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EU State Aid Rules: Industry acronyms call for urgent support for active ingredients

Regole Ue su aiuti di Stato: sigle settore chiedono sostegno urgente su principi attivi
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Rome, 25 November – “The European Union must play a decisive role in supporting the production in Europe of active pharmaceutical ingredients and end medicines with fast, strong and ambitious policies that prioritize patients’ access to medicines, expanding and strengthening its competitiveness and geopolitical position; and opening the door to investment with attractive policies “.

This is supported in a note released yesterday by Medicines for Europe, the European Union of manufacturers of equivalent and biosimilar drugs and European Fine Chemicals Group, the European Union of Fine Chemicals, on the eve of the EU Competitiveness Council meeting in Brussels today .

“Many recent studies on the state of sectoral production in Europe” write the two associations “Show that despite the strong industrial base, a significant part of the production of active pharmaceutical ingredients (API) has been transferred to Asia, where investment and operating costs are 20-40% lower, mainly due to lower labor and environmental costs. Another key factor in oversupply is unsustainable pricing policies in Europe that do not provide predictability for producers, effectively encouraging a “run-down”, do not reward investment in security of supply or environmental improvements, which are fundamentally EU pharmaceutical policy. “

“Alongside” adds the note “The structured dialogue between the Commission and the industry on the security of the supply of medicines shows that this combination of unsustainable prices and top-down economic policies is particularly extreme for non-patented medicines.”

Medicines for Europe and the European Fine Chemicals Group have also developed five indications of the industrial policies that the EU must pursue to support industry production. This is the “pentalog” of the two industrial associations:

1. provide for reforms in EU procurement, pricing and compensation legislation to encourage investment in security of supply, strengthen the competitiveness of European production and support the green transition to drug production;

2. encourage access to production incentives and capital to support manufacturing investment in new technologies and innovations by adapting the EU State Aid framework;

3. optimizing the effectiveness of regulatory policies for medicinal products through the use of digitization and interoperability between European regulatory systems;

4. accompany future changes to sectoral regulations with an in-depth assessment of the impact on the competitiveness of the European industry and the unlicensed pharmaceutical sector;

5. develop a security of supply partnership with the United States to encourage greater investment in manufacturing.





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