This month’s Life Sciences & Healthcare newsletter focuses on the distance selling of medicinal products. In February, the Court of Justice of the European Union made a fundamental decision concerning the legality of distance selling of over-the-counter (OTC) medicinal products. At the same time, in all of the Baltic States the possibilities under the brand “MyHealth@EU” are growing.
Decision of the Court of Justice of the European Union on distance selling of medicinal products
On 29 February 2024, the Court of Justice of the European Union clarified situations when a member state can require from the entity that participates in e-commerce for the sale of medicinal products the status of pharmacist and prohibit a service provided on a website if such status is missing.
Firstly, the court found a service provided on a website which connects pharmacists and customers for the sale of OTC medicinal products via the websites of pharmacies which have subscribed to that service, qualifies as “information society service”. The court held that this service may be provided free of charge to a person purchasing an OTC medicinal product if a contract involving payment has been concluded between the provider of that service and all pharmacists using that service. The court also considered the fact that the service has been provided at the personal request of pharmacists and at the personal request of customers – the pharmacist had to subscribe to the service and the customer had to create an account.
Secondly, the court found that it in order to determine whether a service provided on a website can be prohibited by a member state’s legislation, it needs to be assessed if a) the provider merely connects sellers and customers by means of a service which is specific to and distinct from the sale, or b) whether that provider must be regarded as itself providing the sale. If the provider itself provides sales, then the member state may restrict distance selling to the public by requiring qualified pharmacists to be involved. If the service consists solely in connecting sellers with customers, then the member state can neither require the status of pharmacist nor prohibit the provision of service if the provider does not have such status.
Distance selling of medicinal products & MyHealth@EU in Estonia
Pursuant to the Estonian Medicinal Products Act, a general pharmacy authorisation holder has the right to engage in the distance selling of medicinal products if the State Agency of Medicines has authorised the distance selling of medicinal products by that specific pharmacy. Currently, five e-pharmacies have obtained the relevant right. Supplying or delivering of prescription medicinal products by way of distance selling is permitted only based on a prescription issued electronically.
Additionally, as part of the MyHealth@EU initiative the cross-border digital prescription service is integrated into the pharmacy software used in Estonia. Estonian citizens with an e-prescription issued in Estonia by an Estonian healthcare provider can retrieve their prescriptions at pharmacies in several other countries in addition to Estonia. Including Finland, Latvia, Portugal, the Czech Republic and Croatia. Furthermore, citizens of other countries (e.g. Finland, Latvia, Portugal) can retrieve their e-prescriptions at Estonian pharmacies.
Distance selling of medicinal products & MyHealth@EU
in Lithuania
In Lithuania, pharmacies that comply with requirements established by national laws are authorised to sell over-the-counter and prescription medicines online. Before commencing the sale of medicines online, a pharmacy must notify the State Medicines Control Agency at least 14 business days in advance, by submitting a notification in the form established by the Minister of Health. The remote sale of narcotic and psychotropic medicines is not allowed. Entities who are established in other EEA countries and have a right to sell medicines online in these countries may also sell medicinal products online in Lithuania.
The MyHealth@EU service is presently not available in Lithuania. However, infrastructure and regulation needed for the functioning of MyHealth@EU in Lithuania is currently being prepared. Based on unofficial information from the Ministry of Health, MyHealth@EU is expected to commence operations on 2 May 2024.
Distance selling of medicinal products & MyHealth@EU in
Latvia
In Latvia, in accordance with national regulatory enactments, only the distribution of over-the-counter medicines is allowed by online pharmacies. This kind of online distribution is allowed only for a general or open-type pharmacy, which has received a special permit (licence) for opening a general or open-type pharmacy; the appendix of this permit specifies the permitted special activity condition “distribution of non-prescription medicines via a website”. Currently, 10 e-pharmacies have obtained the relevant right.
Additionally, as of 4 March 2024, it is possible to purchase electronically prescribed medicines prescribed in Latvia at pharmacies in other European Union member states. Cross-border e-prescription data exchange is provided using MyHealth@EU. Estonia, the Czech Republic, Poland, Spain, Lithuania* and Portugal have been the first ones to start exchanging cross-border e-prescription data with Latvia, while other countries will gradually join in the future. This procedure also works in the opposite direction with European Union member states which allow cross-border exchange of e-prescription data.
Residents of Estonia, the Czech Republic, Poland, Spain, Lithuania* and Portugal will be able to purchase e-prescription drugs originally prescribed in their country at Latvian pharmacies. The list of countries will be updated on the “Cross-border E-health services” section of the e-health website www.eveseliba.gov.lv.
* We note that although it is said to be functioning in Lithuania, to our knowledge, it has not yet started in practice.
How does this take place in practice?
Upon commencing a purchase, a person must inform the seller that he or she is a resident of Latvia and wants to buy medicines that were electronically prescribed in Latvia, as well as presenting an identity document (a passport or eID card). It is possible to buy only part of the prescribed amount – for example two out of six prescribed outer packs or inner packs (blisters). The remaining amount can be purchased in Latvia or another member state (the condition applies only to those member states that support the possibility of purchasing packs of medicine that have been split up).
Our international Life Sciences & Healthcare team is at your disposal, should you need advice on any legal issues you are facing.
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