The European Parliament has given its support to increasing the continent's pharmacovigilance systems, making the reporting of adverse events easier and identifying treatments that need special monitoring.
The pharmacovigilance directive, which has already been agreed by the Council of Ministers and the European Parliament's Public Health Committee has now been endorsed. It will see the European Union and its member states set up pharmacovigilance websites, and the national web portals, to be linked to the EU one, will include assessment reports, summaries of product characteristics and patient information leaflets. The portals will also tell patients how to report any suspected adverse reactions.
The portals will be linked to the EU 'Eudravigilance' database, which will be the single point of receipt for all pharmacovigilance information. It will be fully accessible to the member states, the European Medicines Agency and the European Commission, while access "to an appropriate extent" will be available to industry, doctors and the public.
The directive also includes elements of additional monitoring of certain new medicines, which will be identified by a black symbol and an explanatory sentence.
UK MEP Linda McAvan, who steered the draft legislation through Parliament, said "it is very clear that we need to work together. With a pool of 500 million people, it is much easier and quicker to pick up an adverse reaction than when working alone at national level". Czech MEP Jiri Mastalka noted in the debate that the new law will ensure the independence of competent authorities and the sustainability of their budgets and will help guarantee that decisions on patient safety are not "unduly influenced by commercial or other interests".
The directive was approved with 569 votes in favour, eight against and 15 abstentions and the legislation must be put into effect within 18 months of its publication in the EU Official Journal.
Brian Ager, director-general of EFPIA, the European research-based pharmaceutical industry body, noted that the body has "consistently been supportive of these efforts to strengthen and rationalise EU’s pharmacovigilance system". He added that "whilst some of the provisions raise concerns, and will require carefully considered implementing measures be adopted in order to deliver the stated objectives of the legislation, on balance it is a positive move".
Mr Ager went on to say this was only one part of the pharmaceutical package announced in 2008 and urged MEPs to act decisively on the other sections of legislation. “We hope that the EU’s decision makers will demonstrate the same decisive action in adopting the proposals on Information to patients and on measures to reduce counterfeiting," he said.
The European Patients’ Forum welcomed the new rules, "which will strengthen the pharmacovigilance system and make it more transparent". EPF president, Anders Olauson said that “direct patient reporting and a wider access to safety data are necessary as they contribute to patients’ empowerment and greater patient safety".
He added that these efforts "should be seen as integral to the wider EU debate on patient empowerment and health literacy".