Dr. Patrick Costello:

I am the blood, tissue and organ manager at the Irish Medicines Board, which is one of two competent authorities appointed for implementation of the 2010 directive which sets the standard for the quality and safety of human organs intended for transplantation. This was transposed through SI 325/2012. The other competent authority is the HSE, which established the national organ donation and transplantation office as its representative and as a competent authority for implementing the legislation.

The legislation is relatively limited and divides the two organisations' roles. The Irish Medicines Board, IMB, is responsible for the inspection and authorisation of procurement organisations and transplantation centres. It is also responsible for reviewing adverse events or reactions that are attributable to the quality and safety of a transplanted organ. The HSE has a wider role in implementing the legislation. It must develop the framework for the quality and safety of organs. This includes issuing guidance to health care establishments and professionals on best practice in transplantation. It has a role in the establishment of a donor and recipient registry and in the control of organ exchanges between Ireland and other member states. It also plays a critical role in respect of reviewing and learning from adverse events and reactions.

The IMB has been appointed to its role because we have a history of regulating health care facilities, in that we were responsible for implementing the blood and tissue legislation. There is an overlap between tissues and organs. In theory, multi-organ donors could become multi-tissue donors as well. Two of our organ centres are also tissue establishments. We are committed to working with the HSE, the Department of Health and our clinical colleagues, from whom the committee has heard, in the implementation of this legislation.