21 December 2007
The Innovative Medicines Initiative seeks to put right the chaotic treatment of pharmaceutical innovation by EU member states, and will likely fail. The goose that lays golden eggs of medical innovation is cooked to death by member state medicines policies.
Increasing the speed of product development will come to a grinding halt as member states inconsistently apply economic evidence, and thereby stifle adoption of new medicines into clinical use to the benefit of patients.
Current regulatory thinking (i.e. EMEA) is dated as the priorities have moved beyond safety/efficacy issues to outcomes and cost-effectiveness. NICE and its counterparts across Europe have yet to harmonise their methods, adding uncertainty as member states use economic evaluation as a 4th hurdle which varies in height depending on which country you’re in. That economic evaluation is really just a code for controlling health expenditure and reimbursement, and is less about real value and outcomes in many member states only adds to chaos of the regulatory environment into which innovative products are thrown.
So, as we incentivise the early stages of medicines development and speed up the launch of drugs, we continue to tolerate a bottleneck on the utilisation and adoption of medicines themselves within member states. The whole translational medicine process, from bench to bedside, is not just of faster benches, but of clear bedside clinical priorities. We can incentivise the bench until the cows come home, but until we address the real disconnect between adoption and utilisation and link innovation priorities with real-world priorities, patients will still not have the medicines they need. However, the statistics will undoubtedly show a rise in innovation!