MAPGuideⓇ
Equitable Access Toolkit
Defining the Scope of Access Commitments in Funding Agreements
The equitable access commitments made in R&D funding agreements might apply to specific countries, procurement entities, and products, and they may apply for a certain period of time. It is important that the provisions defining the scope of equitable access commitments are carefully considered to ensure that they are sufficient and appropriate for achieving the intended access impact for the funded product.
Clarity on the scope of access obligations also enables funded partners – particularly commercial entities – to consider how best to integrate their commitments into broader business and operational plans, as well as explain to current and future shareholders, investors or funders how these commitments align with the organization’s overall vision and strategy.
Click on the boxes below for explanations and examples of factors that determine the scope of equitable access commitments.
Access Territories
R&D funding agreements usually define a set of access territories for which a funded product is intended to be available and affordable. Territory definitions should take into account:
(i) the location(s) in which the disease(s) that the product is designed to prevent, treat or diagnose is prevalent or endemic, and
(ii) the populations or communities that are likely to be underserved in the absence of any equitable access obligations.
Common approaches used in defining the countries for which affordability and availability commitments apply include linkage to eligibility for Gavi support, or the World Bank’s classifications of middle-, and low-income economies (often abbreviated as UMICs, LMICs and LICs). In some cases, other countries with a high burden of disease are added to the scope of the territory.
An alternative approach used in some agreements for products intended to prevent or respond to pandemics or epidemics is to make the definition depending on the location of a disease outbreak, or a high risk of an outbreak occurring.
Agreements can also allow flexibility for the parties to agree on changes to the countries in the scope of the access commitments over time. This may be particularly useful for countries that transition out of Gavi eligibility, or change World Bank economy classification, but remain with a high burden of disease and access barriers for some of the population. Similarly, changing epidemiology over time may result in a change of countries with the highest burden of disease.
Examples from the MAPGuide
The [Developer] will work with the [Funder] to develop (by the time of completion of Phase II clinical trials) and execute a manufacturing and supply plan that will enable to be met the reasonably expected demand in Developing Countries for any Products. […] The price of the relevant Products in Developing Countries will be such that the Products are affordable to low income individuals in the Developing Countries […].
Related definitions: “Developing Countries” means (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 Gates Foundation (Funder) and Arsanis (Developer) signed in connection with an USD $8 million investment by the Foundation. Partner types: philanthropic funder, industry; Product type: neonatal sepsis mAb (staphylococcus aureus); Development stage at signature: discovery. Read in context.
The Company shall make the Global Access Products available to both public and private purchasers in the Target Countries at a reasonable volume that is sufficient to meet the demands of non-profit organization and public-sector purchasers in accordance with a tiered pricing framework that is commercially reasonable for the Company […].
Related definitions: Target countries listed in this side letter shall be limited to Thailand as well as the Low Income and Lower-Middle Income Countries as defined by the World Bank [list included as appendix to agreement]
[T]he Partner agrees to make Reasonable Efforts to: […] Manufacture the Project Vaccine for use in the Field in the Affected Territory in accordance with the [Funder] Production Timeframe and in the quantities reasonably likely to be necessary and at a Cost of Goods in line with the methodology to determine pricing obligations set out in the [Funder] Equitable Access Policy.
Related definitions: “Affected Territory” means 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;
Procurement Entities
In addition to specifying the countries for which equitable access obligations apply, some agreements make distinctions between the commitments for public and private markets within a country. For these purposes, the definition of public sector often includes multilateral and non-profit organizations as well as government agencies. This approach may particularly be used as a mechanism to balance a funder’s access objectives and a funded partner’s commercial concerns for high- and upper-middle-income countries (HICs and UMICs). These countries often form part of the profit-making, commercial strategy of developers and manufacturers while also having a high burden of disease and/or large communities that are likely to be underserved in the absence of any access commitments.
Any definitions of the procurement entities for which equitable access commitments apply should be aligned with the expected procurement pathway for a particular funded product, including where entities considered to be part of the “private market” may have a role to play. Where there is insufficient information available about the procurement pathway at the point when a funding agreement is signed (for example, for products in early stage development), the agreement can allow for the definition of procurement entities to be established at a later point in development as part of an access plan.
Examples from the MAPGuide
[Developer] shall fill, or cause to be filled, Developing Country requirements for [Product] by using commercially reasonable efforts to supply [Product] to Public Sector purchasers in such quantities and timeframes sufficient to fulfill the purchase orders for use in Developing Countries
Related definitions: “Public Sector” shall mean 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 USD $1.9 million formulation development agreement between PATH (Funder) and Aridis (Developer). Partner types: PDP, industry; Product type: rotavirus vaccine; Development stage at signature: vaccine formulation. Read in context.
The Company shall make Program Products available to non–profit organizations and public–sector purchasers in Target Countries (“Global Health Purchasers”) at a price of no more than 30% above the Company’s COGS […]; provided, however, that any non–profit organization and public–sector purchaser located in Brazil, India, South Africa and Mexico shall need to be approved by the Global Access Committee before qualifying as a “Global Health Purchaser” within the terms of this Global Health Agreement.
Source: taken from a global health agreement between the AXA Prime Impact Master Fund (Funder/Investor) and Revelation Biosciences (Developer) signed in connection with a USD $4 million preferred stock purchase agreement. Partner types: impact investor, industry; Product type: allergic rhinitis therapeutic & diagnostic; Development stage at signature: early stage development. Read in context.
In general the Parties agree that the Eligible Purchasers should be the main focus for Product supply and have the right to the Global Access terms set out under this Section [x].
“Eligible Purchasers” means any and all purchasers within the Public Health Sector and Private Health Sector.
“Private Health Sector” means any non-governmental institute in the health sector which operates on a for-profit basis, and which may have access to preferential access conditions to a Product such as set out under Global Access, and as determined on a case-by-case basis by [Funder].
“Public Health Sector” means (i) any government in the Territory, including any government ministry of health, department or agency, or any local or regional governmental body, authority or entity, and (ii) any officially recognized, not-for-profit organization including private not-for profit organizations, or funds, that pursue activities to relieve suffering, promote the interests of the poor, provide basic social services, or undertake community development, including, but not limited to, the World Health Organization (and other UN organizations), ICRC UNICEF, Save the Children Fund, Médecins Sans Frontières, Unitaid, PEPFAR, the Global Fund, FIND or its authorized designee, and other funding organizations.
Source: taken from sample terms and conditions for FIND project investment agreements. Partner types: PDP, industry; Product type: diagnostics; Development stage at signature: project-dependent. Read in context.
Product and Field
Some funding agreements relate to products which could be used for multiple indications, or to platform technologies or research programs that have the potential to be used for developing multiple products. In these cases, agreements may specify the product, field and/or indication for which equitable access commitments apply.
These definitions can provide clarity to funded partners and their investors on the distinction between “access products” falling within the scope of the funding agreement, and those for which the partner may pursue commercial, profit-making objectives. Additionally, funders making strategic investments in a partner may limit use of the investment proceeds to development of the defined products that are intended to have a global health impact, rather than a broader commercial portfolio.
Examples from the MAPGuide
The Company will work with the [Funder] to develop (by the time of completion of Phase II clinical trials) and execute a manufacturing and supply plan that will enable to be met the reasonably expected demand in Developing Countries for any Products.
Related definitions:
- “Product” means any drug, therapeutic, vaccine, diagnostic, or prophylactic developed pursuant to a Program.
- “Program” means the Neonatal S. aureus Sepsis Discovery Project, the Neonatal S. aureus Sepsis Candidate Development Program, the Neonatal Sepsis Cocktail Development Program and any Discovery Project.
Source: taken from a strategic relationship agreement between the Gates Foundation (Funder) and Arsanis (Developer) signed in connection with an USD $8 million investment by the Foundation to support a Staphylococcus aureus antibody development program. Partner types: philanthropic funder, industry; Product type: neonatal sepsis mAb; Development stage at signature: discovery. Read in context
The proceeds of the Investment will be used by the Company in particular (A) to support the research and clinical development program for [Product] for infectious diseases and (B) to thereby facilitate the advancement of [Product] indicated for melioidosis, tuberculosis, and any other mutually agreed upon products and/or claims by Adjuvant and the Board of Directors of the Company (together, the “Global Access Products”), in order to further the Global Health Objectives and otherwise carry out the Global Access Commitments set forth below, without impairing the sustainability of the Company.
Source: taken from a global health agreement between Adjuvant Global Health Technology Fund and AN2 Therapeutics signed in connection with a USD $7 million share purchase by Adjvant. Partner types: impact investor, industry; Product type: melioidosis and tuberculosis therapeutic (Epetraborole); Development stage at signature: preclinical. Read in context.
Company will use reasonable and diligent steps to: […] promptly, upon WHOPQ or any applicable regulatory approval for distribution of Released Products in a Developing Country for Maternal Immunization, provide reasonable publicity of the availability of the Product for sale for Maternal Immunization in each applicable Developing Country including to Public Sector Purchasers.
Related definitions: “Maternal Immunization” means a use for the Product for immunization of pregnant women to prevent severe RSV disease in newborns and infants pursuant to the Minimum TPP.
Source: taken from a global access commitments agreement between the Bill & Melinda Gates Foundation (Funder) and Novavax (Developer) signed in relation to a USD $83 million grant from the Foundation to Novavax. Partner types: philanthropic funder, industry; Product type: RSV vaccine; Development stage at signature: late stage clinical trials.Read in context.
The Global Health Agreement relates to the following programs of the Company: REVTx-99 (“Program Therapeutic”) and REVDx-501(“Program Diagnostic”) (together “Program Products”).
Source: taken from a global health agreement between the AXA Prime Impact Master Fund (Funder/Investor) and Revelation Biosciences (Developer) signed in connection with a USD $4 million preferred stock purchase agreement. Partner types: impact investor, industry; Product type: allergic rhinitis therapeutic & diagnostic; Development stage at signature: early stage development. Read in context.
Within six (6) months of making an application for marketing approval for the Product in the Field for the commercialization of the Product in the Field, provide to [Funder] a marketing plan setting out the planned activities to make the Product in the Field available to end users […].
Related definitions:
“Product” means the product that is the subject of the Clinical Trial, known as ALTO-100, to the extent used to prevent, diagnose or treat disease in the Field.
“Field” means the diagnosis, prevention and treatment of bipolar disorder, depressive phase.
Source: taken from a USD $11.7 million convertible loan agreement between the Wellcome Trust (Funder) and Alto Neuroscience (Developer). Partner types: philanthropic funder, industry; Product type: bipolar depression therapeutic; Development stage at signature: phase 2b clinical trials. Read in context.
The charitable purpose of the Investment is to ensure that safe, effective, high-quality contraceptives and STI-prevention products are made available for use in public health programs and by private purchasers in LMICs (the “Global Health Objective”). The Company agrees to make the products listed below (the “Global Access Products”) accessible to women in LMICs, to the extent such access can be achieved on terms that are commercially viable for the Company:
(1) Phexxi for the prevention of pregnancy; and
(2) EVO100 for the prevention of chlamydia and gonorrhea, if approved.
Source: taken from a global health agreement between Adjuvant Global Health Technology Fund (Funder) and Evofem (Developer) signed in connection with a program-related investment by Adjuvant of USD $25m in convertible promissory notes. Partner types: impact investor, industry; Product type: contraceptive and STI-prevention products (Phexxi & EVO100); Development stage at signature: U.S. FDA approved (Phexxi); phase 3 clinical trial (EVO100).
Duration
Funding agreements may also specify a period of time for which a funded partner must fulfil the equitable access obligations. These time periods may be linked to different points in the product development and commercialization, such as product registration or first sale of the product, or they may be tied to the effective date of the funding agreement. The duration of some equitable access obligations may also be linked to the duration of a public health emergency.
Establishing the duration of access commitments can support certainty over product availability in the short- to medium-term while allowing the funder, developer, and other stakeholders to plan for longer-term sustainability, potentially through licensing and technology transfer to manufacturers able to meet demand and pricing requirements for different markets
Examples from the MAPGuide
[T]his GACA and the obligations hereunder will expire at the later of (a) 15 years after the Effective Date, or (b) 10 years after the first sale of Released Product to a Public Sector Purchaser for Maternal Immunization for a Developing Country following WHOPQ (“Term”).
Source: taken from a global access commitments agreement between the Bill & Melinda Gates Foundation (Funder) and Novavax (Developer) signed in relation to a USD $83 million grant from the Foundation to Novavax. Partner types: philanthropic funder, industry; Product type: RSV vaccine; Development stage at signature: late stage clinical trials. Read in context.
The commitments set out in this Section [x] (Access to Health Products) will remain in force and effect for a period of ten (10) years from the date of first commercialisation of the Health Products in the Target Countries (“Access Enforceability Period”).
Source: taken from the sample terms and conditions for Unitaid (Funder) funding for Recipients (Developer) under the UnitaidExplore program. Partner types: non-profit funder, industry; Product type: innovations with transformative potential for public health in LMICs; Development stage at signature: multiple. Read in context.
The Global Access Commitments set forth in this Section 4 shall continue for the Term and shall be fully enforceable by the Investor, notwithstanding any other provision of the Investment Documents.
Related definitions: “Term” – The term of this Global Health Agreement shall end on the six (6) year anniversary of the Initial Closing under the Purchase Agreement.
Source: taken from a global health agreement between the AXA Prime Impact Master Fund (Funder/Investor) and Revelation Biosciences (Developer) signed in connection with a USD $4 million preferred stock purchase agreement. Partner types: impact investor, industry; Product type: allergic rhinitis therapeutic & diagnostic; Development stage at signature: early stage development. Read in context.
The Global Access Commitments set forth in this Section 2 shall continue with respect to each Global Access Product (i) until [Funder] ceases to be a shareholder of the Company or (ii) 10 years following [Product] approval for each respective Global Access Product by a stringent regulatory authority such as the US Food and Drug Administration or the European Medicines Agency, to be selected by the Company in its reasonable discretion, whichever event ((i) or (ii)) occurs later, and shall be fully enforceable by [Funder], notwithstanding any other provisions of the Investment Documents. Thereafter, the Company will consider in good faith any recommendation of [Funder] to make the Global Access Products available in the Target Countries in order to advance the Global Access Objectives.
Source: taken from a global health agreement between Adjuvant Global Health Technology Fund (Funder) and AN2 Therapeutics (Developer) signed in connection with a USD $7 million share purchase by Adjvant. Partner types: impact investor, industry; Product type: melioidosis and tuberculosis therapeutic (Epetraborole); Development stage at signature: preclinical. Read in context.
The scope of access obligations may have an impact on the purchasers eligible for affordable pricing commitments, and the amount of time for which the affordable pricing terms will apply.
The scope of access obligations may have an impact on the entities to which the funded partner must provide tender responses, supply committed volumes, and/or make prioritized supplies.
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.