This issue refers to provisions that establish actions to be taken by the agreement parties in order to respond, or be ready to respond, in the event of a disease outbreak or pandemic. 

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 at 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

• How should ‘outbreak’ or ‘pandemic’ be defined?
  • Agreements in the MAPGuide including a definition of “Outbreak” generally state that an outbreak has occurred if either WHO declares a Public Health Emergency of International Concern (PHIEC), or a national government declares a public health emergency on a national or regional scale. Some agreements additionally state that the definition is limited to a material increase or higher than expected frequency of people infected with a disease within the scope of the agreement.

• What should be the scope of activities to prepare for an outbreak or pandemic?
  • Some agreements in the MAPGuide include the concept of “Increased Outbreak Preparation Need” to take into account a need for additional activities or product availability even if the conditions to fulfill the definition of “Outbreak” have not occurred. The obligations on the product developer if an Increased Outbreak Preparation Need is identified are usually the same as those for an outbreak.
  • In recognition of the need to respond rapidly in the event of an outbreak, some funding agreements in the MAPGuide require the product developer to appoint a third party that would be willing and able to participate in outbreak response activities (sometimes referred to as a “Trusted Collaborator”). The developer must conduct a technology transfer to the Trusted Collaborator to enable continued product development and/or manufacturing during an outbreak if the developer declines to do so.
  • In addition, some funding agreements require the developer to manufacture and maintain a ready reserve of clinical trial material and or a stockpile of “Investigational Product” (i.e. a product that has not yet received regulatory approval), which could be used under an emergency use authorization or for clinical trials in the event of an outbreak.

• What should be the scope of activities in response to an outbreak or pandemic?
  • Development funding agreements in the MAPGuide include rights for funders in the event of an outbreak such as:
    • Directing the product developer to undertake additional product development or stockpile manufacturing (at the funder’s expense);
    • Directing the product developer not to proceed with, or to discontinue, a clinical study in an outbreak area if the funder identifies that there is another product with greater potential of success
    • Asking the product developer to enter into a project to develop a new vaccine on the same platform to be used in outbreak response. If the developer declines, then the funder may exercise the Public Health License under the agreement.
  • Most of the agreements in the MAPGuide that include outbreak response provisions require the product developer to make reasonable efforts to manufacture the product during the outbreak at an acceptable price within an acceptable timetable. Other potential obligations on the developer include clinical trial activities such as collecting & sharing trial subject information, negotiation of clinical trial contracts, independent ethics reviews and implementing prepared clinical trial designs.

• How should the end of an outbreak/pandemic be determined, and should any obligations under the agreement change at that point?
  • One approach illustrated in the MAPGuide is that the “Pandemic Period” is declared to be over when it ceases to be a WHO-declared PHEIC. At the end of the Pandemic Period, the developer must continue to manufacture the product to fulfill the requirements of a supply agreement to be negotiated with a global allocation body.

• Should there be any difference in obligations on the parties between the outbreak/pandemic products and other products developed under the agreement?
  • Some agreements in the MAPGuide have different terms for pandemic products (e.g. COVID-19 vaccines and therapeutics) that are added to existing framework agreements. For example:
    • Separate collaboration and technology transfer plans;
    • Expedited results publication processes; or
    • Removal of royalty payments if the products are supplied to third parties at no profit.