Call for reform of European Medicines Agency as head is ousted

A European Court of Justice ruling invalidates Guido Rasi’s appointment as head of the EMA, opening the way for further questions on the governance of the agency

The European Medicine Agency (EMA) is facing calls from some quarters to revise its governance structure following the annulment of the appointment of the executive director, Guido Rasi, three years into his five-year term.

The Agency should consider conducting a broader spring clean, said Huub Schellekens, a professor at the Department of Pharmaceutical Sciences in Utrecht University. He is concerned about EMA staff who simultaneously hold positions of influence in their own countries. “Nearly all members of the EMA’s management board, its Committee for Medicinal Products for Human Use (CHMP), subcommittees, working parties and advisory groups, come from the national regulatory bodies and/or Ministries of Health,” he said.

In effect, they are advising themselves, Schellekens contends. The implication is that the system does not ensure there is no favouritism toward favouring national drug companies.

“There are, in my view, combinations of functions at the EMA that are unacceptable,” Schellekens said. “These include: the chair of a national regulatory committee and member of the CHMP; chair of a working party and member of the CHMP; and member of the science advisory group and chair of a national re-imbursement committee.”

Hiring squabble

Not everyone is calling for root and branch reform. “This is probably the EU operating at its absolute worst,” said Alexander Gaffney, a manager at the US-based Regulatory Affairs Professionals Society. The whole affair is a “petty hiring squabble”, he added.

The EMA declined to comment to Science|Business.

Rasi ‘s appointment as executive director of EMA was annulled by the European Union Civil Service Tribunal, which found his selection in 2011 was invalid because the recruitment process was not objective.

The case was brought by Emil Hristov, Bulgaria’s representative on the management board of the EMA from January 2007 to April 2009, who himself applied for the job of executive director, but failed to make the shortlist. Hristov contended that the presence of two members of EMA’s management board on the committee that drew up the four-person short list constituted a conflict of interest, since the management board also made the final selection of Rasi.

Following the ruling, Rasi has been replaced on an acting basis by Andreas Pott, deputy executive director of EMA. One EU official privately said that choosing a permanent successor may take up to six months.

Governance issues

Questions on governance are not new to the EMA. It was criticised in 2012 by the European Court of Auditors for failing to draw up adequate policies on conflicts of interest.

This is not an isolated case. The court has also criticised three other agencies, the European Food Safety Authority, the European Aviation Safety Agency and the European Chemicals Agency, which were deemed to have failed to control cases or situations of actual or potential conflict of interest. None of them were deemed serious enough for a referral to the European Commission’s anti-fraud office, or to national authorities.

The EMA commented at the time that its biggest challenge is, “To find the right balance between ensuring the impartiality and independence of experts involved in the Agency's work versus the need to secure the best possible scientific expertise to continue to deliver top-quality scientific assessment."

It compiles an annual list containing members and external experts’ declarations of interests.

The European Commission was asked to comment on whether the Rasi affair warranted a wider investigation but no reply was received.

Kent Woods, chair of the management board of the EMA claimed the judgment is about “a procedural formality”. Woods said, “It is not a reflection on Guido Rasi’s competence or ability to run the Agency, something which he has done successfully since November 2011.”

There is a lengthy and explicit set of rules governing the appointment of the heads of the European Union’s (EU) executive agencies. These include specifying which EU bodies must be represented on selection panels and what rank these individuals should hold.

EMA statement here
Court case document here
Clinical trial transparency info here

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