MEDICINAL PRODUCTS FOR PAEDIATRIC USE
Letter from Rt Hon Jane Kennedy MP, Minister
of State, Department of Health to the Chairman
The Employment, Social Policy, Health and Consumer
Affairs Council met on 8-9 December 2005. I am writing to update
you on the discussions that took place on the European Commission's
proposal for a Regulation on medicines for paediatric use.
Political agreement was secured on the Commission's
proposed Regulation. All Member States with the exception of Poland
voted in favour of the proposed Regulation. Poland voted against
because of concerns about the impact of the proposed six months
extension to supplementary protection certificates under the Regulation.
Latvia, while supporting the proposal, said it should not lead
to unreasonable price increases and entered a minute statement
to reflect this point. While supporting the proposal to fund paediatric
studies into off-patent medicines through the Community research
framework programmes, Germany entered a minute statement to clarify
that such funding would be subject to the rules and regulations
governing the framework programmes.
The committee will be aware that the Government's
view was that Article 95 of the Treaty was not an appropriate
legal basis for this Regulation and that Article 308 should have
been used instead for the reasons invoked in case C-66/04 UK v
EP and Council (the smoke flavourings case) Judgment in that case
was given on 6 December 2005. The UK's arguments on the correct
legal base for establishing a centralised procedure were rejected.
I attach a note setting out the UK's grounds of challenge and
the ECJ's findings (not printed). The Court's ruling in this case
has provided useful clarification as to the appropriate use of
Article 95 as a legal base for measures which "lead to"
Given what the Court has said about the breadth
of Article 95 and the measure of discretion conferred on the Community
legislature as regards its use and the fact that the proposed
Paediatrics Regulations do not actually set up a new agency, but
rather establish a new committee within an existing agency, similar
to the situation in the smoke flavourings case, we withdrew our
objection to the legal base for the Regulation at the Council.
We are working to secure a common position under the Austrian
Presidency in the first half of 2006.
19 January 2006
Letter from the Chairman to Rt Hon Jane
Thank you for your letter dated 19 January which
was considered by Sub-Committee G on 2 February.
We are glad to have your confirmation that political
agreement on the Paediatric Medicines Regulation was secured,
as expected, at the Employment, Social Policy, Health and Consumer
Affairs Council on 8-9 December 2005. We were interested to see
the details of the voting which you have given and grateful to
you for setting out the Government's position on the legal base
in the light of the ECJ ruling on the smoke flavourings case.
As you know, our Inquiry on the Paediatric Medicines
Regulation has already been completed. The Inquiry Report was
published today (2 February) and a copy has been sent to you already.
We look forward to receiving the Government's
Response to the Report in due course, in the usual way. We note
that the Government is working to secure a common position on
the Regulation during the Austrian Presidency and would be grateful
if you could continue to report significant developments on that.
2 February 2006
Letter from Andy Burnham MP, Minister
of State, Department of Health to the Chairman
I am writing to inform you that a second reading
agreement was secured on the European Commission's proposed Regulation
on medicines for paediatric use on 1 June 2006. The final text
of the Regulation has been agreed and will be published in the
Official Journal of the European Communities (OJEC) shortly. The
Regulation will enter into force 30 days after publication in
The committee will be aware that this proposal
was a key priority during the UK Presidency and political agreement
was reached on the Regulation at the Employment, Social Policy,
Health and Consumer Affairs Council in December 2005.
18 July 2006
Letter from the Chairman to Andy Burnham
Thank you for your letter dated 18 July. Unfortunately
it did not reach us in time for submission to Sub-Committee G
at their last meeting before the Summer Recess on 20 July, but
copies will be circulated to Members of the Sub-Committee.
We are grateful to you for confirming that the
final text of the Regulation has been agreed and that it will
enter into force in the near future.
As a condition of our releasing the scrutiny
reserve on this Proposal before political agreement was reached
at the December 2005 Council, your predecessor promised that the
appropriate DoH and MHRA officials would brief Sub-Committee G
on development of the guidelines for implementing the Regulation.
We attach great importance to this aspect and will be in touch
with your officials when Parliament resumes following the Summer
Recess to arrange a mutually convenient date for this briefing
to take place.
24 July 2006