Waiting For The Perfect Case: Why EMA Has Yet To Hold A Public Drug Safety Hearing

The European Medicines Agency has yet to use the power it has to hold public hearings on marketed medicines that raise safety concerns. It says it will do so only when the time is right.

A senior European Medicines Agency official has given some insight into why an initiative aimed at giving the public a voice in the safety evaluation of marketed medicines has yet to be set in train.

Commenting on why EMA’s Pharmacovigilance Risk Assessment Committee has still to organize and hold a public hearing on a marketed medicine over which there are safety concerns, Tony Humphreys said: “We’ve done a dry run … we’ve got the rules through the system … and we’re essentially like a surfer waiting for the perfect wave to launch a real live public hearing.”

“You don’t want to do this on a false case, you want [do it on] a proper case,” Humphreys said. His comments give weight to the view that EMA will only hold a hearing if it is convinced that the public input will really benefit the agency’s regulatory decision-making, such as by offering perspectives, knowledge and insights into the way medicines are used in clinical practice. (Also see "EMA Public Hearings On Marketed Medicines To Start Next Year" - Pink Sheet, 7 Oct, 2016.)

An earlier target for a hearing of the fourth quarter of 2016 recently gave way to a much broader target of sometime in 2017. The EMA confirmed to Pink Sheet that this was still the plan, and also that no topic had been identified for discussion or date set for a hearing.

“You don’t want to do this on a false case, you want [do it on] a proper case” – Tony Humphreys, EMA

The public hearing is a new tool aimed at enabling EMA to engage with interested members of the public in the oversight of medicines. Rules and procedures were finalized earlier this year. ( (Also see "Don't Let Sponsors Downplay Genuine Safety Concerns At Public Hearings, HAI Tells EMA" - Pink Sheet, 20 Apr, 2016.)

Humphreys, who is Head of Scientific Committees Regulatory Science Strategy at EMA, described the public hearings tool as one “the key innovations” included in the EU pharmacovigilance legislation, which came into effect in 2012. The hearings will open up the EU process of assessing medicines in the post-marketing phase to the wider public for the first time. “We can’t claim [this] as a major achievement but we’re moving it along slowly”, Humphreys said in relation to the fact that the measure has not yet been used. His comments were part of a presentation at the Annual European Medicines Agency Review of the Year and Outlook for 2017, organized jointly by the EMA and The Organisation for Professionals in Regulatory Affairs. The conference took place in London Dec. 1-2.

From the editors of Scrip Regulatory Affairs.