This issue is used to identify provisions that address the right of a national or regional purchaser of a global health product, particularly in pandemic times, to make donations of that product to other countries or regions. Donation provisions are particularly important in achieving global access to medicines in the context of agreements between manufacturers and higher income countries which provide for a supply volume in excess of that country’s needs, as has been the case for COVID-19 vaccines.

Questions to consider when developing a donation provision

• Should the purchaser be permitted to donate any of the product to third parties? If so, what are the circumstances under which donation is permitted?
• Must the donor ensure that the receiving country has certain capabilities such as a process for regulatory approval of the product?
• How are liability and indemnification requirements addressed?

Example approaches found in the MAPGuide

• Should the purchaser be permitted to donate any of the product to third parties? If so, what are the circumstances under which donation is permitted?
  • Some of the purchase agreements for COVID-19 vaccines and therapeutics in the MAPGuide, particularly those made by the UK or the European Commission, contain provisions that allow the donation of products to other countries or non-profit organizations. Restrictions placed on the circumstances under which donations may be made include:
    • Prior consent for the donation must be requested from the supplier;
    • Donated product should be that which is in excess of the purchaser’s own requirements; and/or
    • The transfer of the product must be at no profit.

• Must the donor ensure that the receiving country has certain capabilities such as a process for regulatory approval of the product?
  • Some donation provisions place responsibility on the purchaser to ensure that the country receiving the donation has appropriate regulatory and quality monitoring processes in place for distribution and use of the product.

• How are liability and indemnification requirements addressed?
  • Most of the MAPGuide provisions that permit donation of the product specify that the receiving country must agree to be bound by the same liability and indemnification obligations that are set out in the purchase agreement.