BRUSSELS, Belgium
,
February 21, 2024
(press release)
–
MLPS (Medical Leaflet = Patient Safety), a subgroup of the European Carton Manufacturers Association (ECMA), is releasing a study today shedding light on the potential economic costs associated with the proposed use of Print on Demand (PoD) leaflets in the pharmaceutical legislation revision. With the European Commission's proposal allowing countries to decide on the format of medical leaflets, MLPS underscores the necessity of understanding the financial implications of this decision. You can read the study here. MLPS emphasizes the need to address the impact of PoD starting with its financial aspect, raising questions about how different Member States will implement PoD in practice, and who will bear these costs. 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. (*1) https://digital-strategy.ec.europa.eu/en/policies/desi
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). 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, labor costs, and taking into account current digital skills and the number of pharmacies across the EU. The study demonstrates the cost impact of PoD is 2 to 3 times larger than the current total cost for medical information leaflets.
"In our commitment to patient safety and accessibility to crucial medical information, it's imperative to thoroughly understand the financial implications surrounding a proposed legislative change such as removing paper leaflets," stated Mike Turner, Managing Director of MLPS. "This study underscores the need for a comprehensive consideration of all factors (social, economic and environmental) involved in the transition to the digitalisation of leaflets and print-on-demand formats; we hope the report will enable an understanding of the implications of PoD to pharmacists, pharmacies and patients."
The report further 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.
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