The European Council has approved two new pieces of legislation that will strengthen pharmacovigilance rules in the European Union. One is a Directive of the European Parliament and of the Council amending Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as regards pharmacovigilance. The other is a Regulation of the European Parliament and of the Council amending Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as regards pharmacovigilance.
The new laws will introduce:
- A symbol – possibly like the black triangle already used in the UK – to show prescribers and patients that particular products need closer monitoring.
- An automatic process for notifying urgent issues at EU level where drugs affect more than one EU member state.
- Increased transparency for the reasons for withdrawing a medicine, so that safety issues can be more easily identified.
- An ensurance that drugs whose introduction depends on post-authorisation safety studies are contained on a special list of drugs for increased monitoring.
The aim of the legislation is to avoid a repeat of the situation where Servier’s Mediator diabetes had been left on the market and caused about 2,000 deaths after serious health concerns had been raised in 1999. The product was eventually withdrawn in 2009. Pharmacovigilance aims to detect, assess and prevent adverse effects from medicines and enable their quick withdrawal on safety grounds.
The new law is expected to come into force by the end of 2013.