Convergence, Divergence and Hybridity: A Regulatory Governance Perspective on Health Technology Assessment in England and Germany

DOIhttp://doi.org/10.1111/1758-5899.12215
Date01 March 2017
Published date01 March 2017
Convergence, Divergence and Hybridity: A
Regulatory Governance Perspective on Health
Technology Assessment in England and
Germany
John S. F. Wright, Anthony J. G. Barron and Sara M. B. Shah
London School of Economics and Political Science
Corinna Klingler
Ludwig-Maximilians-Universit
at M
unchen
Abstract
Countries adopt different methods and processes to evaluate the benef‌its and costs of health technologies. It is important to
identify and analyse the factors that inf‌luence the uptake and use of these methods and processes across countries. In this
article, we introduce a regulatory governance approach to the analysis of convergence, divergence and hybridity in Health
Technology Assessment (HTA) methods, discussing and critically analysing national processes for HTA in two major EU mem-
ber states: England and Germany. We argue that any reasonably sophisticated account of national approaches to HTA must
recognise that globalisation and the emergence of advanced industrial society involves the potential for widely varying pro-
cesses, methods and evidential requirements. We suggest that this potential also confronts health policy analysts with the
challenge of constructing analytical frameworks capable of identifying the diverse institutional, domestic and other factors that
shape national approaches to HTA.
1. Social science research and HTA
Social science research is having an increasingly important
impact on the development and operation of advanced
industrial societies. With the arrival of the digital era, the
social sciences are inf‌luencing public policy across a wide
variety of sectors, contributing to the development of f‌irms
and markets, and shaping wider societal understandings of
policy problems and debates regarding their solutions. In
the health care sector, the inf‌luence of social science
research is evident in government responses to the expo-
nential growth in the availability of new health technologies
and treatment options with the capacity to improve health
and quality of life. In Europe and around the world, policy
makers have attempted to ensure equitable access to novel
and often expensive health technologies by establishing
independent regulatory agencies (IRAs) for HTA, such as the
Institute for Quality and Eff‌iciency in Health Care (IQWiG) in
Germany and the National Institute for Health and Care
Excellence (NICE) in England. These agencies produce evalu-
ations of new health technologies, which incorporate eco-
nomic, epidemiological and public health evidence, among
other elements. These assessments support policies on reim-
bursement, pricing and the use of technologies in clinical
practice. In principle, national IRAs for HTA deliver more
legitimate, transparent and accountable methods and pro-
cesses by which governments can respond to the challenge
of delivering eff‌icient and equitable public access to new
health technologies. For the future, the role of these agen-
cies within national policy making processes is likely to
expand as a wider and more sophisticated array of treat-
ment options becomes available to patients, thus placing
additional pressure on national health budgets.
Despite their common remits, roles and aims, national
IRAs for HTA differ markedly in terms of their structure,
operation, use of evidence and methods for the conduct of
evaluations. Across the EU, governments also differ with
regard to how they employ evidence generated through
HTA within national decision-making processes. These varia-
tions, and their potential to impact upon national health
policies and practices, hold consequences for the delivery of
eff‌icient and equitable health services, and ultimately for
the improvement of population health. For these reasons,
there has been signif‌icant debate and research regarding
the most appropriate methods and process for establishing
the value of health technologies. For example, some Euro-
pean analysts have advocated initiatives for pursuing a sys-
tematic approach to the evaluation of health technologies
across the EU and for adapting evaluations of individual
technologies for cross border use (Dickinson et al, 2003;
Global Policy (2017) 8:Suppl.2 doi: 10.1111/1758-5899.12215 ©2017 University of Durham and John Wiley & Sons, Ltd.
Global Policy Volume 8 . Supplement 2 . March 2017 69
Special Issue Article

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