Assuring quality vaccines and immunisation products for countries that procure their own products with Gavi funds
Countries opting for self-procurement should only use Gavi funds to purchase vaccines and related injection safety devices (auto-disable syringes and disposal boxes) that meet international quality standards.
WHAT IS THE PURPOSE OF GAVI'S SELF-PROCUREMENT POLICY AND HOW DOES IT WORK?
Countries receiving Gavi’s new vaccine support have the following two options for the procurement of vaccines and vaccine devices:
- UNICEF or PAHO’s Revolving Fund procures vaccines using Gavi funds on behalf of Gavi-supported countries, or
- Gavi-supported countries can request the equivalent financial support from Gavi to be used for self-procurement.
Self-procurement of vaccines
Countries that prefer to self-procure vaccines using Gavi support must assure that international expectations of assured quality are met. Self-procured vaccines must either:
- be selected from the list of WHO pre-qualified products; or,
- comply with WHO’s definition of quality vaccines (as described in WHO’s Technical Report Series), where there are no unresolved quality problems reported to WHO. Compliance must be assured by fully functional National Regulatory Authorities (NRAs), as assessed by WHO, in both the country of manufacture and the country of purchase.
Self-procurement of related injection safety devices
Unsafe injections represent a well-established risk and there are no widely-applied national quality assurance mechanisms for these supplies, in the same way as there are NRAs for vaccines. Countries using Gavi funds to self-procure auto-disable syringes are required to procure products, which are pre-qualified under WHO’s Performance, Quality and Safety system.
For syringe and needle disposal boxes, countries self-procuring with Gavi funds must either:
- procure devices that appear on the relevant WHO list of prequalified products; or,
- submit a certificate of quality to WHO from a relevant national authority.
In addition to the application process and information regarding quality assurance, here are two important steps for a country to self-procure using Gavi funds:
- Review by Gavi or its designate of the proposed procurement mechanism to assess whether it adheres to the principles of good public procurement and the requirements of Gavi’s self-procurement policy;
- Recommendationson minimum reporting requirements and possible improvements.
Vaccines self-procured by countries as part of their co-financing obligation are beyond the scope of this policy. However, Gavi strongly encourages countries self-procuring co-financed vaccines and injection safety devices to ensure they are of WHO-defined assured quality, such as those on the WHO list of pre-qualified products or as otherwise described above and that the programmatic suitability of the product has been considered.
For additional information on quality assurance for self-procuring countries, click here.
WHEN WAS THE POLICY APPROVED AND WHEN WILL IT BE UPDATED?
The self-procurement policy was approved by the Gavi Board in June 2016. It formalised the existing guidelines on self-procurement as discussed by the Programme and Policy Committee in 2012. It will be reviewed at the request of the Board.