Generic medicines account for upwards of 80% of the world’s supply of pharmaceutical products. However, for many people, especially those living in LMICs, they remain largely unavailable or unaffordable. Manufacturers of generic and biosimilar medicines have an important role in addressing access gaps and ensuring high-quality essential health products are accessible for people living in LMICs.
The Foundation is developing an analytical framework that outlines the key roles and responsibilities of generic and biosimilar medicine manufacturers in expanding access to medicine. The framework aims to mobilise further action within the industry, in areas where it is urgently needed.
By supplying low-cost, high-volume medicines, generic medicine manufacturers play a crucial role in global health. Through licensing, manufacturers have avenues to bring to scale much-needed innovative medicines to people living in low- and middle-income countries. This framework unpacks opportunities in access and drives progress to ensure medicines are reaching those who need them most.
By examining where and how companies are already taking action, the Research Programme will enable progress to be tracked over time, best practices to be shared to increase adoption of similar practices by other companies, and will trigger greater information-sharing between the actors.
The EC will meet on 29 and 30 November 2022 to discuss and ratify the research areas, themes and assessment parameters of the analytical framework. The EC will also provide strategic guidance on the analytical framework and discuss areas where uncertainty remains, ensuring that it represents areas where industry analysis will have the greatest potential to influence and inspire change-making in expanding access to medicine.
The analytical framework will be published in Q1 2023, when the Generic Medicine Manufacturers Research team will initiate the data collection phase for the first iteration of company evaluations.
Profiles of the 2022 Expert Committee can be found here.
The 2022 Expert Committee
The EC is chaired by Professor Hans Hogerzeil, former Director for Essential Medicines Policies at the World Health Organization (WHO), and current chair of the Access to Medicine Index and the Antimicrobial Resistance Benchmark at the Access to Medicine Foundation. The members of the EC are drawn from a diverse range of backgrounds, including those from industry associations, investors, research and academic institutions and international and non-governmental organisations (NGOs) representing a broad range of experts active in global health and industry.
Professor Hans Hogerzeil (chair), Emeritus Professor of Global Health at the University of Groningen and former WHO Director for Essential Medicines and Pharmaceutical Policies
Alex Bernhardt, Global head of Sustainability Research at BNP Paribas Assest Management
Esteban Burrone, Head of Policy, Strategy and Market Access at the Medicines Patent Pool (MPP)
Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance (IPA)
Mariatou Talla Jallow, Managing Director and Lead Consultant at TalaConsult
Suzette Kox, Secretary General of the International Generic and Biosimilar Medicines Association (IGBA)
Nazeem Mohammed, Head of Pharmaceutical Sector at the Aga Khan Fund for Economic Development (AKFED)
Bart van Osch, Director of Quality Affairs at the IDA Foundation
Mariana Raldao Santos, Technical officer Facilitated Product Introduction (FPI) at the WHO
Where are we now and how did we get here?
In preparation for the EC meeting, the Generic Medicine Manufacturers research team has been preparing and finalising the analytical framework and the associated research areas, themes and assessment parameters. This has included internal review for robustness and effectiveness –underpinned by a rigorous review of peer-reviewed literature, and external reviews by 80 different stakeholders – including representatives working in industry and trade associations, NGOs, global health organisations, research and academic institutions, private organisations, procurement agencies, governments and partnerships, subject matter experts and the generic and biosimilar medicine manufacturers within the scope of the programme. This has ensured a diverse range of viewpoints and technical expertise have been considered and incorporated into the analytical framework, which aims to identify the core roles and responsibilities of generic and biosimilar medicine manufacturers in enabling access to medicine in LMICs.
About the Generic Medicine Manufacturers Research Programme
The Generic Medicine Manufacturers Research Programme is part of the Access to Medicine Foundation’s new Strategic Direction 2022-2026 which aims to mobilise a wider range of healthcare sectors to expand access to medicine in LMICs. The Research Programme seeks to assess how generic medicine manufacturers are approaching access to medicine in LMICs through a tailored assessment approach and will outline specific areas for improvement for each individual company. The Access to Medicine Foundation is funded by the UK and Dutch governments, the Bill & Melinda Gates Foundation, the Helmsley Charitable Trust and AXA Investment Managers.