Demanding Impartiality

It is rare indeed for the European Commission (EC) to go against the decision of the European Medicines Agency (EMA); however, for Spanish pharmaceutical company, PharmaMar, such a rare occasion has become a reality.

Six years ago, in July 2018, the EC implemented its decision to reject the marketing authorization application of PharmaMar’s multiple myeloma treatment, plitidepsin (Aplidin), in concurrence with the opinions of EMA’s Committee for Medicinal Products for Human Use (1). PharmaMar contested the decision and filed a lawsuit against the EC, aimed at getting the rejection decision annulled (2).

After being assessed in the General Court of the European Union (EU) in 2020, PharmaMar’s claim that there was a conflict of interest in the experts appointed to assess plitidepsin by EMA was upheld. However, the decision was appealed before the EU Court of Justice, and three years on, in July 2023, the 2020 judgement was set aside, and the case was referred back to the General Court of the EU to rule again (3).

In July 2024, PharmaMar received notification that the EC had revoked its refusal to grant marketing authorization for its multiple myeloma treatment as a result of a member of the EMA’s scientific advisory group’s conflict of interest (2). This is unusual, not least because of the rarity of such an occurrence happening, but also because the EC did not wait for the final judgment of the General Court (4).

And this is not the only case in progress pertaining to conflicts of interest within EMA advisory committees. French independent pharma company, D&A Pharma, has also had the refusal decisions of EMA and the EC for its alcohol dependency treatment sodium oxybate (Hopveus) overturned in court (5).

For now, EMA will need to re-evaluate plitidepsin with absolute impartiality; whether such actions will become more commonplace in the future remains to be seen, but if they do, the integrity of the regulatory authority for Europe could be called into question.

References

1. EC. C(2024) 4669 Commission Implementing Decision of 28.6.2024 Revoking Decition C(2018) 4831 (final) Refusing Marketing Authorization Under Regulation (EC) No. 726/2004 of the European Parliament and of the Council for “Aplidin–Plitidepsin”, a Medicinal Product for Human Use. Brussels, Belgium, 28 June 2024.
2. PharmaMar. Aplidin Will Be Re-evaluated by the EMA. The European Commission Revokes the Decision that Initially Denied PharmaMar’s Marketing Authorization for Multiple Myeloma due to a Conflict of Interest. Press Release, 8 July 2024.
3. EMA. Aplidin. EMA.europa.eu (accessed 4 Aug. 2024).
4. Miñano, L. Deadly Prices: European Commission Rejects Cancer Drug Removal over ‘Impartiality’ Concerns. Investigate Europe, 22 July 2024.
5. D&A Pharma. The Court of Justice of the European Union Overturns the Decision to Reject the Marketing Authorization for Hopveus: A New Hope for Patients. Press Release, 27 March 2024.

Article details

Pharmaceutical Technology Europe
Vol. 36, No. 7
July/August 2024
Page: 6

Citation

When referring to this article, please cite it as Thomas, F. Demanding Impartiality. Pharmaceutical Technology Europe 2024 36 (7) 6.