title: A regulatory governance perspective on Health Technology Assessment (HTA) in Sweden.
abstract: Independent regulatory agencies (IRAs) for Health Technology Assessment (HTA) are a key means by which national governments have responded to the challenge of ensuring equitable public access to a new range of medicines and treatment options within the context of limited national budgets for healthcare. In this paper, we apply a regulatory governance frame to the study of the Swedish process for HTA. Based on qualitative interviews with key institutional stakeholders, we suggest that the major challenge for Swedish IRAs for HTA is successfully communicating nationally produced research outputs to the regional authorities responsible for the delivery of health services. We conclude that a regulatory governance approach to the analysis of national processes for HTA has the capacity to draw attention to a new range of challenges and issues which have direct relevance to improving the conduct of HTA within national regulatory spaces.
authors.affiliation: LSE Health, Department of Social Policy, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, United Kingdom. Electronic address: sara.shah@sshf.no.
authors.forename: Sara Mehmood Birchall
authors.initials: SM
authors.lastname: Shah
authors.affiliation: LSE Health, Department of Social Policy, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, United Kingdom.
authors.forename: Anthony
authors.initials: A
authors.lastname: Barron
authors.affiliation: Institute of Ethics, History and Theory of Medicine, Ludwig Maximilians University Munich, Lessingstr. 2, 80336 Munich, Germany. Electronic address: Corinna.Klingler@med.uni-muenchen.de.
authors.forename: Corinna
authors.initials: C
authors.lastname: Klinger
authors.affiliation: LSE Health, Department of Social Policy, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, United Kingdom. Electronic address: j.s.wright@lse.ac.uk.
authors.forename: John S F
authors.initials: JS
authors.lastname: Wright
mesh_terms: D020811:Biomedical Technology / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006291:Health Policy / Q000331:legislation & jurisprudence; D006801:Humans; D013548:Sweden; D013673:Technology Assessment, Biomedical / Q000331:legislation & jurisprudence*
keywords: European Union; Health Technology Assessment; Healthcare; Regulation; Sweden