Health Policy 109 (2013) 270–280 Contents lists available at SciVerse ScienceDirect Health Policy j ourna l ho me p ag e: www.elsevier.com/locate/healthpol Review Regulatory space and the contextual mediation of common functional pressures: Analyzing the factors that led to the German Efficiency Frontier approach Corinna Klingler * , Sara M.B. Shah, Anthony J.G. Barron, John S.F. Wright London School of Economics and Political Science, Houghton Street, London WC2A 2AE, United Kingdom a r t i c l e i n f o Article history: Received 24 April 2012 Received in revised form 7 January 2013 Accepted 9 January 2013 Keywords: Health technology assessment Germany Regulation Methods Efficiency frontier Regulatory space a b s t r a c t There are no automatic links between the functional advantages and pressures associated with delegation to independent agencies for Health Technology Assessment (HTA) and their emergence in national regulatory spaces. We argue that the rise of these organizations is mediated by contextual factors, which must be explained. Accordingly, we analyze the Ger- man ‘regulatory space’ for health policy decision-making, identifying contextual factors relevant to the adoption of the Efficiency Frontier approach. Based on qualitative inter- views with key stakeholders, we argue that the development of the Efficiency Frontier can be associated with cultural reluctance to frame healthcare prioritization decisions around cost based valuations of human health and related doubts about the validity of metrics for human health gain. Based on this finding, we conclude that the delegation of authority to independent HTA agencies follows a broadly evolutionary pattern, in which contextual factors allow for significant variation in institutional and methodological responses to the functional pressures and advantages leading to their establishment. © 2013 Elsevier Ireland Ltd. All rights reserved. 1. The rise and development of HTA organizations The development of increasingly sophisticated health- care products with the capacity to extend human life has produced a transnational growth in public demand for access to new health technologies [1,2]. Currently, many developed nations are struggling with the prob- lem of balancing limited healthcare budgets against the requirement to ensure comprehensive and equitable public access to new technologies [3,4]. In Europe, policy-makers have responded to these common pressures by delegating * Corresponding author at: Institute of Ethics, History and Theory of Medicine, Ludwig Maximilian University of Munich, Lessingstr. 2, 80336 Munich, Germany. Tel.: +49 89 5160 2757; fax: +49 89 5160 2712. E-mail addresses: Corinna.Klingler@med.uni-muenchen.de (C. Klingler), sara.m.shah@gmail.com (S.M.B. Shah), anthony.barron@gmail.com (A.J.G. Barron), j.s.wright@lse.ac.uk (J.S.F. Wright). authority to independent Health Technology Assessment (HTA) agencies, such as the Dental and Pharmaceutical Ben- efits Agency (TLV) in Sweden, the Institute for Quality and Efficiency in Health Care (IQWiG), and the National Insti- tute for Health and Clinical Excellence (NICE) in England. Broadly, the function of these agencies is to produce pol- icy relevant information regarding mainly clinical, but also economic, social and ethical issues associated with the use of new technologies 1 [5–7]. Theoretically, they allow for more legitimate, transparent and accountable health care priority-setting and decision-making, and the delivery of maximum public health benefit from finite pub- lic resources. Today, the role of these independent agencies within the national policymaking process is substantial. 1 However, not every agency produces information on all those dimen- sions. The IQWiG focuses heavily on clinical outcome measures as it has not been commissioned to routinely include for example an ethics reflec- tion in its HTA reports. 0168-8510/$ – see front matter © 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.healthpol.2013.01.004