Pharma Groups Challenge Italian Off-Label Law

Three European industry groups are asking the European Commission to block an Italian law that encourages off-label drug use, saying it is driven entirely by economics at the expense of patient health.

According to a petition filed with the commission, the law undermines the framework of the EU regulatory system by allowing drugs to be used for treatments that are not backed up by rigorous clinical trials. Specifically, it allows government reimbursement of off-label uses as a substitute for more expensive, approved alternative treatments.

The law also defies a ruling by the European Court of Justice, which stipulated that member states may not revert to off-label use of a drug as a cost-saving measure when an approved alternative is available, the groups say. They disclosed the complaint, which was filed Jan. 28.

The provision not only poses a threat to patient safety but also acts as a disincentive for drug companies to explore new indications for more innovative and safe products, the groups say. The complaint was filed by the European Federation of Pharmaceutical Industries and Associations, the European Confederation of Pharmaceutical Entrepreneurs and the European Association for Bio-industries.

Last summer, EFPIA challenged a similar French bill allowing drugs to be authorized for off-label uses when no alternative treatment is available with the same active ingredient, pharmaceutical form or dosage. That measure was ultimately adopted in December.

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