TIK-Centre, Faculty of Social Sciences, University of Oslo.
Institute of Health and Society, Faculty of Medicine, University of Oslo.
Milbank Q. 2019 Sep;97(3):762-795. doi: 10.1111/1468-0009.12405. Epub 2019 Jul 21.
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.
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.
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.
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.
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.
政策要点 当前的抗生素耐药性危机需要在地方和全球范围内进行政策改革。不同监管体系的历史洞察力可以为当前的决策提供信息。实施抗微生物药物耐药性措施的强有力监管控制，可以确保促进获取和限制过度使用的双重目标，只有符合公共卫生需求的特定药物才能进入市场。在这一水平上的监管对消费也有强大的影响，需要被视为遏制抗生素耐药性的一种手段。挪威药品监管程序是一个例子，说明国家药品监管机构如何通过仅接受具有附加治疗价值的药物，间接地促进满足公共卫生需求的新药创新。
抗生素耐药性是对全球健康的日益严重威胁，需要采取协调行动。大多数当前的政策努力都针对缺乏药品。也需要对促进所有需要抗生素的人获得抗生素的途径进行新的思考，同时遏制不适当的使用。由于情况需要新的方法，我们研究了一个长期以来将抗微生物药物耐药性（AMR）列入议程的药品监管体系。挪威药品监管体系，特别是其“需求条款”，已在国际辩论中被援引，但以前没有详细研究过。
我们通过检查挪威卫生当局、挪威药品管理局的档案以及该时期的政策辩论，对挪威药品监管系统进行了历史回顾。
挪威药品监管系统侧重于药物的合理使用，紧密联系公共卫生需求。它最初是为了解决不必要的药物消费而制定的，而不是为了保护消费者和安全。该系统中最灵活的元素规定，一种药物必须“需要”才能注册。当抗生素耐药性成为一个问题时，它限制了被认为会促进耐药性的药物（如联合和广谱产品）的市场准入。这是一个强大而灵活的监管手段，也影响了药物消费。
最近，需要条款被作为解决当前问题的替代方案而被提出。抗生素耐药性问题的解决方案不可能到处都一样，我们也不主张在全球范围内采用这种药品监管制度。然而，当前的情况需要考虑许多不同的方面。这个历史案例表明，监管程序如何可以同时用于限制市场准入和促进合理使用。
