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EU Pharma Reform: Negotiations Could See Patient Voice ‘Discarded,’ Warn Patient Groups

 
• By Eliza Slawther

An enhanced role for patients in the European Medicines Agency was a key proposal within the EU pharmaceutical legislation overhaul – but patient groups warn this provision could be scrapped or weakened due to ongoing negotiations.

Plans to include patients in EMA committees could be scrapped under the new pharma legislation reform, patient groups say (Shutterstock)
Key Takeaways
  • Two umbrella organizations representing patients in the EU have said that plans for patients to be involved in European Medicines Agency committees risk being scrapped.
  • The proposal to include patient representatives as voting members of two of the EMA’s scientific committees is part of the proposed overhaul of the EU pharmaceutical legislation.
  • Many regulators are actively pushing for patients to play a greater role in the regulatory process, while drug companies are seeking out patient voices to boost their drug submissions.

Patient representatives are set to play a key role in the European Medicines Agency’s human medicines committee (CHMP) and pharmacovigilance risk assessment committee (PRAC) under the upcoming reform of the...

However, the proposal to include four patient representatives as voting members of the CHMP and PRAC could be discarded under ongoing legislative negotiations, according to EURORDIS-Rare Diseases Europe and the...

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