New peer-reviewed analysis released on “Negotiating public-health intellectual property licensing agreements to increase access to health technologies: An insiders’ story.”
5 September 2023
BMJ Global Health, an open access, peer-reviewed journal publishing research on all aspects of global health, just published an inside perspective by MPP co-authors on Negotiating public-health intellectual property licensing agreements to increase access to health technologies.
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- 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. Understanding some of the complexities of the voluntary licensing model may be useful in calibrating expectations and developing incentives and supportive policies to expand its applications, in addition to MPP learning from past experiences, in terms of understanding which provisions can be most impactful and how to best cater for public health needs in the context of complex negotiations.
This paper examines the case for voluntary licensing, the considerations for balancing public health needs, the challenges of negotiations, and the processes for validating proposed agreements. Every access mechanism has its limitations, and evidence suggests that public-health licensing has an important role to play, although it remains underutilised, to the detriment of people in LMICs needing access to key health technologies as urgently as anyone in high-income countries.
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 scrutinized element of MPP’s voluntary licensing work, there are other critical areas of contribution for MPP both upstream (i.e. identification of suitable candidate medicines through prioritization and development of an enabling environment for in-licensing) and downstream (i.e. 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 begin after an approved product is 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.
Charles Gore, Executive Director of the Medicines Patent Pool and first author of the new publication, wrote: “More than 20 years into the 21st century, it seems unconscionable that where one lives can still determine whether one has access to healthcare and therefore lives or is denied a healthy life. COVID-19 has placed the public health spotlight on equity and access, and, with other efforts to facilitate uptake of essential medicines, public-health voluntary licensing has a role in addressing ongoing access to medicine inequity.”
Key features of voluntary licensing agreements aimed at maximizing the public health impact of priority products. Insights on how these features have been implemented across different licences are available in the article’s online supplemental appendix (available at: https://dx.doi.org/10.1136/bmjgh-2023-012964). EAG: Expert Advisory Group.
- Public-health voluntary licensing of intellectual property rights has been highly effective in supporting the scale up of WHO-recommended HIV and HCV treatments in low- and middle-income countries, saving both money and lives.
- Despite the success and establishment of public health voluntary licensing through the Medicines Patent Pool as the gold standard for large-scale access to medicines, there are recurring demands for these licences to be even better, for example encompassing greater geographic territories. Observers have also raised concerns that voluntary licences may entrench IP rights, be used as a mechanism to manage competition, collect royalties, and segment markets (instead of supporting access) in the absence of patent rights.
- MPP licences are generally more access friendly and include less restrictive terms than licences negotiated bilaterally between patent holders and generic manufacturers. They are also publicly available, which has helped establish global norms for public health licensing. Evidence suggests that MPP public health licences lead to stronger sustainable generic manufacturer competition in more countries faster, driving medicine prices down to lower than tiered prices, creating both economic and health impact.
- This BMJ Global Health Analysis discusses the case for public-health voluntary licensing; the considerations for balancing key public health needs; the challenges, negotiation complexities, and compromises at play; and the processes for assessing the value of and externally validating proposed licensing agreements in the context of a strategic, agile, and voluntary mechanism.
- Contextualising MPP’s work from a perspective of internal understanding of the intricacies of the mechanism, in light of its strengths and limitations, managing expectations, identifying where the model may provide the most added value, and building the necessary support for its sustainable application may help calibrate expectations, develop incentives to expand applications, and overall reinforce the approach.
- Public-health licensing has an important role to play in improving access to medicines, although it remains underutilised; this is particularly relevant to ongoing discussions that are taking place at the WHO, Intergovernmental Negotiating Body, and G20, to name a few.
An online supplemental appendix summarises, in lay language, the key MPP licensing agreement features discussed in the paper. This appendix is also available on the BMJ Global Health website at: http://dx.doi.org/10.1136/bmjgh-2023-012964
Gore C, Morin S, Røttingen J-A, Kieny MP (2023) Negotiating public-health intellectual property licensing agreements to increase access to health technologies: an insider’s story. BMJ Global Health, 0: e012964. doi:10.1136/bmjgh-2023-012964
Access the full article HERE.
This statement is also available in French.
About the Medicines Patent Pool
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, MPP has signed agreements with 20 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, three oral antiviral treatments for COVID-19 and 15 COVID-19 technologies. MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC). MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation and SDC.