At ‘Medical Leaflets = Patient Safety’ we welcome this week’s publication of the Council of the EU’s negotiating position on the general pharmaceutical regulation - the approach to medicine information retains patient safety at its heart.

While the Council position is aligned with the Commission proposal to allow Member States to decide if they want to opt for a digital-only approach, it removes the right of the Commission to adopt secondary legislation mandating that across the EU. It also clarifies that, in those cases where a digital-only approach is pursued, medicine providers would be responsible for guaranteeing that printed information is readily available for all patients who need it.

MLPS spokesperson Mike Turner said “We commend the careful thought that has gone into finding a balanced way forward for medicine information that puts patient safety at the centre. Printed leaflets remain key in providing medicine information to all patients, regardless of their digital literacy and access”.

MLPS is now looking forward to continuing to work together with Member States and share the value of a hybrid approach. 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.

The amended position: a firmer guarantee for patient safety

In those countries that go down the route of digital-only information, the Commission and Council are aligned that printed information should remain available to patients.  However, the  Commission proposal did not define how that would be guaranteed, and who would be responsible for its delivery.

There have been to date no impact assessments showing how this would affect patients. We do know that many patients lack the necessary skills, knowledge or access to easily get to the information online. Nearly one-third of Europeans lack basic digital skills [1]. While more than 80% of EU citizens aged over 65 use prescribed medication, only 57% aged 55-74 actually use the internet regularly [2]. In 2021, more than 60% of Europe’s rural households remained unserved by Very High-Capacity Networks [3].

The Council’s position would amend this, making it clear that it is medicine providers who will need to make both forms of information available to patients in all cases, even if the digital-only solution is allowed in national law. According to their position, “the marketing authorisation holder shall be responsible for both preparing the electronic leaflet and ensuring that the printed version of the package leaflet is readily available to the patient”.

Next steps

Trilogue negotiations between the Council and the European Parliament will now begin, ahead of a final adoption. If this article of the regulation remains as it is, it will then be for medicine providers to decide on the best solution to ensure printed leaflets remain readily available. At MLPS, we commissioned a study [4] looking at the ‘print on demand’ option and what that might mean in terms of costs. It found that the annual cost of producing 'print on demand' leaflets across the EU could be between €1.680 billion and €3.495 billion, varying based on whether the leaflets are printed in black ink or four-colour ink. This is far above the existing costs to provide medical leaflets in every box of medicine.

About MLPS

MLPS was formed in 2020 by a collective of specialist, regulated healthcare packaging makers within the European Carton Manufacturers Association [5]. We positively engage with everyone that has a genuine interest to the safe and secure delivery of medicine information to patients and consumers.  We firmly believe that printed pharmaceutical literature should remain the primary source of information for patients and healthcare professionals to guarantee a safe and accurate delivery of medication information. 

Find out more on mlps-leaflet.org [6]