Navigating the Maze: The EU Pharma Legislation Review and its Implications

The EU Pharma Legislation Review: A Hot Topic

The buzz at the ISPOR Europe 2023 conference in Copenhagen was all about the proposed EU pharma legislation review. This legislation, proposed at a potentially turbulent time, aims to reshape the healthcare landscape in Europe. But has encountered significant resistance from the pharmaceutical industry. The industry is also grappling with the simultaneous implementation of the joint Health Technology Assessment regulation (HTAR).

Balancing Industry and Health Policies: A Complex Task

The panel at the conference highlighted the difficulty of balancing industry and health policies, particularly concerning affordability and sustainability. They concurred that the proposed legislation did little to rectify the misalignment issues, which are further complicated by geopolitical considerations and a lack of clarity in the legislation review.

Perspectives on the Legislation: Industry and Policymaker

Neil Grubert, an independent Global Market Access Consultant, representing the industry perspective, expressed concern about the potential pressure on joint clinical assessment (JCA) timelines due to the expedited timelines proposed in the review. He highlighted the need to consider the global context, particularly as Europe has lost ground to the U.S. in R&D spend and launches.

Yannis Natsis, Director of the European Social Insurance Platform (ESIP), termed the interplay between industry policy and health policy as “complex”. He criticised the legislation for being rushed and for having weak evidence requirements, leading to high prices for certain medicines. He called for more interaction and collaboration between HTA, regulators, payers, and the industry.

The Payer Perspective and Future Implications

Johan Pontén, International Co-ordinator at Sweden’s Dental and Pharmaceutical Benefits Agency, (TLV), expressed concern about the increasing expenditure and drug prices, coupled with lower evidence on effectiveness being presented for assessments. He argued for the compulsory requirement to conduct a comparative study instead of the proposed incentive.

The panel agreed that the lack of clarity in the legislation is causing confusion about potential consequences. While the legislation could lead to significant changes, stakeholders are currently in a grey zone. They are anticipating the switch without the necessary tools or knowledge to take precautionary actions.