Select Committee on European Union Fortieth Report


MEDICINAL PRODUCTS FOR PAEDIATRIC USE (13880/04)

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" harmonisation.

  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 Kennedy MP

  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 OJEC.

  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 MP

  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



 
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