After filing a complaint with the European Commission to stop an Italian law promoting off-label use of drugs, the continent’s pharmaceutical companies are preparing to act as similar legislation is being touted in France.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European association for bio-industries (EuropaBio) recently filed a complaint to the Commission against Italy. They claim the country’s legislation is promoting the use of medicines “for an indication for which they do not have a marketing authorisation, purely for economic reasons”.

Last summer, Italy’s medicines agency AIFA was given the legal right, in some cases, to permit off-label drug use to be reimbursed even if an alternative authorised treatment is available. Notably, AIFA reimburses Roche’s cancer blockbuster Avastin (bevacizumab) for wet age-related macular degeneration which is much cheaper than Novartis' Lucentis (ranibizumab), although the former has no licence for the eye condition.

EFPIA’s director-general Richard Bergstrom told PharmaTimes that the association rarely takes legal action but feels compelled to step in as the case represents a fundamental and worrying attack on a system that has worked well to protect innovation and patient health. He added that it is not limited to the Avastin/Lucentis issue, saying that there is a similar case involving another treatment.

Similar law proposed in France

Mr Bergstrom noted that the Italian agency has been under intense pressure by budget holders to promote off-label use and “a similar law is underway in France which we have to scrutinise and take appropriate action on”. He believes that the “integrity of the regulatory system” is at stake here, adding that the latter, along with patent laws, “are the two legs we stand on” and such drastic changes  “would be changing the rules of the game”.

The EFPIA chief stressed that his members are certainly not against off-label use per se, noting that it is particularly valuable in therapeutic areas such as CNS “where we still don’t understand the diseases well enough”. Off-label also plays an important role in searching for news meds to treat the very young and elderly, but restrictions have to remain in place to stop those “merely chasing pennies”.

Pressure brewing in Europe

Mr Bergstrom went on to tell PharmaTimes that there are “lots of things brewing in Europe”, not least to the debate on pricing highlighted by the cost of the new generation of breakthrough hepatitis C therapies”. He also expressed concern about activists within the Old Continent who are pushing for compulsory licensing to break patents.

“I am not surprised that people are upset,” he said, but he pointed to the efforts of the industry which is “negotiating discounts and access agreements”, working on “sophisticated new payment models”. All these are evolving rapidly and extreme measures that aim to rip up patent and patient safety laws are to be avoided. “Let’s not do anything stupid,” he says.

Specifically on off-label use, Mr Bergstrom said “where will this end”? He gave the example of having a class of compounds made by a company which has undertaken a major R&D investment, then another comes along with their drug. “They say ‘ it’s more or less the same’, they do a small safety study and then ‘oh by the way, we are going to give you a much bigger discount’. This is not acceptable”.  

He concluded by saying that it could lead to a scenario where “companies could start to commercialise products without real approvals or doing real studies. this could be a slippery slope”.