Data Protection Regulation

The European General Data Protection Regulation (GDPR) was agreed in April 2016 and took effect from 25 May 2018. 

The UK implemented a new Data Protection Act at the same time that complemented the regulation. 

Our position

Personal data – such as information collected by a doctor or hospital, or as part of a research study – is a vital resource for research that has the potential to improve and save lives. 

The regulation creates a supportive framework for scientific research, including safeguards to ensure personal information is used appropriately and remains secure. 

During negotiations, the European Parliament proposed amendments to the regulation that would have imposed disproportionate limits on the use of health data. These would have had a devastating impact on research. We’re delighted that the regulation rejected these amendments.

What we’re doing

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. 

The Data Protection Act went through UK Parliament to set out these rules for the UK. We worked with the research community and policy makers to ensure a strong outcome for research. 

The Act creates a complete legal framework for data protection after the UK has left the EU. It is important for data to continue to flow across borders for research purposes and we support close alignment between the regulation and UK law following Brexit.

We also worked with the Health Research Authority and other key organisations to develop guidance on the General Data Protection Regulation for health researchers.

Timeline of key dates

Our timeline sets out the key dates for the agreement and implementation of the new regulation.

2018

  • The regulation takes effect in all European Union member states on 25 May 2018.
  • The UK implements the Data Protection Act 2018 at the same time.

2017

December 2017

  • Working closely with peers and the Department for Culture, Media and Sport, we successfully advocate for the government to introduce amendments to the Bill to ensure there is a clear legal basis for clinical trials to process data. 
  • The Health Research Authority produces guidance for researchers on how to ensure they are complying with the regulation. 

October 2017

September 2017

  • The UK government publishes a Data Protection Bill, which sets out how the exemptions permitted by the regulation will be implemented in the UK.

June 2017

  • Beth Thompson, Wellcome's Head of Policy – UK and EU, is awarded an MBE for her work on the regulation.

May 2017

March 2017

2016

September 2016

May 2016

April 2016

  • The European Parliament and Council of Ministers formally agree the final text of the regulation.

2015

December 2015

  • A compromise text is finalised and receives the support of the European Parliament and member states in informal votes. The regulation rejects damaging amendments proposed by the European Parliament.

July 2015 

June 2015 

  • The Council of Ministers agrees its general approach on the regulation. The Council’s position on research is broadly positive.

2014

March 2014 

  • The European Parliament adopts amendments to Articles 81 and 83 that would severely restrict the use of personal data for scientific research purposes without specific consent. It is vital that amendments to Articles 81 and 83 are opposed in negotiations on the regulation.

January 2014 

2013

September 2013 

May 2013 

February 2013 

January 2013

  • The European Parliament rapporteur publishes a draft report on the regulation. The draft report includes amendments that, if implemented, would have a devastating impact by imposing disproportionate limits on the use of health data in research. 

2012

August 2012 

March 2012 

January 2012

  • The European Commission publishes a draft Data Protection Regulation with a view to replacing the existing Data Protection Directive and associated Member State legislation.    

More information