Paving the way for the digitalisation of healthcare

Due to the economic situation and, more recently, the COVID-19 crisis, developing Europe’s capabilities in the digital space has become even more necessary and urgent. The COVID-19 pandemic has led many governments to rethink the role of innovation and digital technology for health and wellbeing. It has also led to an accelerated shift in how companies have approached digital adoption strategies in response to increased people’s needs.

Harnessing the potential of new technologies in the field of self-care will facilitate the transition to more efficient and preventive healthcare systems and improve access to care while leading to an overall reduction in costs. To do this, Europe must ensure an appropriate and proportionate regulatory framework fostering the trust and security of European citizens so that they can safely benefit from the advantages brought by digital transformation and new technologies.

Data, Real-World Data and Real-World Evidence

The last decade has not only seen an explosion in the amount of data captured, shared and stored, but has also witnessed a change in the way data is processed. However, when it comes to self-care and healthcare, the permitted use of data for research, improving tools or assessing personal needs is rather limited.

While welcoming and strongly supporting initiatives already launched by regulators (e.g., General Data Protection Regulation – GDPR, European Data Strategy, European Health Data Space, etc.), the self-care industry is calling for more concrete authorized applications and data infrastructures for self-care developed and managed in the EU to unlock the potential of data.

In particular, data obtained from the real-world use of medicines and health products can be useful to regulators. In a pioneering article, AESGP experts shed light on the importance of existing and potential applications of real-world data (RWD) and real-world evidence (RWE) for non-prescription medicines and how they can help in regulatory decision-making throughout the lifecycle of self-care medicines.

In addition, AESGP’s position on the European Health Data Space initiative highlights the need to accompany improved data sharing with the necessary (digital) literacy programs. 

Product and Disease Information

Having good information about products and diseases is essential to properly manage our health. Medicines authorized in the EU come with a package leaflet which provides the information needed for the safe and effective use of the medicine. 

However, the content of these leaflets currently has several shortcomings: language that is hard to understand; a design and layout that lacks readability and is not always user-friendly; too much emphasis on risks versus benefits of the medicinal product. People with low literacy are particularly disadvantaged, but generally these issues apply to all patient groups. 

With the review of pharmaceutical legislation and health literacy becoming a priority, this is an opportunity to broaden the debate on how to make the package leaflet more fit for purpose.

Electronic product information (ePI), or e-leaflet, has the potential to address some of the limitations posed by the paper version. ePI can be more dynamic in presentation format with searchable menus, language change and links. It can integrate media tools to help accessibility and visual recommendations of use. It also presents the advantage of being able to have automatic updates. However, in the case of non-prescription medicines, as there may not be any interaction with a healthcare professional that can advise, a paper version of the product information should always remain available with the medicine if needed. 

The development and public use of electronic product information (ePI), self-assessment and self-monitoring applications will help people easily access reliable sources of information and provide a solid foundation for more resilient healthcare systems.

E-Commerce

E-commerce of self-care products is allowed in the EU and there is a harmonized approach to the registration of online pharmacies (e-pharmacies). However, national governments take different approaches as to product classification, which classes of products are allowed to be sold online, which entities can sell the different classes of products, as well as the requirement for online pharmacies to have a physical presence or not.

The main reasons people buy self-care products online are affordability and convenience. For obvious reasons, the COVID-19 pandemic has increased the popularity of e-commerce, including when it comes to buying self-care products. It is important to ensure that adequate resources are allocated and that the right framework is in place so that people who choose to buy their self-care products online can do so safely.