Italy rejects EU pharma package proposals

The Italian government has rejected several proposals in the EU's "pharma package" of legislation on counterfeiting, pharmacovigilance and patient information.

Guido Rasi, director general of the Italian medicines agency AIFA, said Italy would oppose any counterfeiting legislation that does not include obligations on national authorities to inspect production sites of active ingredients that are imported from third countries.

He said there are potential health risks for EU citizens if such controls are not put in place. As an example, 600 people have died in the US from contaminated heparin imported from China.

Italy is also against allowing private companies to carry out checks on sites producing pharmaceutical raw materials.

"Only national authorities can provide adequate assurances in terms of control and certification," said Rasi.

The Italians also oppose the new Pharmacovigilance Risk Assessment Advisory Committee (PRAAC) in its proposed form because it would not provide large enough representation. The body is being set up to work alongside the Committee for Medicinal Products for Human Use (CHMP).

Rasi said Italy would prefer a more extensive new panel with representatives from every EU country, a view shared by "a large majority of other member states".

Italy is not opposed to Eudravigilance, which has been set up to be a centralised database for pharmacovigilance information on drugs, but believes member states should be allowed to keep their national pharmacovigilance networks for the collection of data, which would then be put into the EU database. He pointed out that Italy's pharmacovigilance network is already automatically synchronised with Eudravigilance.

Finally, Rasi said Italy shared the concerns of most other member states about patient information reforms. He warned that the distinction between "information" and "advertising" needs to be much more clearly established and any proposal that would allow companies to provide information directly to patients without specific authorisation from national authorities should be removed.