Pharmacovigilance in the EU: promoting a patient-centred approach

2 November 2016 705 Views
Pharmacovigilance in the EU: promoting a patient-centred approach

by Albert van der Zeijden, patient representative at the Pharmacovigilance Risk Assessment Committee and the Scientific Committee’s Patients’ and Consumers’ Working Party of the European Medicines Agency

On 28th October 2016., DG Sante published an article by Albert van der Zeijden patient representative at the Pharmacovigilance Risk Assessment Committee and the Scientific Committee’s Patients’ and Consumers’ Working Party of the European Medicines Agency on Pharmacovigilance. Mr Zeijden emphasised that the role of the Pharmacovigilance Risk Assessment Committee (PRAC) is to avoid unnecessary harm by the use of medicines. Mr Zeijden further mentioned that “pharmacovigilance rules are necessary for the protection of public health in order to prevent, detect and assess adverse reactions to medicinal products placed on the Union market, as the full safety profile of medicinal products can only be known after they have been placed on the market”.

Pharmacovigilance has shifted the focus of regulators from the medicine to the user of the medicine. By the time a medicine receives market authorisation, there is already an adequate amount of information on the efficacy and safety of the medicine. The most important aspect is the effectiveness of a medicine in the everyday practice. PRAC wants to pursue personalised treatment and achieve patient-centred healthcare.

The European Commission has a published a report on pharmacovigilance in August 2016 demonstrating the developments in this health area.

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