John Deasy
Question:6 Mr. Deasy asked the Minister for Agriculture and Food if he will be inviting submissions in relation to the proposed prescription only medicine exempt; and if he will make a statement on the matter. [8980/03]
Other Questions. - Animal Vaccines.
John Deasy
Question:34 Mr. Deasy asked the Minister for Agriculture and Food if his attention has been drawn to the concerns being expressed by the farming community in relation to the proposed prescription only medicine exempt, which they feel will lead to increased costs of animal vaccines and reduce the emphasis on preventative medicine. [8979/03]
I propose to take Questions Nos. 6 and 34 together.
An Leas-Cheann Comhairle
Twelve minutes will be allowed for this question and one minute for the supplementary questions.
The prescription only exempt category is one of six possible routes of supply which can be applied to an individual veterinary medicine, including veterinary vaccines, under the Animal Remedies Regulations 1996. Therefore, there is nothing new about this category, which has existed since the coming into force of the above regulations on 1 August 1996. The purpose of having a range of routes of supply is to enable products to be subject to the degree of control necessary to safeguard human and animal health, and decisions in individual cases are taken on a scientific basis taking account of the individual characteristics of the product in question and the objective criteria laid down in the Animal Remedies Regulations 1996.
I am aware of certain concerns which have been expressed about the designation of some vaccines to the prescription only exempt category, which means that the product may be purchased from a pharmacy without veterinary prescription. Veterinarians may also supply the products in certain circumstances. Such designations have arisen from a review of the marketing authorisations for all vaccines on the Irish market. It was necessary to conduct this review to ensure that products met the standards determined by current scientific knowledge, thereby maintaining confidence in the regulatory regime that underpins the production and marketing of Irish animal food products on home and export markets.
As regards designation of routes of supply, my Department does not have a general policy to exclude any of the legitimate outlets which are provided for under the 1996 regulations. Neither could this exercise be approached in an arbitrary way to apportion market share as between the various commercial interests in the marketplace. Nonetheless, while it is not an issue my Department can take into account, I do not see how supply of products through pharmacies could, of itself, justify increased costs when compared with other outlets.
My Department will continue, under this review, to designate individual products to the appropriate route of supply which, based on its assessment, is the minimum required to safeguard human and animal health.
Does the Minister not think that a preventative medicine approach might be very useful in this case and that the putting of additional resources into supporting better animal husbandry, for example, would effectively reduce the need for antibiotics in particular? What current scientific evidence indicates that there is a risk to human health that could be related back to the misuse or abuse of antibiotics as purchased via the co-operative system? I understand that there is considerable traceability and a close record kept of any products bought in this way, thus providing accountability. Surely, making the products available on a prescription-only basis will increase the cost significantly.
I think there is a misunderstanding. Question No. 1 referred to intramammaries which we discussed in respect of the designation of prescription-only medication. The Animal Remedies Regulations Act 1996 allows the Minister for Agriculture and Food, as the competent authority in Ireland, to license veterinary vaccines. Therefore, there is a great difference between this case and what we were discussing earlier.
The Minister licenses veterinary vaccines in co-operation with or on the recommendations of the Irish Medicines Board. There is a huge range of vaccines involved, approximately 160 or 170. The board makes its recommendations to the Department of Agriculture and Food, but the Department does not necessarily follow them. In recent years, the Department disagreed with some 18 of 66 recommendations by the board for sound and constructive reasons. This will continue to be the approach of the Department.
We must return to the issue of the cost factor. People will still have the opportunity to apply to the Department for their licences, and it will assess the applications. Strict information has to be provided to the Department and this can only be done by the Irish Medicines Board. We do take its recommendations on board.
Does the Minister agree that there is no evidence to show a risk to human health up to now from the current arrangements? Would he not agree that introducing "prescription only" medicines on a wider basis would lead to a growth in the black market and more risk? Would he agree that the current professionals who are dealing with this issue and are registered are operating, by and large, in a very responsible way and there is, actually, no problem?
I thought I said that heretofore there has not been an problem and that is why the attitude adopted by the Department is the one most people would favour. This is partic ularly true in the case of vaccines as against intramammaries, regarding which we are directed by the Irish Medicines Board. The Irish Medicines Board operates in a consultative capacity in this case. The Department takes on board its recommendations and views but does not necessarily follow them.
There is not any need to worry about the black market in this instance because apart from our pharmacies, vets and co-ops, the bona fide operators who attend at marts must apply for a licence through the Department. There is no question of a black market. The black markets that might have existed in the past have been stamped out. We all know about the "back-of-the-van" syndrome.
In relation to the "prescription only" medicines exemption, does the Minister of State see an animal welfare issue? He mentioned this in his reply to Question No. 1. The same question arises here. What are the animal welfare issues that might be significant here?
When a licence for a product is applied for it goes directly to the Irish Medicines Board, which does a very strict analysis of what is involved and then makes a recommendation to the Department. We have a very professional veterinary unit within the Department. Incidentally, the unit recently won the ISO 9000 quality management systems standard, which is a remarkable achievement for part of a Civil Service organisation. I recently had the pleasure of accepting the award on the unit's behalf. This proves how capable the unit is in dealing with the questions raised by Deputy Upton and I see no reason for concern.
The EU was dissatisfied with some of the loose ends in Ireland and in other member states. Because of the value of our export markets, to which the Minister has already referred, we must be ever vigilant that we have the best products available. We must be able to convince the market that we have those products.
I hear what the Minister of State is saying with regard to not always taking on board the recommendation of the Irish Medicines Board and being judicious about it. Would he accept that there is an important role for Government in counterbalancing the huge pressure from particular vested interests in promoting the pharmaceutical products they have developed with profit in mind at the sales end and from vested interests which want as many products as possible to be on prescription, from the veterinary point of view? Would he accept that there is a Government responsibility to take the long-term view of avoiding immunity build-up to certain pharmaceuticals and in particular to antibiotics, which have a knock-on effect for humans as well as animals? Would he accept that this is a role that goes beyond some of the pressures that are coming on the Department to take on board particular pol icy areas that would reflect the pharmaceutical sector's interests.
I concur with the Deputy's views. That is the reason all of these safeguards are in place. At the same time, regard for public health is the overriding concern of the Department. We are also concerned for animal health and welfare and our third concern is to deliver a service of which our farmers can avail and operate in a practical workable way with safeguards built in. That is what we have been trying to do and that is the reason the Irish Medicines Board is on board.
The Department is most rigid in everything it does. In fact, we are generally accused of being too rigid. The Deputy can rest assured that we are all right in that regard.