title: Regulating the economic evaluation of pharmaceuticals and medical devices: a European perspective.
abstract: Throughout the developed world, economic evaluation of costly new pharmaceuticals and medical devices became increasingly widespread and systematic during the 1990s. However, serious concerns remain about the validity and relevance of this economic evidence, and about the transparency and accountability of its use in public sector reimbursement decisions. In this article, we summarise current concerns in Europe, based on interviews with European health economists from industry, universities, research institutes and consulting firms. We identify five challenges for European policy-makers, and conclude that there is considerable scope for improving decision-making without damaging incentives to innovate. The challenges are: (1). full publication of the economic evidence used in reimbursement decisions; (2). the redesign of licensing laws to improve the relevance of economic data available at product launch; (3). harmonisation of economic evaluation methodologies; (4). development of methodologies for evaluation of health inequality impacts; and (5). negotiation of price-performance deals to facilitate the use of economic evidence in post-launch pricing review decisions, as information is gathered from studies of product performance in routine use.
authors.affiliation: School of Medicine, Health Policy and Practice, University of East Anglia, Norwich Norfolk, NR4 7TJ, UK. r.cookson@uea.ac.uk
authors.forename: Richard
authors.initials: R
authors.lastname: Cookson
authors.forename: John
authors.initials: J
authors.lastname: Hutton
mesh_terms: D002986:Clinical Trials as Topic; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000191:economics* / Q000331:legislation & jurisprudence; D005060:Europe; D005062:European Union; D019317:Evidence-Based Medicine; D033161:Government Regulation; D007407:Interviews as Topic; D040541:Marketing; D011050:Policy Making; D013673:Technology Assessment, Biomedical / Q000191:economics* / Q000331:legislation & jurisprudence