Can ePI be delivered and implemented in the EU in the near term?

Can ePI be delivered and implemented in the EU in the near term? This is a question that must be addressed with the utmost vigour.

What is the definition of Product Information (PI) and which documents does it include?

Product information (PI) is defined as documents providing officially approved information for healthcare professionals and patients on a medicine. They consist of the following:

  • The summary of product characteristics (SmPC)
  • package leaflet (PL)
  • labelling
What is ePI?

Electronic Product Information (ePI) is authorised, statutory product information for medicines (i.e. SmPC, PL and labelling) in a semi-structured format created using the common EU electronic standard. ePI is adapted for electronic handling and allows dissemination via the
world wide web, e-platforms and print.

About the electronic Product Information (ePI) Initiative

The ePI initiative was launched to support the digital transformation of healthcare across the EU, and the commitment laid out by the European Commission to prioritise innovations that will empower citizens and build a healthier society. It is also in line with the Euroopean Medicine Agency’s (EMA’s) current digitalisation efforts aiming to make best use of available resources and prepare for future challenges. 

What do the key principles of the ePI initiative outline?

The European Medicines Agency, in collaboration with Heads of Medicines Agencies (HMA) and the European Commission, has developed key principles through stakeholder consultations to guide the development and use of ePI in the EU. 

They outline how ePI will:

  • benefit public health
  • create efficiency gains for regulatory systems
  • align with the existing legislative framework and complement the paper package leaflet;
  • fit into the EU’s multilingual environment
  • interact with other ongoing digital initiatives at EU and global level.
What are some examples of benefits and functionality that ePI could bring?
  • Immediate access to the most recently regulator-approved product information.
  • Attractive, presentable and user-friendly interface with other potential supportive features (e.g. user font modification) would motivate patients to take a more active interest in their health status.
  • Availability of additional materials to the statutory information: video and audio facilities accessible to support and improve health literacy and safe use of the product.
  • Alerts for major updates to the leaflet.
How is it envisaged that ePI will be made available to users?

It is envisaged that ePI will be made available:

  • to users (e.g. patients/consumers and HCPs) through websites at EMA level and if available, Member State level.
  • for use:
    • in other e-health systems, such as electronic health records and e-prescribing systems.
    • by third-parties who can reproduce ePI and make it available to patients and HCPs (as is already the case for PI today).
Will ePI supersede or negate the requirement to include a package leaflet in all medicine packs?

No, ePI will not supersede or negate the requirement of the pharmaceutical legislation (Article 58 of Directive 2001/83/EC) to include a PL in the packaging of all medicines or directly convey all information required (by Articles 59 and 62 of the Directive) on the outer or immediate packaging.

Since the current legislation does not require the use of an electronic version of PI, the use of ePI will not constitute a new legal obligation.

Some points to contemplate about ePI

ePI is not intended to supersede or negate the requirement to include a package leaflet in the packaging of all medicines. Should the EU not be much bolder in its ambition to deliver ePI? Arguably, to obtain the he maximum benefit of ePI, it should replace paper based package leaflets (at a predetermined date) rather than complementing it. This would go a long way towards moving away from the millions of paper based packaged leaflets that are added to medicines packs across the globe on a daily basis. This should help to improve the environmental footprint of the pharmaceutical industry. It would also help to free up resources that are tied up in the printing, updating, storing,transporting and destruction of unwanted or outdated leaflets . Resources thus saved could be much better employed elsewhere by pharma companies in the fight against diseases and illnesses.

To progress the ePI project rapidly to delivery, it must be given top priority and the requisite funding. There must be solid planning put in place and a very ambitious timeline published, detailing delivery in the near term. Once delivered, implementation must be done simultaneously in all member states. Doing this in any other way means that the project will move at a snails pace and be delivered piecemeal and over a prolonged period time. Also, if implementation is left to be decided at a national level, then it will likely take even longer.

Th ePI project could be a game changer for the delivery of healthcare in the EU, but only if it is delivered in the near term (3-5 yrs), not in ten years time. The EU must ensure that this project is not allowed to languish e.g. like the Clinical Trials regulation which has yet to become applicable, nearly 7 years after it came into force!

Timeline of the progress so far

Below is a timeline of the progress thus far. Links are provided to various reports and other documents. You can also view the timeline in this presentation.

March 22, 2017

2017 – EC report

This European Commission report together with the EMA action plan (see below) identified areas where medicines’ product information (PI), which includes the summary of product characteristics (SmPC) and package leaflet (PL), could be improved to better meet the needs of patients and healthcare professionals (HCPs) and proposed actions to address these shortcomings.

These wide-ranging actions relate to enhancing readability, improving patient input in development and testing, promoting best practices and developing an electronic format.

March 22, 2017
November 14, 2017

2017 – EMA action plan

The EMA action plan together with the EC report (see above) identified areas where medicines’ product information (PI), which includes the summary of product characteristics (SmPC) and package leaflet (PL), could be improved to better meet the needs of patients and healthcare professionals (HCPs) and proposed actions to address these shortcomings.

These wide-ranging actions relate to enhancing readability, improving patient input in development and testing, promoting best practices and developing an electronic format.

November 14, 2017
November 28, 2018

2018 -Workshop

This workshop (Nov 2018) brought stakeholders together to discuss their needs and concerns and decide how to move forward with a common approach. The outcome of the workshop was a draft proposal for ‘key principles’, to form the basis of follow-up implementation plans for ePI.

November 28, 2018
January 31, 2019

2019 – Draft key principles

The draft key principles from 2018 were the subject of a 6-month public consultation (from 31 Jan – 31 July 2019). Following the consideration of submissions received during the public consultation, the key principles were updated.

January 31, 2019
January 29, 2020

2020 – Finalised key principles

The finalised key principles were published on the EMA website and communicated to stakeholders through meetings and dissemination channels.
They now represent EMA-HMA-EC guidance on ePI and form the basis of follow-up
implementation plans for ePI.

January 29, 2020
January 1, 2021

2021 – ePI set-up project started

In 2021, EMA, national competent authorities and the European Commission started an ePI set-up project.

It aims at developing a common electronic standard for ePI, carrying out a proof-of-concept exercise for implementing the standard and creating a roadmap for implementation across the EU.

January 1, 2021