(Reuters) - Europe’s pharmaceuticals industry said on Tuesday it had filed a complaint with the European Commission against a French law promoting the use of Roche’s cancer drug Avastin as a cheap eye treatment.
The move is the latest salvo in a lengthy battle between drugmakers, who argue Avastin has never been authorized for eye therapy, and cost-conscious European healthcare providers, who contend it works as well as far more costly alternatives.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) said the French decision to allow such so-called off-label drug use on economic grounds circumvented EU rules designed to ensure the proper use of medicines.
“It is simply not acceptable for policy makers 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 Bergstrom.
”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 ANSM 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 Sept. 1.
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 authorized 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 euros ($225 million).
Italy has also taken action to encourage the use of Avastin in AMD.
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Reporting by Ben Hirschler, editing by William Hardy