One of the key principles finalized and published in the January 2020 report from published by EMA, HMA and The European Commission titled: "Electronic product information for human medicines in the EU: key principles" is that the implementation of an ePI must improve Accessibility to users with diverse abilities.
In this particular application this refers not only to people who do not have access to internet, smart devices or advanced technologies but also to all those users who, despite having access to the latest and greatest, cannot take full advantage of the innovations that these technologies try to implement.
Statement (definition of digital divide)
ePI will facilitate creation of PI that is accessible to everyone, including users with print impairments, including physical impairments or learning difficulties, or for whom printed PI is difficult to access for other reasons. The ePI allows the use of large fonts or high screen contrast for partially sighted users and audible formats for blind users and those with low literacy levels. ePI on the web will be accessible to screen readers, web and mobile applications, convertible to large font and amenable to other accessible formats. Accessible formats will provide the full and balanced product information to users in formats suitable for their needs.
Rationale
Current PDF and print copy formats of PI do not well serve all citizens equally, given the wide range of abilities throughout society. In contrast with PDF and print copy formats of the PI, the availability of ePI will allow third-parties, such as companies, not-for-profit organisations or patient/consumer groups, to convert the PI into accessible formats. ePI will make it easier to add authorised or supportive video or audio content or other interactive materials (in line with the appropriate guidance) to the PI. Accessible formats refer to format only, and will include the entire PI without any change to the content.
Implication
ePI will be ‘accessible by design.’ This means that accessibility to users with diverse abilities will be taken into account from the beginning and throughout the ePI initiative. Accessible ePI will have to comply with Directive (EU) 2016/2102 on the accessibility of the websites and mobile applications of public sector bodies.
How the eLeaflet solution helps fill the "Digital Divide" gap
The eLeaflet solution from myHealthbox already implements most of the features that are part of the EMA, HMA, EC key principles document:
- support for audio leaflets
- support for large text (customizable)
- support for multi-lingual leaflets
- support for multiple access points: qr code, url on packaging, search engine platform, partner solutions
More information about the eLeaflet solution from myHealthbox is available on the eLeaflet website