EU beefs up medicine surveillance rules

UK MEP Linda McAvan (S&D), who steered the draft legislation through the Parliament, said during the debate that "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".

EU Health Commissioner John Dalli said the vote would ensure greater patient safety and cut red tape by sharing data.

"Once implemented, the new legislation will strengthen and modernise the current system for monitoring medicinal products for human use in the EU, making it more robust and transparent," he said.

Czech MEP Jiří Maštálka (GUE/NGL) said ensuring the independence of competent authorities and the sustainability of their budgets will help guarantee that decisions on patient safety are not "unduly influenced by commercial or other interests".

Portuguese MEP Marisa Matias (GUE/NGL), who is responsible for steering the Counterfeit Medicines Directive through the Parliament, said the H1N1 flu pandemic helped concentrate minds on the need for a stronger surveillance system.

"This Directive ensures more active involvement by health professionals and patients in the identification of difficulties. Cooperation between member states and the Union can be a positive sum game," she said.

Bulgarian MEP Antonyia Parvanova (ALDE) said the new rules would enhance Europe's ability to detect and collect adverse drug reactions, as well as improving coordination between national authorities and pharmaceutical companies.

"Transparency and patients' safety have been one of the ALDE guiding principles during our negotiations. A more transparent communication about pharmacovigilance activities, together with a more efficient overall system at EU level, will enhance patients' trust in the medicines they are taking, as well as in the authorities that guarantee their safety," she said.

BEUC, the European consumers' organisation, noted that around 197,000 Europeans die of adverse reactions each year. "Direct reporting of adverse reactions is an essential tool to empower patients. With direct reporting, problems can be detected earlier and more side effects are reported," said Monique Goyens, director-general of BEUC.

EFPIA, the European research-based pharmaceutical industry body, welcomed the new rules, adding that this is the first element of the pharmaceutical package to be adopted since it was published in 2008.

"EFPIA has consistently been supportive of these efforts to strengthen and rationalise EU’s pharmacovigilance system. 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. EFPIA is fully committed to helping implement the new legislation," said Brian Ager, director-general of EFPIA. The European Generic Medicines Association (EGA) welcomed MEPs' decision to delete the Commission's plan for a boxed summary of essential information in the product literature.

The group stressed that "proper and harmonised" implementation by member states will be crucial if the new rules are to work.

The European Patients' Forum said the new rules on Pharmacovigilance will enable patients and health professionals to work more effectively together for improved medication safety.

"Direct patient reporting and a wider access to safety data are necessary as they contribute to patients’ empowerment and greater patient safety. These efforts should be seen as integral to the wider EU debate on patient empowerment and health literacy, with the aim of enhancing the safety and quality of care for all patients across the European Union," said EPF President Anders Olauson.