Apologies have been received from Ms Avril Doyle, MEP.
Item No. 1 on our agenda is a discussion with officials from the Department of Agriculture and Food on the draft Commission decision on animal medicines. We are joined by Mr. Richard Healy, Mr. Pat Brangan and Mr. Philip Kirwan from the Department of Agriculture and Food. We touched on certain issues in the past and agreed to follow up on what the Commission was proposing on animal medicines. This committee was concerned at the derogation sought by the Department of Agriculture and Food and it now seems this concern was justified.
Directive 2004/28/EC states that a veterinary prescription shall be required for dispensing to the public certain veterinary products. At the time the measure was adopted it was agreed the expert committee, following the presentation of a proposal by the Commission, would determine which products would be covered by this requirement. In October 2005 this committee considered the matter of veterinary medical products for food producing animals and wished the Department success despite concerns being raised at the approach adopted by the Department. It was suggested that, if a wide derogation was not granted by the expert committee, a failure to widen the range of qualified persons permitted to prescribe veterinary medicines, in a way similar to the approach adopted in Britain and Northern Ireland, would result in higher costs to the end user and perhaps result in the emergence of a cross-Border black market.
The Department had contended that changes to the national approach to prescriptions were not required until 1 January 2007 as Article 67 of the adopted measure provided for the Commission to advance a proposal through the expert committee to effectively provide a derogation. A derogation would arise from the Commission proposing, and the expert committee agreeing, to exclude a range of products from the requirements for a prescription. On 9 February the Commission circulated a draft of the derogation it was proposing on the matter. I thank the Department for forwarding its note on this matter. The Department indicates that the proposed criteria would place severe restrictions on the range of medicines which could remain off-prescription. I understand particular concerns relate to the suggestion that exempted products may contain only the active substances listed in Annex 2 of Council Regulation EEC 2377/90, which are substances that require a withdrawal period, and that medical products administered by injection would be excluded from the derogation.
The Commission has not formally presented a proposal to the expert committee on the derogation from requiring a veterinary prescription to dispense veterinary products to the public. Perhaps the most productive approach for our committee to pursue is to determine the possible implications of adopting the current consultation paper as the basis for a derogation for existing veterinary products. More importantly, we should explore what submission, if any, our committee might make to the commission to advance an alternative proposal. We have not done so previously.
Previously, we examined agriculture in a number of different general areas. In this matter, we are pursuing the implementation of a particular EU directive. Members will agree we had difficulties with the way in which the nitrates directive has been implemented, particularly regarding impact assessments. Last October, Department officials made it clear to us this was preferable as they did not believe following the British model was the optimum way to pursue it. Unfortunately, it seems as though the Commission is adopting a stricter approach than we were led to believe. The reason for today's hearing is to ask the Department of Agriculture and Food what is the situation and what can we expect from the consultation with the Commission.
The departmental officials will make a presentation, after which it will be opened up to members.