Technology
What is Preventing the Industry from Providing Electronic Product Information? Abstract In 2017, the European Commission published a report regarding the possible improvements for product information texts used for human medicinal products. The improvements aim to facilitate safe and effective use of medicinal products and, as a result of the report, the European Medicines Agency (EMA) and the national heads of medicines agencies (HMA) agreed on a project to implement structured electronic ePI. Several national electronic patient information (ePI) projects have already demonstrated the potential of a triple-win situation: •
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Patients: Effective provisioning of information to patients, elevating their “user experience” and improving the overall compliance; Industry: Optimising internal processes and improved compliance for managing documents containing patient information; Agency: Facilitating improved work processes between industry and agencies, streamlining the review process and improving analytics capabilities.
It is the intent of the ePI project to harmonise the national initiatives to achieve a common solution related to the identification medicinal product (IDMP) master data, including the controlled vocabularies provided by SPOR. This paper looks at what is preventing us from providing electronic product information as well as how industry can support the wider ePI project. Background In 2004, the requirement “the package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use” was added to Article 59, Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004. And in 2017, the long-awaited 46 INTERNATIONAL PHARMACEUTICAL INDUSTRY
report providing an overview of patient target group experiences was finally published. Before the 2017 report was published, two studies were published, each initiated by the European Commission: The first one was on the package leaflet (PL) and the summary of product characteristics of medicinal products (SmPC) for human use (so called PIL-S study)1. The second report gave more insight into feasibility and value of a possible “key information section” in PLs and SmPCs for human use (PILs-BOX study)2. The general result concluded that readability (comprehension and layout) still needs to be improved for PLs rather than for SmPCs. It was recommended to consider revising the existing guidelines (e.g. readability, content and layout-related issues), to allow more flexibility among different medicines in the QRD template (in the framework of the existing legislation) and to introduce guidance on translations. In parallel, the input from patients should be improved and a more iterative assessment process may be introduced without delaying the authorisation process. The final report from the Commission on the SmPC and PL for medicinal products for human use was adopted by the European Parliament and the Council on March 22, 2017 3. It concluded that the use of electronic formats brings new opportunities for these documents and recommended exploring the use of electronic media to provide information included in these documents to the patient in the future. However, the report does not recommend the removal of the paper leaflet from the box, which some may consider unfortunate, as removing the need for the paper leaflet could bring benefits to the patient. Continuing to provide paper in the box and give the patient the option to view the ePI could cause confusion if the electronic version differs (because it reflects recent updates) from the paper. Removing the need for a paper leaflet in the box and having the electronic version as the legal requirement would take away this potential confusion and ensure patients always have access to the most recent version. Action Plan EMA took the leadership in generating an
action plan on how to achieve the abovementioned objectives4. The starting point was a publicly broadcasted workshop that took place on November 28, 2018, in London at EMA. Representatives of all national competent authorities (NCA), EMA including European Commission, several pharmaceutical industry associations, patients and consumers’ organisations, healthcare professionals’ organisations and academia, health technology assessment bodies (HTAs) and payers took part in the information exchange. EMA presented an outline of potential future use cases and international standards to be employed in the event of an electronic PL being generated5. Representatives from several Member States as well as from pharmaceutical industry projects on electronic developments presented and ran a live demonstration on what an ePI could look like and what the advantages would be. Up to now, a broad range of similar, deviating proposals and developments are underway in many NCAs6. However, for European purposes a harmonised and standardised approach is essential as marketing authorisation holders and regulatory agencies will not be able to assess each electronic publication on a national or company specific solution. In addition, the publication process needs to be automated based on the authorisation issued by the competent authority. In addition to several technical requirements, the features of an application presenting an electronic product information need to be evaluated against patients’ requirements, whether they can and will use them and whether this approach supports the required improvement of comprehension and better readability of PLs7,8 and thereby the better use of medicines by patients and consumers. Whatever improvement of the design and layout of paper PL has been achieved, the flexibility due to the legal framework remains restricted. The access to an electronic version could offer many more benefits to the patient, including: • Improved searching of product information with the potential for tailoring it for personal use of patient, or advanced analytics from regulators; Winter 2020 Volume 12 Issue 4
