Whatever happened to the Norwegian Medical Need Clause? Lessons for current debates in EU pharmaceutical regulation

Abstract

Until 1994, pharmaceutical products seeking market authorisation in Norway were required to demonstrate a fulfilment of unmet medical need. This clause enabled the national regulator to dramatically limit the number of products on the market whilst encouraging price competition to keep drug expenditure low and was credited with encouraging the development of drugs with genuine added therapeutic value and reducing the incidence of antimicrobial resistance. Norway was forced to abandon its Medical Need Clause (MNC) when it joined the European Economic Area as it was incompatible with the acquis communautaire of the European Union. This article reviews Norway's experience with its MNC in light of contemporary debates in European health policy. It discusses the potential contribution of an MNC-style regulation to improving health, reducing illness, ensuring sustainable health systems and fostering pharmaceutical innovation. It concludes by asking how these findings can inform current European Union debates over the growing cost of prescription drugs and direction of pharmaceutical development.

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

“…Our argument is that it merits renewed attention: along with the wider system it was part of, it is relevant to important current debates in the global politics of pharmaceuticals. It has recently again been brought up as a point of reference and contrast—in terms of controlling overall cost, steering pharmaceutical research toward genuine therapeutic advances, or better meeting global health needs …”

“…A need approach also indirectly addresses the current strong disincentives for profit‐driven companies to invest in research for new antibiotics, for which use must be minimized. The need clause has recently been discussed in terms of the costs of pharmaceuticals, and more specifically as a solution to the structural problems of pharmaceutical innovation to a large extent being directed toward classes of drugs that are highly profitable but where very little therapeutic advance is achieved . A need approach offers a radically different set of incentives for research, by only allowing market access to new drugs that offer genuine therapeutic advance or added therapeutic value in today's terms.…”

“…The Norwegian drug regulatory system in the 20th century succeeded in doing both. This system has been cited as a factor in explaining the country's historically lower incidence of antibiotic resistance compared to most other countries and has recently received scholarly attention in the context of current debates over drug regulation . Norway and Sweden were among the first countries to develop drug regulations related to safety and efficacy in the 1920s and 1930s.…”

A historical argument for regulatory failure in the case of Primodos and other hormone pregnancy tests

“…Put into action, the MNC effectively restricted the number of drugs on the Norwegian market in the 1970s to around 2000, which was far fewer than the number in most other European countries (7000–25,000). Finally, the Norwegian Medicines Agency (NoMA) subjected all new drugs to a probationary approval period of 5 years followed by a re-assessment process that could result in de-authorization ( Brooks and Geyer, 2016 ).…”

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

“…However, upon joining the European Economic Area in 1994, Norway was forced to abandon its MNC in order to comply with the dominant regulatory framework in Europe. The resulting growth in the size of the drug market was less than feared but still led to some problematic drug usage and care outcomes (Lu et al ., 2011: 17; Brooks and Geyer, 2015).…”