Standard Material Transfer Agreements 2 (SMTA2)
Under the PIP Framework, a non-GISRS institution that receives PIP biological materials (referred to as ‘PIP BM’ and defined in section 4.1 of the Framework) from a GISRS laboratory is required to conclude an SMTA 2 with WHO. The SMTA2 is a contract that ensures that manufacturers and research institutions that receive PIP BM share with WHO some of the benefits arising from their access to the PIP BM. The SMTA2 requires the manufacturers receiving PIP BM select among several benefit-sharing options that are identified in the model SMTA2 found in Annex 2 of the PIP Framework, and that research institutions consider providing a benefit. Benefits include pandemic influenza vaccines, antiviral medicines and other pandemic related products or technologies. The specifics of each agreement depend on the nature and capacity of the recipient.
WHO will conclude an SMTA2 with each non-GISRS institutions that has received PIP BM. Given the time it takes to negotiate an agreement, and in order to ensure that PIP BM continue to be shared before an agreement is signed, WHO has put in place a system to allow institutions to continue to receive PIP BM during this period.