Select Committee on European Scrutiny Eighth Report


AVAILABILITY OF VETERINARY MEDICINAL PRODUCTS


(22003)
14649/00
COM(00) 806

Commission Communication on the availability of veterinary medicinal products.


Legal base:
Document originated: 5 December 2000
Forwarded to the Council: 5 December 2000
Deposited in Parliament: 17 January 2001
Department: Agriculture, Fisheries and Food
Basis of consideration: EM of 28 February 2001
Previous Committee Report: None
To be discussed in Council: No date set
Committee's assessment: Politically important
Committee's decision: Cleared

Background

  21.1  According to the Commission, Community legislation relating to veterinary medicines aims to guarantee a high level of safety for the animals being treated, whilst protecting the health of those consuming food of animal origin. In order to achieve this, any medicinal product needs to be given a marketing authorisation, based on its quality, safety and efficacy, and a minimum waiting time after use is imposed to ensure that any residues present in foodstuffs produced from the animal concerned are below specified maximum levels (MRLs) set by the European Agency for the Evaluation of Medicinal Products (EMEA) under Council Regulation (EEC) No. 2377/90.[49]

  21.2  The Commission points out that these provisions have led to a reduction in the range of veterinary products available, as the high cost of research into new medicines has resulted in pharmaceutical firms abandoning certain market segments which no longer permit a satisfactory return on investment. Though this situation has also arisen in the case of certain human medicines, the Commission believes the problem to be more acute in the veterinary area because the treatment is directed towards animals with a finite economic value, the costs have to be borne by the owner, and the markets are much more fragmented, given the number of animal species, the restricted size of certain populations, the wide range of pathologies, diverse regional situations, and the specific constraints arising from the evaluation of risks associated with residues. It also says that this situation has become particularly acute since 1 January 2000, on the expiry of the ten-year transitional period under Regulation 2377/90, which allowed firms to submit applications for Community MRLs for "old" medicinal products authorised before 1992. As a result, such products can now be used only under certain conditions.

  21.3  The Commission points out that these factors have created a range of problems. In the case of farmers and veterinarians, the lack of available authorised products provides an incentive to administer substances outside the legal framework, without any approved indication of dosage, or the need to observe a waiting time. This in turn has obvious health implications for consumers, the veterinary medicinal product industry, and enforcement authorities in the Member States.

— Possible solutions

  21.4  As to what might be done to address this situation, the Commission says that the heart of the problem, and its urgency, lies in the absence of Community MRLs for a large number of "old" active substances used to treat certain species, and in the need for measures to broaden the range of new products on offer to the minor segments of the market.

  21.5  In the short term, it points out that, in contrast to past practice, the application of a precautionary approach has resulted in risk evaluations for MRLs now being based on the animal species concerned, and that for certain species (including goats, sheep, laying hens and horses) only a very small number of MRLs exist. Consequently, the Committee on Veterinary Medicinal Products is considering whether MRLs for such species might be defined by extrapolation from those established for others, without jeopardising the present high level of consumer protection or calling for more supplementary data than strictly necessary. The Commission supports this approach, and hopes that guidelines can be agreed, leading to the submission of applications for MRLs both for existing medicines and for new products.

  21.6  For the medium term, the Commission says that a broad review is needed of all aspects of the problem of the availability of substances for species which are of little economic interest, and that it intends to bring forward proposals during the current year to address this question. Without being specific, it suggests that these might involve making investment prior to marketing a new product more attractive, and allowing the use of products authorised in other Member States.

  21.7  It adds that one other possibility being considered is the development of a policy analogous to that for "orphan drugs" for human use, involving indirect incentives to promote new products in abandoned market segments, such as reduced registration fees, technical assistance from the EMEA, and longer exclusive market rights. These steps might also be supplemented by direct incentives, such as financial contributions to research and development, re-imbursement of certain investments on granting market authorisation, and voluntary co-financing by associations of breeders of the species concerned. However, the Commission also cautions that it could take a decade or so to achieve tangible results, given the long lead-in time for developing new products and the need to have the necessary legal and administrative arrangements in place first.

The Government's view

  21.8  In her Explanatory Memorandum of 28 February 2001, the Minister of State (Lords) at the Ministry of Agriculture, Fisheries and Food (Baroness Hayman) says that, although couched in general terms, the Communication provides a fair description of the problem, and that the UK shares the general concerns raised in it. However, she stresses that any proposals will need to ensure the safety of consumers of animal-derived products and the effectiveness of controls. She also points out that the ideas in the Communication primarily involve little or no cost, but that this might not be the case if an initiative on "orphan drugs" were to be pursued.

Conclusion

  21.9  Even without the current emphasis on animal disease, the situation revealed by this Communication would be a matter of some concern, in that the law of unintended consequences seems to have created a situation in which efforts to reduce consumer exposure to residues may have resulted in a greater use of unauthorised veterinary products. We therefore welcome this initiative by the Commission, and, although we are clearing the document, on the grounds that it is a Communication with no specific legislative proposals, we nevertheless think it right to draw it to the attention of the House.



49  OJ No. L 224, 18.8.90, p.1. Back


 
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