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New ministerial guidance letter: a vague framework that contradicts three of the CEPS's positions while leaving it alone in charge of price regulation policy

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The new ministerial guidance letter (‘LOM’) intended to guide the Economic Committee for Health Products (‘CEPS’) on the pricing strategy for pharmaceutical products and medical devices has been signed and published on 5 May 2025.

This LOM is rather ‘poor’ but at least contradicts three of the Committee's positions:

  • the health sovereignty of innovative or essential products must be rewarded, even though the CEPS very rarely agrees to apply the industrial criterion;
  • the price increases enabling access to or sustainability of innovative/essential products may be supported by data certified by a third party;
  • this LOM replaces the previous ones (even though the Committee considered that the LOMs overlapped).

Thus, while reiterating the need to negotiate the new Framework-Agreement on pharmaceutical products, this LOM does not provide any precise indications on the public health strategy that should guide the regulation of healthcare products prices, leaving the CEPS in charge once again... 

 

 

Authored by Charlotte Damiano.

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