CLINICAL TRIALS ON MEDICINAL PRODUCTS
(21201)
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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.
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| Legal base:
| Article 95; co-decision; qualified majority voting
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| Deposited in Parliament:
| 17 May 1999 |
| Department: |
Health |
| Basis of consideration:
| EM of 11 May 2000
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| Previous consideration:
| None; but see (18411) 10607/97: HC 155-vi (1997-98),
paragraph 10 (12 November 1997), and (20130) 7720/99: HC
34-xxiv (1998-99), paragraph 6 (30 June 1999)
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| Committee's assessment:
| Politically important
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| Committee's decision:
| Not cleared; further information requested
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Background
8.1 As we noted in our Report of 12 November
1997, the Commission put forward in September of that year a proposal
to harmonise the conduct of clinical trials using human subjects
intended to discover or verify the effects of a new or established
medicine prior to the granting of a marketing authorisation under
Directive 65/65/EEC[12].
The stated aim was to incorporate internationally established
standards of protection for the subject; streamline the administrative
procedures for initiating a clinical trial; harmonise the reporting
procedures for safety monitoring; and introduce surveillance measures
through inspection. More specifically, the proposal sought to
reduce delays at the start of clinical trials by imposing limits
on the time within which ethics committees and regulatory authorities
must act before a trial can begin; to bring the establishment
and functioning of ethics committees into law; and to introduce
a standard format for supplying information to such committees,
and a system for the delivery of a single ethical committee approval
per Member State in the case of multi-national trials.
8.2 At that stage, the Government said that,
while the UK had no objections to certain aspects of the proposal,
it did reserve its position on a number of provisions, notably
the harmonisation of arrangements for approval of clinical trials
by ethics committees; the need for trials conducted solely within
the UK to comply with the Directive; and the various Guidelines
being developed to support the Directive (on which discussion
and voting within the Council and European Parliament would not
take place) We were also told that there was still "significant"
concern about the time scales for obtaining the approval of an
ethics committee for the start of a trial. 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.
8.3 In April 1999, the Commission produced
an amended proposal, taking into account amendments proposed by
the European Parliament at its first reading on 17 November 1998.
These amendments would have strengthened the rôle of ethics
committees, and given them wider responsibilities; 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.
8.4 In an Explanatory Memorandum of 29 May
1999, the then Parliamentary Under-Secretary of State at the Department
of Health (Baroness Hayman) said that, although the aim of the
proposal was to speed up procedures in Europe as a whole and to
create data that was compatible throughout Europe, the provisions
as drafted would apply to single as well as multiple site clinical
trials and were therefore incompatible with the principles of
subsidiarity. She went on to say that, whilst the UK welcomed
the progress that had been made in achieving consistency with
internationally recognised terminology, it reserved its position
on the proposals for "informed consent", where she considered
the definition as drafted was incompatible with existing UK law;
that the UK had changed and reserved its position on the harmonisation
of arrangements for approval of clinical trials by ethics committees,
in particular to the introduction of specific time scales, which
remained too short; that the UK reserved its position on provisions
which would require compliance with the Directive in respect of
trials conducted solely within the UK; and that it reserved its
position on the increase in the rôle of the EMEA, at a time
when the European procedure was about to be reviewed. She added
that this last concern was shared by the pharmaceutical industry,
which (though seeking to increase the speed of approval of clinical
trials) was also worried about the additional regulatory burden
it introduced. She indicated that a Regulatory Impact Assessment
would follow.
8.5 In the conclusion to our Report of 30
June 1999, we said that we would be interested to see the promised
Regulatory Impact Assessment when it was available, and that,
at that stage, we would also find it helpful if the Minister could
expand on the reasons for the UK's reservations on the proposals
for informed consent, on the application of the Directive to trials
conducted solely in the UK, and on the harmonisation of arrangements
for approval of clinical trials by ethics committees. In the meantime,
we were not clearing the document.
The current proposal
8.6 Although an official text is not available,
the Parliamentary Under-Secretary of State at the Department of
Health (Lord Hunt of Kings Heath) has sent us, together with an
Explanatory Memorandum of 11 May 2000, a copy of an unofficial
text, which he says has been included on the agenda of the Internal
Market Council on 25 May for political agreement. He goes on to
say that the procedure for obtaining ethics committee approval
is now compatible with UK practice, whilst the proposal for obtaining
informed consent has been brought into line with the Council of
Europe Convention on Human Rights and Biomedicine. He adds that,
although the Directive would apply to UK-only based trials, it
will underpin guidelines being followed in the UK by established
clinical research units, by ensuring compliance with internationally
recognised standards.
8.7 The Minister has also enclosed with
his Explanatory Memorandum a draft Regulatory Impact Assessment,
which he says will be refined further once the Directive has been
agreed and implementing regulations drafted. However, at this
stage, it is estimated that the non-recurrent compliance costs
(at current prices), which would fall largely on the innovative
pharmaceutical industry, would be around £4 million, with
a similar amount arising for recurring costs. The Minister suggests
that these are likely to be offset by increased earnings that
will result from bringing products to market more quickly.
Conclusion
8.8 Whilst we note the Minister's statement
that the areas identified in our Report of 30 June 1999 as having
previously been of concern are now acceptable, he does not explain
the ways in which the proposal has been changed to make this so.
Similarly, it is not clear from his Explanatory Memorandum how
the application of the proposal to a trial based in a single Member
State is now seen as compatible with the principles of subsidiarity,
whereas his predecessor (in her Explanatory Memorandum of 29 May
1999) took the view that it was not. Consequently, whilst we note
the timetable for consideration of this measure by the Council,
we would like, before considering clearance of this document,
to have further clarification on these points.
12 OJ No. L 22, 9.2.65, p.369. Back
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