ePIL

Paperless-PIL packages of medicines – ePIL pilot project in Baltic countries

In the European Union, it is required by law that the packages of all marketed medicines include patient information leaflet printed on paper. At the same time, each EU Member State maintains national registers of medicinal products, and many also have privately owned registers, from where electronic information leaflets (ePIL) can be accessed. The requirement for paper leaflets in the packages of medicines was established nearly 30 years ago. However, as time has progressed, we have entered the era of smart devices and technologies.

In Europe, 11 Member States, including Estonia, are currently conducting in parallel pilot projects on medicines without printed PIL. Additionally, at least seven more countries are preparing similar pilot projects. The aim of these projects is to evaluate whether eliminating the printed PIL for hospital medicines will impact the accessibility of product information on medicines and their safe use, and whether this change could enhance the availability of medicines used in hospitals. Phase II of the pilot project, which started in Estonia at the beginning of 2024, is unique in Europe. The project now includes also medicines purchased by patients from a retail pharmacy but administered by a healthcare professional who also advises the patient.

ePIL is a secure, efficient and equivalent to the information provided on paper. It offers several advantages: it is more accessible for the visually impaired due to easily enlargeable text, allows for more functional searches within the text, and can be opened immediately in the right language. Additionally, since there is often a delay in updating paper leaflets with the latest information on medicines, the ePIL ensures that users have access to the most current information.

ePIL is a significant innovative solution that advances public health. The Association of International Pharmaceutical Manufacturers in Estonia (APME) has begun informing the public about the benefits of ePIL over a paper version through press releases, articles and media communication. We believe that the number of ePIL users will grow year after year, and it will become evident that healthcare professionals and pharmacists have the latest information on medicines at their disposal when using ePIL. People’s awareness of the medicines they consume and their ability to take personal responsibility will also contribute to a better treatment compliance and quality of life for each patient.

Where from can you get information?

Information on medicines in pdf-format on the website www.ravimiregister.ee is easy to find for healthcare professionals as well as patients, and it can be read on a computer or a smart device. This creates the opportunity for the gradual introduction of ePIL instead of the leaflets printed on paper.

More information on the medicines included in the project can be found on the website of the State Agency of Medicines at https://www.ravimiamet.ee/ravimid-ja-ohutus/muugiload/paberita-pil-i-projekt.

TIMELINE

• The pilot project of the Association of Pharmaceutical Manufacturers, the State Agency of Medicines and the Estonian Association of Hospital Pharmacies, aimed at testing the readiness to eliminate printed information leaflets for hospital medicines, began on 1. January 2022.

Initially, the project included only medicines supplied to hospital pharmacies and administered in hospitals. For these medicines, the electronic version of the PIL in the Register of Medicinal Products (ePIL) started replacing the paper leaflets in the packaging. In collaboration with marketing authorisation holders, hospital pharmacists and Latvian and Lithuanian colleagues, specific medicines were selected for the first phase of the project. This phase aimed to assess whether eliminating printed package leaflets would affect access to product information or the safe use of medicines, and to what extent it would improve the availability of hospital medicines. The first phase of the project lasted two years.

• The pilot project is in line with the Pharmaceutical Strategy for Europe and the European Digital Strategy and the forward-looking legislative framework for improving access to medicines, innovation, sustainability, promoting technologies that meet the treatment needs of patients, the digital society and climate neutrality.
• According to the current EU directive, all medicines marketed within the EU must include the information leaflet on paper, but discussions of changes are ongoing, and legislation is being amended. An exception to the current requirement was made for conducting the pilot project.
• In April 2023, APME published the final report of the project “Preliminary analysis of the possibilities of implementation of the electronic package leaflet (ePIL) in Estonia”, which maps the achievements and ongoing activities in the field of electronic product information in Europe and describes the alternatives of the ePIL technical solution that meets the needs of the Estonian stakeholders. See the final report here.
• In November 2023, the State Agency of Medicines organised a roundtable with all stakeholders to discuss the pilot project’s content and potential issues as it expands to include more medicines. The roundtable included representatives from the State Agency of Medicines, the Estonian Pharmacies Association, the Pharmaceutical Society of Estonia, the Estonian Chamber of Disabled People, the Estonian Nurses Union, the Association of Pharmaceutical Manufacturers, the Estonian Association of Hospital Pharmacies, the Estonian Pharmacists Association and the Ministry of Social Affairs. All participants agreed that replacing paper leaflets with ePIL is necessary.
• The second phase of the pilot project began on 1. January 2024. In this phase, in addition to hospital medicines, marketing authorisation holders can apply from the State Agency of Medicines to include to the pilot project the medicines administered by healthcare professionals. The project now involves also medicines that are purchased from a pharmacy but administered by a healthcare professional who also advises the patient. Link to the news on the website of State Agency of Medicines: Paberivaba infolehe katseprojekti pikendati kolme aasta võrra | Ravimiamet.
• More information on the project and medicines included into the project can be found on the website of the State Agency of Medicines at https://www.ravimiamet.ee/ravimid-ja-ohutus/muugiload/paberita-pil-i-projekt.
• In spring 2024, the market research agency Norstat conducted a telephone survey commissioned by the Association of Pharmaceutical Manufacturers in Estonia. The survey aimed to find out attitude of Estonian population towards reading information leaflets of medicines only via electronic channels. The results showed that 72% of the population felt positive or neutral about reading the leaflet on a computer, phone or tablet. As expected, young people were more positive, with over 80% of individuals aged between 15–34 expressing favourable opinions. Even among respondents aged 75 and over, 63% or around two out of three, felt positive or neutral about reading the leaflet only in electronic channels.
• In Summer 2024, Vikerraadio discussed the future of medicines without paper leaflets in its show Huvitaja (May) and Raadio 4 also covered the topic in its show Podrobnosti (August). As well Õhtuleht and various web portals, e.g. Tervisegeenius. Media reflections help to raise public awareness to find reliable information about their medicine(s) on the internet and prepare us all for the future without paper leaflets.