Increasingly, EU member states are looking for ways to reduce their health care budgets. In 2011, Germany introduced a new AMNOG system based on an early benefit assessment and mandatory price negotiations with the Statutory Health Insurers for all new chemical and biological entities. Additionally, the EU Transparency Directive 89/105/EEC which provides certain rights for companies in P&R procedures has recently been revised. This session will give an overview of the changes affecting market access in the EU and specifically in Germany.
- Review lessons learned in the first two years of the AMNOG procedure
- Evaluate the upcoming changes in the EU P&R legislation
- Discuss the associated challenges for the biopharmaceutical industry
Ability Level: All
Session ID: 2000