Environment and sustainability questions are becoming common for all industry sectors, thus healthcare sector is no exemption. High quality, safety and efficacy standards in healthcare products must not be affected by environmental initiatives. There are many possible responses to this European Commission initiatives foreseen in Green Deal Plan (EUR-Lex – 52019DC0640 – EN – EUR-Lex (europa.eu) and an Electronic product information leaflets (e-PIL) is one option.
Started already in 2018 (Towards electronic product information for EU medicines | European Medicines Agency (europa.eu), an Electronic product information leaflets (e-PIL) pilot as a collaboration of the pharmaceutical industry and the regulatory authorities in Belgium and Luxembourg (e-pil.pdf (pharma.be). Thus, for a selection of medicines, restricted to hospital use only, a paper PIL was no longer included in folding box, but was consulted online via trusted websites. The objective to show that the electronic format gives sufficient, adequate, and tailored information on the use of medicines to healthcare professionals and patients in a hospital setting was reached and the pilot project was extended until August 2022 to get further results.
It was noted that the absence of the paper patient leaflet in the packaging has had no influence on the everyday process of the pharmacists or even simplify this process. Advantages noticed were as follows: easy access, fast sharing of the information, tailored use, most current information and reducing waste. Concerning disadvantages as reported the access to internet is not always easy or available to the patients and need to adopt lifestyles by learning of new situation.
The European Medicines Agency, in collaboration with Heads of Medicines Agencies and the European Commission, has developed key principles through stakeholder consultations to guide the development and use of ePI in the EU. (https://www.ema.europa.eu/en/electronic-product-information-human-medicines-european-union-key-principles#current-version-section)
They outline how ePI:
- benefits public health;
- creates efficiency gains for regulatory systems;
- aligns with the existing legislative framework and complements the paper package leaflet;
- fits into the EU’s multilingual environment;
- interacts with other ongoing digital initiatives at EU and global level.
In summary, the e-PIL may solve reduction in packaging waste, as well as recalls due to changes in leaflets content. Medicines shortages could potentially benefit at the same time due to e-PIL all the time on-line updated to current version.