The European Court of Justice (ECJ) has given a judgment on the extent to which the application of national laws regulating medicines can limit the activities of online pharmacies.
In the case of A v Daniel B and others, the ECJ has allowed some derogations from the principles of free movement of goods and trading online as long as they are justified.
In this particular case, many of the specific questions were unanswered and sent back to the national court to decide on the facts, but the principles decided by the ECJ were of interest.
The Facts of the Case
This case involved the French Public Code, which regulates the activities of pharmacies in France. "A" in this case was a pharmacy registered in Holland that sold medicines through several websites, and it directed one website to French consumers. The medicines that A marketed had marketing authorisations in France. Several dispensing associations and pharmacy bodies in France objected to some of A's activities, which they said was contrary to the French Public Code. They included the following:
- The First Question: Soliciting customers by certain processes and means, in particular by way of mass distribution of postal letters and leaflets for advertising purposes.
- The Second Question: Making promotional offers aimed at granting a discount on the overall price of the order of medicines when a certain amount is exceeded.
- The Third Question: Selling medicines without first requiring a health questionnaire in the online medicine ordering process.
- The Fourth Question: Using paid referencing in search engines and price comparison sites.
What Did the ECJ Decide?
The ECJ answered as follows:
- First Question: The advertising activity fell within the EU's E-Commerce Directive, but the question was whether the French law amounted to a necessary and proportionate derogation from that EU law. The ECJ answered that a blanket ban on advertising would go too far. The ECJ sent the matter back to the Paris Court of Appeal to determine in this case as to whether any of the French laws in this case had the effect of preventing engagement in any form of advertising of its products - if it was decided so, this would go too far.
- Second Question: The ECJ accepted the objective of the French law precluding offers that incentivised bulk buying of medicines was to discourage overconsumption of such medicines. This could be a proportional derogation to the freedom in the E-Commerce Directive. However, the ECJ did not have sufficient information to determine whether that derogation applied in this case, ie whether it was necessary to prevent overconsumption or inappropriate use of medicines. It was also not clear whether the prohibition applied only to medicinal products or whether it also applied to para-pharmaceuticals. Therefore, again, it sent the questions back to the French national court to consider.
- Third Question: The ECJ accepted that the French national requirement for an increase in online interactive features that customers have to use before proceeding to purchase medicines such as health questionnaires constituted an acceptable derogation to the freedom of movement of goods. This is because it had the objective of reducing the risk of misuse of medicinal products purchased online.
- Fourth Question: Prohibiting paid referencing in search engines and price comparison sites was justified by a need to ensure a balanced distribution of pharmacies throughout France. It is important that the public must have a reliable source of good quality medicines throughout the country, and so this would justify a restriction on trade between EU member states to protect health and life of humans. However, the ECJ found that there had not been sufficient evidence produced to show that the prohibition in this case actually had that effect. Could this be achieved by a less restrictive measure? The ECJ therefore referred this back to the French Court of Appeal for final determination as well.
What Does This Case Show?
This case highlights that national laws and restrictions on selling medicines in the EU can be an excusable derogation from other EU laws, as long as they can be justified and proved as being necessary and proportionate. People exporting medicines online into other EU territories, as well as pharmacies looking to protect their position in their home market, should take note of the findings of this decision.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.