Pharmaceutical products

Tender description

The government has decided that establish two levels of medicine reserves in Norway. A decision has been made in project B180 (National Reserves of Medicines), owned by Helse Vest RHF (the Western Norway Regional Health Authority) and managed by Sjukehusapoteka Vest HF, that a national reserve must be established for several selected medicines. This means that reserves must be developed as soon as possible. The time aspect is central to reserve considerations and in light of the ongoing SARA-CoV-2 pandemic. The Voluntary ex ante transparency notice applies to the delviery of Dexamethasone tablets, 4 mg. ATC-code H02AB02. Sykehusinnkjøp HF, medicines division 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 non-parenteral special pharmaceutical preparations ('LIS 2001b non-parenteral special pharmaceutical preparations' — the 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.