SCIENCE, REGULATION AND BUSINESS IN PHARMACOTHERAPIES: HOW TO SOLVE CONFLICTS AND EXPLOIT SYNERGIES FOR THE BENEFIT OF PATIENTS
29 – 30 September, 2012
Hyatt Regency Warsaw Hotel – Warsaw (Poland)
Fondazione Gianni Benzi, with the support Warsaw Children’s Memorial Health Institute and SIAR (Italian Society for Regulatory Affairs), organized the V Foresight Training Course. The Course focused on the current controversies in the field of pharmacological therapies and discuss possible different solutions.
It brought together stakeholders from 12 countries to discuss clinical trials, timely therapy availability, and pricing/reimbursement of medicines.
Key topics included:
- Clinical Trials: A new EU regulation aimed at streamlining the approval process through a single authorization, while reducing bureaucratic impact based on trial risk levels. Concerns about patient protection, especially for vulnerable groups, were raised.
- Therapy Availability: Adaptive licensing, allowing drugs to be used based on evolving clinical data, was discussed as a solution for faster access, with examples like gene therapy.
- Pricing and Reimbursement: The need to revise the European Transparency Directive was highlighted, aiming for more shared practices across countries to ensure quicker drug availability and fair pricing.
- Health Technology Assessment (HTA): The role of HTA in balancing scientific, ethical, and economic factors was emphasized as a way to offer fairer solutions for citizens.
The course included four sessions on pricing, clinical trials, pediatric drug development, and strategies for quicker access to life-saving medicines, all aiming to improve patient access and innovation in Europe.