First-of-its-kind framework to assess how generics manufacturers expand access to medicine

• This is the first dedicated analytical framework for assessing generic and biosimilar medicine manufacturers on their performance in expanding access to medicine in LMICs.  

• To support the development of the framework, the Foundation consulted with over 60 experts from a diverse range of backgrounds and areas of expertise.  

• Five of the world’s leading generic and biosimilar medicine manufacturers will be profiled in an initial analysis guided by the framework. 

Generic medicines account for the vast majority of the global supply of pharmaceutical products, with manufacturers producing them at-scale and generally pricing them more cheaply than the originator products. But despite this, many quality-assured generic medicines are simply not available or affordable to large numbers of people living in LMICs. To expand access to medicine beyond the status quo, there is now an opportunity for generic medicine manufacturers to go further by leveraging their capacity and expertise to ensure their products reach the people who need them. 

“Even when a generic or biosimilar version of a medicine is available, this is not enough to guarantee that people globally will have access to it when they need it, at a price they can afford. Companies that create generic medicines now need to make a conscious effort to address global health challenges and realise their potential as key players in access to medicine.” – Jayasree K. Iyer, CEO, Access to Medicine Foundation. 

First-ever analytical framework focused on generic and biosimilar medicine manufacturers 

While generic medicine manufacturers have been assessed before by the Foundation, for example as part of our Antimicrobial Resistance Benchmark, this is the first time a framework has been developed specifically to look at generic medicine manufacturers – as well as biosimilar medicine manufacturers – and their performance in terms of key access-to-medicine priorities. 

It comes at a pivotal moment. Without clearly defined roles and responsibilities for generic and biosimilar medicine manufacturers, and without sustained effort and collaboration, inequalities in healthcare will continue to widen, and the chance to meet the target of universal health coverage (UHC) by 2030 will be missed. 

This first framework will guide 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. Considering their portfolios, resources, global reach and local presence, these companies have clear opportunities and responsibilities to increase access to medicine. 

“By highlighting what action is being taken, by whom, and where, the framework will help map good practices, areas where greater attention is still needed, and incentivise positive change." – Claudia Martinez, Research Programme Manager, Access to Medicine Foundation.

The analytical framework will be used to assess companies against their individual capability to expand access to medicine in LMICs, across three Research Areas: 

• Expanding access to essential products  

• Supply & quality 

• Research & Development 

The Research Areas provide companies with a toolkit of actions they can take to focus their efforts and reach more people in LMICs with their products. All three areas show where companies have the greatest opportunities to improve access to medicine. 

How the framework was developed 

To develop this framework, the Foundation undertook a rigorous process to ensure the assessment criteria were robust and relevant for companies. Proposals were then reviewed by an Expert Committee, which provided strategic guidance to ensure the proposals represented areas where industry analysis would have the most change-making potential. 

In addition, the team drew on insights from a first-of-its kind workshop held by the Foundation in April 2022. This workshop 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 supplying affordable generic medicines.

What’s next? 

The Access to Medicine Foundation is now in the process of using the analytical framework to inform future activities of the Generic Medicine Manufacturers Research Programme.  

Over the coming months, the analytical framework will be used to conduct a first analysis of how five of the leading generic and biosimilar medicine manufacturers are leveraging their know-how, broad manufacturing footprint and technical expertise to make their products more available, accessible, and affordable in LMICs. Further companies will then be included in future analyses using the Programme’s analytical framework.     

Generic Medicine Manufacturers Research Programme

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About this research  

The Access to Medicine Foundation is an independent non profit organisation that seeks to transform the healthcare ecosystem by motivating and mobilising companies to expand access to their essential healthcare products in low- and middle-income countries. As part of the Access to Medicine Foundation’s Strategic Direction for 2022- 2026, the Foundation recently launched the Generic Medicine Manufacturers Research Programme. This programme has been developed to guide and stimulate generic and biosimilar medicine manufacturers to deepen their efforts to expand access to essential medicines in LMICs. The Foundation is funded by the Dutch and UK governments, the Bill & Melinda Gates Foundation, the Leona M. and Harry B. Helmsley Charitable Trust, and AXA Investment Managers.