e-PIL Pilot Project in Luxembourg and Belgium
IML Innovative Medicines for Luxembourg
Innovative Medicines for Luxembourg helps Luxembourg's patients to get access to innovative treatments.
Package leaflet provides information about the medicinal product to the user. The printed leaflet is familiar and available, however poorly legible, mainly when containing multiple languages. It is resourceful to update, has the potential to go missing or get damaged, and is environmentally burdensome. The pharmaceutical manufacturers in Luxembourg and Belgian have been granted permission to market selected hospital medicinal products without printed package leaflets.?
The public/private pilot project e-PIL is expected to promote the availability of medicinal products and patient safety via increased access to therapeutic information. It was initiated by the associations of the innovative pharmaceutical industry in Luxembourg and Belgium, IML and Pharma.be with the support of the Luxembourg and Belgian competent Authorities and the associations of hospital pharmacists.?
Background
A package leaflet aims to give the user information about the medicinal product. In the European Union (EU), Directive 2001/83/EC on the Community code relating to medicinal products for human use requires that the precisely structured technical document must be available in all official languages of the Member State where it is marketed and in a physical form within the packaging of the medicinal product (Articles 58–59).
The e-PIL project aims to evaluate whether the medicinal products would be used safely without the paper package leaflet for hospital medicinal products.??
In August 2018, the pharmaceutical industry launched the first 'e-PIL' pilot project in Belgian and Luxembourg hospitals for 24 months. To make the implementation of the project possible, it was first necessary to obtain a derogation of article 58 of EU Directive 2001/83/CE from the European Commission.
The pharmaceutical industry has been promoting the idea of assessing the impact of replacing the paper Patient Information Leaflet (PIL) for hospital products with an electronic one (e-PIL), as this would bring numerous advantages. To name but a few: the possibility to update all product information in real-time without having to withdraw stock and replace the data, display the information in the desired language and reduce packaging and thus the environmental impact.?
Practical implementation
For the selected medicinal products available in Belgium and Luxembourg markets but restricted to hospital use, as part of the pilot, the manufacturers can remove the paper PIL from the packaging and only provide it electronically (e-PIL) via one or more trusted sources (among them https://www.e-notice.be/ and https://medicinesdatabase.be/human-use).
Extensions of the pilot project
Thanks to approving the first interim results, the Belgian and Luxembourg authorities agreed to request an extension of the project to the European authorities, which has been approved for an additional 24 months and included more products. In this project's second phase, a total of 42 products restricted to hospital use from 18 pharmaceutical companies were included in the e-PIL pilot project.
In August 2022, the European Commission allowed a new extension of this pilot project for three years and its scope to new medicines exclusively used in hospitals.?
领英推荐
Phase 1 – 01 August 2018 – 01 August 2022
Phase 2 – 01 August 2020 – 01 August 2022
Phase 3 – 01 August 2022 – 01 August 2025
Latest Interim results 2022 (t 48m, after phase 2)
Results demonstrated general support for removing package leaflets from selected hospital products. Main benefits included
?????????the consultation of the e-PIL went from 75% to 98% after the study (only 4% of consulted hospital pharmacists printed out the digital leaflet from the online source.
?????????97% declared that having only a digital version of the leaflet did not inconvenience their daily practice.
?????????100% declared that the absence of paper leaflets did not cause any inconvenience to the physician.
?????????95% would have favoured the removal of the paper PIL from all hospital-only medicines.
Conclusion
The removal of paper leaflets could be extended to more products based on the positive feedback for this pilot project. The pilot project was well received among the healthcare providers, mainly hospital pharmacists, who showed readiness to continue using ePIL as the only media for information.?
IML sees the ePIL initiative as an opportunity to tackle availability, strengthen pharmacovigilance, and decrease the environmental footprint of packaging. The ecological footprint of the paper leaflets in the packaging is enormous. It has been calculated that by moving away from paper leaflets, more than 100 tonnes of paper waste per year could be avoided, and the dependence on the paper supply would be resolved.