Page last updated at 14:23 GMT, Tuesday, 21 September 2010 15:23 UK

New law to report adverse effects of medicines

MEPs have given their backing to a tougher rules to increase the amount of information about side effects of medicines.

The so-called Pharmacovigilance directive has already been agreed by the Council of Ministers and the European Parliament's Public Health Committee.

It would require national governments and the Commission to set up "medicine web-portals" to give patients more information on products and side effects.

There would also be increased information about how to report any suspected adverse reaction to the medicine.

Opening the debate on 21 September 2010, the Parliament's rapporteur on the directive, British Labour MEP Linda McAvan highlighted the devastating side-effects of thalidomide.

She said that having an EU-wide system of reporting and monitoring of side effects would be a more effective way of flagging up potential risks and avoiding similar health problems in the future.

It was broadly welcomed across the political spectrum, with Czech Conservative MEP Milan Cabrnoch saying it puts "the patient on the same level as the doctor", and Irish Labour MEP Nessa Childers claiming the directive could help tackle the problem of fake and fraudulent medicines.

All national web-portals on medicines would be linked to the EU's "Eudravigilance" database, which contains information about medicines and side effects.

The draft law was passed by 559 votes to 7 at the voting session the next day.

Read more here at Democracy Live's guide to the European Parliament plenary sessions.

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