From Vision to Reality: The EU's Pharmaceutical Reforms and the Path to Improved Access.

Abstract

Disparities in access to oncology medicines in European Union (EU) member states can impact patient outcomes profoundly, with availability and timely access varying significantly across and within member states. This paper discusses the intersection of the new European Health Technology Assessment Regulation (HTAR), the provisions of the proposed pharmaceutical legislation and their potential impacts on access to oncology medicines across EU member states. The HTAR, seeking to standardise the clinical evaluation of new medicines, has the potential to streamline the evaluation process but also risks oversimplifying diverse national healthcare needs. While the HTAR may accelerate access in countries with less-developed health technology assessment systems, it could potentially conflict with established practices in countries with advanced assessment systems, resulting in both joint and national clinical evaluations becoming necessary. The proposed pharmaceutical legislation reform, in both initial and updated forms, aims to incentivise an EU-wide launch of new medicines that challenges the feasibility for manufacturers, particularly in the context of diverse and complex national pricing and reimbursement systems. Both initiatives mark a significant shift towards more collaborative European healthcare policy yet faces the potential of unintended consequences owing to an apparent lack of pragmatism, such as delays in access because of increased administrative burdens and possible deterrents for innovation in Europe. The paper underscores the need for policy adaptation and multi-stakeholder collaboration to ensure the legislative changes achieve equitable and timely access to oncology treatments across the EU.