To be truly future proof, the revision of the EU Pharmaceutical Legislation must enable the European Union to remain globally competitive and attractive for investments and innovation. AmCham EU, which speaks for American companies committed to Europe, views the European Parliament’s position adopted on Wednesday, 10 April in the plenary session as an improvement upon the European Commission proposal in its recognition of the importance of an improved regulatory framework for innovative companies.
However, concerns remain that the position does not secure globally competitive incentives for research and development and adds additional unnecessary administrative burdens on companies. It is crucial that the legislation strengthens the legal certainty that enables innovation in the EU, notably through a predictable and attractive intellectual property framework as well as an agile and future-proof regulatory ecosystem.
Changes to obligations under the revision – particularly those relating to supply chains, financial flow and environmental criteria – should be clearly defined, evidence-based, proportionate to the risks, coherent with existing legislation and balanced to ensure a competitive life sciences ecosystem. As an example, if co-legislators adopt proposals in the Parliament position to include social and environmental standards in pharmaceutical Good Manufacturing Practice (GMP) inspections, they risk invalidating the EU’s existing Mutual Recognition Agreements on GMP with seven key trading partners, including the US, Canada and Japan. Because these social and economic standards are not linked to internationally harmonised inspection practices, they could slow market access for European patients.
As discussions at the Council continue, co-legislators must continue to focus on strengthening Europe’s life sciences sector, addressing its relative decline in comparison to competitors while delivering more timely and equitable access to cutting-edge innovation for European patients.
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