The Fund supports networks of state health policy decision makers to help identify, inspire, and inform policy leaders.
A bipartisan group of state health policymakers from both the executive and legislative branches who are focused on improving population health.
Networks of state officials, advocates, and others aiming to invest in and transform primary care.
A program dedicated to advancing state-based efforts to make health care more affordable for residents, employers, and states.
The Milbank Memorial Fund supports two state leadership programs for legislative and executive branch state government officials committed to improving population health.
A leadership development program for early and mid-career state government officials who are committed to improving the health of all people in their communities.
A leadership program for senior state government officials who are committed to improving population health.
The Fund focuses on creating an affordable health care system built on strong primary care and partnerships that improve health outcomes for all.
Improving state leaders’ ability to enact and implement evidence-based health policies.
Advancing policies that create a more prevention- and primary care-oriented health system.
Improving population health through policies that contain health care cost growth.
Our state health policy resources offer relevant data analysis and best practices.
The Fund publishes reports, issues briefs, and case studies on state health policy issues.
Short takes on health policy issues from Milbank staff and guest authors.
Insights from Milbank President Debra Lubar on state health policymaking.
Reported articles and Q&As on timely health policy issues, as well as foundation updates.
Milbank Memorial Fund and Milbank Quarterly webinars featuring state health policymakers and researchers.
Updates and expert contact information for reporters.
The Milbank Memorial Fund is a private foundation that works to improve population health and health equity.
September 2019 (Volume 97)
Quarterly Article
Bård Hobæk
Anne Kveim Lie
Oct 14, 2026
September 2026
Back to The Milbank Quarterly
Policy Points:
Context: Antibiotic resistance is an increasingly serious threat to global health that requires coordinated action. Most current policy efforts address the lack of medicines. There is also a need for new thinking on promoting access to all who are in need of antibiotics, while simultaneously curbing inappropriate use. As the situation calls for new approaches, we examined one drug regulatory system in which antimicrobial resistance (AMR) has been on the agenda for a long time. The Norwegian drug regulatory system, and particularly its “need clause,” has been invoked in international debates but not previously studied in detail.
Methods: We conducted a historical review of the Norwegian drug regulatory system by examining the archives of the Norwegian health authorities, the Norwegian Medicines Agency, and policy debates in the period.
Findings: The Norwegian drug regulatory system focused on the rational use of drugs, tied closely to public health needs. It was originally written to address unnecessary consumption of drugs, not consumer protection and safety. The most flexible element within this system stated that a drug must be “needed” in order to be registered. When antibiotic resistance became a concern, it limited the market entry of drugs considered to promote resistance, such as combination and broad‐spectrum products. This was a powerful and flexible regulatory device that also influenced drug consumption.
Conclusions: The need clause has lately been promoted as an alternative to address the current situation. The solutions to the problem of antibiotic resistance cannot be the same everywhere, and we do not argue that this drug regulatory system should be adopted globally. However, the current situation calls for consideration of many different aspects. This historical case demonstrates how regulatory procedures can be used to limit market entrance and promote appropriate use simultaneously.
Keywords: drug regulation, pharmaceutical policy, antibiotic resistance, need clause.
Read on Wiley Online Library
Published 2019 Volume 97, Issue 3 (pages 762-795) DOI: 10.1111/1468-0009.12405