Intergraf calls on EU to retain paper leaflets in medicinal products, pharmaceutical packaging and reconsider Article 63.3 of proposed Directive on Medicinal Products; relying on digital access to medication information risks excluding many patients

Sample article from our Government & Public Policy

November 6, 2023 (press release) –

 

Intergraf takes a stand in defence of consumer rights, particularly those related to medicinal products for human use. Intergraf urges the European Union to reconsider Article 63.3 of the proposed Directive on Medicinal Products, emphasizing the essential role of medical leaflets in pharmaceutical packaging.


Accessibility and patients’ safety
The legislative proposal under consideration aims to ensure the accessibility and safety of patient information in a digital format. While this goal is commendable, Eurostat 2023 data point out the stark reality that 70.7% of Europeans possess only basic, low, or no digital skills, whereas 7.5% of European households have no internet access. Thus, the reliance on digital access to medication information risks excluding many patients, particularly those who are vulnerable due to age, lack of digital skills, or limited resources. The advancement of the digital healthcare system should not result in the exclusion of a significant part of the population; it is crucial to prioritize the safety and health of all patients.


Patient’s right to printed leaflet
Article 63.3 proposes that patients can request free printed copies of digital-only package leaflets. However, this idea lacks practical implementation solutions. Pharmacies cannot meet the rigorous printing standards and security requirements for medical leaflets, unlike industrial-level processes in the pharmaceutical industry.


Printed and digital leaflets are not mutually exclusive
Intergraf underscores the importance of complementarity between electronic product information (ePI) and paper leaflets. ePI enhances access to medication information for some demographics but cannot replace paper leaflets accompanying medicines. The exclusive use of ePI should only be considered in exceptional circumstances, such as when medicines are administered by medical professionals, like in-hospital patients.


In light of these concerns, Intergraf calls for the mandatory retention of paper leaflets in the packaging of medicinal products.


Intergraf’s position paper on the proposal is available here. Download this press release in pdf here.


Intergraf is a supporter of MLPS – Medical Leaflet = Product Safety, which regroups specialist and regulated healthcare packaging producers.

* All content is copyrighted by Industry Intelligence, or the original respective author or source. You may not recirculate, redistrubte or publish the analysis and presentation included in the service without Industry Intelligence's prior written consent. Please review our terms of use.

See our dashboard in action - schedule an demo
Chelsey Quick
Chelsey Quick
- VP Client Success -

We offer built-to-order government & public policy coverage for our clients. Contact us for a free consultation.

About Us

We deliver market news & information relevant to your business.

We monitor all your market drivers.

We aggregate, curate, filter and map your specific needs.

We deliver the right information to the right person at the right time.

Our Contacts

1990 S Bundy Dr. Suite #380,
Los Angeles, CA 90025

+1 (310) 553 0008

About Cookies On This Site

We collect data, including through use of cookies and similar technology ("cookies") that enchance the online experience. By clicking "I agree", you agree to our cookies, agree to bound by our Terms of Use, and acknowledge our Privacy Policy. For more information on our data practices and how to exercise your privacy rights, please see our Privacy Policy.