Italian medicines agency facing corruption probe - UPDATE

Pressure is building for wholesale changes at Italy's medicines agency, AIFA, after the arrests of two officials on corruption charges.

Pasqualino Rossi, Italy's representative at the EMEA and a member of the agency's CHMP scientific committee, has been accused of accepting kickbacks in exchange for influencing the drug approval process. According to numerous Italian press reports, he has admitted accepting gifts worth Euro 20,000 from representatives of pharmaceutical companies in exchange for information.

However, he denied that he had ever accepted money and said that he was unable to influence the drugs authorisation process.

EMEA spokesman Martin Harvey said the agency could not comment on the arrests, but pointed out that Rossi was only an "alternate member" who served alongside Italy's full CHMP member, Giuseppe Nistic². Alternate members attend CHMP meetings fairly regularly and can play a full part in discussions but they have voting rights only when the full members are absent, he said.

The other AIFA official, Antonella BovE, worked in the secretarial offices. Her main role was to prepare the documentation of AIFA's decisions.

According to Italian press reports, both agency officials have been asked to appear at the magistrates offices in Turin for questioning. They are likely to be accused of negligence on account of their failure to stop alleged irregularities in the working of the agency.

A press report in the financial daily Il Sole 24 Ore said that the head of AIFA, Nello Martini, and that Martini and another AIFA director, Caterina Gualano, have both been formally told that they are part of the investigation. Gualano is said to be part of the marketing authorisation department at the medicines agency.

Nello Martini has reportedly denied any involvement, saying that he was more concerned about the impact of the investigation on the agency than for his own future. "I am afraid that this scandal will destroy 10 years of work (and) an agency which works well and which provide extensive safeguards for citizens," he said.

The Turin investigation started in 2005 after suspicions that bio-equivalence tests for generic drugs had been faked. Investigating magistrates started a probe into the whole drugs marketing authorisation process in Italy. In September 2006, AIFA withdrew marketing approval for 11 generic medicines because of fears of irregularities in the applications.

The current probe has uncovered 22 suspect drug authorisations, the Italian health ministry has revealed, but it said that none represents a risk to public health, and that "restrictive measures", such as withdrawal, do not need to be taken.

It appears that market authorisation documentation for Italy for the medicines, which are sold throughout Europe, was out of date and had not been modified to take into account changes. In some cases the authorisations were "many years" out of date, the ministry said.

The welfare minister, Maurizio Sacconi, who is also responsible for the health ministry, has ordered an immediate inquiry. A commission will look at implications for public health and the efficiency of procedures and controls inside the drugs agency in relation to the corruption charges.

The commission will be composed of three authoritative experts who will asked to present their preliminary findings within a week and submit a more comprehensive report by the end of July.