DIA EuroMeetings have become – for many Life Sciences professionals around the globe – a jour fixe in their annual calendars and a true ‘not-to-miss event’ in a given year. They certainly have become for us at Moravia, and the EuroMeeting 2013, held in Amsterdam from March 4 to 6, was an event that provided a good snapshot of what is moving and shaking the European pharmaceutical and regulatory world. It was also a great opportunity to meet again with many of you.
With more than 100 sessions across 17 themes and 300+ speakers, there was something for everyone during DIA. One track that really enthused me dealt with the new innovative approaches to Product Information for medicines. This information includes the summary of product characteristics (SmPC), labeling and package leaflet (PIL), being one of the most frequent types of content that needs translation for market authorization in Europe.
The Public Face of Medicines
Jan MacDonald, Head Patient Information Quality at the Medicines and Healthcare products Regulatory Agency (MHRA) put it very nicely: “patient information is the public face of the medicine”, adding the caveat that “regulators need to work on closing the gap between the ideal and the practical reality.” Some of the issues highlighted by Jan are also immediately understandable to just about any patient that gets to read PILs:
- Information included in PILs is not pertinent to individual readers – they contain information for many conditions while each patient will likely only have one of these. Plus, PILs are often seen as being too long and repetitive, with their hierarchy not immediately obvious. No wonder with so much of the text being truly “small print.”
- The language used is not engaging, too technical, and in general poor quality English.
- There are translation issues (ouch!), resulting in the meaning being lost (in translation, literally).
- Possible benefits are not put in the context of the risks, meaning that PILs give the impression of being too scary.
All this makes perfect sense, and there is more in store. The European Commission has initiated a comprehensive report on shortcomings of the current approach (to be executed by Nivel based in Utrecht), with the final report expected in mid-2013.
The PILs of the Future
Jan also offered a few suggestions that would help improve the situation:
- Common PILs for most common medicines. This seems logical, and would reflect the way Product Information for generics is modeled on the patented products.
- Improving quality of English source content for medicines which are authorized via the decentralized and the centralized procedures.
- Enhancing QRD templates and improving their design.
- Using more colloquial language, and one that is consistent from company to company.
- Making other formats and languages immediately available.
- Electronic access to information, ideally via apps, and making the information available prior to the decision on prescription, not after, empowering patients in their communication with doctors.
Similar feedback came from the representatives of patients, with readability (font size, complex wording and visual presentation) and the relevance of information to specific patients’ needs, topping the list of “user complaints.”
And Now for Some Hard Facts
Echoing these sentiments, some hard data were provided by Gesine Bejeuhr, Senior Manager Regulatory Affairs/Quality at vfa (the Association of Research-Based Pharmaceutical Companies). She listed some of the main shortcomings of the current way SmPCs are approached in Europe, based on a qualitative and quantitative analysis conducted in Germany. For instance, the recommendations from the European Federation of Pharmaceutical Industries and Associations (EFPIA) sounded all too familiar, and included:
- Language fit for reading – which would obviously apply to any source English content as well as the translated versions.
- Easy navigation and finding information (length, structure).
- Fast and easy access to reliable and up-to-date information.
- Clear information on benefits and risks of a given medication.
The proposal for a new concept developed for SmPCs and PILs then includes dropping the requirement for physical presence of leaflets in packaging and exploring instead the options offered by electronic media. Tailor-made information, with links to additional content, searchable, always up-to-date and available everywhere – on the web and mobile devices.
It is not usual to have so many stakeholders – users, agencies and industry professionals – sharing essentially the same sentiments. So chances are the future package leaflets you are going to read will speak a clear, simple language you will immediately understand, and be delivered on your phone, while you discuss the prescription with your doctor. Wouldn’t that be nice?