Is it lawful to sell glasses and contact lenses online in Italy?

It must be said that the legal framework regarding the online sale of medical devices is rather complex, also given the legislative evolution in this field. The Directive 93/42/EEC on medical devices did not specifically regulate the online sale of medical devices, since it was issued in 1993, when there was virtually no electronic commerce.

After the entry into force of Legislative Decree 46/97 that implemented the European Directive in Italy, the Ministry of Health issued on 23 July 1998 a Ministerial Decree which established that eyeglasses could only be sold by opticians. This is due to the fact that only an optician has the necessary expertise to be able to interpret medical prescriptions, ensure that glasses are correctly manufactured, and that they fit the client. In 2003, the Italian Ministry of Health issued a Decree on contact lenses, which clarified that only a specialised doctor or a dispensing optician are able to identify any problems that may arise with respect to the use of contact lenses and that they can recommend their use only after a "careful examination of the subject".

These two measures, although not aimed at regulating online commerce (that was still in its infancy) introduced an obligation regarding the presence of the optician in the sales phase, thus implicitly prohibiting online selling. Over the years, however, the economic and (consequently) the regulatory framework, have undergone radical changes, increasingly opening the way to online sales. On December, 2, 2010, the European Court of Justice issued the judgement C-108/09 on the online selling of contact lenses.

In the judgment, the Court clearly states that "any person who wishes to wear contact lenses may be obliged to undergo a precautionary ophthalmological examination in the course of which a check is made that no medical factors preclude that person from wearing lenses and a determination is made of the exact values, in dioptres, of the correction required". Therefore Member States have full power to decide whether to subject the sale of contact lenses to the precautionary examination of an optician. The judgement, however, also states that “those services are required, as a general rule, only when contact lenses are first supplied”.

At the time of subsequent supplies, it is sufficient that the customer informs the seller of the type of lenses which were provided when lenses were first supplied, and any adjustements having been made to those lenses, by an ophthalmologist who has issued a new prescription taking into account any changes in the customer’s vision. In essence: it is possible to prohibit the online sale of contact lenses for health security reasons, but only for the first sale (when the health condition of the customer is determined). Moreover, national provisions "must not go beyond what is necessary in order to attain” the objective of health protection, by excessively restricting the free movement of goods that underlies the European spirit.

Even if the judgement addresses only the topic of online sales of contact lens, and doesn’t mention glasses, it has to be acknowledged that the regulatory framework has now changed. The general principle supports the freedom to sell online, which can suffer limitations only for health protection reasons and - above all - only within the limits of achieving this objective. This new EU and national architecture is well expressed in the new Digital Single Market strategy, which has the objective of creating a digital single market and supporting the conditions for its growth and development.

The new EU Regulation 2017/745 on medical devices, already in force, is in line with this principle and will become fully effective on 20 May 2020. This regulation addresses for the first time (in art. 6) the online selling of medical devices, stating the full legitimacy of the electronic commerce of medical devices. The same regulation states in paragraph 4 that "for reasons of public health protection, a member state may require that Information Society service providers, as defined in Article 1 (1) (b) of the European Directive 2015/1535, cease their activities ". In other words, it is established that the limitations on the online sale of a medical device can be posed by Member States only for health reasons and only by implementing the communication and Community control systems referred to in Directive 2015/1535.

In conclusion, it goes without saying that the 1998 Ministerial Decree on custom-made glasses and the 2003 Decree on contact lenses can no longer be considered applicable tout court in the light of the principles established by the judgment of 6 December 2010 of the European Court of Justice, and in any case they must be reviewed through the Community control system referred to in Directive 2015/1535.