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Position Paper on the Issue of Smaller Countries and Pharmaceutical Legislation Revision on EPI

MLPS (Medical Leaflet = Patient Safety), a subgroup of the European Carton Manufacturers Association, is deeply concerned about the Commission's proposed Directive revising the medicinal products for human use Directive concerning the use of electronic product information (ePI), particularly in the context of smaller Member States. We urge the Commission to consider the following points in relation to this issue:

Specific Language Needs:

In smaller countries such as Malta, Norway and Cyprus with lesser used languages, there may be challenges in providing all necessary translations. Whilst we recognise this concern, we believe that completely removing paper leaflets is not the appropriate solution. Instead, we propose a complementary approach that offers ePI benefits with a wider array of languages while retaining mandatory paper leaflets for critical medical information. Pharmaceutical companies could agree with leaflet printers to print medicine information in smaller quantities (from 1000) to supply paper leaflets in specific languages where necessary and be delivered with a very short deadline (within a week).

Print on Demand (POD) Limitations:

While the concept of POD has been proposed as an alternative to paper leaflets, it presents several practical challenges. POD would require pharmacists to print the full product information leaflet for the patient, creating workflow risks and challenges as well as the potential risk of printer malfunction and character substitution. Moreover, the possibility of information getting lost or separated during transport are valid concerns. We recommend the removal of POD as an alternative and focus on retaining mandatory paper leaflets as a complementary solution to ensure patient safety.

Medicine Shortages:

Whilst MLPS appreciates the European Commission's efforts to address medicine shortages, it is essential to clarify that paper leaflets are not the cause of this problem, as indicated in the European Parliament report on the shortage of medicines. The report advocates for the supplementation of paper information notices with ePI leaflet notices in all languages to enhance the movement and sales of medicines within the single market, but it does not attribute medicine shortages to the use of printed leaflets.[1] The shortages have arisen due to a combination of factors, including increased demand, manufacturing delays, and production capacity issues, affecting not only smaller Member States but all EU countries.[2] Hence, we stress that ePI is not the only solution to the issue. Instead, we advocate for a complementary approach that retains mandatory paper leaflets, ensuring accessibility, patient safety, and privacy for all citizens, while embracing the advantages of digital advancements in medical information distribution. We encourage the Commission to collaborate with relevant stakeholders to devise patient-centric solutions that address the unique challenges faced by smaller Member States.

In conclusion, MLPS urges the Commission to consider the unique challenges faced by smaller Member States in implementing electronic product information. A complementary approach, with the retention of mandatory paper leaflets, ensures accessibility, patient safety, and privacy for all citizens, while also facilitating the benefits of digital advancements in medical information distribution. We are committed to collaborating with relevant stakeholders to find the most suitable and patient-centric solutions in these smaller countries.

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).

The manufacture of pharma paper information leaflets by MLPS members employs over 3100 people in 14 countries, contributing around €150 million directly to the European economy per annum in employee costs and additional expenditure on paper, inks and equipment of more than €147 millions.

[1] European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem

[2] Medicine shortages go beyond antibiotics, as global crisis hits home, Times of Malta, December 31, 2022


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