Master Alliance Provisions Guide (MAPGuideⓇ)
Equitable Access Obligations in Product R&D Funding Agreements:
Best Practice Considerations
Best Practice Considerations
How do we approach best practice?
One of the most frequent questions we hear from the funder and PDP community is: “What are the best practice provisions that should be included in product R&D funding agreements?” However, instead of focusing on universal best practice language for agreements, GHIAA believes that best practice for product development funding agreements is ensuring that all issues that might have an impact on achieving the intended equitable access outcomes of the agreement have been considered and addressed as appropriate. The “Equitable Access Pyramid” shown below is a tool to aid such best practice approaches by presenting key building blocks for the translation of an equitable access policy into meaningful and measurable agreement provisions. Decisions as to which of these blocks should be addressed in a specific agreement and how, must take into account the type, stage of development and intended end users of the funded product.
The Equitable Access Pyramid
Equitable Access Policy
The Pyramid presents equitable access provisions as a series of layers, starting at the top with the general underlying principles of an equitable access policy that a medical product should be sustainably available and affordable to all those who need it, when they need it. The middle layer of the Pyramid identifies the types of agreement provisions that directly address the achievement of these equitable access goals by setting obligations related to the price, profile, regulatory strategy and supply of a funded product, as well as the management and sharing of related intellectual property, technology and data. The bottom, and equally necessary, layer of the pyramid contains the provisions that support the monitoring, evaluation and enforcement of equitable access obligations.
Each block in the Pyramid is linked to a more in-depth explanation of why the topic is important for achieving equitable access objectives and the different approaches that can be used to address the topic depending on the context, alongside illustrative examples of language that has been used in actual agreements. These in-depth explanations also provide insight into the interactions needed between the different blocks and layers of the Pyramid in order to develop an agreement that can be enforced, monitored and measured.
GHIAA’s recommendation for a best practice approach is that organizations use the blocks in the Equitable Access Pyramid, and the more detailed analysis behind each block, to form their own checklists and guidelines to follow when developing and negotiating product development funding agreements. This approach can support the creation of a template funding agreement containing a set of ‘ideal’ terms reflecting the context in which the organization operates. However, it is important to recognize that a signed agreement may not contain all of these terms, and that priorities need to be identified when preparing for an agreement negotiation.
‘Ideal’ and ‘must have’ provisions
Agreement negotiations depend on the relative negotiating leverage of each party, and flexibility will be required to reach a set of provisions that both parties can accept. When considering the blocks in the Equitable Access Pyramid, it is important for organizations to identify the ‘must have’ obligations which will enable the achievement of their equitable access goals. Provided that ‘must haves’ can be negotiated, then arriving at a signed agreement that does not contain all of a funder’s ‘ideal’ obligations does not mean that it will fail at achieving its goals, particularly if the alternative is no agreement and therefore no progress towards developing a product at all. However, funders and PDPs should identify milestones and metrics that enable them to demonstrate the impact of the negotiated agreement provisions on equitable access to the funded product.
Organizations should also consider maintaining records of how the blocks in the Equitable Access Pyramid were negotiated and addressed in signed agreements, including the rationale for accepting any variations from template or ‘ideal’ terms. This experience can then be leveraged to accelerate agreement negotiations in the future, minimizing the resource costs associated with protracted negotiations and shortening timelines for the commencement of product R&D activities.
The value of increased transparency
GHIAA advocates for greater transparency of agreement terms and outcomes to facilitate future negotiations and the development of common approaches across the field. Organizations within the global health community can support each other in achieving their equitable access goals by sharing the approaches that they have successfully taken to address the topics outlined in the Equitable Access Pyramid. While many provisions need to be specific to the context of an agreement, increased transparency of the approaches taken by different product development funders can contribute to the creation of certain equitable access norms or standards that product developers should expect to be attached to public or philanthropic funding. The development of this shared understanding can have an impact on the speed and efficiency of future agreement negotiations, as well as facilitating the implementation of these agreements by creating a more streamlined set of obligations with which product developers must comply, and for funders, PDPs and other stakeholders to monitor and evaluate.
Authors: Bridie Telford, Julia Barnes-Weise
First publication date: November 21, 2022