The transplantation of human tissues and cells is a strongly expanding field of medicine offering great opportunities for the treatment of as yet incurable diseases. Tissues and cells include haematopoietic blood stem cells, umbilical cord blood, bone, heart valves, liver vessels, corneas and reproductive cells – eggs, sperm and embryos. Because of the unique nature of these substances, it is important that their quality and safety when used for transplantation is ensured, particularly in order to prevent the transmission of disease possible with their use. Hospitals, Assisted Reproduction Centres and other sites that undertake activities associated with the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells fall within the scope of the legislation for which the HPRA is responsible.
HPRA Role in Regulating Tissues and Cells
The HPRA’s role is:
- Competent authority for this legislation
- Implementation of the legislation
- Inspection and authorisation of tissue establishments
- Receipt, evaluation and follow up of serious adverse reactions and events (SAR/E)
With certain exceptions, requirements relating to quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells for human application are regulated under Statutory Instrument No. 158 of 2006 (Quality and Safety of Human Tissues and Cells) Regulations.
These Regulations apply to ‘prescribed activities’ which are defined as follows:
‘Prescribed Activity’ means any activity consisting of the donation, procurement, testing, processing, preservation, storage of distribution of tissues or cells for human applications.
Any individual or site which carries out any prescribed activity is required to be authorised by the HPRA. In order to obtain a tissue establishment authorisation, an application must be made to the HPRA for tissue establishment authorisation. Compliance with the requirements of relevant Regulations must be demonstrated by applicants. To ensure that compliance with these requirements are maintained, inspectors monitor compliance through regular on-site inspections.