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A milestone for Europe’s pharmaceutical legislation

26 Apr 2023
All Committees

The proposals for the revision of the EU’s pharmaceutical legislation published on Wednesday, 26 April, represent a once-in-a-generation opportunity. While AmCham EU supports the modernisation of the legislation, it must ensure predictability and attractive conditions that encourage further investments.

AmCham EU shares the European Commission’s goal to achieve more equitable, timely and affordable access to innovative medicines and other medical technologies across Europe. However, root causes of unavailability and access delays for innovative medicines are complex and mostly found at the national level. These cannot be tackled by weakening the baseline regulatory protections in existing legislation that ensure predictability and stimulate long-term investment.

Efforts to create regulatory incentives, such as a Transferable Data Exclusivity Voucher, to drive R&D against anti-microbial resistance, and a strengthened role for the European Medicines Agency to accelerate access, are welcome, however dialogue with industry should be maintained to ensure that it delivers the intended results. Likewise, the definition of unmet medical need in the legislation must be sufficiently broad to serve patients and support industry’s efforts to meet their needs.

Finally, the package seeks to ensure security of supply by harmonising requirements across Member States. It is important to avoid excessive reporting obligations and restrictions so that companies can remain focused on meeting consumer demands where they arise.

Building on our deep transatlantic ties in science and investment in health, AmCham EU member companies stand ready to help EU policymakers seize the landmark opportunity of this revision to improve outcomes for patients and bolster Europe’s global competitiveness at the cutting-edge of life sciences innovation.