Alternative Access Schemes and De-agencification in Pharmaceutical Regulation

Pharmaceutical policy decisions regarding the funding status of new medicines in publicly financed health systems have long been influenced by three powerful interest groups: the pharmaceutical industry, patient organizations, and physician associations. In the past 30 years, the rising cost of new medicines and calls for greater transparency in governance have prompted European countries to adopt evidence-based frameworks to assess the benefits and costs of new drugs before granting public funding. However, more recently, expensive medicines are bypassing these frameworks through alternative access schemes, such as the English Cancer Drugs Fund or individual patient funding requests. Drawing from an expert survey in 20+ countries, this paper develops a typology of these alternative access schemes across Europe. It explores how decisions are made, which patient groups and manufacturers benefit, and the broader policy implications for patients and public finances. We argue that these schemes signal regulatory retrenchment, a shift away from formal regulatory oversight in pharmaceutical policymaking. This trend is linked to the rise of Michael Moran's "club government," where decisions are made behind closed doors by a small group of insiders. These schemes bypass traditional regulatory processes, reducing the state's role and increasing opacity. We examine whether this shift reflects interest group politics or an inevitable need for more flexible policy approaches. Additionally, we explore the role of patient organizations in shaping funding decisions. Although typically perceived as less influential than pharmaceutical companies in marketing authorizations, patient groups may exert more power when it comes to funding new medicines. This paper highlights the intersection of these interest groups and their combined influence on the evolving regulatory landscape.