Master Alliance Provisions Guide (MAPGuideⓇ)
MAPGuide Commentaries and Analysis
In this section you will find blog posts discussing issues, provisions and agreements found in the MAPGuide. This section will be regularly updated with new content.
Creating Successful Stewardship and Access Plans
Stewardship and access plans can play an important role in achieving equitable access to medical product innovations. Global health funders often include requirements for such plans in their access policies and/or through contractual obligations in product development agreements. However, it can be difficult to understand the key building blocks of an effective stewardship and access plan.
Liability and Indemnification Provisions in COVID-19 Vaccine Supply Agreements
In the face of the COVID-19 pandemic, national governments and pan-national organizations have sought to secure access to vaccine doses even before vaccines have received marketing authorization. In these unusual circumstances, the relative leverage between the vaccine supplier and the purchaser can be altered. One area where this is particularly evident is in liability and indemnification provisions.
The Global COVID-19 Contract Conundrum
While wealthier countries have vaccinated large portions of their populations and many have even started “booster” programs, low-income countries still don’t have enough doses to vaccinate their populations. As global attention focuses on addressing vaccine inequities, often overlooked is the fundamental role of the language in contracts in facilitating—or sometimes limiting—access to vaccines. Article published in Think Global Health.
Funder Approaches to Equitable Access
This section provides links to equitable access resources developed by several R&D funders. The information in these documents helps users to gain a better understanding of the challenges surrounding equitable access and how funders 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 agreements.
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.
BMGF
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.
CEPI
Enabling Equitable Access to COVID-19 Vaccines
This document outlines CEPI’s approach to enabling and accelerating equitable access to COVID-19 vaccines. It sets out how CEPI seeks to enable access throughout the vaccine development processes, as well as providing summaries of CEPI’s COVID-19 agreements. CEPI also commissioned an external equitable access review of its COVID-19 vaccine development agreements.
RIGHT Fund
Global Access Policy
The Research Investment for Global Health Technology (RIGHT) Fund 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 Health Technologies: Lessons from COVID-19
This report outlines Wellcome’s assessment of key challenges to equitable access, including specific issues for R&D funders, and lessons learned from the COVID-19 pandemic. The report provides recommendations to tackle the challenges identified and sets out Wellcome’s own plan of action.
GHIT Access Policy
Applying for Funding: Access Policy
This document outlines Global Health Innovative Technology 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 Partnership Approaches to Equitable Access
This section provides links to policies and agreements developed by non-governmental organizations to promote equitable access to healthcare technologies.
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.
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.
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.
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.
University Approaches to Equitable Access
This section provides links to resources developed by academic institutions and related organizations to promote equitable access to university innovations and support socially responsible licensing.
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.
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.
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.
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 also advocates for the adoption of a Global Access Licensing Framework.
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 1) improving equitable access to health technologies; 2) promoting the development of health technologies; and 3) improving transparency in health technology transfer.
