MAPGuideⓇ
Equitable Access Toolkit
Establishing Equitable Access Objectives in Funding Agreements
Philanthropic, multilateral and non-profit R&D funders often enter into funding agreements with the primary goal of facilitating equitable access to end products, and it can be helpful to ensure that all parties to the agreement are aligned on this fundamental principle before entering into detailed agreement negotiations.
The high level access principles discussed during agreement negotiations can then be documented as a statement in the preamble, and/or as a provision in the main body of a funding agreement affirming the parties’ commitment to, and understanding of, the equitable access objectives for the funded product. These statements may be linked to the mission of one or more of the parties and may include a definition of what “access” means for the purpose of the project.
While an “access principles” provision should aim to align the expectations of the parties from the start of a funded project, the inclusion of such a provision in a funding agreement may also be useful if a funded partner later fails to fulfil its access obligations, as it could be leveraged in dispute resolution proceedings to demonstrate that the funded partner was always aware of the funder’s equitable access objectives.
Examples from the MAPGuide
The Recipient acknowledges that the objective of the Project is to ensure that the Health Products are made widely available, as quickly as possible and on a continuing basis, at an affordable and sustainable price, to the Public Sector seeking to supply them to LMICs and in sufficient quantities to meet the needs of LMICs (the “Access Objective”). The Recipient will make best efforts to ensure that the Health Products are developed and commercialised in a manner which is consistent with the Access Objective.
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 mission of [Funder] is to accelerate the development of a [disease] vaccine for pediatric indications and ensure its availability, affordability and accessibility for the developing world. The objective of the [Funder] [disease] program is to reduce the number of deaths and hospitalizations of children in the developing world due to [disease] infection through advanced development and introduction of safe, affordable and efficacious new [disease] vaccines.
Source: taken from a development funding & collaboration agreement between PATH (Funder) and Aridis (Developer). Partner types: PDP, industry; Product type: rotavirus vaccine; Development stage at signature: vaccine formulation. Read in context.
Certain key purposes of the Investment are to provide relief to the poor and distressed, improve the health of those living in Low and Lower-Middle Income Countries (as defined by the World Bank and if approved by the Global Access Committee) (“Target Countries”), and educate health practitioners and public health officials on cost-effective technologies that will improve the health and safety of poor and low-income individuals globally (the “Global Health Objectives”).
Source: taken from a global health agreement between the AXA Prime Impact Master Fund (Funder/Investor) and Revelation Biosciences (Developer) made 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 [Funder’s] primary purpose in making the Foundation Investment is to further significantly the accomplishment of the [Funder’s] charitable purposes, including the relief of the poor and distressed or of the underprivileged, the advancement of science, or the promotion of health by seeking to (i) address global health challenges that disproportionately impact developing countries, and (ii) increase the access of poor and distressed individuals and families in the developing world to life-saving and other important vaccines and drugs that can improve their health care (collectively, the “Charitability Requirement”).
[…]
The Company understands and acknowledges that a primary organizational objective of the [Funder] is to provide funding to support the development of drugs and vaccines to address diseases that have a disproportionate impact on people within developing countries, and to ensure that such products can be made available and accessible at reasonable cost and with all due speed to people within developing countries (the “Global Access Objectives”).
Source: taken from a strategic relationship letter agreement between the Gates Foundation (Funder) and Visterra (Company/Developer) made in connection with a USD $6.8 million Series A preferred stock investment. Partner types: philanthropic funder, industry; Product type: platform technology, vaccines, therapeutics; Development stage at signature: early stage development. Read in context.
[Funder] is committed to achieving equitable access to the results of all [Funder]-supported programmes pursuant to the “Equitable Access Policy” referenced in [Funder]’s Third Party Code. Equitable Access means that a Project Vaccine is available first to populations at risk when and where they are needed at affordable prices.
Source: taken from a development funding agreement for up to USD $384 million between CEPI (Funder) and Novavax (Developer). Partner types: non-profit funder, industry; Product type: COVID-19 vaccine; Development stage at signature: phase I clinical trials. Read in context.
How do the access principles set out in a funding agreement align with the parties’ organizational access policies?
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.