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De-Agencification in Pharmaceutical Regulation: Who Benefits from the Return to Club Government?

Civil Society
Interest Groups
Public Policy
Regulation
Business
Decision Making
Lobbying
Activism
Olga Löblová
Universität Tübingen
Verena Eireiner
Universität Tübingen
Olga Löblová
Universität Tübingen

Abstract

Pharmaceutical policy, or the decisions on the funding status of new medicines in publicly financed health systems, have long been seen as the result of lobbying efforts of three powerful interest groups: the pharmaceutical industry, patient organizations, and physician associations. In the last 30 years, the increasing cost of new medicines and general trends towards transparency in governance has prompted most European countries to establish evidence-based regulatory frameworks to assess the benefits and costs of new drugs before granting public funding. Yet, increasingly, expensive new medicines bypass this scrutiny. Instead, they enter health systems through alternative access schemes: diverse provisions that provide patients with access to treatment that are not routinely funded – for example the English Cancer Drugs Fund or individual patient funding requests. Drawing on the results of an expert survey in 20 countries, this paper develops a novel typology of alternative access schemes in Europe. It examines how decisions in these schemes are made, which patient groups and pharmaceutical manufacturers benefit, and the broader policy implications for patients and public finances. We argue that these schemes suggest a trend toward de-agencification and a retreat from the regulatory state in pharmaceutical policymaking. This shift is accompanied by the rise of Michael Moran’s “club government,” characterized by opaque decision-making by insider groups. The paper asks whether this phenomenon reflects a response to interest group politics or an inevitable need for flexibility in public policy. Notably, we examine the role and influence of patient organizations on these regulatory decisions. We hypothesize that although patient organizations’ power has been described as limited in comparison to that of pharmaceutical manufacturers in existing literature on marketing authorization approvals, they may well exert more influence when it comes to funding decisions. This exploratory paper juxtaposes three sets of interest groups, each with a different logic but often with a confluence of interests, in a novel area of study.