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 new strategic direction. Our research scope now spans companies across five healthcare sectors, which we aim to mobilise in the fight against healthcare inequality: Big Pharma, generic medicine manufacturers, vaccine manufacturers, diagnostics companies and medical gas companies.
Recent publications have included the 2022 Access to Medicine Index; the 2021 Antimicrobial Resistance Benchmark; and a research report from our diabetes stream looking at what companies are doing – and what more they can do – to ensure access to insulin in LMICs.
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 Dutch and UK governments, the Bill & Melinda Gates Foundation, the Leona M. and Harry B. Helmsley Charitable Trust and AXA Investment Managers. 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. It is independently funded, currently by the Dutch and UK governments, the Bill & Melinda Gates Foundation, the Leona M. and Harry B. Helmsley Charitable Trust and AXA Investment Managers.
Who publishes the Access to Medicine Index?
The Index is produced and published by the Access to Medicine Foundation, an international non-profit organisation.
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. The 20 companies in the Access to Medicine Index account for around 70% of global pharmaceutical revenues.
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 2022 Access to Medicine Index measure?
The 2022 Access to Medicine Index assesses 20 of the world’s largest pharmaceutical companies in relation to 108 countries, including two countries newly in scope: Algeria and Venezuela. It looks at 83 diseases, conditions and pathogens, which have been identified as the most critical priorities. Since the previous Index, osteosarcoma and thalassemia have also come under consideration, based on stakeholder consensus and the disproportionate burden of these diseases in countries in scope. Compared to the previous Index, the number of indicators has decreased from 33 to 31, which are spread across three Technical Areas: Governance of Access, Research & Development, and Product Delivery. The Index will modify the weighting of its three Technical Areas, decreasing the weighting of Governance of Access to 15% (from 20%) and increasing Research & Development to 30% (from 25%).
How were the 20 companies selected?
The Access to Medicine Index analyses 20 of the world’s largest research-based pharmaceutical companies. They are selected based on their size, market capitalisation and the relevance of their product portfolio and pipeline.
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 2022 Index includes relevant data from 1 June 2020 to 31 May 2022.
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 Index is James Hazel. 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. The report was also reviewed by the Chair of the ERC.
How was the methodology for the Index developed?
The 2022 Index is the product of a rigorous methodology that is aligned every two years with new developments in access to medicine. The 2022 Index builds on a review for the 2021 Index that began in 2019 and included a series of internal checks on indicators, data sets and analytical approaches. For this 2019 analytical framework update, the Foundation carried out a broader range of consultations than for previous iterations of the Access to Medicine Index, engaging with more than 100 experts and organisations. The resulting consensus was translated into a new analytical framework, first applied in the 2021 Index, for capturing how far the world’s largest pharmaceutical companies are meeting society’s expectations on access to medicine. This updated analytical framework has been maintained in 2022 to facilitate longitudinal trend analysis. The 2022 Index assesses 31 indicators of performance, grouped in three Technical Areas, reflecting the core priorities for pharma company action.
How can my organisation contribute to the methodology development of the next Access to Medicine Index?
Every two years, we carry out a targeted review of how stakeholders view pharma’s role in access to medicine. We engage with specialists from multilateral organisations, governments, research institutions, the pharma industry, NGOs, patient organisations and investors. These activities follow set timelines. If you would like to contribute, please get in touch.
Can you compare the 2022 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.
How is the Index funded?
The 2022 Access to Medicine Index has been independently developed by the Access to Medicine Foundation, using funding from UK Foreign, Commonwealth, and Development Office, the Dutch Ministry of Foreign Affairs, Bill & Melinda Gates Foundation, the Leona M. and Harry B. Helmsley Charitable Trust, Wellcome Trust and AXA Investment Managers. The Foundation is an independent non-profit organisation.
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.
Which companies take the top spots in the 2022 ranking and why?
GSK retains the number one spot, followed closely by Johnson & Johnson. AstraZeneca has risen to third, with Novartis in fourth. These four companies are the clear leaders among the companies assessed by the Index. GSK (1st) tops both the overall ranking and the R&D sub-ranking. The company develops treatments for diseases that disproportionally affect people in LMICs. It is also in the top three of the other two Technical Areas, and its access-to-medicine strategy is a central to its approach in ensuring that medicines reach those that need them most. Johnson & Johnson (2nd) demonstrates strong performance in all three Technical Areas and performs strongly across all assessment criteria including access strategies, R&D access planning and capacity building. AstraZeneca (3rd) has newly joined the top three, ranking as the number one company in the Product Delivery Technical Area by excelling in its approach to patent transparency and technology transfers. The company also performs highly in Governance of Access. Novartis (4th) performs well in R&D access planning and equitable access strategies and was the first company to agree a non-exclusive voluntary licence coving a prod-uct for a non-communicable disease.
How many Best Practices were identified in the 2022 Index?
The Access to Medicine Index seeks best practices in each of the areas it measures. Once identified, these are shared to accelerate their uptake by other pharmaceutical companies, to help raise the level of standard practice and to achieve greater access to medicine. The 2022 Index identified 19 best practices from 18 companies: three in Governance of Access, six in Research & Development and ten in Product Delivery.
How did the 2022 Index cover COVID-19?
Just as in the previous Index, the 2022 Index captured how pharmaceutical companies have responsed to COVID-19. It does so not only when it comes to pandemic preparedness, but also in safeguarding their access-to-medicine programmes more broadly. In the 2022 Index, a Special Report details how companies have responded to the COVID-19 pandemic. All company efforts during R&D are highlighted in a deep dive of the pipeline. The same goes for those efforts which were made on providing access to the medicines and vaccines companies have in their portfolios. To see where these companies stand on improving access to COVID-19 products in LMICs, voluntary licences, technology transfers and procurements are discussed as mechanisms to drive access. For R&D, not only COVID-19 projects in the pipeline are discussed. The Special Report also shines a light on what companies are developing against emerging infectious diseases, as well as what innovations in R&D are still needed to improve access to products in LMICs. Both of which will be necessary to be better prepared for future pandemics.
What other Special Reports are found in the 2022 Index?
In addition to the Special report on COVID-19 and pandemic preparedness, the Index will feature two additional Special Reports:
Women's health and SRHR: Women in low- and middle-income countries (LMICs) lose out when it comes to sexual and reproductive health and rights (SRHR). The COVID-19 pandemic has made an already challenging situation worse, for example by disrupting HPV vaccination programmes, postnatal care, and access to family planning services. This special report will evaluate how companies are responding to the challenge of increasing access to their products – and whether they are stepping up on women’s health and SRHR.
Longitudinal Analysis: This will be the eighth edition of the Access to Medicine Index, which was first published in 2008. The continuity in the methodology for the 2022 Index will enable detailed longitudinal analysis of where progress has been made since the previous Index– and where it has not. This will provide the clearest picture yet of whether the industry is doing more to improve access to medicine, despite the challenge of the COVID-19 pandemic, and whether the UN's Sustainable Development Goal 3 (SDG3) can be met by 2030.
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)
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.