The way patients access critical medication information is evolving. In this expert discussion, Philipp Thomas from Schlafender Hase speaks with Manuela Wiegand, pharmacist at Rote Liste® Service GmbH, about Gebrauchsinformation 4.0 (GI 4.0®) — Germany’s move toward digital patient information leaflets. They explore how this shift enhances accessibility, improves regulatory processes, and what pharmaceutical companies need to know about its future implementation. Will digital patient information fully replace printed leaflets? What are the challenges and opportunities ahead? Read on to find out.
Philipp Thomas: Good day, esteemed ladies and gentlemen,
A warm welcome to our expert discussion today, held in collaboration with the Rote Liste. It’s my pleasure to welcome Ms. Wiegand. Manuela Wiegand is a pharmacist at Rote Liste Service, and my name is Philipp Thomas. I work at Schlafender Hase as an Account Executive, and today we will be discussing electronic patient information in German-speaking regions – specifically in Germany, where it is known as Gebrauchsinformation 4.0 (GI 4.0®). For those who are not yet deeply familiar with the topic: what is this all about? It refers to the digital version of the package leaflet for medicinal products, which is being introduced in many countries as a supplement or replacement for printed package inserts. ePILs (electronic Patient Information Leaflets) enable a more up-to-date, interactive, and accessible provision of information for both patients and medical professionals. With Ms. Wiegand, I would like to discuss a few questions today.
Hello, Ms. Wiegand.
Manuela Wiegand: Hello, Mr. Thomas.
PT: Let’s dive right in – introductions are done. My first question I’d like to ask is: Could you briefly explain what Gebrauchsinformation 4.0 means from your perspective and what added value it offers for both patients and pharmaceutical companies?
MW: GI 4.0® originated from a European initiative, developed in close collaboration with regulatory authorities, some industry associations, patient organizations, and pharmaceutical companies. The goal, as you have already mentioned, is to transform the paper-based package leaflet from the physical packaging into the digital world. This led to the development of the GI 4.0® website and app. The service is ad-free and serves as a trustworthy source of information.
You also asked about the added value: The digital patient information provided through GI 4.0® offers significant benefits for both patients and pharmaceutical companies. Patients receive up-to-date information more quickly, thanks to shorter processes within pharmaceutical companies. Moreover, the structured data format makes the digital patient information easy to navigate and searchable. A screen reader can read the contents aloud, and users can individually adjust the font size, which is typically very small in classical printed package leaflets.
PT: Wonderful. Thank you for these first responses. That definitely sounds very promising. At the same time, as well as all these very positive things, such a large-scale initiative –especially at a European level – also comes with challenges. What challenges do you see in implementing GI 4.0® in Germany, particularly for the pharmaceutical industry in terms of regulatory requirements?
MW: I’d say that the changeover from paper-based package leaflets to structured data is similar to other process changes – it requires companies to familiarize themselves with the new processes, which takes time to prepare for. It’s not something that can happen overnight, but it shouldn’t be something to shy away from either. Digital patient information is becoming increasingly important. For example, it also plays a role in the EU Pharma Package, which presents an opportunity for this digital format. Anchored in law, it could become a standard requirement in the future. At present, though, digital patient information is an optional add-on to the printed package leaflet.
PT: Is there a timeline for when it might become mandatory?
MW: As is often the case with legislation, all this is still ongoing. The European Commission has already made a proposal, the European Parliament has voted on it, and further steps will follow. However, it will still take some time.
PT: So, there’s no immediate pressure on this matter, but everyone should start taking steps for this. How do you see the balance between printed and digital patient information? Should both continue to exist side by side, or do you think the future is fully digital?
MW: We anticipate a transition phase in which both printed and digital formats will be available parallel. This is important so that patients can become familiar with the digital format. However, the future will be digital patient information because, as I mentioned, it offers many advantages.
In addition to what I’ve already mentioned is patient safety. For example, digital patient information is accessible at any time for anyone, and includes features like the display of changes. Digital patient information can also help address shortages. If a foreign medicine package is allowed to be distributed in Germany with, for instance, a French-language package leaflet, GI 4.0® can provide the corresponding German version. This eliminates the need for pharmaceutical companies to print and package separate German inserts, allowing patients to receive their medication more quickly.
PT: That’s of course a very practical example, ensuring patient safety in such situations. You have already touched on some future developments and talked about the benefits. What do you expect to see in the coming years regarding GI 4.0®, and how will the Rote Liste contribute to this transformation?
MW: For us, it is important to make sure that patients can easily navigate the change to GI 4.0®, so we continuously optimize web and app. Additionally, we aim to support pharmaceutical companies in creating digital patient information and making the process underlying it as simple as possible. A well-functioning text comparison tool, like the one from Schlafender Hase, is very useful here. Schlafender Hase’s tool is continuously being improved.
Another current topic for Rote Liste is the diGItal pilot project that goes back to an initiative by pharmaceutical industry associations. The goal of this project is to further drive the adoption of digital patient information.
PT: That’s an interesting topic. Maybe we can dedicate a second expert discussion on that. It sounds like there is a lot of demand for more insights. Ms. Wiegand, that concludes our expert interview for today. Thank you for your valuable insights and view into the future, and for sharing this important information, which is highly relevant, especially for the industry. We will see how this topic evolves and when we will have the necessary legal framework in place. Thank you!
