The cycle of vaccine procurement
How to select suppliers?
The supplier selection for vaccine procurement is the assessment of commercial and technical suitability of prospective vaccine suppliers. This selection is also divorced from specific procurement contracts. The aim is to develop a list of reliable, reputable and technically competent suppliers of each vaccine from which the procurement entity can solicit bids for specific vaccines on an as-needed basis. Unless the procurement entity has concerns about the commercial viability of a manufacturer, the list of selected vaccine suppliers should include each vaccine producer that has a product which has been prequalified (i.e., licensed) by the country's NRA, but only for that specific product. The purpose of compiling such a list is to ensure a pool of commercially and technically reputable and competent suppliers from which vaccines can be purchased. The list may also include prospective “suppliers who are not manufacturers” from which licensed vaccines may be purchased. (Appropriate quality assurance documents from the manufacturer will always be required.)
Senior procurement staff and ministry officials normally participate in the assessment of potential non-manufacturing vaccine suppliers. The business and management aspects of this second level pre-qualification are not appropriate areas of concern for NRA’s; however, they must be consulted on all technical matters Once a producer has been selected, this status remains so unless a particular reason arises for a review. However, it is also appropriate that reviews of producers and vaccines be undertaken every few years (3 to 5) to ensure that pre-qualification standards are maintained or earlier should an event trigger an earlier review.
Selection of suppliers should be made in advance of any contracting process. Selection should not be carried out each time a contract is to be placed.
Selection opportunities may be advertised on a periodic basis by the procurement entity If the government deems it appropriate to canvass additional suppliers for prequalification, it may publicly advertise an invitation to bid for prequalification such as through an Express on Interest (EOI) process.
Selection questionnaires that have been approved by the NRA of the purchaser’s country may be sent to known, reputable manufacturers and suppliers of specific vaccines required by the immunization programme, as well as to prospective suppliers that respond to the advertisement.
The sample selection questionnaire is available as a guide (LINK) it combines enquiries appropriate to manufacturers as well as non-manufacturing suppliers. It is designed to reveal the exact activities of each applicant, as these can sometimes be unclear and may sometimes be deliberately misrepresented.
Before conducting a supplier selection process the following steps should be established:
- Determine whether a selection exercise is necessary (procurement entity)
- To increase the number of licensed vaccines of the required types (licensing of vaccine by the purchaser’s NRA is mandatory under WHO guidelines)
- To increase the number of qualified suppliers for each vaccine
- Manufacturers
- Manufacturer’s licensed representatives
- To eliminate unsuitable potential suppliers
- To eliminate offers of unacceptable or inferior products
- To reduce the number of tenders to be evaluated and compared
- To provide a basis for rejecting unsolicited offers
- Ensure there is sufficient time to conduct this process prior to the tendering process.
- Develop selection criteria for suppliers who are not manufacturers of the licensed vaccine (with advice from the purchasing entity’s NRA if applicable). For example:
- In business for at least 5 years (desirable but not mandatory) Financially stable
- Direct relationship with manufacturer of the pre-qualified vaccine (essential)
- Currently registered as business entity in country of domicile
- Currently registered as business entity in country of purchaser
- History of satisfactory business with at least five similar customers
- List documentation that will be required to establish supplier's appropriateness. For example:
- Business history
- Financial references and annual report
- Proof of legal representation agreement with manufacturer
- Proof of business registrations
- Customer references
In addition to setting certain criteria regarding commercial and financial eligibility of a supplier, other factors to evaluate include:
- current licenses or permits, including other countries where licensed to sell and certificate of registration in country of origin;
- date of last inspection for Good Manufacturing Practices (GMP) and certificate of proof;
- information on bulk quantities or vaccines produced and/or exported, including filling, labeling and packaging capabilities;
- registration status with NRA for each product for sale;
- quality control data, including production and quality control summary protocols.
- Develop a selection questionnaire and instructions for use in initial contact with unregistered vaccine manufacturers and non-manufacturing suppliers.
- Evaluate technical and commercial merit of applicants
- Review completed selection questionnaire and attachments
- Check references
- Seek assistance/concurrence from National Regulatory Authority
- Notify qualified applicants
- Advise, as necessary, on next steps for licensing/registration of vaccines offered for sale
- Advise as required on any steps required for formal licensing or registration of supplier
- Notify unqualified applicants
Last updated: 9 October 2008