Italian medicines agency officials arrested in corruption probe

Two officials from the Italian medicines agency, AIFA, including an EMEA representative, have been arrested after a corruption investigation in Turin.

Two officials from the Italian medicines agency, AIFA, including an EMEA representative, have been arrested after a corruption investigation in Turin.

The city's public prosecutor's office has ordered the arrest of a total of seven people. Four of those are in prison while the other three are under house arrest. The police are seeking an eighth person suspected of being involved in the case.

The head of the public prosecutor's office, Marcello Maddalena, named the AIFA officials as Pasqualino Rossi, Italy's representative at the European drugs agency EMEA, and Antonella Bove. According to reports in the Italian press, Rossi, a member of the Committee for Proprietary Medicinal Products (CHMP), is in prison while Bove is under house arrest.

manipulation

The other five people arrested were described as employees in pharmaceutical companies, businessmen from the pharma sector and buyers in pharma companies. All seven are accused of having manipulated the applications of drugs for marketing authorisation by either delaying or accelerating the approval process.

According to the prosecutor's office a further 22 people and many pharmaceutical companies have been investigated in the corruption probe and further arrests could not be ruled out.

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.

evidence

Officials from the public prosecutor's office said that they have evidence on film and from intercepted phone calls that crimes were committed including the payment of kickbacks. They believe that the money may have been paid to slow down the authorisation process for some drugs and speed it up for others.

In September 2006, AIFA withdrew marketing approval for 11 generic medicines because of fears of irregularities in the applications. The medicines agency said at the time that it had alerted the magistrates to the irregularities.

The European Medicines Agency (EMEA) said it was aware of the reported arrest of the two AIFA officials, but insisted that any wrongdoing seemed to be confined to Italy.

EMEA spokesman Martin Harvey said the agency could not comment on the arrests, particularly as it seemed the people involved were still being questioned and nobody had been charged.

little influence

Rossi is of particular interest to the EMEA as he is a member of the CHMP scientific committee that meets every month to decide the fate of new drug applications. But Harvey pointed out that he 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.

Harvey stressed that an individual member of the CHMP would have great difficulty influencing committee decisions, given the many checks and balances in place at the EMEA. "Individual members do contribute to the committee's work...that is why they are there, but they don't have the ability to sway the entire committee. If anyone tried to push a particular line they would have to defend it scientifically," he said.

"We are sometimes accused of being bureaucratic and heavy-handed - now you know why. The checks and balances are deliberately there as a safeguard."

These checks and balance include a new peer review system by which members of the CHMP review the rapporteurs' and co-rapporteurs' scientific evaluations, as well as the validity of the scientific/regulatory conclusions reached. This quality assurance system applies during the initial phase of the assessment of a new marketing authorisation application.