Select Committee on European Scrutiny Tenth Report


9 Medicinal products for paediatric use

(26060)

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

Legal baseArticle 95 EC; co-decision; QMV
DepartmentHealth
Basis of considerationMinister's letters of 24 September and 12 November 2005
Previous Committee ReportHC 34-iv (2005-06), para 7 (20 July 2005)
To be discussed in CouncilDecember 2005
Committee's assessmentLegally and politically important
Committee's decisionCleared

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


 
previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2005
Prepared 25 November 2005