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Industry files complaint against France's off-label law

Protests against promotion of Roche's Avastin as cheap eye medication
Avastin Packshot, Roche

A new law in France that allows prescribing of medicines for unapproved uses has been challenged by groups representing Europe's pharmaceutical industry.

The Temporary Recommendation for Use (RTU) regime - which was adopted at the end of last year but came into effect yesterday - gives France's medicines regulator the power to issue a temporary marketing authorisation for off-label use of drugs.

The law has been drawn up specifically in response to a case involving Roche's cancer drug Avastin (bevacizumab) and Novartis' Lucentis (ranibizumab), which is sold for the eye disorder age-related macular degeneration (AMD). Both drugs are VEGF inhibitors that block the formation of blood vessels.

For years, doctors have been prescribing Avastin instead of Lucentis for AMD because it is much cheaper and according to publicly-funded trials is as effective as Novartis' drug. The two pharma manufacturers have lobbied against this off-label use and have taken legal action in some instances to try to block the substitution.

France's RTU Regime is designed to provide a legally robust right to prescribe drugs off-label in these cases, but has been controversial because it departs fundamentally from the prior situation in law which said it could only take place when there was no approved alternative drug available. 

A similar law was introduced last year in Italy, where Roche and Novartis have previously been investigated on suspicion of colluding to block Avastin prescribing for AMD while Roche has been criticised for not seeking approval of Avastin for AMD.

The trade groups maintain that France's move is directly in opposition to EU laws that prohibit member states from supporting off-label use for economic purposes, and is a trend that undermines the current regulatory framework and "could put patients' health at risk."

They have argued in the past that as Avastin is not formulated for injection into the eye, it could be hazardous and the benefit:risk profile for ocular use has not been systematically reviewed by health authorities applying the same stringent standards as required for regular drugs.

"This development is troubling and contravenes EU law and jurisprudence," claim the industry bodies - the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European Association for Bioindustries (EuropaBio).

EFPIA's Director General Richard Bergström said in a statement: "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."

The complaint argues that patients should be made fully aware of the potential benefits and risks associated with the use of an off-label medicine and explicitly consent to its prescription.

Proponents of the RTU system argue that it specifies that only therapeutic considerations should guide off-label prescribing, and insist the decision must only be made after a thorough examination of the patient and based on the their specific medical needs.

Earlier this year, an investigation by the British Medical Journal (BMJ) accused Novartis of intense lobbying to try to block clinical trials comparing the two drugs. In 2012, the company was forced to cut the UK price of Lucentis to prevent off-label use of Avastin.

The World Health Organization (WHO) has also backed the drug for AMD, adding the drug to its essential medicines list.

Article by
Phil Taylor

2nd September 2015

From: Regulatory



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