4 March 2024

Intergraf welcomes the release of a study by our partner MLPS (Medical Leaflet = Patient Safety), a subgroup of the European Carton Manufacturers Association (ECMA) shedding light on the potential economic costs associated with the proposed use of Print on Demand (PoD) leaflets in the pharmaceutical legislation revision.

The study, commissioned by MLPS, addresses a critical question left unresolved in the proposed Directive: the enormous total cost implications of implementing PoD leaflets alongside electronic Product Information (ePI).

MLPS states:

“The study's conservative quantification provides stakeholders with valuable insights into the economic impacts of PoD leaflets. The estimated total cost of PoD leaflets across Europe-27 ranges from €1.680 billion to €3.495 billion annually, depending on whether leaflets are printed in black or four-color ink. It is unclear who will bear these costs, which are currently borne by the pharma industry.

The calculation of the unit cost per PoD leaflet is composed of several key components required for pharmacies to provide PoD, including paper, ink, printers' depreciation, labour costs, and taking into account current digital skills and the number of pharmacies across the EU. The study has calculated the number of PoD leaflets needed based on the digital skills and the part of the older population being more in need of medication. The study demonstrates the cost impact of PoD is 2 to 3 times larger than the current total cost for medical information leaflets.

The report shows how the older population will be disproportionately affected by the removal of paper leaflets, as over 50% of dosages are consumed by people aged over 65. Citing the European Commission’s Digital Economy and Society Index[1], the report illustrates that this segment of the population has the lowest level of digital skills, especially in Eastern European countries. Therefore, PoD will still result in a significant number of paper leaflets being requested by patients.”

Intergraf Secretary General, Beatrice Klose: “Intergraf welcomes the release of the MLPS study on the costs of printing medical leaflets on demand. It confirms that the Commission’s proposed “patients’ right to a printed copy of leaflets” as an alternative for paper leaflets has a significant financial impact, in addition to the logistical burden for pharmacies of leaflet storage and matching the right leaflet with the right medicine. These costs would no longer be covered by the pharmaceutical industry but would have to be covered by society.”


Link to the original MLPS press release:

Link to the study:

MLPS, a subgroup of ECMA (TR: 948591610750-02), represents printers of regulated pharmaceutical information, including Package Inserts (PIs), Medication Guides (MedGuides), and Patient Package Inserts (PPIs). The MLPS industry, spanning 16 countries and employing over 3100 people, contributes significantly to the European economy, with annual expenditures exceeding €150 million on employee costs and over €147 million on paper, inks, and equipment.




Download the joint statement in .pdf here.