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ESMO Welcomes Final Version of European General Data Protection Regulation


News provided by

European Society for Medical Oncology (ESMO)

Apr 14, 2016, 03:19 ET

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LUGANO, Switzerland, April 14, 2016 /PRNewswire/ --

 

  • Inclusion of one-time consent "crucial" for future of cancer research 
  • Regulation will aim to harmonise public health research across all 28 EU member states  

ESMO - the leading European professional organisation for medical oncology - has today welcomed the European Parliament's adoption of the EU General Data Protection Regulation, which it describes as being "crucial" for the future of cancer research.

Creating a uniform set of rules governing how personal data can be used in today's digital age, the Regulation will aim to harmonise the different frameworks governing health research across the EU's 28 Member States. In particular, the Regulation includes provision for a 'one-time consent' from patients allowing their data and tissues to be used for future research, which will also ensure the viability of bio-banking.

"The inclusion of a one-time consent for retrospective research on clinical data and biological tissues is crucial because it means the oldest form of medical research - going back to patient records to analyse and correlate data - can continue to make a contribution today, to solving the challenges of tomorrow," said Dr Paolo G. Casali, Chair of the ESMO EU Policy Committee.

ESMO had previously expressed concern that an earlier draft of the Regulation could have made retrospective clinical research impossible because it stipulated the need for 'explicit and specific patient consent'. This would have required researchers to approach patients every single time new research was planned, to obtain their agreement to consult their personal data or tissue samples stored for research purposes.

The new Regulation also ensures that researchers have access to high-quality, population-wide data, which by definition must include the entire population, and therefore cannot be subject to patient consent. This exemption from consent is important because it allows disease-based registries to continue to exist and benefits not only cancer research but medical research in general. In the case of cancer, this data is collected and stored in cancer registries, which are used by governments to formulate new cancer control policies and update national cancer plans and ultimately improve patient outcomes.

"Under ESMO's leadership, the European cancer community has achieved a tremendous success, ensuring that crucial aspects of cancer research can flourish in the years ahead," continued Casali. "I would like to express my gratitude to all our partners and colleagues who have supported us throughout this long and complex process."

ESMO President Fortunato Ciardiello, added: "We want to thank the EU legislators for the diligence, dedication and the openness with which they listened and responded to the concerns of the cancer community and have successfully managed to strike the right balance between protecting personal data and encouraging progress in cancer research."

The General Data Protection Regulation is an essential component of the European legislative framework which will underpin research in the field of cancer on a pan-European basis and beyond in the future. The Council Presidencies and everyone else involved should be congratulated for their outstanding work and achievement.

About ESMO 

ESMO is the leading professional organisation for medical oncology. With more than 14,000 members representing oncology professionals from over 130 countries, ESMO is the society of reference for oncology education and information. We are committed to supporting our members to develop and advance in a fast-evolving professional environment.

http://www.esmo.org 

Contact:
Vanessa Pavinato
+41(0)91-973-19-07

SOURCE European Society for Medical Oncology (ESMO)

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