Simon Coveney
Ceist:109 Mr. Coveney asked the Minister for Agriculture and Food if he is implementing “prescription only” by stealth. [20180/04]
Amharc ar fhreagraTuesday, 6 July 2004
Ceisteanna (77, 78)
Simon Coveney
Ceist:140 Mr. Coveney asked the Minister for Agriculture and Food the number of medicines classified as prescription only since 1 October 2003. [20181/04]
Amharc ar fhreagraFreagraí scríofa
I propose to take Questions Nos. 109 and 140 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 medicines — this reply relates only to vaccines.
The licensing regime that had been in place for veterinary vaccines in Ireland and which was based on the Therapeutic Substances Act 1932, was significantly out of date in terms of EU legal requirements and particularly in regard to the level of expert scientific evaluation applied to individual products.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 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 23 vaccines licensed by my Department, 17 were assigned to the ‘Prescription Only' (POM) route, while, of the remainder, 3 were assigned to the ‘Licensed Merchant' (LM) route and 3 to the ‘Prescription Only Exempt' (POME) route. In overall terms, of the 117 vaccines reviewed to date, 67 have been designated ‘POM(E)', 45 ‘POM' and 5 ‘LM'.
There is no question, as suggested, of implementing ‘POM' by stealth. I have on a number of occasions in the past outlined to the House the situation in regard to veterinary vaccines. My Department has also met the various stake holders to explain its approach in this area.
I propose to make a number of amendments to national legislation in this area. As I indicated, these changes will improve the operation of the prescription regime and provide a basis for a greater degree of price competition in the supply of veterinary medicines. It is also intended to transfer licensing competence for vaccines from my Department to the Irish Medicines Board.