Feature Briefing

Avastin and Lucentis: a guide through the legal maze

BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h1377 (Published 01 April 2015) Cite this as: BMJ 2015;350:h1377
  1. David Lock, Queen’s Counsel, London, UK
  1. DLock{at}landmarkchambers.co.uk

Many doctors believe that bevacizumab (Avastin) is a clinically acceptable alternative to ranibizumab (Lucentis) for patients with wet age related macular degeneration (AMD) and presents a more cost effective alternative for the NHS. However is a doctor acting lawfully when prescribing bevacizumab for patients with wet AMD?

Prescribing a drug “off-label”

Every drug for clinical use needs a marketing authorisation, commonly called a licence, before it can be lawfully marketed by a drug company in the UK. The marketing authorisation defines the patient group for which the drug can be advertised. A drug that does not have a marketing authorisation is unlicensed and (broadly) can be sold in the EU only if there are no licensed alternatives. But the licensing regime does not impose legal obligations on doctors to use drugs only for the conditions set out in the licence. Using a licensed drug for conditions that are outside those described in the licence is commonly called “off-label” prescribing.

Bevacizumab is licensed for treatment of cancer, but Roche cannot advertise it for wet …

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