EMA told to sharpen communications
And change its information output to target its messages
A communications specialist has suggested the European Medicines Agency (EMA) set up a special board to advise on its risk communications.
Dr Frederic Bouder, of King’s College, University of London, said EMA should also change its information output from one-size-fits-all press releases to messages targeted at audiences, because it has to communicate with non-specialist patients as well as highly trained pharmaceutical and medical professionals.
‘Standard documents, e.g. Q&A and press releases, are neither adapted to experts nor the general public. To some extent they miss both targets,’ he said.
Bouder said this special board should contain risk communication and medical experts and ‘help integrate risk communication research into everyday processes’ at EMA.
The board should link this expertise ‘to develop situation-specific two-way communication models that meet the expectations and needs of the various publics’.
Bouder also called on EMA to be more proactive in liaising with patients’ organisations, involving them as regards sensitive issues ‘early in the assessment phase’. He said this should become routine where patients’ organisations have expressed concerns, where risk perceptions are negative, or where intense media coverage is likely.
‘Health experts would be wrong to assume that top-down messages resonate among non-experts,’ he added.
EMA said it had already begun implementing some of Bouder's findings, noting that it was considering using them when operating the new EU pharmacovigilance legislation.
The agency has come under fire recently in the British Medical Journal over how it publicises clinical trial-related information, notably phase III trial results in its European public assessment reports.
EMA argued that the agency works closely with the industry and patients to improve the structure and content of its information on medicines, and said it remains open to suggestions on how to improve this further.
EMA stressed that 700 public assessment reports are available on its website that are updated throughout a medicine’s life. It said each assessment summarises the grounds for the agency’s opinion in favour of granting or refusing the marketing authorisation for a medicine, and results from the review of data supplied by the applicant and discussions during committee meetings.