Reimagining ePI for the benefit of all

Shimon Yoshida

Data digitization, regulatory evolution and social change have converged to create the perfect environment to reimagine medicines product information to improve health equity and inform decision-making. Each of us has the chance to be involved in the development of patient-centric, trusted medicines information to improve human health at this pivotal moment.


Information regarding prescribed medicines is traditionally contained in the paper leaflet inserted into packs or accessed electronically. This ‘product information’ is approved by regulators and updated as information on the product changes with the intent of providing a critical source of scientifically validated information to assist healthcare professionals in prescribing and dispensing the medicine, and to inform patients and consumers about its safe use. Despite some format variations between countries, the general scope of product information is standard and has varied little since its introduction over 60 years ago.

More recently, there has been a paradigm shift in how product information is viewed by regulators, industry, patients and healthcare organizations. Product information is increasingly recognized as a broader resource with the potential to educate, engage and empower patients along their health and care journey. The reimagining of product information has been a story of convergence, with digitization, regulatory requirements and changing societal attitudes combining to create a unique opportunity for positive change.

Drivers of the evolution in product information
Data digitization: a drive for interoperability of digital information using common data standards that enable disparate systems to exchange, interoperate and surface tailored information for users
Confidence and confidentiality: debates about trust and data privacy, catalyzed by the enabling potential of digitization to bring new information into the public domain
Patient centricity: greater consideration of patient preferences and a shift towards greater patient engagement in shared decision-making
User centricity and digital enablement: divergence in consumer needs among the digitally literate and those who prefer more traditional methods of communication and information access
Transparency: increasing demands for access to the evidence underlying regulatory approvals as well as improved access to accurate and unbiased information that users can trust to inform decision-making
Environment: opportunity to reduce the environmental impact of production information and medicines packaging through the digitization of information

The foundations of ePI

The foundations for the transformation of product information were set many years ago when the USA and Japan established technical requirements for the ‘structuring’ of product information according to defined rules. In the USA, this was known as Structured Product Labeling (SPL) introduced in 2005, and in Japan the Pharmaceuticals and Medicines Agency introduced a custom generalized mark-up language (SGML) standard in 2014. These initiatives were a game-changer because they allowed product information to be reimagined as data rather than as text. Yet the potential of this rich data resource lay relatively untapped until later developments in Europe.

In 2020, the European Medicines Agency released new principles for what has become known as electronic product information (ePI). ePI mandated adherence to the Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) data standard. At a stroke, this change constructed a bridge between medicines and healthcare, not only structuring text into data but also enabling interoperability of that data with European Union healthcare systems. At a technical level, it also became possible to personalize product information according to users’ needs, interoperate with e-prescriptions, electronic health records and health education materials through single digital interfaces, and to tailor the user experience to meet a wide range of health literacy needs.

The changing regulatory environment has prompted national health authorities to assess the emergent opportunities of ePI. Product information is already moving online at pace; in some countries (e.g. Japan), paper-based product information has almost entirely disappeared. Importantly, as the shift to digital continues, there is now also consideration of how best to integrate the common HL7 FHIR data standard within digital ePI replacements. It is conceivable that we will see this standard being adopted internationally within the next 5 years.

The importance of transparency

One critical characteristic of product information is that it is provided to all patients on receipt of their prescription. This channel of communication is enshrined in most countries worldwide, and while there are local nuances, the concept is universally understood to be of high value. In summary, it is an established communication route that could be built upon for other meaningful purposes.

With such thinking in mind, Christopher Rains (a founding member of Open Pharma and then Vice President of Global Medical Affairs at Takeda ) suggested ePI as a potential vehicle to share plain language summaries and other iterations and published versions of the clinical trials that underpinned the product approval. As Christopher noted: “The move to ePI provides a great opportunity for transparency and clarity – [ePI is] received by every patient, is available to every prescriber and could link directly to an easily understandable version of the underlying evidence.”

At the time, patient interest was beginning to drive the creation of plain language summaries of clinical trial data, and patient demands for transparent access to trial evidence were leading to increased use of open access publishing by the pharma industry. Yet the challenge remains that patients need to know where to find these clinical trial summaries, plain language summaries and literature articles with no reliable structure to connect them to the right information from trusted information sources.

The concept of using ePI as a platform to link to plain language summaries has since been championed by Open Pharma members at events such as the Drug Industry Association e-Labelling Conference and International Society for Medical Publication Professionals (ISMPP) Annual Meeting. One such activity was an expert panel discussion titled Towards patient-friendly ePI, which took place at the 20th Annual Meeting of ISMPP.  An audience poll taken during the session indicated that 85% of attendees thought it was important/very important to link ePI to the underlying medical evidence, and 76% of the attendees believed that publication professionals have an important part to play in shaping the future of ePI.

The time has come to take the next steps. In the words of Chris Winchester (Chief Executive Officer of Oxford PharmaGenesis and Chair of the ISMPP panel debate): “Regulators have signaled their desire to improve the value added by ePI. We have a unique opportunity to improve the discoverability of medical evidence by linking from the ePI, with the potential to improve transparency and trust.”

Writing the next chapter

The transformation of product information, the drive towards transparency and the potential to link the two represent a pivotal moment to put patients at the center of trusted medicines information.

Capitalizing on this growing momentum, I am thrilled to announce the launch of a formal working group that will help move the community towards operationalizing the concepts described in this blog.

We will develop a pilot in full consultation with health authorities, the pharma industry, patient groups and healthcare organizations. The aims of the working group will be to:

  • establish a viable process through which ePI can link to relevant articles
  • survey the use, access and understanding of those materials by patients
  • survey the views of all stakeholders.

It is an exciting time for everyone involved in this work. If you care about the principles of patient-centricity, transparency, equity and trust, we urge you to join us in this endeavor to realize a future in which patients are empowered with accessible, reliable information on their medicines.

Formal calls for participation will be issued shortly, but if you are interested in getting involved, please click on the following link and send your expression of interest to the team at Open Pharma.

Shimon Yoshida is Executive Director, Head of Pfizer’s International Labeling Group.