Voluntary licenses increase access to costly but essential drugs

Written by Ilana Landau, Editor

A new study, employing difference-in-differences analysis, has observed that voluntary license induction has significantly increased patients’ access to high-cost, essential, hepatitis C virus (HCV) drugs in low- and middle-income countries (LMICs).

The poor affordability of high-cost, essential drugs is a critical barrier to patients’ access in low- and middle- income countries (LMICs). Industry-led initiatives, such as voluntary licensing, aim to increase in-need patients’ access to such drugs, including hepatitis C virus (HCV) therapies. A new study has employed difference-in-difference analysis to assess whether the selective introduction, and temporal variation, of voluntary licenses for HCV drugs increased treatment uptake in LMICs.

HCV liver infection is responsible for approximately 700,000 deaths worldwide each year. The World Health Assembly (Geneva, Switzerland) has adopted the Global Health Sector Strategy on Viral Hepatitis 2016—2021; this aims to eradicate viral hepatitis as a public health threat by the year 2030. Critical to achieving this goal is ensuring worldwide, affordable access to HCV drugs, such as direct-acting antivirals (DAAs).

In instances of large drug demand, competition is the most effective and sustainable means of lowering drug costs. Voluntary licenses are agreements, subject to licensing terms, between original and generic drug manufacturers that allow for the generic marketing of drugs in certain countries. Licenses that are access-oriented and granted to multiple manufacturers are considered important for the affordable access of patients in LMICs to patented therapies.

Since 2014, the application of voluntary licenses to extra-HIV and AIDS drugs — such as HCV drugs — has increased.

In this study, researchers from Imperial College London (UK) assessed annually available data concerning HCV therapy uptake — representative of patients’ access to HCV drugs — from the Polaris Observatory (CO, USA) between 2004–2016. Difference-in-difference analysis was employed to compare pre- and post-voluntary license introduction trends and determine how license introduction impacted HCV therapy uptake in LMICs covered by the license, compared with LMICs not included in the licensing agreements.

Researchers observed that, subsequent to a time lag following implementation, voluntary license introduction in 19 LMICs was associated with a treatment uptake increase of 69.3 per 1000 individuals diagnosed with HCV, compared with 14 LMICs in which licensing agreements were not in place. This was according to the simplest model, adjusting solely for country and year-fixed effects.

The benefits of voluntary license introduction increased over time; 2 years post-licensing, treatment uptake was greatest.

Voluntary licenses likely increased the availability of generic drug products that introduced competition and lowered drug costs.

Expansion of voluntary license application for other high-profile drugs has been discussed. Bryony Simmons, study co-author from the Department of Medicine at Imperial College, commented: “Voluntary licenses appear to be a useful tool to lower costs and significantly reduce the time-scale for accessing patented medicines in poorer countries. Our results should be used to advocate for an expanded scope of license agreements.”


Simmons B, Cooke GS, Miraldo M. Effect of voluntary licences for hepatitis C medicines on access to treatment: a difference-in-differences analysis. Lancet Glob. Health. Doi: 10.1016/S2214-109X(19)30266-9. (2019) (Epub ahead of print);