Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2020-11-24
Buyer: Sykehusinnkjøp HF
Country: NO
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33600000: Pharmaceutical products
Estimated value: 300000 NOK
Award criteria: Lowest price

Technical requirements: The government has decided that establish two levels of medicine stand-by in Norway. A decision has been made in project B180 (National Stand-by Stores of Medicines), which is owned by Helse Vest RHF and managed by Sjukehusapoteka Vest HF, that a national stand-by must be established for several selected medicines. This means that stand-by stores must be developed as soon as possible. The time aspect is central to stand-by considerations and in light of the ongoing SARA-CoV-2 pandemic.
The voluntary ex ante transparency notice applies to injections of 10 mg/ml of morphine. ATC code: N02AA01.
Sykehusinnkjøp HF, medicines division (Sykehusinnkjøp), is procuring and obtaining tenders for health company financed medicines. Sykehusinnkjøp has been given a mandate to procure the medicine. Sykehusinnkjøp (Norwegian Hospital Procurement) has previously announced and held an open tender contest for parenteral pharmaceutical special preparations ('LIS 200c Parenteral Pharmaceutical Special Preparations’) (contest). The contest included the mentioned medicine, as the tender documentation annex 3 — 'Active Ingredients List' requested tenders for the active ingredient (the medicine or reasonable alternatives).
Sykehusinnkjøp therefore believes that there are grounds to make the procurement without a contest. The basis for the grounds are in accordance with the public procurement regulations, Section 13-4 a), c.f., Section 13-3.
Tenders were not received in the above-mentioned contest for the active ingredient in question (medicine or reasonable alternatives), and this part of the contest must therefore be marked as unsuccessful.
Sykehusinnkjøp has now examined which relevant medicines fulfil the regulatory requirements in Norway. If a medicine has a marketing licence in Norway, you cannot just procure an alternative medicine with a marketing licence in another country in the EU/EEA area. This is in the law on medicines, etc., Sections 8 and 10, sml. regulations on medicines chapter 2. This is further connected to Sykehusinnkjøp as a medicine intermediary having a right to its operations, c.f., the regulations on wholesaler operations with medicines, Section 33.
According to www.legemiddelsok.no there are no other companies that the Supplier that have a marketing licence for the medicine in Norway.
Sykehusinnkjøp has assessed that no other possible tenderers of the medicine will be able to fulfil the regulatory requirements in Norway (marketing licence in Norway), and be able to deliver so that the contract is fulfilled by the contracting authority's required date, and that there are no reasonable alternatives to the medicine.
It is, therefore, objectively impossible to hold an ordinary contest or a contest in accordance with the public procurement regulations, Section 13-3. The scope of the contract is not larger than necessary.
Based on this, Sykehusinnkjøp intends to enter into a contract between Helse Vest RHF and the Supplier for the procurement of the medicine.
Sykehusinnkjøp requests that those who have objections to this voluntary ex-ante transparency notice submit feedback before the waiting period, which is set to 10 days calculated from the day after the publication of the voluntary ex-ante transparency notice. If no objections are received, a contract will be signed after the waiting period has expired.
Sykehusinnkjøp HF, medicines division (Sykehusinnkjøp), is procuring and obtaining tenders for health company financed medicines. Sykehusinnkjøp has been given a mandate to procure the medicine. Sykehusinnkjøp has previously published and held an open tender contest for parenteral pharmaceutical special preparations (‘LIS 2001 Parenteral Pharmaceutical Special Preparations, call for tenders’). The tender includes the named medicine, as the tender documentation Appendix 3 — 'Active Ingredients List' tenders were requested for the active substance (the medicinal product or reasonable alternatives).
Sykehusinnkjøp therefore believes that there are grounds to make the procurement without a contest. The basis for the grounds are in accordance with the public procurement regulations, Section 13-4 a), c.f., Section 13-3.
Tenders were not received in the above-mentioned contest for the active ingredient in question (medicine or reasonable alternatives), and this part of the contest must therefore be marked as unsuccessful.
Sykehusinnkjøp has now examined which relevant medicines fulfil the regulatory requirements in Norway. If a medicine has a marketing licence in Norway, you cannot just procure an alternative medicine with a marketing licence in another country in the EU/EEA area. This is in the law on medicines, etc., Sections 8 and 10, sml. regulations on medicines chapter 2. This is further connected to Sykehusinnkjøp as a medicine intermediary having a right to its operations, c.f., the regulations on wholesaler operations with medicines, Section 33.


Winner: Takeda AS
Award value: 300000