Regulation of medicines is a complex process, and involves a wide range of stakeholders. The quality of interactions between these stakeholders is pivotal – it can change timescales or determine eventual outcomes.
Escher research looks at crucial questions that arise while arriving at regulatory decisions. For example: who are the relevant parties in the marketing authorisation or HTA process? At what moment should they be involved? What type of involvement is appropriate and how should it be implemented? And what authority should be given to stakeholders’ voices?
Interactions between European regulators and pharmaceutical companies have been a particular focus. Dialogue on scientific issues can critically influence development direction and timelines. This may depend on the character of discussions between regulators and companies, timing of such interactions and the involvement of health technology assessment bodies.
The following projects have addressed issues in this area:
- Drug life cycles and public trust in drug development, regulation and marketing of medicines
- Ethical Issues in Postauthorization Drug Trials
- Patient involvement in scientific committees in the assessment of benefits and risks of medicinal products
- Studies on marketing authorization of innovative drugs and scientific advice in the European regulatory system