Central and Eastern Europe.
In most countries in the region where the law firm bnt attorneys in CEE is represented, online sales of prescription medicines (also “Rx”) are prohibited by national legislation. An exception is Estonia or Germany, where online sale of prescription-only medicinal products is allowed.
Are there limitations to cross-border internet sales of Rx medicinal products within the EU/EEA? Can a foreign internet pharmacy established in a MS where a concrete medicinal product is categorized as an over-the-counter medicine (“OTC”) sell that product online to a MS where the same medicinal product is categorized and registered as “prescription-only”? What is the status of eHealth in the CEE countries?
Slovakia has strict and clear rules. An internet pharmacy can only sell OTCs registered in Slovakia, supplements, medical devices ‒ with certain exceptions ‒ and non-prescription vitamins. Furthermore, only those stationary pharmacies which notify SIDC of online sales can run an internet pharmacy. SIDC will subsequently register the internet pharmacy with the list of authorized holders for internet sales available at SIDC website. It is crucial for the internet pharmacy to appear on the list as it serves as a “guarantee” for the customers that the online pharmacy is certified, and the online sale is secure. If the SIDC, the National Criminal Agency (NAKA) or other supervising authority finds out that an internet pharmacy is not on the list or sell medicinal products which are not registered in Slovakia, it can start administrative proceedings for imposition of a fine against the entity concerned.
Sale of prescription-only medicinal products via the internet is also prohibited in the Czech Republic, Bulgaria, Hungary, Belarus and Poland.
In Estonia, an internet pharmacy can sell prescription medicines with a digital prescription (except medicinal products in the form of narcotic drugs or psychotropic substances and anabolic steroids).
In Lithuania, Rx-medicinal products can so far not be distributed online. However, a project is under way to amend the Law on Pharmacy in the parliament. If adopted as suggested, then online sales of Rx-medicinal products would be possible.
Cross-border sale of Rx-medicinal products
Differences may exist between the member states as to classification of medicinal products into groups as prescription-only /OTC products. For example, a medicinal product may not require medical prescription in one-member state but be prescription-only in another.
For this reason, each internet pharmacy must adjust its portfolio of products available via the internet to the laws of each member state. If internet supply is delivered from a foreign internet pharmacy, the operator of the pharmacy (a licensed drugstore) must adjust its choice of products to the legislation of the member state, to which the order was sent.
If an order to a Slovak online pharmacy is for a medicinal product requiring a prescription in Slovakia but not requiring a prescription in e.g. Hungary, the medicinal product cannot be supplied to Slovakia.
However, even internet pharmacies that allow the sale of prescription-only medicinal products do not have to accept a digital medical prescription from each country in the EU/EEA.
The Court of Justice of the European Union (“CJEU”) offered an interesting perspective in the matter of cross-border online sale of Rx medicines in its judgment in C‑148/15 Deutsche Parkinson Vereinigung eV vs Zentrale zur Bekämpfung unlauteren Wettbewerbs eV of 19 October 2016. The CJEU decided that German legislation establishing fixed prices for Rx medicinal products for human use in pharmacies does not comply with European law. As a result, internet pharmacies based in the EU can provide discounts and bonuses if they send prescription-only medicinal products to Germany, although the ban on discounts still applies to German pharmacies. However, this “benefit” only applies to internet pharmacies in MS that allow cross-border online sale of Rx medicinal products.