17. Authorisation of human and veterinary
medicines: centralised procedures
| (24644)
10449/03
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| Amended draft Regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.
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| Legal base | Articles 95 and 152(4) EC; co-decision; QMV
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| Document originated | 12 June 2003
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| Deposited in Parliament | 19 June 2003
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| Department | Health and Environment, Food and Rural Affairs
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| Basis of consideration | EM of 30 June 2003
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| Previous Committee Report | None, but see footnotes
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| Discussed in Council | 2-3 June 2003
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| Committee's assessment | Politically important
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| Committee's decision | Cleared
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Background
17.1 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).
17.2 In October 2001, the Commission produced, as required by
Regulation 2309/93, a Report[43]
on its operation to date, accompanied by proposals[44]
to amend the procedures both in that Regulation and in the Community
codes relating to human and veterinary medicines (which are 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.
17.3 The Commission subsequently put forward in December 2002,
in the light of the amendments suggested by the European Parliament
at its first reading on 23 October 2002, a revised proposal[45]
incorporating a number of changes to its proposals on the centralised
procedures in Regulation 2093/93. We reported on this on 4 June,
noting that the Greek Presidency intended at a meeting of the
Council on 2-3 June to seek political agreement to a common position,
and that, although the UK had a number of outstanding concerns
(set out at some length in paragraphs 14.4-14.11 of our Report),
the Government felt that it should support the Presidency's efforts
to achieve agreement, as the accession of the new Member States
could significantly delay matters. Given this, and the fact that
the original proposal had previously been debated (and appeared
to have limited financial implications for human medicines), we
cleared the amended proposal. However, we also asked the Government
to let us know the outcome of the Council.
The current document
17.4 The current document sets out the text agreed by the Council
on 2-3 June, and we have now received a joint Explanatory Memorandum
from the Parliamentary Under-Secretary of State for Health at
the Department of Health (Lord Warner of Brockley) and the Parliamentary
Under-Secretary of State (Commons) at the Department of Environment,
Food and Rural Affairs (Mr Ben Bradshaw), identifying those issues
of most importance to the UK. These are as follows.
Scope of centralised authorisation procedure
17.5 The Commission had proposed, with the support of the European
Parliament, to extend the scope of the legislation to require
all new active substances to be authorised centrally, a step opposed
by the UK, particularly in the case of veterinary medicines, where
it was concerned that this would restrict the industry's flexibility
to develop new products. The Ministers say that the Council agreed
a compromise for human medicines which limits the application
of a mandatory centralised procedure to products containing active
substances in four disease areas — neuro-degenerative disease,
HIV, cancer and diabetes. In the case of veterinary medicines,
the status quo would be maintained.
Periods of data exclusivity
17.6 The Commission's original proposal would have harmonised
data exclusivity periods at ten years across the Community, with
an additional year for human medicines if a significant therapeutic
indication is found within the first eight years (10+1); in the
case of veterinary medicines, an additional year would be added
for each additional food-producing species added within the first
five years, to a maximum of 13 years (10+3). The Ministers say
that the Council agreed to adopt this approach for the centralised
procedure, but that, for the decentralised procedure (and for
those voluntarily using the centralised procedure), a different
approach, offering potentially shorter periods of exclusivity,
would apply. They add that the Government sees no justification
for this distinction, but that this was a minority view in the
Council, and that it voted in favour of the overall package, for
the reasons set out in paragraph 14.13 of our Report of 4 June.
Abolition of renewals
17.7 The Commission had supported a European Parliament package
on licence renewals, involving a single renewal after five years,
with an indefinite authorisation thereafter for both human and
veterinary products, and it had also introduced a two year "sunset
clause", extending to three years the maximum length by which
a licence can remain dormant. The Ministers say that several
Member States had expressed concerns about this, and that the
Council eventually agreed that there should be a single renewal
after five years, but with the opportunity to undertake a second
renewal after a further five years if there are justified pharmacovigilance
grounds. The Ministers say that the Government is satisfied that
the overall package enables robust levels of public health protection
to be maintained.
Structure of the EMEA board
17.8 With enlargement in mind, the Commission had originally proposed
that the Management Board of the EMEA should in future have four
representatives each from the Member States, Commission, European
Parliament and "civil society" (the pharmaceutical industry
and consumers). However, it subsequently amended its view in favour
of the model suggested by the European Parliament (and based on
that of the European Food Standards Agency), under which the Board
would comprise 15 members drawn from bodies such as industrial
associations, patients' and doctors' groups, and social security
schemes, with each member being appointed by the Council and European
Parliament from a list drawn up by the Commission. The Ministers
say that the Council has agreed that each Member State would appoint
one representative, with the Commission able to nominate four
members. They add that this approach is in line with the Government's
view.
Support for small and medium-sized enterprises (SMEs)
17.9 Administrative and financial assistance would be provided
to those small and medium-sized companies required to use the
centralised procedure, an outcome which the UK now supports in
the light of the agreement reached on the scope of that procedure.
Supply of unlicensed human products on compassionate grounds
17.10 There would be a derogation allowing unlicensed products
to be made available on compassionate grounds between the dates
of market authorisation and the actual placing on the market.
The Ministers say that, although the UK had some concerns about
this, it is now content since the provision is more clearly defined.
Conditional authorisations
17.11 The text agreed would allow, in exceptional circumstances
and following consultation with the applicant, an authorisation
to be granted subject to an obligation to establish special mechanisms
for assessing the safety of the products. The Ministers say that
the UK is now content.
Pharmacovigilance
17.12 The Ministers say that the Commission's modified proposals
include a number of provisions on pharmacovigilance, and that
the UK supports moves to enable the EMEA to facilitate exchange
of relevant data between Member States, whilst maintaining that
the collection of such data should remain primarily a national
responsibility.
Financial and regulatory implications
17.13 The Ministers say that, although, the proposals for human
medicines mainly involve a fine tuning of an already rigorous
system, the shifting of the balance between centralised and decentralised
authorisations could have an adverse effect on the funding arrangements
of national regulatory authorities.
Conclusion
17.14 Since we have already cleared an earlier version of the
Commission's proposal, we are simply drawing the attention of
House to the changes made in the Council on 2-3 June, and to the
Government's comments on them.
43 (22867) 13361/01; see HC 152-xxii (2001-02), paragraph
3 (20 March 2002). Back
44
(23022) 14591/01; see HC 152-xxii (2001-02), paragraph 3 (20 March
2002). Back
45
(24142) 15793/02; see HC 63-xxiii (2002-03), paragraph 14 (4 June
2003). Back
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