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The sample case of bevacizumab poses a more general regulatory issue.
We have already proposed (BMJ 2010;341:c3721) that when commercial
interests hamper or even oppose public health expectations, regulatory
authorities should be enabled to recognise the indications that meet
patients' needs best, meaning more effectively, more safely, or at lower
cost. The European Commission should amend the legislation that prevents
the EMA initiating authorisation procedures independently of the
pharmaceutical industry or mandating a compulsory licence for another
company for a specific indication.
No competing interests
21 January 2011
Mario Negri Institute for Pharmacological Research, Milan