183.  As noted earlier, the Government had been pressing us for some time[79] to clear the Proposal from Parliamentary scrutiny in the hope that political agreement might be reached on it at the Health Council on 9 December 2005.

184.  It is most unusual to lift the scrutiny reserve before publishing a Report on an Inquiry and we would normally be very reluctant to do so. In this case, we carefully considered the Minister's request in the light of all the evidence we had received. We took particular note of the assurances the Minister had given us, especially about the protection of the health, welfare and rights of any children involved in paediatric testing.

185.  We also took account of the overwhelming weight of professional opinion we had seen and heard which broadly supported the Proposal and was anxious to see it implemented as soon as possible. We also considered the indications of broad support from industry representatives, both in response to our own consultations and those of the MHRA. We also noted that the European Parliament had endorsed the Proposal[80] on First Reading in September 2005.

186.  We told the Minister[81] that ideally we would have preferred to have spent more time considering the Proposal in greater depth. But in view of her assurances, the evidence we had been given and the widely-felt need to move forward in the interests of children, we said we would be willing exceptionally to grant her request to lift scrutiny so long as she was prepared to address the following principal outstanding concerns:

• The Government should press for clarification of the Commission's position on the Clinical Trials Database and support the case for full access to the Database vigorously at the Council meeting and in subsequent discussion of the guidelines.
• Because so many important aspects of the safe and ethically-acceptable implementation of the Regulation would largely be determined by guidelines which had yet to be worked out, appropriate Departmental officials should give us on-the-record briefing in due course on the progress made in developing those guidelines.
• Because of the uncertainties surrounding the incentive arrangements, the impossibility of determining at this stage how they would work and what effect they might have, and the difficulty in providing meaningful estimates of the likely costs and benefits, the Government should strive to secure a firm and unambiguous commitment from the Commission for a full economic review of the Proposal.
• If the Commission was unable to include such a review in the general report required within 6 years of implementation, they should explain clearly to the satisfaction of the Council why it would be premature to do so at that stage and ensure that the review was undertaken as soon as possible after that.

187.  We were also anxious to ensure that the Commission's six year review would contain a full evaluation of all other aspects of the working of the Regulation which we would expect to be subjected to rigorous Parliamentary scrutiny.

188.  We added that the Minister would be expected to report on the outcome of the December Council meeting and to set out in that report the remaining steps leading to implementation if the expected political agreement was secured.

189.  We also made clear that, even if the scrutiny reserve was lifted as proposed, we could not guarantee that on such an important issue, with potentially far-reaching consequences for the welfare of children and with so many uncertainties inherent in the nature of the Proposal, a debate in the House might not be called for on publication of the Report.

190.  The Minister replied[82] accepting these conditions and pointing out that a full economic analysis would be undertaken within ten years of the Regulation coming into force, if not before. She also reiterated the Council's view that, at the very least, the results of all paediatric clinical trials, whether terminated prematurely or not, should be publicly accessible. We acknowledged this acceptance and confirmed that scrutiny clearance had been lifted with effect from 25 November 2005 on that understanding[83].

191.  The Government subsequently reported[84] that political agreement had been reached at the Council on 9 December 2005.

192.  We regard this as a satisfactory outcome. We will continue to follow developments closely. In the meantime, we make this Report to the House for information.

80   Reported in Commission document 11956/05 CODEC 705 ECO 94 SAN 134 Back

81   pp 57-59 Back

82   pp 59-60 Back

83   p 60 Back

84   pp 61-62 Back