MEDICINES : MEPS WELCOME UPDATES ON PHARMACOVIGILANCE.

Considered satisfactory by rapporteur Linda McAvan (S&D, UK), the European Commission's two proposals(1) concerning amendments to the Pharmacovigilance Regulation and the Pharmacovigilance Directive do not, for the time being, give rise to numerous proposals for amendments. The adoption, in plenary, of the two draft reports drawn up by McAven, which were the subject of an exchange of views in the European Parliament's Committee on Environment and Public Health (ENVI), on 25 January, is scheduled for 15-16 March or 6-7 April.

In proposing to update rules for these two legislative instruments, the Commission is coming up against identical problems, its objective being to modernise the entire pharmacovigilance system.

While MacAven warmly welcomes the creation of a European Pharmacovigilance Commitee within the EMEA (European Medicines Agency), she believes it is necessary to reinforce its framework. Suggesting that the number of its members be extended to one representative per member state and to two patient and health professional representatives, McAven is convinced that it is necessary to "modify its responsibility". A simple consultative body, "the committee could make recommendations and ensure follow-up".

Another important point is the debate on the EudraVigilance database. A provision by the Commission authorises a company to draw up a single report to EudraVigilance on an adverse drug reaction (ADR), adding that member states should not, therefore, impose new declaration obligations on marketing authorisation holders. Member states, which have gradually developed their own system, say they are reluctant to let information be sent to a central base in Europe. "I understand," admitted the rapporteur, adding that "if I were a government minister, I would very quickly want to know whether, in my country, there are any adverse drug reactions". Nevertheless, considering that it is essential to collect this information, the rapporteur thus proposes a compromise. EudraVigilance could immediately trasmit to member states the information on ADRs communicated by...