Compulsory licensing in pharmaceutical industry: current state of affairs and prospects

Gaydin TY1,2, Rozhnova SA1
About authors

1 Pirogov Russian National Research Medical University, Moscow, Russia

2 Lomonosov Moscow State University, Moscow, Russia

Correspondence should be addressed: Timofey Yu. Gaidin
Ostrovityanova, 1, Moscow, 117997; ur.usm.noce@a81ytag

About paper

Author contribution: Gaydin TY analyzed the literature, conducted the study and wrote the draft of the manuscript; Rozhnova SA planned and conducted the study, analyzed the literature and wrote the draft of the manuscript

Received: 2021-02-09 Accepted: 2021-02-22 Published online: 2021-03-09

The problem of compulsory licensing (CL) in the pharmaceutical industry is being discussed worldwide. The aim of this paper was to analyze the effects of using CL for pharmaceutical drugs (PD) as part of competitive policies aimed at safeguarding the life and health of the population. Using PEST-analysis, we identify the main political, economic, social and technological problems associated with using CL in the pharmaceutical industry. We demonstrate the potential of CL as a tool for countering the threats to public health caused by the abuse of market dominance by pharmaceutical patent holders. At present, both developers of pharmaceutical innovations (patent-holders) and other entities involved in drug circulation are protected by law. There is ongoing debate about the efficacy of CL as a tool ensuring the implementation of competitive policies aimed at safeguarding the rights to life and health. However, in Russia CL is applied only under exceptional circumstances. An economic balance should be sought between the incentives for innovation, long-term profits from selling PDs and PD accessibility.

Keywords: compulsory licensing, competition in pharmaceutical industry, drugs, PEST-analysis