ABPI publishes data protection in pharmacovigilance guidance

The Association of the British Pharmaceutical Industry (ABPI) has announced the publication of new guidance on data protection in post-marketing pharmacovigilance processes.

Allying with the Pharmaceutical Information and Pharmacovigilance Association and PV Legal, the document aims to help companies ensure patients' personal data is held and transmitted in line with data protection legislation.

It covers topics such as receipt of safety data, rectification and objection rights, retention and redaction of personal information, and issues pertaining to access and security.

According to the ABPI, this will make it easier for pharmaceutical companies to correctly navigate the challenges posed by the complex pharmacovigilance process.

The organisation said the aim of this guide is to "help companies be compliant with their legal obligations for both pharmacovigilance and data protection but also to promote examples of good practice which should lead to better, more consistent protection of patients' safety data".

Last month, the ABPI welcomed the publication of updated guidance by the General Medical Council on best practice in prescribing, which it believes will help to enhance patient safety.