ISSUE: Rare diseases represent a major public health issue in Europe. Orphan medicinal product (OMP) legislation introduced in 2000 has led to an increase in new OMPs being developed, but patient access to these medicines is imperfect and variable between countries. This variation partly reflects challenges in pricing and reimbursement for OMPs and different approaches across Europe. In March 2017, the ORPH-VAL Working Group, a European multi-stakeholder group of rare disease experts, published a set of principles for value assessment and funding processes in rare diseases. These principles aim to help improve the quality and consistency of OMP P&R processes in Europe and ensure that value assessment and P&R processes reflect the specificities of rare diseases. This session will consider how the P&R systems for OMPs in Germany, France and UK align with the principles and explore opportunities for improvement and consistency. OVERVIEW: Professor Lieven Annemans, the chair of the ORPH-VAL working group will provide an overview of the 9 principles and the results from an assessment of the alignment of the principles with the P&R systems currently used in Germany, France and UK to assess OMPs. He will be accompanied by three payers from the countries of interest. The panelists will be invited to respond to the analysis and discuss the areas of alignment or misalignment in their countries and the potential need for change. They will subsequently be asked to think about how the OPRH-VAL principles could be implemented in practice in their respective country by 1) identifying opportunities and pathways they would recommend in order to align with the principles, 2) highlighting challenges or hurdles that may exist, and recommend pathways for improvements and potential reforms. Professor Lieven Annemans will summarise the arguments and invite the audience to provide their perspective.