PHARMACEUTICALS : PHARMACOVIGILANCE: COUNCIL GIVES GREEN LIGHT TO BLACK TRIANGLE'.

The first debate concerning the pharmaceutical package, dedicated to strengthening pharmacovigilance for drugs authorised for human use, has been officially closed. On 29 November 2010, agriculture ministers adopted, without debate, the European Parliament's previously negotiated compromise on a proposal to modify Directive 2001/83/EC and a proposal to modify Regulation (EC) 726/2004. As amended, the proposals prioritise safety, health and transparency and reinforce the role of patients, doctors, pharmacists and other health professionals, while limiting the role played by drugs companies.

Member states will from now on be responsible for gathering information in the event of overdose, misuse, abuse and prescription errors and to provide their national authorities with this information according to Eudravigilance data rules. States now have 18 months in which to conform to the two legislative texts.

The side effects of new drugs currently cause around 197,000 deaths per annum, the fifth-largest cause of hospital deaths. The modified texts thus aim to protect patients better, in particular by making it possible to immediately inform the medical profession of a new drug's undesirable effects via national websites and a European portal. New products (the absolute safety of which cannot be assured) will have a black triangle applied to their records and summaries of product characteristics to highlight the potential risks to patients prescribed the new drug. The triangle will be also be accompanied by an invitation to patients...