Tim O'Malley (Limerick East, Progressive Democrats)

It has always been the case that whenever the Irish Medicines Board proposes to refuse the grant of an authorisation or licence in respect of a medicinal product, either human or veterinary, it must consult with the appropriate independent expert scientific advisory committee. This consultation is only mandatory where the refusal is on grounds relating to safety, quality or efficacy of a medicinal product. At present, there are two independent scientific expert committees to which referrals in such circumstances are required. These are the advisory committee on human medicines and the advisory committee on veterinary medicines. The reason for requiring a referral in such matters is to ensure that any such refusal is justified on the basis of appropriate independent expert scientific advice.

The current amendment is being made with a view to extending the same facility to applicants for manufacturing and wholesaling licences, when refusals are based on quality, safety or efficacy. At present, there are three independent expert advisory committees. The third such committee is the one which advises on medicinal devices. All of these committees operate on an ongoing basis to advise the board with regard to its evaluation of applications made to the board and on matters relating to pharmacovigilance. They act on a consultative basis.