I thank Deputy Kirk for raising this matter. I know how important this is to him, particularly in regard to the Cooley Peninsula, but also to other prominent sheep-raising areas throughout the country.
The market in veterinary medicines, which includes veterinary vaccines, is regulated under a comprehensive body of EU legislation. Member states are obliged to implement this legislation in a uniform way so as to ensure that the Single Market operates effectively. The EU legislation has been transposed into Irish law by means of the Animal Remedies Act 1993 and regulations made thereunder. The primary objective of this legislation is the protection of public health. Protection of animal health and welfare are also key objectives of the legislative regime.
The Irish Medicines Board is designated as the competent licensing authority for all categories of veterinary medicines, except for veterinary vaccines, where competence rests with the Department of Agriculture and Food. In the case of vaccines, prior to the enactment of the Animal Remedies Regulations 1996, product licences had been issued under outdated legislation, namely, the Therapeutic Substances Act 1932. Consequently it was necessary to fully review the licences for all vaccines on the Irish market by reference to current scientific standards and in accordance with the detailed requirements of the current regulatory regime. In order to achieve this, the Department reached agreement with the Irish Medicines Board that the board, using its established expertise, would carry out the detailed examination of the voluminous and complex application dossiers from applicant companies and on this basis make a recommendation to the Department on the grant or otherwise of a licence and on the conditions to accompany such a licence. The Department as competent authority, then makes a final decision on each product application taking full account of the recommendation received from the Irish Medicines Board.
The product in question is used to vaccinate sheep against looping ill disease which, in Ireland, is geographically limited to rough hill grazing areas where the tick which spreads the disease is prevalent. The assessment of the product under the review process was begun by the Irish Medicines Board in April 2001. Expert examination of the application dossier revealed that the information and data submitted did not reach the required standard to demonstrate the quality, safety and efficacy of the product to enable it to be recommended by the Irish Medicines Board for licensing by the Department.
I understand that in the intervening period a number of detailed exchanges took place between the Irish Medicines Board and the sponsoring company about the outstanding requirements and that the board had been prepared to afford the company concerned adequate opportunity to provide the required information and data which would demonstrate the quality, safety and efficacy of the vaccine. I further understand that the company concerned informed the Irish Medicines Board in March last that it did not intend to sustain its application and consequently intended to withdraw the product from the Irish market.
The company subsequently entered into correspondence with my Department about arrangements for withdrawal of its product from the Irish market. My Department wrote to the company concerned in mid-May seeking further relevant information and details and a response from the company is, as of now, awaited.
It will be evident from the above that the Department, as competent authority, has not had the opportunity to reach a final determination on a licensing application for this product. Indeed, the decision by the company to withdraw the product from the market pre-empted a final recommendation from the Irish Medicines Board on the grant or otherwise of a licence. It goes without saying that the initiative as to the maintenance of a licence application rests in the first instance with the applicant. That said, the Department continues to await a response to the issues raised with the company within the last two weeks. The company must respond to the Depart ment before a final decision can be made on this matter.
