9 August 2018 - Comparing the U.S. and the European Union, where do patients have greater access to cancer drugs? This question isn’t as easy to answer as it would seem. 

Patient access to pharmaceuticals is multidimensional; the two main dimensions being the regulatory framework and pricing and reimbursement. The regulatory dimension is relatively straightforward. In the U.S. the approvals process is centralised for all drugs, while in the European Union it is centralised for cancer drugs and biologics. Leaving aside complicating factors such as off-label uses, access depends first on whether drugs are approved and the speed to approval. 

During the period 2000-2017, 106 cancer drugs (new molecular entities and biologics) were approved by FDA, while 87 were approved by the EMA. Of the cancer drugs approved by both agencies over 85% were approved first by FDA. It would appear that regulatory incentives such as accelerated approval and priority review mechanisms have played an important role.

Read Forbes magazine article