MAPGuideⓇ: Equitable Access Toolkit
Implementing Equitable Access Policies:
a Toolkit for Product Development Funders
Some (Not So) Simple Questions to Begin...
What Does Equitable Access Mean?
“Equitable access” is a term that is used by many but perhaps not always understood in the same way. In the context of medical products, there is not a single, universally accepted definition of equitable access. In this commentary, we present our own definition and an overview of the key components of equitable access policies.
Why Are Contracts Critical to Implementing Equitable Access Policies?
It’s a long journey from product development to population-level impact, with many partnerships formed along the way. Learn why a variety of contracts, in a variety of forms, are vital tools for governing those partnerships to ensure equitable and sustainable access to medical products.
The Next Step: From Policy to Agreement
GHIAA has developed the Equitable Access Pyramid, an interactive tool exploring the key building blocks for incorporating equitable access obligations into product development funding agreements. Click on a block in the pyramid to read more about the range of options for addressing key issues and see examples of agreement language from the GHIAA MAPGuide.
<<< Click on the graphic to read more
Dive into the Details:
Issues and Options for Equitable Access Provisions
This commentary discusses how product development funding agreements can facilitate sustainability through provisions that require: (i) a price that is sustainable for the manufacturer as well as affordable for lower-income populations; (ii) a commitment on the part of a developer or manufacturer for continuous long-term supply of the product; (iii) an ‘access license’ that a funder can exercise to ensure the continuity of product development and manufacturing in the event that their partner cannot do so, or if the partnership is terminated; and (iv) the transfer of equitable access obligations to successor organizations in the event that the partner is acquired or transfers project-related IP to another organization. Read more.
Ensuring that a product is affordable for the populations that need it is critical to achieving equitable access, and there are multiple approaches available for the inclusion of affordable pricing provisions in product development funding agreements. This commentary discusses options for fixed, soft and indirect obligations that can have an impact on the price of a final product, as well as providing insight into how and when they are most likely to be effective. Read more.
Ensuring that a product is ‘available’ to the populations that need it requires the consideration of multiple factors. This commentary examines how agreement provisions can support the achievement of product availability by addressing three key issues: (i) developing products that are appropriate and adoptable for all relevant populations; (ii) timely regulatory approval for use in all relevant markets; and (iii) sufficient and timely supplies of the product when and where it is needed. Read more.
Intellectual property (IP) management provisions in development funding agreements need to address: (i) which party owns the pre-existing and newly developed IP needed to support the project; (ii) if and how project-related IP will be protected; and (iii) if and how IP will be shared through licensing and technology transfer agreements. This commentary discusses the different approaches that can be taken to address each of these questions depending on the goals of the agreement. Read more.
Before entering into detailed negotiations for provisions addressing matters such as affordable pricing and product supply, it can be helpful for the parties to a funding agreement to agree upon some fundamental principles for the conduct of the project, including the parties’ intention to ensure equitable access to the product developed under the agreement and/or other results of the project. Read more.
There are many ‘access provisions’ that need to be considered to achieve the objective of making a funded product sustainably affordable and available to all those who need it. Access plans often include considerations related to a number of the building blocks of equitable access and can be a key tool in establishing and coordinating the concrete actions that a product developer will take to achieve equitable access to a safe and efficacious final product. Read more.
The definition of the territory, or markets in which a product must be sustainably affordable and available, should be considered based on: (i) the location(s) in which the disease(s) that the product is designed to prevent, treat or diagnose is prevalent; and (ii) the populations that are likely to be under-served in the absence of any equitable access obligations. This commentary provides examples of the definitions used across a range of agreements. Read more.
Sharing information and data related to the activities under a funding agreement can help to inform related research and development in the field, therefore broadening the impact of a funder’s investment. This commentary discusses the following approaches to information sharing: (i) providing non-public information to a funder under confidentiality restrictions; (ii) sharing underlying scientific data (e.g. clinical trial data) with the research community; and (iii) formal publication of the results of a project in a peer-reviewed journal. Read more.
The particular context of some product development funding agreements means that they need to include provisions designed to address issues that are specific to the product. This commentary examines two examples of such provisions: (i) stewardship obligations for antibacterial products; and (ii) preparedness and response provisions for products intended for use during a disease outbreak. Read more.
Governance provisions are a mechanism that enables funders to monitor a developer’s progress and use of funds on a project. This commentary provides insight into agreement provisions that establish the structure, responsibilities, decision-making authority and meeting format for project governance bodies. Read more.
Frequent project reports are an important tool for funders and PDPs in evaluating the progress of a project in achieving its objectives. Failures by a developer to produce timely reporting, meet deliverable and milestone deadlines, and/or manage the project budget can be indicators of risk to a funder’s investment. This commentary discusses different approaches for the type, structure, and frequency of reporting requirements and related audit rights that can be included in product development funding agreements. Read more.
While the partnerships formed through funding agreements start with the best of intentions, the parties may need to address disagreements, breaches of obligations, or product failures at some point during the project. This commentary discusses how dispute resolution and termination provisions can provide options for the agreement parties to pursue if such challenges arise. Read more.
To Achieve the End Goal - Impact
Measuring the Impact of
Product Development Funding
Milestones and metrics are key measures that enable organizations to demonstrate the impact of development funding from partnership formation to final product. This commentary explains how impact milestones can be monitored throughout the life of an agreement, followed by broader impact metrics when the product achieves marketing approval.
The Impact of Agreement Provisions:
a Real-World Example
Explore how the components of equitable access discussed in these materials play out against the backdrop of a pandemic in this case study of agreements related to the Novavax COVID-19 vaccine.
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.