The Court of Justice of the European Union (CJEU) has upheld Italy’s ban on the sale through parapharmacies of prescription medicines which are paid for entirely by the purchaser.
The Court was ruling in a case brought by three Milan pharmacists whose request to be allowed to sell such products through their parapharmacies was rejected by their local health authorities and the Italian Ministry of Health. They then brought their case to the regional administrative court in Lombardy, claiming that this refusal was contrary to EU law.
In its judgement, the CJEU notes that the establishment of pharmacies in Italy is subject to planning rules. The aim of these is, first, to avoid pharmacies becoming concentrated only in areas which are commercially more attractive and to ensure that each pharmacy has a market share and, second, to ensure that requirements for medicines can be met nationwide.
The EU judges point out that the geographic distribution of pharmacies and monopoly for dispensing medicines remains a matter for individual EU member states. And in Italy, a pharmacist who wishes to set up a parapharmacy is excluded from the economic benefits accruing from sales of prescription-only drugs which are wholly paid for by the purchaser; these can only be sold through pharmacies.
While this legislation does constitute a restriction on freedom of establishment, it may be justified by overriding reasons of public interest, they add.
Italy's legislation pursues the objective of ensuring that the supply to the public of medicines is “reliable and of good quality.” If the sale of some prescription-only medicines were to be allowed in parapharmacies, that would amount to the products being sold without being subject to the planning rules, thus risking a concentration of parapharmacies in areas deemed to be the most profitable, which would reduce customer numbers and income for pharmacies in those areas, say the judges.
“That situation might then bring about a lower quality of service provided by pharmacies to the public and also result in the definitive closure of some of them – a shortage of pharmacies in some parts of Italy could cause the supply of medicinal products to be unreliable and not of good quality,” they add.
By not allowing parapharmacies to sell prescription-only drugs which are paid for in full by the purchaser, the Italian system “reduces the risk of a shortage of pharmacies in a manner which is proportionate to the objective of ensuring that the supply of medicinal products to the public is reliable and of good quality,” the Court judgement concludes.