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

Eleanor Brooks, Robert Geyer

Research output: Contribution to journalArticlepeer-review


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?
Original languageEnglish
Pages (from-to)179-192
Number of pages14
JournalHealth Economics, Policy and Law
Issue number2
Early online date3 Sep 2015
Publication statusPublished - Apr 2016


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