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Availability of veterinary medicinal products
1) OBJECTIVE
This Communication aims to present the Community legal background to authorisations for veterinary medicinal products, analyse the problem of the reduction in the range of veterinary medicinal products, and put forward possible short, medium and long-term solutions for dealing with this situation.
2) ACT
Communication from the Commission of 5 December 2000 on the availability of veterinary medicinal products [COM(2000) 806 final - Not published in the Official Journal].
3) SUMMARY
THE LIMITED AVAILABILITY OF VETERINARY MEDICINAL PRODUCTS: WHAT IS CAUSING THE PROBLEM?
Community legislation relating to veterinary medicines aims to guarantee a high level of quality, safety and medicinal efficacy for the animal being treated.
In the specific case of veterinary medicinal products destined for animals producing food products, the possible persistence of residues of these medicinal products in the foodstuff needs to be assessed in order to protect the health of the consumer of foods of animal origin.
Council Regulation (EEC) No 2377/90 lays down a Community procedure for evaluating the residues of active substances in veterinary medicinal products leading to the establishment of maximum residue levels ( MRLs ) in foodstuffs of animal origin from animals treated with these products. These MRLs are thresholds which guarantee that the concentrations of residues (active substances from veterinary medicinal products) do not cause side-effects in the consumer.
Faced with the cost of the scientific studies required to establish these MRLs (the costs to the veterinary sector itself plus those involved in applying for a marketing authorisation for any medicinal product), veterinary pharmaceutical firms have lost interest in certain market segments which are not profitable enough. They are therefore developing fewer and fewer new products targeted at so-called "minor" species or less common therapeutic conditions. This phenomenon is compounded by other specific factors in the veterinary medicinal products sector which are hampering the development of new products:
- the animals to be treated, particularly farmed animals, have a finite economic value, whilst the totality of treatment costs must be borne by the owner;
- the markets are much weaker and more fragmented than that of human healthcare, because of the large number of animal species concerned, the restricted size of certain populations, the wide range of pathologies, the diversity of regional situations as well as the continued existence of national authorisation systems.
In addition, in accordance with Regulation (EEC) No 2377/90, there has been a ban since 1 January 2000 on treating food-producing animals with medicinal products containing active substances for which no MRL has been established. The European Agency for the Evaluation of Medicinal Products has identified more than 100 active substances used in veterinary medicine which have been prohibited for all foodstuff-producing animal species throughout the Community.
PERSONS CONCERNED BY THE REDUCTION IN THE RANGE OF VETERINARY MEDICINAL PRODUCTS
Farmers and veterinarians
Given the lack of medical products available within the legal framework, these parties often have no alternative but to use veterinary medicinal products which are available "illegally" without any approved indication of dosage, without known therapeutic efficacy and without any safety evaluation for the final consumer. This conduct has become the only possible recourse for those who are unwilling to allow sick animals to suffer and are unable to bear the large potential economic costs of the animal's sickness.
Consumers
Foodstuffs should not contain residues of medicinal products capable of representing a health risk to the consumer. However, in the case of certain niches for which there are no authorised products, account must be taken of the true situation regarding the use of veterinary medicinal products outside the legal framework when evaluating the risk to the final consumer.
The veterinary medicinal product industry
Given the time taken to develop new products and the need to anticipate and define medium- and long-term economic aims, the animal health industry no longer feels itself economically able to defend "old active substances" for animal species or conditions when the investment returns are negligible (investment in additional research mainly to meet new Community requirements for the establishment of MRLs, toxicological studies, pre-clinical and clinical studies).
The competent authorities
The Member States are required to apply Regulation No 2377/90 and in particular, as of 1 January 2000, to withdraw from the market all veterinary medicinal products intended for food-producing animals containing active substances which have not been included in Annexes I, II or III of the Regulation. As a result, they have to cope with a - sometimes significant - reduction in the therapeutic armoury for certain animal species, but still ensure that the health of the consumer is protected through checks on residues of these substances which are no longer authorised.
WHAT CAN BE DONE?
In such a situation, the task is therefore to find possible answers:
- to the health-care and welfare needs of food-producing animals;
- to the requirement for a high level of consumer protection;
- to the economic interests of the veterinary medicinal products industry.
Short term solution: adapt the scientific requirements for establishing MRLs
Originally, the establishment of MRLs did not depend on an approach specific to each animal species concerned. However, following changes to the marketing authorisations demanding more and more precise information, there has been a certain drift towards determining MRLs for each individual species. The so-called "main" species have been virtually the sole beneficiaries of this trend. As a result, only a very small number of MRLs exist for certain species (bees and fish, but also goats, sheep, laying hens, horses and others). To combat this problem, the Committee on Veterinary Medicinal Products (an advisory committee to the Commission made up of national scientific experts) is examining the possibility of defining MRLs for certain species by extrapolation from those established for others.
The aim of this type of approach is to expand the number of substances benefiting from MRLs for species whose economic importance is limited or for small market segments. This principle could also be applied to new substances and become a factor encouraging the development of new medicinal products for these "abandoned" species.
Medium term solution: adapt the law
The Commission has two objectives:
- To enhance pharmaceutical firms' interest in certain markets by making the investments required prior to marketing more attractive and by adapting as far as possible the system of marketing authorisation to the particularities of the animal health sector whilst maintaining the high level of consumer health protection;
- To permit and, if possible, facilitate the veterinary use of medicinal products not available in the Member State concerned but authorised elsewhere in the Community.
The Commission thus proposes, as part of its revision of the marketing authorisation system legislation, to take account of the special features of the veterinary sector and the question of the availability of veterinary medicinal products.
The Commission is also continuing its reflections on the possibility of developing in parallel a policy analogous to the " orphan drugs for human use " scheme for veterinary medicinal products, by means of a specific legal instrument.
The paths to be explored should seek in particular to define indirect incentives to promote the development of new veterinary medicinal products specific to these "abandoned" market segments (reduced registration fees, technical assistance from the Agency, longer exclusive market rights, and others). Direct incentives could also be considered (financial contributions to R&D, "reimbursement" of certain investments on granting of marketing authorisation, voluntary co-financing by associations of breeders of the species concerned, etc.) The Commission considers, however, that if such a proposal should see the light of day, the scope and the ways and means of its application would need to be precisely identified. It is important to recall that such an approach will take a decade or so to achieve tangible effects.
Last updated: 20.04.2005