Q&As

How does the General Data Protection Regulation affect the pharmacovigilance sector?

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Produced in partnership with Rishi Wadwha of International Association of Privacy Professionals
Published on LexisPSL on 13/02/2020

The following Life Sciences Q&A Produced in partnership with Rishi Wadwha of International Association of Privacy Professionals provides comprehensive and up to date legal information covering:

  • How does the General Data Protection Regulation affect the pharmacovigilance sector?

Pharmacovigilance (PV) is the practice of monitoring the effects of medicinal drugs after they have been licensed for use to identify and evaluate adverse events or reactions one experiences on consumption of a drug or medicine and identifying any additional safety problems not uncovered during clinical testing. The General Data Protection Regulation, Regulation (EU) 2016/679 (the GDPR) defines ‘data concerning health’ as personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveals information about their health status. Hence, the provisions of the GDPR would be applicable on PV services since the same requires processing of data concerning health. Entities that are in the PV business would be required to be mindful of various requirements and controls that flow from the GDPR in relation to handling of data and beyond, in case of transfer of data.

The EU regulates safety monitoring of medicines through Directive 2010/84/EU and Regulation (EU) 1235/2010 as per which marketing authorisation holders (MAHs) should collect as much information as possible on the suspected drug-related adverse events. MAHs is a status bestowed on entities to market a specific medicinal product in one or more EU Member States. Therefore, requirements under the GDPR would be applicable to PV data since it includes information that identifies the pat

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