Europe’s pharmaceutical industry trade body has developed a code of conduct on data protection in clinical research, which will soon be submitted to EU authorities.
The implementation of the EU’s General Data Protection Regulation, which was drawn up to protect personal data, has caused problems for health research since coming into force in 2016. Complaints have been raised over burdensome bureaucracy, and research groups have reported that uncertainties over compliance have put the brakes on data sharing.
Codes of conduct on how to deal with data privacy are seen as a potential solution to such problems, and the European Federation of Pharmaceutical Industries and Associations said on 13 January that it has drawn up a code of conduct on clinical trials and pharmacovigilance.
Efpia said such a code “will enable the sector to align on key data protection positions, thereby providing more consistency, more clarity and more certainty for clinical research”, adding that it will benefit patients, ethics boards and hospitals in addition to the pharmaceutical industry.