The e-PIL project: paper information leaflet gives way to electronic version in hospitals

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: a brief description

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.

The pilot project kicks off

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.

A first call was made in April 2018 for up to twenty medicinal products available on the Belgian and/or Luxembourg markets to be included in the pilot project. The medicinal products were to be used only in hospitals and were not allowed to be handed over to individual patients. After the final selection of medicinal products, the project officially kicked off. “The main goal of the e-PIL project is to demonstrate that electronic information leaflets are just as effective for a hospital pharmacist as the paper versions,” says Iris Geussens. “They must to be able to find the necessary information to correctly administer a medicinal product to the patient.”

For the manufacturers, this project did require quite a lot of preparation. The manufacturing of pharmaceutical packages without leaflets meant a thorough adjustment of the internal production process. In each case, the participating firms had to inform the FAMHP of the batches they had released to hospitals without information leaflets. Each delivery came with a letter explaining why there was no information leaflet included in the package. This allowed the FAMHP and the partners involved to closely monitor the project.

Iris Geussens

The first positive results

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.

What does the future hold?

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.

Our FAMHP experts

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.

More information

The e-PIL pilot project (pharma.be)

The e-PIL pilot project: positive interim results