Case StudyHEALTH SYSTEM
Case StudyHEALTH SYSTEM
Disparate stakeholders working together to address intractable problems.
This work engages multiple stakeholders, asking each to acknowledge and move beyond individual interests to co-create solutions to shared problems.
A better way to develop
medicines in Europe
Objective
Many medicines that received regulatory approval in Europe were not getting to patients, as European Member States had differing requirements for reimbursement that were unclear to developers.
Our Approach
- While at another firm, Matt and Nicholas co-designed an expanded version of the EMA’s Scientific Advice process that brought Health Technology Assessment agencies to a shared table with regulators to consult with developers on specific development programs.
- Negotiated the participation of the six largest European Member States.
- Piloted the new process on six development programs sourced from global pharmaceutical pipelines.
Outcome
The success of the pilots and the benefit to medicine developers led the EMA and the European reimbursement authorities to institutionalize Parallel Scientific Advice. It has been a staple part of the European medicines ecosystem for over a decade.
Final Report
Parallel joint scientific consultation with regulators
and health technology assessment bodies
and health technology assessment bodies