The approval of new cancer drugs in Europe is built on the benefit—risk paradigm, based on objective criteria of efficacy and safety, to the exclusion of economic considerations. This limits the extent to which the European Medicines Agency (EMA) can contribute to the debate on cost-effectiveness. Still, EU regulators share the growing concerns about sustainability of expenditure on cancer drugs. Regulators are exposed to challenges from stakeholders who often have opposing views, such as the
The Lancet Oncology, Volume 12, Issue 10, Pages 930 - 931, September 2011
doi:10.1016/S1470-2045(11)70229-7Cite or Link Using DOI
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