The economic and public health impact of intellectual property licensing of medicines for low-income and middle-income countries: a modelling study

Abstract

Background: Non-exclusive voluntary licensing that is access-oriented has been suggested as an option to increase access to medicines to address the COVID-19 pandemic. To date, there has been little research on the effect of licensing, mainly focused on economic and supply chain considerations, and not on the benefits in terms of health outcomes. We aimed to study the economic and health effect of voluntary licensing for medicines for HIV and hepatitis C virus (HCV) in low-income and middle-income countries (LMICs).

Methods: A robust modelling framework was created to examine the difference between scenarios, with (factual) and without (counterfactual) a Medicines Patent Pool (MPP) licence for two medicines, dolutegravir and daclatasvir. Data were obtained from MPP licensees, as well as a large number of external sources. The primary outcomes were the cost savings and health impact between scenarios with and without MPP licences across all LMICs. Through its licences, MPP had access to the volumes and prices of licensed generic products sold in all covered countries on a quarterly basis. These data informed the volumes, prices, and uptake for the past factual scenarios and were the basis for modelling the future factual scenarios. These scenarios were then compared with a set of counterfactual scenarios in the absence of the studied licences.

Findings: Cumulatively, between 2017 and 2032, the model's central assumptions predicted an additional uptake of 15·494 (range 14·406-15·494) million patient-years of dolutegravir-based HIV treatments, 151 839 (34 575-312 973) deaths averted, and US$3·074 (1·837-5·617) billion saved through the MPP licence compared with the counterfactual scenario. For daclatasvir-based HCV treatments, the cumulative effect from 2015 to 2026 was predicted to be an additional uptake of 428 244 (127 584-636 270) patients treated with daclatasvir, 4070 (225-6323) deaths averted, and $107·593 (30·377-121·284) million saved with the licence compared with the counterfactual scenario.

Interpretation: The chain of effects linking upstream licensing to downstream outcomes can be modelled. Accordingly, credible quantitative estimates of economic and health effects arising from access-oriented voluntary licensing were obtained based on assumptions that early generic competition leads to price reductions that influence procurement decisions and enable the faster and broader uptake of recommended medicines, with beneficial economic and health effects.

Funding: Unitaid.

Figure 1

Approach used to estimate effect of access-oriented licensing (A) Chain of effects linking licensing to outcomes. Parallel factual and counterfactual scenarios are modelled following this chain of effect. (B) Modelling past and future outcomes of access-oriented licensing in a factual scenario in comparison to a counterfactual scenario allows for estimating the effect on uptake, cost savings, and health benefits.

Figure 2

Uptake and effect of the MPP licence for dolutegravir (A) Dolutegravir uptake in patient-years treated in low-income and middle-income countries with or without the MPP license, in the central scenario by year. Low, central, and high health and economic impact scenarios for cumulative deaths averted (B) and cost savings (C) from the implementation of the license were obtained by considering a set of ranges for key health and generic competition variables (appendix p 12). MPP=Medicines Patent Pool.

Figure 3

Uptake and effect of the MPP licence for daclatasvir (A) Daclatasvir uptake in patients treated in low-income and middle-income countries with and without the MPP license, in the central scenario by year. Low, central, and high health and economic impact scenarios for cumulative deaths averted (B) and cost savings (C) from the implementation of the license were obtained by considering a set of ranges for key health and generic competition variables (appendix p 13). MPP=Medicines Patent Pool.