1.1.

Buyer

Official name: Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency

Email: hadea-procell@ec.europa.eu

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

Email: hadea-procell@ec.europa.eu

Legal type of the buyer: EU institution, body or agency

Activity of the contracting authority: General public services

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

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: 6 000 000,00 EUR

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.

5.1.

Lot: 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, 79330000 Statistical services

5.1.3.

Estimated duration

Duration: 48 Months

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: 6 000 000,00 EUR

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