Data protection legislation

In the UK, the use of identifiable data in research is governed by the Data Protection Act (1998) and the common law duty of confidence.

The Data Protection Act is based on the European Data Protection Directive (95/46/EC). In January 2012, the European Commission published a draft Data Protection Regulation with a view to replacing the existing Data Protection Directive and associated Member State legislation. Unlike a Directive, a Regulation takes direct effect in all EU Member States and does not have to be transposed.

The Regulation is now being considered and amended by the European Parliament and Council before it is adopted. This process may take until 2014.

The Regulation covers the use of personal data across a wide range of sectors and will affect how patient data are used in research. The Wellcome Trust is currently working with other stakeholders to ensure that the Regulation creates a clear legal framework that facilitates research while protecting the interests of patients.

We welcome the provisions in the Regulation to support health research. It is essential that the research provisions are maintained as the Regulation moves through the legislative process. We also think it is vital that amendments are made to clarify the research provisions to ensure these achieve their intended purpose and ensure that the scope of the Regulation is clear.

Our position on the Regulation is set out in a joint statement from a group of scientific research organisations [PDF].

The Federation of the European Academies of Medicine and other pan-European organisations have produced a similar statement [PDF].

The rapporteur of the LIBE committee has proposed amendments to Articles 81 and 83 that would severely restrict the use of personal data for scientific research purposes without consent. Article 7 of the Regulation requires consent to be “specific, informed and explicit”, which is often difficult to achieve in health research. The combination of the LIBE rapporteur’s amendments and the requirements for consent is therefore highly problematic for research. Vital research from across Europe that produces benefits for public health and healthcare would not be possible if the LIBE rapporteur’s amendments were to pass. This briefing from the Trust and the Federation of the European Academies of Medicine sets out our concerns about the LIBE rapporteur’s amendments [PDF].

For further information, see:

Wellcome Trust response to the Ministry of Justice’s call for evidence on EU Data Protection Proposals [PDF]

Wellcome Trust response to the House of Commons Justice Committee inquiry on the EU Data Protection Framework Proposals [PDF].