Europe warned over cancer research risk
pharmafile | July 27, 2014 | News story | Medical Communications, Research and Development, Sales and Marketing | ESMO, EU, Macmillan, data
A leading European doctors’ group is warning that new data protection rules could make cancer research ‘impossible’ whilst also adding a ‘significant burden’ to cancer patients.
This is according to ESMO that believes the wording of a new EU General Data Protection Regulation, which requires ‘explicit and specific patient consent’, will stifle R&D.
This, the doctors say, is because researchers would have to approach patients every single time research is planned in order to consult their data or use tissue samples stored for research purposes.
“This could put a halt to many public health research efforts,” warns ESMO President Rolf Stahel.
ESMO says that the text of the EU General Data Protection Regulation should include a ‘one-time consent’ for research, ensuring patients are aware of what they are consenting to, and with the appropriate safeguards in place.
“Our proposal achieves the correct balance between the right to privacy and the right to health,” Stahel adds. “It actually ‘empowers’ patients, allowing them to choose whether to donate their data and tissue for public health research, which has the ultimate goal of finding cures.”
Paolo Casali, ESMO’s public policy committee chair and author of the official ESMO position paper on the risks of the new EU Data Protection Regulation, says: “We understand the need for the EU to address data privacy concerns in many sectors, with the surge of risks brought about by the use of digital information, but its effect on public health research may have been unintentionally overlooked.”
Casali adds: “If a patient is allowed not to consent use of his/her anonymised data for the registry, the data provided by that registry will be unrepresentative and can lead to incorrect conclusions for public health actions.”
Casali concludes: “We are calling upon the European Union to assure that all forms of public health research will survive and be able to function within the safeguards that are in place, without adding the nearly impossible administrative burden of re-consenting each patient, every time, for every single project, which could irreversibly slow down the accelerated pace that cancer research has gained over the past decades.”
In the UK Mike Hobday, director of policy and research at Macmillan Cancer Support, is calling on Chris Grayling, the justice secretary, to fight the proposals.
He says that the regulatory regime had to support new discoveries as well as protecting patients’ confidentiality. “Currently, the European Parliament’s draft regulation on data protection utterly fails to achieve this balance and, if implemented, would severely restrict advances in cancer research,” he says.
Ben Adams
Related Content
Sharp invests $100m in US and EU manufacturing and packaging facilities
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across …
Sarclisa recommended for EU approval in newly diagnosed multiple myeloma
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi’s …
EU approval granted for rare kidney disease treatment
The EU has granted marketing authorisation (MA) for Filspari – CSL Vifor and Travere Therapeutics’ …
