Italian medicines agency to be comprehensively reorganised

Italy's medicines agency, AIFA, is to be comprehensively reorganised, according to a government official.

Ferruccio Fazio, a health undersecretary, told the annual meeting of the Italian pharma association, Farmindustria, in Rome that a radical shake-up of the agency is necessary because of the excessively long drugs authorisations processes.

He cited examples of drug registration processes that require 90 days at the European Medicines Agency but take 200 days in Italy. He also pointed out that that authorisation procedures in Italy, along with Spain and Greece, are the slowest in Europe.

Fazio said that the reorganisation of AIFA would be designed to ensure that different functions are divided more effectively and to make the agency more efficient. He added that the medicine agency's relationships with other institutions, including the health ministry, would also be reordered for the same reason.

Earlier during the Farmindustria meeting, pharma executives had highlighted the lengthy drug authorisation periods as one of the main problems facing the industry in Italy.

Angelos Papadimitriou, ceo of GlaxoSmithKline, said that Italy is from most points of view, an attractive place for foreign pharma groups to invest. But he warned it needs to be more "competitive" when it comes to bureaucracy, rules and, most of all, drug registration processes.

The first step in the AIFA reorganisation has been the appoinment of a new head of the agency. Guido Rasi, a microbiology professor who has been a director at Italy's Istituto Superiore di Sanità and a former interdepartmental co-ordinator at AIFA itself, will take over as director general of the medicines' regulator.

He will replace Nello Martini who was suspended from his position after a judge agreed to requests from magistrates investigating corruption allegations that he be removed from his post.

"The mission entrusted to professor Rasi is that of putting into place as quickly as possible not only measures to contain (drugs) spending but also to ensure that registration times are respected," the health ministry said.

The appointment has not been welcomed universally, however. A senior AIFA official has threatened to resign over the decision to replace Martini.

Luigi Bozzini, who is head of AIFA's scientific support group, told local newspaper L'Arena di Verona that he has been sickened by the decision. He described what had happened at the agency as "disgusting" and said he intended to resign from his position at AIFA. Bozzini claimed that other officials at the medicines agency would follow him.