Dr. Elaine Breslin:

I thank the Chairman and the committee members. I am a clinical assessment manager, and I am joined by my colleague, John Lynch, the director of compliance. We are pleased to provide this opening statement in response to the committee’s request to consider the matter of the authorisation of medicines for the termination of pregnancy, in light of the impending introduction of abortion services in Ireland. The HPRA, as the competent authority for the authorisation of health products in Ireland, seeks to fully inform the committee in this regard by providing the following information.

We will briefly outline the medicines for medical termination of pregnancy and the system for the authorisation of medicines in Ireland and across the European network, in particular the mutual recognition procedure which is relevant to these medicines. We will then provide an update on our work to date to secure authorised medicines, while respecting the applicants’ confidentiality. We will conclude with a description of the exempt medicines scheme, which is relevant to facilitating the availability of a medicine where an authorised equivalent is not available.

By way of background, medical termination of pregnancy is achieved by the taking of two medicines, up to 48 hours apart, to induce a miscarriage. The use of these medicines, in combination, results in a safer and more effective procedure. In the European Union, both of these medicines are subject to prescription and can only be prescribed and administered in accordance with a country’s national laws and regulations.