Written Answers. - Bovine Disease Controls.
Sean Fleming
Question:
111
Mr. Fleming
asked the
Minister for Agriculture, Food and Rural Development
the position regarding proposals made by the Irish Medicines Board that all ruminant vaccines be reclassified as prescription only; and if he will make a statement on the matter.
[10455/01]
Regulation of the veterinary vaccines market is covered by a comprehensive body of legislation at both EU and national levels, namely, Council Directive 81/851 EEC and the Animal Remedies Regulations, 1996. Under the aforementioned national legislation, the Minister for Agriculture, Food and Rural Development is designated as competent authority as regards approval of individual vaccines.
The primary impetus for changes in the licensing regime in Ireland was the fact that existing licences no longer met the requirements of EU legislation, not least because they did not designate a legally binding route of supply for each product. It was, therefore, necessary to fully review all vaccines on the Irish market. Under relevant EU rules, such review must be carried out to a precise, demonstrable standard, which involves detailed expert examination of product dossiers submitted by applicant companies. As provided for under the relevant legislation, it was agreed that the Irish Medicines Board, IMB, would carry out the detailed examination of the application dossiers and recommend in each case on the grant or otherwise of a licence and the conditions which might be attached to such licence. In other words, the IMB would recommend but I would in each case decide on the grant of a licence and on the conditions which should be attached to such licence.
It is not the case, as implied by the Deputy's question, that the Irish Medicines Board has recommended that all ruminant vaccines should be reclassified as "prescription only". In fact, the essence of the board's recommendations in respect of ruminant vaccines is that they be classified as "prescription only exempt". The key difference between the two classifications is that while the former may only be supplied on the prescription of a veterinarian, no such restriction applies in the case of the latter category, which may be sold directly by pharmacists.
I should make clear that the position of the Irish Medicines Board, notwithstanding final decisions on the appropriate routes of supply for individual vaccines, rests with me under the relevant legislation. In terms of exercising my statutory function as competent authority, I should stress that I do not have a general policy which would necessarily preclude any of the interests provided for in the 1996 Animal Remedies Regulations from selling vaccines. Rather, each case will be fully evaluated on an objective basis, taking particular account of the criteria governing the designation of routes of supply contained in the 1996 regulations and also having due regard to the recommendation of the IMB in each case. Where, on the basis of this examination, it is concluded that a particular sales category meets all the necessary requirements, that category will be utilised.
