Italy loosens restrictions on use of 'off label' drugs but legality of changes questioned

Out-Law News | 03 Jun 2014 | 2:34 pm | 1 min. read

Pharmaceutical medicines may be prescribed for different treatments than those they were originally intended for and the cost of that use paid for by the Italian national health service under recent changes to Italian legislation.

The rules on 'off-label' drugs use and funding were altered in a change to Italian laws that came into force earlier this month.

Under the changes, certain listed medicines will be able to be used 'off-label', for example a purpose they have not received approval for, even if there is an alternative authorised medicine that could be used to treat the patient, subject to other conditions.

The Italian Medicines Agency (AIFA) must take the view, having taken account of the results of studies into the matter, that the "product is safe and effective with regard to the proposed use", a Ethical Medicines Industry Group (EMIG) summary of the Italian legal changes, as described at a recent conference hosted by the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), said.

In such cases, the 'off-label' use of the drugs would be "reimbursed by the Italian national health service".

Previously, the Italian rules restricted reimbursement for the off-label use of medicines to cases where the medicines were included on the AIFA's list of approved drugs and where there was no authorised alternative therapy to treat the patient.

The updated Italian laws also now provides for funding of research into the off-label use of medicines.

EUCOPE has said that the changes in the law appear to flout EU rules on marketing authorisations for drugs.

"The Court of Justice of the EU has clearly underlined in [a 2012 case] that (i) exceptions to the marketing authorisation requirement have to be interpreted narrowly and (ii) that financial considerations in themselves cannot justify such an exception," EUCOPE said. "Despite this unambiguous case law, the new Italian law directly promotes the non-authorised use of a product for purely financial reasons."

Life sciences expert Paul Ranson of Pinsent Masons, the law firm behind Out-Law.com, said: "The Avastin and Lucentis case in the UK is an example where the off-label use of a lower priced drug was evaluated against an on-label use of a higher priced drug. It was concluded that the two drugs were equally effective in treating 'wet AMD', a condition that causes some older people to lose their sight. Four NHS bodies in England initially used Avastin, the off-label but cheaper treatment for the condition, but changed its practice after Novartis, the manufacturer of Lucentis, lowered its prices for use of its drug."