WRITTEN QUESTION E-3677/02

by Bart Staes (Verts/ALE) to the Commission

(18 December 2002)

Subject: Combating leukaemia with stem cells from umbilical cord blood

Bone marrow transplants have been used for years in the treatment of leukaemia, proper patient-donor compatibility being the greatest problem in this connection. Bone marrow and the peripheral bloodstream contain hematopoietic stem cells. Placental and umbilical foetal blood is the richest source of stem cells, however, though it has been known about for only a few years. At the start of 2001, two doctors set up Europe's first private umbilical cord blood bank Cryo Cell Europe (www.cryoc.com) which is based in Mechelen but already contains blood stocks from throughout Europe. Despite the fact that the operation is thriving, Cryo Cell Europe is not welcomed everywhere with great acclaim. Some university hospitals have had their own umbilical cord blood banks for a few years. The big difference between Cryo Cell Europe and the universities is that the university blood banks make blood available anonymously and, furthermore, give it to children from poor backgrounds who need a transplant. Cryo Cell Europe is a private firm, however, which banks blood on a personalised basis, storing it for the owner in return for payment. Storing blood stocks for a 20-year period will cost a total of EUR 1 000, the likelihood that the owner's child will need the umbilical cord blood being negligible. In November 2000, the European Group on Ethics issued an opinion on the use of human stem cells, albeit without specifically addressing the ethical aspects of such practices.

How does the Commission propose to provide sufficient stem cells for those in need if, possibly, they are stored only on a personalised basis and universities consequently have insufficient stocks of umbilical cord blood to provide a public service? Is this not the start of two-tier medical treatment?

Is the fact that the website mentions only the insurance company Mercator & Noordstar and that, in return for taking out a hospitalisation policy, that insurer will reimburse laboratory and transport costs not an instance of improper, bundled selling in Belgium?

Answer given by Mr Byrne on behalf of the Commission

(3 February 2003)

The Commission is aware that cord blood may be stored for the exclusive future use of the concerned newborn. The Commission recognises that this practice may have implications for the availability of allogeneic haematopoetic stem cells for patients awaiting such transplantations. As Article 152 of the EC Treaty specifically excludes Community measures that affect national provisions on the donation or medical use of blood, only aspects related to the quality and safety of cord blood can be regulated currently at European level.

This explains the scope of the Directive of the Parliament and of the Council setting standards of the quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components(1) adopted by the Parliament and the Council on 18 December 2002, and the scope of the proposal for a Directive of the Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells(2) now under discussion in both Institutions. The Commission can also inform the Honourable Member that, following its opinion of November 2000 on the ethical aspects of research on human stem cells, the European Group on Ethics in science and new technologies is planning to start work in 2003, specifically on the very subject of cord blood storage.

The question related to bundled selling falls under the responsibility of the Belgian authorities.

(1) OJ L 33, 8.2.2003.

(2) OJ C 227 E, 24.9.2002.