Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2022-02-25
Buyer: Sykehusapotekene HF
Country: NO
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33141614 | 33600000: Pharmaceutical products | 33692000 | 33692510
Estimated value: 120000000 NOK
Award criteria: Lowest price

Technical requirements: Contract production services for sterile stock products - notification of a new framework agreement with an existing supplier
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.
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.
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 13-4 (2). We believe that a contest is impossible due to technical reasons as there are no reasonable alternatives and the lack of competition is not due to the contracting authority having adapted the procurement documents for a specific service provider. Technical reasons mean that there is only one tenderer who can carry out the service or produce the product.
It is not probable that any new contract producer will be able to establish and get the necessary authority certifications for equivalent production in time for the contract to be signed with Sykehusapotekene HF. Sykehusapotekene HF also fears delivery lapses and, as an extreme consequence, this can affect patient safety if we have to wait for a public procurement and facilitate so that a new actor is able to establish equivalent production premises in Norway before a contract can be signed. The contract that will be signed will be based on an existing contract.
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 13-4 (2). We believe that a contest is impossible due to technical reasons as there are no reasonable alternatives and the lack of competition is not due to the contracting authority having adapted the procurement documents for a specific service provider. Technical reasons mean that there is only one tenderer who can carry out the service or produce the product.
It is not probable that any new contract producer will be able to establish and get the necessary authority certifications for equivalent production in time for the contract to be signed with Sykehusapotekene HF. Sykehusapotekene HF also fears delivery lapses and, as an extreme consequence, this can affect patient safety if we have to wait for a public procurement and facilitate so that a new actor is able to establish equivalent production premises in Norway before a contract can be signed. The contract that will be signed will be based on an existing contract.


Winner: Fresenius Kabi Norge AS
Award value: 120000000