Frequently Asked Questions
The Access to Medicine Foundation
What is the Access to Medicine Foundation?
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.
What research does the Access to Medicine Foundation undertake?
The Foundation uses research to trigger change in how essential healthcare companies bring their medicines to people in low- and middle-income countries (LMICs). We use our tried-and-tested 'model for change' to define the actions that healthcare companies should take, analyse what companies are actually doing and promote best practices.
In 2022 we announced our strategic direction. Our research scope now spans companies across five healthcare sectors, which we aim to mobilise in the fight against healthcare inequality: R&D-based pharma companies, generic medicine manufacturers, vaccine manufacturers, diagnostics companies and medical gas companies.
Recent publications include the 2024 Access to Medicine Index; a research report from our AMR stream looking at key areas pharmaceutical companies can address to expand access to antibiotics and curb AMR; and a research report from our Index programme on how pharmaceutical companies are measuring and reporting the number of patients they reach with their lifesaving products.
How does the Access to Medicine Foundation drive change?
As an independent research foundation, we catalyse change by triggering essential healthcare companies to play their part and raise their game on access. To achieve this, we use a combination of data, research insights, rankings and report cards, including our Access to Medicine Index. In addition, we leverage a network of influential stakeholders, including investors, governments, and the public.
Our 'model for change' has three key components:
Building consensus on where companies can and should act to improve access to medicine;
Benchmarking companies and stimulating competition by identifying top performers;
Advocating best practices identified through our research.
How is the Access to Medicine Foundation funded?
The Foundation is an independent non-profit organisation, funded by the UK and Dutch governments, the Bill & Melinda Gates Foundation, The Leona M. and Harry B. Helmsley Charitable Trust, the Wellcome Trust, AXA Investment Managers and Stewart Investors. The Foundation is a registered charity in the Netherlands (ANBI status).
Who governs the Access to Medicine Foundation?
The Foundation is led by the Executive Board, represented by Jayasree K. Iyer, Chief Executive Officer. The Executive Board is responsible for the Foundation’s organisational and strategic development and day-to-day operations.
The Foundation has a Supervisory Board that oversees the management and strategic direction of the Foundation. The Supervisory Board also has an advisory function. The board meets every quarter and regular agenda topics include: strategy, finance, risk management and staffing.
How and when was the Access to Medicine Foundation founded?
The Access to Medicine Foundation was established in 2003 by Dutch entrepreneur Wim Leereveld. In 2008, the first Access to Medicine Index was published, ranking 20 of the world’s largest pharmaceutical companies on their policies and practices for improving access to medicine. The Index has since been published every two years and has become a widely respected tool for stimulating pharmaceutical companies to take action on access to medicine issues.
In October 2015, Wim Leereveld handed over leadership of the Foundation to Dr Jayasree K. Iyer. Under Jayasree’s leadership, new research programmes were established, including the Antimicrobial Resistance Benchmark.
In 2022, we expanded our scope, launching additional research programmes targeted at moving companies across a wider range of healthcare sectors. Visit the page on our story to learn more about the Foundation's journey to make health inequity a thing of the past.
The Access to Medicine Index
What is the Access to Medicine Index?
The Access to Medicine Index ranks 20 of the world's largest research-based pharmaceutical companies in how they improve access to medicine, vaccines and diagnostics in low- and middle-income countries. It has been published every two years since 2008.
What is the aim of the Access to Medicine Index? How does it change pharmaceutical companies?
The Index is a tool for driving change in the pharmaceutical industry. It identifies best practice, tracks progress and shows where critical action is needed to improve access to medicine for the poor. It provides companies and other stakeholders with a transparent means by which they can assess, monitor and improve companies’ performances in practice, as well as their public and investment profiles.
Why does the Access to Medicine Index focus on pharmaceutical companies?
Considering their size, resources, pipelines, portfolios and global reach, large pharmaceutical companies have a critical role to play in improving access to medicine. The Access to Medicine Index was established with two aims: first to define a clear list of what pharmaceutical companies can and should be doing to improve access; and second to spur companies to compete to perform best against this list of expectations. Before the Index, there was no clear path for pharmaceutical companies to follow in improving access to medicine.
Are pharmaceutical companies solely responsible for addressing access to medicine?
The access to medicine challenge is multi-faceted and many different actors must take responsibility. This includes the scientific research community, local governments, public health and regulatory agencies, overseas development agencies, philanthropists, trade administrators, the non-profit sector including product development partnerships, and both the research-based pharmaceutical companies and manufacturers of generic medicines. Pharmaceutical companies, with the resources and the knowledge to develop medicines, have a responsibility to ensure these technologies are made available to people, regardless of their socioeconomic standing. Improving access to medicine creates new routes to market, opening up demand for new and adapted products. As companies enter new markets, they must do so ethically and responsibly.
What does the 2024 Access to Medicine Index measure?
The 2024 Access to Medicine Index assesses 20 of the world’s largest pharmaceutical companies in relation to 113 countries, including five countries newly in scope: Jamaica, Jordan, Lebanon, Marshall Islands and Saint Lucia. It looks at 81 diseases, conditions and pathogens, which have been identified as the most critical priorities. Compared to the previous Index, the number of indicators has increased from 31 to 32, which are spread across three Technical Areas: Governance of Access, Research & Development and Product Delivery. Notably, patient reach is now included within Governance of Access as a priority topic, along with a standalone patient reach indicator. The weighting of its three technical areas is as follows: Governance of Access (15%), Research & Development (30%), and Product Delivery (55%).
How was the data collected and verified?
To make the Access to Medicine Index, the Foundation's research team analyses data from public sources and collected via a detailed survey of pharmaceutical companies regarding their policies and practices on access to medicine. Sources include the US Food and Drug Administration, the European Medicines Agency, Health Canada, ClinicalTrials.gov, MedsPal, LexisNexis, annual filings and reports from companies, among others. Data submitted by companies is verified, cross-checked and clarified by the research team using public sources and supporting documentation provided by the companies.
Does the data reflect a set time period?
The 2024 Index includes relevant data from 1 June 2022 and 31 May 2024.
Who conducted the analysis?
The data-collection, analysis and scoring was completed in-house by a dedicated research team. The Research Programme Manager for the Access to Medicine Index is Camille Romero. Key sections of the report were submitted by the Foundation for peer reviews by independent experts, including members of the Expert Review Committee (ERC) for the Index.
How was the methodology for the Index developed?
The 2024 Index is the product of a rigorous methodology that is aligned every two years with new developments in access to medicine. The 2024 Methodology review commenced in 2023, with the Index team carrying out a targeted internal review of the analytical framework, scopes and indicators used in the 2022 Index. This was followed by an external review to reaffirm the consensus view among stakeholders on the appropriate role of pharmaceutical companies in improving access to medicine in LMICs. As in previous years, consultations were carried out with global health experts to ensure a diverse range of viewpoints and technical expertise were incorporated. For the 2024 Index Methodology, this included consultations with over 100 stakeholders from varying sectors, including all 20 pharmaceutical companies evaluated in the 2022 Index. The resulting consensus has been translated into a refined set of metrics for assessing how well the world’s largest pharmaceutical companies are doing in fulfilling their roles and meeting society’s expectations. The 2024 Index assesses 32 indicators of performance, grouped in three Technical Areas, reflecting the core priorities for pharma company action.
Can you compare the 2024 Index to previous Indices?
The Index is a relative ranking, where companies are compared with each other rather than against an absolute, ideal state. As a result, a direct longitudinal analysis, indicator by indicator, is not possible. This is due to changes over time in the data collected and the methods used to either verify, compare or otherwise analyse them. In our reporting, where we make a statement about change over time, we conduct specific analyses of the original data to ensure a comparison is possible.
Why is access to medicine a global issue?
The UN has estimated that two billion people worldwide lack access to diagnostics, vaccines and treatments because they are unaffordable, unaccessible or unavailable in their country. The constitution of the World Health Organization asserts that all people have the right to the highest attainable standard of health.
What other Reports were released in relation to the 2024 Index?
For the 2024 Index, a new priority topic on measuring and reporting patient reach was introduced in the Governance of Access Technical Area, including a standalone patient reach indicator, “GA8: Measuring and Reporting Patient Reach.” In September 2024, the Foundation released a report highlighting the findings for this indicator: Patient centricity: How is the pharma industry addressing patient reach? The report provides an in-depth analysis of how some of the largest pharmaceutical companies are tracking and reporting the reach of their access efforts, particularly in LMICs. While the report offers broader insights into pharmaceutical companies' practices, the 2024 Index further evaluates product-specific examples of patient reach and incorporates these findings into the overall company scores.
AMR Benchmark
What is antimicrobial resistance and why is it a major threat to global health?
Antibiotics are being overused, which means they are becoming less effective. That is because, each time we use an antibiotic, bacteria are given the chance to adapt and develop resistance. Without action to tackle this, experts predict that most antibiotics could stop working. Common infections and simple surgery would once again become deadly.
How can antimicrobial resistance be controlled?
We can’t stop antibiotic resistance completely, but we can bring it under control. The key is to closely manage access to antibiotics to ensure they are used only when needed. This requires action at all levels of society, including governments, health authorities, the agricultural and pharmaceutical industries.
What is the role for pharmaceutical companies in controlling AMR?
To help slow the rise of antibiotic resistance, the role for pharmaceutical companies is clear: to develop new medicines to replace ones that no longer work, make them available and accessible to those who need them, and ensure all antibiotics are produced and promoted responsibly.
What is the Antimicrobial Resistance Benchmark?
The Antimicrobial Resistance Benchmark provides the only independent comparison of what pharmaceutical companies are doing to bring antimicrobial resistance under control and improve appropriate access to antimicrobials in low and middle-income countries. The 2021 AMR Benchmark was published on 18 November 2021.
What does the Benchmark aim to achieve?
The goal of the AMR Benchmark is to guide pharmaceutical companies to take effective action to tackle the problem of drug resistance. By giving pharmaceutical companies public recognition for their actions on AMR, the Benchmark provides accountability as well as an incentive for them to expand their activities. The Benchmark identifies good practices that are already being implemented as guidance for other companies to make further progress. Stakeholders such as investors and governments use the Benchmark analysis to inform their own strategies for influencing the industry.
What does the Benchmark analyse?
The Benchmark compares the actions and policies of 17 pharmaceutical companies, including those with the largest R&D divisions and major market presence. It evaluates their activities in antibiotic and antifungal R&D, their antibiotic manufacturing strategies and policies, as well as the steps they take to ensure antimicrobials are available and being used carefully. The Benchmark evaluates companies in three research areas: Research & Development; Responsible Manufacturing; Appropriate Access & Stewardship.
How were the 17 companies selected?
The Access to Medicine Foundation worked with an expert advisory board to define which companies should be evaluated in the 2020 Benchmark. To preserve capacity for tracking progress, the companies in scope are unchanged since 2020. Each group of companies was selected using different criteria. To select the large R&D-based pharmaceutical companies, the Foundation looked at the size of companies’ R&D activities and their presence on the market. It selected generic medicine manufacturers selling the highest sales volume and/or sales value of antibiotics, and/or if they are a large vendor of active pharmaceutical ingredients (API).
How was the data collected and verified?
The Benchmark analyses data from several sources. Companies were asked to verify the accuracy of publicly sourced data and to provide additional necessary information directly to the Benchmark. The data submitted by the companies for analysis has been cross-checked against publicly available sources. For example, regarding R&D clinical pipelines, projects declared by the companies were verified against clinical trials registries, including the NIH ClinicalTrials.gov and the EU Clinical Trials Register, to confirm their existence and the clinical phase. For example, R&D projects had to be ongoing, approved or awaiting approval between 22 June 2019 and 30 April 2021, when the data collection period ended. The status of market approval for late-stage R&D projects were monitored after the end of the period of analysis on 30 April 2021 and until 24 September 2021. If approved between these dates, the status was updated in the pipeline for each company within the report. In another example, collaborations submitted by companies (such as R&D projects or educational programmes) were confirmed using the websites of the corresponding partner, such as Wellcome Trust or BARDA. Data was accepted for evaluation if it related to a policy, project or other activity that was in effect during the period of analysis.
Does the data reflect a set time period?
The 2021 Benchmark includes relevant data from 22 June 2019 to 30 April 2021.
How was the methodology for the Benchmark developed?
The AMR Benchmark has been developed, researched and published independently by the Access to Medicine Foundation, drawing on its ten years of experience in developing industry metrics related to public health. To build the methodology, the Foundation identified where stakeholders agree that pharmaceutical companies can and should be taking action to curb AMR. These opportunities for action were then translated into 20 metrics for evaluating company behaviour and published in a methodology report.
Which experts did you work with?
To develop the methodology, the Foundation sought input and gathered feedback from reports and a variety of stakeholders, such as governments, non-governmental organisations (NGOs), pharmaceutical companies and industry associations, investors, academia, public-private partnerships and relevant international organisations. Strategic guidance was provided by the Expert Committee (EC) for the Antimicrobial Resistance Benchmark, an independent body of experts, from top-level academic centres, donor governments, local governments in low- and middle-income countries, investors and companies.
Who conducted the Benchmark analysis?
The data-collection, analysis and scoring was completed in-house by a research team dedicated to the Benchmark. The Foundation wrote up its findings, with reviews by external experts. The research was also reviewed by the Chair of the Committee Hans Hogerzeil, Professor Emeritus of Global Health of the University of Groningen, and formerly of WHO.
How is the Benchmark funded?
The Benchmark has been independently developed by the Access to Medicine Foundation, using funding from the UK's Foreign, Commonwealth and Development Office, AXA Investment Managers, and the Dutch Ministry for Health, Welfare and Sport. The Foundation is a non-profit organisation.
When will the next Benchmark be published?
The 2021 AMR Benchmark was published on 18 November 2021.
What is a priority pathogen?
The Benchmark looked at whether pharmaceutical companies are developing new medicines or vaccines for bacteria and fungi that pose the greatest threat to human health because of their widespread resistance against the existing standard of care. For example, the list includes strains of the Enterobacteriaceae bacteria that are already resistant to the beta-lactam class of broad-spectrum antibiotics. To identify priority pathogens, the Benchmark used the most recent priority pathogens lists published by the WHO and the CDC. The WHO and CDC use a variety of criteria to flag a pathogen as an AMR priority, including mortality, treatability and prevalence of resistance. The Benchmark also assessed companies’ projects targeting the most critical priorities in these lists, i.e. targeting the pathogens classified in the WHO and CDC lists as ‘’Critical’’ or ‘’Urgent’’, respectively.
What is stewardship?
Stewardship is the broad term given to a range of actions and policies that are designed to support efforts to use antibiotics conservatively. For example, governments can implement prescription-only policies for antibiotics, to prevent people from buying them over the counter without a diagnosis of a bacterial infection. Pharmaceutical companies can pool the data they have collected on where their products are becoming less effective, so that hospitals and other agencies can make informed decisions about which antibiotics they should be using.
What do you mean by appropriate access?
Today, more people die because they can’t get hold of antibiotics when they need them than die due to resistant or untreatable infections. People living in poorer countries are on the frontlines for antimicrobial resistance – they generally get poor healthcare advice yet face higher rates of resistance and infectious diseases. It is important that efforts to control the use of antibiotics do not overshadow the need to improve access. When access to an antibiotic is provided, it must be appropriate: the right medicine matched to a susceptible pathogen and in the right doses.
Poor access to antibiotics and healthcare advice can prompt people to use antibiotics in ways that encourage resistance. For example, a worried parent may split a single course of antibiotics between two sick children – which will leave both at greater risk of resistance.
Why are pharma companies leaving the anti-infectives market?
The commercial incentives for pharmaceutical companies to stay and invest in the antibiotic market are weak. R&D is risky and expensive, antibiotics offer slim margins, and growth in demand comes mainly from poorer countries with smaller healthcare budgets. New products are likely to be tightly controlled to minimise the risk of antimicrobial resistance. Plus, antibiotic supply chains are complex, with batches being passed between multiple distributors before they reach the patient. This leads to low visibility and accountability, and little alignment to ensure supply matches demand. Since the 2018 AMR Benchmark, two large research-based companies – Novartis and Sanofi – have retreated from new antibiotics R&D, while two further companies – Achaogen and Melinta – have filed for bankruptcy.
How does the Benchmark's pipeline analysis compare with those by WHO and PEW Trusts?
The Benchmark analysis incorporated an additional review and verification step using the clinical pipelines reported by the WHO in their publication, 2020 Antibacterial Agents in Clinical Development: an analysis of the antibacterial clinical development pipeline (April 2020), and the Pew Trust’s Antibiotics Currently in Global Clinical Development (March 2021). Inclusion criteria differed between each reporting entity, such as the companies in scope, as well as the following:
i. adapted projects in the pipeline (ATMF only)
ii. vaccines
iii. non-traditional approaches (i.e. phages, lysins)
iv. anti-tuberculosis agents
v. antifungal agents (ATMF only)
ATMF used both references to compare among the analyses which companies, projects, and phases were included in each of the clinical pipelines, respectively. Benchmark analysis complements the WHO and Pew Trusts analyses by comparing specific companies on specific aspects of antimicrobial R&D.