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HERA Stakeholders Hub

Privacy Statement

Introduction

The European Commission (hereafter ‘the Commission’) is committed to protect your personal data and to respect your privacy. The Commission collects and further processes personal data pursuant to Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data (repealing Regulation (EC) No 45/2001).

This privacy statement explains the reason for the processing of your personal data, the way we collect, handle and ensure protection of all personal data provided, how that information is used and what rights you have in relation to your personal data. It also specifies the contact details of the responsible Data Controller with whom you may exercise your rights, the Data Protection Officer and the European Data Protection Supervisor.

The information in relation to processing operation “Access administration and stakeholder engagement – HERA Stakeholder Hub” undertaken by Directorate-General Health Emergency Preparedness and Response Authority (HERA), Unit 03 (HERA.3), is presented below.

Why and how do we process your personal data?

The Communication on addressing medicines shortages in the EU (COM(2023) 672 final), adopted on 24 October 2023, sets out a comprehensive framework of short- and long-term actions to address medicine shortages and enhance the security of supply across the EU. Its objective is to provide predictability, foster resilience, and ensure a coordinated approach with stakeholders at both the EU and global levels, particularly in relation to critical medicines (CMs) and medical countermeasures (MCMs).

In this context, the European Commission, through the Health Emergency Preparedness and Response Authority (HERA), has committed to developing communication tools that improve supply and demand forecasting, strengthen stakeholder networks and partnerships, and enhance coordination across the healthcare ecosystem. Specifically, HERA has been mandated to establish a matchmaking platform, enabling economic operators and developers to flag their capabilities and collaboration needs. This platform is a key measure to mitigate critical medicine shortages, particularly in the immediate and short term.

This mandate aligns with the Commission Decision of 16 September 2021 establishing HERA, which outlines HERA's role in improving preparedness and response to serious cross-border health threats. According to Article 1(a) of this Decision, HERA is tasked with strengthening health security coordination within the Union, both during preparedness and crisis response periods, and bringing together Member States, industry, and other relevant stakeholders in a common effort. Moreover, Article 2(c) entrusts HERA with addressing market challenges and boosting the EU's open strategic autonomy in the production of medical countermeasures.

To support these objectives, the HERA Stakeholders Hub was established as a secure, interactive platform. It serves as a centralised ecosystem for stakeholders—such as companies, NGOs, research institutions, and public health bodies active in the healthcare and pharmaceutical sectors—to collaborate and engage with HERA and each other. The Hub facilitates:

  • Streamlined communication: Providing a single point of access for stakeholders to submit requests and inquiries.
  • Networking and matchmaking: Enabling connections for industrial and research collaborations.
  • Governance for CMA and JICF Members: Supporting secure interaction and information exchange for members of the Critical Medicines Alliance (CMA; Critical Medicines Alliance - European Commission) and Joint Industrial Cooperation Forum (JICF; Commission Decision C(2021)6712, Art. 4 (2).

Specifically, the portal hosts the following functionalities:

  1. Inform HERA: The Hub allows stakeholders to contact HERA through a single, streamlined channel. Previously, stakeholders navigated multiple mailboxes, websites, and points of contact for different HERA activities. The Hub centralises these processes, enabling stakeholders to submit meeting requests, questions about funding opportunities, and inquiries about policy measure; share information on innovative projects in the MCM sectors; apply for membership in initiatives such as the CMA and JICF.

    Requests are submitted via secured, encrypted forms, ensuring confidentiality and compliance with data protection regulations. HERA directly receives these requests, acts upon them, and coordinates responses.

  2. Matchmaking Platform: The Hub provides an interactive matchmaking tool, allowing economic operators and developers to flag collaboration needs or supply chain gaps. Stakeholders can post organisational profiles; search for partners based on specific criteria (e.g., supply chain collaboration or research projects); communicate privately through secure channels.

    HERA facilitates this process by establishing governance rules for platform use but does not monitor or assess uploaded content. Users independently manage their interactions and decide on collaborations based on their individual criteria. All exchanges occur through private channels visible only to the concerned parties. 

  3. Virtual Spaces for CMA and JICF Members:
    The Hub includes secure virtual spaces for CMA and JICF members to:
    1. Access and contribute to a repository of strategic documents.
    2. Retrieve meeting materials, cast votes, upload revised documents, and post comments on consultations.

HERA acts as a facilitator and coordinator, uploading relevant materials and managing access to ensure secure and structured interaction. Comments and feedback submitted during consultations are visible to all group members, but only organisational data (e.g., affiliation) is shared.

Purpose of the processing: HERA.3 processes your personal data for the following purposes:

  1. User Profile Setup and Access Management: to ensure secure access to platform functionalities such as matchmaking, Inform HERA forms, and CMA/JICF virtual spaces, HERA verifies user identities and organisational affiliations through the following methods:
    1. Fetching information from the Organisation Management System (OMS): Users can register their organisations by linking to the European Medicines Agency’s Organisation Management System (OMS) (OMS; SPOR Web UI). OMS provides a single source of validated organisation and location data (OMS Dictionary), supporting EU regulatory activities and business processes. Netcompany, as part of the maintenance activities, cross-references the provided information with OMS data. Additional details are available in the OMS Web UI data protection notice.
    2. Providing an EU VAT number: Users can register their organisations by submitting an EU VAT number. These VAT numbers are validated by the contractor (Netcompany) using the VAT Information Exchange System (VIES) search engine. The relevant privacy-statement is accessible on the VIES website.
    3. Manual registration: for organisations not registered via OMS or VIES, users can manually input organisational data. The contractor verifies this information through publicly accessible sources such as official websites or online registries.

EU Login is used to ensure secure authentication for individual users, in alignment with DIGIT's privacy framework (DPR-EC-03187)

  1. Enable Secure Stakeholder Engagement and Information Exchange: to securely receive and respond to stakeholder submissions about projects, funding opportunities, and policy inquiries.
  2. Facilitate Networking and Matchmaking: to connect stakeholders in the through organisational profiles. No profiling of individual users occurs; matches are based on organisational attributes and organisation’s activities.
  3. Govern Governance for CMA and JICF Members: to enable secure access to documents, voting, and collaboration within these groups.
  4. Provide News and Updates: to inform users about events and activities relevant to HERA’s objectives.

Your personal data will not be used for an automated decision-making including profiling.

On what legal ground(s) do we process your personal data

HERA.3 processes your personal data, because:

(a) processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the Union institution or body;

(b) the data subject has given consent to the processing of his or her personal data for one or more specific purposes.

Processing of personal data of the staff of the European Commission and of its contractors is necessary for the management of the HERA Stakeholders Hub and, therefore, the management and functioning of the Union institutions and bodies. The processing is done on the basis of the necessity for the performance of a task carried out in the public interest by Union institutions and bodies.

The data of the users of the Hub is based on their consent to the operation.

Which personal data do we collect and further process

In order to carry out this processing operation staff working in HERA.3 collects the following categories of personal data:

Personal identifying information:

  • Name, surname and email address are collected automatically from EU login: more information is available in the corresponding record DPR-EC-03187.
  • Title
  • Job title
  • Phone number
  • Organisation/company name
  • Organisation type

Logging details:

  • IP addresses for security logging

How long do we keep your personal data?

HERA.3 only keeps your personal data for the time necessary to provide access to the platform and engage with stakeholders, essentially until you request to have your profile deleted from the HERA Stakeholder Hub. To have your profile eliminated from the HERA Stakeholder Hub, you can send an email to the data controller, HERA.3, at: HERA-STAKEHOLDERS-HUB@ec.europa.eu. Users will be prompted to update their account once a year.

The default duration for logs retention is 6 months. In specific cases, this retention period may be extended when duly justified for operational or security reasons. (e.g., ongoing investigations or similar actions).

How do we protect and safeguard your personal data?

All personal data in electronic format (e-mails, documents, databases, uploaded batches of data, etc.) are stored either on the servers of the European Commission or of its contractors. All processing operations are carried out pursuant to the Commission Decision (EU, Euratom) 2017/46 of 10 January 2017 on the security of communication and information systems in the European Commission.

The Commission’s contractors are bound by a specific contractual clause for any processing operations of your data on behalf of the Commission, and by the confidentiality obligations deriving from the transposition of the General Data Protection Regulation in the EU Member States (‘GDPR’ Regulation (EU) 2016/679).

In order to protect your personal data, the Commission has put in place a number of technical and organisational measures in place. Technical measures include appropriate actions to address online security, risk of data loss, alteration of data or unauthorised access, taking into consideration the risk presented by the processing and the nature of the personal data being processed. Organisational measures include restricting access to the personal data solely to authorised persons with a legitimate need to know for the purposes of this processing operation.

Who has access to your personal data and to whom is it disclosed?

Access to your personal data is provided to the Commission staff responsible for carrying out this processing operation and to authorised staff according to the “need to know” principle. Such staff abide by statutory, and when required, additional confidentiality agreements.

The data recipients are indicated here below.

Access to all data:

  • Commission staff when managing its activities related to the HERA Stakeholder Hub administered by DG HERA.
  • Contractor: Netcompany-Intrasoft, 2b, rue Nicolas Bové L-1253 Luxembourg (Commission contractor providing maintenance support to the Hub).

Access to IP addresses:

  • Contractor: AMAZON WEB SERVICES EMEA SARL, Avenue John F. Kennedy 38, LU-1855 Luxembourg (Commission contractor providing cloud infrastructure).

Personal data is not shared with recipients outside your organisation or transferred to third countries or international organisations.

The information we collect will not be given to any other third party, except to the extent and for the purpose we may be required to do so by law.

What are your rights and how can you exercise them?

You have specific rights as a ‘data subject’ under Chapter III (Articles 14-25) of Regulation (EU) 2018/1725, in particular the right to access, your personal data and to rectify them in case your personal data are inaccurate or incomplete. Where applicable, you have the right to erase your personal data, to restrict the processing of your personal data, to object to the processing, and the right to data portability.

You have the right to object to the processing of your personal data, which is lawfully carried out pursuant to Article 5(1)(a) on grounds relating to your particular situation.

You have consented to provide your personal data to HERA.3 for the present processing operation. You can withdraw your consent at any time by notifying the Data Controller at HERA-STAKEHOLDERS-HUB@ec.europa.eu. The withdrawal will not affect the lawfulness of the processing carried out before you have withdrawn the consent.

You can exercise your rights by contacting the Data Controller, or in case of conflict the Data Protection Officer. If necessary, you can also address the European Data Protection Supervisor. Their contact information is given under Section 9 below.

Where you wish to exercise your rights in the context of one or several specific processing operations, please provide their description (i.e. their Record reference(s) as specified under Section 10 below) in your request.

Contact information

  • The Data Controller

If you would like to exercise your rights under Regulation (EU) 2018/1725, or if you have comments, questions or concerns, or if you would like to submit a complaint regarding the collection and use of your personal data, please feel free to contact the Data Controller, HERA.3, at HERA-STAKEHOLDERS-HUB@ec.europa.eu.

  • The Data Protection Officer (DPO) of the Commission

You may contact the Data Protection Officer (DATA-PROTECTION-OFFICER@ec.europa.eu) with regard to issues related to the processing of your personal data under Regulation (EU) 2018/1725.

  • The European Data Protection Supervisor (EDPS)

You have the right to have recourse (i.e. you can lodge a complaint) to the European Data Protection Supervisor (edps@edps.europa.eu) if you consider that your rights under Regulation (EU) 2018/1725 have been infringed as a result of the processing of your personal data by the Data Controller.

Where to find more detailed information?

The Commission Data Protection Officer (DPO) publishes the register of all processing operations on personal data by the Commission, which have been documented and notified to him. You may access the register via the following link: http://ec.europa.eu/dpo-register.

This specific processing operation has been included in the DPO’s public register with the following Record reference: DPR-EC-30068.1.