood and blood components from paid “donors” should include permission to member states to stop all blood products from paid “donors”.

The rules about full traceability should cover all blood products (including plasma derivatives) in Article 14, 1 of Directive 2002/98.

The European health programme should include measures to enhance blood safety and sufficiency of supply. Some of the member states still need support for implementing the Blood Directives - and the European Union should expand its programmes to include support for promotion of recruitment and retention of voluntary non-remunerated blood donors.

Interested parties such the IFBDO should (in line with Art 8 B of the Lisbon Treaty and art 25 of Directive 2002/98) be consulted as an interested party when the blood directives are being updated.

The European Parliament should call for a continued reporting from the European Commission in the progress of voluntary non-remunerated blood donation, as foreseen in Art 20,2 of Directive 2002/98, under which member states every three years must report on their progress towards achieving full voluntary non remunerated blood donation. As you know, the Commission should also inform to the Council and the Parliament of necessary complementary measures, it intends to take to achieve this goal.

Thank you very much for your attention.

Niels Mikkelsen

President of the IFBDO/FIODS