Select Committee on European Scrutiny Nineteenth Report


CLINICAL TRIALS ON MEDICINAL PRODUCTS


(a)
(18411)
10607/97
COM(97) 369

Draft Directive on the approximation of laws, regulations and
administrative provisions of the Member States relating to the
implementation of good clinical practice in the conduct of clinical trials
on medicinal products for human use.

(b)
(20130)
7720/99
COM(99) 193

Amended draft Directive on the approximation of laws, regulations and
administrative provisions of the Member States relating to the
implementation of good clinical practice in the conduct of clinical trials
on medicinal products for human use.

(c)
(21201)


Amended draft Directive on the approximation of laws, regulations and
administrative provisions of the Member States relating to the
implementation of good clinical practice in the conduct of clinical trials
on medicinal products for human use.
Legal base: Article 95; co-decision; qualified majority voting
Department: Health
Basis of consideration: Minister's letter of 22 May 2000 
Previous consideration: (a) HC 155-vi (1997-98), paragraph 10 (12 November 1997)
(b) HC 34-xxiv (1998-99), paragraph 6 (30 June 1999)
(c) HC 23-xviii (1999-2000), paragraph 8 (17 May 2000)
Committee's assessment: Politically important
Committee's decision: Cleared

Background

  9.1  In September 1997, the Commission put forward a proposal[28] to harmonise the use of human subjects in clinical trials for medicines. The stated aim was to incorporate internationally established standards of protection; streamline the administrative procedures; harmonise the reporting procedures for safety monitoring; and introduce surveillance measures. More specifically, the proposal sought to reduce delays by imposing limits on the time which may elapse before a trial can begin; to bring the functioning of ethics committees into law, with a standard format for supplying information to them; and to introduce a system for the delivery of a single ethical committee approval per Member State in the case of multi-national trials.

  9.2  When we considered this on 12 November 1997, we noted that, while the UK had no objections to certain aspects of the proposal, it did reserve its position on a number of provisions. We therefore asked to be kept informed of the progress of negotiations, and to be provided in due course with the text on which it was expected that a Common Position would be agreed. In the meantime, we said that we were maintaining a Scrutiny Reserve.

  9.3  The Commission subsequently produced an amended proposal[29] in April 1999, taking into account amendments proposed by the European Parliament at its first reading on 17 November 1998. This would have strengthened the rôle of ethics committees; reinforced the provisions governing exchanges of information between Member States; introduced a new procedure for the commencement of clinical trials; and provided for the involvement of the European Agency for the Evaluation of Medicinal Products (EMEA) in clinical trials of medicinal products deriving from biotechnological processes.

  9.4  However, as we noted in our Report of 30 June 1999, the UK continued to have a number of reservations. In particular, it felt that the application of the provisions to single as well as multiple site clinical trials was incompatible with the principles of subsidiarity; that the definition of "informed consent" was incompatible with existing UK law; that it now reserved its position on the harmonisation of arrangements for approval of clinical trials by ethics committees; and that it also reserved its position on the increase in the role of the EMEA. We therefore said in our conclusion that we would find it helpful if the Government could expand on the reasons why it had these various reservations In the meantime, we were not clearing the document.

The current document

  9.5  Although an official text is not available, the Parliamentary Under-Secretary of State at the Department of Health (Lord Hunt of Kings Heath) sent us, together with an Explanatory Memorandum of 11 May 2000 and a draft Regulatory Impact Assessment, a copy of an unofficial text, which he said was to be included on the agenda of the Internal Market Council on 25 May for political agreement (document (c)). He went on to say that the procedure for obtaining ethics committee approval was now compatible with UK practice, whilst the proposal for obtaining informed consent had been brought into line with the Council of Europe Convention on Human Rights and Biomedicine. He added that, although the Directive would apply to UK-only based trials, it would underpin guidelines being followed in the UK by established clinical research units, by ensuring compliance with internationally recognised standards. In the conclusion to our Report of 17 May 2000, we noted that, although the Minister had said that the areas previously of concern were now acceptable, he had not explained the ways in which the proposal has been changed to make this so. Similarly, it was not clear how the application of the proposal to a trial based in a single Member State was now seen as compatible with the principles of subsidiarity, whereas the Government had previously taken the view that it was not. We therefore said that, before considering clearance of this document, we would like to have further clarification on these points.

Minister's letter of 22 May 2000

  9.6  In his letter of 22 May 2000, the Minister addresses each of these points in turn. As regards the procedures for obtaining ethics committee approval, he points out that earlier drafts had required committees to give a written opinion within 30 days (with a further 30 days allowed if more information had been requested), whereas the current text allowed 60 days. In addition, there was now an allowance for specialist committees both to consider highly specialised products, such as those involving gene therapy or xenotransplantation, and to do so on a longer time-scale. On informed consent, the Minister said that the previous wording had incorporated the legal systems of some Member States, but not those of others (including the UK). A revised definition, proposed by the UK and based on that in the Council of Europe Convention on Human Rights and Biomedicine, would accommodate all systems in Member States.

  9.7  On the question of subsidiarity, the Minister confirms that the UK was originally concerned about the application to trials conducted only in one Member State of a proposal dealing with multi-centre, multi-national trials. However, he goes on to say that further consideration showed that it would be necessary to apply the measure to trials conducted solely in one Member State as this would be consistent with existing European legislation on the licensing of medicines. He adds that this would also ensure a level playing field, and that the same high standards were applicable throughout the Community: this would not only protect trial participants, but give reassurance that the data generated is credible, thereby helping to safeguard public health in the Community.

Conclusion

  9.8  We are grateful to the Minister for these further explanations, and are now clearing this document, as well as the two earlier versions of the proposal, on which we had entered a scrutiny reserve.


28   (18411) 10607/97. Back

29   (20130) 7720/99. 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 2000
Prepared 16 June 2000