CAN - monoclonal antibody for RSV prevention - Directorate of Health

This is a contract award notice after having formerly published voluntary ex-ante transparency notice no. 23222. Description of the purchasing: The Chief epidemiologist (ID no. 7101695009) has obtained the approval of the Ministry of Health to purchase sufficient doses of long-acting monoclonal antibody against RSV to provide all children in …

CPV: 33600000 Produits pharmaceutiques
Lieu d'exécution:
CAN - monoclonal antibody for RSV prevention - Directorate of Health
Service d'adjudication:
Fjársýsla ríkisins
Numéro d'adjudication:
23222

1. Buyer

1.1 Buyer

Official name : Fjársýsla ríkisins
Legal type of the buyer : Body governed by public law
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : CAN - monoclonal antibody for RSV prevention - Directorate of Health
Description : This is a contract award notice after having formerly published voluntary ex-ante transparency notice no. 23222. Description of the purchasing: The Chief epidemiologist (ID no. 7101695009) has obtained the approval of the Ministry of Health to purchase sufficient doses of long-acting monoclonal antibody against RSV to provide all children in the target group with immunization over the 2025-2026 and 2026-2027 RSV seasons.
Procedure identifier : 9e15acaa-a81b-4890-8532-bb60181b80bd
Internal identifier : 23222
Type of procedure : Negotiated without prior call for competition
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33600000 Pharmaceutical products

2.1.2 Place of performance

Anywhere in the European Economic Area

2.1.4 General information

Legal basis :
Directive 2014/24/EU

5. Lot

5.1 Lot technical ID : LOT-0000

Title : CAN - monoclonal antibody for RSV prevention - Directorate of Health
Description : This is a contract award notice after having formerly published voluntary ex-ante transparency notice no. 23222. Description of the purchasing: The Chief epidemiologist (ID no. 7101695009) has obtained the approval of the Ministry of Health to purchase sufficient doses of long-acting monoclonal antibody against RSV to provide all children in the target group with immunization over the 2025-2026 and 2026-2027 RSV seasons.
Internal identifier : 23222

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33600000 Pharmaceutical products

5.1.2 Place of performance

Anywhere in the European Economic Area
Additional information :

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.10 Award criteria

Criterion :
Type : Price
Name :
Description : 100
Category of award weight criterion : Fixed value (total)
Award criterion number : 100
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Kærunefnd útboðsmála -
Information about review deadlines : 0

6. Results

Value of all contracts awarded in this notice : 1 Euro
Direct award :
Justification for direct award : The contract can be provided only by a particular economic operator because of an absence of competition for technical reasons
Other justification : Reasoning for purchase of medical product in ATC class J06BD08 for general immunization of children born May 1 2025 to March 31 2027 as was put forward in former VEAT notice: ''A critical criterion for products to be offered for inclusion in the Icelandic immunization schedule is marketing authorization in Europe. At this time, no long acting monoclonal antibody for RSV prevention other than Beyfortus® (nirsevimab, produced by Sanofi Pasteur), has marketing authorization in Europe. No other manufacturer would be able to offer in a tender procedure in that timeframe. The contract will be limited to two seasons without possibility of extension and without exclusivity. If the product results in as large a reduction in healthcare costs related to RSV disease in infants in Iceland as anticipated, a tender procedure will be initiated in early 2027, as other manufacturers may have entered the European market with comparable monoclonal antibodies to prevent RSV in young children at that time.'' The value of the awarded contract is confidential and is not one euro as the notice says.

6.1 Result lot ldentifier : LOT-0000

At least one winner was chosen.

6.1.2 Information about winners

Winner :
Official name : Sanofi Pasteur
Tender :
Tender identifier : Sanofi Pasteur
Identifier of lot or group of lots : LOT-0000
Value of the tender : 1 Euro
Subcontracting : No
Contract information :
Identifier of the contract : Sanofi Pasteur

6.1.4 Statistical information

Summary of the review requests the buyer received :
Number of complainants : 0
Received tenders or requests to participate :
Type of received submissions : Tenders
Number of tenders or requests to participate received : 1

8. Organisations

8.1 ORG-0001

Official name : Fjársýsla ríkisins
Registration number : 5402697509
Department : Procurement
Postal address : Katrínartún 6
Town : Reykjavík
Postcode : 105
Country subdivision (NUTS) : Höfuðborgarsvæði ( IS001 )
Country : Iceland
Contact point : Brynjar Steinn Haraldsson
Telephone : +3545457500
Roles of this organisation :
Buyer

8.1 ORG-0002

Official name : Kærunefnd útboðsmála
Registration number : 550169-1269
Postal address : Borgartúni 21
Town : Reykjavík
Postcode : 105
Country subdivision (NUTS) : Höfuðborgarsvæði ( IS001 )
Country : Iceland
Telephone : +354 575 8700
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : Sanofi Pasteur
Size of the economic operator : Large
Registration number : 1
Town : Lyon
Postcode : 69000
Country subdivision (NUTS) : Allier ( FRK11 )
Country : France
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0000

8.1 ORG-0004

Official name : Mercell Holding ASA
Registration number : 980921565
Postal address : Askekroken 11
Town : Oslo
Postcode : 0277
Country subdivision (NUTS) : Oslo ( NO081 )
Country : Norway
Contact point : eSender
Telephone : +47 21018800
Fax : +47 21018801
Internet address : http://mercell.com/
Roles of this organisation :
TED eSender
Notice information
Notice identifier/version : 81c29d40-4d2b-4768-a8d8-09dc03f2c2a4 - 03
Form type : Result
Notice type : Contract or concession award notice – standard regime
Notice dispatch date : 27/05/2025 13:11 +00:00
Notice dispatch date (eSender) : 27/05/2025 13:11 +00:00
Languages in which this notice is officially available : English
Notice publication number : 00347331-2025
OJ S issue number : 103/2025
Publication date : 30/05/2025