In its report on the liberalisation of professional services to Parliament and Government, the Italian Competition Authority (the "Authority") has reiterated the importance, as well as the need, to liberalise the distribution of over-the-counter ("OTC") medicines. The aim is to extend their sale to supermarkets and make it possible to install self-service machines outside pharmacies.
According to the Authority, the liberalisation would benefit consumers by making pharmaceutical products more easily available to them, whilst the increase in the number of the points of sale would prompt competition between pharmacies, giving them the incentive to apply significant discounts.
Although a recent amendment to the legislation did not embody the amendments that would have expressly opened the market in the way described above, the Authority considers that a particular interpretation of Article 9 bis of Law No 405 of 16 November 2001 would still allow the installation of self-service automats with access from the street. The current regulation foresees "free, direct access by citizens to self-administered medicines", stipulating that such access must be "in a pharmacy".
In the Authority’s view an automat placed outside a pharmacy would still be part of the pharmacy and, above all, the products would be loaded into it by the qualified pharmacist, thus guaranteeing his participation and responsibility in the distribution of medicines. These automats could carry notices making it easier for the consumer to receive professional advice on the medicines thus distributed (for example, the address and phone number of the local emergency doctor).
Finally, the Authority noted that such a regulatory barrier is not justified as also established by the European Court of Justice (case C-322/01), which found that a tout-court prohibition of selling OTC medicines through alternative distribution systems is a measure not compatible with EU law since it is not proportionate with the objective of safeguarding public health.
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.