BBMRI-ERIC welcomes GDPR to safeguard patients’ interests

Biobanking and BioMolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC) acknowledges and welcomes the potential of the General Data Protection Regulation (GDPR) for realizing the European Research Area (ERA). It could become a major tool for allowing simplified transnational health research and cross-border exchange of data for the benefit of European citizens.

Graz/Brussels, 19 November 2015

Health research depends both on high quality data and on commitment of research participants to donate and allow the use of data. To assure both individuals’ protection as well as to allow necessary research for societal benefits, the opinions of all concerned stakeholders have to be taken into account. The GDPR should provide a framework for maintaining this balance. As an EU research infrastructure BBMRI-ERIC is close to many relevant stakeholders throughout Europe and is therefore well qualified to provide input into the decision-making process.

Ill-conceived provisions of the GDPR could seriously hamper pan-European health research, as highlighted in the BBMRI-ERIC‘s current position paper (available upon request). BBMRI-ERIC therefore urges that the following concerns are taken into account in the ongoing legislative process:
• The GDPR should safeguard the interests of patients in medical research;
• The distinction between processing of personal data for scientific research purposes and other forms of processing should be maintained;
• Consistent harmonised rules at the EU level are needed to promote research collaboration Europe-wide;
• The GDPR should leave sufficient leeway for Member State-specific approaches in the absence of harmonized health systems.

Speaking in advance of the trilogue in Strasbourg next week, prof. Jan-Eric Litton, BBMRI-ERIC Director General, said: “To strengthen biological and medical research and to overcome the fragmentation of European biobanks, BBMRI-ERIC was initiated to create an important part of the ERA, as requested by the European Council. The EU GDPR is designed to establish a single set of rules for data privacy across Europe and to strengthen consumer protection, which we fully support. Patients have a legitimate expectation in an increase of knowledge, as recognised by Council and Parliament. For this reason, the Regulation should safeguard the interests of patients in medical research and not hamper the possibilities for the ERA to improve future knowledge of health.”

"Clearly there is a need to protect sensitive personal data, and appropriate and proportional regulation is in the interests of everyone. However, for patients and families living with life limiting and lethal intractable diseases there is much to be gained from the free sharing of data between those with a legitimate need to know. Research, the development of innovative therapies and the improvement in patient care are crucially dependent on access to accurate, timely and traceable information, and any regulation that created undue obstacles between patients, families, high quality research and the delivery of effective clinical care would be widely seen as a failure of courage on the part of regulators and parliamentarians," added Alastair Kent, the director of Genetic Alliance UK.

For BBMRI-ERIC, contact:
Michaela Th. Mayrhofer PhD
Senior Project Manager, BBMRI-ERIC
Email: [e-mail]
Tel: + 43 316 34 99 17-13
www.bbmri-eric.eu

For Media, contact:
Luc Deltombe
Communication/finance assistant, BBMRI-ERIC
Email: [e-mail]
Tel: + 43 316 34 99 17-21
www.bbmri-eric.eu

Parole chiave

• data protection

Paesi

Austria, Belgium