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MLPS one-pager: Medicine shortages: Can Removing Paper Leaflets Solve the Issue?

3 days ago3 min read

Paper Leaflets Do Not Cause Medicine Shortages in the EU

Medicine shortages in the European Union have become an increasing concern, affecting patient care, healthcare providers, and supply chains. However, it is essential to dispel the misconception that paper leaflets lead to medicine shortages in EU Member States by hindering the supply of medicines across borders. Medicine shortages are a complex issue caused by various factors, none of which are linked to the presence or absence of printed patient information leaflets.

 

Addressing the Facts: Medicine Shortages and the Role of Paper Leaflets

Studies, including an extensive European Commission report on pharmaceutical legislation (1), confirm that medicine shortages in the EU are driven by several critical factors. Nowhere in these reports are paper leaflets identified as a cause of supply disruptions.

 

Understanding the Real Causes of Medicine Shortages in the EU

According to the European Commission (1), the primary reasons for medicine shortages are:

  1. Quality and Manufacturing Issues – These account for approximately 50% of reported shortages, including problems with Good Manufacturing Practices (GMP), compliance failures, and production disruptions.

  2. Commercial and Market Factors – Single-winner procurement practices, low-profit margins, and industry consolidation has lead to supply imbalances.

  3. Increased Demand – Market withdrawals, pricing strategies, and unforeseen spikes in demand, such as those experienced during the COVID-19 pandemic, have created supply bottlenecks.

  4. Manufacturing consolidation – Fewer production sites due to industry restructuring, limiting capacity and flexibility, exacerbate shortages.

 

What the European Parliament and European Commission Say About Leaflets

The European Parliament report (2) and European Commission report (1) on medicine shortages do not cite printed leaflets as a cause of shortages. The European Commission’s study suggests increased use of multilingual packaging and digital supplements to enhance medicine distribution across Member States but do not propose eliminating printed leaflets. Moreover, current legislation (4) already allows medicines to be placed on the market without a printed leaflet in the official language of the Member State if necessary for distribution.

 

The MLPS Stance: Complementary Solutions for Better Accessibility

MLPS (Medical Leaflets = Patient Safety) advocates for a complementary approach to information access, combining paper leaflets with digital solutions rather than eliminating printed materials. This ensures that:

  • Patients Without Digital Access Are Not Left Behind – Elderly patients, those with lower education levels, and individuals in rural areas rely on printed information.

  • Smaller EU Member States Have Solutions – The leaflet printing industry can support pharmaceutical companies by offering small print runs (from 1,000 copies) for lesser-used languages.

  • Pharmacists and Healthcare Providers Are Not Overburdened – Shifting to fully digital formats could create additional financial and workload responsibilities for pharmacists. Print on Demand

 

Ensuring Patient Safety and Medicine Availability

The real solution to medicine shortages lies in addressing manufacturing, regulatory, and market-driven issues (1, 3). Eliminating paper leaflets will not solve medicine shortages but may create new accessibility problems for millions of patients.

 

MLPS calls on the European Commission, European Parliament, and the Council of the EU to uphold a balanced approach that ensures patient safety, accessibility, and the continued availability of critical medicines.


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