15. Authorisation of veterinary medicines:
decentralised procedures
| (24460)
8813/03
COM(03) 163
| Amended draft Directive amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
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| Legal base | Articles 95 and 152(4) EC; co-decision; QMV
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| Department | Environment, Food and Rural Affairs
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| Basis of consideration | EM of 3 July 2003
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| Previous Committee Report | HC 63-xxiii (2002-03), paragraph 5 (4 June 2003)
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| To be discussed in Council | 22-23 July 2003
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| Committee's assessment | Politically important
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| Committee's decision | Cleared
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Background
15.1 In order to remove obstacles to the internal market in pharmaceuticals,
whilst at the same time ensuring a high level of public health
protection, the Community has gradually developed a harmonised
legislative framework for human and veterinary medicinal products.
The present system is based on two separate procedures for the
granting of marketing authorisations:
- a centralised procedure, granted by a Commission decision
under Regulation 2093/93, and based on a scientific evaluation
from the European Agency for the Evaluation of Medicinal Products
(EMEA), leading to a single marketing authorisation valid throughout
the whole Community;
- a decentralised (mutual recognition) procedure under
Council Directives 2001/82 and 2001/83/EC for those medicinal
products not eligible for the centralised procedure or where the
applicant chooses not to follow that procedure: this has to be
used where an application for a marketing authorisation concerns
two or more Member States, with one carrying out the scientific
evaluation which the others are required to recognise (subject
to the right to raise objections).
15.2 In October 2001, the Commission produced, as required by
Regulation 2309/93, a report on its operation to date, [38]
accompanied by proposals[39]
to amend the procedures both in that Regulation and in the Community
codes relating to human and veterinary medicines set out in Directives
2001/83 and 2001/82 respectively. We reported on these two documents
at some length on 20 March 2002, and, following our recommendation
to that effect, they were debated in European Standing Committee
C on 18 June 2002.
15.3 The Commission subsequently put forward in April 2003, in
the light of the amendments suggested by the European Parliament
at its first reading on 23 October 2002, the current document
incorporating a number of changes to its proposals on the decentralised
procedures in Directives 2001/83/EC and 2001/82/EC, which relate
respectively to human and veterinary medicines. We reported on
these on 4 June, but, since negotiations in Brussels had not yet
been concluded on decentralised approvals for veterinary medicines,
we left that aspect of the proposal uncleared.
Supplementary Explanatory Memorandum of 3 July 2003
15.4 We have now received a supplementary Explanatory Memorandum
of 3 July 2003 from the Parliamentary Under-Secretary of State
(Commons) at the Department for Environment, Food and Rural Affairs
(Mr Ben Bradshaw), in which he confirms that there was no discussion
of the proposed Directive on veterinary medicines at the Council
on 2-3 June. However, he says that, following further discussion
at working level, agreement was reached on all the substantive
issues at a meeting of COREPER on 26 June, and that a text may
be submitted for political agreement at a Council meeting on 22-23
July. According to the Minister, the changes made have the following
additional implications, as compared with those set out in paragraphs
5.10-5.14 of our Report of 4 June.
Prescription requirements for food-producing animals
15.5 As a result of the original Commission proposal, and the
European Parliament amendments it had accepted, all veterinary
medicines for food-producing animals would be available only on
prescription. The UK was opposed to this, as there are a number
of medicines routinely used here by farmers and animal owners
for which such a prescription is not considered necessary, and
the proposal would have significantly increased costs, and have
resulted in a reduction in product availability. The Minister
says that the Government had therefore sought either deletion
of this provision or an amendment which would allow the UK to
retain its present arrangements, but had received little support
from other Member States. He adds that the Commission had subsequently
accepted that its proposal might not be appropriate in some cases,
and had suggested that in such cases a prescription might be issued
by some one other than a veterinarian. However, the Greek Presidency
had suggested instead that Member States should be allowed to
permit exemptions from the prescription requirement for categories
of medicines on a list to be developed under comitology procedures.
This would be accompanied by transitional measures allowing Member
States to continue their current national arrangements until the
exemption list has been adopted.
15.6 The Minister says that, provided this approach encompasses
the main groups of medicines currently available in the UK without
prescription, it is now the most effective way of securing the
UK's objective, and the Government therefore supported it in COREPER.
It will now seek to influence the development of the proposed
list, but, if that is not sufficiently comprehensive, it intends
to consider amending national legislation to allow veterinary
prescriptions to be written for certain types of medicines by
those other than veterinary surgeons. He adds that this approach
would reflect a provision in the draft Directive allowing a prescription
to be issued by a "professional person qualified to do so".
Renewal of marketing authorisations
15.7 The considerations here are similar to those arising on human
medicines, but the veterinary pharmaceutical industry had been
concerned by the additional costs arising from a requirement to
submit a full dossier when requesting an authorisation renewal
after five years. The Minister says that, following clarification
from the Commission about the circumstances in which this provision
would apply, the Government is able to support it.
Data exclusivity period and definition of a generic medicinal
product
15.8 The Commission has amended the definition of a generic product
to align it with the provisions for human medicines. It has also
extended from three to five years the period within which further
protection of data can be given when an additional food-producing
species is included under a marketing authorisation. These changes
are supported by the Government.
Conclusion
15.9 In the light of the further information provided by the
Minister, we are now clearing this remaining part of the document.
38 (22867) 13361/01; see HC 152-xxii (2001-02), paragraph
3 (20 March 2002). Back
39
(23022) 14591/01; see HC 152-xxii (2001-02), paragraph 3 (20 March
2002). Back
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