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European "pharmaceutical package": letter on clinical data exclusivity

 Advancing Healthcare Policy  Prescrire was a cosignatory of a letter sent to members of the European Parliament asking them not to extend the regulatory protection afforded to originator medicinal products. 
Full article available for download (free)

In March 2024, along with over 20 European civil society groups, Prescrire signed a joint letter to members of the European Parliament responsible for handling the revision of European pharmaceutical legislation (known as the "pharmaceutical package"). This letter asked them not to extend the "data protection" period during which clinical data pertaining to originator products enjoy regulatory protection, and to put public health, healthcare users and patients before the interests of pharmaceutical companies (1).

Unfortunately, this view was not reflected in the plenary vote held in the Parliament on 10 April 2024, with members opting to practically obliterate the reduction in the duration of regulatory data protection periods that had been proposed by the European Commission, and is supported by civil society (2).

References
1- "Patients say NO to extending the duration of intellectual property protection for medicines" 5 March 2024: 2 pages.
2- "P9_TA(2024)0221 (…) European Parliament legislative resolution of 10 April 2024 on the proposal for a regulation (…)": 160 pages.
 

©Prescrire 1 October 2024

Source: "European "pharmaceutical package": letter on clinical data exclusivity" Prescrire Int 2024; 33 (263): 251. Free.

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See also:

"Revision of European
pharmaceutical legislation"
Prescrire Int 2024;
33 (256): 55.
Free

"European Commission
public consultation
on the revision of European
pharmaceutical legislation:
Prescrire's response"
Prescrire Int 2024;