October 15, 2020

Italian Competition Authority says that the rules on the remuneration of health care services provided by pharmacies are anti-competitive

The Italian Competition Authority once again criticizes the introduction of legislative provisions that reserve only to pharmacies the provision of certain public health services paid by the NHS

The Italian Competition Authority (AGCM or ICA) with letter dated 10 March 2020 sent to the Parliament and to the Government within the scope of its advocacy powers (Article 21 of Law 287/90), once again criticized the introduction of rules that reserve only to pharmacies the provision of certain public health services paid by the National Health Service. It had already done so in 2010, 2014, 2016 and 2018.

The occasion for this new report was the institutional consultation occurred between the AGCM and Parliament on competitive issues arising from some provisions contained in the 2020 Budget Law (law no. 160 of 27 December 2019). Among other things, the ICA criticized the provisions relating to the “experimentation for the remuneration of services and assistance functions provided by pharmacies and reimbursed by the National Health Service” (article 1, paragraphs 461 and 462 of the law). These rules provide that the experimentation for these remunerated services – already in place in nine Regions since the 2018 Budget Law – is, on the one hand, extended to the two-year period 2021-2022 and, on the other, extended to remaining Italian Regions. These services were fully defined in Article 1 of Legislative Decree no. 153/2009. They concern a series of care tasks and functions aimed at: a) ensuring the participation of pharmacies in the performance of the integrated home care service, in order to encourage patients to adhere to medical therapies; b) collaborating in health education programs and prevention campaigns for the main diseases with a strong social impact on the population, carried out at national and regional level; c) providing so-called “second level” services for individual patients, also using nursing staff, such as carrying out first-instance laboratory analyzes and excluding in any case the prescription and diagnosis activity as well as blood or plasma sampling using syringes or equivalent devices; d) allowing the booking of specialist visits and examinations at the authorized public and private facilities and the communication of the results (in compliance with the provisions of the Privacy Code).

According to the ICA, the rules in question unjustifiably exclude “para-pharmacies” (i.e., a category of pharmacies with less requisites and limited authorization to sell certain drugs only, which was introduced in Italy by law in 2006) from the distribution of these services, thus precluding citizens from an additional important supply channel that would ensure a more efficient coverage of the citizens’ needs and demand of health services. Furthermore, the ICA points out that reserving these services only to pharmacies gives them an undue competitive advantage, since it deprives para-pharmacies of a source of revenues in an area of ​​activity in which they can legitimately compete with pharmacies, contributing to a higher quality and efficiency of the services.

The ICA highlights that the legislative provisions in question could lead to an unjustified restriction of competition to the extent that the para-pharmacies authorized to sell SOP and OTC medicines to the public were not included in the experimentation. In this regard, the legislator must take into account that the applicable law requires a qualified pharmacist to run a para-pharmacy, who possesses professional preparation and competence deemed necessary by the legal system to guarantee the health care required by the NHS for the correct performance of the public service.

Lastly and incidentally, by recalling its previous reports on the need to open the Italian market for the retail of pharmaceuticals and health-related services, the ICA points out that it could be appropriate to combine the liberalization of the sale of all class C medicines with a reorganization of the supply regime of these products (with and without the obligation of a medical prescription), in particular by eliminating inconsistencies in the classification, in accordance with the provisions of Article 32, paragraph 1-bis, of the Legislative Decree of 6 December 2011 n. 201 (so-called “Save Italy Decree”).

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