Select Committee on European Scrutiny First Report



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 EC; co-decision; qualified majority voting
Department: Health
Basis of consideration: Minister's letter of 30 November 2000 and EM of 11 December 2000
Previous consideration: None; but see (18411) 10607/97: HC 155-vi (1997-98), paragraph 10 (12 November 1997)
Committee's assessment: Politically important
Committee's decision: Cleared


  16.1  In September 1997, the Commission put forward a proposal[31] 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.

  16.2  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.

  16.3  The Commission subsequently produced an amended proposal[32] 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 role 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.

  16.4  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.

  16.5  Although an official text was not available, the Parliamentary Under-Secretary of State at the Department of Health (Lord Hunt) sent us, together with an Explanatory Memorandum of 11 May 2000 and a draft Regulatory Impact Assessment, a copy of an unofficial text[33] which was to be included on the agenda of the Internal Market Council on 25 May for political agreement. He said that the areas previously of concern were now acceptable, and, after a further explanation of the detailed changes which had enabled that conclusion to be reached, we cleared the latest document, and the two earlier versions of the proposal, at our meeting on 24 May.

Minister's letter of 30 November 2000 and Explanatory Memorandum of 11 December 2000

  16.6  We have now received from the Minister a letter of 30 November, followed by an Explanatory Memorandum of 11 December. The first of these points out that the European Parliament Environment Committee adopted its draft report on 21 November, at which over 60 amendments were proposed, most of which were not in the interests of the UK. In liaison with the Commission and the Rapporteur, the Presidency had subsequently drawn up 24 new amendments designed to draw the Parliament and Council closer together, and it was the Presidency's intention to ask COREPER on 1 December for a mandate to agree these compromise proposals with the Rapporteur, who it was expected would then present the agreed position to the Parliament's plenary session on 11-14 December. Since the UK understood that the European Parliament could be persuaded to accept the proposals, and thus avoid conciliation, the Minister said that, even though this latest version had not been subjected to proper scrutiny, he intended to lift the UK's scrutiny reserve at the COREPER meeting. He justified this on the grounds that the UK supported the text now on the table, and was concerned that, if it maintained a reserve, there was potential for a blocking minority in the Council, which might in turn create a risk of the Rapporteur introducing provisions unacceptable to the UK. However, he also stressed that the compromises being sought "do not represent any sticking points for the UK".

  16.7  The Explanatory Memorandum of 11 December confirms that the Presidency has now reached an agreement with the European Parliament's Rapporteur, and the Parliament's plenary was due to vote that day on the proposal. He adds that, if a compromise "is in prospect", the Health Council will consider the draft Directive on 14 December, and that formal adoption would take place at a Council before the end of the year.

  16.8  The remainder of the Explanatory Memorandum spells out in more detail the main changes which would arise if the compromise proposals are agreed. First, the Parliament wished to introduce specific criteria for the conduct of clinical trials in children, which the UK was concerned would cut across a separate initiative led by the French Presidency inviting the Commission to bring forward measures covering all aspects of the development of paediatric medicine. However, it considers the Presidency proposals ensure consistency. Secondly, the Parliament had referred to "patients" in connection with clinical trials subjects, the implication being that medicines could not be tested on healthy children, thus ruling out trials in such children of vaccines against childhood illnesses. The Government considers that the revised proposals clarify this point. Thirdly, the Parliament's amendments referred to the use of a "legal representative" in connection with obtaining informed consent, whereas UK law does not provide for this for incapacitated adults, and the Government was concerned that the use of this term would mean a significant legal change. However, the Presidency has since confirmed that the wording will accommodate the UK system. Lastly, the UK was concerned that the Parliament's amendment would impose too short a deadline for certain biotechnology medicinal products, but the Government says that the Presidency proposals provide for an acceptable limit.


  16.9  We have noted the position set out by the Minister in his letter and Explanatory Memorandum. We do of course understand the tactical arguments he has put forward in favour of the United Kingdom supporting a version of the proposal with which it was content, and we accept that the changes of substance being made in this instance are not fundamental. In view of this, and of our clearance of the earlier version of the proposal, we are clearing this document.

  16.10  Nevertheless, we are concerned that, as the Minister himself acknowledges, the course he has chosen to follow runs counter to the scrutiny arrangements laid down by Parliament, and our concerns are all the stronger in that we have also considered today a letter from his ministerial colleague at the Department of Health (Ms Gisela Stuart), which puts forward essentially the same arguments in connection with the proposed Directive on the content and labelling of tobacco products. Though the outcome in that instance was different, we would be concerned if these two examples were to become part of a wider trend, and we look to the Government for an assurance that this will not be the case.

31   (18411) 10607/97; see headnote to this paragraph. Back

32   (20130) 7720/99; see HC 34-xxiv (1998-99), paragraph 6 (30 June 1999). Back

33   (21201) - ; see HC 23-xix (1999-2000), paragraph 9 (24 May 2000). Back

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