Framework contract in cascade for the implementation of pharmaceutical legislation and data-driven policy for medical products

The subject of this call for tenders is to establish a framework contract (FWC) to support the European Commission in its activities to inform and shape policy making related to the medical products sector (mainly medicinal products and medical devices). The objective of the FWC is to procure, by means …

CPV: 79400000 Business and management consultancy and related services, 79310000 Market research services, 79330000 Statistical services
Deadline:
Nov. 26, 2024, 5 p.m.
Deadline type:
Submitting a bid
Place of execution:
Framework contract in cascade for the implementation of pharmaceutical legislation and data-driven policy for medical products
Awarding body:
Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Award number:
HADEA/2024/OP/0029

1. Buyer

1.1 Buyer

Official name : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Legal type of the buyer : EU institution, body or agency
Activity of the contracting authority : General public services

1.1 Buyer

Official name : EC - European Commission
Legal type of the buyer : EU institution, body or agency
Activity of the contracting authority : General public services

2. Procedure

2.1 Procedure

Title : Framework contract in cascade for the implementation of pharmaceutical legislation and data-driven policy for medical products
Description : The subject of this call for tenders is to establish a framework contract (FWC) to support the European Commission in its activities to inform and shape policy making related to the medical products sector (mainly medicinal products and medical devices). The objective of the FWC is to procure, by means of multiple specific contracts, timely and high-quality services to ensure that the Commission has, when needed, access to sector specific data and specialised economic expertise on medical products to support policy decision making. The work envisaged would involve data gathering and economic analysis of large data sets as well as relevant contextual and sectoral/company account data. The work will aim to provide insight to the Commission on the medical products sector such as on how well relevant policies/legislation are performing and how changes in the regulatory framework affect the functioning and structure of the markets including market actors as well as products on the market and their use. Relying on both quantitative and qualitative data, the work will include economic and other analysis of the market development including factors that influence pricing, competition, and market structure and the interaction of key healthcare actors (including patients, healthcare providers, public payers and industry), and the actors within supply chains.
Procedure identifier : e2008b62-720f-4015-92cd-bf8538f5ad5e
Internal identifier : HADEA/2024/OP/0029
Type of procedure : Open
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 79400000 Business and management consultancy and related services

2.1.3 Value

Estimated value excluding VAT : 6 000 000 Euro

2.1.4 General information

Additional information : In case of unavailability or disruptions in the functioning of the electronic means of communication provided in Section 5.1.11 in the last 5 calendar days before the time limit for receipt indicated in Section 5.1.12, the contracting authority reserves the right to extend this time limit and publish the extension at the Internet address provided in Section 5.1.11, without a preceding publication of a corrigendum to this notice. Economic operators interested in this procurement are invited to subscribe to the call for tenders at the address in Section 5.1.11 in order to get notified when new information or documents are published.
Legal basis :
Regulation (EU, Euratom) 2018/1046

2.1.6 Grounds for exclusion

Bankruptcy : For the full list of exclusion grounds please consult the procurement documents.

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Framework contract in cascade for the implementation of pharmaceutical legislation and data-driven policy for medical products
Description : The subject of this call for tenders is to establish a framework contract (FWC) to support the European Commission in its activities to inform and shape policy making related to the medical products sector (mainly medicinal products and medical devices). The objective of the FWC is to procure, by means of multiple specific contracts, timely and high-quality services to ensure that the Commission has, when needed, access to sector specific data and specialised economic expertise on medical products to support policy decision making. The work envisaged would involve data gathering and economic analysis of large data sets as well as relevant contextual and sectoral/company account data. The work will aim to provide insight to the Commission on the medical products sector such as on how well relevant policies/legislation are performing and how changes in the regulatory framework affect the functioning and structure of the markets including market actors as well as products on the market and their use. Relying on both quantitative and qualitative data, the work will include economic and other analysis of the market development including factors that influence pricing, competition, and market structure and the interaction of key healthcare actors (including patients, healthcare providers, public payers and industry), and the actors within supply chains.
Internal identifier : HADEA/2024/OP/0029

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 79400000 Business and management consultancy and related services
Additional classification ( cpv ): 79310000 Market research services
Additional classification ( cpv ): 79330000 Statistical services

5.1.3 Estimated duration

Duration : 48 Month

5.1.4 Renewal

The buyer reserves the right for additional purchases from the contractor, as described here : The framework contract is concluded for an initial period of 24 (twenty-four) months, renewable 1 (one) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 6 000 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : EU4Health Programme (2021/2027)
The procurement is covered by the Government Procurement Agreement (GPA) : yes
Information about previous notices :
Identifier of the previous notice : 439399-2024

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Weight (percentage, exact) : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
Weight (percentage, exact) : 30
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 26/11/2024 17:00 +01:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 27/11/2024 14:00 +01:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union
TED eSender : European Commission

8. Organisations

8.1 ORG-0001

Official name : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Registration number : HADEA
Department : HADEA - Directorate of HaDEA,HADEA.A - Health and Food,HADEA.A.2 - EU4Health/SMP Food
Postal address : COV2, Place Charles Rogier 16
Town : Brussels
Postcode : B-1210
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Internet address : https://hadea.ec.europa.eu
Roles of this organisation :
Buyer
Group leader
Central purchasing body awarding public contracts or concluding framework agreements for works, supplies or services intended for other buyers

8.1 ORG-0002

Official name : EC - European Commission
Registration number : COM
Postal address : Office SC 14 8/64
Town : Brussels
Postcode : B-1049
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Internet address : https://hadea.ec.europa.eu
Roles of this organisation :
Buyer

8.1 ORG-0003

Official name : Court of Justice of the European Union
Registration number : CURIA
Postal address : Rue du Fort Niedergrünewald
Town : Luxembourg
Postcode : L-2925
Country subdivision (NUTS) : Luxembourg ( LU000 )
Country : Luxembourg
Telephone : +352 4303-1
Internet address : http://curia.europa.eu
Roles of this organisation :
Review organisation

8.1 ORG-0004

Official name : European Commission
Registration number : EUCOM
Postal address : Mondrian (CDMA), Rue du Champ de Mars 21
Town : Brussels
Postcode : B-1050
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Roles of this organisation :
TED eSender

10. Change

Version of the previous notice to be changed : a4286929-d207-4f49-bdba-52bef5f41e5a-01
Main reason for change : Information updated
Description : Extension deadline and opening date

11. Notice information

11.1 Notice information

Notice identifier/version : e23e32f2-662d-489d-98b8-2cbbcfad8aed - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 06/11/2024 11:31 +01:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00678954-2024
OJ S issue number : 217/2024
Publication date : 07/11/2024