This roundtable discussion was organised as part of discussion series ‘Transformations - How pharmaceutical innovation is changing healthcare’, a joibnt initiative of EPC and Shire. Andrzej Rys, Director for Health systems and Products from DG Health and Consumers, European Commission, Richard Torbett, Chief Economist at the European Federation of Pharmaceutical Industries and Associations (EFPIA), Yann Le Cam, Chief Executive Officer at European Rare Disease Patients Association (EURORDIS) and Susan Boynton, Head Regulatory Affairs, Policy and Intelligence from Shire led the discussion on how to support innovation in pharmaceuticals, particularly with reference to regulatory frameworks. The event was chaired by Hans Martens, EPC Senior Adviser. Pharmaceutical regulation aims to support innovation, while at the same time protecting public safety. There was general consensus that European-level regulatory approval for drugs was appropriate, but disagreement over whether EU-level pricing agreements would be preferable to national arrangements. Many predicted a necessary decline in the use of large clinical trials, particularly as personalised and rare-disease treatments are developed, where large-scale trials may not be possible. There was some discussion on harmonisation as part of the broader TTIP trade deal, and such work was seen as difficult, but potentially rewarding.