lectronic labeling (eLabeling) generally refers to the distribution of the approved product information of medicinal products via electronic means. This in turn allows prompt communication of current safety information to patients and healthcare professionals (HCPs). If local regulations allow the removal of hardcopy leaflets (HCL), eLabeling can also reduce paper consumption.

Across the globe, numerous health authorities (HA) have implemented (e.g., Singapore, Egypt), or have initiated piloting of (e.g., Belgium, Taiwan), eLabeling. This adoption of eLabeling accelerated significantly during the COVID-19 pandemic, due to the urgent need for rapid communication of the latest labeling information to different stakeholders.

This article will present a global overview of initiatives where users are able to access the electronic Product Information (ePI) on their digital devices via a Uniform Resource Locator (URL), Data Matrix (DM) code, or Quick Response (QR) code printed on the outer carton (OC), leaflet, or other documents supplied with the commercial pack. Alongside the global overview, a global pharmaceutical company (hereinafter referred to as “the organization”) will share their insights on eLabeling for some markets which they have participated in.

Global Overview

The below overview of eLabeling initiatives worldwide organizes details into four key parameters similar to those mentioned in the survey by Matsui et al., 2022. The survey authors reported the eLabeling status of 12 markets in the Asian region and concluded that there are different levels of eLabeling initiatives in the region. They also agreed that close collaboration between the different stakeholders is important to ensure successful eLabeling implementation.

Table 1: General overview of various eLabeling initiatives worldwide. See above list of acronyms for full descriptions. (Note: The organization contributing this article participated in only some of these initiatives.)

†Gulf Health Council: A regional organization which establishes, develops, and unifies health strategies, policies, and systems for all Gulf Cooperation Council (GCC) countries.

Many HAs host all their approved ePIs on a single, trusted, centralized platform. This eliminates the need to refer to multiple websites to access ePIs.

QR codes appear to be the most widely adopted method by which HAs provide access to ePI. This could stem from its easy implementation (i.e., readable by phone camera without specialized software). End users are also likely accustomed to the use of QR codes due to increased usage during the pandemic. However, certain markets (e.g., Japan) are using GS1 barcodes due to legacy reasons and the high cost to transition to QR codes.

Several HAs still require including HCL in commercial packs; many others have made this condition voluntary or are planning to eventually remove it. These different conditions may be due to local requirements or local perceptions of the importance of HCL. In Singapore, HCL with prescription medications usually contain only prescribing information, so removing HCL seems appropriate for these products. However, if the commercial packs contain printed PIL, authorities may prefer to retain the HCL to accommodate patients who may not be familiar with, or do not have access to, digital technology.

Lastly, most HAs still do not require a standardized content structure like Health Level Seven Fast Healthcare Interoperability Resources (HL7 FHIR), which has great potential to add value to the current landscape as it facilitates the sharing of information and provides interoperability.

One Global Pharmaceutical Company’s Experience

Recognizing the benefits of eLabeling, one organization has been actively involved in numerous eLabeling initiatives worldwide. Its involvement in specific markets is further highlighted below.

Asia: Singapore

In 2019, the organization was one of the first to successfully implement eLabeling in Singapore. To avoid discrepancy between HCL and ePI during the transition period, the organization decided to remove the HCL from commercial packs and enabled healthcare professionals (HCPs) to scan the QR code on the OC to access the ePI. By the end of 2024, the organization had implemented eLabeling for all marketed prescription products in Singapore, reducing its paper consumption in Singapore, streamlining internal processes, and (crucially) expediting communication of the latest safety information to HCPs.

Europe: Belgium, Estonia, Germany, Latvia, Lithuania, Luxembourg, and Portugal

Due to strong interest in eLabeling, numerous pilots are currently ongoing in the European Union (EU) in which this organization has participated.

In a pilot started in Belgium and Luxembourg in 2018, the organization teamed with industry counterparts to demonstrate that removing PILs for HCP-administered products in a hospital environment led to no reported requests for printed PILs. Success of this pilot led to its extension until 2025 and to similar pilot initiations in Estonia, Latvia, Lithuania, and Portugal, in which the organization is also participating. The organization and its industry counterparts in Belgium continue to explore how to extend the ePI pilot out of the hospital environment while ensuring that the printed PILs are still readily available for patients who may require them.

In Germany, the organization is involved in the pilot launched by trade associations and other stakeholders such as patient organizations and pharmacists’ associations. This pilot started in 2016 and uses the existing GS1 barcode or 2D DM on the OC to link users to the electronic PIL via an additional application, preventing the possible confusion of having two codes on the OC.

The European Medicines Agency (EMA) is working together with pharmaceutical companies and other stakeholders to implement ePI in a harmonized manner across the EU. EMA is currently developing an EMA ePI platform with the aim of hosting the ePI for all approved medicinal products in the EU. The organization has participated in the user testing of this system.

North America: Canada

In 2020, the organization successfully implemented the removal of HCL for two products. Since 2022, the organization has been actively involved in industry working groups that have engaged with Health Canada (HC) on the opportunities and benefits of eLabeling. In April 2022, HC issued an interim notice outlining its expectations for eLabeling for human prescription drugs. Although HC cannot currently consider the removal of HCL as public policy, it acknowledges the importance of ensuring that their regulations adapt to the digital environment.

South America: Argentina

In 2020, the organization was one of the first companies to implement eLabeling for one product in Argentina by adding a QR code on the OC that linked users to the ePI. Since then, the organization has expanded eLabeling to additional products. One trade association formed an eLabeling taskforce led by the organization in 2021. The extensive research of this taskforce contributed to discussions with ANMAT, patient associations, and GS1. These findings resulted in a position paper which supported the development of technical and regulatory frameworks, and a draft formal regulation, for eLabeling, which is currently in development and planned to be in force by the end of 2024.

Conclusions

eLabeling is becoming increasingly common globally, as it can accelerate the communication of updated product information to HCPs and patients, while reducing paper consumption. Nonetheless, the diverse approaches to eLabeling observed among HAs may hinder adoption. These challenges are actively discussed in forums and conferences (such as DIA) to work towards developing a harmonized approach.

References are available upon request.

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