A conversation with Ann Van Den Broucke
Ann Van Den Broucke is a pharmacist and works at the Proper Use of Medicine Division of the Federal Agency for Medicines and Health Products (FAMHP). Among other things, she is committed to digital initiatives such as PharmaInfo and the electronic patient information leaflet, which make reliable medicines information more accessible to the public and patients.
With the revision of European pharmaceutical legislation, the concept of the “electronic product information leaflet” for medicines is being introduced. In brief, what roadmap have the European authorities set out for implementation (and within what timeframe)?
“The electronic product information leaflet offers many opportunities to make information on medicines more accessible to patients. Europe has opted for a phased introduction. Under the supervision of the European Medicines Agency (EMA), a common European standard and technical infrastructure have been developed for the exchange of electronic product information. The next step is to ensure that patients can access this information in a user-friendly way. The European legislation provides for a transition period of several years. As a Network Subject Matter Expert, I am participating in the EMA’s European ePI project on behalf of the FAGG. This enables us to share our Belgian experience and actively contribute to a European approach.”
How is the FAMHP preparing for the introduction of this electronic product information leaflet in Belgium?
“Together with patient organisations, health insurance funds, pharmacists, doctors, the pharmaceutical industry and European partners, we are exploring how we can make information about medicines more accessible to patients and members of the public. In doing so, particular attention is being paid to vulnerable groups, such as people with limited digital skills. In the short term, PharmaInfo is developing a scan function which will allow members of the public to access the digital patient information leaflet (in PDF format) and additional information directly via an existing code on their medicine’s packaging. In the longer term, we aim to offer a structured electronic patient information leaflet, so that patients can find the information they are looking for more quickly.”
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