Italy: New rules on direct supply to the public and wholesale distribution of medicinal products for human use under the Italian Medicines Code (Legislative Decree No 219/2006) as recently amended by decree no. 274/2007 (the “Decree”)

09 May 2008

Mauro Turrini

The Decree introduces, inter alia, new rules on dispensing medicinal products under prescription, the possibility of new forms of dispensation of OTC products (e.g. via automatic distributor machines remotely connected to a pharmacist - so called “Pharmaclick”) and ad hoc requirements as to medical information activities addressed to healthcare professionals operating in non-public structures (e.g. in case of gadgets to be freely distributed). It also introduces new provisions on the direct supply to the public and wholesale distribution of medicinal products for human use.

Article 16 of the Decree, amending Article 100 of the Italian Medicines Code, expressly introduces the possibility for pharmacists, undertakings operating pharmacies and undertakings running estate pharmacy to wholesale distributing medicinal products for human use.

These amendments are intended to:

  • align existing practice with recent developments/innovations introduced by Decree No 223 of 4 July 2006 transposed into Law No. 248 of 4 August 2006 (the so-called “Bersani Decree on privatisations”, as a result of which the sale/direct supply of all medicinal products, except prescription medicines is now generally permitted in Italy provided that at least one qualified pharmacist constantly supervises the sale/supply of the products); and

  • implement the Communication of the Italian Antitrust Authority (“AGCM”) on the “incompatibility between wholesale distribution and direct supply to the public of medicinal products”, while respecting the fundamental principle of protection of public health (e.g. by imposing that all pharmacies have a manager who is a qualified pharmacist).

The intention of the legislator is to foster competition in this field for the benefit of consumers and patients, for example via the price reduction of medicinal products.

In particular, according to the AGCM Communication, the Italian Medicines Code should be further revised to consider:

  • the incompatibility between wholesale distribution and direct supply to the public of medicinal products. The AGCM does not believe there is a real risk of a conflict of interest due to both the provisions already in place relating to the wholesale distribution of medicinal products (i.e. Legislative Decree 30 December 1992 No. 538 implementing Directive 92/25/CE) and the ethical rules applicable in this situation.

  • the ban preventing non-pharmacists running pharmacy activities. The AGCM believes that this limitation of a commercial activity may be justified in principle only in cases where it is necessary to ensure that the individuals formally running such activities have the required specific expertise but not in cases where the same result can be otherwise achieved by for example simply employing an individual with the required expertise to supervise the sale.

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