Question to the Minister for Health (Dr. James Reilly, TD)
To ask the Minister for Health if he will outline the legislative and regulatory provisions in place which govern the operation of fertility clinics; if, in his opinion, there is a need to review such provisions or the absence thereof; and if he will make a statement on the matter. – Jerry Buttimer T.D.
For WRITTEN ANSWER on 16/04/2013
REPLY.
Certain aspects of the operation of fertility clinics are currently regulated. The handling, processing, storage, etc, of human tissue, including gametes (eggs and sperm) and embryos, is currently regulated under the European Communities (Quality and Safety of Human Tissues and Cells) Regulations (Statutory Instrument No.158 of 2006) came into law on 7 April, 2006. The Regulations apply to tissues establishments involved in the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications. The aim of the Regulations is to ensure a high level of protection of human health. The Regulations include criteria for assessing the status of prospective donors, inspection and control measures, traceability of donations and qualifications and training for persons working in tissue establishments.
Fertility clinics are tissue establishments under the Regulations and thus, they must be inspected and authorised by the Irish Medicines Board (IMB), which is the competent authority under the Regulations, to ensure that they meet quality and safety standards.
The Medical Council provides specific guidance in the area of AHR in the ethical guidelines issued periodically to registered medical practitioners for application in the clinical situations in which they work. However, these Guidelines have no statutory remit and do not apply to anyone working in the area other than medical practitioners. Section B (20.1-20.4) of the 7th Edition of the Medical Council Guidelines provides as follows:
20.1 Assisted human reproduction treatments, such as In Vitro Fertilisation (IVF), should only be used after thorough investigation has shown that no other treatment is likely to be effective. You should ensure that appropriate counselling has been offered to the patient and that the patient has given informed consent before receiving any treatment.
20.2 Assisted reproduction services should only be provided by suitably qualified professionals, in appropriate facilities, and according to international best practice. Regular clinical audit and follow-up of outcomes should be the norm.
20.3 If you offer donor programmes to patients, you must consider the biological difficulties involved and pay particular attention to the source of the donated material. Such donations should be altruistic and non-commercial. You should keep accurate records for future reference.
20.4 You should not participate in creating new forms of life solely for experimental purposes. You should not engage in human reproductive cloning.
I am currently considering policy proposals to further regulate Assisted Human Reproduction and related matters.