This procurement system is being used by six countries within the Gulf Cooperation Council (GCC), either occasionally, or to supply the majority of vaccines. The Kingdom of Saudi Arabia, the largest country in the GCC, and the administrative centre, is by far its largest user. A timeframe of approximately nine months is required from the first committee meeting held to establish which items will be required. In preparation for this process, pre-qualification of potential suppliers is required. The procurement process revolves around four committee meetings: pre-tender preparation, bid opening, adjudication and post-tender evaluation. All countries are represented at all meetings although individual members may vary according to the expertise required. The meetings require a consensus on specifications, but variations are allowed for quantities, deliveries and payment terms. Each country makes an independent assessment of needs and provides this forecast to the GCC Committee. Examples of demand forecasting are described below.

In Saudi Arabia each province makes a forecast for traditional vaccines, based on historical usage figures and making adjustments for observed problems, such as low or high stocks. Multiple dose vials may be considered for traditional products. The country has approximately 1700 sites offering immunization services, opening on average twice a week. This gives an average number of sessions per year of 170 000. As there are approximately 415 000 newborns each year, this means that the average number of clients per session will be 415000/170000 = 2.14. This very low number indicates that multiple dose vials would waste considerable amounts of vaccine if the client only receives one dose and the large vial is discarded at the end of the session. For measles, having two sessions per day (morning and evening) potentially adds additional wastage. The vial opened in the morning cannot be safely used for the evening session. This lowers the average number of clients per session to just over one. Single dose vials are thus the best choice.

In 1996, Oman switched to the Opened Vial Policy allowing for liquid vaccines to be used beyond a single session. The reductions in wastage resulting from this change have been significant. Prior to the introduction of the policy, wastage rates for DTP and OPV were about 50% and for TT, about 60%. After the policy was introduced, the wastage rates dropped to about 30% for DTP and OPV and 45% for TT, resulting in vaccine savings of about 20%. Wastage rates for measles and BCG remained unchanged at about 80%, as the new policy applied only to liquid vaccines.

Tendering

Countries make a selection of items based on recommendations from the immunization programmes. The addition or deletion of items follows an internal review by EPI technical committees, with experts invited for the items under discussion. New vaccines may be proposed by any country for inclusion in the GCC tender, but must be registered in more than one country. For new items or new approaches to immunization such as polio eradication, the quantities are decided nationally.

For new products, single dose presentations are usually chosen. Single dose presentations are more expensive but are safer, easier to administer and have minimal wastage with generally predictable usage. Countries may elect not to procure any item for their own use.

Specifications fall into two areas: those relating to the vaccine itself and those relating to the packaging items such as vials, boxes, monitors, and package inserts. The specifications and standards of the vaccine are covered separately. Specifications relating to non-vaccine items are generally contained within the technical conditions of the tender document. Specifications are standardized for all countries. No variation is allowed. This helps by allowing a final order of large quantities of standardized items but reduces country flexibility in their choice of items to meet programme needs. Specifications for the tender are made by a committee, which includes input from each of the six countries.

Supplier qualification and selection

Quality is first assured through a conservative licensing and pre-qualification system. Pre-qualification allows only companies with an excellent international reputation to be chosen. Awards are made based on expert knowledge and do not necessarily comply with the tender specifications. After tender opening, all offers are tabulated and details such as price, specification, registration, etc. are noted on a summary sheet. These tabulations are prepared by a committee with representatives from each country, and reviewed by an award committee, which includes representatives from each country. Awards are made based on the lowest price, tempered with comments from the tender opening committee. However, security of the immunization programme is the first concern.

Licensing

The system of licensing of immunobiologicals in the Kingdom of Saudi Arabia functions in a similar way to that for pharmaceutical products. That is, the registration dossier is submitted for review, a sample is submitted for testing, and the registration committee makes a decision based on the laboratory report and the file review. There is a requirement that the product be licensed in the producing country and by one or more recognized NRAs. While this system was set up for pharmaceutical products, it may not adequately address the inherent variability of biological products and the need for special expertise and procedures for their licensing. The staff of the licensing group rely on the Central Laboratory for Food and Drug Analysis (the national regulatory laboratory) for input into these decisions.

In Oman, vaccines are not licensed in the country; rather, a no objection letter is supplied to a local agent for importation. The choice of manufacturers from which to procure (through UNICEF, through the GCC tender, or by local tender) depends on recommendations from the immunization programme. The directorate is preparing to license vaccines, but currently, vaccines are selected from sources with which the immunization programme has already had good experience, that is, those used by UNICEF or the GCC. For pharmaceutical products, the licensing system is similar to that described for Saudi Arabia, with a provision for licensing products for which there are local agents. A free sale certificate must be provided, and three recognized NRAs must have licensed the product. This process will also be applied for vaccines in the future.

Receipt, release and surveillance

There are two aspects to release: lot release, which assumes a regulatory review to ensure that all quality standards have been met in the production of the specific vaccine lot, and receipt release, which refers to a check for compliance with the specifications of the tender, relying mainly on physical inspection. The former is the responsibility of the NRA, while the procurement agent or the immunization programme generally performs the latter.

In the case of vaccines procured through UNICEF, release is carried by staff of the Expanded Programme on Immunization (EPI), who arrange for clearance through customs and transport to the vaccine stores. The consignment is then checked carefully for compliance with the specifications of the order. There is a physical quarantine system. In the case of vaccines procured either by local tender or GCC tender, the local agents of the manufacturer are responsible for customs clearance. A Receiving Committee composed of staff from product registration, medical stores, and the pharmaceutical quality control laboratory takes the vaccines to the EPI cold store for quarantine pending clearance. They check to see if the product complies with specifications; if so, a receipt voucher is made to release payment to the manufacturer’s agent. The consignment is then cleared by EPI prior to use.

Each GCC country is able to include its own payment terms, delivery places and schedule. For some countries, this implies monthly shipments, while for others, shipments are on a less frequent basis. No problems were reported in maintaining a system with this degree of flexibility. As the process of tendering takes about nine months, the system will not be applicable in emergencies, but only for routine and predictable vaccine needs.

There are generally two instances when disputes may arise in a procurement procedure: on receipt of the vaccines, if they are found not to meet specifications, and if a problem is noted in the use of the vaccine in the field. In the case of the GCC system, dispute resolution is the responsibility of the procurement group.

A system of post-marketing surveillance is required for continuing assurance of the safety and efficacy of biological products, and to be able to provide data to the manufacturer should there be a problem with a procured vaccine. The system of monitoring and investigation of adverse events following immunization through EPI works well in Oman and provides a useful model for other countries.

Conclusions

In general, the GCC system has profited from the advantages of the group procurement system while not suffering from possible disadvantages. A system of group procurement may be useful for other country or regional groups and some countries may use combined mechanisms for procurement. However, it is important to respect the role of a competent and independent national regulatory authority working on behalf of the procurement system for the licensing and lot release of products included in the tender.

References

1. World Health Organization. Procurement of Vaccines for Public Sector Programmes - A reference Manual. WHO/V&B/99.12

2. World Health Organization. Guidelines for the Procurement of Vaccines and Sera. WHO/V&B/98.05.

3. GCC Procurement System.