Legislative Hold-Up

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As we enter the second quarter of 2023, the revised pharmaceutical legislation for Europe is still, at the time of writing, unpublished. The latest delay to the publication of the new pharma reform, which is the third postponement, came towards the end of March 2023, much to the dismay of members of the European Parliament (MEPs).

MEP and member of the Renew Europe Group, Véronique Trillet-Lenoir, urged the president of the European Commission in a letter issued shortly after the delayed publication was revealed to publish the legislation. In her letter, Trillet-Lenoir indicated that the commission has given into industrial pressure to further postpone the legislative revisions, and she stated that the lack of justification for the delay and the fact that no alternative date for publication has been provided is simply “unacceptable” (1).

“This legislation is key to ensure the fair and equitable access of medicines to all patients, to all Europeans,” she wrote (1). “Today, we are urging you [Ursula von der Leyen] to publish this important legislative package no later than April 2023 to allow the legislative process to start.”

However, there have been glimpses to what might be in store for industry as, at the end of January 2023, the internally circulated proposed reforms were leaked and were met with trepidation by industry. The European Federation of Pharmaceutical Industries and Associations (EFPIA) expressed particular concern about the leaked reforms, which it warned would “irretrievably sabotage” the European Union’s pharma industry (2).

“Whether it is naivety, blind optimism, or a more conscious decision for Europe to rely on innovation from the [United States] and Asia, there should be no doubt that in its current form, this proposed legislation will be extremely damaging to the competitiveness of Europe’s industry and to our region’s strategic autonomy,” specified Nathalie Moll, EFPIA director general, in the reaction press release. “It will have a negative impact on jobs, investment, the European research eco-system, growth, patient access to new clinical trials, and availability of the latest treatments for decades to come.”

With no defined date for publication of the EU’s pharma legislation reforms, the question now becomes whether or not these revisions can be appropriately reviewed before the 2024 European parliamentary elections.

References

1. Trillet-Lenoir, V. Twitter Post, @VTrillet_Lenoir, 23 March 2023.
2. EFPIA. EFPIA Reaction to Leak of the Proposed Pharmaceutical Legislation. EFPIA.eu, Press Release, 10 Feb. 2023.

About the author

Felicity Thomas is the European/senior editor for Pharmaceutical Technology Group.

Article details

Pharmaceutical Technology Europe
Vol. 35, No. 4
April 2023
Page: 6

Citation

When referring to this article, please cite it as Thomas, F. Legislative Hold-Up. Pharmaceutical Technology Europe 2023 35 (4) 6.