Adaptive licensing: Is EMA chief Rasi heading for a fight with the commission and others in the EU?

摘要

The European Commission and German health technology assessors have poured cold water on aspirations by European Medicines Agency head Guido Rasi to introduce an adaptive licensing approach for evaluating and approving medicines. Adaptive licensing - under which drugs would be approved earlier on than at present and on the basis of less evidence - would not comply with the risk-averse bent of the current legal system, said Florian Schmidt, a legal officer in the pharmaceuticals unit at the commission. Thomas Mullen of Germany's G-BA, the federal joint committee that among other things decides whether drugs should be reimbursed by state health insurers, expressed concern that adaptive licensing could be perceived as a lowering of EMA standards and he cast doubt on the value of the approach as an attractive business model for companies. Dr Schmidt and Dr Muller made their comments on 29 November at the European Medicines Agency Review of the Year and Outlook for 2013 annual meeting in London, UK.