Simon Coveney
Ceist:131 Mr. Coveney asked the Minister for Agriculture and Food the number of medicines classified as prescription only since 1 October 2003; and if he will make a statement on the matter. [25475/03]
Written Answers. - Veterinary Medicines.
Paul Nicholas Gogarty
Ceist:151 Mr. Gogarty asked the Minister for Agriculture and Food if his attention has been drawn to the additional cost on the farming community of vaccines, which traditionally have been distributed through co-ops and merchants, becoming only available through veterinary surgeons and pharmacists into the future; and if he will review this policy to minimise both costs and use of pharmaceutical products where possible. [25607/03]
Simon Coveney
Ceist:171 Mr. Coveney asked the Minister for Agriculture and Food if he is implementing prescription only medicines; and if he will make a statement on the matter. [25474/03]
I propose to take Questions Nos. 131, 151 and 171 together.
Given that the current remit of my Department as licensing authority is confined to veterinary vaccines, with the Irish Medicines Board having licensing responsibility for other veterinary medi cines, this reply relates only to vaccines. I have on a number of occasions in the past outlined to this House the situation in relation to veterinary vaccines. My Department has also met with the various stakeholders to explain its approach in this area.
The licensing regime that had been in place until recently for veterinary vaccines in Ireland and which was based on the Therapeutic Substances Act 1932, was significantly out of date in terms of EU legal requirements and particularly in regard to the level of expert scientific evaluation applied to individual products. As well as other deficiencies, the regime did not provide for mandatory routes of supply which has been an EU requirement for many years. Accordingly, it was necessary to commence a thorough review on an individual basis of all veterinary vaccines currently on the Irish market. My Department, as provided for in the legislation, reached agreement with the Irish Medicines Board so that the board would carry out the detailed technical examination of application dossiers submitted by sponsoring companies. On the basis of this examination, IMB recommends to my Department, as the licensing authority on the grant or otherwise of a license and the conditions, including route of supply, to attach to such licence.
Since 1 October 2003, of four vaccines licensed by my Department, one was assigned to the "Prescription Only", POM, route, while, of the remainder, two were assigned to the "Licensed Merchant", LM, route and one to the "Prescription Only Exempt", POME, route. In overall terms, of the 98 vaccines reviewed to date, 66 have been designated POME, 29 POM and three LM.
As regards concerns which have been expressed about additional costs arising for farmers, the principal dynamic driving the actions by Department in this area has and will continue to be the need to protect public health and animal health and welfare. While my Department does not have a policy of excluding any of the commercial outlets provided for in the legislation, it has a responsibility under the legislation to apply to individual products the degree of control, in terms of route of supply, consistent with the risks it judges to be associated with each. However, I am conscious of cost considerations, particularly at this time, and that my Department will keep this matter under review to ensure a workable regime consistent with the overall objective of protecting public and animal health and welfare. My Department is reviewing its remit as licensing authority for veterinary vaccines.