Influenza

Standard Material Transfer Agreements 2 (SMTA2)

The SMTA2 is one of the two PIP Benefit Sharing mechanisms. It is a legally-binding contract between WHO and an influenza product manufacturer, research institution, or other entity that receives PIP Biological Materials, such as influenza viruses with pandemic potential (IVPP), from a laboratory which is part of the Global Influenza Surveillance and Response System (GISRS).

In exchange for access to PIP Biological Materials, the entity commits to provide to WHO benefits resulting from their use. This includes specific items that can be used to prepare for (e.g. training, technology license) or respond to (e.g. vaccines, antivirals, diagnostic kits) pandemic influenza.

By concluding SMTA2s now, these legally binding advance supply contracts ensure WHO will have predictable access to pandemic vaccine and other products.

Who is required to sign an SMTA2?

Non-GISRS recipients of PIP biological materials must sign an SMTA2 with WHO.

The PIP Framework was recently amended to clarify certain terms in the SMTA 2. The text of the amendment is available below:

How are recipients of PIP biological materials traced and notified?

Transfers of PIP biological materials (including IVPP) are tracked through the Influenza Virus Traceability Mechanism (IVTM). The IVTM is a publicly accessible, online system that records the transfer and movement of PIP biological materials into, within and to parties outside the WHO GISRS.

Shipments of PIP biological materials (IVPP) are accompanied by a Shipping Notice informing recipients that in exchange for using the virus materials they are required to sign an SMTA2. A copy of this notice is available below:

The purpose of the SMTA2 is to obtain legally binding commitments from users of PIP biological materials (including IVPP) to share certain benefits with WHO. Recognizing that there are different types of recipients PIP biological materials, the signatories are classified into the following three different categories:

  • Category A: Influenza vaccine and antiviral manufacturers
  • Category B: Manufacturers of other pandemic related products (e.g. diagnostic kits)
  • Category C: All other recipients (universities, research institutions, bio-tech companies, etc.)

The recipients, depending on their nature and capacity, choose from the specific list of benefit options found in Annex 2, Article 4 of the PIP Framework and summarized in the table below.

Summary of the options available to each category of recipient of PIP Biological Materials:

Manufacturers of vaccines and/or antivirals (Category A)

To date WHO has concluded 13 agreements with vaccine and antiviral manufacturers and through these SMTA2s has secured approximately four times the amount of pandemic vaccine available during the H1N1 pandemic. These signatories include 5 multinational companies and the largest developing country manufacturer.

Manufacturers of other pandemic related products (Category B)

Under this category WHO is securing access to products such as diagnostic test kits, ancillary products as well as resources to conduct training. To date, agreements have been signed with 2 large diagnostic manufacturers, providing WHO with a supply of diagnostic kits and syringes during the next pandemic.

Academic & research institutions
(Category C)

To date WHO has concluded 70 agreements with academic and research institutions and, although not required, 29 have offered to provide a benefit-sharing contribution. Most of these institutions have offered to provide Laboratory and Surveillance Capacity Building (training) as their contribution.

To implement some of these training offers, WHO collaborated with the University of Siena, Italy, which offered to host a training workshop as its SMTA2 contribution.