Proposed revisions to the European Union (EU) pharmaceutical legislation are poised to deter investment in medical research and development, hurt Europe’s patients, and negatively impact economies and workers. In this post, we’ll examine how the legislation would harm innovation, resulting in fewer new treatments for patients.
- The proposed legislation would roll back the policies proven to drive innovation. Previous policies the EU put in place to incentivize innovation for pediatric and rare diseases have delivered for patients. Since its adoption in 2000, the EU Orphan Regulation has enabled the pharmaceutical sector to deliver treatments for up to 6.3 million EU patients. However, the proposed pharmaceutical legislation disregards this progress and would rollback proven policies. Without proper incentives for developing new medicines, fewer patients will benefit from needed therapies to address their condition.
- Many European Union Members already have environments that don’t properly encourage innovation, necessitating stronger – not weaker – incentives and protections for innovators. Vas Narasimhan, CEO of Novartis, warns that Europe already has “an ecosystem that’s not investing in innovation at the same level as other markets around the world.” Instead of making progress towards a stronger innovation ecosystem, the proposed legislation would shorten the period of regulatory data protection granted to innovators, thus discouraging innovation further.
- The proposed legislation fails to address the real barriers to access. The proposed legislation will penalize pharmaceutical companies if a medicine is not available in all EU Member States within two years. Pharmaceutical innovators, however, have already recognized disparities in the time for patients to access new medicines in different Member States. To address this they committed to file for pricing and reimbursement (P&R) in all EU countries as soon as possible, and no later than two years from the central EU market authorization, provided that the local system allows it. The majority of delays in access occur after a company has filed for P&R and is awaiting a decision. Policymakers should address the barriers that cause these delays, rather than penalize innovators for delays that are out of their control.
Europe’s policymakers should not erode their innovation ecosystem with short-sighted measures that would ultimately hurt the development of new technologies and hinder access. By leaning into policies that strengthen IP rights and other incentives and protections, EU leaders can realize their vision of increasing access to medical innovation to patients across the continent.
Without proper incentives for developing new medicines in Europe, fewer patients would benefit from needed therapies to address their condition.