Master Alliance Provisions Guide (MAPGuideⓇ)
This issue is used to identify provisions that address the right of a 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 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 is liability and indemnification addressed?
Example approaches found in the MAPGuide
- The purchaser is permitted to donate product in excess of its own requirements to other organizations at no profit.
- Donation of product, either to other countries or via NGOs or the WHO is only permitted with the prior consent of the supplier. Consent will not be unreasonably withheld, but the purchaser must ensure that the receiving country: (i) will fully assume liability obligations; and (ii) has the necessary regulatory/quality/GMP/GDP process in place.
- The purchaser (the EU) may donate excess product to lower and middle income countries or public institutions. It may also donate product to other European countries if the receiving country agrees to be bound by the applicable terms of the purchase agreement.