Unlocking New Horizons: The Benefits of the Revision of EU Pharmaceutical Legislation for Online Pharmacies.
The landscape of healthcare and pharmaceutical services is rapidly evolving, driven by technological advancements and changing consumer preferences. Within this context and in response to these transformative shifts, the European Union (EU) has embarked on a significant revision of its current pharmaceutical legislation, which dates back to 2001: a comprehensive package was published on 26 April 2023 and is currently being discussed by EU Institutions. It´s a once-in-a-lifetime-opportunity since this forward-looking initiative aims to address emerging challenges and embrace opportunities presented by the digital era. For online pharmacies, this revision marks a pivotal moment, unlocking a host of benefits that will reshape operations and improve patient care. In this article, we explore the key advantages of the revised EU Pharmaceutical Legislation for online pharmacies and its potential to enhance the delivery of pharmaceutical services.
Harmonisation of Rules Across EU Member States
One of the significant challenges faced by online pharmacies has been the lack of uniformity in regulations across different EU Member States. The online sale of Over-the-Counter (OTC) medicines is allowed in most EU Member States, as foreseen in the current version of the EU pharmaceutical legislation, however the sale of prescription (Rx) medicines online is only limited to a number of digitally-advanced EU Member States[1]. The future updated pharmaceutical legislation should therefore seize the momentum to facilitate the adoption at the Member State level of a regulatory framework that enables patients to obtain their Rx medication online in a safe, easy and secure way, as is currently common practice in e.g. Germany, the Netherlands, Sweden, Finland, Lithuania, Estonia, Latvia and Portugal. Allowing the online sale of Rx medicines across the EU holds significant potential to enhance accessibility, convenience, affordability, patient empowerment, and informed decision-making. In summary: the revised pharmaceutical legislation should seek to harmonize rules, making it easier for any healthcare provider, including online pharmacies, to operate across borders while making the most out of existing digital tools to support patients in need. As a result, online pharmacies can expand their reach and provide seamless access to medications for patients across the EU.
Digital makes Its Entry
Given the fact that the proposal is the first revision in twenty years´ time, it is good to see that digital aspects are being implemented in the proposal, such as the electronic product information leaflet (e-PIL) but also for being able to increasingly use digital technologies to conduct e.g. inspections remotely.
Conclusion
The pharmaceutical package must provide a clear regulatory framework, for online pharmacies to leverage ground-breaking opportunities to become pioneers in the evolving healthcare landscape. As to the timeline, we expect this piece of legislation to take many years to be finalised, also due to the upcoming EU elections (June 2024) which will give light to a new European Commission and European Parliament. An agreement is highly unlikely to be reached by then. In contrast, since the stakes for healthcare providers, especially pharmaceutical companies, are very high and since the proposed legislation is a multi-100 pages package, time is needed to get a comprehensive understanding of the package and ensure a future-proof regulatory framework.
