By judgment No. 216 of 18 July 2014, the Italian Constitutional Court upheld the constitutional legitimacy of Article 5, paragraph 1 of Decree-Law No. 223 of 4 July 2006 (Decree-Law 223/2006) which prohibits para-pharmacies from selling prescription-only Class C medicinal products, the cost of which, however, is not borne by the National Health Service ("NHS").

Background

By Decree-Law 223/2006, the Italian legislator allowed the opening of para-pharmacies, i.e. stores authorised to sell only OTC and prescription free medicinal products with the exclusion of prescription medicines. A number of Italian Administrative Courts, doubting the legitimacy of the provisions of Decree Law 223/2006 prohibiting the sale of prescription free medicines not reimbursed by the NHS on the ground of the provisions of the Constitution safeguarding the free exercise of business and economic activities, decided to stay the proceedings and to request a ruling of the Constitutional Court.

The aforementioned Administrative Courts alleged infringement of the above principle due to the fact that the cost of prescription-only medicinal products is to be borne entirely by the customer.

With respect to medicinal products reimbursed by the NHS, the Administrative Courts acknowledged that the prohibition on para-pharmacies selling such medicinal products is justified by the need to control public spending for pharmaceutical assistance. However, they argued that the prohibition at issue also applies to medicines that, although subject to medical prescription, are entirely paid for by the customer.

The Administrative Courts claimed that, absent of any justification in terms of health protection, the above provision impinges on the free exercise of business and economic activities provided by the Italian Constitution.

Reasoning of the Constitutional Court

In its judgment, the Constitutional Court stated that the pharmacies planning system falls within the general objective of protecting public health. For this reason, the territorial distribution of the pharmacies has been subjected to quotas considered suitable to respond to demand from the people concerned and to prevent such pharmacies from becoming concentrated solely in more commercially desirable areas.

The Constitutional Court declared that the unconditional liberalization of the prescription-only medicinal products will affect the territorial distribution of the para-pharmacies which, being exempted from the quota, could distort the pharmacies planning system established for the protection of public health.

In its reasoning, the Constitutional Court also quoted the judgment issued by the European Court of Justice ("ECJ") in the joined Cases C 159/12 to C 161/12 on the compatibility between the freedom of establishment (Article 49 TFEU) and "a national legislation prohibiting para-pharmacies from selling prescription-only medicinal products the cost of which is borne by the patient".

In the above case, the ECJ ruled that "protection of the public health can justify restrictions on freedom of establishment" (para 41) and that "the legislation (…) which reserves the sale of prescription-only medicinal products (…) exclusively to pharmacies (…) is appropriate to guarantee (…) the protection of public health" (para 55). In light of the above, the ECJ concluded that the planning system set up by the Italian legislation "is reliable and of good quality and does not appear to go beyond what is necessary to attain [protection of the public health]" (paras 58 to 65).

Consequences of the judgment

As a consequence of the Constitutional Court judgment, prescription-

only medicinal products continue to be sold only by pharmacies ensuring the stability of the pharmacies planning system and, therefore, public health.