MAPGuideⓇ: Equitable Access Toolkit
Best Practice Considerations for Equitable Access Provisions
There is no “one-size-fits-all” approach to developing equitable access provisions. Instead, a best practice approach requires consideration of the full range of rights and obligations that may be appropriate given the specific context and goals of an agreement. At a high level, factors impacting the equitable access provisions in an agreement may include:
Agreement partners
Agreement type & scope
Product characteristics
Development stage
What are the capabilities of each of the parties to the agreement?
How do the activities under the agreement align with each party’s mission and objectives, including their commitments to equitable access?
What activities is the agreement intended to cover?
How is the agreement intended to contribute to achieving equitable access to an end product?
What would be a successful outcome for the agreement?
What factors are most likely to affect equitable access?
Which therapeutic areas and patient populations will the product address?
What are the relevant regulatory and procurement pathways?
What access commitments can be agreed at the point of agreement signature based on: (i) what is known about the product at that time; and (ii) the stage(s) of product development that the agreement is intended to cover?
The Equitable Access Pyramid: a tool to support best practice
GHIAA’s “Equitable Access Pyramid” is a tool to aid best practice approaches by presenting key building blocks for the translation of equitable access objectives into meaningful and measurable agreement provisions.
The Pyramid organizes equitable access provisions into three interconnected layers:
Equitable access objectives: high level objectives related to the sustainable availability of an affordable and appropriate product.
Access provisions: the different types of agreement provisions that can directly address the achievement of these equitable access objectives.
Supporting provisions: provisions that support the monitoring, evaluation and enforcement of equitable access obligations.
Equitable Access Objectives
Access Provisions
Supporting Provisions
- Why the topic matters for achieving equitable access objectives
- Different approaches that can be used depending on context
- Illustrative examples of language from actual agreements
- How provisions interact across different blocks and layers to create enforceable, measurable, and implementable access commitments
- Why the topic matters for achieving equitable access objectives
GHIAA’s recommendation for a best practice approach is that organizations use the blocks in the Equitable Access Pyramid, as well as the more detailed analysis behind each block, to form their own checklists and guidelines for developing and negotiating access provisions, as appropriate for their agreements.
‘Ideal’ and ‘must have’ provisions
While organizations may develop ‘ideal’ or model access provisions for their agreements using the approach recommended above, agreement negotiations depend on the relative negotiating leverage of each party. A degree of flexibility is therefore 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 access commitments were negotiated in signed agreements, including the rationale for accepting any variations from model 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 access provisions and their resulting impact. Such increased transparency can enable better coordination between stakeholders in the access roadmap for a product, supporting more efficient use of resources and reducing timelines for achieving access to an end product. Further, greater visibility of access commitments made, how they were fulfilled, and if they resulted in the intended contribution to equitable access can provide insight into which provisions really work in practice. This knowledge can be leveraged to facilitate more aligned approaches to access across stakeholders and accelerated agreement negotiations focused on effective access provisions.
What types of R&D agreements might need to include access provisions?
How will the access provisions in an individual agreement be aligned with end-to-end access 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.