‘’Although the existing EU legislation states that the paper version of a medicine leaflet is obligatory, there are many studies of electronic product information (ePI) that present the feasibility and benefits of electronic information. ePI covers the most recent, regulatory approved information without any delay, which leads to increased patient safety, enhances health literary and adherence to the treatment.’’

• Koen Nauwelaerts, Regulatory policy and innovation lead at Bayer

Introduction

The pandemic caused an acceleration in the digitalization of healthcare in Europe, and one feature of digitalization is the implementation of electronic product information (ePI[1]) for human medicines. The objective of ePI is the expansion of access to information on medicines and to enable access to the most updated regulator-approved information without a delay.

The provision of comprehensive, accurate and recent regulatory-approved information on medicinal products, both for patients and healthcare professionals (HCPs), is abundantly supported by the pharmaceutical industry. The conclusion from European Medicines Agency (EMA)/Heads of Medicines Agencies (HMA’s) is that it is essential to discover alternate innovative pathways of distributing information electronically. The amendment of the forthcoming pharmaceutical legislation revision must be leveraged to seize the benefits of ePI and those benefits will require implementation for both Centrally and Nationally Authorized medicinal products. As the end users of medicinal products, the requests of all patients and healthcare professionals (HCPs) must be prioritized in the development and implementation of ePI[2],[3].

Benefits for Patients, Healthcare professionals and ultimately to the Environment

There are many stakeholders involved to make the transition from paper leaflets to ePI happen, but the needs of patients and HCPs must be leading the implementation, whereas the method itself would come from the European regulators (EU Commission (EC)/EMA/HMA).

There are numerous end-user benefits[4],[5]:

• ePI has the potential to address patient and HCP needs for accessible, relevant information on medicines at the right time during treatment
• Accessibility to user with diverse abilities
• Provision of the latest information on a medicine’s safety, benefits and conditions of use
• Informed decision-making by patient/consumer and HCPs
• Availability of ePI in multiple languages
• Attractive, presentable and user-friendly interface with other potential supportive features (e.g. user font modification) would motivate patients to take a more active interest in their health status
• Availability of additional materials to the statutory information: video and audio facilities accessible to support and improve health literacy and safe use of the product
• Alerts for major updates to the leaflet

However, it is important to state that the implementation of ePI should not lead to health inequalities among citizens with limited access to electronic information. Moreover, it is crucial to empower patients by concentrating on the construction of an EU common standard for harmonized and structured PI, which could be implemented gradually across Member States, followed by the whole of Europe.

Finally, EU’s Green deal and the EU Commission agenda to improve the environment would be supported with a great potential of ePI to reduce the volume of paper and ink (and all associated industrial activities) that are currently used to produce the paper leaflet. ePI will contribute to the decrease of the Carbon footprint.

Current scene

Currently, multiple EU countries like Belgium, Luxembourg, Germany, Spain and the Baltics have ongoing initiatives relating to the implementation of ePI for some medicinal products. These initiatives include ePI pilots for some medicinal products[6].

e-PIL pilot in Belgium/Luxembourg

At the initiative of the pharmaceutical industry and with the support of the national competent authorities and the associations of hospital pharmacists, the electronic patient information leaflet (e-PIL) pilot project was launched on 1 August 2018 in Belgium and Luxembourg for an initial period of two years, with the aim to demonstrate that the electronic leaflet is equivalent to the paper leaflet.

The Pilot surveys recognized that when the respondent hospital pharmacists had to consult the e-PIL, 96% of them viewed the e-PIL online, with only 4% requiring a printout from the online source. Furthermore, for 98% of the respondent hospital pharmacists, the absence of the paper PIL did not affect their daily practice in a negative way, or in their obligation to respond to questions from doctors or other HCPs. The results also show that patients very infrequently demand the PIL of their medicine. Accordingly, 98% of the respondent hospital pharmacists would be in favor for the removal of the paper PIL from all hospital-only medicines.

Since the participating stakeholders (hospital pharmacists, other HCPs and pharmaceutical companies) believe that the experience gained in this pilot project is a valuable source of empirical evidence to support the policy initiatives in this area, the EC prolonged the pilot until August 2022. Furthermore, as there is currently potential to support the change in the EU general pharmaceutical legislation, another pilot extension request was made to include more products in the scope of the pilot. Since December 2020, a total of 42 products restricted to hospital use from 18 pharmaceutical companies are included in the e-PIL pilot project[7],[8].

Meeting the needs of Ukrainian patients in the EU

One of the many challenges faced by 7 million Ukrainian’s refugees now in the EU is accessing up-to-date information about prescription medicines in their own language. To help address this need, EFPIA and Member companies with the support of technology provider GS1 launched a technical solution allowing the Ukrainian patients displaced in Poland a rapid, direct, and free of charge access via their mobile phone to essential product information on prescription medicines, in their native language. 

How does it work?

Every pack of medicines in the EU has a unique datamatrix code printed on the packaging. Using a free, dedicated app, clinicians or patients can scan the datamatrix code on the medicines packaging and access the electronic Product Information Leaflet (e-PIL) in Ukrainian. These e-PILs are a faithful translation of the official PIL available in paper format for each medicine. For patients, clinicians or other groups wanting to access the service please go to the following links:

App Store link to download the application. 

Play Store link to download the application. 

The way forward

The results of these initiatives could be used cooperatively to support the recognition of ePI and its use in the step-by-step elimination of paper leaflets starting with hospital medicines. Thus, the expansion of pilot projects investigating the benefit of replacing paper leaflets with ePI for hospital/HCP administered products, should be stimulated. Furthermore, the EC needs to ensure legislative readiness to convert to ePI by conducting legal framework analysis for the development of an ambitious ePI roadmap.

For patients and HCPs, educational campaigns should be organized to raise awareness on ePI. Also, discussions on how to secure safe and easy access to ePI for patients need to be held, while making sure that the elderly population and those who may not have electronic access, will not be left behind[9]. The future of better and timely information on medicines is knocking on the door – all stakeholders will hopefully open this door with a warm welcome!

>> Discover more on our the Regulatory Road to Innovation <<

[1] According to EMA-HMA-EC, ePI is authorised, statutory product information for medicines (i.e. SmPC, PL and labelling) in a semi-structured format created using the common EU electronic standard. ePI is adapted for electronic handling and allows dissemination via the world wide web, e-platforms and print. ePI fulfils the key principles.

[2] https://www.ema.europa.eu/en/documents/report/report-european-medicines-agency-ema/heads-medicines-agencies-hma/european-commission-ec-workshop-electronic-product-information-epi_en.pdf

[3] https://www.medicinesforeurope.com/wp-content/uploads/2021/02/IATF-ePI-report_final_complete.pdf

[4] https://www.ema.europa.eu/en/documents/report/report-european-medicines-agency-ema/heads-medicines-agencies-hma/european-commission-ec-workshop-electronic-product-information-epi_en.pdf

[5] https://aesgp.eu/content/uploads/2021/02/IATF-ePI-report_executive-summary.pdf

[6] https://pharma.be/nl/e-pil-soortgelijke-projecten-in-europa

[7] https://pharma.be/sites/default/files/2022-04/2021_E-PIL%20pilot%20project_one-pager_final.pdf

[8] https://pharma.be/sites/default/files/2022-06/rr-april-2022-e-pil.pdf

[9] https://aesgp.eu/content/uploads/2021/02/IATF-ePI-report_executive-summary.pdf