I will not be engaging in political comment. Members will be aware that the forthcoming regulations dealing with veterinary medicines were the subject of a detailed motion and counter motion during Private Members' business in the Dáil last week. In the course of that debate the Minister for Agriculture and Food, Deputy Coughlan, made a comprehensive statement on the background and approach being adopted to the regulations. Consequently, apart from dealing with some of the issues raised by the Chairman, I do not propose to make a detailed statement on those aspects covered by the Minister. Subject to the committee's agreement, I propose to make a short contribution mainly on developments since the Dáil debate. After that we will attempt to deal with questions members may have. Copies of the Minister's statement from last Tuesday are available if members wish to peruse it.
Veterinary medicines in Ireland are regulated by the Animal Remedies Act 1993 and regulations made thereunder in 1996, 1998 and 2002. That legislation transposed what was then EU legislation and it also included national provisions. In recent years a major review was undertaken of the national arrangements in the regulations and, following a major review, EU legislation was amended with the adoption of Directive 2004/28. Apart from those two issues, the Irish Medicines Board also published a report on intramammary controls in December 1999. The proposed new regulations arise from the foregoing and are designed to adapt national legislation to make the provisions more operational and to transpose the EU directive into Irish law.
The proposed regulations were drawn up after comprehensive consultations with the relevant stakeholders and other interested parties. They took into account developments in veterinary medicine and consumer demands for effective regulation in food related areas. Issues, such as concerns about antimicrobial resistance, have come more to the fore. Maintaining effective regulation in the area of veterinary medicines entails keeping pace with and accommodating these and other evolving considerations in a manner which can be reconciled with the practical realities of farming and food production and processing. One of the objectives of the EU directive was to address concerns about the continuing competitiveness of the EU pharmaceutical industry and the loss of veterinary treatments. Hence the directive and the national implementing regulations include a range of measures designed to address these problems, as well as comprehensively updating the licensing process and the regulatory regime
The consultation process here was intensified recently following publication of the draft regulations in August. The consultation process involved meetings with the statutory Animal Remedies Consultative Committee and a range of stakeholders. On completion of that consultation process, the Minister confirmed in a statement on 22 October that she was finalising the regulations following her consideration of the views put forward. In her statement she said that in finalising the measures, her overall objective was to put in place a workable system for the distribution of medicines within the parameters of the EU directive which, at the same time, protects public and animal health, facilitates our food export trade and minimises costs for producers. She pointed out in particular that while the directive required that all medicines for food producing animals should be made subject to prescription, the directive also contained a mechanism for categories of medicines to be excluded from that requirement. The EU must adopt a decision on the relevant exemption criteria before 1 January 2007. The directive also provides that pending those decisions, existing national prescription arrangements can remain in place and the Minister indicated she was proceeding on that basis. That means the regulations will not require any current medicines to be made subject to prescription as of now and farmers can continue for the time being to get such medicines on the same basis as at present.
As regards intramammaries, the Minister said it was clear there was no prospect of intramammaries that contain antibiotics qualifying for exemption at EU level and, consequently, such medicines must become subject to prescription. However, in order to allow for an orderly transition to the new arrangements, the Irish Medicines Board will manage the reclassification process with a view to having it completed for all products by 1 January 2007. This new deadline will also allow further time to finalise arrangements for prescriptions to be written in the context of mastitis control programmes implemented by co-operatives and will avoid the prescription requirement applying to different products from varying dates.
The Minister confirmed that she intended to avail of the exemption clause in the directive to the maximum extent possible and would retain most of the existing prescription and distribution arrangements until the issue of the exemption criteria was resolved at EU level. As existing products "off-prescription" will continue to be available as such, the Minister stated it was not necessary at this stage to decide whether persons other than veterinary practitioners should be permitted to write prescriptions for certain medicines such as wormers and certain vaccines for which prescriptions were not required currently. She indicated that the issue would be reviewed, in particular, the qualifications needed by non-veterinarians and the categories of products that may be prescribed by them in the light of the outcome of the EU decision on the exemption criteria with a view to ensuring competition in the marketplace while at the same time protecting public and animal health.
The suggestion that we should make provision in the regulations at this stage to permit qualified professionals other than veterinarians to write prescription is at best premature. In essence, we would be throwing in the towel before the negotiations on the exemption criteria started. It is not practical to make a decision to extend the range of prescribers until we know what additional medicines will become prescription-only. It would be unwise to provide at this stage for prescriptions to be written by non-veterinarians because to do so would oblige us to designate as prescription medicines some of the medicines currently "off-prescription". More importantly, it would completely undermine our negotiating position on the exemption criteria if we were to unilaterally recategorise non-prescription medicines. Deferring the decision on whether it will be necessary to extend the range of prescribers until the exemption criteria issue is resolved is the best approach to take in the circumstances I have outlined.
The Minister's statement confirmed also that the regulations would include a number of measures to minimise costs to farmers and to foster effective competition in the supply of veterinary medicines. These include the removal of the requirement for mandatory farm visits by the practitioners prior to writing a prescription, the extension of the life of a prescription from the current figure of 31 days up to six months and the introduction of a new requirement on veterinary practitioners to issue prescriptions in all cases. In addition, the Minister indicated she would be introducing a requirement that prescriptions must indicate at least two products where a suitable alternative was available in order to give farmers more choice as to the appropriate products. Furthermore, licensed merchants will be permitted to supply certain prescription medicines for the first time from 1 January 2007.
In her statement the Minister stated that, as well as the delay in the recategorisation of intramammaries as prescription medicines, she was deferring until 1 January 2007 the abolition of the prescription only medicine — exempt — category and the extension of the sale of prescription medicines by licensed merchants. In regard to the latter, and because most licensed merchants are not currently trained to dispense prescription medicines and many of their premises do not meet the required standards, the Minister was deferring until 2007 allowing licensed merchants to sell prescription medicines to enable the appropriate arrangements to be put in place. She confirmed that it was her intention to finalise the range of products that could be sold by licensed merchants and to set down the training and standards of premises requirements in more detail early in 2006 in order to allow licensed merchants time to meet the new requirements.
More generally, the Minister stated that, reflecting what was contained in the EU directive, the new regulations would also include a range of measures which would have a positive effect in securing an innovative pharmaceutical industry and the continued availability of an adequate range of treatments. Some of the measures, particularly those relating to the mutual recognition and cascade regimes, will bring particular benefits to small peripheral markets such as Ireland. The Minister stressed that the forthcoming regulations would be reviewed next year in light of the outcome of the exemption criteria issue and practical experience and she undertook to provide a suitable regime for intramammaries. She has also indicated that there will be full consultation with all the stakeholders on the range of matters involved before a final decision is taken.
A number of specific issues were raised. On exemptions, the Commission has undertaken to submit the exemption criteria early in 2006. We have made a submission to the Commission requesting that all medicines currently off-prescription be accommodated, namely, that we retain the status quo other than for intramammaries, which, because they contain antibiotics, fall into a different category. The proposal from the Commission will be submitted to a standing committee and a decision will be taken by a qualified majority. The Minister has made it abundantly clear that in the event of our not being successful, she will revisit the issue before 2007 with a view to allowing for non-veterinarians to issue prescriptions for certain medicines.
As stated earlier, if we were to allow that all non-veterinarians could prescribe, we would, in effect, have to provide that medicines currently not subject to prescription, namely, wormers and so on, be so prescribed. I do not believe that is what people want. The arrangement to push for criteria which will allow our range of medicines to remain exempt is the best approach. We do not believe there is a risk of a black market in this area. While the UK is going in a slightly different direction, it has, in effect, given up on the prospect of obtaining exemptions. We, however, are seeking to retain the current regime until 2007. The Minister has given her assurance that if we are not successful she will change the regime in the course of 2006.
The UK has gone a different direction and has effectively given up the prospect of having certain medicines exempted. We do not believe the prospects are remote. In any event, we would not necessarily follow the UK all the way down the line on this. We are aware of its experience with a range of diseases and so on in recent years. The issue is not one of whether we follow the example of the UK or that of the continental market, which has a much more rigid approach to veterinary prescriptions. We have a major interest in ensuring that our regime is effective and that regulators and consumers have confidence in our products. We tend to seek a much tighter regime than would be the case in a small number of member states. The vast majority of the current 15 EU member states operate tighter regimes than we would contemplate. This is about striking a balance between achieving a reasonably flexible regime with strong controls and having a tight regime.
I am not sure if I have answered all the questions raised. The Competition Authority was under the misapprehension that a raft of medicines would immediately become prescription only. In addition, there was a great deal of misunderstanding or exaggeration as to what the regulations would entail. We have since clarified the position for the authority. We wish to maintain competition. Some of the measures included in the regulations will contribute towards maintaining a competitive market.
