EMA to Implement Ombudsman’s Recommendations on Avoiding Bias

Regulatory NewsRegulatory News | 26 November 2019 |  By 

In a letter to the EU ombudsman Emily O’Reilly last week, the European Medicines Agency (EMA) said it will adopt her recommendations to avoid the perception of bias in marketing authorization assessments.
The letter follows an inquiry by the ombudsman that began in 2017 over concerns that interactions between drugmakers and EMA during the pre-submission phase could influence EMA’s decision to recommend an application for authorization.
Initially, EMA pushed back against the ombudsman’s concerns, with EMA Director Guido Rasi writing in 2017 that “no single person has the final say on a medicine’s approval,” and emphasizing that the agency has safeguards in place to manage conflicts of interest.
However, after further discussions with EMA, the ombudsman presented a set of suggestions last July recommending that EMA ensure a separation between its experts who provide early scientific advice to a sponsor and those who subsequently review an application.
Now, EMA said it will take steps in line with the ombudsman’s recommendations to guarantee the independence of its reviewers to avoid the perception of bias.
“We are looking at our procedures to formally introduce to the greatest extent possible the separation in prominent roles between those acting as coordinators for providing scientific advice and those subsequently involved as rapporteurs in evaluating an application for marketing of the same medicine,” Rasi wrote.
Specifically, Rasi said the agency will keep a record of any experts that play a prominent in providing scientific advice that will be considered when appointing rapporteurs to a marketing authorization application.
Rasi added that in some exceptional cases EMA may need to appoint a rapporteur who provides scientific advice on the same product if their specific expertise is needed, but noted that the agency’s processes “should ensure that at least one of the two rapporteurs had no prominent role in the pre-submission activities concerning that medicine.”
The new measures will be implemented through revised internal procedures for rapporteurship appointments, Rasi said. The agency will also add a log of scientific advice to the European Public Assessment Report (EPAR) that will include the names of the coordinators that played a role in providing advice.
Rasi noted that the agency will inform its Management Board of these changes at its upcoming meeting in December and will follow up with the ombudsman on implementing the new steps in the first quarter of 2020.
The ombudsman welcomed EMA’s response in a post to its website, writing that the measures will “improve the transparency and objectivity of EMA’s assessment of new medicines.”


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