House of Lords - European Union - Twentieth Report

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Select Committee on European Union Twentieth Report

CHAPTER 10: CONCLUSIONS AND RECOMMENDATIONS

Chapter 3 - The Need for the Regulation

193. We conclude, in principle, from the evidence we have had that there is an overwhelming and urgent need to take effective action at European level to govern clinical trials in children and the authorisation of medicinal products for paediatric use with the minimum of delay.

Chapter 4 - Ethical Considerations

194. We conclude that the Clinical Trials Directive is an appropriate basis for this Regulation.

195. We recommend that, in drawing up the guidelines underpinning the Clinical Trials Directive, the Government should ensure that particular attention is paid to the rights and capacity of children to give informed consent to trials. The guidelines must cover adequately and clearly the vulnerability of children, the possibility of conflict between the consent of parents and children involved in trials, the definition of informed consent and the distinction between consent and acquiescence in circumstances which are likely to arise during trials involving children, as well as the extent to which any trials concerned might benefit the child in question.

196. We conclude that, in many other respects, the ethical validity and effectiveness of the Regulation will depend as critically on the guidelines to be developed as on the text of the Directive itself. While detailed discussion of such aspects is appropriate for legal, medical and pharmaceutical experts, who must be adequately consulted, we recommend that the underlying issues of public policy should be given wider attention and political oversight. We therefore welcome the Minister's agreement that the relevant officials should give us on-the-record briefing on the progress made in developing those guidelines at an appropriate time after the Directive has been agreed by the Council.

197. We recommend that once the guidelines are drawn up the Government should ensure that they are fully understood by the medical and pharmaceutical professions and explained to the general public.

198. We further recommend that the Government should ensure that the guidelines are kept fully up-to-date in line with changes in medical and scientific knowledge and practice.

Chapter 5 - Information

199. We recommend that the Clinical Trials Database should contain full details of all paediatric trials, whether terminated prematurely or not. The database should be publicly available as a vital safeguard not only for those who might be involved in clinical trials but also for the medical profession and the paediatric population of Europe as a whole. This principle must be assured in the Regulation itself and in any guidelines developed from it.

200. We recommend that the Government should give further and serious consideration to the proposal that the products should be labelled in a way which indicates their suitability for use in children.

201. It is abundantly clear from our evidence that children are not just young adults: their reaction to drugs varies considerably in relation to age and other factors and the newly-born are particularly vulnerable. We therefore recommend that any labelling scheme that is devised must take full account of this and make plain the risks of using products without consulting the relevant product information, especially for products which are available without prescription. Product information should also be summarised in clear, non-scientific language that leaves no doubt whatsoever about the risks of misuse and the need to follow carefully the dosage information.

Chapter 6 - Mechanism for Implementing the Regulation

202. We conclude that the European Medicines Agency (EMEA) is the appropriate body to oversee and coordinate the tasks envisaged by the proposed Directive. We welcome the Minister's assurances that the EMEA should be sufficiently resourced to carry out this task and that experience suggests it will work smoothly and effectively with the health services and agencies of Member States in doing so. But we recommend that these aspects should be kept under close review by the Government once the Directive enters into force.

203. We conclude from the evidence we have been given that the overall composition of the Paediatric Committee is about right. We fear that any increase in the size of its permanent membership might run the risk of making it unwieldy.

204. But, because the effective functioning of the Committee is crucial to the success of this Directive, we recommend that the Government should keep the composition of the Committee under review and ensure that it draws, where necessary, on relevant available ethical and practical expertise from Member States which may not be directly available through the Committee's own membership.

205. We are unable to judge from the limited evidence and time available to us whether the proposal for funding research into paediatric use of off-patent medicines through the Community's research framework programmes will be adequate. Nor are we able to assess the need for a separate Community-funded research programme on the lines of the Medicines Investigation for the Children of Europe (MICE) proposal. But we recommend that the Government should ensure that both aspects are adequately addressed, in consultation with interested parties, when the Commission review the working of the Regulation

Chapter 7 - Rewards and Incentives

206. We recognise that the package of incentives and rewards proposed in the Regulation are a political compromise, based on the acknowledged need to provide incentives and the apparent success of the US model. But we conclude that they are essentially a leap of faith: it is impossible to judge from the information we have been given whether these arrangements are likely to provide the necessary incentives to industry, whether they are likely to be equitable and proportionate, or whether they may give rise to excessive profits, penalise the health services of Member States or create unacceptable disadvantages for the manufacturers of generic products.

207. We accept that a political compromise is necessary for the time being to launch the Regulation in the hope that it will bring the desired benefits for the children of Europe at a reasonable cost. But we recommend that the Government should continue to press the Commission to ensure that a full economic review of these proposals is made as soon as possible.

208. If the Commission are unable to provide such a review within six years of implementation, as required by Article 49 of the Regulation, we recommend that they should be required to explain to the satisfaction of the Council why it would be premature to do so at that stage and to ensure that it is done as soon as possible after that.

209. We also recommend that our successors should subject that review to very rigorous examination when it is submitted for Parliamentary scrutiny.

210. In the meantime, we recommend that the Government should make every effort to improve on the adequacy of the estimates of costs and benefits produced in the Partial Regulatory Impact Assessment as soon as it is practicable to do so and to submit the results to Parliamentary scrutiny.

Chapter 8 - Legal Base

211. In principle, we continue to believe that the Government should take a robust and consistent line in opposing proposals by the Commission which are, in the Government's view, brought forward on an inappropriate legal base. In this particular instance, in light of the overriding importance of the proposal and the need to make rapid progress in implementing it, we conclude that the Government is justified in agreeing to the present proposal with a Minute Statement recording its objection to the legal base.

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