The European Court of Justice ruled in November 2007 that Directive 2001/83/EC on the community code related to medical products for human use had harmonized the sphere of advertising medicinal products. Although the judgment was published months ago, it is remarkable that the media has paid virtually no attention, particularly in an environment where national rules related to medicinal products generally tend to be stricter than European regulations.
In its judgment the European Court of Justice stated that Directive 2001/83/EC explicitly lists the cases in which member states are authorized to adopt provisions departing from the rules laid down in the directive. For example, member states can ban advertising of medicinal products whose cost may be reimbursed and show more flexibility in respect to minimum information required on the product, or more rigor by requiring additional information. Also, distribution of free samples might also be stricter than provided in the directive.
In all other cases, including attempts to lay down stricter rules for advertising, member states may not derogate from the text of the directive. The court argued that the directive created a well-defined framework, and the complete harmonization of the rules on advertising contributes to the removal of hindrances to trade in medical products between member states, in accordance with Article 95 EC.
The court's judgment opens up the door for broadening pharmaceutical companies' advertising options. This will definitely be a welcomed option in Estonia.
The Estonian Medical Products Act prohibits the advertisement of medical products on the Internet. It does not provide any kind of room for maneuver in this sphere. Hence, Estonian legislation has created a general ban for advertising on the Internet 's not only for prescription drugs but also over-the counter medicines. In light of the aforementioned judgment, we see that there needs to be an express reference in the directive to the possibility of laying down more restrictive or simply different rules.
When analyzing Directive 2001/83/EC we see that it does not provide any kind of absolute and unconditional prohibitions on the means of communications. Hence, there is no lawful legal basis for a total prohibition on advertising on the Internet.
Furthermore, Estonian legislators have clearly failed to notice one fundamental earlier judgment of the European Court of Justice 's the case of Deutscher Apothekerverband, where the court analyzed whether the application of a ban under the Germany's medicines law on imports of medicinal products ordered over the Internet from pharmacies in other member states infringed Articles 28 EC and 30 EC.
In the Deutscher Apotheker-verband case, the court found that this kind of prohibition is more of an obstacle to pharmacies outside Germany than to those within it. The court reasoned that such a breach might be acceptable only if there are justifiable circumstances under EU law 's for example, the need to protect the health and life of humans. The court elaborated on this issue and concluded that the ban is only justified with regard to prescription drugs, while there may be risks attached to the use of these medicinal products.
However, as regards non-prescription medicines, the prohibition was found to be unjustified. The court even mentioned some advantages of Internet buying - for example, the ability to place an order from home or the office, time to think about the questions to ask the pharmacists, etc. It is noteworthy that the court's judgment in Deutscher Apotheker-verband case was made on the premise that the sale of medicinal products to end consumers was not subject to full community harmonization at that time. While the European Court of Justice with its recent judgment has decided that Directive 2001/83/EC created the complete harmonization as regards to advertising of the medicinal products, then the outcome of the judgments is even more apparent: advertising of over-the-counter drugs in the Internet should be allowed, and it can only be limited with the restrictions applicable for the content as regulated in the directive 2001/83/EC.
For Estonia it means that this absolute ban of Internet advertising should be eliminated from the Estonian Medical Products Act.
Silja Elunurm is an attorney at the law firm Glikman & Partners, a member firm of the Baltic Legal Solutions, a pan-Baltic integrated network of law firms including Kronbergs & Cukste in Latvia and Jurevicius, Balciunas & Bartkus in Lithuania, dedicated to providing a quality 'one-stop shop' approach to clients' needs in the Baltics.
