The government has decided that two levels of medicine reserves are to be established in Norway. A decision has been made in project B180 preparedness reserves (National Reserves of Medicines), owned by Helse Vest RHF and managed by Sjukehusapoteka Vest HF, that a national reserve must be established for several selected medicines.
The voluntary ex-ante transparency notice is for:
N05AD01, Haldol inj 5mg/ml, 5x1 ml, up to a total value of maximum AIP NOK 67,000,
N05AX08, Risperdal Consta inj subst 37,5mg, 25mg and 50mg, up to a total value of maximum AIP NOK 1,315,000,
N05AX13, Xeplion depotinj 100mg, 75mg and 150mg, up to a total value of maximum AIP NOK 6,050,000
for the National Preparedness Reserves, B180.
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 special pharmaceutical preparations ("LIS 2207c Parenteral medicines). The contest included the mentioned medicine, as the tender documentation annex 3 - 'Price Form' requested tenders for the active ingredient (the medicine or reasonable alternatives).
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, § 33a.
According to www.legemiddelsok.no, there are no other companies than Janssen-Cilag AS that have a current 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 Regulation § 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 Tenderer for the procurement of the medicines.
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.