C02 – Earlier Access to Medicines and Medical Technologies and the Medicine and Medical Device Regulatory Review (MMDR)

There has been considerable effort since October 2014 with the announcement of the Expert Panel Review of Medicines and Medical Devices (MMDR) in progressing the reforms culminating in a senate Inquiry recommending  its passing.  Although the regulatory pathways being established are different for medicines and medical technologies, the goal of earlier access to therapeutics without compromising safety, efficacy and quality is a common goal for all stakeholders.  What will be the potential impacts of the new regulatory pathways (accelerated and priority review) on reimbursement of medicines and the PBAC process. How will clinical evidence requirements (including clinical data generated overseas) be viewed for medical devices? Our assembled speakers will examine these and other issues with both local and global lenses to examine the core question of how the reforms are progress us to achieving earlier access to medicines and medical technologies.

Chairperson: George Papadopoulos, Managing Director, Emerald Corporate Group