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Digital and Paper: Ensuring Universal Access to Pharmaceutical Information

The European Commission’s recent proposal to review pharmaceutical legislation has sparked a significant debate. The directive’s suggestion to allow Member States to opt between electronic and traditional paper medical leaflets raises valid concerns about the potential marginalization of older and vulnerable demographics. MLPS, Medical Leaflet = Patient Safety, is a subgroup of ECMA (TR: 948591610750-02), the European Carton Makers Association, and represents the printers of regulated pharmaceutical information, including Package Inserts (PIs), Medication Guides (MedGuides), and Patient Package Inserts (PPIs). As MLPS (Medical Leaflet = Patient Safety), a branch of the European Carton Manufacturers Association, we echo these apprehensions. We advocate for a complementary approach that seamlessly merges the advantages of both electronic and paper mediums. Recent surveys underscore the importance of this complementarity. A study by the European Consumer Organisation (BEUC) spanning Belgium, Italy, Portugal, and Spain revealed a telling statistic: 79% of consumers believe that paper leaflets should accompany medications, even if a QR code alternative exists. The primary concerns? The potential sidelining of the elderly (81%) and an over-reliance on the internet (70%). While electronic leaflets offer numerous benefits, an outright replacement of paper leaflets could inadvertently deprive many Europeans of essential medical information. Such a move risks medication errors and compromises patient safety. The digital divide is real: Eurostat data shows that only 57% of those aged 55-74 use the internet regularly. Even in tech-savvy nations like Denmark, a significant 23% lack smartphones. Furthermore, digital access remains elusive for many, especially in countries with higher poverty rates. The proposed ‘Print on Demand’ (POD) policy, which would allow pharmacists to print leaflets upon request, is fraught with challenges. Beyond the added burden on pharmacists, there’s the undeniable risk of inaccuracies when using standard printers, which could jeopardize patient safety. Smaller nations with unique languages face their own set of challenges. However, the solution isn’t to eliminate paper leaflets. A dual approach, offering digital translations while ensuring paper leaflets for those less tech-savvy, is the way forward. The printing industry is poised to support this, offering tailored solutions for these nations. Electronic leaflets also bring up concerns about data privacy. With cyber threats on the rise, the safety of online health data is under scrutiny. It’s essential to provide patients with offline access to critical information, ensuring their privacy remains uncompromised. The proposed five-year transition to electronic leaflets seems rushed. Given the digital challenges many Europeans face, a more extended ten-year transition period would be more prudent, ensuring patient safety isn’t compromised. In essence, the path forward requires a harmonious blend of the digital and traditional. By leveraging the strengths of both electronic and paper leaflets, we can guarantee safe, accessible, and private information for every patient. It’s time to prioritize patient well-being and craft a pharmaceutical legislation revision that leaves no one behind. Source:


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