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Advancing healthcare policy

Pharmacovigilance

Advancing healthcare policy

Pharmacovigilance: Actions
Pharmacovigilance activities: the Commission's proposed changes to the 2012 Regulation encourage greater independence, better quality control and disclosure, but further improvements still needed (October 2021)

Paris, 14 October 2021

In its response to the public consultation on the proposed revision of the 2012 Regulation on pharmacovigilance activities, Prescrire notes that the proposed changes seem to go in the direction of greater independence from drug companies and better quality control and disclosure of pharmacovigilance data. Nevertheless, there is further need to improve public access to pharmacovigilance data and to facilitate the dissemination of knowledge on the risks of adverse drug reactions and medication errors.

> Click here to download Prescrire's contribution (pdf, 491 Ko)

Introduction

From the outset, Prescrire has attached great importance to the European pharmacovigilance system. Prescrire has analysed the proposed amendments of the Regulation (EU) 520/2012 very carefully as, in association with the International Society of Drug Bulletins (ISDB), we had contested several aspects of the implementing Regulation when it was designed in 2010.

We appreciate that the European Commission learns from the experience gained by the EMA and the Pharmacovigilance Risk Assessment Committee, reflected in the proposed revision.

Our analysis aimed to see whether the provisions envisaged indeed contribute to the improvement of patients' safety, in particular by correcting some of the flaws we already identified ten years earlier.

> Click here to download Prescrire's contribution (pdf, 491 Ko)

In brief
The status of the reorganisation
Actions
- Pharmacovigilance activities: the Commission's proposed changes to the 2012 Regulation encourage greater independence, better quality control and disclosure, but further improvements still needed (10/2021)
- Prescrire's response to EMA consultation on pharmacovigilance and risk management (5/2016)
- EU Pharmacovigilance public hearings (10/2014)
- EMA's policy on pharmacovigilance data (9/2014)
- European Medicines Agency and pharmacovigilance: no to a fee-for-service system (9/2012)
- Black triangle for medicines: Positive move but poor implementation plan (8/2012)
- Signal detection left to pharmaceutical companies: danger! (11/2011)
- Final proposals on pharmacovigilance: Some progress, but a missed opportunity (12/2010)
- EU Commission's proposals endanger the population (10/2009)
- EU Commission's proposals on pharmacovigilance dismantle the entire system (6/2009)
The Legislative Process
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Advancing healthcare policy

Pharmacovigilance

Advancing healthcare policy

Pharmacovigilance: Actions Pharmacovigilance activities: the Commission's proposed changes to the 2012 Regulation encourage greater independence, better quality control and disclosure, but further improvements still needed (October 2021)

Pharmacovigilance: Actions
Pharmacovigilance activities: the Commission's proposed changes to the 2012 Regulation encourage greater independence, better quality control and disclosure, but further improvements still needed (October 2021)