Intended for healthcare professionals


Off-label drugs directly compete with licensed drugs for same use, rules European court

BMJ 2018; 360 doi: (Published 31 January 2018) Cite this as: BMJ 2018;360:k511
  1. Deborah Cohen,
  2. Clare Dyer
  1. The BMJ

Drugs used off label for a particular condition can be considered to be in direct competition with those that have market authorisation for that use, the European Court of Justice (ECJ) has ruled.

The ruling confirms that an alleged agreement between Roche and Novartis to discourage doctors from prescribing the cheaper bevacizumab (Avastin) for eye conditions in favour of the pricier ranibizumab (Lucentis) is covered by European competition law, and the companies could face penalties if found to have acted anti-competitively.

Lincoln Tsang, a partner at the Arnold & Porter law firm in London, who advises drug makers and previously worked for the Medicines and Healthcare Products Regulatory Agency, told the news agency STAT,1 “This case has immense implications for the EU, given the increasing pressure imposed by governmental payers to …

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