Understanding the trends in international agreements on pricing and reimbursement for newly marketed medicines and their implications for access to medicines: a computational text analysis

Kyung-Bok Son

doi:10.1186/s12992-020-00633-9

Abstract

BackgroundHealth systems are struggling with unprecedented drug spending and governments have devised various policy options to manage high-priced medicines. Meanwhile, some pricing and reimbursement processes are currently moving under the jurisdiction of international agreements. This study aims to understand trends in international agreements from the perspectives of pricing and reimbursement policies for newly marketed medicines.MethodsWe proposed the framework to interpret the international agreements as code and applied computational text analysis to understand international agreements as data. In particular, we selected the AUSFTA, KORUS, and TPP to assess the progress and evolution in international agreements and investigate the existing relevant content on the pricing and reimbursement of newly marketed medicines.ResultsSimilar to the provisions for intellectual property, the scope of international agreements regarding pricing and reimbursement decisions are broadened and strengthened. Over time, the domain of transparency, re-naming procedural fairness, has changed significantly more than the remaining domains. Pharmaceutical companies will have more opportunities to advocate for their positions, to protect their interests in decision processes, to investigate the decisions on listings and setting the amounts of reimbursement, and to challenge these decisions.ConclusionsRecently signed international agreements favor companies over governments with underscoring procedural fairness and timely access. However, access to affordable medicines is the goal towards which international agreements should aim. In a similar vein, substantial fairness and the accountability of companies should be discussed when negotiating agreements or adopting international agreements through domestic legislation.

Highlights

Health systems are struggling with unprecedented drug spending and governments have devised various policy options to manage high-priced medicines
New trade and industry norms are expanding their scopes into low- and middle-income countries through international trade agreements [10, 11], implying that some pricing and reimbursement processes are currently moving under the jurisdiction of international agreements
Suggested framework to understand international agreements on the pricing and reimbursement of pharmaceuticals The pricing and reimbursement of pharmaceuticals has been a source of continuous policy debate [38,39,40,41]

Summary

Introduction

Health systems are struggling with unprecedented drug spending and governments have devised various policy options to manage high-priced medicines. Governments have devised various policy options to reduce the uncertainty in budget impacts and to manage pharmaceutical expenditure incurred by high-priced medicines [4,5,6,7,8,9]. The Korea-US Free Trade Agreement (KORUS) includes articles entitled “access to innovation” and “transparency”, and the Trans-Pacific Partnership (TPP) provides articles entitled “procedural fairness” and “transparency”. These articles could affect governments’ decisions on the pricing and reimbursement of newly marketed medicines [11]

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Discussion

Conclusion