Data Protection Regulation
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 new European Data Protection Regulation was agreed in April 2016 and will take effect from May 2018.
The regulation creates a supportive framework for scientific research, including safeguards to ensure personal information is used appropriately and remains secure. See our analysis of the key clauses [PDF 106KB].
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.
Now, the research community and policy makers must work together on implementation to ensure the regulation fulfils its potential.
What we’re doing
The new regulation leaves it up to European Union member states to put detailed rules in place to govern the use of personal data in research.
As the regulation is implemented, we’ll work with the research community and policy makers to ensure a strong outcome for research.
Timeline of key dates
Our timeline sets out the key dates for the agreement and implementation of the new regulation.
- The European Commission publishes a draft Data Protection Regulation with a view to replacing the existing Data Protection Directive and associated Member State legislation.
- We respond to the Ministry of Justice’s call for evidence on EU Data Protection Proposals [PDF 92KB].
- We respond to the House of Commons Justice Committee inquiry on the EU Data Protection Framework Proposals [PDF 75KB].
- 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.
- Together with the Federation of the European Academies of Medicine, we issue a detailed briefing setting out concerns about the rapporteur’s amendments [PDF 306KB].
- With other research organisations, we issue a joint statement on the European Parliament’s position [PDF 349KB].
- We issue a briefing from a round table workshop in the European Parliament: Keeping health research alive in the EU [PDF 436KB].
- We send an open letter to The Times highlighting research concerns ahead of the European Parliament vote on the Data Protection Regulation.
- 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.
- The Council of Ministers agrees its general approach on the regulation. The Council’s position on research is broadly positive.
- The European Parliament, Council of Ministers and European Commission begin trilogue negotiations.
- We ask the Council of Ministers, European Parliament and European Commission to work together to find a compromise position that maintains important exemptions for research while including proportionate safeguards.
- We publish a joint statement from patient, academic and non-commercial research organisations summarising our position [PDF 635KB] and a detailed analysis with preferred solutions [PDF 133KB].
- 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.
- The European Parliament and Council of Ministers formally agree the final text of the regulation.
- The regulation becomes law and must be implemented in two years.
- The regulation will take effect in all European Union member states.
- Between 2014 and 2015 we were part of the European Data in Health Research Alliance, which brought together academic, patient and research organisations committed to ensuring that the Data Protection Regulation allows vital health research to continue.
- Find out more about our work on using patient data in research.
If you have any questions, contact Beth Thompson:
Sharing data helps researchers to access and build on new information and knowledge.
The European Union supports science through legislation, funding opportunities and programmes to help cross-border collaboration.
Science policy affects a broad range of issues, ranging from data sharing and gene editing, to intellectual property and regulation.
Regulation creates an environment where research and innovation can flourish.