7 Regulating clinical trials
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12751/12
COM(12) 369
+ ADDs 1-3
| Draft Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Commission Staff Working Documents: Impact assessments
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| Legal base | Articles 114 and 168(4)(c) TFEU; co-decision; QMV
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| Department | Health |
| Basis of consideration | Minister's letter of 8 October 2012
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| Previous Committee Report | HC 86-xi (2012-13), chapter 9 (5 September 2012)
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| Discussion in Council | No date set
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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 AND
PREVIOUS SCRUTINY
7.1 Clinical trials provide essential information on the safety,
efficacy and therapeutic benefits of particular drug treatments
and increasingly involve participants at different trial sites
across a number of Member States. Since 2004, the authorisation
and conduct of clinical trials within the EU has been regulated
by the Clinical Trials Directive. The Commission believes that
the Directive has improved the safety and ethical soundness of
clinical trials across the EU, as well as the reliability of the
data obtained. However, it also acknowledges that, since its
entry into force, the Directive has increased costs and contributed
to a decline in clinical trials in the EU, describing it as "arguably
the most heavily criticised piece of EU legislation in the area
of pharmaceuticals."[36]
7.2 The draft Regulation would repeal the Directive, introduce
a new and less costly authorisation procedure, and seek to ensure
that the rules governing the conduct of trials are differentiated
to take account of the degree of risk associated with each trial.
An EU portal, linked to a database, would provide a single point
of entry for the submission of all the information needed to assess
the therapeutic and public health benefits of a proposed clinical
trial, as well as potential risks to patients taking part in the
trial. The EU portal would be used for all clinical trials.
However, for trials involving more than one Member State, a single
'reporting Member State' would be responsible for making an initial
assessment, taking into account any views communicated by other
Member States in which the clinical trial is proposed to take
place. This initial clinical assessment would be supplemented
by a further assessment, undertaken by each Member State, of those
aspects of the draft Regulation which the Commission describes
as "intrinsically national, ethical or local" - these
include the well-being of those participating in the clinical
trial and requirements for obtaining their informed consent, the
suitability of the clinical trial site and of those conducting
the trial, and compensation arrangements. In order to reduce
delays in the time taken to authorise clinical trials, the draft
Regulation would introduce time limits for each stage of the procedure.
7.3 In an attempt to reduce the financial burden associated
with clinical trials, the Commission draws a distinction between
'low intervention' clinical trials, where the risk to participants
only marginally exceeds that already inherent in normal clinical
practice, and others where there may be additional risk. For
low intervention clinical trials, the sponsor would not be required
to establish a specific damage compensation scheme beyond that
already in place for those conducting the trial. By contrast,
each Member State would be required to set up a national indemnification
mechanism, which would operate on a not-for-profit basis, for
other types of clinical trial. This is intended to help non-commercial
sponsors, such as academics involved in medical research, to obtain
the necessary insurance cover as premiums in the commercial insurance
market have (the Commission suggests) become unaffordable.
7.4 The Government told us that it welcomed the draft Regulation,
supported the introduction of "a proportionate and risk-adapted
approach" to clinical trials, and considered that it had
the potential to reduce regulatory, administrative and financial
burdens. However, it suggested that there should be a clearer
description of how the single authorisation procedure would work
(in particular, the relationship between the reporting Member
State and other Member States likely to be involved in a clinical
trial), and that a notification scheme, rather than a simplified
authorisation procedure, would be suitable for low risk clinical
trials. The Government questioned the need for each Member State
to establish a national indemnification mechanism for all clinical
trials other than those which qualify as low risk and said that
the Commission should focus, instead, on making the commercial
insurance market more competitive. It also questioned whether
there was a need, or a legal base, for the Commission to carry
out inspections to verify whether Member States were ensuring
full compliance with the draft Regulation. Our Eleventh Report
of 5 September 2012 provides a more detailed overview of the content
of the draft Regulation and the Government's preliminary assessment.
7.5 We recognised that there was a broad consensus on the
need to change the existing regulatory framework for clinical
trials within the EU, but agreed with the Government that there
needed to be far greater clarity about the role of the Member
State chosen to assess the clinical aspects of a clinical trial
(the reporting Member State) and the way in which that assessment
would take account of the views expressed by other Member States
in which the trail was also intended to take place. We asked
the Government whether, in multi-state clinical trials, it was
satisfied that the grounds (set out in Article 8 of the draft
Regulation) on which a Member State may disagree with the reporting
State's initial assessment and, in effect, opt out of a particular
trial, were sufficiently comprehensive and safeguarded the interests
of all Member States.
7.6 We noted the Government's reservations regarding the proposed
introduction of a national indemnification scheme in each Member
State to cover claims for damages arising from participation in
a clinical trial, and asked what type of action it thought the
Commission should take to tackle the escalating costs for obtaining
insurance cover in a sustainable and effective way. We agreed
that it would be helpful to have further information on the nature
of any controls and inspections to be undertaken by the Commission,
but thought that some form of EU oversight would be needed to
ensure that all Member States were applying the Regulation correctly.
Finally, we welcomed the Government's intention to launch a formal
consultation and asked to be informed of the outcome. We also
requested progress reports on the negotiations.
THE MINISTER'S
LETTER OF
8 OCTOBER 2012
7.7 The Parliamentary Under-Secretary for Quality (Earl Howe)
says that the scope for opting out of multi-state clinical trials
should be as limited as possible. He continues:
"Only with a limited opt-out can we achieve
an effective authorisation of multi-state trials and reduce the
administrative and regulatory burden on researchers. To adequately
safeguard the interests of individual Member States I believe
that the process for the assessment of multi-state trials as currently
written down by the Commission should be improved to ensure that
the role of the Reporting Member State is clear and that the comments
of Concerned Member States are taken into account. My officials
are working with other Member States to come up with amendments
to the Commission's proposals. I think an improved procedure will
safeguard the interests of Member States better than a wider opt-out."
7.8 Turning to the proposed introduction of national
indemnification schemes in each Member State, the Minister acknowledges
that the Commission's analysis of the cost of obtaining insurance
for clinical trials is worrying, but considers that the Commission
should have explored other options to tackle the problem. He
adds:
"My officials are talking to a range of stakeholders
in the UK to identify the size of the problem. Preliminary responses
from stakeholders have not given a clear view on whether insurance
of trials is an issue for them. My officials are also looking
at how such a scheme relates to mechanisms that are already in
place in the NHS and how these would be impacted on by a national
indemnification scheme. I think the issue of insurance requires
some further investigation into the actual problem and whether
an indemnification scheme is the right solution. I will update
your Committee on any further developments on this issue."
7.9 Finally, the Minister considers that the
Commission has sufficient existing instruments to ensure that
Member States comply with the draft Regulation, without the need
for further powers of control or inspection. He continues:
"I am not convinced that setting up a new inspection
role for the Commission, as the Commission proposes, will make
a difference; especially since it is not clear what powers these
inspectors would have, and any findings would have to lead to
an infraction procedure against a Member State which the Commission
can initiate anyway. If a Member State, for example does not
apply the timelines, this would emerge anyway and the Commission
would be able to take action. Again, I believe that the solution
here is to amend the proposed process for joint assessment as
I have outlined above."
7.10 The Minister undertakes to provide regular
progress reports on the negotiations.
CONCLUSION
7.11 We thank the Minister for his letter and
look forward to receiving further progress reports. We trust
that the reports will include information on possible improvements
to the assessment and authorisation procedure, particularly if
a more robust process for assessing multi-state clinical trials
at the initial authorisation stage is intended to obviate the
need to create a new inspection role for the Commission to ensure
that the draft Regulation is properly applied in all Member States.
7.12 We also look forward to hearing stakeholders'
views on the impact that insurance premiums have on the conduct
of clinical trials, and ask the Government for some concrete indication
of how it considers that the escalating costs for obtaining insurance
cover should be tackled. Meanwhile, the draft Regulation remains
under scrutiny.
36 See p.17 of ADD 2. Back
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