Efforts to ramp up wider local availability of medicines through voluntary licensing and technology transfers are limited

• Historically, some companies have used voluntary licensing to increase access to their products in low- and middle-income countries (LMICs), particularly treatments for HIV and hepatitis C and, most recently, for COVID-19.

• However, only two new non-exclusive voluntary licensing (NEVL) agreements were issued during the period of analysis for the 2024 Index, with a third following after. This is despite public health organisations prioritising at least ten key patented treatments in companies' portfolios as candidates for licensing.

• Despite some promising examples of companies pursuing technology transfers, aside from South Africa, sub-Saharan Africa remains widely overlooked; overall efforts from companies remain largely concentrated in Brazil, China and India.

Voluntary licensing agreements, particularly when supported by technology transfers to local manufacturers, is a powerful way in which pharmaceutical companies can improve long-term and sustainable access to their essential healthcare products.
By adopting these mechanisms, companies can help ensure patients – no matter where they live – have timely, affordable and sustained access to medicines, vaccines and diagnostics, especially in regions where companies have limited or no operations.

Momentum of non-exclusive voluntary licences is slowing

Non-exclusive voluntary licences (NEVLs), such as those issued for products targeting HIV and hepatitis C, have enabled significant improvements in healthcare for patients living in LMICs. Although some of these NEVLs were issued 15 or more years ago, the 2022 Access to Medicine Index identified six newly issued NEVLs, signalling an encouraging trend and a willingness from companies to engage in NEVLs. However, the 2024 Index has identified a noticeable slowdown in licensing activities, which have now reverted to a level last seen prior to the COVID-19 pandemic – indicating a concerning loss in the momentum gained over the last few years. This is despite companies having several prioritised patented products, including cancer treatments, in their portfolios for which licensing could be a viable option to expand access.

Not only has the overall number of companies with voluntary licensing agreements decreased from ten in the 2022 Index to nine, but there has also been a decline in the number of new NEVLs issued. Even when voluntary licences are granted, some countries in need of access are excluded from these agreements, placing greater responsibility on companies to ensure affordable access directly.

During the period of analysis for the 2024 Index^*, only two new licences were issued, both through the Medicines Patent Pool (MPP). One additional licence was announced outside the period of analysis:

• July 2022: cabotegravir long-acting (CAB-LA), for HIV pre-exposure prophylaxis (PrEP), issued by ViiV Healthcare (a company majority owned by GSK), marked the first NEVL for a long-acting injectable for HIV prevention. The licence covers 90 countries, 88 of which are LMICs covered by the Index analysis, including all low-income countries, all least developed countries, and all sub-Saharan African countries. The licence was agreed seven months after U.S. Food and Drug Administration (FDA) approval.

• October 2022: nilotinib, indicated for chronic myeloid leukaemia, issued by Novartis, was the first licence of its kind for a non-communicable disease (NCD). The licence covered 43 of the LMICs covered by the 2024 Index analysis.

• October 2024 (outside the period of analysis), Gilead announced that it had entered NEVLs with six generic manufacturers to produce and distribute lenacapavir, indicated for HIV prevention (pending regulatory approval) and treatment, in 120 LMICs, 96 of which are included in the 2024 Index analysis.

Although the CAB-LA and nilotinib licences were issued at the beginning of the period of analysis for the 2024 Index, and Novartis’ licence for nilotinib was granted less than a year before the expiration of the main patent, these licences were promising milestones. They served as examples of how other companies could follow suit in paving the way for broader access in LMICs – especially for innovative products in therapeutic areas such as NCDs.

Since 2022, the CAB-LA licence has been issued to three sublicensees and the nilotinib licence has been issued to four sublicensees. CAB-LA is a more complex product, so the development process and obtaining approval for generics will take time. It is estimated that the first regulatory filings from generic manufacturers could be in late 2026, with potential registration estimated for 2027.¹

While these latest announcements are welcome, these are the first new actions from companies in voluntary licensing in almost two years. For impactful change to take place, more action is needed and there is ample opportunity for more companies to do so. For example, of the 13 products specifically included in the MPP’s priority list for in-licensing, ten are patented by the companies analysed in the Index. By licensing even some of these key products, they could make a significant impact in broadening access in LMICs.

More companies engage in technology transfers in a few select countries, but efforts in sub-Saharan Africa lag

The 2024 Index identified that 17 companies have transferred financial resources, infrastructure and know-how to expand manufacturing capacity in the LMICs covered by the 2024 Index. Notably, of these 17, Eli Lilly and Merck & Co, Inc. (MSD) have newly engaged in technology transfer initiatives in the LMICs analysed. Three companies – AbbVie, Astellas and Bristol Myers Squibb – do not engage in technology transfers.

However, as shown in the figure above, the Index does reveal a stark disparity in technology transfer efforts across different regions, with a few countries, particularly India, Brazil, and China being the major recipients of such initiatives. Of the 47 initiatives identified in the 2024 Index, India has received 11, while Brazil accounts for nine and China for seven. In contrast, local manufacturing efforts on the entire African continent stand at just 17 initiatives across 12 companies. Of these, most are concentrated in only two countries: Algeria (5/17) and South Africa (5/17). Aside from South Africa, initiatives in sub-Saharan Africa are sparse. Only six companies – Boehringer Ingelheim, Gilead, Merck KGaA (Merck), Novo Nordisk, Pfizer, and Sanofi – report having established technology transfer initiatives in this region. The companies’ initiatives here include products for HIV, hepatitis, COVID-19, diabetes mellitus and neglected tropical diseases, including schistosomiasis and rabies.

Concerted efforts are underway to help ensure a continuous supply of medicines across Africa. The African Union Development Agency (AUDA-NEPAD) initiated the Pharmaceutical Manufacturing Plan for Africa in 2005 (further developed into a Business Plan by the African Union in 2012) and has also led the development of the African Medicines Agency. More recently, in 2021, under the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union (AU) launched the Partnership for African Vaccine Manufacturing. Through this Partnership, the AU aims to enable the African vaccine manufacturing industry to produce 60% of vaccine doses required on the continent by 2040, under the New Public Health Order initiative. Given this traction to foster local availability in Africa, companies can pursue more targeted approaches to help strengthen supply chains and develop local manufacturing across more countries on the continent.

Here, the 2024 Index has identified some promising examples of such targeted initiatives in Africa. For instance, Merck KGaA is partnering with Universal Corporation Ltd. in Kenya to manufacture its schistosomiasis treatment, apraziquantel, with the aim to supply it to endemic countries in Africa. Similarly, in 2024, Sanofi signed a technology transfer agreement with Biovac in South Africa to manufacture and supply its polio vaccine in Africa through UNICEF. While polio is not one of the diseases included in the Index analysis, the initiative is notable in this context.

What next?

Voluntary licensing and technology transfers are clear ways in which companies can improve the local availability of their medicines, vaccines and diagnostics in countries where they lack a local presence. Improving local production of healthcare products can also contribute to building robust, self-sustaining healthcare systems in LMICs, thereby decreasing the need for costly investment by countries and international agencies to procure products.

However, the current stagnation in voluntary licensing and the geographic limits of technology transfers mean that many opportunities to maximise local availability are being missed – leaving patients in the poorest regions of the world without access to newer and often more expensive products that are critically needed.

Companies now need to take decisive action to not only remain engaged in current efforts, but to evolve them to encompass a broader range of products, include more countries and address a wider variety of diseases.

With ten products in companies’ portfolios listed by the MPP as priorities for voluntary licensing, and many more emerging from their pipelines, companies already have clear opportunities to enter new licensing agreements for critical products. However, for these agreements to be truly impactful, they must include access-oriented terms and, critically, technology transfer provisions as well. While such agreements may be feasible for only a limited number of local manufacturers – who must demonstrate both capacity and quality – this potential cannot be overlooked. By prioritising partnerships with local manufacturers capable of ensuring quality-assured production and collaborating with them to facilitate technology transfers, companies could make a significant impact.

_{*Although both licences were announced outside the period of analysis for the 2022 Index, each was highlighted in that report due to their significance within the realm of voluntary licensing. These licences are included in the 2024 Index assessment.}

_{1. Medicines Patent Pool. Generic CAB-LA for PrEP development and access. Published May 24, 2024. Accessed September 5, 2024. https:// www.prepwatch.org/wp-content/ uploads/2024/06/MPP__LA_PrEP_ Coalition_CS_Caucus__For_sharing. pdf}