14 AUTHORISATION OF HUMAN AND VETERINARY
MEDICINES: CENTRALISED PROCEDURES
(24142)
15793/02
COM(02) 735
| Amended draft Regulation laying down Community procedures for the
authorisation and supervision and pharmacovigilance 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; qualified majority voting
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| Document originated | 10 December 2002
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| Deposited in Parliament |
7 January 2003 |
| Department | Health and Environment, Food and Rural Affairs
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| Basis of consideration |
EM of 17 January 2003 and Minister's letter of 29 May 2003
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| Previous Committee Report |
None, but see footnote |
| To be discussed in Council
| 2-3 June 2003 |
| Committee's assessment | Politically important
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| Committee's decision | Cleared
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Background
14.1 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).
14.2 In October 2001, the Commission produced,
as required by Regulation 2309/93, a Report[32]
on its operation to date, accompanied by proposals[33]
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.
The current document
14.3 In this document, the Commission has
proposed, in the light of the amendments suggested by the European
Parliament at its first reading on 23 October 2002, a number of
changes to its proposals on the centralised procedures in Regulation
2093/93. The most important of these, together with the UK's reactions,
were set out in a joint Explanatory Memorandum of 17 January 2003
from the then Parliamentary Under-Secretary of State at the Department
of Health (Lord Hunt of Kings Heath) and the Parliamentary Under-Secretary
of State (Commons) at the Department for Environment, Food and
Rural Affairs (Mr Elliot Morley), though it was agreed that it
would be sensible to defer consideration until comparable information
was available on the decentralised procedures under Directives
2001/83 and 2001/82 (see paragraph 5 above).
ABOLITION OF RENEWALS
14.4 In its original proposal, the Commission
proposed that the present requirement for marketing authorisations
to be renewed every five years should be replaced by one involving
a continuous five-year administrative renewal, backed up by strengthened
"pharmacovigilance" and supervision arrangements. It
has now 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.
At the same time, it has introduced a two year "sunset clause",
extending to three years the maximum length by which a licence
can remain dormant. The UK continues to have concerns about the
abolition of five-yearly authorisation renewals and the introduction
of a sunset clause, preferring instead a system which places the
emphasis on the holder of an authorisation to supply information
at regular intervals (at renewal) to justify that the risk benefit
remains favourable and the authorisation remains up to date.
STRUCTURE OF THE EMEA BOARD
14.5 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). It now supports
the model suggested by the 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. However, the UK considers
that the functions of the EMEA and Food Standards Agency are completely
different, and supports national representation in the former
case, on the grounds that Member States are important stakeholders
in the European regulatory system. Also, it opposes the inclusion
of representation from social security schemes and industrial
associations.
SUPPORT FOR SMALL AND MEDIUM-SIZED ENTERPRISES (SMES)
14.6 The Commission now proposes to provide
administrative and financial assistance to those small and medium-sized
companies required to use the centralised procedure, whereas the
UK supports the maintenance of flexibility in the choice of licensing
route which would enable SMEs to target individual Member States
to market their products and remove the need for financial assistance.
14.7 In addition, the Government says that
the Commission has secured the support of the European Parliament
in the following areas.
SCOPE OF CENTRALISED AUTHORISATION PROCEDURE
14.8 The European Parliament has supported
the Commission's proposal to extend the scope of the legislation
to require all new active substances to be authorised centrally.
However, the Ministers say that the UK remains opposed to any
extension of the centralised procedure, particularly in the case
of veterinary medicines, where it is concerned that this would
restrict industry's flexibility to take account of differences
in species, farming techniques, environmental factors and disease
patterns among Member States when developing new products. In
particular, they believe that this would severely limit the development
of medicines containing new active ingredients for minor species
or indications and pet animals. They say that, in the light of
the Parliament's position, the UK will modify its original support
for greater choice as regards the licensing route, and will now
argue for the retention of the status quo (which requires the
use of the centralised procedure only for products derived from
biotechnology and innovative products).
SUPPLY OF UNLICENSED HUMAN PRODUCTS ON COMPASSIONATE
GROUNDS
14.9 The Commission has proposed a derogation
allowing unlicensed products to be made available on compassionate
grounds, and has accepted a European Parliament proposal enabling
such access between the dates of market authorisation and the
actual placing on the market. The Minister says that the UK still
has some concerns about the proposal as drafted, but is working
with Member States to define better its use and the precise groups
of patients to whom it might apply.
CONDITIONAL AUTHORISATIONS
14.10 The Commission has supported a European
Parliament proposal which 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 continues to have concerns about this.
PHARMACOVIGILANCE
14.11 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
14.12 The Government has supplied with its
Explanatory Memorandum of 14 May 2003 on the proposed amendments
to the decentralised procedures (see paragraph 5) a Regulatory
Impact Assessment which covers as well the proposals in this document
on the centralised procedures. This Assessment highlights the
benefits which a centralised approach would provide in avoiding
barriers to trade (whilst pointing out that these would also need
to be weighed against the benefits which many see in the decentralised
mutual recognition process); and it also draws attention to the
potential benefits to public health, patients and other users
arising from a more streamlined authorisation process, bearing
in mind also the major contribution which the pharmaceutical industry
makes to the UK economy. However, the Assessment also suggests
that, in the case of human medicines, the proposals mainly involve
a fine tuning of an already rigorous system, and that consequently
there do not appear to be any significant financial implications.
Minister's letter of 29 May 2003
14.13 We have received a letter of 29 May
2003 from the Parliamentary Under-Secretary of State at the Department
of Health (Mr David Lammy) saying that the Greek Presidency intends
at a meeting of the Council on 2-3 June to seek political agreement
to a common position on this proposal, and on the amendments proposed
to the decentralised procedures for human medicines set out in
Directive 2001/83. He says that a number of compromises have
emerged following publication of these modified proposals, and
that agreement has been reached in several important areas. At
the same time, the issues on which further discussion is likely
include the harmonised periods of data exclusivity, the scope
of the centralised procedure for human medicines, and the legal
base (where the UK believes that Article 308 of the Treaty should
be used, rather than Articles 95 and 152(4)). The Minister acknowledges
that agreement on 2-3 June would mean that we would not be able
to consider the current proposals beforehand, but he adds that
there are important grounds for supporting the Presidency's efforts
to achieve agreement at this particular meeting, as the accession
of the new Member States (who strongly oppose the proposal on
data protection favoured by the UK) could significantly delay
matters.
Conclusion
14.14 We have noted the Government's
comments on the Commission's response to the European Parliament's
proposed amendments, and that political agreement to a common
position may have been reached by the Council at its meeting on
2-3 June. We also note the Minister's comments on the desirability
of an agreement then, notwithstanding the absence of scrutiny
clearance.
14.15 Having
said that, we recognise that the issues still outstanding on the
proposal, which was debated in European Standing Committee C in
June 2002, have been clearly identified, and that the financial
implications so far as human medicines are concerned are unlikely
to be significant. We are, therefore, clearing this document,
but we would like the Government to let us know what is agreed
by the Council.
32 (22867) 13361/01;see HC 152-xxii (2001-02), paragraph
3 (20 March 2002). Back
33
(23022) 14591/01;see HC 152-xxii (2001-02), paragraph 3 (20 March
2002). Back
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