WRITTEN QUESTION E-3677/02 by Bart Staes (Verts/ALE) to the Commission. Combating leukaemia with stem cells from umbilical cord blood.
Date: 2002-12-18
Institutions: European Parliament, Provisional data
Subjects: Belgium, bio-ethics, blood disease, blood transfusion, competence of the Member States, private sector, storage, storage cost, trade in organs

C 137 E/238

Official Journal of the European Union

EN

12.6.2003

Nevertheless, since Italy had unilaterally deferred the Article 19 deadline (28 January 1980) for the start of
medical studies to the 1984-1985 academic year, the Court in its above-mentioned judgment found that it
had failed to fulfil
its obligations under Directives 78/686/EEC and 78/687/EEC. As Italy could not
implement this judgment on its own (except by revoking the authorisation of the roughly 4 000 doctors
concerned to practice the activities in question), Directive 2001/19/EEC (3) introduced specific measures
designed to regularise the status of these practitioners (an aptitude test to be organised by the Italian
authorities).

In conclusion, non-specialist doctors may not practice dentistry or odontostomatology unless the
derogation conditions laid down in Article 19(1) or (2) of Directive 78/686/EEC, as amended by Directive
2001/19/EC, are satisfied. This state of affairs is not contrary to Directive 93/16/EEEC (4).

(1) OJ L 233, 24.7.1978.
(2) ECR 1995 I-1319.
(3) Directive 2001/19/EC of the European Parliament and of the Council of 14 May 2001 amending Council Directives
89/48/EEC and 92/51/EEC on the general system for the recognition of professional qualifications and Council
Directives 77/452/EEC, 77/453/EEC, 78/686/EEC, 78/687/EEC, 78/1026/EEC, 78/1027/EEC, 80/154/EEC, 80/155/
EEC, 85/384/EEC, 85/432/EEC, 85/433/EEC and 93/16/EEC concerning the professions of nurse responsible for
general care, dental practitioner, veterinary surgeon, midwife, architect, pharmacist and doctor (Text with EEA
relevance), OJ L 206, 31.7.2001.

(4) Council Directive 93/16/EEC of 5 April 1993 to facilitate the free movement of doctors and the mutual recognition

of their diplomas, certificates and other evidence of formal qualifications, OJ L 165, 7.7.1993.

(2003/C 137 E/269)

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 (cid:1) Cryo Cell Europe (www.cryoc.com) (cid:1) 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?

12.6.2003

EN

Official Journal of the European Union

C 137 E/239

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.

(2003/C 137 E/270)

WRITTEN QUESTION E-3726/02

by Glenys Kinnock (PSE) to the Commission

(19 December 2002)

Subject: Comenius programme

Is the Commission aware that schools wishing to participate in the Comenius programme are experiencing
serious difficulties in finding partners from other EU countries?

Does the Commission intend to take steps to coordinate the exchanges between schools more effectively?

Answer given by Mrs Reding on behalf of the Commission

(27 January 2003)

The Commission is not aware of serious difficulties of this nature arising out of the systems in place. The
feedback received by the Commission so far would indicate that the systems generally operate in a
satisfactory manner.

Comenius 1, the Comenius action relating to school partnerships, has been defined as a decentralised
action in the Decision No 253/2000/EC of the Parliament and the Council of 24 January 2000 establishing
the second phase of the Community action programme in the field of education ‘Socrates’ (1). Thus, the
implementation of decentralised actions is devolved to National Agencies, designated by the national
authorities in the participating countries (2).

These National Agencies have the responsibility to inform the target public about the programme and to
advise institutions on how to find partners abroad. It is the role of the national authorities to see to it that
their National Agency provides the necessary support to interested parties in their country.