Dáil Éireann díospóireacht -
Tuesday, 5 Dec 2000

Vol. 527 No. 3

Written Answers. - Animal Vaccines.

P. J. Sheehan

Ceist:

73 Mr. Sheehan asked the Minister for Agriculture, Food and Rural Development if he will guarantee that all ruminant vaccines will continue to be available to the farming community through co-ops, vets, pharmacies and licensed merchants under the Animal Remedies Act, 1996. [28274/00]

Minister for Agriculture, Food and Rural Development (Mr. Walsh)

It is not possible, nor would it be appropriate to give an absolute guarantee as to the future availability of all ruminant vaccines. To do so, would be to prejudice the outcome of the ongoing review of veterinary vaccines currently on the Irish market, which must be carried out on the basis of objective and detailed criteria laid down under relevant EU and national legislation.

Regulation of the veterinary vaccines market is covered by a comprehensive body of legislation at both EU and national levels, that is, Council Directive 81/851EEC 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.

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. Furthermore, while I must give due regard to the recommendation of the IMB in each case, I am not bound by any such recommendation. 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. 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.

It should be clear from the forgoing that leaving the present control arrangements in place, is not an option if we are to meet our legal obligations under EU law and if our regulatory systems are to enjoy the confidence of counterparts in other member states. It should be borne in mind that many of these countries are important markets for our agricultural output. As far as my own approach is concerned, it should be equally clear that no appropriately licensed outlet provided for by the 1996 regulations will be excluded as a matter of general policy.