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

Brooks, Eleanor and Geyer, Robert (2016) Can a medical need clause help manage the growing costs of prescription drugs in the EU? Health Economics, Policy and Law, 11 (2). pp. 179-192. ISSN 1744-1331

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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?

Item Type:
Journal Article
Journal or Publication Title:
Health Economics, Policy and Law
Additional Information: The final, definitive version of this article has been published in the Journal, Health Economics, Policy and Law, 11 (2), pp 179-192 2016, © 2016 Cambridge University Press.
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02 Mar 2016 15:32
Last Modified:
18 Oct 2023 00:54