MAPGuideⓇ
Equitable Access Toolkit
Product Uptake and Adoption Considerations for Funding Agreements
Equitable access to a funded product depends on successful product introduction and adoption so that the product can reach the patients that need it. Consideration of the activities needed to support the sustainable uptake of a funded product may form part of a funder’s broader access-related interventions, as well as being addressed through the development of an access roadmap. In some circumstances, particularly in funding for later stage R&D or commercialization-ready products, it may also be appropriate for a funding agreement to include obligations for a funded partner to undertake activities that will directly support product uptake. These obligations could include:
Undertaking studies as part of the funded project to support implementation of the funded product.
Engagement with communities or end users during the product development process.
Cooperating with activities undertaken outside of the funded project by the funder or third parties to support the inclusion of the funded product in national policy or treatment guidelines.
Undertaking publication and dissemination activities to increase product visibility and make data available to support uptake activities.
Providing training to local practitioners to promote awareness and appropriate use of the product.
Incorporating stewardship considerations into product sales and marketing activities, for example acting in compliance with recognized industry guidelines for combating AMR.
Ensuring timely launch readiness planning, potentially with oversight from a joint steering committee.
If applicable for the product (e.g., diagnostics or devices), establishing mechanisms for local product maintenance services.
Examples from the MAPGuide
Beginning in the year immediately following year in which any Program Product receives European or FDA approval/clearance, the Company shall allocate $50,000 per year to the Global Access Committee to work on training programs to be conducted by the Company or by partners approved by the Global Access Committee, such as the WHO, Gates Foundation and others, in Target Countries on the use of the Program Products with a target of training leading practitioners each year in the Target Countries, as defined by the Global Access Committee, as well as to work on access and promoting demand in the Target Countries. The Company shall work with global health authorities and partner organizations, including but not limited to the World Health Organization, the Clinton Health Access Initiative (CHAI), and the Bill & Melinda Gates Foundation (BMGF) and use commercially reasonable efforts to have the Program Products added to protocols and treatment guidelines.
Source: taken from a global health agreement between the AXA Prime Impact Master Fund (Funder/Investor) and Revelation Biosciences (Developer) signed 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 purpose of [Funder] is to protect humanity from the most serious threats from drug-resistant bacterial infections by accelerating antibacterial product development. Over the long term, the new products invented or developed with [Funder] funding (the “Products”) must be sustainably managed and used to promote “Access, Not Excess,” including:
(i) Thoughtful and effective stewardship of new Products whose utility is diminished by resistance, to prevent inappropriate use and therefore premature resistance, in line with the Global Action Plan on Antimicrobial Resistance developed by the World Health Organization;
(ii) Through planning for and ensuring appropriate access to new Products, especially in low and middle-income countries; and
(iii) Avoidance of misaligned commercial incentives, which go against the above-stated goals.
Therefore, the [Developer] agrees that Products will be manufactured, marketed, and sold under practices consistent with the applicable principles of the Davos Declaration on Antimicrobial Resistance – January 2016 or the Industry Roadmap for Progress on Combatting Antimicrobial Resistance – September 2016.
Source: taken from the CARB-X (Funder) portfolio company agreement template with subrecipients (Developer). Partner types: non-profit funder, industry/non-profit research organizations/academic institutions; Product type: innovative therapeutics, preventatives and rapid diagnostics targeting drug-resistant bacteria; Development stage at signature: early stage development. Read in context.
Within [***] of the expected launch date of each of [Products], Awardee shall ensure that its Sub-Awardees develop and provide Awardee and [Funder] with a launch readiness supply plan for Non-Traveler’s Market Countries.
Integrated product development plan [agreement annex]
Valneva’s objective is to improve and extend the future use of Valneva’s chikungunya vaccine. Planned studies aim at generating evidence to:
- Facilitate and improve the implementation of the vaccine: Such as, antibody persistence, long-term safety, safety and immunogenicity in special populations (e.g. pregnant women, immune- compromised); very importantly, data to demonstrate effectiveness of the vaccine against chikungunya virus in endemic areas, as well as – if necessary – local registration studies (e.g. India)
Source: taken from a USD $41.3 million funding agreement between CEPI (Funder) and Valneva (Developer/Awardee). This provision is passed through in a license agreement between Valneva and Serum Institute of India (Valneva’s Subawardee). Partner types: philanthropic funder, industry; Product type: Chikungunya vaccine; Development stage at signature: licensed product. Read in context.
Company 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 Company’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.
Each Party recognizes the requirements of Global Access and shall ensure that any Product arising from the Agreement will, subject to the terms and conditions of this Agreement and the Party’s freedom to operate, be made available broadly in accordance with Global Access, including but not limited to: a) providing access to the Product at an Affordable Price, as defined below, including required local registrations in the Territory, and local maintenance, service, and support.
Source: taken from sample terms and conditions for FIND project investment agreements. Partner types: PDP, industry; Product type: diagnostics; Development stage at signature: project-dependent. Read in context.
How will the requirements to support product uptake under the funding agreement integrate with broader activities as part of end-to-end access planning?
How will the publication of data and results support policy decisions and increase product visibility?
Will a joint steering committee or other governance body or advisory committee have oversight over product launch planning?
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.
