Digital Transition
AESGP pursued its advocacy efforts in key strategic areas according to the digital strategy released in 2021. As a reminder, these strategic areas are real-world data and evidence, artificial intelligence, product and disease information, the building of the digital workforce capacity, and eCommerce.
e-Commerce
In June 2023, AESGP released a position paper on E-Commerce in self-care. This paper describes the challenges and opportunities of online sales in the self-care space. It also proposes several recommendations to the key stakeholders involved. It concludes that synergies from online and brick and mortar retail should be forged to ensure the best quality of self-care for everyone.
Electronic Product Information (ePI)
- AESGP
In February 2023, AESGP commissioned IPSOS to run a consumer survey in six EU Member States as a first step towards building a better understanding of EU consumers’ perceptions and expectations with regard to product information for non-prescription medicines and their readiness to use digital formats.
Building up on the results of the study, AESGP ePI EG delivered a position paper paving the way on transitioning towards digital product information.
- AESGP and the Inter-Association Task Force for ePI
In addition to the work performed by its dedicated WG on ePI, AESGP also pursued its engagement through the Inter-Association Task Force for ePI . AESGP co-leads the two existing working groups and is a member of the steering group.
At steering group level, AESGP continued to work on the assessment of proposed changes to the general pharmaceutical legislation with regard to implementing ePI, and developed a set of proposals for desired changes. Throughout 2023, the steering group engaged on a number of topics with different stakeholders, such as the European Medicines Agency (EMA), European Community Pharmacists (PGEU), and the European Association of Hospital Pharmacists (EAHP).
Real World Data (RWD) — Real World Evidence (RWE)
The AESGP RWD/RWE working groups continued to explore the potential usage of RWD/RWE for non-prescription medicinal products.
A literature search was performed to identify if any new relevant publications had been made available after the release of AESGP scientific publication on “How can real-world evidence aid decision making during the life cycle of nonprescription medicines”. In parallel, AESGP was involved in the GSCF RWD/RWE that is developing a playbook on RWD/RWE successful applications.
In relation to herbal medicines, a dedicated AESGP RWD/RWE on herbal medicines conducted a literature review concerning herbal medicines and RWD-RWE, and presented an analysis of some key articles at its hearing with the EMA’s Herbal Medicinal Products Committee.
Under the leadership of AESGP, the Content WG developed a set of recommendations informed by input from patients as well as carer and user testing companies to improve patient leaflet content. Those recommendations were presented to the EMA Quality Review of Documents (QRD) group and contributed to the review of the QRD template.
The WG Technical continued to provide support to the nominated ePI SMEs and shared with the EMA what was perceived as needed before going live with the ePI portal.