BACKGROUND
3. On 29 September 2004 the European Commission
adopted a Proposal for a Regulation on Medicinal Products for
Paediatric Use[4] which
was sifted to Sub-Committee G for scrutiny on 16 November 2004.
4. We gave our initial reactions to the Proposal
to the Department of Health on 9 December 2004[5].
The Department did not reply until 11 July 2005[6].
We responded to the Minister on 21 July[7].
5. At the same time, we also decided to carry
out a selective consultation with relevant professional organisations
and other interested parties. We hoped this would give us a better
understanding of the ethical and practical aspects of the Commission's
Proposal, for consideration after the Summer Recess.
6. We have drawn on the evidence contained in
the responses to that consultation,[8]
as well as subsequent oral evidence from Professor Sir Cyril Chantler,
the Chairman of the Great Ormond Street NHS Trust[9].
The other main sources have been oral evidence and correspondence
from the Minister of State and officials at the Department of
Health and details provided by the Minister of a consultation
on the Proposal carried out by the Medicines and Healthcare Products
Regulatory Agency (MHRA). We are very grateful to all those who
have assisted this short Inquiry.
7. Our Inquiry was carried out in this limited
way in a very short timescale because we were aware that the Government
were very anxious to try to secure political agreement on the
Proposal before the end of the UK Presidency of the European Union.
Moreover, the independent evidence demonstrated overwhelming support
in principle for rapid progress in setting up the arrangements
envisaged by the Commission Proposal.
8. Ideally, we would have preferred to have spent
much longer studying this important and potentially sensitive
proposal in greater depth. But we are satisfied, on the basis
of the evidence we have had, that we have a sufficient understanding
of the key issues to justify the Conclusions and Recommendations
we make in this Report.
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