Contract production services for sterile stock products - notification of a new framework agreement with an existing supplier

Description

Sykehusapotekene HF (SAHF) currently has a framework agreement for contract production services for sterile stock products with Fresenius Kabi AS in Halden. The contract with Fresenius Kabi AS expires in the first half of 2022. SAHF now plans to enter into a renewed 4-year framework agreement for contract production services for sterile stock products. Sykehusapoteket Oslo, Rikshospitalet is the product owner of the products. This procurement is planned to be made as a direct procurement. Lot 1: Fresenius Kabi AS procures the raw product in the form of medicines in concentrate from SAHF and dilutes this in infusion bags to ready-to-use solutions. This is classified as stock production in accordance with the pharmacy regulations. The supplier thus has a production licence from Statens Legemiddelverk (SLV), and, in addition, a wholesaler licence. The products are sold directly to all the hospital pharmacies in Norway, which have a delivery obligation for medicine. Users are health personnel that treat patients at home and in the primary and specialist health service. The products are sold via hospital pharmacies nationwide to hospital wards, and possibly for use in nursing homes or home treatment. The rules for the import/export of the active ingredients/raw products (ATC groups B05B, N01A, N02A, V03A) require in practice that the supplier must be located in Norway. Sykehusapotekene HF knows the contract production market well, and carried out a thorough market survey in the pharmacy and medicine environment in 2017. We made an updated review of all companies with a production licence from SLV per 2022. We cannot see that there are any new suppliers in the Norwegian market that can offer this type of contract production services of sterile stock products. Our mapping indicates that there is currently only one manufacturer who has the necessary qualified premises, equipment and personnel in Norway to carry out contract production for a product portfolio that includes a-preparations and that are manufactured in accordance with the Pharmacist Act. The contract with Fresenius Kabi AS expires in the first half of 2022. SAHF now plans to enter into a renewed 4-year framework agreement for contract production services for sterile stock products. Sykehusapoteket Oslo, Rikshospitalet is the product owner of the products. This procurement is planned to be made as a direct procurement. SAHF believes that there is a legal basis to make a procurement without a contest in accordance with the public procurement regulations, section 13.