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Introduction The new European Union (EU) Regulations on medical devices and on in vitro diagnostics provide manufacturers and Notified Bodies with new tools to improve pre-market and post-market clinical evidence generation especially for high-risk products but fail to indicate what type of clinical evidence is appropriate at each stage of the whole lifecycle of medical devices. In this paper we address: i) the appropriate level and timing of clinical evidence throughout the lifecycle of high-risk implantable medical devices; and ii) how the clinical evidence generation ecosystem could be adapted to optimize patient access. Areas covered The European regulatory and health technology assessment (HTA) contexts are reviewed, in relation to the lifecycle of high-risk medical devices and clinical evidence generation recommended by international network or endorsed by regulatory and HTA agencies in different jurisdictions. Expert opinion Four stages are relevant for clinical evidence generation: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market. Each stage has its own evaluation needs and specific studies are recommended to generate the appropriate evidence. Effective lifecycle planning requires anticipation of what evidence will be needed at each stage.

Introduction: Tobacco smoking claims 700 000 lives every year in Europe and the cost of tobacco smoking in the EU is estimated between €98 and €130 billion annually; direct medical care costs and indirect costs such as workday losses each represent half of this amount. Policymakers all across Europe are in need of bespoke information on the economic and wider returns of investing in evidence-based tobacco control, including smoking cessation agendas. EQUIPT is designed to test the transferability of one such economic evidence base—the English Tobacco Return on Investment (ROI) tool—to other EU member states. Methods and analysis: EQUIPT is a multicentre, interdisciplinary comparative effectiveness research study in public health. The Tobacco ROI tool already developed in England by the National Institute for Health and Care Excellence (NICE) will be adapted to meet the needs of European decision-makers, following transferability criteria. Stakeholders' needs and intention to use ROI tools in sample countries (Germany, Hungary, Spain and the Netherlands) will be analysed through interviews and surveys and complemented by secondary analysis of the contextual and other factors. Informed by this contextual analysis, the next phase will develop country-specific ROI tools in sample countries using a mix of economic modelling and Visual Basic programming. The results from the country-specific ROI models will then be compared to derive policy proposals that are transferable to other EU states, from which a centralised web tool will be developed. This will then be made available to stakeholders to cater for different decision-making contexts across Europe. Ethics and dissemination: The Brunel University Ethics Committee and relevant authorities in each of the participating countries approved the protocol. EQUIPT has a dedicated work package on dissemination, focusing on stakeholders' communication needs. Results will be disseminated via peer-reviewed publications, e-learning resources and policy briefs. ...

Gesundheitsökonomen nehmen Stellung zu den "Eckpunkten zu einer Gesundheitsreform" der Koalitionsparteien vom 4. Juli 2006.