Delivering vaccines with detailed information in the patient’s and health professional’s own language ensures that patients can make informed decisions and that health professionals can administer vaccines correctly. European Union (EU) law aims to protect patients by ensuring that all vaccine packaging components – immediate packaging (syringes, vials, and applicators for nasal or oral vaccines), outer packaging (boxes or cartons), and the Patient Information Leaflet (PIL) – include information in the official language(s) of the distribution country.
Traditionally, the PIL has been a paper leaflet, which can be challenging to distribute efficiently. Vaccines need to be stored in refrigerated conditions with limited space, meaning leaflets must be small and restricted to three languages. There are 24 official languages in the EU/European Economic Area (EEA), and some countries have up to three official languages. Because of this, and because many EU countries are small, vaccination packaging needs to be made in small, country-specific batches.
This process is not only inefficient but also prevents timely responses to crises such as vaccine shortages due to the need to either repackage the vaccine, or to gain authorisation from the National Competent Authority of the concerned Member State to distribute the vaccination with packaging written in a foreign language.
To improve this process, EUVABECO partner Vaccines Europe suggests using neutral, common EU packaging, and replacing paper leaflets with Electronic Patient Information Leaflets (ePIL) [1]. The ePIL provides the same crucial information as the PIL but through digital platforms and offers several benefits:
- Real-time updates, ensuring accurate information, unlike paper leaflets that can become outdated.
- Reduced production time and improved logistical efficiency by simplifying packaging.
- Easier and faster re-routing of vaccines.
- Optimized refrigeration and storage capacity by minimizing bulky packaging.
- Increased environmental sustainability by reducing paper use and energy consumption.
For those with limited digital access, ePILs can be printed by healthcare professionals or family members in the patient’s preferred language, ensuring everyone receives essential vaccine information.
With Vaccines Europe’s expertise, EUVABECO is planning pilot projects in Belgium, Germany, Greece, Latvia, and Portugal starting in October 2024. These pilots aim to develop and test implementation plans for ePILs and will follow existing EU laws, particularly Directive 2001/83/EC, which governs the labelling and packaging of medicinal products.
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