EU member states are not under all circumstances allowed to restrict the sale of OTC medical devices only brick-and-mortar shops which specialise in medical devices. That is the outcome of the recent Ker-Optica judgment of 2 December 2010, concerning a dispute about the legality of Hungarian legislation which authorises the sale of contact lenses only in shops which specialise in the sale of medical devices and which prohibits, consequently, the sale of contact lenses via the Internet.
The European Court ruled on two points of law important to the medical devices industry seeking to sell medical devices online to consumers.
First, it clarified the scope of the e-commerce directive with respect to the national rules in question: the e-commerce directive covers relating to whether or not medical devices can be sold via the internet because medical devices are not excluded from the scope of the e-commerce directive. However, national rules that seek to regulate how medical devices are supplied to the end user (e.g. only after a prior examination for fitting) fall outside the scope of the e-commerce directive and can, consequently, not be assessed by the rules that directive imposes. Those rules have to be assessed under the general EU rules on free movement of goods. Given that the sale of medical devices via the internet falls within the scope of the e-commerce directive, the European Court ruled that those sales cannot be prohibited, even in cases where a prior examination by qualified staff would be necessary, because that examination can be separated from the subsequent internet sale.
Second, what then are the restrictions that general EU free movement of goods rules impose on national requirements to sell certain medical devices only from shops with qualified personnel? First of all, these rules hinder access to the market of the member state that has those rules more for foreign traders than for local traders, reasoned the court with references to the DocMorris case about internet sales of medicinal products (if you are interested in the legal mechanics of that case, I wrote an annotation of that case in the legal journal NTER). That restriction must therefore be justified. However, the European Court finds that the type of devices in question does not justify this type of restriction for these three reasons (paraphrased wording from the judgment):
- As regards the requirement that the customer must be physically present to have his eyes examined by an optician at the sales outlet, it must be observed, first, that precautionary examinations, carried out for investigative purposes, can be undertaken by ophthalmologists in places other than opticians’ shops. However, there was no requirement that an optician must make every supply of lenses dependent on a precautionary examination or on medical advice having first been obtained or that those conditions are imposed, in particular, on each occasion when there is a series of supplies of lenses to the same customer. Accordingly, undergoing such examinations and obtaining such advice must be held to be optional, and consequently it is primarily the responsibility of each contact lens user to make use of them, while the task of the optician in that regard is to give advice to the users. If that is the case, customers can be advised, in the same way, before the supply of contact lenses, as part of the process of selling the lenses via the Internet, by means of the interactive features on the Internet site concerned, the use of which by the customer must be mandatory before he can proceed to purchase the lenses.
- Member states can require that the determination of which type of contact lenses is the most appropriate should be undertaken by a optician, who is under an obligation, at that time, to check the positioning of the lenses on the customer’s eyes and to make available to the customer advice on the correct use and care of the lenses. However, that is normally only required when contact lenses are first supplied. At the time of subsequent supplies, there is, as a general rule, no need to provide the customer with such services. It is sufficient that the customer advise the seller of the type of lenses which were provided when lenses were first supplied, the specifications of those lenses having been adjusted, where necessary, by an ophthalmologist who has issued a new prescription which takes into account any change in the customer’s vision.
- While the extended use of contact lenses must be accompanied by supplementary information and advice, those can be given to the customer by means of the interactive features of the website of the internet sales provider, e.g. through a qualified optician whose task is to give to the customer, at a distance, individualised information and advice on the use and care of the contact lenses. The provision of such information and advice at a distance may, moreover, offer advantages, since the lens user is enabled to submit questions which are well thought out and pertinent, and without the need to go out.
In summary: because the legislation in question was not proportionate, it was contrary to the general rules on free movement of goods.
This judgment has important consequences for national rules impacting internet sales of medical devices in the EU. Any restriction to internet sales, even if it is intended to protect consumer health, must also be proportionate to that goal. Even in case of devices for which initial clinical / fitting advice would be prudent, member states re not allowed to completely ban internet sales of the devices. The same is true for national advertising rules that impact the advertising of medical devices sold via the internet. Companies that experience difficulties with their internet sales in EU member states now definitely have an interest to take a good look at the possibilities to attack the legislation concerned.
Another important point of this case is in my opinion that the European Court views medical devices (at least OTC devices) as different from medicinal products, because it held in the DocMorris case that the restrictions on internet sales of medicinal products were not justified. It will be interesting to see if the European Court rules different in the case of other medical devices, e.g. self tests for high risk medical conditions.
Finally, this judgment may prompt the European Commission to start to think about including regulation of advertising in the upcoming Recast of the EU medical devices rules.