Local view for "http://purl.org/linkedpolitics/eu/plenary/2001-05-02-Speech-3-198"
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"en.20010502.15.3-198"2
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"Mr President, I welcome the Commissioner to the House. On welfare, therapeutic and economic grounds, it is essential that European veterinarians have access to the fullest possible range of veterinary medicines to treat all food-producing animals, while at the same time keeping consumer health protection at the top of all our agendas.
I am very aware of the concerns of the horse industry, particularly the thoroughbred industry, and I do not have to remind the Commissioner that if a full and up-to-date range of therapies is not available, there is a real risk that foreign investment in stud and training establishments throughout Europe will be lost to third countries. Having said that, it cannot be ruled out that any horse could enter the food chain at the end of its useful life and therefore safeguards are necessary to cover this aspect, as I have already mentioned.
In conclusion, I would urge the Commission to ensure that as quickly as possible we have a short-term resolution to the crisis for minor food-producing species in relation to the availability of state-of-art veterinary medicines. It is a welfare issue, it is a therapeutic issue, it is an economic issue, and it is in every Member State of the EU. We urge the Commission to move as quickly as possible to amend the necessary regulation, to allow extrapolation, the use of passports for horses and to resolve the problem.
Requirements for the placing of veterinary medicinal products on the market have been harmonised since the early 1980s when Council Directive 81/851 was adopted. A series of availability problem have arisen, compromising animals health and welfare across species. There is a need for urgent short-term solutions as well as for a broad review of all the legislation involved. This is what the Commission proposes and I fully endorse it. No veterinary medicinal product can be used in food-producing animals unless maximum residue limits, MRLs, are set up for its active substances. A recent evaluation of the EU product licensing procedures observed, and I quote, "significant concern in the veterinary sector about the decreased availability of established medicinal products for food-producing animals as a result of the introduction of the MRL requirements."
The issue was brought to a head at the end of 1999 with the expiry of a transitional period for fixing MRLs for established drugs. In many cases, the lack of adequate economic return has been an important factor in the failure of sponsoring companies to commit the necessary resources to generating the data necessary to satisfy EU regulatory requirements for fixing MRLs. Many pharmaceutical companies have been spending up to 25% of the research budget in defending their products.
In its communications the Commission announces a number of short-term measures, the extrapolation of MRLs, and medium-term actions such as incentives for industry, more flexible rules for the use of products and the revision of the existing legal instruments. They announced these measures to increase the availability of products. These actions are to be welcomed and, in particular, the extrapolation of MRLs between species that could help to maintain on the market many products intended for minor species.
The MRL problem gives rise to greatest concern in these minor food-producing species, such as horses, goats, rabbits, fish, bees – minor in terms of their economic importance for the pharmaceutical companies, hence their lack of defence of the various veterinary products required. But major species have also been affected. In my own country, Ireland, there is no legal local anaesthetic to use on cattle at this point in time. Every country can point to a major species where a drug has been taken off the market, not because it is not available somewhere in Europe, but because there has not been a marketing authorisation for that particular Member State. Hence, the point I am making – and the Commission also shares this view – is that we need a pan-European system whereby a product authorised properly in one Member State can be used throughout the EU.
I would also encourage Member States to develop this system as quickly as possible, because it will be part of the short-term resolution of the crisis, and I use that word advisedly, that exists at the moment with the availability of veterinary medicines on the ground.
Many new Member States have been pressing the Commission for some time to deal with the availability problem, taking particular account of the unique situation of horses. None of the other minor food-producing species I have mentioned exhibit similar features as the length of the life span, sections of the industry not being oriented towards food production, high monetary value of individual animals and the recreational and sentimental value.
A further complication is that three DGs are involved in all of this: ENTR, SANCO and indeed AGRI. In December 1999, DG SANCO proposed to allow the veterinary use of substances without MRLs in horses, provided records of treatment are kept and horses do not enter into the food chain before six months after use. Provisions relating to the equine passport were modified through Decision 2000/68 but it subsequently ran into legal problems.
Passports are now obligatory for all horses and contain a new annex for recording of veterinary treatments. Directive 81/851 and Council Regulation No 2377/90 are however still to be amended to allow such use."@en1
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