Mr President, I thank Mrs Grossetête and Mrs Müller for their personal commitment. There is a lot of good in the package before us but, if we are honest, there are a lot of problems as well. We have tried to do too much, too fast, with the threat of conciliation and enlargement used as the big stick to knock us into line. I object. In the months and years ahead we will pay the price, not least to the lawyers who unfortunately will have a field day. Commissioner Liikanen, you mentioned that one of the objectives included the need to prepare for enlargement. I say to you that a race to conclude this package before enlargement is not the same thing. On the Human Medicines Directive, concerns have been raised that, with the wide definition of medicinal products and the supremacy clause, it is possible that food and food supplements, cosmetics and medical devices could all be classified as drugs. The Commission's and the Council's solution to this problem is to insert wording in recital 7 Amendment No 60 to the effect that: 'Where a product comes clearly under the definition of other product categories ... this directive should not apply', thereby distinguishing between medicinal products and other products. The problem with this solution is that recital 7 will not have any legally binding effect. Indeed this recital will not actually go into the Pharmaceuticals Directive itself. I have seen an expert legal opinion which advises that, unless modified, the Pharmaceuticals Directive will completely subsume the Food Supplements Directive. I have two specific questions on this, which I would like you to answer, Commissioner. Why did the Commission and the Council not propose that the recital 7 wording should go into the operative article of the directive to ensure that it has legal effect? What assurance can the Commission give that even if recital 7 wording is not put into an operative part of the directive, it will still be effective in addressing the problem of borderline or frontier products? The Veterinary Medicinal Directive would have benefited significantly if it had been dealt with on its own rather than as part of a package. It has not had the scrutiny it deserves, not least in the working groups where it has been dragged along in the wake of the Human Medicines Directive. Commissioner Liikanen, you accepted my amendment consolidated Amendment No 3 at first reading over 12 months ago on the prescription-only medicines issue. You accepted this in principle, but the text presented to the Council and hence the second reading in Parliament of the common position amounted to the deliberate thwarting of the clearly expressed will of Parliament on three occasions and your own will as Commissioner. The common position now requires all medicines for use in food-producing species to be subject to veterinary prescription, but with the possibility of an exempted list of medicines being available without prescription. From considerable correspondence with you, Commissioner, it is clear to me that the exemptive list will contain very few medicines and is not a solution. Medicines must be available to the farmer in a sensible manner. Animal welfare and food safety must be our priority. We all appreciate the ability to purchase certain medicines over the counter, without the need to go to the doctor. Simple pain relievers, cough medicines, vitamin supplements are cases in point. Likewise the farmer should have access to certain medicines without the need to consult a veterinary surgeon. By making access to medicines too difficult, use will decline and animal welfare will suffer. The use of preventative medicines such as vaccines will decline and we will end up treating sick animals with antibiotics, as opposed to protecting the animal against disease. This is not a food safety issue. All our information confirms that residues arise from medicines that are already the subject of a prescription regime in all Member States, namely antibiotics. Putting even more medicines into the prescription regime will do nothing for food safety. Food safety can only be improved by intensive monitoring programmes and large penalties for anyone who violates the residue limits. I very much welcome the proposed resolution of the present crisis concerning the availability of veterinary medicines for a range of minor species, including equine veterinary medicines, but this crisis arose because of inadequate scrutiny and inadequate understanding of a previous directive. In conclusion, there is no public veterinary medicine as in human medicine, only private veterinary medicine. We have an extra duty of care on grounds of animal welfare, the integrity of the veterinary practice, the truth about the impact of the food chain and, most importantly, the economic viability of our farmers. We turn to you to ensure that in future there is protection in all these areas, and proper scrutiny, particularly of the Veterinary Medicines Directive.

Political group: PPE-DE