European Medicines Regulators Put New Conflict-of-Interest Policy in Place

Regulatory NewsRegulatory News | 20 November 2014 |  By 

The European Medicines Agency (EMA) has released a new conflict-of-interest policy it says is meant to take a more "balanced" approach to handling conflicts presented by its scientific committee members and experts it consults with.


In 2012, EMA was publicly chided by the European Court of Auditors (ECA), which said it had inadequately managed situations involving conflict of interest (COI). "A number of shortcomings of varying degrees have been identified in Agency-specific policies and procedures as well as their implementation," ECA wrote.

While those COIs spanned a wide number of areas, among the most critical identified by the ECA was the need for EMA to address "post-employment issues."

Just prior to the ECA's report, EMA's former leader, Thomas Lönngren, was accused of "setting up a consultancy while still in office," raising concerns about COIs at the highest levels of the agency. Lönngren left EMA two months after forming his consultancy, but critics said at least nine pharmaceutical companies seeking regulatory approval had ties to the company Lönngren's consultancy was affiliated with.

ECA's concerns were considered so serious that the European Parliament refused to sign off on EMA's 2013 budget until it was assured EMA had developed better and more transparent COI policies.

Early Conflict-of-Interest Policy

In the aftermath of ECA's report, EMA and its then-new leader, Guido Rasi, moved to dramatically increase the transparency of its operations and COI policies. The new policy called for a three-tiered risk assessment system in which EMA employees would either be unrestricted, partially restricted or prevented from performing duties for the agency. EMA also said it would distinguish between academic conflicts of interest and conflicts involving the pharmaceutical industry.

A "three-year cooling off period" was foreseen by EMA as being sufficient to absolve someone of their conflicted interests, and EMA also released a new "best practices" guide in April 2014 meant to prevent a Lönngren-like situation from happening again.

In April 2012, EMA also established two specific policies intended to establish how the agency would deal with conflicts of interest held by members of its scientific committees or its various experts. (More)

An Updated Policy

Now, just weeks after Rasi was forced out from his position as Executive Director, EMA is out with an updated version of that policy set to come into effect on 30 January 2015.

The new policy, EMA said in a statement, will put a special emphasis on an expert or committee member's last six months of employment.

As EMA's notice makes clear, the regulator does not consider all conflicts to be created equal. Research grants to an expert from a pharmaceutical company, for example, will be treated with far more suspicion than would involvement in academic trials or publicly funded research.

Of note, anyone who has ever held an "executive role, or a lead role in the development of a medicine" at a pharmaceutical company will be banned for life from participating in any involvement with either the company or its products.

EMA said its new policy also hopes to better take into account the "nature of the declared interest"—the context, in other words—prior to applying restrictions to an expert's involvement or participation.


EMA Statement

EMA Conflict of Interest Overview

EMA COI Policy


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy