AIFA's future hangs in the balance

Published: 5-Jun-2008

The future of the Italian Medicines Agency, AIFA, is said to be hanging in the balance as a judge considers whether to heed a call for the agency to be put into a form of administration.


The future of the Italian Medicines Agency, AIFA, is said to be hanging in the balance as a judge considers whether to heed a call for the agency to be put into a form of administration.

Investigating magistrates in Turin want AIFA's chief, Nello Martini, and the head of drugs registration, Caterina Gualano, to be suspended. They are reported to have accused the agency officials of "culpable disaster" because of the failure to ensure that medicines approved for the Italian market were safe.

If the officials were to be suspended, the agency would be put into a kind of administration, led by temporary replacements.

What evidence the magistrates have of corruption at AIFA remains unclear. They have made no official statements about the case since the arrests of the officials. A commission appointed by the government to look into the accusations made against AIFA has found nothing that suggests public health in Italy is in danger, the health ministry has said.

In its preliminary report into the affair, the three-man inquiry panel has given a clean bill of health to 22 drugs that are suspected to have had their authorisation processes manipulated.

The ministry still has not named the drugs whose authorisation processes are part of the ongoing corruption probe. Nor have the magistrates officially named any drugs whose registration processes they suspect may have been manipulated.

The government-appointed commission will now start a longer and more extensive inquiry into the workings of the medicines agency. When it reports, later this summer, it may make recommendations about reforms - if it deems them necessary.

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