Friday, December 8, 2023

First e-information for EU-approved drugs: Beware of digital divides, Dutch say

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The Netherlands is taking part in a pilot project for the online publication of drug information, together with three other EU countries. Coordinated by the European Medicines Agency (EMA), the programme has just released the electronic product information (ePI) for the first seven medicines out of 25.

While such advances – making product information available online – can be game changers, authorities are already being mindful of digital divides that may emerge as the project makes progress.

The product information of a medicine includes a summary of the product’s characteristics, labelling information, and a package leaflet. These documents accompany every medicine authorised in the EU and explain how it should be prescribed and used.

In a statement, the EMA said that Denmark, Spain, and Sweden are also participating in the pilot project, established in 2022 and set to conclude in July 2024.

The published ePIs are for medicines evaluated by the EMA or the national authorities of these four EU states. The outcomes will help medicines agencies decide how to integrate the ePIs into common practice and expand their use across the EU.

The ePIs can be viewed on an EMA portal either in English for centrally approved medicines or in local languages for those approved by national bodies.

This digital platform aims to share information electronically, keep it constantly updated, and make it more accessible to end users such as healthcare professionals and patients.

In the future, the portal could include automatic notifications and videos explaining how a drug should be taken, according to the EMA.

Complementing not substituting

Dony Potasse, a spokesperson for the Dutch Medicines Evaluation Board (MEB), told Euractiv that in addition to ePI, providing the paper package leaflet is particularly important for patients and consumers with low digital literacy or limited internet access.

In the future, ePIs for centrally authorised medicines will be available in all EU languages, Potasse said.

Earlier this year, Luxembourgish Green MEP Tilly Metz said digital leaflets should complement rather than substitute printed medicinal information. Her comments were made in light of the European Commission’s proposed pharmaceutical strategy that left this decision up to countries.

“ePI will be implemented in line with the legislation in force. ePI will not supersede or negate the requirement of the pharmaceutical legislation,” Potasse said, referring to articles 58, 59, and 62 of Directive 2001/83/EC.

The EMA, headquartered in Amsterdam, is hosting quarterly demo events to update the pilot’s progress and answer questions it receives.

“The pilot itself is expected to identify the main challenges and areas for improvement with ePI, as well as the mitigating actions that can be put in place as a result,” a spokesperson for the EMA told Euractiv.

Asked how the pilot project’s participants were selected, the spokesperson said that experts from the national competent authorities of Sweden, the Netherlands, and Denmark had already been involved in ePI development in their own countries.

“And the project is managed by product owners from EMA and the [Spanish Agency for Medicines and Health Products]. For this reason, these countries are also involved in the pilot,” the spokesperson explained.

Integrating ePIs with AI opens a world of possibilities

While negotiations on the EU’s AI act hit some hurdles, with EU Parliament representatives walking out of a technical meeting on foundation models, the rest of the world is continuing to experience advancements in this area of technology.

In the future, ePIs could also get an AI boost.

“Availability of the product information data in an electronic format will undoubtedly open up opportunities for dissemination, accessibility, administrative efficiencies and research, and will enable the European Medicines Regulatory Network to explore the use of emerging technologies such as AI using a risk-based approach,” Potasse told Euractiv.

Yeelen Knegtering, CEO of the Dutch software provider Klippa, which specialises in meaningful AI-powered automation, said digitising medication inserts could serve as a foundation for a wide range of AI applications which would make product information instantly accessible.

“Think about interacting with the inserts via chatbot prompts or even via speech. Patients and healthcare professionals alike could simply ask questions about possible side effects, allergies, when and how to take the medicine, have complicated terms explained, and request the information in their own languages,” Knegtering told Euractiv.

He also saw the potential for AI to assist people with visual impairments.

“All in all, we’re living in a time of huge improvements for patient education and the safe use of medication,” he said.

Knegtering suggested that inserts should be digitally stored in structured data formats (e.g. XML or CSV). Ensuring that the digital text is formatted for machine readability would allow chatbots and other AI models to interpret the information efficiently, he said.

Consultants from Klippa’s AI consultancy branch, DataNorth, told Euractiv that potential integrations of AI with ePIs could include stock prediction based on seasonal changes, personalised dosage reminders, and automatic warnings about potential adverse reactions when a patient has certain allergies.

The ePI initiative is an action under the Pharmaceutical Strategy for Europe supported by the EU funding programme EU4Health.


[By Christoph Schwaiger – Edited by Vasiliki Angouridi/Zoran Radosavljevic |]

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