Patient Friendly Language a Major EMA Goal
Written by Gillian King, Head of Global Consulting, Global Professional Services, CSC Life Sciences
Regulatory agencies have been more focused on the patient in the past few years, including with regard to patient friendly language on material such as leaflets, cartons, or indeed any promotional material patients come into contact with. The regulations about patient information are already strict in some countries, such as the UK, and now the EMA is putting policies in place to require all countries in Europe to follow suit. The goal is harmonisation across the EU.
One of the difficulties is the language and the rules surrounding how those local patient information leaflets are put together and are not consistent across the EU. If companies go through the Centralised Procedure, the process is by and large consistent, but labeling for products submitted through the National Procedure can be a bit of nightmare since companies must take into account local requirements as well as European requirements. Harmonisation would be helpful, but it may be easier said than done. For example, some things don’t translate across all countries and getting consistency across countries generally means turning to specialist companies for help, because only the very big companies will have a presence in every European country.
Industry Gripe
One bone of contention for companies surrounds the quality review of documents (QRD) templates, which are used by the health authorities and assessors to decide whether the right sort of information is in the leaflets before the wording is made patient friendly. The QRDs include many annexes and require companies to fill in a great deal of information.
The industry’s biggest gripe – raised during the October TOPRA conference -- is that the QRD template doesn’t take into account the new guidelines that have come from the health authorities on how patient information leaflets need to be put together. This was relayed to the representatives from the health authority that attended TOPRA, who simply smiled and nodded and said “you’re right, it’s not.” And there was silence, and everyone laughed and said: “Any clue if something is going to happen at some stage?”, to which the agency representative would only say that something needed to happen, without indicating when and if this “something” would take place. This left many industry representatives confused. After all, they’ve put in a lot of time and effort to adhere to the requirements around patient-friendly information, yet they are still in the position of not feeling comfortable with the process. Harmonisation is well and good, but in order for the information that patients receive to be tighter and cleaner – as the agency has stipulated – the health authorities need to provide more help, too.