MAPGuideⓇ
Equitable Access Toolkit
Territory Definitions
The definition of the territory, or markets in which a product must be sustainably affordable and available, should be considered based on:
1. The location(s) in which the disease(s) that the product is designed to prevent, treat or diagnose is prevalent; and
2. The populations that are likely to be under-served in the absence of any equitable access obligations.
Some common terms used in funding agreements to describe the territory to which equitable access requirements apply are “Developing Countries,” “LMICs,” and “Access Countries.” These terms are usually defined as either:
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- The group of countries eligible for Gavi support; or
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- The countries identified as low-, lower-middle, or upper-middle income economies by the World Bank.
In some cases, other countries are added to the scope of the territory even if they do not fall within the Gavi or World Bank definitions – some examples are provided below.
Examples from the MAPGuide
(i) countries eligible for GAVI support as of 2016, (ii) countries in the process of transitioning out of GAVI support in 2016, and (iii) Botswana, Brazil, Philippines, South Africa and Thailand. “Developing Countries” also means any countries reasonably requested by the [Funder] that are part of the [Funder’s] strategies to which the [Developer] consents in writing, such consent not to be unreasonably withheld […].
Source: taken from a strategic relationship agreement between the Bill & Melinda Gates Foundation (Funder) and Arsanis (Developer) in connection with an $8 million investment by the Foundation to support a Staphylococcus aureus antibody development program. Read in context.
Those countries identified by the World Bank […] as having “low income economies,” or “lower-middle income economies” or “upper-middle income economies” […] as may be amended from time to time by the World Bank.
Source: taken from a development funding & collaboration agreement between PATH (Funder) and Aridis (Developer) for the formulation development of a rotavirus vaccine. Read in context.
The countries (each an “Access Country”) on the World Bank list of low-income and lower middle-income economies […] on the Effective Date, which are set forth on Appendix [x]. If after the Effective Date a country which was an Access Country on the Effective Date (i) is removed from such list and (ii) if such country becomes part of the European Union or is subject to another treaty with other non-Access Countries which leads to a material increase of the risk of parallel imports, the Parties will cooperate in good faith to reasonably reduce the risk of parallel imports and if it is not possible to reduce the risk to a degree that is acceptable to both Parties, such country will be removed from the list of Access Countries for purposes of this Agreement.
Source: taken from a global access commitments agreement between Bill & Melinda Gates Foundation (funder) and CureVac (developer) related to an investment by Gates to support the development of CureVac’s mRNA platform technology. Read in context.
“[Developer’s] Traveler’s Market” means those countries listed below [redacted] and any country that is defined by the Organization for Economic Co-operation and Development from time to time as a high income country; provided that if any such country becomes an LMIC, such country will no longer be included in the [Developer’s Traveler’s Market and will become a Non-Traveler’s Market Country.
Related definitions: “Low and Middle Income Countries” or “LMICs” are those countries defined by the Organization for Economic Co-operation and Development.
Source: taken from a global access commitments agreement between CEPI (Funder) and Valneva (Developer) for late-stage clinical development and manufacturing of a Chikungunya vaccine. Read in context.
Low- and Lower-Middle Income Countries (as defined by the World Bank and if approved by the Global Access Committee).
Source: taken from a global health agreement between the AXA Prime Impact Master Fund (Funder) and Revelation Biosciences (Developer) for the development of a therapeutic for allergic rhinitis and a diagnostic for respiratory virus infections. Read in context.
An alternative approach used in some agreements that are aimed at response to an epidemic or pandemic is to define a set of Affected Territories. “Affected Territories” are a defined area in which there is a disease outbreak, or a high risk of an outbreak occurring.
Examples from the MAPGuide
The geographic area of any country where there is an Outbreak or that is at risk of an Outbreak taking into account epidemiological data, travel and migration patterns and the lack of availability of other products or product candidates;
Related definitions: “Outbreak” means a Public Health Emergency of International Concern declared by WHO or a public health emergency on a national or regional scale declared by one or more national governments and in each case for a material increase in the number of cases of people infected in the Field including any regional outbreak, an epidemic or a pandemic.
Source: taken from a framework partnership agreement between CEPI (Funder) and CureVac (Developer) for the development of CureVac’s mRNA platform technology for the rapid manufacture of vaccines against infectious diseases. Read in context.
Some agreements further specify that equitable access obligations apply to public sector organizations making purchases for populations within the defined territory. For the purpose of these agreements, the public sector often includes governments as well as multilateral organizations and non-profit organizations.
Examples from the MAPGuide
Governmental health ministries and other governmental agencies of Developing Countries, the Global Fund for Children’s Vaccines, the WHO, World Bank, UNICEF and other governmental and non-profit charitable agencies or organizations, including PATH, and shall include without limitation United States and European governmental agencies (e.g. USAID, DANIDA, DFID and GTZ) that may purchase vaccines for delivery, distribution and/or sale to Developing Countries.
Source: taken from a development funding & collaboration agreement between PATH (Funder) and Aridis (Developer) for the formulation development of a rotavirus vaccine. Read in context.
Non-profit organizations and public-sector purchasers in Target Countries.
Source: taken from a global health agreement between the AXA Prime Impact Master Fund (Funder) and Revelation Biosciences (Developer) for the development of a therapeutic for allergic rhinitis and a diagnostic for respiratory virus infections. Read in context.
Related Commentaries
Developer obligations to make a funded product available at an affordable price are often limited to a defined territory.
Decisions about protecting, and granting licenses to, intellectual property created under a funding agreement may vary between territories.
This toolkit has been built based on the data in the MAPGuide and the GHIAA team’s experience of negotiating and implementing agreements. We intend that the toolkit will evolve and expand over time based on input from MAPGuide users and availability of new agreements showing examples of alternative approaches. We welcome ongoing constructive dialogue around these materials and encourage you to contact us or fill in our feedback survey to share your thoughts, questions and suggestions.
Authors: Bridie Telford
First publication date: November 21, 2022