News
First-of-its-kind framework to assess how generics manufacturers expand access to medicine
15 February 2023
The 2023 Analytical Framework for the Generic & Biosimilar Medicines Programme
The Access to Medicine Foundation has published a new analytical framework for assessing generic and biosimilar medicine manufacturers, which can be used to stimulate and guide these companies to expand access to their essential healthcare products in low- and middle-income countries (LMICs).
Date
15 February 2023
Published as part of the Foundation’s new Generic & Biosimilar Medicines Programme, this is the first time a framework has been developed specifically to evaluate this key group of pharmaceutical companies on their performance in terms of key access-to-medicine priorities, and to outline what ‘good practice’ looks like.Â
What’s in the framework?
The challenge
Generic medicines account for the vast majority of the global supply of pharmaceutical products. While manufacturers produce them at scale and they are generally lower-cost than the originator products, many quality-assured generic medicines are not available or affordable to large numbers of people living in LMICs.Â
Building the framework
A rigorous process was undertaken to ensure the assessment criteria were robust and relevant for companies. Proposals were reviewed by an Expert Committee, which provided strategic guidance. Insights were also drawn from a first-of-its kind workshop, which brought together experts working with and within the generic medicine industry, and focused on opportunities to expand access to medicine beyond companies' conventional roles in manufacturing and suppling affordable generic medicines. Â
Analytical framework
Companies will be assessed in terms of their individual capability to expand access to medicine within 108 LMICs and relating to 82 diseases and 102 products. Their actions will be assessed across three Research Areas: Expanding access; Supply & quality; and Research & Development.Â
Next steps: using the frameworkÂ
The analytical framework will be used to carry out an analysis of the actions and strategies of some of the world’s leading generic and biosimilar medicine manufacturers, starting with an initial group of five companies: Cipla Ltd, Hikma Pharmaceuticals plc, Sun Pharmaceutical Industries Ltd, Teva Pharmaceutical Industries Ltd, and Viatris Inc.  Â
The framework can also be used as a tool by generic and biosimilar medicine manufacturers globally – as well as by other global health stakeholders, such as institutional investors and policymakers. It outlines priority areas and themes where companies can make the biggest impact on access to medicine in LMICs.Â
By examining what actions these manufacturers are currently taking to expand access to medicine, the Research Programme will facilitate greater information-sharing between companies and other stakeholders. It will highlight where greater engagement is urgently needed and outline specific opportunities for these companies to focus their efforts and break down access barriers in LMICs.Â
