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
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(20130) 7720/99. Back
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