MAPGuideⓇ
Equitable Access Toolkit
License Agreement Provisions to Facilitate Development of Appropriate Products
Agreement provisions that can facilitate development of products that are appropriate for use by the relevant patient populations and in the access territory include:
Is the importance of access to appropriate and quality assured products acknowledged as part of the overall access objectives for the agreement?
What is the intended field of use for the licensed product or technology?
How will product development activities align with a target product profile?
How will the design of any clinical trials under the agreement consider the settings and populations for which the end product is intended to be made available?
Will the scope of the agreement include training or community engagement activities to support appropriate use of the licensed product once it is approved for use? Are there any stewardship considerations for the product?
What best practice guidelines and standards will the licensee comply with for the development and manufacturing of a quality-assured end product?
How could project results, data and/or materials be made available to the scientific community to support implementation research?
Will factors impacting product appropriateness be addressed as part of an evolving access plan for the product?
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.
