Negotiating public-health intellectual property licensing agreements to increase access to health technologies: an insider's story

Abstract

Public health voluntary licensing of intellectual property has successfully been applied to increase access to medicines in certain disease areas, producing health benefits and economic savings, particularly in low-income and middle-income countries. There is however limited understanding of the intricacies of the approach, the modalities by which it works in practice, its levers and the trade-offs made. Such knowledge may be critical in deciding what role licensing should have in pandemic preparedness and equitable access to health technologies more broadly. This paper examines the case for licensing, the considerations for balancing public health needs, the challenges of negotiations, and the processes for validating proposed agreements. No access mechanism is perfect, but evidence suggests that public-health licensing has an important role to play, although it remains underused. Understanding some of the realities, strengths, limitations and complexities of applying the model may help calibrate expectations and develop incentives to expand its applications.

Keywords: health economics; health policies and all other topics; health policy; infections, diseases, disorders, injuries; public health.

Figure 1

The context and key features of voluntary licensing for public health. (A) Complementary voluntary licensing areas of work and the medicine development to access life cycle. While this paper focuses on in-licensing as the central and most scrutinised element of MPP’s voluntary licensing work, there are other critical areas of contribution for MPP both upstream (ie, identification of suitable candidate medicines through prioritisation and development of an enabling environment for in-licensing) and downstream (ie, out-licensing, licence management, technology transfer and support for access). As mentioned in MPP’s strategy for 2023–2025, MPP in-licensing activities have generally started around late product development, regulatory approval and early market entry. In some cases, in-licensing efforts have begun after an approved product was prioritised by a global health mechanism (such as the WHO Model List of Essential Medicines). Moving forward, MPP in-licensing efforts will take place more upstream to embed access considerations earlier in the innovation process, support product development, and shorten the time from product approval to affordable access in LMICs. MPP will also increase its work further downstream to support affordable access to licensed products and, in exceptional circumstances, continue to work on licensed products beyond patent expiry if that can help pave the way for future priority products. (B) Key features of voluntary licensing agreements aimed at maximising the public health impact of priority products. Insights on how these features have been implemented across different licences are available in online supplemental appendix. EAG, Expert Advisory Group; MPP, Medicines Patent Pool.