Europe’s pharmaceuticals industry said on Tuesday (1 September) it had filed a complaint with the European Commission against a French law promoting the use of Roche’s cancer drug Avastin as an alternative to more expensive eye treatments.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) said the French decision to allow such ‘off-label’ drug use on economic grounds circumvented EU rules designed to ensure the proper use of medicines.
The EFPIA complaint is the latest move in a lengthy battle between drug makers, who argue Avastin has never been authorised for eye therapy, and cost-conscious European healthcare providers, who contend it works as well as far more costly alternatives.
“It is simply not acceptable for policymakers concerned with the size of healthcare spending to introduce legislation that not only contradicts EU law, but also puts the overall EU regulatory system aimed at guaranteeing the highest patient safety standards at risk,” said EFPIA director general Richard Bergström.
“The pharmaceutical industry collectively calls on the European Commission to address this public health issue urgently and preserve those safeguards that have been put in place.”
The French medicines regulator decided earlier this year that Avastin should be allowed for the treatment of wet age-related macular degeneration (AMD) and the law became effective on 1 September.
Although Roche’s Avastin is not approved by health regulators as a treatment for AMD, it works in a similar way to the treatments currently authorised for AMD, such as Lucentis, marketed by Novartis and Roche, and Eylea, from Bayer and Regeneron.
France has argued that encouraging the use of Avastin, which costs around 30 times less than those rival treatments, could bring annual savings of some €200 million.
Italy has also taken action to encourage the use of Avastin for cases of AMD.
It has long been common practice for doctors to prescribe Avastin off-label to treat the eye disease. Italian antitrust regulators last year took drug makers Roche and Novartis to court for allegedly plotting to convince doctors not to use the cheaper drug.