Data protection: Guidance on post-marketing pharmacovigilance

Data protection: Guidance on post-marketing pharmacovigilance

Guidance has been published by the Association of the British Pharmaceutical Industry (APBI), Pharmacovigilance Expert Network, together with the Pharmaceutical Information and Pharmacovigilance Association and pv legal to help the UK pharmaceutical industry comply with UK data protection regulation when performing post-marketing pharmacovigilance.

Pharmacovigilance is the science relating to the collection, detection, assessment and monitoring of adverse effects arising from the use of pharmaceutical products.  It is designed to identify adverse drug reactions associated with pharmaceutical products in order to minimise the risk of harm that may be caused to patients.

Data is routinely collected by companies when carrying out pharmacovigilance, and such data may include personal data and sensitive personal data.  As such, companies must comply with the Data Protection Act 1998 when processing personal data and have transparent and robust processes to ensure it is protected.  Key areas for compliance that are highlighted in the guidance include:

  • Regular training in data protection requirements for all company staff involved in pharmacovigilance
  • Data subjects should be informed of who will receive their personal data, and the information should be set out in a clearly written data protection notice
  • Companies should practice “data minimisation” and hold the minimum of personal data needed to properly fulfil their safety reporting activities.  Elements of the type of data recommended for retention and redaction are specified

A copy of the guidance can be accessed here.

Please contact Beverley Flynn for more information.

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