Legal framework
In March 2016, the host country of the Central Coordinating Unit (CCU) was selected by the Steering Committee (SC): France. The SC, set up as a decision-making body in the framework of the ERINHA2 project, adopted the legal status of an AISBL in May 2016. A Memorandum of Understanding (MoU) was signed by 7 members willing to join ERINHA RI as founding members: France (Inserm), Sweden (FoHM), Hungary (NCE), Italy (INMI), Romania (SVB), Portugal (INSA) and Greece (HPI). The legal statutes were signed by 3 founding members on the 26th of April 2017: France (Inserm), Sweden (FoHM) and Portugal (INSA). Additional members will join ERINHA from the beginning of the implementation phase. In parallel, ERINHA2 worked on the development of an operational structure, defining a set of internal procedures on specific operational aspects such as data management, an access strategy and a human resources policy. Recruitment of the ERINHA CCU is underway.
Financial sustainability
An analysis of the current financial landscape of the future Research Infrastructure (RI) was conducted through a market study in which more than 38 potential users of ERINHA were interviewed. A user strategy was then developed to address the expectations of potential users. Simultaneously, a study was performed to clearly identify the costs, capacities and expertise of each consortium partner, which enabled a mechanism for contribution fees from member countries to be agreed on. Attention was given to the costs of BSL4 partners and the number of users that could access services within ERINHA. The analysis reveals that the demand is currently higher than the available capacities. The complete analysis of ERINHA’s financial sustainability is provided in a Business Plan (BP) which includes a risk assessment, an access policy and a description of the services. The BP was one of the key documents in obtaining commitment for the RI. Efforts have been made to identify alternative funding for ERINHA and include the RI in public funding schemes, by approaching relevant ministries and other funding agencies. Private investors or sponsors (Industries, NGOs, etc.) were also contacted.
Research strategy
During ERINHA2, the consortium updated the Research Portfolio (RP) – a framework for the research that will be carried out within ERINHA by external and internal users. The revised RP takes into account the West African Ebola outbreak, the WHO R&D blueprint for Action to Prevent Epidemics Plan of Action and recommendations from the High Level Expert Group (HLEG) monitoring the project for ESFRI.
It describes the pathogens prioritized by ERINHA – Ebola, Marburg, Lassa fever, Crimean Congo Haemorrhagic fever, Nipah/Hendra and unknown agents and bacteria; the potential outputs – diagnostic tools, vaccines, therapeutics, increased knowledge and evidence-based infection control; the services – transnational access to BSL4 and complementary facilities, training, advice and expertise and project management, as well as the impact of the RI and its position within a landscape of initiatives. The RP was signed by the Consortium and SC members with the exception of Belgium.
The RP was presented at the successful ERINHA conference in Brussels on the 10th of May 2017 “Launching the European Research Infrastructure on Highly Pathogenic Agents’ scientific strategy: a workshop for potential users” which was attended by over 60 participants, including speakers from the EC, the WHO, CEPI, IMI, BARDA, Sanofi Pasteur and academic institutions (INMI, FoHM, PHE, Aix-Marseille Université).
Advocacy and obtaining commitment
A stakeholder engagement and communication strategy was developed to obtain commitment and to position ERINHA on the European and international high containment research landscape. France, ERINHA’s host country’s political and financial commitment were secured in 2016. The written approval of ERINHA’s scientific strategy (RP) at the end of 2016 paved the way towards further political and financial commitments: signature of a MoU and letters of intent provided by France, Portugal, Sweden, Hungary, Greece and the Netherlands. ERINHA was successful in sparking the interest among potential members outside the ERINHA consortium.
European and international policy and public health decision-making organizations were approached (EC, ECDC, WHO, CEPI, etc.) and the RP was presented to such stakeholders to gather feedback and position ERINHA in the current landscape. ERINHA also liaised with industry via IMI and EFPIA. These interactions have increased ERINHA’s visibility in the European infectious diseases R&I arena.
A study was conducted to determine the current needs of societal stakeholders (i) to identify which services relevant stakeholders need, and (ii) to further expand the database of potential users of ERINHA. The results of this task are 1) a potential users’ database of 545 individuals 2) a brochure to respond to needs identified by potential users.
Finally, a broad range of communication tools were developed to support advocacy and communication activities: ERINHA brochure, FAQ, Research portfolio, Factsheet on health, promotional materials etc.).
