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Can a medical need clause help manage the growing costs of prescription drugs in the EU?

Published online by Cambridge University Press:  03 September 2015

Eleanor Brooks  and
Robert Geyer
Eleanor Brooks*
Affiliation:
Department of Politics, Philosophy and Religion, Lancaster University, Lancaster, UK
Robert Geyer
Affiliation:
Department of Politics, Philosophy and Religion, Lancaster University, Lancaster, UK
*
*Correspondence to: Eleanor Brooks, Department of Politics, Philosophy and Religion, Lancaster University, County South Building, Lancaster LA1 4YL, UK. Email: e.brooks@lancaster.ac.uk
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Abstract

Innovation in the development of new drugs has to balance the needs of health actors and administrators, the pharmaceutical industry and patients. Differing perspectives on what constitutes an innovation, where research and development should be directed and how new drugs should be evaluated and priced cause ongoing tensions within the regulatory framework. In the current climate, where Europe’s health systems face rising demand for health services and increasingly restricted resources, the efficiency of pharmaceutical regulation and drug development is under even greater scrutiny. How can regulation foster innovation and industry growth while also serving the public health needs of society, and what is the EU’s role in pursuing this objective? Drawing on a provision which formerly existed in Norwegian pharmaceutical legislation, this article explores the potential of a medical need clause (MNC) in addressing these issues. In restricting market authorisations to those drugs that offer an added therapeutic value, might a MNC foster innovation and spending efficiency in Europe’s health systems?

Type
Articles
Information
Health Economics, Policy and Law , Volume 11 , Issue 2 , April 2016 , pp. 179 - 192
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Copyright
© Cambridge University Press 2015 

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