MAPGuideⓇ
Equitable Access Toolkit
Governance Provisions as a Mechanism to Monitor and Support the Fulfilment of Equitable Access Commitments in Funding Agreements
Project governance structures can provide funders with valuable opportunities to monitor the progress of a funded project, and to provide input or guidance on key decisions including those that may have an impact on the achievement of equitable access objectives for an end product. As discussed further here, project governance provisions often establish the composition, meeting frequency, responsibilities, and decision-making authority of a joint steering committee or similar joint project management body.
Some specific considerations for ensuring that project governance structures can support and monitor the fulfilment of equitable access commitments include:
Whether review, monitoring and update of an access plan attached to the agreement will be part of the responsibilities and decision-making authority of the steering committee, or if a separate equitable access sub-committee will be established for this purpose;
Mechanisms for inviting third party experts or relevant stakeholders to attend meetings of the steering/equitable access committee to provide input on equitable access-related matters, for example access plan reviews or alignment with activities to support end-to-end access;
Requirements for additional or more frequent meetings of the relevant committee at critical points in the equitable access plan, such as first product launch in the access territory, or during a health emergency; and
Requirements for prompt notification to the steering/equitable access committee of any issues that may impact the fulfilment of access commitments.
Examples from the MAPGuide
Within [***] of the effective date the parties will establish an Equitable Access Group (the “Equitable Access Group“) that will meet regularly to monitor the progress of, and advance the Awardee’s commitment to, Equitable Access. The LMIC Manufacturer will be a member of the Equitable Access Group and will keep the other members regularly informed of its commitment to Equitable Access.
Source: taken from a USD $41.3 million funding agreement between CEPI (Funder) and Valneva (Developer). Partner types: philanthropic funder, industry; Product type: Chikungunya vaccine; Development stage at signature: licensed product. Read in context.
Promptly following the Effective Date, the Parties will establish a joint monitoring and advisory group (“JMAG”) that shall meet regularly as specified in the Team Charter to monitor progress of and advance the Project. The JMAG shall coordinate the efforts of [Funder] and [Developer] to: (a) facilitate communication between the Parties; (b) review the progress of the Project; (c) discuss substantial proposed changes in the scope or conduct of applicable clinical and animal studies; (d) discuss clinical trial protocols, publications and regulatory submissions; (e) coordinate the sharing of any Project Results identified in a Work Package as intended for use by other [Funder] awardees; (f) review and update the Project Continuity Plan; (g) review and update the Equitable Access Plan; and (h) discuss plans, as appropriate, for the development of manufacturing and its scale-up and scale-out.
Source: taken from a development funding agreement for up to USD $33 million between CEPI (Funder) and Variation Biotechnologies (Developer). Partner types: non-profit funder, industry; Product type: COVID-19 vaccine; Development stage at signature: early stage development. Read in context.
[Developer] will use reasonable and diligent steps to: […] keep the [Funder] promptly informed of the activities related to progress on the Project (including providing the [Funder] with information reasonably requested by the [Funder] related to the Product, trials and deliberations of review committees) and [Developer]’s Global Access Commitments and consult with the [Funder] in good faith in connection with Developing Country launch strategic decisions, including by holding meetings with the [Funder] no less often than once every three (3) months
Source: taken from a global access commitments agreement between the 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.
As a condition to the [Funder] making the [Funder] Investment and to ensure satisfaction of the Charitable Purpose and Global Access, the [Developer] agrees to the following (collectively “Global Access Commitments”):
The [Funder] and the [Developer] will each designate three individuals who are subject matter experts to be part of a joint steering committee (the “Joint Steering Committee”) that will provide a forum for discussion of the application of the Platform Technology and the progress of each of (i) the [disease] Project, (ii) the [disease] Project and (iii) all Additional Projects.
Source: taken from a strategic relationship letter agreement between the Gates Foundation (Funder) and BioNTech (Developer) signed in relation to a USD $55 million investment in BioNtech by the Foundation. Partner types: philanthropic funder, industry; Product type: products for the prevention or treatment of TB and HIV; Development stage at signature: preclinical. Read in context.
The [Developer] shall advise the JMAG when they believe that the sharing of any particular data set or biological material might foster the development of vaccine candidates against [disease]. The JMAG will discuss whether and how such data or materials could be shared with other [Funder] awardees or the broader [disease] research community, under appropriate contractual provisions, including confidentiality.
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.
Further examples of funding agreement provisions related to the establishment of joint steering committees, including details of structure, responsibilities and decision-making authorities, can be found here.
What happens if a governance committee cannot reach agreement on key decisions?
How do the reporting requirements in the agreement align with the governance committee schedules and responsibilities?
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.