9 Medicinal products for paediatric use
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13880/04
COM(04) 599
+ ADD 1
| Draft Regulation on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/83/EC and Regulation (EC) No. 726/2004
Commission staff working paper
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| Legal base | Article 95 EC; co-decision; QMV
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| Department | Health |
| Basis of consideration | Minister's letters of 24 September and 12 November 2005
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| Previous Committee Report | HC 34-iv (2005-06), para 7 (20 July 2005)
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| To be discussed in Council | December 2005
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| Committee's assessment | Legally and politically important
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| Committee's decision | Cleared
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Background
9.1 At present, over 50% of the medicines prescribed for children
in the EU have not been authorised for paediatric use although
they have been authorized for adults. In such cases, doctors do
not have the results of clinical trials of the safety, efficacy
and side-effects of the drug on children. This situation is widely
agreed to be unsatisfactory.
9.2 The draft Regulation is intended to help remedy
the situation. It would require, and provide incentives for, companies
to conduct research and seek authorisation of medicines for children.
9.3 In November 2004 the previous Committee welcomed
the proposal and asked the Government some questions about it.[29]
In July 2005, the Minister of State at the Department of Health
(Jane Kennedy) sent us a comprehensive letter answering the questions
and providing a progress report on the negotiations.[30]
In particular, she told us that the Government had registered
its concern that Article 95 of the EC Treaty might not be an appropriate
legal base for the provisions in the draft Regulation for setting
up procedures and new bodies. The Government has challenged the
use of Article 95 for two previous (unrelated) Regulations. Those
cases are still before the European Court of Justice and until
they are decided the Government will continue to register its
concern about the use of Article 95 for this measure.
9.4 The Minister also told us that the Government
was in the midst of consultations with the Royal Medical Colleges,
the pharmaceutical industry, medical charities and others. We
asked the Minister for a summary of the responses to the consultation
paper and to provide further progress reports.
The Minister's letter of 24 September 2005
9.5 In her letter of 24 September, the Minister told
us that 24 organisations had responded to the consultation paper.
All of the respondents welcomed the draft Regulation. Some thought
that a few of the provisions needed clarification.
9.6 The Minister said that there was strong support
from other Member States for the UK's proposal for the addition
to the draft Regulation of a requirement for a full review of
the impact of the legislation after ten years.
9.7 She also told us that, at first reading on 7
September, the European Parliament voted for the adoption of the
Regulation. Negotiations would continue in the Council working
groups during the autumn. The draft Regulation would be on the
agenda for the Health Council's meeting in December.
The Minister's letter of 12 November 2005
9.8 The Minister tells us that, following the amendments
adopted by the European Parliament, the Commission has produced
a revised draft of the Regulation. She says that the key changes
proposed are as follows:
- Parts of the database of paediatric
clinical trials would be made available to the public. The Minister
says that this would be in line with the Government's commitment
to improving access to data on clinical trials.
- There would be provision to fund the study of
off-patent medicines from the Community's Framework Programmes
for research and development. The Government supports this proposal.
- A symbol would be placed on the labels of all
medicines authorised for paediatric use. The symbol would be decided
by the Paediatric Committee. This, too, would be acceptable to
the Government.
9.9 The Minister also tells us that the Government
and most other Member States support the provision in the draft
Regulation for a six-month extension of the "supplementary
protection certificate".[31]
Two of the four Member States which had expressed concerns about
the provision have indicated that they are prepared to drop their
reservations.
Conclusion
9.10 We share the Government's view on the acceptability
of the changes included in the revised draft of the Regulation.
We note that the Royal Medical Colleges, medical charities and
the pharmaceutical industry welcome the proposal.
9.11 We also note, however, that doubts remain
about the use of Article 95 of the EC Treaty as the legal base
for the draft Regulation. We share those doubts. Accordingly,
we ask the Minister:
- if the Government remains
of the view that use of the Article would not be appropriate;
- if it does, whether the Government intends
to take part in a political agreement on the document; and
- if it intends to do so, what is the Government's
justification for acquiescing to a measure which has a legal base
which appears inappropriate.
Pending the Minister's reply, we shall keep the
document under scrutiny.
29 See HC 42-xxxvii (2003-04), para 6 (17 November
2004). Back
30
See headnote. Back
31
Provision for supplementary protection certificates was included
in the original draft of the Regulation. Where a company which
has a patent on a product includes with an application the results
of studies conducted in compliance with the Paediatric Investigation
Plan, the company would be entitled to a six-month extension of
the patent. Back
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