Transitioning to ePI and how AI is Transforming PIL Creation

The way we communicate and consume information about medicines is on the brink of a significant evolution. The traditional paper leaflet is being reimagined as Electronic Product Information (ePI), a digital-native format for the officially approved documents that accompany a medicine, i.e. the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and labelling. Created using the EU ePI Common Standard based on Fast Healthcare Interoperability Resources (FHIR), this innovation will enable up-to-date critical medicinal information to be disseminated seamlessly across websites, mobile applications, and integrated directly into electronic health systems.

Running parallel to this digital shift is the rise of AI Labelling, which refers to the use of artificial intelligence tools to generate or assist in creating PILs. While AI promises to automate and accelerate content creation, its application in this highly regulated space must be carefully managed to ensure accuracy, empathy, and unwavering compliance with regulatory standards. This article will explore the dual landscape of ePI and AI, examining the immense benefits they offer for enhancing patient safety and health literacy, while also navigating the complex challenges that lie ahead.

The Rise of Electronic Product Information (ePI)

What Is ePI and Why It Matters

The ePI initiative was launched to support the digital transformation of healthcare across the European Union, reflecting a core commitment from the European Commission to prioritise innovation that empowers people and builds a healthier society. This aligns perfectly with the European Medicines Agency’s (EMA) ongoing digitalisation efforts, which aim to make the best use of available resources and prepare the healthcare ecosystem for future challenges. From its inception, ePI has been designed with patients and healthcare professionals in mind, and these end-users have been actively involved throughout its development.

Stakeholder Engagement and Patient Information Improvements

Stakeholders have been invited to participate in workshops and consultations, and have been presented with the ePI prototype and the results of the pilot phase, ensuring the final system is both functional and user-centric.

As part of its broader action plan to improve product information, the EMA began an assessment of the quality review of documents (QRD) template in September 2023. In collaboration with patients, healthcare professionals, and industry specialists, this assessment seeks to enhance the readability of the PIL and improve the information patients receive.

Preparing for Implementation and Legislation

With the framework for ePI solidifying, now is the time for pharmaceutical companies to strategise their approach to implementation as soon as the Product Lifecycle Management (PLM) portal goes live with ePI functionality.

Looking ahead, the ePI initiative is included in the current proposal for new EU pharmaceutical legislation. If adopted, this will establish a legal basis for its implementation across Europe, ensuring that the full public health benefits of ePI reach all patients and healthcare professionals. Globally, the picture is more varied. While the direction of travel is clearly towards digital, countries are at different stages of transition. Some are aiming to completely replace paper with electronic versions, while others view ePI as a complementary tool. This divergence requires companies to maintain a flexible and informed regulatory strategy.

Timelines and How Companies Can Create ePI

The overall EU pharmaceutical legislation is not expected to be fully adopted before 2026. Industry associations have proposed that ePI will be fully operational within four years after the new legislation takes effect, where centrally authorised products will be required to submit their ePI first. Furthermore, the Product Lifecycle Management (PLM) system will apply exclusively to centrally authorised products, while national authorities will need to develop their own PLM solutions for nationally authorised products.

Companies with centrally authorised products will be able to create ePI directly using the editor in the PLM portal, import ePI FHIR files from their own systems, or partner with a specialised vendor. All necessary resources, including the ePI implementation and style guides, will be available on the PLM portal to ensure a compliant and effective transition.

The Advantages and Hurdles of ePI

The transition to ePI promises a wealth of benefits, but it is not without its challenges.

Pros of ePI:

• Accessibility and Inclusion: ePI provides immediate access to the most up-to-date, regulator-approved product information. Its digital format is inherently adaptable, supporting multilingual content, screen-reader compatibility, and adjustable fonts to cater to diverse abilities. An attractive and user-friendly interface with searchability can motivate patients to take a more active interest in their health.
• Enhanced Health Literacy: By enabling the use of videos, searchable text, and simplified language, ePI can significantly improve patient comprehension and engagement with their health.
• Environmental Sustainability: Shifting from paper to digital could reduce the carbon footprint of the pharmaceutical industry by an estimated 500,000 tonnes of CO₂ annually, saving an average of 500,000 trees and 1.6 billion litres of water each year.
• Operational Efficiency: Digital systems allow for instant alerts for major updates, faster regulatory review timelines, and more streamlined supply chains. Modernising how information is authored and submitted enhances industry-regulator collaboration.
• Seamless Integration: ePI is designed to be compatible with Electronic Health Records (EHRs), e-prescriptions, and other clinical decision support systems, creating a more connected healthcare environment.
• Portability: Digital information is accessible across borders, a critical advantage during emergencies, as demonstrated by its potential utility for displaced populations like Ukrainian refugees.

Cons of ePI:

• The Digital Divide: A significant risk is the potential exclusion of individuals who lack reliable internet access or the digital literacy required to navigate electronic formats.
• Implementation Complexity: The transition requires substantial investment in infrastructure, comprehensive training for healthcare professionals, and coordinated efforts among all stakeholders.
• Regulatory Alignment: The pace of adoption varies globally. While the EU is moving forward, some countries will still mandate paper formats, creating a complex compliance landscape for multinational companies.

Equity and Accessibility in the Digital Age

A successful transition to ePI must be inclusive. This requires actively addressing the digital divide for people with disabilities, low health literacy, or limited internet connectivity. Applying Universal Design principles such as ensuring screen reader compatibility and considering audio descriptions is crucial. Furthermore, co-creating ePI with patients improves relevance and builds trust, while local initiatives through libraries and pharmacies can support community-level access and training.

AI and the PIL: A Double-Edged Sword

As digital transformation reshapes healthcare, Artificial Intelligence (AI) has emerged as a powerful tool for streamlining processes and generating content. One of its most promising applications is in creating PILs.

AI presents considerable opportunities for improving healthcare communication, particularly by streamlining the creation of PILs through rapid content generation and scalability. Using well-designed prompts, AI can deliver structured, fact-based drafts efficiently, making it an appealing solution for pharmaceutical companies and regulatory bodies aiming to enhance efficiency. However, these advantages are offset by notable challenges, such as limited understanding and potential compliance risks. AI-generated materials often lack empathy, cultural nuance, and may introduce bias or inaccuracies due to reliance on underlying data. Therefore, robust human oversight remains critical to guarantee accuracy and adherence to regulatory standards.

The Promise of AI in Healthcare Communication

AI-driven tools can generate draft PILs rapidly, offering:

• Speed and Scalability: Quick turnaround for large volumes of content.
• Content Coverage: Ability to match factual information with targeted prompts.

These advantages make AI an attractive solution for pharmaceutical companies and regulatory teams seeking operational efficiency. However, the benefits come with caveats that demand rigorous oversight.

Key Limitations of AI in PIL Development

Despite its capabilities, AI faces critical limitations when applied to patient-facing content:

• Lack of Contextual Awareness: AI often produces generic content that fails to address medical conditions or patient-specific needs.
• Health Literacy Challenges: Balancing clarity and accuracy is essential. AI-generated text can be overly technical or too simplistic, hindering comprehension.
• Regulatory and Ethical Compliance: PILs must adhere to strict standards for readability, formatting, and legal disclaimers. AI tools may not consistently meet these requirements, posing compliance risks.
• Absence of Empathy: Effective communication requires emotional intelligence, acknowledging patient fears and sensitivities. AI lacks this human touch, especially in areas like oncology or mental health.
• Cultural and Linguistic Sensitivity: Global healthcare demands content that resonates across cultures and languages. AI often struggles to adapt to regional norms, risking miscommunication.
• Human-Centric Quality Assurance: Errors in medical content can have serious consequences. Human oversight remains indispensable to validate accuracy and safety.
• Data Dependency and Bias: AI relies on training data, which may be incomplete or biased. Without careful curation, misinformation or omissions can occur.

The Collaborative Solution: Human Expertise Meets AI Efficiency

To harness AI’s potential while mitigating its risks, a hybrid approach is essential. AI can be a powerful assistant, automating routine tasks and generating initial drafts. However, human experts must remain at the helm to ensure the final content is accurate, empathetic, culturally appropriate, and fully compliant with regulatory standards. This collaborative model ensures that PILs not only inform but also empower patients and build trust. Human validation is non-negotiable to ensure the accuracy and safety of all medical information.

Navigating the Digital Future with Confidence

The shift towards ePI and the integration of AI in labelling represent a fundamental change in how we approach medicinal communication. ePI is a transformative innovation that enhances patient safety, improves health literacy, and promotes environmental sustainability. Simultaneously, AI offers powerful tools to drive efficiency, but its role must be carefully managed. By combining AI-driven speed with human-centric judgment and empathy, we can create patient information that fosters trust and supports better health outcomes.

As regulatory bodies align to support these digital-first solutions, the onus is on pharmaceutical companies to prepare. Proactive engagement, investment in IT infrastructure, and a focus on patient co-creation will be key to a successful transition. The future of medicinal communication lies in an enhanced, integrated, and inclusive ePI, deeply embedded within the digital health ecosystem.

At DLRC, we are experts in navigating the evolving regulatory landscape. Our team can provide the strategic guidance and operational support needed to integrate ePI and AI into your PIL development processes effectively and compliantly. Whether you are developing your ePI submission strategy or seeking to leverage AI safely, we can help you stay ahead of the curve. Contact us today at hello@dlrcgroup.com to learn how we can support your transition to the future of digital health.