Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2018-09-18
Buyer: Amgros I/S
Country: DK
Contract type: Supplies
Procedure: Negotiated without a prior call for competition
CPV classification: 33600000: Pharmaceutical products
Estimated value: 4000000000 DKK
Award criteria: Lowest price

Technical requirements: Cystic fibrosis is a genetic disorder that affects mostly the lungs, but also the pancreas, liver, kidneys, and intestine. It is caused by the presence of mutations in both copies of the gene for the cystic fibrosis transmembrane conductance regulator (CFTR) protein. Today, patients with cystic fibrosis are mainly treated with pharmaceuticals which reduce the symptoms of cystic fibrosis without treating their underlying cause. Amgros wishes to enter into a contract ensuring that public hospitals in Denmark, Greenland and the Faroe Islands will be able to offer all their cystic fibrosis patients treatment with pharmaceuticals, which treat the underlying cause of cystic fibrosis (CFTR modulators).
Amgros will enter into a contract covering the need of supply of CFTR modulators in the treatment of all existing and future cystic fibrosis patients treated at public hospitals in Denmark, Greenland and the Faroe Islands. In order to ensure budget security, it will be required by the supplier to deliver all the pharmaceuticals needed at a fixed rate per year without regard to the number of cystic fibrosis patients or the number of products needed in their treatment. Furthermore, the contract shall cover both CFTR modulators already having a marketing authorization for Denmark as well as all future CFTR modulators (including but not limited to CFTR correctors and CFTR potentiators) in the portfolio of supplier which will be marketed during the term of the contract.
The contract will cover an initial period of 4 years. Amgros will have the option of prolonging the contract with up to additional 6 years.
The pharmaceutical company Vertex Pharmaceuticals has developed several unique pharmaceuticals which are able to correct the defective Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) channel. Vertex Pharmaceuticals is the only company in the world having a portfolio of such unique CFTR modulators, covering both the already marketed pharmaceuticals Orkambi (Lumacaftor/Ivacaftor), Kalydeco (Ivacaftor) and the products in development: Tezacaftor/Ivacaftor as well as the next generation CFTR modulator pharmaceuticals (triple combination products). Vertex holds several patents to these medicinal products. Each product is currently covered by at least one patent/supplementary protection certificate that expires in 2027 or later. Additional patent applications are currently pending which, if granted, would expire between at least 2029 and 2037. These pharmaceuticals cannot be substituted by other medicinal products and it will not be possible for parallel importers to meet the needs of Amgros for these products. Because of the above, Amgros considers Vertex Pharmaceuticals to be the only possible supplier for many years to come of CFTR modulators such as the pharmaceuticals mentioned above already marketed or under development by Vertex Pharmaceuticals. Consequently, the contract falls under the Danish Public Procurement Act section 80, 3 as the CFTR modulators can only be supplied by Vertex Pharmaceuticals due to the absence of competition for technical reasons and due to the protection of exclusive rights.
In relation to section V.2.1 please note that the date stated is the date of submission of this (voluntary ex ante transparency) note. The contract with Vertex Pharmaceuticals (Europe) Limited will not be entered into before the expiry of a standstill period of 10 calendar days counted from the day after the publication date of this (voluntary ex ante transparency) note.
The contract with Vertex Pharmaceuticals (Europe) Limited will not be entered into before the expiry of a standstill period of 10 calendar days counted from the day after the publication date of this (voluntary ex ante transparency) note.
Complaints may be lodged with the Danish Complaints Board for Public Procurement during the standstill period. Not later than at the time of lodging a complaint with the Danish Complaints Board for Public Procurement, the complainant must notify Amgros in writing that a complaint has been lodged with the Danish Complaints Board for Public Procurement and that the appeal was lodged during the standstill period, see section 6(4) of the Danish Act on the Complaints Board for Public Procurement, etc. (lov om Klagenævnet for Udbud m.v.) (the Act is available (in Danish) at www.retsinformation.dk).
Upon signing of the contract, a notice will be published in the Official Journal of the European Union that the contracting authority has entered into a contract. Complaint of Amgros having entered into the contract without prior publication of a contract notice must be lodged with the Danish Complaints Board for Public Procurement within 30 calendar days counted from the day after Amgros' publication of the notice in the Official Journal of the European Union that Amgros has entered into the contract, see section 7 (3) of the Danish Act on the Complaints Board for Public Procurement.


Winner: Vertex Pharmaceuticals (Europe) Limited
Award value: 4000000000