EU member states are not under all circumstances allowed to restrict the sale of medical devices to only brick-and-mortar shops that specialise in medical devices.

That is the outcome of the recent Ker-Optica judgment (C-108/09 of 2 December 2010), concerning a dispute about the legality of Hungarian legislation which authorises the sale of contact lenses only in shops that specialise in the sale of medical devices and, consequently, prohibits the sale of contact lenses via the Internet.

The European Court ruled on two points of law important to members of the medical devices industry seeking to sell medical devices to consumers in the EU online.

First, it clarified the scope of the e-commerce directive with respect to the national rules prohibiting Internet sales of contact lenses. It held that national rules relating to whether or not medical devices can be sold via the Internet fall within the scope of the e-commerce directive because medical devices are not excluded from its scope. 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, consequently, cannot be assessed by the rules that the e-commerce directive imposes. Those national rules have to be assessed under the general EU internal market 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 Internet sales as such 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, the court reasoned, with reference to the DocMorris case (C-322/01 of 11 December 2003, [2003] ECR I-14887) concerning Internet sales of medicinal products. 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 three reasons (paraphrased wording from the judgment):

  1. In regards to the requirement that the customer must be physically present to have his eyes examined by an optician at the sales outlet, it must first be observed 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 customer's use of which must be mandatory before he can proceed to purchase the lenses.
  2. Member states can require that the determination of which type of contact lenses is the most appropriate be undertaken by an optician, who is under an obligation, at that time, to check the positioning of the lenses on the customer's eyes and advise the customer 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 was 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.
  3. 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 able to submit questions that 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 governing Internet sales of medical devices in the EU. Any restriction on Internet sales, even if it is intended to protect consumer health, must also be proportionate to that goal, and whether that is the case will differ from device to device. Even in cases concerning devices for which initial clinical/fitting advice would be prudent, EU member states are 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. Medical device companies that experience difficulties with their (intended) Internet sales in EU member states should now definitely have an interest in taking a good look at whether the legislation concerned is proportionate.

Another important point of this case is that the European Court seems to view 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 differently 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.

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