I am grateful to the Chair for the opportunity to raise this issue. The Irish Medicines Board has recommended to the Minister for Agriculture, Food and Rural Development a number of changes in the classification of animal vaccines. The principal change proposed which has given rise to considerable concern among farmers is that all vaccines for ruminant animals should be classified as prescription only. This would mean that the substantial number of licensed merchants who now supply these medications to farmers would no longer be permitted to do so, sources of supply to farmers would be seriously restricted, competition in the trade would be sharply reduced and there would be a considerable danger of a large price increase, similar to that which happened in the UK when a similar measure was applied in that country.
I asked the Irish Medicines Board for the reasons behind its recommendation. Specifically, I asked for information on any studies or reports that might have led to the recommendation. I want to compliment, and record my gratitude to, Dr. Hallinin, the chief executive of the Irish Medicines Board, who replied to my query within a week. I wish that all organisations in the public sector would be that prompt in their replies. I also thank Dr. Hallinin for the comprehensive nature of his reply, a model of clarity which I wish the rest of the public sector could imitate.
The reply gave me the clear impression that there were no studies or reports of the kind which I suspected might be there. The principal part of the reply read as follows:
The scientific principle needed to be applied at all times. Each decision to vaccinate an animal required that the animal be healthy and free of concurrent disease. It was difficult to establish how this could be achieved unless under veterinary control. Furthermore, given the fact that vaccines can rapidly lose their potency under adverse heat conditions and poor hygiene, and that untrained personnel are unlikely to have a proper understanding of the factors affecting the antigenic activity of the products, it would be difficult to justify the absence of veterinary prescriptions for most products.
I would consider the remainder of the IMB reply to be pure bureaucracy and I will not detain the House with it. The kernel of the IMB's case, which I have quoted, totally ignores the fact that licensed merchants must satisfy the Department of Agriculture, Food and Rural Development as to the training of their personnel in courses approved by the Department. They are obliged to have premises with facilities for the proper storage of the products, with proper refrigeration facilities and with facilities for the rotation of stock, and they must keep proper records on entries, stocks and disposal of the products. All that is done under the supervision of the Department of Agriculture, Food and Rural Development.
Licensed merchants advise farmers on the proper use and storage of the products. As I am sure the two Ministers of State opposite will agree, no farmer will go to the expense of buying vaccines and either not storing them properly or not using them properly. It would be nonsense, as the two Ministers of State will know, to require, for example, that a dairy farmer who fears the onset of mastitis would feel he had to call in a vet in every case, and that is what is being proposed by the IMB. The IMB has not been able to point to any human health or animal health problem or, indeed, any evidence of misuse in any way of the products in question.
The final part of the IMB's reply seems to me to be one to which the Minister should pay particular attention. It states that the Department of Agriculture, Food and Rural Development was free to accept or otherwise the proposed category of supply as a result of other considerations such as economic factors which are outside this board's remit.
I would urge the Minister to operate on the basis of that invitation, ignore this advice on the basis of practical everyday farming common sense, and allow farmers and their suppliers of medicines to get on with their business in peace without this unnecessary proposed bureaucratic intervention.
Minister of State at the Department of Agriculture, Food and Rural Development (Mr. N. O'Keeffe): I congratulate Deputy Dukes on his appointment as Fine Gael spokesperson on agriculture. He will be like a breath of fresh air and of course he will be very combative as Opposition spokesperson. I wish him well.
The House will be aware that the veterinary medicines industry is regulated under a comprehensive body of national legislation which is ultimately rooted in European law. A detailed approval and regulatory framework for veterinary medicines and vaccines has been developed at EU level over the past two decades, which member states are obliged to implement uniformly in the interests of the proper functioning of the internal market. The primary objective of this legislation is the protection of human health. By definition, this is also a complex area which is inextricably linked with technological developments in the pharmaceutical area and the product of research and development by pharmaceutical companies.
Consumers rightly expect that the food which they eat will be safe and wholesome. They equally expect that those charged with responsibility for the protection of public health will put in place and maintain systems and regimes which will ensure that this will be the case. We are all aware that Ireland is uniquely dependent on export markets for our agricultural output. It follows that in order to command consumer confi dence, both at home and on export markets, our regulatory and control environment must be on a par with the very best.
My Department has given a high priority in recent years to ensuring that the highest possible standards are applied to our agriculture, food and related industries. In the veterinary medicines area, there is in place a modern and comprehensive body of legislation based on the Animal Remedies Act, 1993. This Act has provided a basis for more detailed provisions, in particular the Animal Remedies Regulations, 1996. I am proud of the sustained efforts which my Department have made over recent years in giving full effect to this legislation and in addressing unacceptable practices in this area. At the most extreme end of the spectrum, the Department's success in this regard is evidenced by the number of successful prosecutions taken in the courts.
Since 1996, with the coming into effect of the Animal Remedies Regulations, my Department has assumed statutory responsibility for licensing veterinary vaccines. This had hitherto been the responsibility of the then Department of Health under the Therapeutic Substances Act, 1932. With developments in EU legislation over the past number of years, the approval systems which were the basis for licences issued under the Therapeutic Substances Act, 1932, no longer met EU requirements. Consequently, it was necessary to review all vaccines currently licensed on the Irish market in the context of the current EU regulatory environment and with specific regard to the routes of supply of such vaccines.
There is an inter-agency involvement in the current licensing regime for veterinary vaccines. This involves my Department and the Irish Medicines Board. As provided for in the relevant legislation, the IMB carries out the detailed examination of application dossiers submitted by applicant companies. The requirements imposed under the relevant legislation for establishing the quality, safety and efficacy of individual vaccines are quite onerous and result in voluminous application dossiers which require expert examination.
Having completed its technical examination of an application dossier, the IMB must make a formal recommendation to my Department on the grant or otherwise of a licence, including the conditions to be attached to a licence. These conditions will include the route of supply. The final decision on licensing rests with my Department, as competent licensing authority.
I understand that the IMB made an announcement earlier this year outlining its general approach in terms of recommending to my Department what the appropriate routes of supply should be for categories of vaccines. The IMB is, of course, perfectly entitled to outline its thinking in the matter but, as I have said, statutory responsibility for the final determination in each case rests with my Department.
In approaching the issue of supply routes, my Department does not have a general policy to exclude any particular part of the commercial sec tor which is provided for and appropriately licensed under the legislation. While this has been made clear to a number of concerned parties, I am not sure that this message is as yet fully understood. I want, therefore, to repeat that my Department will look at each case on its merits and in reaching its decisions will have regard to all relevant and valid considerations relating to routes of supply.
My Department's decisions will be made in the interests of public health and will take account of animal health and welfare considerations and relevant legislative and technical requirements, including the criteria outlined in the Animal Remedies Act, 1993, and, in particular, the Animal Remedies Regulations, 1996. These criteria are comprehensive and cover aspects such as risk to the consumer, the person administering the substance, the animal, or the environment. Aspects such as the need for a prior diagnosis, special storage conditions and professional advice are also among the criteria covered. As Deputies would expect, my Department will have careful regard to the IMB's recommendations in each case and decisions will be taken on a case by case basis. To suggest, however, that henceforth all vaccines will be licensed for supply only through veterinary surgeons and pharmacists would be to misunderstand and misrepresent the position.
I thank Deputy Dukes for raising this important matter.