Since 2018, the FAMHP has been actively participating in the e-PIL project, an initiative launched by the pharmaceutical industry in hospitals in Belgium and Luxembourg. The paper information leaflet is no longer inserted in the package of certain medicinal products but is only available online on trusted websites. The various partners involved in this project want to show that an electronic information leaflet is just as effective, or even better, than a paper one.
Iris Geussens, expert at the FAMHP, explains why this pilot project was initiated: “A survey showed that even prior to this project, most hospitals were removing the medicinal products from the package at each delivery and throwing away the information leaflets. In reality, the electronic leaflets were already frequently used. Many hospitals also have their own system with a portfolio of medicinal products they use, and all electronic leaflets are included in it.”
The e-PIL project is an initiative of the associations of the (bio)pharmaceutical industry launched in 2018 by pharma.be and the Innovative Medicines for Luxembourg (IML). The project is supported by the Federal Agency for Medicines and Health Products in Belgium and the Direction de la santé in Luxembourg.
According to European legislation, all pharmaceutical packages put on the market must contain a paper information leaflet. So to launch this project, a derogation had to be requested from the European Commission to manufacture packages without leaflets. The first derogation was granted in 2018 for a period of two years.
After one year, pharma.be launched a first survey among hospital pharmacies … and the results were positive. The electronic information leaflets turned out to offer numerous advantages. By reading the electronic leaflet, users are always sure that they are using the latest version containing up-to-date information. An electronic information leaflet is also more user-friendly: unfolding the leaflet and looking for the right language are a thing of the past. The electronic information leaflet immediately provides the necessary information in the right language. There was also an ecological benefit as much less paper was thrown away.
An extension was immediately requested from the European Commission and green light was given to include more products in the project. That’s when Medaxes, the Belgian umbrella organisation for pharmaceutical companies that focus on generic medicinal products and biosimilars, also joined the project.
The e-PIL project was again extended in 2022. The FAMHP experts, in cooperation with experts from the Luxembourg government, are currently screening medicinal products that can be added to the project.
The e-PIL project is a pioneer project in Europe: Belgium and Luxembourg were the first countries to implement this project. Meanwhile, we have already received many requests from other member states wishing to initiate a similar project. This proves that digitisation, both on a national and European level, is undergoing an important evolution, also within the pharmaceutical sector.
Iris Geussens is head of the Marketing Authorisation Division (variations and renewals). The members of this division handle applications for variations and renewals of authorisation applications as well as applications for parallel import.