Brexit has forced the European Medicines Agency (EMA) to hit pause on plans to improve product information after assessing the capacity constraints that are imposed. The EMA had planned to spend the next two years implementing the plan, but will now hold off on starting most of the work until at least 2020.
European officials had formally assessed the shortcomings of package leaflets and the summary of product characteristics a long time before the United Kingdom voted for Brexit. The product information initiative continued after the vote, which led to the publication of an action plan by the EMA in November 2017. However, the plan was made without taking the impact of Brexit into account. The EMA will continue to work on actions related to electronic product information in 2018 and 2019, but everything else is on hold. The EMA would like to explore the use of electronic media to communicate product information and plans to hold a multi-stakeholder workshop in the third quarter to discuss the implications of this idea.
Therefore, it will be 2020 or later by the time the EMA starts to improve the readability of product information, share the best practices with industry and gather greater input from patients. Until then, the EMA will persist with product information the European Commission called “too complex” and “not always user friendly” in a 2017 assessment.
The EMA disclosed details of the delayed start to its product information plan in its 2017 report on stakeholder engagement.