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

Summary: 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 considerat...

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Main Authors: Sébastien Morin, PhD, Hannah Barron Moak, MPH, Oliver Bubb-Humfryes, MA, Christian von Drehle, MSc, Jeffrey V Lazarus, ProfPhD, Esteban Burrone, MPH
Format: Article
Language:English
Published: Elsevier 2022-02-01
Series:The Lancet Public Health
Online Access:http://www.sciencedirect.com/science/article/pii/S2468266721002024
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author Sébastien Morin, PhD
Hannah Barron Moak, MPH
Oliver Bubb-Humfryes, MA
Christian von Drehle, MSc
Jeffrey V Lazarus, ProfPhD
Esteban Burrone, MPH
author_facet Sébastien Morin, PhD
Hannah Barron Moak, MPH
Oliver Bubb-Humfryes, MA
Christian von Drehle, MSc
Jeffrey V Lazarus, ProfPhD
Esteban Burrone, MPH
author_sort Sébastien Morin, PhD
collection DOAJ
description Summary: 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.
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spelling doaj.art-f708fc41f9834967a7385744724ea7b42022-12-21T17:16:52ZengElsevierThe Lancet Public Health2468-26672022-02-0172e169e176The economic and public health impact of intellectual property licensing of medicines for low-income and middle-income countries: a modelling studySébastien Morin, PhD0Hannah Barron Moak, MPH1Oliver Bubb-Humfryes, MA2Christian von Drehle, MSc3Jeffrey V Lazarus, ProfPhD4Esteban Burrone, MPH5Medicines Patent Pool, Geneva, Switzerland; Correspondence to: Dr Sébastien Morin, Medicines Patent Pool, Geneva CH-1202, SwitzerlandMedicines Patent Pool, Geneva, SwitzerlandCambridge Economic Policy Associates, London, UKCambridge Economic Policy Associates, London, UKBarcelona Institute for Global Health, Hospital Clínic, University of Barcelona, Barcelona, Spain; Prof Jeffrey V Lazarus, Barcelona Institute for Global Health, Hospital Clínic, University of Barcelona, Barcelona ES-08036, SpainMedicines Patent Pool, Geneva, SwitzerlandSummary: 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.http://www.sciencedirect.com/science/article/pii/S2468266721002024
spellingShingle Sébastien Morin, PhD
Hannah Barron Moak, MPH
Oliver Bubb-Humfryes, MA
Christian von Drehle, MSc
Jeffrey V Lazarus, ProfPhD
Esteban Burrone, MPH
The economic and public health impact of intellectual property licensing of medicines for low-income and middle-income countries: a modelling study
The Lancet Public Health
title The economic and public health impact of intellectual property licensing of medicines for low-income and middle-income countries: a modelling study
title_full The economic and public health impact of intellectual property licensing of medicines for low-income and middle-income countries: a modelling study
title_fullStr The economic and public health impact of intellectual property licensing of medicines for low-income and middle-income countries: a modelling study
title_full_unstemmed The economic and public health impact of intellectual property licensing of medicines for low-income and middle-income countries: a modelling study
title_short The economic and public health impact of intellectual property licensing of medicines for low-income and middle-income countries: a modelling study
title_sort economic and public health impact of intellectual property licensing of medicines for low income and middle income countries a modelling study
url http://www.sciencedirect.com/science/article/pii/S2468266721002024
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