EMA accepts need for regulators to improve communication of benefits of medicines
Information on the benefits of medicines may not be revised as effectively as risks
A European Medicines Agency (EMA) official has accepted that regulators need to improve their performance over communicating the benefits and use of medicines, working with patients and healthcare professionals.
Following an EMA workshop on the topic, Dr Tomas Salmonson, Chair of EMA’s committee for medicinal products for human use (CHMP), said there were 'clear differences between communication needs at the time of approval of a new medicine, and those post-approval…'. However, giving a balanced, in-depth assessment of benefit and risk 'would always be easier at approval, precisely because the process involved a detailed and structured assessment of both'.
One problem, he stressed, was that information on the benefits of medicines may not be revised as effectively as risks.
'There was a clear desire for better communication on benefits, an area which regulators had tended to handle poorly and where there was a need for improvement,' he said. However, it was 'legitimate' to ask if perspectives about such benefits varied between groups and individuals 'as had been shown with perspectives about risk'.
Salmonson said: 'Overestimating benefits could lead to the acceptance of unreasonable levels of risk.'
CHMP work on representing benefit-risk information as 'effects tables' was one possible way forward, he said.
'It might be possible to develop and individualise these so that the benefits and risks of particular importance to the patient could be represented.'
EMA’s Isabelle Moulon said regulators had 'heard, loudly and clearly, the need to incorporate the views of those most affected when assessing and communicating the benefits and risks of medicines'.