Master Alliance Provisions Guide (MAPGuide)

Approaches to Equitable Access

This page provides links to equitable access policies and other resources developed by global health R&D funders, Product Development Partnerships (PDPs) and academic institutions. The information in these documents provides insight into the challenges surrounding equitable access, and how organizations may seek to achieve their access objectives. In particular, the resources give examples and explanations of the ways in which equitable access requirements may be addressed in funding and licensing agreements.

Global Health Funders

CARB-X

Stewardship & Access Plan Development Guide

This document provides guidance for developers of therapeutics, diagnostics and preventatives. It outlines CARB-X’s expectations of product developers regarding stewardship & access plans, and aims to inspire other organizations to develop and act upon their own access principles.

CEPI

Equitable Access Policy

This document outlines CEPI’s approach to achieving equitable access to the outputs of all CEPI-supported programmes
including vaccines, platforms, data, results, and materials. CEPI has also published a separate document related to enabling and accelerating equitable access to COVID-19 vaccines and has commissioned an external equitable access review of its COVID-19 vaccine development agreements.

Gates Foundation

Global Access Statement & Humanitarian License

This statement provides an explanation of the concept of global access and sets out some of the requirements that the Bill & Melinda Gates Foundation may make of its grantees. Standard global access commitment and humanitarian licence clauses are provided in the Humaniarian License FAQs.

RIGHT Foundation

Global Access Policy

The Research Investment for Global Health Technology (RIGHT) Foundation sets out a Global Access Policy based on: (i) the prompt & broad dissemination of project data; and (ii) accessibility and availability in terms of price, quantity, quality and timeframe of products & innovations arising from funded projects.

Wellcome Trust

Equitable Access to Healthcare Interventions

The Wellcome Trust’s statement on maximising access to healthcare interventions includes contractual mechanisms such as global access plans, revenue sharing agreements, and stewardship plans. Wellcome has also published a report setting out its commitments to tackling access-related challenges, and a follow-up report reflecting on lessons learned from the COVID-19 pandemic.

GHIT

Product Access Policy

This document outlines Global Health Innovative Technology (GHIT) Fund’s data access policy and product access policy. The core principles of the product access policy are: (i) the granting of royalty-free licenses to organizations in lower-income countries; and (ii) the use of no profit/no loss pricing in lower- and middle-income countries.

Product Development Partnerships

DNDi

Access Policy

The Drugs for Neglected Diseases Initiative (DNDi) provides access policies well as gold standard terms. DNDi’s access policy emphasizes two guiding principles: (1) the need to ensure that drugs are affordable and available in an accessible manner, and (2) a motivation to develop drugs as a public good whenever possible.

MMV

Socially Responsible Agreements

The Medicines for Malaria Venture (MMV) highlights the need to meet its public health mission through socially responsible agreements. In order to support its mission, MMV retains the rights to the intellectual property required for launching new drugs for their target patients. MMV’s policies emphasize that IP rights must be exclusive, royalty-free, and transferable. 

GARD-P

Access and Stewardship

The Global Antibiotic Research and Development Partnership (GARD-P) emphasizes responsible and sustainable access to high quality drugs through appropriate stewardship. GARD-P sets out a Sustainable Access Framework to consider the needs of specific products and communities.

TB Alliance

Socially Responsible Agreements

The TB Alliance follows a “AAA Mandate”:  new products must be Adopted by regulatory bodies, must be Available to populations in need, and must be Affordable to patients with TB, within their health systems. To achieve this mandate, the TB alliance works with stakeholders and partners to ensure new products are endorsed and recommended, to perform and disseminate new research, and to ensure a consistent and affordable global supply chain.

FIND

Global Access Policy

FIND’s global access policy statement outlines “Four A’s” that govern its work with over 160 partners each year: Available, Appropriate, Affordable, and Adopted. FIND avoids a one-size-fits-all approach and instead focuses on best-fit solutions, affordable and quality products, affordable diagnostic solutions, and accelerated adoption with the context of LMICs.

Academic Institutions

Harvard, MIT, and Stanford

COVID-19 Technology Access Framework

The COVID-19 Technology Access Framework was jointly developed by Harvard University, the Massachusetts Institute of Technology, and Stanford University. The Framework sets out commitments for equitable access to university innovations during the COVID-19 pandemic.

AUTM

Nine Points to Consider in Licensing University Technology

AUTM provides principles and guidelines as well as a global health toolkit to support the development of licenses that promote global access. AUTM endorses the Nine Points to Consider, as well as providing a set of COVID-19 Licensing Guidelines.

UC Berkeley

Socially Responsible Licensing Program

The Socially Responsible Licensing Program (SLRP) page from the UC Berkeley Office of Intellectual Property & Industry Research Alliances (IPIRA) provides a number of useful resources including model agreement clauses, articles, presentations and examples of SLRP projects.

Netherlands Federation of University Medical Centres

Ten Principles for Socially Responsible Licensing

The Netherlands Federation of University Medical Centres (NFU) developed the Ten Principles in 2019, and together with the Association of Universities in the Netherlands (VSNU), has added a toolkit including template patent license agreement terms to build on these principles. The organizations also provide a set of principles for public-private partnerships.

University of Edinburgh

Essential Medicines Position Statement

The University of Edinburgh recognizes that access to medicines is essential in advancing the development of low- and middle-income countries. This statement outlines the University’s responsibilities to promote global public health through (i) improving equitable access to health technologies; (ii) promoting the development of health technologies; and (iii) improving transparency in health technology transfer.

Universities Allied for Essential Medicines

Equitable Access Framework & Global Licensing Principles

Universities Allied for Essential Medicines (UAEM) is global network of university students promoting global access to university healthcare innovations. UAEM has developed an Equitable Technology Access Framework which sets out goals, principles and modalities for tech transfer. UAEM has also written a Global Access Licensing (GAL) Toolkit which provides examples of terms that can be included in university license agreements to ensure access to and affordability of resulting products.

Emory University

Technology Transfer for Global Access

This document from Emory University’s Office of Technology Transfer outlines the university’s guiding principles in innovation access. These guiding principles include seeking industry partners and creating new companies, engaging in open discussion with industry partners in regards to philanthropic access, supporting production in low- and middle-income countries, and following effective global access principles when licensing Emory inventions.

University of British Columbia

Global Access Principles

The University of British Columbia’s (UBC) Global Access Principles include a statement that societal impact has become a key metric alongside standard throughput, financial and economic measurements in measuring the success of technology transfer activities. UCB will seek to enter into public/private partnerships to develop new technolgies for the developing world, as well as negotiating “at cost” pricing for developing countries under exclusive license agreements.

McGill University

Global Access Principles

McGill University’s Global Access Principles include (i) an open science approach and the availability and accessibility of information; (ii) evaluation of the necessity and benefits of intellectual property protection for different territories; and (iii) the structuring of licensing terms to improve global access, such as non-exclusive and field or territory specific licenses, sublicensing programs, and royalty structures that encourage commercialization at a reasonable cost.  

UCLA

Considering Underserved Populations When Licensing Medical Research Discoveries

UCLA has stated its commitment to transparent and equitable biomedical research, including ensuring affordable access for underserved populations. In order to support affordability, UCLA licensees must provide an affordable access plan upon receipt of FDA approval for a licensed product. The affordable access provision included in UCLA license agreements is the result of discussions between UCLA leadership, student advocacy groups and the Medicines Patent Pool. A meeting summary is available here.

Harvard University

Global Access Provisions

Harvard has developed a set of global access provisions which may be required in exclusive licenses for technology which could have significant public health benefits. The provisions include: (i) definitions of Developing Countries, Humanitarian Purposes and Qualified Humanitarian Organization; (ii) retained rights for humanitarian purposes; (iii) the right to grant third party licenses for sale and distribution of a licensed product in developing countries; and (iv) tiered royalty rates for developing countries.