Dáil Éireann Debate, Tuesday - 18 November 2014
349. Deputy Ruth Coppinger asked the Minister for Health in order to honour Ireland's human rights obligations not to interfere with the right to obtain the highest possible standard of health, his views that the appropriate changes be made to the law to allow Mifepristone and Misoprostol to be available here for use in safe, early abortions. [43955/14]
View answerThe Minister for Health has no proposals to amend the Protection of Life During Pregnancy Act or to revisit the Eighth Amendment of the Constitution.
The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland. Medicinal products can be placed on the market in Ireland only after a marketing authorisation is granted by the HPRA following an application from the manufacturer. Medicines may also be authorised for use across Europe by virtue of a centralised marketing authorisation issued by the European Commission on behalf of the EU.
Under the medicines legislation a prescriber may prescribe a medicine which is not authorised in Ireland, or may prescribe a medicine authorised in Ireland for one indication to treat a different indication if this is considered to be medically necessary. However the use of the medicine must be consistent with the relevant legislative provisions and requirements, including the Protection of Life During Pregnancy Act.
