Equitable Access Toolkit
The term “equitable access” in the context of medical products does not have a single, universally accepted definition, and not all organizations use the same term to describe this concept. Other related terms used by global health funders and Product Development Partnerships (PDPs) include “global access,” “stewardship and access,” and “socially responsible agreements.”
Looking across definitions from different sources, equitable access can be summarized as:
Ensuring that medical products are sustainably available and affordable to all populations in need, when they are needed.
Components of equitable access policies
Global health funders and PDPs generally state their approaches to equitable access in policies or statements. A review of policies from a range of these organizations shows that there are varying approaches depending on an organization’s particular mission and objective, but some common areas of consideration include:
Ensuring that products are registered for use in countries where they are needed, and that the product reaches patients.
Ensuring that there is a sustainable supply of a product where and when it is needed.
Ensuring that the product is priced so that all those who need it can afford to purchase it.
Ensuring that the product has suitable characteristics (for example, the formulation, delivery system, and storage requirements) for use by those who need it, and that there is appropriate education or promotion to support its use.
Ensuring that there is a plan of action to promote appropriate use of the product. This is particularly important for certain product types, such as antimicrobials.
Ensuring that the data, knowledge and information gained from a project is promptly and broadly shared, often supported by “open access” policies.
(i) ensuring that the necessary rights will be transferred to another partner to enable continued development and manufacturing of a funded product if the original partner becomes unwilling or unable to do so; and/or
(ii) ensuring IP rights and technology are shared through technology transfer with manufacturers working to supply the lowest income markets.
Ensuring that a product developer earning high profits from a funded product gives back to a charitable purpose.
Many of the activities undertaken by funders and PDPs to implement their equitable access policies require partnering with other organizations to develop, manufacture, and commercialize medical products. These partnerships should be governed by agreements containing terms that address the actions needed to achieve equitable access objectives, often supported by an access plan. The implementation of these terms and access plans must then be monitored and enforced throughout the life of the agreement.
Contracts have an important role in formalizing the partnerships between funders, PDPs and product developers and ensuring alignment on equitable access goals.
GHIAA has developed an infographic providing an overview of the key terms to be included in R&D funding agreements in order to support the achievement of equitable access policies.
Measuring the impact of the implementation of equitable access policies through funding agreement requires the establishment and monitoring of key metrics.
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