EU data protection regulation
In 2012, the European Commission published its proposal for a new data protection regulation. The aim of this legislation is to strengthen privacy rights, specifying –among others- the conditions under which personal data can be collected, processed and accessed. This regulation is important for medical research and healthcare, since the new legislation will affect the way patients’ data (such as individual patient records) is used in scientific activities.
The Commission’s proposal gives specific provisions for the use of patients’ data in health care as well as scientific activities (articles 81 and 83). It included a requirement for specific and explicit consent for the use and storage of personal data, but provided an exemption for research and scientific activities, subject to certain safeguards. This recognised that individuals’ interests can be protected through strong ethical and governance safeguards, such as approval by a research ethics committee.
However, the European Parliament introduced a number of amendments that may seriously harm medical research in Europe, should they be adopted in the final text. Among other issues, the Parliament’s amendments would (a) prohibit the use of personal data for other than pre-specified purposes. Under the proposal, personal data will be collected and processed for specified purposes only and may not be used for a purpose incompatible with the original one; and (b) prohibit the use of identifiable personal data in scientific research without specific consent. Researchers only use identifiable data without consent where other approaches are not practicable, and this is currently only allowed subject to ethical approval and strict confidentiality safeguards.
EULAR is concerned about the possible outcome of the negotiations between the main EU institutions, and has engaged in several advocacy actions aiming to raise awareness about the possible consequences of the new legislation in case the Parliament proposed amendments are finally adopted.
In October 2013, in its capacity as Secretariat of the European Parliament Interest Group on RMDs, EULAR organised a meeting in the European Parliament, bringing together the main EU institutions and a number of stakeholders to discuss the development of the new Regulation.
In 2014, together with a number of other scientific organisations, EULAR has signed a statement calling the EU Council and the European Commission to oppose the European Parliament’s amendments and keep the specific provisions for healthcare and research activities the Commission established in articles 81 and 83 of its proposal.