EU legislation


European research needs modern copyright rules fit for the digital age.The European Commission’s (EC) proposal for a revision of the Copyright Directive was published in September 2016. We are collaborating with relevant stakeholders togive a stronger voice for research-friendly reforms during  European Parliament and the Council discussions held as part fo the legislative process.

Key needs are

  • the provision of legal certainty around cross-border research activities,
  • the removal of barriers to Text and Data Mining (TDM)
  • the deployment of new technologies for research and innovation.

Relevant documents includes those prepared under Science Europe including the Joint Open Letter, those prepared by the international coalition led by SPARC Europe including the position statement that is supported by HRB, and the European Commission documents on Modernisation of the EU copyright rules.  


General Data Protection Regulation

The European General Data Protection Regulation (GDPR) was agreed in April 2016 and will take effect from May 2018. The Regulation leaves it up to European Union member states to put detailed rules in place to govern the use of personal data in research.  A Data Protection Bill 2018 sets out these rules for Ireland.

Personal data provide a vital resource for research to benefit society and save and improve the lives of patients. The regulation creates a supportive framework for research, including safeguards to ensure personal information is used appropriately and remains secure.  During negotiations, we were a member of the EU Lobby group led by the Wellcome Trust UK that successfully opposed  EU Parliament amendments to the regulation that would have imposed disproportionate limits on the use of health data.

An analysis of the key clauses of the Regulation related to research are available online on the Welcome Trust website.


Implementing the Regulation to support health research

The Department of Health is preparing specific rules for health data and implementation of the General Data Protection Regulation (GDPR) in Ireland that will sit alongside the Irish Data Protection Bill.  Aligned to this, the HRB is advising on the development of appropriate structures and guidance for health researchers on how to ensure compliance with this Regulation.  As soon as the specific rules have been agreed with the Attorney General’s Office they will be shared with the research community.

Until such time as the Regulations are published, researchers should ensure that all of their current data processing practices are fully compliant with the existing Data Protection Law and that they are working within their own institutions on GDPR preparations.