🏥 Aplidin is a drug used to treat multiple myeloma, a type of blood cancer.
🔬 The EMA experts involved in the negative recommendation of Aplidin had a conflict of interest that violated impartiality.
👨⚖️ The European Court of Justice confirmed this view in 2020.
💊 The Commission reviewed the involvement of experts and EMA rules to ensure objectivity and impartiality.
⚖️ The EMA rules at the time prohibited one expert from participating in the authorization procedure.
💰 The decision raises questions about who will pay for the lost profits within the patent term of Aplidin.
Introduction:
The European Commission has corrected its decision not to grant marketing authorisation for Aplidin (plitidepsin) due to conflicts of interest of leading EMA experts. PharmaMar SA filed a complaint against the EMA arguing that the negative recommendation of the CHMP was influenced by conflicts of interest. The European Court of Justice confirmed this view in 2020, leading the Commission to review the criteria for the involvement of experts in the authorization procedure. The Commission found that one of the experts involved in the Phase I tests of a competitor product should not have been allowed to participate in the authorization procedure for Aplidin.
- The European Commission has corrected its decision not to grant marketing authorisation for Aplidin due to conflicts of interest of leading EMA experts.
- The EMA experts involved in the negative recommendation of the CHMP had a conflict of interest that violated the principle of impartiality.
- PharmaMar SA filed a complaint against the EMA arguing that the negative recommendation of the CHMP was influenced by conflicts of interest.
- The European Court of Justice confirmed this view in 2020.
- The Commission reviewed the criteria for the involvement of experts in the authorization procedure to ensure objective impartiality.
Conclusion:
The European Commission has upheld PharmaMar SA’s complaint against the EMA, recognizing the conflicts of interest that influenced the negative recommendation of the CHMP. This decision highlights the importance of ensuring the objective impartiality of experts involved in the authorization procedure for medicinal products. Going forward, the Commission will review and update its criteria to prevent conflicts of interest and maintain the integrity of the authorization process.
