Taken from”The Legal Newspaper”, the legal information newspaper of the Wolters Kluwer Italia group and edited by Cedam, Utet Giuridica, Leggi d'Italia and Ipsoa.

By 17 July 2021, Member States must transpose the Directive (EU) 2019/1024 Which brings significant News on the reuse of open public sector data. Among the most interesting news, art. 10 of the Directive extends the field of reuse also to data produced as part of publicly funded research, to be kept distinct from 'scientific articles'.

The data will be reusable for commercial or non-commercial purposes, transnationally within the EU, if they are produced as part of publicly funded research and are made available through databases managed at the institutional level or on a thematic basis. In compliance with the principle “as open as possible, as closed as necessary”, in the current phase of transposition, each member State is called upon to draw up exceptions to the general rule of “open by default” provided for in art. 10, taking into account in particular the requirements for the protection of personal data and the intellectual property rights of third parties.

The current pandemic has dramatically confirmed the centrality of public policies to support research and data sharing scientific for the purpose of identifying effective solutions to global emergencies. The still dark scenario in which we are struggling paradoxically sheds new light on a particular provision of Directive (EU) 2019/1024 that must be transposed by member States by next July 17: this is art. 10 of the aforementioned Directive, which makes the regulation of reuse - harmonized at EU level - applicable for the first time to data produced in the field of scientific research funded by public funds.

The reuse of research data before Directive (EU) 2019/1024

To understand the potential of art. 10 in comment, it is necessary to remember the current situation in the EU as of today with regard to reusability of research data.

The EU has adopted a harmonized regulation on the reuse of open data by Public Administrations with the Directive 2003/98/EC (also known as”PSI Directive” or “Public Service Information Directive”), which - both in its original version and in the version amended by Directive 2013/37/EU - excludes scientific research data from the obligation to reuse. This exclusion was motivated by the EU legislator of 2003-2013 by the fact that the research data were largely the 'domain' of intellectual property rights, which were difficult to reconcile with the 'open by default' principle.

Prior to Directive (EU) 2019/1024, for this reason, the EU did not have harmonized rules on the reuse of scientific research data. Each member State therefore remained free to adopt laws applicable in this regard on a 'national scale', as France did, for example, with the adoption of Plan national pour la science ouverte. For States without similar regulatory provisions, it was up to each research center - if not each researcher - to choose to comply with the principles formulated over time by the scientific community (and therefore qualified as”Community Norms”), in an attempt to increase traceability and data sharing. Among these principles, the so-called FAIR PRINCIPLES, in application of which researchers are able to produce data that is' Findable ',' Accessible ',' Interoperable 'and 'Reuseable'. It should also be borne in mind that the FAIR principles recommend making known the conditions for the reuse of data, but not obliging researchers to make the same data available to anyone without restrictions.

The changes introduced by Directive (EU) 2019/1024

The non-binding nature of the FAIR principles therefore finally led the EU legislator in 2019 to formulate a harmonized legal discipline on the reusability of research data, in order to unleash their potential within the EU internal market. This is how art. 10 of the Directive (EU) 2019/1024, which consists of two paragraphs better analyzed below.

Before going into the merits of the rule, however, it should be remembered that Directive (EU) 2019/1024 is an act of so-called minimum harmonization, which therefore leaves each member State, during transposition, the right to adopt more stringent provisions regarding opening and reuse also for what concerns scientific research data.

With this in mind, we can therefore delve into reading the standard. Article 10 regulates “research data” defined as “documents in digital format, other than scientific publications, collected or produced during scientific research and used as evidence in the research process, or commonly accepted in the research community as necessary to validate research conclusions and results” (see art. 2, n. 9). This category includes, for example, “statistics, results of experiments, measurements, observations resulting from field research, survey results, images and recordings of interviews, as well as metadata, specifications and other digital objects” (cons. 27).

Art. 10, par. 1

In relation to Research data so defined, art. 10 par. 1 requires member states to adopt “relevant national policies and actions to make publicly funded research data openly available ('open access policies') according to the principle of openness by default and compatible with FAIR principles”. These national policies will apply both to organizations that carry out research activities and to organizations that fund research.

As clarified by cons. 27, in the context of Directive '[l]'open access is understood as the practice of providing online access to research results free of charge for the end user and without restrictions on use and reuse beyond the possibility of requiring the author's recognition”. National open access policies will therefore be aimed at ensuring not only researchers but also “the general public access to research data as soon as possible in the dissemination process and to facilitate their use and reuse.”

In the implementation of the principle”Open by default” within the framework of national policies, each member country must draw up the exceptions by proceeding with a special balance between opposing protection requirements according to the maxim “as open as possible, as closed as necessary”. The exceptions may correspond in particular to “concerns regarding intellectual property rights, protection of personal data and confidentiality, security and legitimate commercial interests.”

Art. 10, par. 2

Article 10, par. 2 defines the cumulative conditions under which research data will be reusable for commercial and non-commercial purposes:

(i) The standard requires first of all that the data in question are not covered by rights of Intellectual property of third parties (pursuant to art. 1, par. 2 letter c);

(ii) the data must also be the The result of research funded by public funds in whole or in part (cons. 28);

(iii) Finally, the data must have been”already made public through a database managed at institutional level or on a thematic basis.”

Even in this case, in delimiting the scope of application of reuse, art. 10, par. 2, allows Member States, at the time of transposition, to define the relevant exceptions, taking into account, in particular, “legitimate commercial interests, knowledge transfer activities and pre-existing intellectual property rights”.

As for the “procedural provisions” on reuse, art. 10, par. 2 refers to chapters III and IV of Directive (EU) 2019/1024. For this purpose, in the presence of the above-mentioned substantive conditions prescribed by art. 10, par. 2, the research data must be returned available with related metadata in machine-readable formats (art. 5), free of charge and at no additional cost (art. 6, par. 6 and cons. 28). Reuse must also be granted on the basis of standard licenses (art. 8), such as Creative Commons CC-BY 4.0, which is considered adequate for the protection of “databases”.

Reuse must also be granted under non-discriminatory conditions for comparable categories of use, even at a transnational level between member countries (art. 11), so that the related licenses may not - as a general rule - contain exclusives (art. 12). Exceptionally, however, art. 12, paragraph 2 allows for exclusive rights - temporarily limited and subject to periodic review - where this is necessary “for the provision of a service of public interest”. Based on the practice relating to SGEI (Services of General Economic Interest), it could therefore be considered admissible to provide for exclusive rights where this is actually necessary and proportionate (from an economic point of view and the recovery of dedicated investments) for the implementation of activities of general interest that would not otherwise be developed by the market.

Key points in the transposition of art. 10

This brief overview of art. 10 - so full of notions and references - makes it possible to highlight some crucial junctions for the effective transposition of the norm in the national context.

The first joint relates to the same The notion of 'research data' (to be kept separate from “scientific publications”) and the reusability of only data that, in addition to not being covered by the intellectual property rights of third parties, are already made public through databases managed at the institutional level or on a thematic basis. This first basic piece of the rule seems to require, therefore, the provision (upon transposition) of appropriate incentives so that the data are actually made available in open databases.

The second hub concerns the drafting and especially the subsequent application of the exceptions to the “open by default” principle. If it is true that - at least in law - the exceptions to the general obligations provided for by the Directive must be interpreted and implemented in a necessarily restrictive sense, it is up to national legislators - in the current phase of transposition - to establish on the merits the fair balance between the opposing protection requirements, achieving formulations that are as clear as possible in substantial transposition of the maximum”As Open As Possible, As Closed As Necessary”.

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