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

Morin, Sébastien; Moak, Hannah Barron; Bubb-Humfryes, Oliver; Drehle, Christian von; Lazarus, Jeffrey V.; Burrone, Esteban

doi:10.1016/s2468-2667(21)00202-4

Cited by 12 publications

(19 citation statements)

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“…We identified eight papers for review; all were published between 2017 and 2021 and used data ranging from 2004 to 2020 (six years prior to the establishment of the MPP in 2010 and a decade after). All studies performed quantitative analysis, including four studies that applied a quasi-experimental approach using difference-in-difference [34,36,54,55] two ex-ante impact assessment models [48,56], one study that focused on database construction and descriptive analysis [6], and one study that estimated the effectiveness of current voluntary measures in achieving the SDG goals of HCV elimination by 2030 [57]. Two studies investigated both licenses administered via the MPP alongside licenses agreed bilaterally between major pharmaceutical companies and manufacturers in developing countries [6,55].…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

“…About half of the studies looked at HIV/AIDS antiretrovirals included in the pool [6,34,36,48] due to data availability. Others considered medicines for HCV [55], specific case studies of medicines for HIV and HCV [56], or a broad combination of EMs for HIV, HCV, and TB [54]. Most studies reported on impact on the total number of licenses signed through the pool, drug quantities purchased by LMICs and donors, and shares of generics [6,34,36,54], three studies estimated past and projected cost savings [36,48,56], and only two studies looked on treatment uptake [55] and potential public health gains [56].…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

“…Others considered medicines for HCV [55], specific case studies of medicines for HIV and HCV [56], or a broad combination of EMs for HIV, HCV, and TB [54]. Most studies reported on impact on the total number of licenses signed through the pool, drug quantities purchased by LMICs and donors, and shares of generics [6,34,36,54], three studies estimated past and projected cost savings [36,48,56], and only two studies looked on treatment uptake [55] and potential public health gains [56]. One study also investigated the effects of VL on cumulative innovation [36], and another included exploratory analysis of the effects on information asymmetries [34].…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

“…Focusing on HIV medicines, the earliest assessment by Juneja and colleagues [48] from 2017 estimated that actual cumulative savings generated by MPP licenses between 2010 until 2028 would reach US$2.3 billion, while the pool's operational costs are expected to reach only US$50 million over the same period. Morin and colleagues [56] have recently updated the MPP assessment model to account for additional assumptions on the effect of drug prices on procurement decisions in the absence of pooled licensing when drug prices are usually higher. Their model predicted that between 2017 and 2032, over US$3 billion saved through the MPP license for dolutegravir-based HIV treatments compared with the counterfactual scenario, and US$107 million saved for daclatasvir-based HCV treatments between 2015 and 2026.…”

Section: Actual and Projected Cost Savingsmentioning

confidence: 99%

“…Their model predicted that between 2017 and 2032, over US$3 billion saved through the MPP license for dolutegravir-based HIV treatments compared with the counterfactual scenario, and US$107 million saved for daclatasvir-based HCV treatments between 2015 and 2026. For comparison, the authors note that cost savings for dolutegravir are equivalent to the total HIV investments made by The Global Fund in Nigeria, South Africa, and Zimbabwe since 2002 [56].…”

Section: Actual and Projected Cost Savingsmentioning

confidence: 99%

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TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

Mermelstein

Stevens

2021

Pharmaceutics

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Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, the current medical R&D system requires significant trade-offs between innovation and high monopoly prices for patented drugs that restrict patient access to medicines. Since its implementation, few amendments have been made to the original TRIPS agreement to allow low- and middle-income countries (LMICs) to facilitate access by generic manufacturers through flexible provisions, such as compulsory licensing and parallel import. Although a useful policy tool in theory, the routine use of TRIPS flexibilities in LMICs in the procurement of new essential medicines (EMs) is regarded as a ‘last resort’ due to strong political response in high-income countries (HICs) and new trade agreements’ restrictions. In this context, access-oriented biomedical Public-Private Partnerships (PPPs) have emerged. More recently, leading multilateral health organizations have recommended different types of intellectual property (IP) interventions, voluntary biomedical patent pools, as strategies to reduce prices and increase the diffusion of novel EMs in LMICs. Nevertheless, the recent Ebola and COVID-19 outbreaks highlight growing concerns regarding the use of TRIPS flexibilities and the limited success of voluntary mechanisms in promoting access to medicines in the Global South amidst health crises. This review aims at describing the state-of-the-art empirical research on IP-related options and voluntary mechanisms applied by emerging PPPs to guarantee timely and affordable access to EM in LMICs and reflect on both models as access paradigms. Some suggestions are put forward for future research paths on the basis of these analyses and in response to contemporary debates on waiving key IP rights on COVID-19 therapies, diagnostics, and vaccines.

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Section: Study Selection and Characteristicsmentioning

confidence: 99%

Section: Study Selection and Characteristicsmentioning

confidence: 99%

Section: Study Selection and Characteristicsmentioning

confidence: 99%

Section: Actual and Projected Cost Savingsmentioning

confidence: 99%

Section: Actual and Projected Cost Savingsmentioning

confidence: 99%

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TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

Mermelstein

Stevens

2021

Pharmaceutics

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Voluntary licensing of long‐acting HIV prevention and treatment regimens: using a proven collaboration‐ and competition‐based mechanism to rapidly expand at‐scale, sustainable, quality‐assured and affordable supplies in LMICs

Gaayeb,

Das,

James

et al. 2023

J Int AIDS Soc.

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Introduction:Emerging long-acting (LA) prevention and treatment medicines, technologies and regimens could be gamechanging for the HIV response, helping reach the ambitious goal of halting the epidemic by 2030. To attain this goal, the rapid expansion of at-scale, sustainable, quality-assured, and affordable supplies of LA HIV prevention and treatment products through accelerated and stronger competition, involving both originator and generic companies, will be essential. To do this, global health stakeholders should take advantage of voluntary licensing of intellectual property (IP) rights, such as through the United Nations-backed, not-for-profit Medicines Patent Pool, as a proven mechanism to support broad access to existing HIV medicines across low-and middle-income countries (LMICs). Discussion: While voluntary licensing may unlock the possibility for generic competition to take place ahead of patent expiry, there are additional elements-of amplified importance for more complex LA HIV medicines-that need to be taken into consideration. This paper discusses 10 enablers of voluntary licensing of IP rights as a model to rapidly expand at-scale, sustainable, quality-assured, and affordable supplies of LA HIV prevention and treatment regimens in LMICs: 1. Identifying promising LA technology platforms and drug formulations at an early developmental stage and engaging with patent holders 2. Consolidating a multidisciplinary network and strengthening early-stage coordination and collaboration to foster innovation 3. Embedding public health considerations in product design and delivery 4. Building innovative partnerships for product development and commercialization 5. Raising awareness of and creating demand for emerging LA products 6. Estimating the market size, ensuring sufficient competition and protecting sustainability 7. Using technology transfer and hands-on technical support to reduce product development timelines and costs 8. Exploring de-risking mechanisms and financial incentives to support generic manufacturers 9. Optimizing strategies for generic product development and regulatory filings 10. Aligning and coordinating efforts of stakeholders across the value chain.Conclusions: Rapid access to emerging LA prevention and treatment regimens and technologies can be facilitated by voluntary licensing-catalyzed and supplemented by enabling collaborative and non-duplicative efforts of various other stakeholders. This can effectively lead to improved-accelerated and cheaper-access to quality-assured medicines for populations in LMICs.

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Scientific advances and the end of tuberculosis: a report from the Lancet Commission on Tuberculosis

Reid,

Agbassi,

Arinaminpathy

et al. 2023

The Lancet

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

Cited by 12 publications

References 16 publications

TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

Voluntary licensing of long‐acting HIV prevention and treatment regimens: using a proven collaboration‐ and competition‐based mechanism to rapidly expand at‐scale, sustainable, quality‐assured and affordable supplies in LMICs

Scientific advances and the end of tuberculosis: a report from the Lancet Commission on Tuberculosis

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