Pharmaceutical industry develops guidelines for data sharing

The code of conduct follows the problems encountered by the health research sector in the implementation of European data regulations

The professional association of the European pharmaceutical industry has drawn up a code of conduct on data protection in clinical research, which will soon be submitted to the EU authorities.

The implementation of the EU General Data Protection Regulation, which was developed to protect personal data, has caused problems for health research since it came into effect in 2016. Complaints have been raised about cumbersome bureaucracy, and research groups have reported that uncertainties about compliance have hampered data sharing.

Codes of conduct on how to manage data privacy are seen as a potential solution to these problems, and the European Federation of Pharmaceutical Industries and Associations said on January 13 that it had developed a code of conduct on clinical trials and pharmacovigilance.

Efpia said such a code “will enable the industry to align with key positions on data protection, thereby providing more consistency, more clarity and more certainty for clinical research”, adding that ‘it will benefit patients, ethics committees and hospitals in addition to the pharmaceutical industry. .

Sector concerns

The group intends to submit its code of conduct for approval by the European Data Protection Board, a body set up to ensure consistent application of the GDPR.

In June 2021, the Guild of European Research-Intensive Universities warned that uncertainty over GDPR rules “has caused researchers to avoid sharing and reusing health data for research purposes to ensure compliance. and called on the EU to clarify the provisions of the regulation.

The call echoed concerns raised by a slew of European scientific and medical associations that the GDPR was hampering the sharing of health data with researchers outside the EU.

Sean N. Ayres