AVAILABILITY OF VETERINARY MEDICINAL PRODUCTS
(22003)
14649/00
COM(00) 806
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Commission Communication on the availability of veterinary medicinal products.
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| Legal base:
| — |
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| Document originated:
| 5 December 2000 |
| Forwarded to the Council:
| 5 December 2000 |
| Deposited in Parliament:
| 17 January 2001 |
| Department: |
Agriculture, Fisheries and Food
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| Basis of consideration:
| EM of 28 February 2001
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| 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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