EU court ruling on internet sales for contact lenses has far-reaching consequences
This article was originally published in RAJ Devices
The judgment of the Court of Justice of the EU that Hungary cannot prohibit the selling of contact lenses via the internet has important consequences for other member states and for the sale of other medical devices online1.
According to the 2 December 2010 court ruling in Ker-Optika Bt v ÀNTSZ Dél-dun�ntúli Region�lis Intézete, any restriction on the sale of contact lenses via the internet must be proportionate to the goal of protecting consumer health. Whether similar prohibitions will be proportionate to this objective will differ from device to device. Medical devices companies experiencing difficulties with regard to selling – or plans to sell – their products via the internet in an EU member state should now take a good look at whether the legislation concerned is proportionate.
The Ker-Optika case concerns a dispute about the legality of Hungarian legislation that 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 CJEU ruled on two points of law important to the medical devices industry seeking to sell medical devices to consumers online in the EU.
Firstly, the court clarified the scope of the E-Commerce Directive (2000/31/EC) with respect to national rules prohibiting internet sales for contact lenses. It held that because medical devices are not excluded from the directive's scope, national rules on whether or not medical devices can be sold via the internet also fall under its scope.
It noted that national rules that seek to regulate how medical devices are supplied to the end user (eg only after an examination for fitting) fall outside the scope of the E-Commerce Directive and can, consequently, not be assessed by the rules the directive imposes. These national laws must be assessed under the general EU internal market rules on free movement of goods.
However, because the sale of medical devices via the internet falls under the E-Commerce Directive, the 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.
Secondly, the court considered how the Hungarian prohibition could obstruct EU rules on the free movement of goods. With reference to the DocMorris case of 2003 regarding internet sales of medicinal products2, the court reasoned that the restriction hindered access to the market of a member state more for foreign traders than for local traders.
Such a restriction must, therefore, be justified. The court noted that by reserving the supply of contact lenses to optician shops that offer the services of a qualified optician, the Hungarian legislation was appropriate for securing the attainment of the objective of ensuring protection of consumer health. However, it found that contact lenses did not justify this type of restriction for the following three reasons.
Firstly, with regard to the requirement that the customer must be physically present to have his eyes examined by an optician at the sales outlet, the court said that precautionary examinations, carried out for investigative purposes, can be undertaken by ophthalmologists in places other than optician shops. Also, 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 website concerned, the use of which by the customer must be mandatory before he can proceed to purchase the lenses.
Secondly, member states can require that the determination of which type of contact lenses is the most appropriate should 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 to make advice available to 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 that 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 that takes into account any change in the customer's vision.
Thirdly, while the extended use of contact lenses must be accompanied by supplementary information and advice, these can be given to the customer by means of interactive features on the website of the internet sales provider, for example, 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 that are well thought out and pertinent, and without the need to physically leave their home.
In summary, because the Hungarian legislation in question was not proportionate, the court found it to be contrary to the general rules on free movement of goods.
The CJEU judgment in Ker-Optika has implications for other national laws governing internet sales of medical devices in the EU. Even in the case of devices for which initial clinical/fitting advice would be prudent, member states are not allowed to ban completely internet sales of such products, unless they can justify why that would be a proportionate measure for devices concerned. The same is true for national advertising rules that affect the advertising of medical devices sold via the internet.
Another important point in this case is that the court seems to view medical devices as different from medicinal products, because it held in DocMorris that a German prohibition on the mail-order sale of authorised prescription-only medicines by internet pharmacies in other member states to German patients is justifiable3. However, the court in DocMorris also ruled that, with respect to authorised non-prescription medicines, the German ban cannot be justified because there is not an increased risk to public health, as sufficient advice and information is available to the consumer. The court in DocMorris was very categorical in that it seemed to express that a ban on internet sales of OTC medicinal products can never be justified by the need of pharmacist advice, while the court in Ker-Optika appears to be less categorical with respect to OTC medical devices, saying that expert advice may be imposed if this is proportionate. In this respect, OTC medicinal products seem to be regulated less strictly than OTC medical devices. It will be interesting to see how the application of the proportionality criterion develops with respect to online sales of medical devices. More specifically it will be interesting to see if the court rules differently in the case of higher risk medical devices, for example, self-testing diagnostics for high-risk medical conditions.
Finally, the CJEU judgment may prompt the European Commission to start thinking about including advertising regulation in the upcoming recast of the EU medical device directives. The promotion of medical devices per se is not regulated under the directives at present except in Article 4 (3) that concerns showing of medical devices that are not yet CE marked at trade fairs.
References
1. Case C-108/09, Ker-Optika bt v �NTSZ Dél-dun�ntúli Region�lis Intézete, 2 December 2010, OJ, C30/2, 29 January 2011, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2011:030:0002:0003:EN:PDF
2. Case C-322/01, Deutscher Apothekerverband eV v 0800 DocMorris NV and Jacques Waterval, 11 December 2003, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:62001J0322:EN:HTML
3. Ban on mail-order sale of authorised POMs is justified, Regulatory Affairs Pharma, 13 January 2004
Erik Vollebregt is a lawyer at Greenberg Traurig LLP in Amsterdam, the Netherlands. Email: