Masterarbeit
Regulatory Analysis: Quality of Patient Information – current EU status. What we can learn from Non-EU countries and other product classes.
Petra Gossen (2025)
Language: English
The patient information is an important element for a safe and effective use of medicinal products. Inadequate information may result in medication errors. Over the past few decades, due to growing regulations, patient information has become increasingly complex and less patient-friendly. The EMA action plan was launched to improve the readability of patient information. This thesis analyses what can be learned from Non-EU countries (the USA, Australia, Japan) and other EU product classes (medical devices and cosmetic products) to improve the patient information for a better understanding. Focus of the analysis is the outer labelling and the patient leaflet.
Recently, the EMA has issued the proposal of a patient-friendly QRD template and strengthened the ePI introduction which enables access to PL via QR code. Both innovations support flexibility and better readability. The EU is thus following Non-EU countries that have already implemented these innovations. An upcoming new Directive repealing Directive 2001/83/EC on medicinal products is expected. It will further specify how to handle the ePI introduction in future. The current plan is to leave it up to the countries to decide whether to market a PL in paper or electronic form, or both. However, a harmonized approach without country-specific solutions would be more beneficial for patients.
To further improve the patient information EMA envisaged the key information section as an introductory part of the package leaflet. This section, which contains main safety messages and benefit risk information, is still under debate and not subject of the upcoming new Directive. At this point in time, it is not yet possible to say what such a section within the EU would look like or when it would be established. But it would be the right moment to reconsider other options even going one step further like the CHI Australian approach or the Drug Fact box in USA. Both models show us that patients would also benefit from a key EU information section in the outer labelling, which is quicker recognisable. User tests are needed to further evaluate these scenarios for European patients who are not yet accustomed to such a labelling form.
It would be furthermore beneficial to commit to more legal harmonization in the EU to minimize national peculiarities in the outer labelling and patient leaflet. A ‘Regulation’ like for medical devices and cosmetic products replacing the ‘Directive’ should be discussed. This is also an opportunity to promote the use of stand-alone symbols. Symbols can source from ISO Norms how it is done for medical devices or can be exclusively defined for medicinal products within their legal framework analogue to cosmetic products. Symbols are universal, ease navigation and help to reduce text. That all supports readability.
EMA has taken necessary action to improve the PI and is making progress in implementing the planned measures. However, it can be learned even more from other product categories and Non-EU countries and benefit from their experiences. Further innovative ways will help to improve healthcare information for a safe use of medicinal products.
Pages: 52
Annexes: 17, Pages: 69