B1MGplus M2.2 - Overview of legal documents required

The B1MGplus project supports the creation of a European cross-border network of genomic and clinical data to improve healthcare. The project provides coordination and support to the 1+ Million Genomes (1+MG) initiative. To support the 1+MG initiative, the B1MGplus project focuses on several objectives, one of which is to support the preparatory work for the creation and operation of a European Digital Infrastructure Consortium (EDIC). As per the GA. the general objective of WP2 is to “provide input to the GDI Project and the Genome EDIC that is to be set up to support the EDIC in becoming operational. The work will provide the foundation (i.e. content creation) for the negotiations of member countries in the GDI Pillar I on the data governance and governance implementation, sustainability and business model as well as the input into the development of the IT infrastructure. The work will be limited to cover a minimum viable product that allows the Genome EDIC to become operational but not cover any future developments yet as these plans will be too volatile during the lifetime of the project and the provided funds not sufficient to cover additional scenarios.” Within this framework, the DoA allocates to T2.3 the aim “Once the governance and data governance are finally decided” to help translating “the relationship between the various actors … into standard legal documents enabling binding commitments and regulating the rights and obligations of all the entities to the extent that they are not provided for in the statutes.” (emphasis added). Accordingly, M2.2 is described as “List and scope of contracts and other legal documents that are necessary for operations. In this contest, the purpose of Milestone 2.2 is to identify the extent of the legal documents required to transform the Genomic Data Infrastructure into an EDIC, establish it and draw up its statutes. To reach this aim, T2.3 needed first to identify the legal documents and content that must be addressed in the statutes and those that the governing body will need to address directly, once established and since the early implementation stages. The latter documents will require the expression of the full political and technical decision-making of the assembly of members pursuant to ar. 16 of the (DECISION (EU) 2022/2481 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 December 2022 establishing the Digital Decade Policy Programme 2030 – hereinafter also “DDDP”). Yet, T2.3 could contribute to identify the general scope of expected contracts to fulfil the needs of the procurement policy of the Genome EDIC since their specific content would be subject and dependant on national applicable law. If time and resources will allow it, the scope of T2.3 could be expanded to help defining a general strategy in the content design of agreements or other relevant document among and with multiple “public entities, including regions or private entities with a public service mission” from the same participating Member State to ensure the MS participation is governed unitarily and in a harmonized way. Yet it must be stressed that the Statutes could only envisage obligations and rights in general harmonized terms, but it would necessarily be to each and every Member State to decide the forms (e.g. eventually not a contract but an interinstitutional agreement) actually used pursuant to the relevant national applicable law.