The Royal College of Physicians (RCP) has joined the European Office of the NHS Confederation in warning that amendments to a proposed regulation aimed at harmonising data-protection laws across the EU could “erode the quality and effectiveness” of health research in the UK, as well as undermining the delivery of patient-focused care through the National Health Service.
The European Parliament’s Committee for Civil Liberties, Justice and Home Affairs (LIBE) has adopted, by 51 votes to one (three abstentions), its position on amendments to the data-protection regulation introduced last January in a draft report by rapporteur Jan Philipp Albrecht.
These changes constitute Parliament’s mandate to start negotiations with national governments through the Council of the European Union on the legislative package, which includes a general regulation covering the bulk of personal-data processing in the EU (the data-protection regulation) and a directive on processing data to prevent, investigate, detect or prosecute criminal offences or to enforce criminal penalties.
Inter-institutional talks on the legislative package will start as soon as EU countries agree on their own negotiating position. Parliament’s aim is to reach an agreement on the data-protection reforms before the May 2014 European elections.
Articles 81 and 83
As far as health research goes, the RCP and the NHS Confederation are particularly concerned about amendments to Articles 81 and 83, as well as the accompanying Recitals 122, 123, 125, 126, that were taken up in the LIBE vote.
The two Articles define specific conditions for processing personal data related to health (Article 81) and data used for historical scientific and statistical research (Article 83), while the Recitals explain further the circumstances under which these Articles would be expected to apply.
The net impact of the new amended text, explained Pamela Forde, data protection officer for the Royal College of Physicians, is to introduce much more stringent requirements for explicit consent to use personal data for health or scientific research than exist under the current legislation.
Moreover, Forde noted, the exemptions currently relied on for processing personal health data have been replaced with a requirement to demonstrate “high public interest” to use these data without the explicit consent of the data subject.
“Many large scale studies which are of great benefit to EU citizens would be impossible to undertake if explicit consent were required from all the data subjects,” she warned.
The proposed regulation takes a general position that where data-processing is based on consent, there needs to be clear permission from the data subject, who could withdraw his or her consent at any time.
Consent in these circumstances would mean “any freely given, specific, informed and explicit indication of his/her wishes, either by a statement or by a clear affirmative action”.
Article 81 of the data-protection regulation, as amended, stipulates that member-state laws may provide an exemption to the consent requirement where personal health data are processed for research purposes, but only if the research serves “exceptionally high public interests” and “cannot possibly be carried out otherwise”.
The data in question would have to be “anonymised or, if that is not possible for the research purposes, pseudonymised under the highest technical standards, and all necessary measures shall be taken to prevent re-identification of the data subjects”.
Article 83 applies the same strictures to personal data “processed for historical, statistical or scientific research purposes”.
According to Forde, other articles in the draft regulation “also make the position of consent around health care much less certain, with ambiguity as to whether consent is required and in what form”.
Moreover, there are persistent concerns about the extra administrative burden imposed by the amended text on all data-processing organisations.
Patient data are “an invaluable resource for health research, forming the basis of studies into the causes and risk factors of disease, and helping researchers identify suitable participants for studies and clinical trials”, Forde commented.
“It is important that this legislation recognises the crucial role such research plays in maintaining and improving public health - and restores the support for scientific health studies.”