Tuesday, 18 October 2005
Draft Animal Remedies Regulations 2005: Motion.
Denis Naughten (Longford-Roscommon, Fine Gael)
That Dáil Éireann,
notes the recent publication by the Minister for Agriculture and Food on the Draft Animal Remedies Regulations 2005 and recognises that:
—Ireland must legislate for EU Directive 2004/28 by 31 October 2005;
—the Government's proposals will impose unimplementable and unworkable restrictions on farmers;
—the current proposals are over-bureaucratic and will seriously restrict the availability of animal medicines;
—the regulations will add an additional €80 million to the cost of veterinary medicines in this country;
—the Competition Authority has expressed serious reservations regarding the implementation of the EU directive in its current manner;
—it will seriously discriminate against the competitiveness of Irish food production and farming;
—the proposals will facilitate the creation of a monopoly in the sale of animal medicines;
—it will hinder good farming practice and have a negative impact on animal welfare;
—it is becoming progressively difficult to maintain veterinary practices in certain parts of the country;
—Northern Ireland has taken a more farmer-friendly interpretation of the EU directive which may promote a cross-Border black market for such products;
—the regulation will inhibit the development of an all-Ireland animal health regime;
and calls on the Government and the Minister for Agriculture and Food to:
—allow qualified professionals, other than but including vets, to issue prescriptions;
—implement a regulation similar to that of the UK authorities, which will eradicate the potential for cross-Border trade in animal remedies;
—retain the wide availability of animal medicines while ensuring that Ireland continues to produce food to the highest standards;
—publish the proposed exemption list which has been submitted to the European Commission;
—review the draft regulation to introduce a simplified system of compliance; and
—allow Irish farming publications to advertise and provide detailed information regarding the efficacy of animal remedies in line with similar UK publications circulating in Ireland.
On 10 August, the Department of Agriculture and Food published draft regulations on the issuing of animal remedies. Many believe the proposal highlights the Government's blatant disregard for Ireland's food industry. The Government is more interested in attracting transient foreign investment than in supporting indigenous employers. Sadly, this view has been copper-fastened by the publication earlier this year of the enterprise strategy action plan, the blueprint which will guide the development of Irish enterprise for at least the next ten years. It made no mention of our agrifood industry, the gross value of which to the economy is estimated to be more than €11 billion per annum.
Currently, red tape is strangling many farmers. It is no wonder that producers are losing confidence in a Government and a Minister for Agriculture and Food who have failed to realise the significance of the continual and persistent over-regulation which has a serious impact upon the competitiveness of our food industry. Over the last ten years, half of our abattoirs have gone out of business. Others in this sector are considering their future due to the shifting sands of regulation, which continually require expensive re-investment to meet existing food standards. This is further compounded by proposals to ban the sale of meat from butchers into the catering industry, the backbone of the business of small processors.
It is now vital that the Government reviews the array of new rules and their associated costs before we price our food sector out of business. Since 2002, the Government has introduced an array of stealth taxes which have facilitated massive increases in charges for services such as electricity prices, motor charges, VAT and VHI that are essential to the farming community. At the same time, farmers do not even get the basic cost of production back from the marketplace. This is at least partially caused by the undercutting of our food by cheap imports. Stealth taxes which increase the cost of production in Ireland are facilitating the importation of more and more produce from third countries, compounding the problem. As if this was not bad enough, veterinary expenses are now 44% more expensive than they were ten years ago. The Government seems intent on squeezing farmers' pockets even more by introducing further restrictions allowing only veterinary surgeons to issue prescriptions for animal medicines.
For many, the Minister for Agriculture and Food's interpretation of EU Directive 2004/28, which will implement the new animal medicine regime, is the final straw. According to the directive, the definition of a veterinary prescription is any prescription for a veterinary medicinal product issued by a professional person who is qualified to do so in accordance with applicable national law. It is thus the responsibility of each member state to designate who is qualified to prescribe different medicines. Under the terms of the directive, it is possible for Ireland to maintain its current system, which is a model for the rest of Europe and has gained Irish farmers an international reputation as high quality food producers.
While the Minister has stated that these new rules will not come into force until 2007, this is not correct. From the end of this month intramammary products will only be available from a veterinary practitioner. This will have a significant impact on the cost of these vital treatments. Furthermore, the prescription only medicine exempt category, which allows pharmacists and veterinary practitioners to prescribe designated animal remedies, will be abolished immediately. This will mean that some treatments such as vaccines and immunological and non-immunological products, which had been available without prescription, will now only be available from a veterinary practitioner on prescription. This is deceptive and contrary to comments which have been made to date by the Minister on the regulation and the implementation timeframe.
It should also be pointed out that the prescription only medicine directive was opposed tooth and nail by the Government through two readings in the European Parliament and Council of Ministers. The then Minister for Agriculture and Food, Deputy Walsh, was browbeaten into accepting the prescription only medicine directive as part of a wider compromise package agreed by the then Minister for Health and Children, Deputy Martin. Under pressure, Deputy Walsh agreed to sacrifice our hard won system of veterinary medicine prescription in the interests of securing a deal on the human medicines directive and regulation, which was seen as a priority for the Italian Presidency.
The same Department of Agriculture and Food which now puts forward these proposals was vehemently opposed to this directive at the time of its final sign-off as a last minute achievement of the Italian Presidency. Its about turn on the likelihood of securing exemptions is both mind-boggling and inexplicable.
The Minister is trying to create a false sense of security by gambling that the Commission will grant exemptions from the prescription requirement to all of the products that are currently available from licensed merchants. Currently, there is no EU-wide definition of a veterinary prescription and no common procedure for dispensing such a prescription. The implications of these differing approaches will become clear when the Commission's standing committee convenes to draft this list of exemptions from the prescription requirement, which has become the Department of Agriculture and Food's Holy Grail.
During negotiations, the only other countries who had a similar regime and worries to our own were the United Kingdom and the Netherlands. While to a lesser extent Spain and Portugal were sympathetic, the other member states pushed for a strict application of the prescription only medicine directive because it was a codification and an endorsement of their existing systems and because it is easier and cheaper to obtain a prescription in these countries than it is in Ireland. I understand from Avril Doyle MEP's discussions with EU colleagues that in their firm opinion, this approach is unlikely to succeed, especially in the light of objections raised in the Council and the European Parliament during the drafting of the veterinary medicines directive in 2003.
However, the Minister has given a vague commitment that if she fails to get a satisfactory result on the proposed exemption list, she will review the situation and will consider redrafting the regulation to allow pharmacists and licensed merchants to issue certain limited prescriptions.
This tactic will give rise to serious problems. First, in the unlikely event that we do secure such exemptions, this list will be closed. New drugs developed in the future will automatically be prescription only medicine and must be prescribed by a vet, whether they warrant a prescription or not. Second, most people with any knowledge of the workings of the EU believe it is very unlikely that Europe will allow a member state to return with a watered down proposal, after it has already submitted a comprehensive and extremely restrictive law. Third, this revised proposal will be submitted very late in the day, over 12 months after each member state is meant to have its law in place.
Realistically, it will be at least November 2006 before any agreement, if there is to be one, will be in place on the exemption list. This will leave approximately four weeks for our Government to draft a new regulation, enact it in the Houses, submit it to Brussels and gain the EU's approval before the new rules come into effect on 1 January 2007.
The most sensible and straightforward approach is the reclassification of medicines into different categories of drugs that can be prescribed by registered persons qualified and authorised to do so by the Irish authorities, including licensed merchants and pharmacists. This is the approach taken by the authorities in the United Kingdom. The United Kingdom has designated vets, pharmacists and licensed merchants to issue prescriptions within the confines of the EU directive.
If the Minister for Agriculture and Food maintains her current position, there will be cross-Border distortions of the market in veterinary medicinal products, which will have a detrimental effect on the food chain through the development of a black market. A similar legislative approach must be adopted on both sides of the Border, thus avoiding the development of a cross-Border black market, which is essential for the maintenance of the ongoing integrity of veterinary medicinal practices. The divergent approaches taken on both sides of the Border will be a serious and significant impediment to the goal of developing an all-Ireland animal health regime, which is vital for the future promotion of Irish food products.
The Competition Authority has expressed serious reservations regarding the implementation of the EU directive by the Minister for Agriculture and Food in this manner. It believes the regulation may be anti-competitive and lead to increased costs for farmers. It is estimated the additional cost to farmers will be in the region of €80 million per annum. The Competition Authority has highlighted the Government's policy, as laid down in the White Paper, Regulating Better, that new regulation be introduced only on clear need. However, there is no evidence of such a need for the regulation of preventative medicines and the authority believes putting all farm animal medicines on a prescription-only basis would be a disproportionate means of addressing public health concerns. It goes on to say this new law will effectively increase the exclusive profit earning potential of vets and will lead to reduced choice and increased costs for farmers.
Another key question that the Minister has ignored is where are farmers going to find vets. This is a genuine issue on the tips of farmers' tongues across the country. We all know the growing difficulty in getting vets. We have already seen significant problems in places such as counties Mayo and Donegal where it is extremely difficult to gain access to veterinary practitioners. If there is no local network via the vets to distribute medicines, many parts of the country will not be able to avail of animal remedies. Is it the Minister's intention to pay vets to provide a service in peripheral parts of the country, as is the case with doctors? This is a critical question. Will she guarantee the availability of vets throughout the country to provide this service?
Another significant barrier to competition will be the requirement that vets identify a particular brand on a prescription. In cases where an equally effective substitute exists, this potentially allows for the closure of the animal medicines market to new medicines that may not have a widely recognised brand name or where the vet is tied into an arrangement with a particular manufacturer. This directly contravenes the directive itself, which specifically and categorically states the implementing legislation cannot hinder the development of industry or the legitimate trade in medicinal products.
This type of problem has existed for years in Ireland's medical profession and in order to address the problem, the Department of Health and Children introduced the indicative drug target saving scheme in 1993. Under the scheme, the Department incentivises GPs to refrain from naming branded products on prescriptions and instead opt for generic brands because of the massive cost implications involved for the health service. To date, in excess of €90 million has been paid out nationally to participating doctors by the Department under this scheme. The Department of Agriculture and Food is now proposing a structure similar to what was in place for human medicines prior to 1993, claiming that it will not impact on cost or competition. Of course, the Department will not need to pick up the bill for increased costs in this instance as it will be borne directly by farmers across the country.
The excuse for introducing such draconian rules is that it will protect public health. The Competition Authority has pointed out that the proposed regulation would not provide any significant benefits to public health. This is supported by a study carried out in Denmark where 90% of the incidents of antibiotic resistance in human cases was caused by imported non-EU meats. Obviously, whatever medicines are being used in third country meats have the potential to significantly affect human health. Therefore, if the Minister wants to eradicate antibiotic residues in food and protect public health she, along with her EU counterparts, should focus on these imports rather than try to make Irish farmers less competitive and thereby promote the consumption of further risky food from third countries. They were trying to make scapegoats of Irish farmers who have clean bills of health and where there is no issue in respect of residues. The only such issue highlighted within the European Union was in Denmark, where it was clearly shown to be due to imported non-EU meats.
If the Minister wants to do something, she should start by addressing the issue of the huge anomaly in relation to substantial transformation. Sadly, she has not done so to date. She said she has discussed it with her EU colleagues but she still has not addressed it or the issue of labelling within the catering trade, which is within her competency, in order to ensure a watertight system is put in place and no allegations are made against Irish food, allegations that are completely erroneous and doctored due to the fact we have an anomaly within the food labelling regime that allows for the relabelling and reprocessing of food from third countries to be passed off as Irish food products.
Two key factors in protecting the food chain are, first, ensuring high levels of animal health and welfare by encouraging farmers and animal owners to take a preventative approach where veterinary medicines are concerned. This can best be done by enabling them to procure and administer routine management drugs as easily as possible. This avoids the use of antibiotics in the first instance and, therefore, avoids residues altogether. The second key factor is observance of the withdrawal period for each veterinary medicine administered. As long as the withdrawal period is observed, the maximum residue levels established for each drug will not be present in the animal at slaughter. Observance of withdrawal periods has absolutely nothing to do with whether a medicine is prescribed. This will not be addressed by the proposed regulations. For the Minister to say she is bringing these proposals forward on the basis of public health is an inaccuracy that should be corrected when she has the opportunity to do so.
If we want to protect public health and the consumer, it is imperative we provide farmers, who are professional keepers of animals, with as much information as possible about preventative care, animal medicines and their withdrawal periods. However, the regulation does the exact opposite. For the first time in legislation, the farmer is not defined as a professional keeper of animals and the only information to be provided concerning how animals should be medically treated is a prescription to do so through vets. The farmer is not entitled to have even the most basic information but the Department would be very quick to prosecute farmers if they did not have their documentation and did not monitor and implement the withdrawal periods set in place for each of these medicines. The Department is asking farmers to implement rules and regulations without giving them the basic information they require.
It is essential that farmers are in a position to easily inform themselves of the various options available, whether it be through reading specialist farm press, which should include responsible advertisements for veterinary medicinal products, or through consultation with animal health professionals who are qualified to advise them. However, under the proposed regulation, farmers will not be able to avail of such information, which will be solely confined to veterinary professionals.
Advertisements for lice and other topical treatments will be banned but similar advertisements for humans are legal and appear on a daily basis. Since advertisements for animal medicines in the UK media will be legal, will a number of officials from the Department of Agriculture and Food be deployed to go into every newsagent which sells the UK Farmers Weekly magazine to remove the offending pages carrying advertisements? Is that the intention of the Minister? Obviously, censorship is still part of the Government psyche.
I am disappointed the Minister tabled an amendment to this fair and reasonable motion. The amendment refers not only to implementing this directive but also to implementing changes which arise from a review of existing national legislation. Perhaps that is the reason the Minister has tabled these proposals and she is merely using the directive as an excuse and a vehicle to do so.
These proposals will significantly increase the cost of medicines to farmers, which will have a direct impact on animal husbandry and the cost of food production. I accept that in the case of some medicines, veterinarians are the most appropriate people to write a prescription. However, this should be limited to a restricted number of medicines and should not apply across the board. I call on the Minister and her backbench colleagues, who have stated that they are opposed to this proposal, to use their feet when they walk through the lobbies and support this motion. I commend the motion to the House.