Dáil Éireann - Volume 663 - 14 October, 2008
Written Answers. - Hospital Procedures.
Deputy Thomas Byrne Deputy Thomas Byrne
Deputy Thomas Byrne asked the Minister for Health and Children the Health Service Executive position on cord blood collection at the time of infant birth; and if there are plans to investigate stem cell treatment and the medical benefits of such treatment. [34963/08]
Deputy Mary Harney Deputy Mary Harney
Deputy Mary Harney: The collection of cord blood for the purpose of potential later human application comes within the scope of the European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006 (No. 58 of 2006). The Irish Medicines Board (IMB) has been designated as the competent authority under the Regulations. The purpose of the Regulations is to ensure the quality and safety of tissues and cells, to protect donors and recipients, whether the donor and recipient are the same person or not, and to prevent the transmission of diseases.
Under the Regulations, any entity which collects material such as umbilical cord stem cells as well as any entity which is involved in testing, processing, preservation, storage and distribution of human tissues or cells intended for human use is required to apply to the IMB for an authorisation to perform such activities. The IMB is obliged to ensure that tissue and cell procurement is carried out by persons with appropriate training and experience and that it takes place in conditions which meet quality and safety standards and are authorised for that purpose.
Under the Regulations, it is permissible for a maternity hospital, or other institution, to apply for an authorisation to procure umbilical cord blood on its premises. It is also permissible for an organisation, company or person to apply for an authorisation to procure umbilical cord blood at premises other than their own. In this latter instance, the applicant is required to have a written contract or service level agreement in place with any hospital, clinic or person carrying out the actual act of procurement.
The Clinical Indemnity Scheme (CIS), which has responsibility for the indemnification and management of all clinical negligence claims in the Health Service Executive, public hospitals and certain scheduled agencies issued a notice on 29th September 2008 on collection of umbilical cord blood. The notice clarifies that collection of cord blood for personal banking by a commercial organisation does not come within the definition of “professional medical services” as defined in the National Treasury Management Agency (Delegation of Functions) Order 2003 (No. 63 of 2003). A doctor, midwife or nurse who procures blood on behalf of a third party is not covered by the CIS for such procurement.
The HSE has made provision for directed donation of umbilical cord stem cells for high risk cases. In such cases, collection on foot of a request by a consultant haematologist in respect of the treatment of a named individual is organised by the Irish Blood Transfusion Service, which is authorised by the IMB for this purpose and is covered by the CIS.
In relation to research, I am aware that a range of research projects are underway which are examining the potential benefits of stem cell treatment. My Department will keep this issue under review.
Dáil Éireann 663 Written Answers. Hospital Procedures.