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Advancing healthcare policy

Pharmacovigilance

Advancing healthcare policy

Pharmacovigilance: Actions

At certain key points, citizens can bring their actions to bear upon European deputies and upon the ministers of Member States.
Below is a recap of our 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)

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. Read on...
Prescrire's response to the EMA public consultation on good pharmacovigilance practices and risk management programmes (May 2016)

To improve patient safety, the priority should be patients, not companies. Read on...
EU Pharmacovigilance public hearings should be as transparent and independent as in the US (October 2014)

In their joint comments to EMA's public consultation, Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB), the Medicines in Europe Forum and the Nordic Cochrane Center (NCC) call for more independence and transparency to make the most of EU pharmacovigilance public hearings. Read on...
EMA's policy on pharmacovigilance: access to qualitative data is needed, pharmacovigilance data are not "trade secrets" (September 2014)

Joint response to the EMA consultation by the Cochrane AEMG, HAI Europe, ISDB and MiEF. "Protection of personal data" must not be used as a pretext to strengthen intellectual property over pharmacovigilance data. Read on...
European Medicines Agency and pharmacovigilance: no to a fee-for-service system (September 2012)

In a joint press release, the International Society of Drug Bulletins, Medicines in Europe Forum and HAI Europe argue that the European Commission’s proposed pharmacovigilance fee structure turns the European Medicines Agency (EMA) into a mere provider of services to the pharmaceutical industry . Other funding strategies need to be considered to safeguard the Agency’s independence. Read on...
Black triangle for medicines: Positive move but poor implementation plan (August 2012)

In a joint press release, the International Society of Drug Bulletins (ISDB) and the Medicines in Europe Forum (MiEF) observe that the draft paper on the quality review of documents submitted for consultation by the European Medicines Agency (EMA) does not reflect the spirit of the new pharmacovigilance legislation, which is to prevent drug-induced harm. Read on...
Signal detection left to pharmaceutical companies: danger! (November 2011)

In its answer to the "Concept paper on pharmacovigilance implementing measures", the International Society of Drug Bulletins points out that the first and critical step in pharmacovigilance, namely the detection of safety signals, is left to pharmaceutical companies, despite their conflict of interest. Full transparency is key to avoid missing safety assessment opportunities. Read on...
Final proposals on pharmacovigilance: Some progress, but a missed opportunity to genuinely strengthen patient safety (December 2010)

If the safety of European patients is to be genuinely reinforced, the European Commission’s priorities must be to improve the quality of the evaluation of medicines before they are granted marketing authorisation and to increase the independence of drug regulatory authorities, to enable them to better fulfil their public health remit, particularly when evaluating and reviewing the harm-benefit balance of medicines. Read on...
Pharmacovigilance in Europe: the European Commission’s proposals endanger the population (October 2009)

In this Joint Analysis, the Medicines in Europe Forum and International Society of Drug Bulletins examine the European Commission proposals and make 15 concrete recommendations for improvement. Among the key issues of concern: the spread of weak marketing authorisation practices; the withholding of adverse drug reactions data, the collection and interpretation of which are abandoned to pharmaceutical companies; the increased financial and intellectual dependency of health authorities on pharmaceutical companies. Read on...
EU Commission's proposals on pharmacovigilance dismantle the entire system (June 2009)

In December 2008, the European Commission published a proposed Regulation and Directive concerning pharmacovigilance. In spite of recent public health disasters, several of the proposed measures will weaken rather than strengthen the European pharmacovigilance system. Read on...