Immunization, Vaccines and Biologicals

Vaccine Procurement

Vaccine procurement describes the activities of a country that are necessary to acquire vaccines domestically or internationally, utilizing specific procurement procedures and/or mechanisms.

The objective of vaccine procurement is to ensure that country programmes receive products of assured quality at affordable prices in a timely manner in order to optimize immunization programme performance and achieve their goals of reducing mortality and morbidity caused by vaccine preventable diseases.

Various approaches and tools are available to realize this objective, focusing on issues such as the diversification of the supply base, improved predictability of demand and reliability of suppliers, improved value for money, as well as performance monitoring. WHO supports an open and competitive approach to procurement that allows for the economical purchase of products of assured quality originating from manufacturers all over the world.

Vaccine Procurement is a specialized field that is different from the procurement of other pharmaceuticals and health products in several ways. Despite some similarities to other pharmaceuticals, vaccines possess a number of peculiarities which require specific consideration during the procurement process.

Vaccines vs. other pharmaceutical products

Vaccines are highly sensitive and complex biological products. The manufacturing process of vaccines involves the manipulation of living organisms and incorporates significant risks of production failures. Vaccines therefore depend on a highly regulated environment that ensures the strict enforcement of quality at all stages of the production, storage and transportation processes. Specific features such as the limited shelf life and temperature sensitivity of vaccines require careful stock and supply chain management that need to be taken into account during the whole procurement process.

Vaccines are in the most part government or donor funded, often with no official end user charge. Vaccines are mostly of a preventive nature and are administered to otherwise healthy individuals, most commonly children. The risks arising from poor quality vaccines are considerable. Adverse effects caused by using poor quality vaccines can destroy public confidence in immunization programmes and put lives at risk. Public acceptance of vaccination is highly dependent upon the quality of the vaccines used. Therefore, when procuring vaccines, contracts should never be awarded based on price only. Quality should always be of overriding importance.

In contrast to the pharmaceutical industry, the global vaccine market is limited to relatively few manufacturers and suppliers. Due to the biological nature of vaccines, there are no generic products as such, which is reflected in the high entry costs to manufacturers. At the present time, there are no more than 25 manufacturers that export significant quantities of vaccines prequalified by WHO. For the majority of vaccines there are only between one and five manufacturers for each specific product, with new vaccines often resulting in monopolies of supply.

The highly sensitive and complex nature of vaccines has implications for their manufacturing process. Since the production of vaccines involves biological processes, it can take 6-24 months to produce a single dose, depending on the type of vaccine. The increase of production capacities can take between 2 and 3 years, whereas the construction of a new plant from inception to production may take between 5 and 7 years. Furthermore, regulatory requirements and strategic considerations of companies following the worldwide introduction of new vaccines can affect availability.

Depending on products, it can take up to one year between the time when demand is confirmed with a manufacturer and the time that the vaccine is delivered to the country. While manufacturers may have existing inventory to meet the immediate needs of a buyer, it is often the case that supply is fully committed to existing purchasers and a new purchase order cannot be met immediately. Therefore, predictability of global and country demand is essential to ensure the timely delivery of vaccines and avoid constrained supply scenarios.

Complexity of vaccine procurement

The procurement of vaccines is a complex process that requires specialized knowledge in order to ensure their quality, as well as their sustainable, adequate and timely supply. Different procurement methods can affect the price and timely access to vaccines and it is essential to develop strategies that meet the individual vaccine markets in order to achieve optimal results. Good procurement practices allow countries to accurately forecast, plan, finance, conduct and monitor their purchasing system.

The individual market for each of the EPI and new vaccines is very different with specific characteristics applicable for each vaccine. The market for new vaccines, such as rotavirus, pneumococcal and HPV vaccine, has been growing over the past years, bringing increasing challenges to manufacturers as well as procuring countries. Operating within these markets requires good market knowledge and adaptation of procurement methods to optimize the chances of effective and efficient procurement. New vaccines are considerably more expensive than traditional vaccines and governments need to significantly increase their vaccine and immunization budgets when deciding to add new vaccines to their immunization programme. The introduction and purchase of new vaccines therefore needs to be approached very carefully, taking into account all budgetary, logistical and programmatic implications.

There are only a limited number of manufacturers producing new vaccines and purchasing countries need to effectively engage in long-term strategic planning in order to gain access to affordable and sustainable vaccine supply. Little to no competition on the supplier side, limited production capacities and a restricted variety in vaccine presentations pose a number of challenges to national immunization programmes. Consequently, strategic procurement approaches, which take into account multiple demand and supply dimensions as well as programmatic and regulatory aspects, are increasingly replacing the standard annual transactional purchase of products and related services.

Access to resources

In order to fully understand the complexities of vaccine procurement, it is essential to be familiar with the different forms of procurement mechanisms, best practices and available guidelines and standard operation procedures (SOP). Furthermore, it is important to understand the intricacies and peculiarities of the vaccine market as well as the complexities of vaccine pricing.

Highlights

28 November 2014