The research process
Detailed process for collection and verification
During data-collection, the research team uses public sources of information as well as data submitted directly by the companies evaluated. These sources include the US FDA, the European Medicines Agency, Health Canada, ClinicalTrials.gov, MedsPal, LexisNexis, the Pharmaceuticals and Medical Devices Agency, annual filings and reports from companies, amongst others.Â
During this phase, the research team follows a detailed process for verifying and clarifying the data it analyses. This includes requesting specific supporting documentation from companies as proof that the strategies and policies they report are being implemented in practice, including the codes of conduct for ethical marketing, internal policies for reporting substandard and falsified medicines, and processes for engaging with local stakeholders. The team also uses public registries of information, such as the US FDA's Orange Book, to cross-check certain data sets. Information about partnerships is also verified using information in the public domain, often published by product development partnerships (DNDi, MMV, etc).
Strict set of scoring guidelines
The research team scores the companies in each of the 33 metrics against a strict set of scoring guidelines, developed with reference to external experts. The scores are weighted according to the relative importance of each metric for access to medicine. The research team compiles an extensive, detailed database of all products and R&D projects that qualify for analysis by the Index, as a central analytical platform. In 2021, the database includes 757 products and 1,073 R&D projects.
Identifying best practice and where further action is needed
Once scoring is complete, the team begins combing the data to assess the current level of standard practice across the industry, as well as signs of progress or stagnation, and to identify best practices.Â
Best practices are not new practices, rather they are the most effective ways of achieving access goals, for example in research and development or in distribution. Publishing and sharing best practices stimulates other companies to adopt them in their own ways of working. To identify best practices, the Index team compares company initiatives against four criteria: sustainability, replicability, alignment with external standards and/or stakeholder expectations, and proven effectiveness. Once analysis is complete, key sections of the report are shared with independent experts for their view on the findings.
Behind the research
The Foundation has a dedicated team of researchers working on the Access to Medicine Index, supported by colleagues from across the Foundation. The Research Programme Manager for the Index is James Hazel. Find out more about the team.