title: Money or your life? The health-wealth trade-off in pharmaceutical regulation.
abstract: For decades the development of pharmaceuticals has been regulated by safety, efficacy and quality rules for product registration. In public health care systems, these three 'hurdles' are increasingly being supplemented by a fourth: the mandatory requirement to demonstrate economic efficiency in order to obtain reimbursement. This requirement challenges the wealth creation ethic of industry (money) with the population health ethic of public health and health economics (your life). Despite practical and methodological obstacles to the use of economic evidence in decisions, the logic of this development is evident: in order to maximise improvements in population health, scarce resources must be targeted towards developing and applying technologies that deliver the greatest health gains per unit cost. The impact of this policy change on industry practice and profits will be considerable, and companies that fail to demonstrate the economic efficiency of their products will stumble at the fourth hurdle.
authors.affiliation: York Health Policy Group, University of York, Genesis 6, Science Park, York YO10 5DQ, UK.
authors.forename: A
authors.initials: A
authors.lastname: Maynard
authors.forename: R
authors.initials: R
authors.lastname: Cookson
mesh_terms: D018672:Community Health Planning / Q000191:economics*; D004345:Drug Industry / Q000191:economics* / Q000331:legislation & jurisprudence*; D017598:Efficiency, Organizational / Q000191:economics; D005062:European Union; D015276:Health Care Rationing; D006801:Humans; D017063:Outcome Assessment, Health Care; D011634:Public Health; D011787:Quality of Health Care; D013222:State Medicine; D006113:United Kingdom