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

Abstract

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.

Advancing use of long‐acting and extended delivery HIV prevention and treatment regimens

“…Recognizing these constraints, four manuscripts focus on cost considerations as a critical barrier to access and discuss strategies that can be leveraged to overcome these challenges. Gaayeb and colleagues [ 12 ] discuss voluntary licensing ahead of patent expiry as a strategy to accelerate access to affordable HIV treatment and prevention products. They propose 10 enablers of voluntary licensing of Intellectual Property (IP) rights, with special consideration given to early identification of products designed for low‐ and middle‐income country contexts, technology transfer and innovative partnerships for product development, strategies to optimize regulatory review and de‐risking mechanisms.…”