22 July 2024
Leïla Miñano
Deadly prices: European Commission rejects cancer drug removal over ‘impartiality’ concerns
Alexia Barakou
Deadly prices: European Commission rejects cancer drug removal over ‘impartiality’ concerns
22 July 2024Days after the publication of our investigation into the European Medicines Agency, the European Commission ordered the re-examination of a drug which the medicines regulator had controversially rejected for authorisation.
The European Commission has taken the rare step of rejecting a recommendation from the European Medicines Agency (EMA), and is preventing the removal of a cancer drug from the European market. The EMA had previously assessed that Aplidin, used to treat multiple myeloma, a type of blood cancer, was not fit for authorisation. Officials in Brussels, however, have assessed otherwise in a move that breaks with their practice of religiously following scientific advice from the regulator.
As Investigate Europe earlier revealed as part of its Deadly prices investigation, the Commission had identified a perceived conflict of interest, or a “procedural irregularity” in the make-up of the EMA expert group that had assessed Aplidin, a drug owned by the Spanish company Pharmamar. “The Commission notes that one of the consulted scientific advisory group experts who was involved in the development of a “rival” product was allowed to take part in the marketing authorisation procedure,” it announced on 28 June.
The Commission has now ordered the EMA to conduct a new assessment of Aplidin, “to avoid any doubt as regards the objective impartiality of the assessment”.
The scientific expert concerned, who was not named by the Commission, is Hareth Nahi. He is a Swedish scientist who was part of the EMA’s scientific advisory group for oncology, according to confidential minutes from March 2018, obtained by Investigate Europe. It transpired that Nahi is also the co-owner of the patent for CellProtect, a drug against the same multiple myeloma, currently in development. He declined to comment when previously contacted by Investigate Europe.
The EMA said it would begin the review shortly, starting from when it first re-evaluated Aplidin in 2018. “The Commission's refusal decision from 2018 was based on EMA's scientific assessment that concluded twice (in 2017 and after re-examination of the negative opinion in 2018) that the benefits of Aplidin did not outweigh its risks.”
Pharmamar said in a press release that it will “demand the reassessment process be conducted with absolute impartiality, equality and transparency by the EMA”.
The European Commission's decision is all the more exceptional in that it did not wait for the final judgment of the European Court of Justice, which has been investigating the alleged conflict of interest. The ECJ had ruled in Pharmamar's favor in the first instance, before overturning it on appeal. It then asked for a new ruling and Pharmamar was expecting the final decision "before the summer". No need: Pharmamar has won its case, and Europe’s medicines regulator will have to re-evaluate Aplidin.
One question remains unanswered: will the Commission's decision set a precedent?
A similar case is already ongoing. On 14 March, the EMA was condemned by the ECJ for conflicts of interest in a case against a French laboratory. D & A Pharma had discovered that two experts working on its marketing authorisation dossier for Hopveus, a drug against alcohol dependency, were employed by a rival. The experts had been called in as part of an “ad hoc” committee, a rare arrangement used when there is no dedicated committee on the subject. Except, as the court noted, a psychiatry committee did exist.
The ECJ said that the EMA should “systematically consult” its scientific advisory groups, inferring that “ad hoc” committees should no longer be used. However, the EMA told Investigate Europe: “Ad hoc expert groups continue to be involved in EMA's scientific assessment procedures, as and when required."
"We also expect the European Commission to also revoke the decision to refuse Hopveus marketing, taken in 2017. Especially since the EMA itself acknowledged that the procedure was flawed,” a D & A Pharma spokesperson told Investigate Europe.
Several other re-examinations are in the pipeline, including a review of a decision to reject Translarna (ataluren), a drug used to treat Duchenne muscular dystrophy. Marketing authorisation applications for Syfovre (pegcetacoplan) and lecanemab are also being scrutinised by the regulator.
An EMA spokesperson said: “EMA is currently revising its policies on handling competing interests... to strike the right balance between safeguarding impartiality and independence and access to the best scientific expertise to support EMA's assessments.”
As Investigate Europe earlier revealed as part of its Deadly prices investigation, the Commission had identified a perceived conflict of interest, or a “procedural irregularity” in the make-up of the EMA expert group that had assessed Aplidin, a drug owned by the Spanish company Pharmamar. “The Commission notes that one of the consulted scientific advisory group experts who was involved in the development of a “rival” product was allowed to take part in the marketing authorisation procedure,” it announced on 28 June.
The Commission has now ordered the EMA to conduct a new assessment of Aplidin, “to avoid any doubt as regards the objective impartiality of the assessment”.
The scientific expert concerned, who was not named by the Commission, is Hareth Nahi. He is a Swedish scientist who was part of the EMA’s scientific advisory group for oncology, according to confidential minutes from March 2018, obtained by Investigate Europe. It transpired that Nahi is also the co-owner of the patent for CellProtect, a drug against the same multiple myeloma, currently in development. He declined to comment when previously contacted by Investigate Europe.
The EMA said it would begin the review shortly, starting from when it first re-evaluated Aplidin in 2018. “The Commission's refusal decision from 2018 was based on EMA's scientific assessment that concluded twice (in 2017 and after re-examination of the negative opinion in 2018) that the benefits of Aplidin did not outweigh its risks.”
Pharmamar said in a press release that it will “demand the reassessment process be conducted with absolute impartiality, equality and transparency by the EMA”.
The European Commission's decision is all the more exceptional in that it did not wait for the final judgment of the European Court of Justice, which has been investigating the alleged conflict of interest. The ECJ had ruled in Pharmamar's favor in the first instance, before overturning it on appeal. It then asked for a new ruling and Pharmamar was expecting the final decision "before the summer". No need: Pharmamar has won its case, and Europe’s medicines regulator will have to re-evaluate Aplidin.
One question remains unanswered: will the Commission's decision set a precedent?
A similar case is already ongoing. On 14 March, the EMA was condemned by the ECJ for conflicts of interest in a case against a French laboratory. D & A Pharma had discovered that two experts working on its marketing authorisation dossier for Hopveus, a drug against alcohol dependency, were employed by a rival. The experts had been called in as part of an “ad hoc” committee, a rare arrangement used when there is no dedicated committee on the subject. Except, as the court noted, a psychiatry committee did exist.
The ECJ said that the EMA should “systematically consult” its scientific advisory groups, inferring that “ad hoc” committees should no longer be used. However, the EMA told Investigate Europe: “Ad hoc expert groups continue to be involved in EMA's scientific assessment procedures, as and when required."
"We also expect the European Commission to also revoke the decision to refuse Hopveus marketing, taken in 2017. Especially since the EMA itself acknowledged that the procedure was flawed,” a D & A Pharma spokesperson told Investigate Europe.
Several other re-examinations are in the pipeline, including a review of a decision to reject Translarna (ataluren), a drug used to treat Duchenne muscular dystrophy. Marketing authorisation applications for Syfovre (pegcetacoplan) and lecanemab are also being scrutinised by the regulator.
An EMA spokesperson said: “EMA is currently revising its policies on handling competing interests... to strike the right balance between safeguarding impartiality and independence and access to the best scientific expertise to support EMA's assessments.”