15.8.2008   

EN

Official Journal of the European Union

C 209/33

1.

Is the term activity ‘closely related’ to hospital care in Article 13A(1)(b) of the Sixth Directive (1) to be interpreted as implying a temporal requirement so that the hospital care to which the service is closely related must exist or be specifically performed, commenced or envisaged, or is it sufficient that the service will potentially be closely related to possible, but as yet non-existent or undetermined future hospital care, so that the services supplied by a stem cell bank, consisting in the collection, transportation, analysis and storage of umbilical cord blood from newborns for autologous use, are covered by it?

In that connection, is it relevant that the services described cannot be performed at a later time than the time of delivery?

2.

Is Article 13A(1)(b) of the Sixth Directive to be interpreted as covering general preventative services where the services are supplied before the hospital or medical care takes place and before the hospital or medical care is required in both temporal and health terms?

3.

Is the term ‘other duly recognised establishments of a similar nature’ in Article 13A(1)(b) of the Sixth Directive to be interpreted as covering private stem cell banks where the services — which are performed and supplied by professional health personnel in the form of nurses, midwives and bioanalysts — consists in the collection, transportation, analysis and storage of umbilical cord blood from newborns with a view to autologous use in connection with possible future hospital care where the stem cell banks concerned do not receive support from the public heath insurance scheme and where the expenditure on the services provided by these stem cell banks is not covered by the public health insurance scheme?

In that connection, is it relevant whether or not a private stem cell bank has obtained authorisation from a Member State's competent health authorities to handle tissue and cells — in the form of processing, preserving and storing stem cells from umbilical cord blood for autologous use — pursuant to national legislation which implements Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (2)?

4.

Is the answer to Questions 1 to 3 affected by whether the above services are supplied with a view to possible allogeneic use or provided by a private stem cell bank which has obtained authorisation from a Member State's competent health authorities to handle tissue and cells — in the form of processing, preserving and storing stem cells from umbilical cord blood for autologous use — pursuant to national legislation which implements Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells?