[Ip-health] Pharmaceutical Field - Pharma fury at French off-label legislation

Elizabeth Rajasingh elizabeth.rajasingh at keionline.org
Thu Sep 3 06:26:34 PDT 2015

Pharma fury at French off-label legislation

The biopharmaceutical industry in Europe has joined forces to file a
complaint against French law promoting government-initiated off-label use
“without the involvement or consent of patients and their physicians”.

The complaint has been made to the European Commission against the French
‘RTU Regime’, which allows the country’s medicines regulator (ANSM) to
issue a temporary authorisation for use of a product in an unauthorised
indication, “also for economic purposes, notwithstanding the existence of
an authorised alternative treatment”.

The law is a result of the case involving Roche’s cancer drug Avastin
(bevacizumab), which is already used off-label for wet age-related macular
degeneration. It is much cheaper than licensed products such as Roche’s own
Lucentis (ranibizumab), marketed in Europe by Novartis, and Bayer’s Eylea

In a joint statement, the European Federation of Pharmaceutical Industries
and Associations (EFPIA), the European Confederation of Pharmaceutical
Entrepreneurs (EUCOPE) and the European Association for Bioindustries
(EuropaBio), said France’s move “is troubling and contravenes European
Union law and jurisprudence”. EFPIA director-general Richard Bergström
said: "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."

Alexander Natz, secretary-general of EUCOPE, added that “it should be up to
the physician to make the decision about the individual patient’s treatment
and not the legislator or payer”.

Elizabeth Rajasingh
Perls Research and Policy Fellow, Knowledge Ecology International
1621 Connecticut Ave. NW, Suite 500
Washington, DC 20009
elizabeth.rajasingh at keionline.org | 1-202-332-2670

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