Master Alliance Provisions Guide (MAPGuideⓇ)
These commentaries provide a discussion of key issues and considerations related to global health agreements and equitable access.
Comments on the Zero Draft of the WHO CA+
As an organization that advocates for the inclusion of equitable access terms in global health agreements, GHIAA welcomes the sections of the draft text published on February 1, 2023 related to the “conditionalities” that should be attached to the use of public funds for medical products. However, there is still work to be done. In this commentary, we make recommendations on the further development of concrete, actionable commitments.
The Global COVID-19 Contract Conundrum
While wealthier countries have vaccinated large portions of their populations and many have even started “booster” programs, low-income countries still don’t have enough doses to vaccinate their populations. As global attention focuses on addressing vaccine inequities, often overlooked is the fundamental role of the language in contracts in facilitating—or sometimes limiting—access to vaccines. Article published in Think Global Health.
Creating Successful Stewardship and Access Plans
Stewardship and access plans can play an important role in achieving equitable access to medical product innovations. Global health funders often include requirements for such plans in their access policies and/or through contractual obligations in product development agreements. However, it can be difficult to understand the key building blocks of an effective stewardship and access plan.
Liability and Indemnification Provisions in COVID-19 Vaccine Supply Agreements
Equitable Access Toolkit
The Equitable Access Toolkit consists of a number of commentaries which, together, are intended to support medical product R&D funders with the translation of equitable access policies into funding agreement provisions that result in meaningful and measurable impact. You can read more about why we created the Toolkit here.
“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. Read more.
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. Read more.
A starting point for learning about the implementation of equitable access policies, this overview outlines the steps that product development funders need to take to translate their policies into meaningful agreement provisions with measurable impact. Read more.
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. Read more.
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. Read more.
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.
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. Read more.