Globally, 2 billion people still cannot access the medicine they need. Among the many stakeholders working to improve this situation, pharmaceutical companies have a crucial role to play. For almost ten years now, the Access to Medicine Foundation has built stakeholder consensus on what we can expect from pharmaceutical companies.

The methodology report describes the key dilemmas, discussions and outcomes of the most recent phase of consensus building, and how they translate into the methodology for the next Access to Medicine Index. In 2015, the emphasis has shifted further towards measuring performance where it matters.

The Index is the product of a rigorous methodology for benchmarking companies’ access-to-medicine performances against stakeholder expectations for company behaviour. This methodology is reviewed every two years with input from experts working across the access-to-medicine field. These reviews align the methodology with evolving global health priorities, while continually reinforcing and refining the Index metrics in key areas. The methodology report describes the outcome of the latest review, and translates the methodology into a set of ambitious, yet achievable and clear expectations for pharmaceutical company behaviour in each area measured by the Access to Medicine Index.

Key changes in 2015

The 2015 methodology will give greater emphasis to companies’ performances over their commitments. It will have a deeper focus on how companies approach people with the highest access needs, including through pricing and R&D. Following minor adjustments, the analysis scopes remain largely unchanged. The 2015 methodology comprises 83 indicators.

The weighting of the Performance Strategic Pillar has been increased to 50%: in the 2016 Index, companies’ scores in the Performance pillar will account for half of their overall Index scores. The Commitment Pillar has been reduced to 15%. This change will incentivise more companies to make the shift from commitment-making to action-taking. This is the first change to the Pillars weighting since 2012.

New measurements have been developed to uncover whether companies take action where the need is highest. For example:

A new measurement of needs-based pricing: The 2016 Index will map companies’ pricing actions against disease burdens and inequality, assessing how companies customise pricing strategies according to socio-economic factors. This will allow for more rigorous benchmarking of company pricing behaviour and an analysis of how they differentiate strategies according to patients’ needs and ability to pay.

More recognition for R&D with no viable market: Stakeholders generally agreed that the Index should especially recognise companies’ eff orts to engage in R&D for products with no real chance of significant profitability. In response, the Index methodology will give more credit to R&D projects that are demonstrably addressing high-need, non-commercial product gaps.

A closer analysis of access strategies in middle-income countries: Middle-income countries increasingly face high levels of socio-economic inequality. In response, the 2016 Index will look specifically at pricing actions in countries where both the burden of disease and inequality are comparatively high. In licensing, the 2016 Index will look more closely at whether and how companies license products for manufacture and distribution in middle-income countries.

How we measure: analytical framework for the 2016 Access to Medicine Index

Evolution of the framework
For the 2016 Index, the weighting of the Performance pillar has increased to 50%. For the previous two Indices, its weighting remained static at 40%.

Analysis scopes in 2016

The 2016 Index will measure the same 20 companies as the 2014 Index, as they remain the largest R&D-based pharmaceutical companies with the most relevant expertise and portfolios. The geographic scope now totals 107 countries: a handful of countries have moved out of scope, as socio-economic conditions have improved, while others (Iran, Jamaica, Mexico, Panama and Peru) have moved into scope. The disease scope for the 2016 Index comprises 50 conditions and diseases. Since 2014, more up-to-date data on disease burdens have become available, bringing three additional non-communicable diseases into scope.

83 indicators

The 2015 methodology comprises 83 indicators: 6 are new and 9 are mergers of pre-existing indicators. 9 indicators from the previous methodology have been removed. Changes were made following statistical analyses, either to improve our measurements of company practice, to align with changes in global-health priorities, or to improve efficiencies in analysis and data capture.

Review and consensus

The Index methodology is the product of a rigorous review, including an extensive series of indicator-level qualitative and quantitative analyses. It is informed by advice and insights from experts working across the access-to-medicine field. For almost ten years now, the Access to Medicine Foundation has built stakeholder consensus on what we can expect from pharmaceutical companies.

The Index team followed its indicator-level analyses by developing proposals for new measurements of company behaviour where necessary. During this process, the team held individual and collective discussions with governments, investors, industry, universities, think tanks, policy centres, patient organisations and other research organisations. Discussions covered specific questions relating to pharmaceutical company policy and practice, as well as broader perspectives on the role for the industry regarding access.

With the assistance of its formal committees, the Index team balanced the viewpoints provided to identify workable ways forward. Strategic guidance was provided by the Foundation’s Expert Review Committee (ERC), an independent body of experts from, among others, the WHO, governments, patient organisations, the industry, academia and investors.

The Access to Medicine Index analyses the top 20 research-based pharmaceutical companies and ranks them according to their efforts to improve access to medicine in developing countries. Each Access to Medicine Index is the product of a two-year process known as the ‘Index cycle’, which begins with a review of the Index methodology.

2015 is Year One of the current Index cycle: the Index team has completed its 2015 Methodology Review, refining the methodology with strategic guidance from the Expert Review Committee, to align it with changes in access-to-medicine priorities and how pharmaceutical companies can make products more available, accessible and affordable. We also used the review to reaffirm the robustness of the next Index analysis, and ensure our capacity for trend analysis is maintained.

Building on past reviews

The previous methodology review was carried out in 2013 and assessed the Index methodology point by point. This resulted in a refinement of what the Index measures as well as how it measures. The 2015 Methodology Review built on this process. In line with a set of core design principles, the review addressed technical questions relating to specific areas of the methodology, with guidance from independent experts and stakeholders active in access to medicine.

Since the first Access to Medicine Index in 2008, members of the Foundation’s Expert Review Committee (ERC) have provided independent, strategic guidance to each review of the Access to Medicine Index methodology. The current ERC is made up of independent experts, including from the WHO, the industry, NGOs, academia and investors. They are all active on the access to medicine agenda and together represent a variety of stakeholder groups. The ERC provides external advice on the scope, structure, and analytical approach of the Access to Medicine Index.

For the 2016 Index cycle, we are pleased to welcome four new members to the Expert Review Committee: Sanne Frost Helt (Danish Government), Suzanne Hill (WHO), Aurelia Nguyen (GAVI), and Helena Vines Fiestas (BNP Paribas Investment Partners). Below is a full list of all ERC members, past and present.

Hans Hogerzeil
Hans Hogerzeil
Professor in Global Health at the University of Groningen, The Netherlands. Former WHO Director for Essential Medicines and Pharmaceutical Policies
Sanne Frost Helt
Sanne Frost Helt
Chief Advisor for Global Health, HIV/AIDS and SRHR, Ministry of Foreign Affairs, Denmark
Suzanne Hill
Suzanne Hill
Director, Essential Medicines and Health Products,WHO
Regina Kamoga
Regina Kamoga
ountry Manager, Community Health and Information Network (CHAIN), Uganda
Richard Laing
Richard Laing
Professor of Global Health, Boston University School of Public Health, USA
Aurelia Nguyen
Aurelia Nguyen
Director of Policy & Market Shaping, Gavi
Eduardo Pisani
Eduardo Pisani
Director General, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Dennis Ross-Degnan
Dennis Ross-Degnan
Associate Professor at the Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute
Dilip Shah
Dilip Shah
Member, Management Committee, IGPA and Secretary General, Indian Pharmaceutical Alliance
Helena Viñes Fiestas
Helena Viñes Fiestas
Head of Sustainability Research (SRI/ESG), BNP Paribas Investment Partners (BNPP IP)

The 2015 Methodology Review for the 2016 Access to Medicine Index followed four design principles:

1. Reflect changes in the access-to-medicine landscape and role for pharmaceutical companies

The research team reached out to a broad range of experts active in access to medicine, including from governments, international institutions such as the World Health Organisation, from academia, investors and the pharmaceutical industry, to gather technical advice on specific aspects of the changing access-to-medicine landscape and how these can be reflected in the next Index analysis.

2. Preserve the capacity for fine-grained comparison between companies’ performances

The ability of indicators to reveal differences between company performances was checked using analyses such as correlation matrices, distribution analyses and response rate analyses.

3. Maintain capacity for trend analysis between successive Indices

Adjusted indicators were checked to ensure that they collect data that is comparable to data from past Indices for key access-to-medicine topics.

4. Ensure data can feasibly be collected by companies

New and adjusted indicators were checked to ensure that data can actually be collected by the companies measured. The team also considered the entire breadth of data being requested, given the time-frame for data-collection and resources required.

In 2015, the Index team reviewed the Index methodology drawing on feedback from independent experts and stakeholders active in access to medicine.

Through these broad consultations, the team aligned the methodology with changes in access-to-medicine priorities and how pharmaceutical companies can make their products available, accessible and affordable to people living in developing countries.

The Index team gathered feedback on the methodology in three main ways:

1. Formal review and advice

During the review, the methodology approach, proposal and final version were reviewed by the Expert Review Committee (ERC), which provides strategic guidance and makes recommendations. Specialist advice on key areas of the Index analysis was provided by members of the Technical Sub-Committees (TSCs). The ERC and TSC members are all experts in different aspects of access to medicine and the pharmaceutical industry. The final methodology was ratified by the ERC before publication.

2. Targeted expert consultations

The Index team reached out to a broad range of experts with different expertise and perspectives, including from governments and the global health and investor communities. Many of these consultations were based around specific questions relating to our methodology and analysis. These questions had been defined during an indicator-level stress-test, based on data gathered in 2014, to reaffirm the robustness and usefulness of the next Index analysis.

3. Feasibility checks with pharmaceutical companies

In 2015, companies provided feedback on the process of gathering, submitting and verifying data.

While refining and finalising the methodology for the next Index, we took account of all comments and feedback received via these consultations, weighing them in balance with each other.

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