Master Alliance Provisions Guide (MAPGuideⓇ)
Preparedness & Response
This issue identifies provisions related to activities that parties to an agreement should undertake in order to respond, or be ready to respond, to a disease outbreak or pandemic. Agreements may include definitions that establish when pandemic/outbreak provisions are triggered, and distinguish between obligations for the development and commercialization of ‘pandemic’ and ‘non-pandemic’ products. Preparedness and response provisions can play an important part in achieving global access because they define actions to be taken to ensure that medical products are available to the populations that need them by the time they are needed.
Questions to consider when developing an outbreak preparedness provision
- How should ‘outbreak’ or ‘pandemic’ be defined?
- What should be the scope of activities to prepare for an outbreak or pandemic?
- What should be the scope of activities in response to an outbreak or pandemic?
- How should the end of an outbreak/pandemic be determined, and should any obligations under the agreement change at that point?
- Should there be any difference in obligations on the parties between the outbreak/pandemic products and other products developed under the agreement?
Example approaches found in the MAPGuide
- The developer is required to use reasonable efforts to develop the funded product before any outbreak and to use all reasonable endeavors to develop the product for use in affected territories after an outbreak has been declared.
- The funder may request that the developer manufactures and maintains a ready reserve of clinical trial material, which may be used for further clinical trials to advance product development and for emergency use.
- In the event of an outbreak, the funder has the right, at its own expense, to direct the product developer to take certain actions including additional product development or manufacturing of a stockpile of investigational product (to be used for clinical trials in outbreak conditions).
- The developer is required to create and maintain a contingency plan, reasonably approved by the funder, to address possible impact of the COVID-19 pandemic on the funded project.
- “Pandemic Products” are products for an indication declared to be a pandemic by the WHO and/or a governmental authority, and purchased by a procurement agency. The Pandemic Products are subject to different terms to other products developed under the collaboration & license agreement, including specific collaboration plan and technology transfer plans, and an expedited results publication process. No additional royalties are payable if the licensee supplies the Pandemic Products to a third party at cost.