Description of the HERA Stakeholders Hub
The HERA Stakeholders Hub (thereafter: Hub) is a secure, multifunctional online platform aimed at facilitating collaboration, partnerships and strategic alliances to address critical gaps in the pharmaceutical supply chain across the European Union and thus enhance the resilience of the medicine supply chain. It also aims to support the coordination of actions at the EU level in view of addressing medicine shortages and supply chain vulnerabilities.
The Hub is an online tool, hosted by HERA and developed by a contractor (Netcompany). The technical architecture of the Hub prioritizes user-friendly interfaces, robust security protocols, and seamless integration with existing EU digital tools It features:
- Matchmaking Platform: A dual-component system to connect companies with partners for supply chain collaboration and research project partnerships, equipped with screening tools to maintain data integrity and privacy.
- Inform HERA: A streamlined contact form, utilizing a tailored survey approach, to prioritize and optimize stakeholder interactions with HERA, including encrypted spaces for stakeholders to share sensitive information, ensuring confidentiality and access to information on a “need to know” basis.
- Virtual Spaces: an exclusive area for members of the Critical Medicines Alliance and the Joint Industrial Cooperation Forum to access and contribute to strategic documents and communications.
The Matchmaking Platform of the HERA Stakeholders Hub
The Matchmaking Platform (thereafter: Platform) allows companies to find partners with complementary capabilities and skills to achieve a faster production and supply of medical countermeasures (MCMs) and/or critical medicines that are authorised or under development in the EU.
The Platform provides a secured space for manufacturers of relevant raw materials, companies with relevant production capacities, or other key inputs, to engage with the developers and manufacturers of the MCMs and/or critical medicines seeking to match their demand with the supply of potentially scarce inputs. The participating companies will be able to log in to the secured space of the Platform, create their business profile, and create requests to find partners by exchanging information online.
Companies operating at different levels of the supply chain, but also companies competing directly on the same market level, might express interest in participating at the Platform, which is open to any operator concerned with production or development capacity.
User account
To access the Hub’s functionalities, each user must register via EU Login and create an account under a registered organisation and/or register a new organisation.
There are two types of users with different permission levels:
- Organisation Administrator User
- Organisation Member User
The first user that register for a given organisation is subject to a validation process and, once validated, is approved as Organisation Administrator User. The Organisation Administrator User will have permissions to approve or revoke any subsequent Organisation Administrator Users or Organisation Member Users affiliated to the same organisation.
HERA recommends that each organisation has at least two registered Organisation Administrator Users.
For validation purposes, Organisation Administrators must use an email address that matches their organisation's website domain when registering a new organisation.
Users are responsible for all activities that occur under their account or password. Any user ID and password that users may have for the Hub are confidential. It is also the users’ responsibility to keep their profile details up to date. Users can self-manage their account through the User profile at any time.
Legal requirements
All data and information shared on the Hub are provided directly by the registered users, who have full control over what they choose to disclose and what they prefer to keep confidential.
Users are required to observe and comply with all applicable EU competition laws during their use of the Matchmaking Platform, including in any communications, interactions, or collaborations with other users. The Platform is a tool to facilitate lawful business interactions, and users are responsible for ensuring that their use of the Platform and all communications within the Platform do not lead to, nor facilitate anti-competitive practices.
Some activities may involve interaction that could potentially raise competition law concerns, such as sharing sensitive commercial information. Any exchange of sensitive commercial information beyond what is strictly necessary for the use of the Platform (the production and supply challenges of MCMs or critical medicines authorised or under development in the EU) is unlikely to be justified under competition law rules and could result in a violation of these rules. Communication on prices, discounts, costs, sales, production volumes, commercial strategies, expansion plans and investments, customers list, or any other information concerning important elements of a firm’s strategy or commercial plans are especially likely to violate competition law, particularly if the information is made available to actual or potential competitors ([1]).
Users are also required to keep detailed records of the topics discussed during their interactions to ensure compliance with competition law and for confidentiality purposes and are advised to engage specialised independent counsel to ensure compliance.
Users are further required to implement appropriate "Ethical Wall" procedures within their organizations to prevent the improper exchange of sensitive information between individuals or departments that could create conflicts of interest or raise competition law concerns. These procedures should establish clear internal barriers to ensure that any sensitive or confidential, or otherwise competitively sensitive data and information is restricted to those with a legitimate need to access it for the lawful use of the Platform. Users must take proactive measures to minimize risks, including ensuring that relevant staff members are adequately trained and that robust internal controls are in place.
Confidentiality
Users are responsible for managing the confidentiality of their own data and communications. The Platform provides secure tools to facilitate the exchange of information, but it is the responsibility of Users to ensure that they protect their sensitive and/or confidential information.
Users are required to ensure that their exchanges of information comply with applicable confidentiality obligations and are restricted to what is strictly necessary for the scope of their collaboration.
Intellectual Property
Users are solely responsible for ensuring that they possess the necessary intellectual property rights to any content they upload or share on the Hub. Before publishing content, Users must verify that they either own the content outright or have obtained the appropriate permissions or licenses to use and/or share it. Users must not infringe on the intellectual property rights of others when sharing content on the Hub.
Any false or misleading representations regarding intellectual property ownership or permissions are the sole responsibility of the User.
Variation of terms
The European Commission reserves the right to change the Hub’s Terms and Conditions at any time. Users will be required to accept the new Terms and Conditions on their first access to the Hub after the modification.
General Disclaimer
Users are fully responsible for ensuring that their actions and content on the Hub comply with all applicable laws and regulations. Moreover, Users are fully responsible for the accuracy, and ownership of the content they upload, and for managing their own confidential information. Any legal consequences arising from a User’s actions rest solely with the User.
The European Commission disclaims all liability for any violations of law, or any claims or penalties resulting from User actions, as well as for any actions, content, or behaviour of third parties. The European Commission is not liable for any damages, including direct, indirect, incidental, or consequential damages, arising out of the use or inability to use the Hub, regardless of the nature of the claim.
[1] For more guidance, Users may consult Guidelines on the applicability of Article 101 of the Treaty on the Functioning of the European Union to horizontal co-operation agreements, Chapter 6.