The European Commission’s drive for digital health promises many benefits, including improved patient access, efficiency, and management of healthcare. But we must avoid a drive for digitalisation at all costs: it threatens to leave the most vulnerable Europeans behind.
This threat is evident today with the revision of the General Pharmaceutical Regulation, which proposes to soften rules around medicine safety information without any assessment of the impact on patients.
As it stands, medicine boxes may no longer be required to contain key information leaflets with the dose, side effects, and interactions, as long as the boxes have a QR code leading to that information online.
With serious disparities in Europe, we must ensure that printed medical leaflets are available to vulnerable patients when they need them
This proposal would leave it up to EU countries to decide whether to keep the leaflet in paper format, make it digital, or have a hybrid of both. Printed pharmaceutical leaflets are the only failsafe method of ensuring the right information is available to patients when they need it.
That is why a complementary approach, with both digital and printed solutions, is the safest way forward.
Protecting patients is key
While the Commission aims to ensure all Europeans can access digital healthcare by 2030, 32% of Europeans still lack basic digital skills, and only 57% aged 55-74 use the internet regularly. More than 80% of EU citizens aged over 65 use prescribed medication and 45% of all medicines prescribed are to this age group. In 2021, more than 60% of Europe’s rural households remained unserved by Very High-Capacity Networks (VHCN).
The digital divide is a significant issue that cannot be ignored. With serious disparities in Europe, we must ensure that printed medical leaflets are available to vulnerable patients when they need them.
‘Print on demand’ is not a practical solution
If the revised Regulation survives in its current form and some countries implement a digital-only regime, pharmacists would be expected to offer a ‘print on demand’ option to all patients who need it.
This risks dangerous information errors, adds costs, and puts additional pressure on pharmacists for space, equipment and time. Patients mindful enough to ask for a printout will have to wait longer at the pharmacy and receive several pages of A4 to carry home. The annual cost of producing 'print on demand' leaflets across the EU is estimated to be between €1.680 billion and €3.495 billion, varying based on whether the leaflets are printed in black ink or four-colour ink.
What’s more, digital platforms are susceptible to technical issues, such as server outages or cyber-attacks, which could prevent patients from accessing vital information. Printed leaflets, on the other hand, are always available together with the medication, and do not rely on patient access to technology.
As discussions continue, we must make sure the General Pharmaceutical Regulation puts patients back at the heart of healthcare. We must leave no one behind – that means digital solutions available for those who are currently able to access them, together with printed solutions to ensure we provide everyone in our societies with the right care.
MLPS is a group that advocates for the safe and secure delivery of medicine information to patients and consumers. They believe that pharmaceutical literature should remain the primary source of that information, to guarantee a safe and accurate delivery of medication information. The group was formed in 2020 by a collective of specialist, regulated healthcare packaging makers within the European Carton Manufacturers Association.
Learn more on how printed medical leaflets ensure inclusive access to healthcare at mlps-leaflet.org.
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