The Impact of Adaptive Pathways and Adaptive Access on Intellectual property and Regulatory exclusivity rights
On April 12th 2017, the IMI ADAPTSMART consortium hosted a multi-stakeholder workshop. Twenty-two representatives attended, including: medicine developers, independent IP and regulatory lawyers, payers, academics and policy makers.
The workshop was opened by Stuart Faulkner (CASMI) who set out the objectives of the meeting. Andre Broekmans (Lygature) provided an “Overview of MAPPs and ADAPTSMART”, in particular he summarized the rationale for Adaptive Pathways and the details of ADAPTSMART project and consortium. As last part of the introductory session, Ian Hiscock and Alex Meier (Novartis) provided the “Perspective of a company: Intellectual Property & Regulatory Exclusivity Rights – Why do we need it?”
Following the introduction, participants joined two consecutive breakout sessions. The first reviewed the marketing authorization (MA) scenarios that could occur under MAPPs and their implications. The second session discussed a series of recommendations within the current legal framework and options for future work.