Generic medicine manufacturers research programme 2023: analytical framework

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Generic medicines account for the vast majority of the global supply of pharmaceuticals. Yet, even though generic medicines are generally priced more affordably than patented originator medicines, there are still huge global access gaps. Many people living in low- and middle-income countries (LMICs) simply do not have access to an affordable, reliable supply of the medicines they need.

As at-scale suppliers of essential medicines, the impact and global footprint of generic medicine manufacturers is immense. Among the medicines included on the World Health Organization (WHO)’s Model List of Essential Medicines (EML) –meaning that they ought to be available in every country’s health system – only 10% are on-patent, i.e. covered by a patent that excludes other companies from making or marketing the drug unless permissions are explicitly granted. This indicates the central role of off-patent medicines, i.e. generics or biosimilars, as essential treatments across the world. Consequently, if generic and biosimilar medicine manufacturers step up their efforts to expand access to their products to more people living in LMICs, they can move the dial on access to medicine. Greater action by these companies, alongside other global health stakeholders such as national governments, is vital to achieving universal health coverage (UHC) and the Sustainable Development Goals (SDGs), specifically Goal 3.

In recognition of the critical role generic and biosimilar medicine manufacturers can play in tackling global health inequities by ensuring and expanding access to much-needed medicines in LMICs, the Access to Medicine Foundation has launched the Generic Medicine Manufacturers Research Programme. The programme’s first analytical framework, outlined in this report, will form the basis of a per-company assessment of the actions and strategies of some of the world’s leading generic medicine manufacturers.