I propose to take Questions Nos. 140, 155, 162, 177, 185 and 199 together.
The draft regulations on veterinary medicines which were circulated by my Department in August for consultation are designed to give effect to EU Directive 2004/28 and to reform aspects of the existing national regime. My Department has received written submissions from most of the main stakeholders and has also subsequently met with many of these stakeholders as part of the consultative process. In addition, as required by the relevant legislation, the Animal Remedies Consultative Committee will meet shortly to consider the draft regulations, following which I will make final decisions on the issues involved so that the regulations can be brought into force by the transposition deadline.
I am aware of the views that have been expressed about the possible impact of the draft regulations on competition in the supply of veterinary medicines, in particular, from the requirement in the EU directive that all veterinary medicines for food producing animals must be subject to prescriptions. I should explain, however, that the directive also includes a provision for exemption criteria to be adopted at EU level, which will provide a mechanism for certain categories of medicines to be exempted from the prescription requirement. The EU has not yet adopted a decision on the exemption criteria but must do so before 1 January 2007. Pending this decision, existing national prescription and distribution arrangements may remain in place.
It is my intention to avail of the exemption clause to the maximum extent possible and my Department has made a submission to the EU with a view to retaining ‘off prescription' in Ireland all products, other than intramammaries, which currently enjoy this status. The draft regulations published by my Department provide that veterinary medicines, such as wormers and certain vaccines, will continue to be available off-prescription for the time being and in practice, this means that, apart from intramammaries, we are retaining the essence of our existing national prescription and distribution regime. In view of this, it is not necessary at this stage, for competition reasons, to extend the range of persons who may be permitted to prescribe. I will, however, review the regulations and in particular the provisions relating to the categories of persons who would be permitted to prescribe medicines in the light of the exemption criteria that are agreed at EU level in due course.
With regard to the recommendations of the Competition Authority, many of these recommendations are based on the misapprehension that all veterinary medicines will be subject to a prescription only regime from 1 November, which I have explained is not the case. However, their views will be taken into account, along with those of the other stakeholders, in my final decisions. My position is that while regulations in this area must, of necessity, give primacy to protection of public health and animal health and welfare, it is also important to minimise costs to the farming sector and, with this in mind, my Department has included a number of important changes in the draft legislation to achieve this objective. Among these are: the removal of inflexibilities in the existing prescribing regime which will reduce the need for mandatory farm visits by practitioners and extending the life of a prescription from the current 31 days up to six months will facilitate the farmer and his-her vet, where appropriate, anticipating needs, particularly for management type products; the new requirement for veterinary practitioners to issue written prescriptions in all cases and to ensure that farmers are made aware of the cost of medicines as distinct from the professional service given and to facilitate the purchase of medicines at premises other than that of the veterinary practitioner; and permitting licensed retailers to supply for prescription only medicines for the first time.
It is evident from the foregoing that my Department is doing everything possible, in so far as it has the flexibility to do so, to create an environment to ensure that there continues to be competition in the supply of veterinary medicines.
In relation to availability of veterinary practitioners to issue prescriptions, the draft regulations published by my Department will, as I have said earlier, substantially retain the existing regime in relation to off-prescription products until I January 2007, which means that, with the exception of intramammaries, medicines currently available generally from pharmacies and licensed merchants will continue to be available from these outlets until that date. I should point out that veterinary practices are primarily commercial entities and their location is driven by commercial realities. In so far as Government involvement is concerned, I would also draw attention to measures in the new Veterinary Practice Act, which should help to address any shortages in Irish trained vets. For the first time, the Veterinary Council is being enabled to recognise qualifications from applicants in third countries generally and this, taken also with the recent enlargement of the EU, should make for the improved availability of practitioners from outside the State to meet any shortfalls in the supply side.
With regard to the regulatory impact assessment, the EU directive which is sought to be transposed via these regulations pre-dated the introduction of the regulatory impact assessment initiative by the Government. Notwithstanding this, my Department has carried an assessment of the impact of the draft regulations in the course of the consultative process with the stakeholders and I will be taking account of this in my final decisions on the regulations.