Our work to improve access to generic medicinesShare
Generic medicines account for an estimated 80% of the world's supply of pharmaceuticals. Yet they are out of reach for many people in low- and middle-income countries. The Access to Medicine Foundation is bringing manufacturers to the table to increase access to generic medicines.
Which factors keep generic medicines out of reach?
Generic medicines work in the same ways and offer the same benefits as brand-name versions. Using large-scale manufacturing, generic medicine manufacturers can supply billions of much-needed doses. Plus, with multiple companies producing generic versions of the same medicine, competition has driven down prices for many essential medicines.
Yet, generic medicines are not always available or accessible to everyone who needs them, due to issues such as inadequate or insecure supply, insufficient manufacturing in low- and middle-income markets, unaffordability, lack of compatibility with local needs, and substandard quality. There are four main factors that are keeping generic medicines out of reach for millions:
- Inadequate supply
Often, there are just not enough products available. A lack of local generic medicine manufacturers can mean populations cannot find reliable products, particularly in the face of import restrictions and disrupted supply chains.
- Lack of compatibility with local needs
Health products are only useful when they meet demographic needs. Medicines developed to meet the needs of high-income settings may not meet the needs (heat-stable variations or long-acting injectables, for example) of patients in LMICs.
- Substandard quality
Maintenance of quality standards is of utmost importance in the manufacturing process of generic medicines. Substandard medicines pose significant risks for the efficacy of the treatment, safety of the patient and trust in the healthcare system.
- Lack of affordable products
Those in the world’s lowest-income countries face some of the biggest barriers to access to essential medicines. Patients must often pay the full cost of medicines and healthcare out of their own pockets, leaving little money for living expenses.
Key roles in access
Which specific actions can manufacturers take to improve access?
Just as the world relies heavily on a handful of Big Pharma companies to develop and supply innovative medicines, we also increasingly rely on a few large manufacturers to supply generic versions of essential medicines.
These companies not only have the large-scale manufacturing capacity needed to supply billions of much-needed medicines to poorer countries, but they also have expertise in adapting products through R&D to ensure generic versions best meet the needs of people living in low- and middle-income countries.
There are three key areas where generic medicine manufacturers can play a specific role in ensuring access to medicine:
Ensuring continuous supply and product quality by increasing local manufacturing capacity, addressing shortages and stockouts, strengthening supply chains, and ensuring Good Manufacturing Practice standards are applied.
Some generic medicine manufacturers have a role to play in R&D. They can ensure access by investing in products prioritised by the global health community, and adapting medicines to the needs of patients in low- and middle-income countries.
Engaging in non-exclusive voluntary licenses, prioritising underserved populations and registering medicines widely in low- and middle-income countries to expand access.
A roadmap to action
How we work to mobilise generic medicine manufacturers
The Access to Medicine Foundation is expanding its work to mobilise generic medicine manufacturers. Several of the world’s largest generic medicine manufacturers have already been tracked by the Foundation’s antimicrobial resistance (AMR) research programme and Benchmark, but they will now be examined and analysed on their performance in more therapeutic areas.
The Foundation will engage companies that hold dominant positions in key regional markets, including some of the largest players in the generic sector. For each of these companies, the Foundation will critically analyse their unique role in improving the supply of essential healthcare products, depending on their portfolios, R&D commitments, and their manufacturing and distribution footprints. In the following years, the Foundation plans to track the manufacturers' progress against tailored frameworks for action.
If you want to know more, please contact Claudia Martínez.
The generic sector is characterised by a few major global players, alongside smaller manufacturers
Bringing industry leaders to the table
Leveraging the Foundation's convening power
As part of the new programme, the Foundation will bring together experts working with and within industry-leading generic medicine manufacturers. An initial workshop on 6 April will explore strategies for improving access to healthcare products in low- and middle-income countries.
Participants will discuss concrete examples of how generic medicine manufacturers are working to improve access on the ground, focusing on innovative approaches and practical steps that can be taken forward.
Find out more about the Foundation's events here.
Three ways to fix healthcare supply chains and improve global health security
In an Amsterdam Session on Global Health Security, the Foundation brought together leading experts from industry, global health and governments to identify solutions and mindset shifts in supply chain management and procurement.
How are generic medicine manufacturers responding to AMR?
A cross-section of the world’s largest generic medicine manufacturers have been tracked by the Foundation’s antimicrobial resistance (AMR) research programme and Benchmark since 2017.
The 2021 AMR Benchmark evaluated 17 companies with a major stake in the anti-infectives space, including nine generic medicine manufacturers.
Many of the generic manufacturers have moved slowly in the right direction since the previous Benchmark report was published in 2020, despite the ongoing COVID-19 pandemic. Overall, progress by the generic medicine manufacturers could be seen in transparency, stewardship, sales practices, and wider registration of medicines in low- and middle-income countries. But while progress can be seen on some fronts, the Benchmark also identified concerning gaps in performance.
Our new Strategic Direction
Mobilising more essential healthcare sectors
This programme is part of the Foundation's 2022-2026 Strategic Direction. In the coming years, the Foundation will apply its model for change to cover a total of five healthcare sectors: Big Pharma, generic medicine manufacturers, vaccine manufacturers, diagnostic companies and medical gas companies.
The Foundation will seek to bring a critical mass of companies to the table across each of the five essential healthcare sectors. Central to these efforts will be a focus on driving access at scale and on the continuum of care, from prevention through to diagnosis, treatment, and aftercare. Our research on generic medicines is crucial to this aim to ensure that all aspects of healthcare are available to patients worldwide.
Taking access to the next level: mobilising five essential healthcare sectors
With a new strategic direction for 2022-2026, the Access to Medicine Foundation will be expanding the range of companies and healthcare sectors which we aim to mobilise in the fight against healthcare inequality.