For the last hundred years, pharmaceutical services have been considered as “primary state activities” in Italy, where the number of pharmacies has been strictly limited and, moreover, distributed over the whole Italian territory.

A more recent law of 4 July 2006 allowed the opening of para-pharmacies, where some medicinal products can also be distributed. However, the latter do not have access to the distribution of prescription-only medicinal products. Those products may, indeed, under Italian law, only be distributed in formal pharmacies, even if the patients have to bear the total costs for the products.

A. Venturini, M-R Gramegna and A. Muzzio are three qualified pharmacists, who opened para-pharmacies but were not granted authorization to open pharmacies under the 1913 law. Therefore, despite their competencies and training, they are not entitled to deliver prescription-only drugs.

In a preliminary ruling, the Court of Justice was to answer a question raised by the administrative court of Lombardy on the possible preclusion by the principles of freedom of establishment, non-discrimination and the preservation of competition under Article 49 et seq TFEU to national legislation which does not allow a pharmacist, who is qualified and registered with the appropriate professional body but does not own a pharmacy in the area, to also offer for retail sale, in the para-pharmacy owned by that pharmacist, medicinal products for which a prescription in the form of a ‘ricetta bianca’ is required – that is to say, medicinal products the cost of which is borne not by the national health service but wholly by the purchaser – and which also establishes in that sector a prohibition on the sale of certain categories of pharmaceutical products, as well as a quota in relation to the number of commercial outlets which may be established in the national territory.

Apart from some ruling-specific questions, this case confirms prior case law of the Court.

The Court confirms that legislation such as the one in question is liable to hinder or render less attractive the establishment on Italian territory of a pharmacist who is a national of another Member State and has the intention of operating a para-pharmacy there.

However, such limitation:

  1. applies without discrimination on grounds of nationality;
  2. is supposed to pursue the objective, which falls within a more general objective of protecting public health, of ensuring that the public has a supply of medicinal products which is reliable and of good quality;
  3. is appropriate to attaining that objective; and
  4. does not go beyond what is necessary to attain the objective pursued.

The main interest of this case is related to the last two points above.

Regarding the third point, the ECJ values that an unrestricted possibility of selling products in para-pharmacies might hinder the efficiency of the “grid”. The Court further states: “Accordingly, it is not inconceivable that such an option would lead to a concentration of para-pharmacies in areas deemed to be the most profitable, and therefore the most attractive, at the risk of reducing the number of customers of pharmacies in those areas and, therefore, of depriving them of a large part of their income, all the more so as pharmacies are subject to a number of particular obligations in the way that they manage their business.” (paragraph 52).

The loss of revenue, therefore, could impact the quality of the service and even result in the closure of some pharmacies, thus affecting the supply of other pharmaceutical products in less attractive parts of the Italian territory.

On the fourth point – the proportionality – the Court states: “… it is important that, where there is uncertainty as to the existence or extent of risks to human health, a Member State should be able to take protective measures without having to wait until the reality of those risks becomes fully apparent.”

Regulatory requirements are about safety. So is the precautionary principle. A combined use of both is likely to ensure a safe and effective access to health technology.

Source: ECJ, Joined Cases C-159/12 to C-161/12, 5 December 2013.