On April 26, the European Commission released proposed revisions to the EU pharmaceutical legislation, and there are many reasons for innovators and patients to be concerned. While the Commission says it aims to support equitable access to new medicines in the European Union, the policies will do the opposite. Instead, this legislation would erode critical intellectual property (IP) and other existing incentives that are essential for Europe’s ability to research, develop, manufacture and deliver innovative treatments to patients.
Here’s how the legislation will hinder progress:
- Reduce incentives to invest in medical research and development (R&D). The proposed legislation would reduce the regulatory data protection term in Europe by two years and only provide limited, ill-defined or illusory “opportunities” for the innovator to restore lost years.
- Hurt Europe’s innovation ecosystem. Already, many European Union member countries don’t have environments that encourage or foster innovation. The proposed legislation would rollback proven policies that have helped deliver innovative medicines to patients with rare diseases and children.
- The legislation would hurt economies, workers and patient access. The biopharmaceutical industry directly employs 840,000 workers in Europe and indirectly employs three times as many. Discouraging existing and future R&D investments would jeopardize these highly skilled jobs and send investment elsewhere. Likewise, steering away R&D efforts could leave Europeans with fewer clinical trials, which can offer patients early access to novel treatments and cures.
The European Commission has the opportunity to build on existing incentives and make systemic improvements that would spur investment in innovation to the benefit of economies and patients in Europe. Instead, the current proposal would significantly reduce investment incentives and further the decline of Europe’s global economic competitiveness and the life sciences ecosystem. If the Commission truly wants to help patients access innovative new therapies, policies must protect and support innovators in their resource-intensive work.
“[T]his legislation would erode intellectual property (IP) and existing incentives that are essential for Europe’s ability to research, develop, manufacture and deliver innovative treatments to patients”