It is a pleasure to be here today.
The purpose of this meeting is to examine the distribution of veterinary medicines. In representing the manufacturers of these products we have a very deep interest in the process. In advance of placing our products on the market we must get a licence from the Irish Medicines Board. Typically, a company will spend ten years and perhaps €200 million developing a product before it is placed on the market. One of the most important elements we must prove is safety - for the farmer, animal, environment and the consumer. Having spent €200 million developing a product, members will appreciate that we have a deep interest in making sure our products are used correctly. We want them distributed through appropriate distribution routes.
In terms of various issues, we have concerns about what is happening. Before mentioning them we should examine the monitoring work carried out by the Department of Agriculture and Food. In 2001 it took appropriately 67,000 samples of animal based produce which it tested for residues of a wide range of medicines and other substances. The results were extremely good. Only 0.58% of samples contained any residues.
Specifically, I would like to talk about three issues, intramammaries vaccines and work at EU level. On intramammaries, the Minister for Agriculture and Food asked the Irish Medicines Board some time ago to review distribution routes. The board identified three issues: residues, resistance of bacteria in animals and the possibility of transfer of resistance to humans. As regards residues, the monitoring work carried out by the Department clearly shows that we do not have problems in relation to excessive residues of antibiotics in milk. The co-operatives which purchase milk have found similar results. There are practically no residues.
As regards the development of resistant bacteria in animals, the report from the Irish Medicines Board does not provide any information. It would have been useful if it had looked at resistance in this jurisdiction versus other similar countries where there are different distribution routes. However, it failed to do this. We know from our information that there are no differences. The distribution routes in this country for intramammaries work extremely well. We know this from comparing the situation with the United Kingdom where there is a prescription regime. The levels of resistance are low but similar in both countries.
As regards resistance transfer to humans, there is no information to suggest that there are any problems arising from the use of antibiotics to treat mastitis. We do not have bacteria from milk infecting the human population which is related to the use of antibiotics. We do not have resistance transferring to other bacteria related to the use of antibiotics for treating mastitis. Objectively, the system works well. An analysis of the Irish Medicines Board's report shows no justification for changing distribution routes. That is our strong message to the committee.
The other mantra we frequently hear is that all antibiotics should be available on prescription, a concept with which we strongly disagree. We have a system which demonstrates safety. One could argue that if we had a prescription regime, there might be an increase in the usage rates of intramammaries which the committee may be surprised to hear. If we look at other systems across the European Union, we know from our statistics that the usage rate of products in Ireland is about middle of the league. Our distribution routes are not causing excessive use. One could argue that if we followed the Scandinavian model referred to in the Irish Medicines Board's report, we would use a lot more antibiotics. That would be negative.
We believe the current distribution routes work. The usage data demonstrates this fact. However, we are open to improvements. We advocate that we should gather statistics at a per farm level, work out the average usage rate of products, identify the top 10% of users and attempt to provide on-farm information to reduce the rate of use. By doing that, we argue we would have a system of continuous improvement. We ask the committee to support our view that the distribution regime should not be changed.
As regards vaccines, these products have traditionally been on free sale. They are administered to animals to provide immunity against disease for the animal, the animal's offspring or both. Farmers are well aware of the utility of the products. We, as an industry, strongly advocate the use of vaccines. We prefer to treat animals to prevent disease rather than using medicines to treat sick animals. Using vaccines is the better option. Farmers are well aware of how to use vaccines. As regards monitoring results, we do not have residues because the products in question have a zero withdrawal period and are naturally occurring constituents in the body of the animal in many cases. We do not have problems with residues.
I come from a farming background. I grew up vaccinating sheep and other animals. I know how to use the products in question and that farmers are intelligent and literate beings, just like any other sector of the community. They are well able to read the instructions on use, just as people dwelling in the city are able to read instructions on the use of products to treat fleas or internal parasites in their cats and dogs. It is not difficult to do this.
We are concerned about the Irish Medicines Board's policy that all the products in question should be available only from the vet or the vet and the pharmacist. As many members represent rural constituencies, they are aware of the existence of licensed co-operatives and private merchants who traditionally distribute these products, of which perhaps they sell in excess of 60%. The Irish Medicines Board's policy will put them out of business. We do not see any reason to do this. This morning we had a meeting of our manufacturers at which I was appalled to learn that licences which were being issued for products which had always been supplied through the co-operatives and merchants were now being confined to vet and pharmacy use only. The Department has the final say on how these products are distributed. It stated at a previous committee meeting that it would take an independent view. However, from our knowledge of what is happening, it is taking a more conservative view than the policy advocated by the Irish Medicines Board. If that policy continues in the next couple of weeks, licensed merchants will be out of this business rapidly. There is no justification for such a scenario. I ask the committee for its support to send a strong message to the Department not to isolate and take the licensed merchant out of the market.
My final point relates to the EU review of legislation on the package of directives and other legal instruments dealing with veterinary medicines. As regards distribution, there is a proposal that all medicines destined for use in food producing animals, including the vaccines to which I referred, should only be available under a prescription regime. We, as an industry, are opposed to this concept. It is utterly illogical to require a farmer to obtain a prescription to use a vaccine in his or her sheep. I keep using that example because it is a good one. The concept becomes farcical if one considers the need to call out a veterinary surgeon to examine a new born animal in advance of putting iodine on the animal's navel. It beggars belief. While the latter concept is a caricature of what might happen, it illustrates the ridiculous nature of the concept. We were delighted when the European Parliament rejected the proposal in October. However, we face a big uphill battle in the Council.
Many member states have their products available only under prescription regimes. In many states only the veterinary surgeons supplied medicines, something I do not have a problem with. However, in other member states, such as our own, different routes of distribution have developed. We do not believe there is any logic, sense or reason to confine these products to prescription regimes. We ask for the committee's support to convey these views to the Minister and his staff. As they are involved in negotiating this issue on behalf of Ireland, they should send a strong message that we should retain the right to decide how medicines are distributed by each member state. Subsidiarity should prevail. We should decide how medicines are distributed in our market. If we decide on a licensed merchant system, so be it. If Germany wishes to have everything on a prescription regime, so be it. We should decide at national level.
I thank the committee for the opportunity to address it. I look forward to the presentations from the other parties present and our discussions afterwards.