Provision Database

Issue Introduction: Access Plans & Principles

This issue refers to provisions that acknowledge the equitable access objectives of a project and require product developers to act in accordance with a set of access policies. To support compliance with these policies, some agreements may also require the development of an access plan which details the actions to be taken to ensure that the funded product is made accessible to populations in need.

Questions to consider when developing an Access Principles provision

  • How should equitable or global access be defined?
  • Should the developer be required to comply with an equitable access policy?
  • Should the developer be required to establish an access plan?

Example approaches found in the MAPGuide

  • How should equitable or global access be defined?  Different ways in which ‘access’ is defined in agreements in the MAPGuide include:
    • Prompt and broad dissemination of knowledge and making funded products available and accessible at an affordable price.
    • Making a medical product available first to populations at risk when and where they are needed at affordable prices.
  • Should the developer be required to comply with an equitable access policy?
    • A number of agreements in the MAPGuide agreements state that the development, exploitation and commercialization of a funded product must be conducted in accordance with the funder’s equitable access policy. Some organizations have also referred to this as an ‘access, not excess’ policy.
    • Some agreements, particularly those related to equity investments by a global health funder, include a set of global access commitments. These can include commitments from the developer to collaborate with the funder on a certain number of product development projects, publish project results and share data with the funder, and manufacture a certain number of product doses for use in certain ‘access countries’.
    • In addition to requiring compliance with certain policies, some MAPGuide provisions also state that the developer may not enter into any arrangements that would restrict the funder’s rights in relation to the access commitments made. The commitments will also survive acquisition of, or change of control in, the developer.
    • Some licensing agreements contain provisions stating that the licensor will require any sublicensees that commercialize the licensed product will do so in a manner that facilitates widespread availability.
  • Should the developer be required to establish an access plan?
    • Some agreements in the MAPGuide require the creation of ‘project’, ‘equitable access’, ‘global access’ or ‘stewardship and access’ plans/strategies including product development & marketing plans, plans for product registration in access countries, and pricing for access countries. These plans may also require the identification of relevant intellectual property and approaches for sharing this IP along with other data and materials.
    • The development of a full access plan may be left to a certain phase of the project, for example, some agreements state that the plan will be developed when a product enters pivotal clinical trials (usually a Phase III trial for vaccines and therapeutics). 
    • Access plans are not usually made publicly available, however the MAPGuide does include an example of a requirement for access plans to be published.

Related MAPGuide Commentaries & Resources