July 22, 2019

Less Is More: Norwegian Drug Regulation, Antibiotic Policy, and the “Need Clause”

July 2019 | Bård Hobæk, Anne Kveim Lie | Early View, Original Scholarship

Policy Points:

  • The current crisis of antibiotic resistance calls for policy reforms locally and globally. Historical insight in different regulatory systems can inform current decision making.
  • A strong regulatory control implementing antimicrobial resistance concerns can ensure the combined objective of promoting access and limiting excess use by letting only certain drugs onto the market in compliance with public health needs.
  • Regulation at this level also has powerful effects on consumption and needs to be considered as a tool for curbing antibiotic resistance.
  • The Norwegian drug regulatory procedures was an example of how national drug regulatory authorities can promote innovation of new drugs that meet public health needs indirectly by accepting only drugs of added therapeutic value.

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.

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Published 2019
DOI: 10.1111/1468-0009.12405