Dáil Éireann Debate, Tuesday - 16 April 2013
1174. Deputy Billy Kelleher asked the Minister for Health his plans to carry out clinical trials of low dose Naltrexone for the treatment of multiple sclerosis and other autoimmune diseases; and if he will make a statement on the matter. [16400/13]
View answerThe Irish Medicines Board (IMB) is the competent authority for the authorisation of clinical trials with medicines in Ireland. However, the IMB does not carry out trials and neither does the Department of Health. Clinical trials are conducted by sponsors from industry or academia and carried out by healthcare professionals according to protocols authorised by the IMB and approved by an ethics committee.
Under European and Irish legislation, before a medicine can be placed on the Irish market the manufacturer has to seek an authorisation from the Irish Medicines Board (IMB) or in the case of certain medicinal products, the European Medicines Agency (EMA). A determination on an application for authorisation of a medicine is based on a rigorous scientific assessment of the application against legal and regulatory requirements.
Naltrexone is authorised in Ireland for the treatment of alcohol and drug dependence; it is not authorised for the treatment of multiple sclerosis or autoimmune disorders and there are currently no clinical trials authorised for these conditions in Ireland.
