E-DRUG: Press release EP expert meeting on pharmacovigilance 27 Jan 2010
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Joint press release
Brussels, 2 February 2010
Managing Medicines Risks in Europe
PATIENT SAFETY COMES FIRST
On Wednesday, January 27, Michèle Rivasi MEP (France, Greens) and Linda McAvan MEP (United Kingdom, S&D) chaired an expert meeting on the European Commission's legislative proposals on pharmacovigilance, at the European Parliament in Brussels (1).
The experts highlighted the need to improve patients' safety in Europe by genuinely strengthening pharmacovigilance (2), which is the process of evaluating and improving the safety of medicines.
The experts questioned a number of the Commission's proposals that could weaken the current pharmacovigilance system, such as the possibility that premature marketing authorisations become the rule rather than an exception justified on public health grounds or the risk that Member States' pharmacovigilance authorities could be increasingly bypassed in favour of pharmaceutical companies.
The legal provisions to allow direct reporting of adverse drug reactions by patients to health authorities were strongly welcomed and experts shared recent evidence on the added value of spontaneous patient reports that provided crucial complementary information to health professional reports.
MEP Michèle Rivasi (France, Greens) said:
"The influenza A/H1N1 "false pandemic" is just another example of the influence of commercial interests over the health sector. Evidence shows that it is irresponsible to outsource the collection and interpretation of pharmacovigilance data to pharmaceutical companies because of their conflicts of interest. Public funding of pharmacovigilance activities should be maintained to preserve the independence of health authorities."
MEP Linda McAvan (United Kingdom, S&D) said:
"A robust pharmacovigilance system has the potential to quietly save many lives in Europe. To work well, side-effects need to be reported quickly, and Member States need to cooperate to detect signals and then follow these up with action. I want to encourage the "informed patient", and welcome the proposals to enable patients to directly report their own side-effects."
Recommendations put forward to strengthen the Commission's proposals included to proactively prevent adverse drug reactions, to clarify roles and responsibilities to ensure independent expertise and to avoid conflicts of interest in the collection and analysis of pharmacovigilance data.
Other propositions were aimed at restoring citizens' trust, including granting public access to pharmacovigilance data, increasing transparency in decision-making, and improving information in patient leaflets and on packages (i.e. black triangle for medicines 'under intensive monitoring' in order to encourage patients to report adverse drug reactions).
The European Parliament is currently discussing the pharmacovigilance proposal and is expected to vote on it later this year in the May plenary sessions.