Re-Use of Research Data

It may now be easier for private companies to re-use research data generated by the public sector. Thanks to Italian legislative decree no. 200 of 2021 implementing Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information, re-use of research data – whether for commercial or non-commercial purposes – may be carried out so long as intellectual property rights and privacy rights are respected.

In other words, if research data is anonymized and does not include intellectual property, free re-use is possible whenever such research data is generated from public funding and made available by researchers or research institutions through public data bases. Research data must comply with Findability, Accessibility, Interoperability, Reusability (FAIR) principles.

What is “research data”? Research data means “documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results”.

Are you in need of an example? “Research data includes statistics, results of experiments, measurements, observations resulting from fieldwork, survey results, interview recordings and images. It also includes meta-data, specifications and other digital objects. Research data is different from scientific articles reporting and commenting on findings resulting from their scientific research” (whereas no. 27 of the 2019/1024 Directive).

Certain scholars have pointed out how the principle of scientific open data is framed in terms that are too restrictive and continue to clash with intellectual property rights, database and algorithm protection.

While the push for reuse of research data may appear timid at this point in time, the EU seems in any case determined to continue its open data agenda through the Data Governance Act.

About Paola Sangiovanni

Partner of GITTI and Partners. Seasoned transactional and regulatory legal counsel with a thorough understanding of the life sciences industry.

Leave a Reply

Please log in using one of these methods to post your comment:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s