There is a slow-down in licensing activity, and the global pharmaceutical industry needs to recommit to voluntary licensing (VL) and technology transfers to bridge health inequities, says the 2024 Access to Medicine Index report.

In the last two years, non-exclusive voluntary licensing (NE-VL) agreements have dipped to just two (in the review period), compared to six in Index 2022, says the report brought out by Access to Medicine Foundation (ATMF), a Netherlands-based non-profit organisation.

The momentum in licensing activity has “stalled”, the report said, “signalling a missed opportunity to improve local availability of innovative medicines.” And this, despite public health organisations prioritising at least ten key patented treatments across companies, in therapeutic areas including cancer - as viable for licensing, it added.

The slowdown could impact Indian drugmakers, who participate in these global VL and tech transfer pacts.

The scale and pace of progress in expanding access-related initiatives should have been higher, says Jayasree K . Iyer,  ATMF Chief Executive Officer, attributing the slowdown to companies, possibly, not seeing “the true value of scaling up access via VLs”.

Many did not prioritize low-and-middle income countries (LMICs) for access to new drugs, as they believed the infrastructure was inadequate to deliver the treatments effectively, Iyer told businessline. Besides, all licenses relied heavily on donor funded mechanisms to procure products eventually, she said, adding that companies and Governments needed to work towards addressing these issues, as funding also comes under pressure.  

Cross-country agreements

The two NE-VL agreements involved ViiV Healthcare’s Cabotegravir, for HIV pre-exposure prophylaxis, and Novartis’ nilotinib, to treat chronic myeloid leukaemia. (ViiV is owned by GSK).

A third NE-VL involving Gilead’s lenacapavir (HIV), was also formalized, however it was outside the scope of this study, conducted between June 1,2022 and May 31 2024.  Indian drugmakers including Aurobindo, Cipla, Dr Reddy’s Laboratories, Hetero and Emcure have been part of these different pacts.

“Voluntary licensing agreements, particularly when supported by technology transfers to local manufacturers, are a powerful way in which pharmaceutical companies can improve long-term and sustainable access to their essential healthcare products, especially in regions where they have limited or no operations,” the report explained.  

Further, the report said, companies pursuing technology transfers were concentrating their initiatives in upper middle-income markets, with efforts lagging in sub-Saharan Africa (except for South Africa). Only six companies – Boehringer Ingelheim, Gilead, Merck, Novo Nordisk, Pfizer and Sanofi – report having established technology transfer initiatives in this region, it added.

Clinical trials

The ATM Index also found that only 43 percent of clinical trials take place in the 113 LMICs, covered by its analysis, despite them being home to 80 percent of the global population. Since companies include “access planning” in countries where they conduct trials, “this leaves much of the world behind,” the report noted.

“Early designing and thinking on access planning helps tremendously,” says Iyer, urging companies to develop better plans for broader access, and to include more regions in their clinical studies, and eventually ensure that registration, supply and affordability is planned for broader access, especially in countries with the highest burden of disease.

On countries becoming inward looking in their policies and political campaigns, she said, if funding is limited, the progress will also be affected negatively. “It’s important to realize that the programmes for infectious diseases and vaccines are cornerstones of health systems and also deliver on treatments and care for non communicable diseases like Cardiovascular diseases, diabetes, cancer care.

This is not the time for industry to slow down and they need leaders in government and communities and investors to work with to drive success in access,” she said.

Top spot

The Index report ranked Novartis at the top spot, followed by GSK -  across all three technical areas analysed : Governance of Access, Research and Development and Product Delivery, a note on the report said.

The Index report analysed 20 large research-based pharmaceutical companies with products for high-burden diseases in LMICs. It is endorsed by over 145 investors, collectively managing assets worth over USD 22 trillion, it added. The Foundation is funded by the UK Foreign, Commonwealth and Development Office, the Dutch Ministry of Foreign Affairs, the Bill & Melinda Gates Foundation, the Leona M. and Harry B. Helmsley Charitable Trust, the Wellcome Trust, AXA Investment Managers and Stewart Investors.

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