The proposal to revamp the EU regulatory framework for pharmaceuticals leaves it up to individual countries to decide whether drugs’ package leaflets come in a paper or electronic format, or both – prompting concerns over digitisation and accessibility.
In the EU, every medicine package must contain a patient information leaflet (PIL), which contains regulated and scientifically approved information, such as its intended purpose, how it should be used or what side effects may occur when taking it, to ensure the proper use of the medicine.
As the digital transformation of healthcare across the EU picks up, the revamp of the bloc’s regulatory framework for pharmaceuticals, presented by the Commission on 26 April, proposed that “member states may decide that the package leaflet shall be made available in paper format or electronically, or both”.
This proposal has met mixed reactions from stakeholders, with some arguing that this will hamper access to medical information for some, and others stating the opposite. Both sides agree that no one should feel left behind in the digitalisation process.
The benefits of electronic leaflets
Digital leaflets have their benefits, such as ensuring fast access for patients to updated information about the medicine.
According to the European Medicines Agency (EMA), digital platforms open additional possibilities to disseminate product information (PI) electronically.
In their news release, EMA argued that digitalising information could address limitations of paper versions, such as making information interoperable with other electronic health systems such as e-prescription and electronic health records.
Additionally, digital platforms can “better meet patients’ and healthcare professionals’ needs for accessible, trustworthy and up-to-date information on medicines available at the right time,” EMA said.
Sophie Dagens, Regulatory Policy Officer at Medicines for Europe, shared similar thoughts: “Electronic product information could enhance health literacy, through search functions, and videos”.
“It will also fill a gap: currently, surveys have revealed that patients in hospitals or for products administered by healthcare professionals, such as vaccines, do not receive the paper leaflet,” she told Euractiv.
Public Health Advisors at pharma.be Marie Vande Ginste and Nathalie Lambot in a joint comment listed benefits for patients of digital leaflets such as: “an immediate access to the last up-to-date information, access to information tailored to their needs, and that the healthcare professionals remain with a key role in accompanying the patient when reading the product information”.
Moreover, in their paper “Electronic leaflet pilot in Belgium and Luxembourg hospitals” they both argued that having electronic leaflets could have a positive impact on medicine shortages.
“This is because it would make it unnecessary to recall products to update the product information in the paper PIL,” they explained adding that this could also facilitate imports between countries in Europe.
Taking the right approach
However, the move towards digitised leaflets without having paper versions has stirred worries that it could also harm patient safety, as only 54% of Europeans in 2021 had at least basic digital skills according to Eurostat.
Ancel.la Santos Quintano, Senior Health Policy Officer at the European Consumer Organisation (BEUC), is worried that “the Commission could decide in a few years’ time to get rid of paper package leaflets altogether which would be a mistake”.
“Digital information should not replace paper leaflets but complement them,” Quintano added, referring to article 63 paragraph 5, stating that the Commission can later amend the legislation and make electronic package leaflets mandatory.
“Consumers need to access crucial information about the medicine inside the box, and not only through some QR code, which we know will lead to fewer people consulting this information,” Quintano said.
BEUC has also previously warned that certain people could be left behind, as has the European Patients Forum, which calls “access to high-quality information is an important aspect of health equity” and states that “electronic product information (ePI) should not be seen as a substitute for the paper leaflet, but rather as an opportunity to expand available formats.”
Ensuring access to printed information
So far the Commission’s proposal to digitise the leaflets comes with the addition that if they are only available electronically, “the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.”
Dagens from Medicines for Europe, assured that the industry is willing to look for solutions: “We are committed to finding solutions for all patients to ensure that no one is left behind. This includes the right to printed information.”
“We are open to dialogues with other stakeholders to find solutions for patients who will not be able to access – in countries like New Zealand and Australia, the leaflet is printed out by healthcare professionals and pharmacists for patients who request it,” Dagens said.
But Pharmaceutical Group of the European Union (PGEU) does not seem too optimistic about this. “In addition to causing serious workflow disruptions and delays in the delivery of medicines to patients, it would also place an unsensible financial burden on pharmacies and a responsibility that is today a key regulatory obligation for pharmaceutical companies,” the group write in their position paper.
Therefore Ginste and Lambot are in favour of “a gradual implementation depending on the setting, hence starting in the hospital setting and for products administered by the healthcare professionals”.
Ginste and Lambot added the importance of educating citizens about the existence and benefits of digital leaflets “to support a future smooth transition also outside the hospital setting, which takes on board all citizens”.
“Only when citizens are well aware of the existence of the digital leaflet and how to access the digital leaflet, an implementation in ambulant care can be envisaged,” they said adding that “it remains the patients’ right to have access to a printed leaflet”.
[Edited by Nathalie Weatherald]
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