Overview
The European Medicines Agency is working to facilitate the use of electronic product information (ePI) for human medicines in the EU. EPI pertains to “authorised statutory product information for medicines (including the summary of products characteristics, package leaflet, and labelling)” modified for electronic dissemination. The development of ePI within the EU is backed by the Eu4Health programme 2021-2027 – a vision for a healthier Europe. The EU established the programme in response to the COVID-19 pandemic to enhance “crisis preparedness” in the EU. In 2023, a draft of the reformed EU pharmaceutical legislation called for mandatory ePI on all medicines.
Benefits
The benefits of enhanced ePI include:
- Enhanced access to essential and up-to-date information about medicines for patients and healthcare professionals.
- Accelerated market readiness of medicines as the requirement to produce a printed leaflet is eliminated.
- Improved health literacy by providing videos, audio descriptions, larger text, and other accessibility tools, enhancing patient’s understanding of their treatment.
- Improved sustainability within the medicine supply chain by eliminating the need for paper and printing.
- Digital interoperability to to allow health information to flow smoothly between manufacturers, healthcare professionals, and patients.
Global Outlook
- Australia: Information on all medicinal products is available via ePI. Paper product information is optional.
- China: In 2024, China adopted an ePI pilot programme that utilises QR codes.
- Japan: In 2021, a government mandate necessitated the need for all patient information leaflets to be uploaded to the Pharmaceuticals and Medical Devices Agency.
- Singapore: In 2021, the Health Sciences Authority approved sharing ePIs through URL or QR codes.
- USA: In 2014, the US Food and Drug Administration proposed amending the requirement that prescribing information be provided primarily on paper. The idea has faced political and legislative resistance.
Progress
On 16 December, findings from the European Commission and the European Medicines Agency were published regarding a pilot exploring the creation and testing of ePIs in regulatory procedures. The report concluded that the EU is generally ready to begin the phased adoption of ePI. However, the EU requires a “more developed” and “joined up”regulatory system, with extra features and integration within existing IT systems, to handle digitalised medicines information. Furthermore, the report suggested enhancing guidance for ePI users and streamlining business processes to ensure seamless integration of ePI.
Despite the need for further development and improvement, the report specified that “there were no blocking aspects identified that would prevent inclusion of electronic product information (EPI) in regulatory procedures as an add-on to current processes”. The report emphasised that, in 2025, the EU should work towards a phased approach to EPI implementation, beginning with voluntary adoption for centrally authorized products. Following this, the EU should “progressively expand to nationally authorized products based on countries’ readiness and available resources”.
Lastly, the report recommended that the regulatory network, pharmaceutical industry, medicine information providers, and healthcare professionals integrate EPI into their planning and preparation processes. Ultimately, it is the product information from pharmaceutical firms that will need to be adapted upon the introduction of enhanced ePI. Therefore, pharma firms must engage constructively with regulators and solution providers to prepare for the evolution of the technology.
