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The document provides a summary of the proposal for pro-competitive legislative changes submitted by the Italian Competition Authority to the Italian Government on 23 March 2021. The Italian Competition Authority identifies eight trajectories of possible reform: 1. Measures to encourage and speed up investment in strategic infrastructures; 2. Reform of the public procurement sector; 3. Completion of the reform of local public services, limitation of in-house management and rationalisation of State-owned companies; 4. Measures to remove obstacles to the entry of new operators and to the development of a dynamic competitive environment; 5. Proposals for pro-competitive reforms to facilitate the achievement of environmental sustainability goals; 6. Actions to strengthen the health system and public health protection; 7. Amendments to Italian competition law no. 287/90; 8. Miscellaneous concerning other relevant competition-related matters.
This is a brief summary of the proposal for pro-competitive legislative changes submitted by the Italian Competition Authority (“ICA”) to the Italian Government on 23 March 2021.
Every year the ICA is called on to submit a report to the Italian Government on its activities carried out during the preceding year.[1] Such report is the basis for the Government’s drafting of the Annual Competition Law, which is conceived for the purposes of removing regulatory or administrative obstacles to market opening, promoting the development of competition and ensuring consumer protection.
In this context, on its own motion or upon request, the ICA provides the Government with proposals for pro-competitive reforms of the legal and regulatory framework. The Government has to take into account the ICA’s proposals during the preparation of the draft Annual Competition Law which, once completed, is sent to the Parliament for formal adoption through the legislative process.
With respect to the 2021 submission summarised here below, in a report consisting of over 100 pages, the ICA identifies eight trajectories of possible reform:
The ICA focuses on investments in fixed and mobile communications network, highlighting the importance of (i) infrastructure competition, (ii) the removal of obstacles to investment, (iii) the alignment with European standards and (iv) the boosting of consumer demand and mobility. These areas of intervention have to be dealt with by a transparent and non-discriminatory regulatory framework.
The ICA proposes interventions in the field of concessions in order to remove obstacles to investment. In particular, the ICA advocates identifying clear, transparent and non-discriminatory criteria for the granting of port concessions, as well as for their duration and termination procedures. The ICA also advocates limiting the prohibition of the cumulation of concessions for smaller ports. Finally, the ICA suggests repealing the provision limiting the right to self-handling of port operations and services.
The ICA considers it necessary to reform the Italian Code on Public Procurement, so as to update and simplify its rules, following the approach drafted by EU Directives of 2014:[2] on the one hand, a greater discretionary margin has to be ensured for contracting authorities and, on the other hand, the rules and procedures should be simplified.
According to the ICA, in order to reduce the constraints on contracting authorities and businesses, there are two areas where action is needed: (i) simplification of the Code on Public Procurement, which is currently fragmented and complicated, leading to serious inefficiencies when it comes to actual enforcement; and (ii) proper qualification of contracting authorities and economic operators, to be implemented also through the development of innovative procedural tools.
With respect to the public services sector, and in particular that of State-owned businesses, the ICA’s proposals focus on the need for (i) the adoption of an organic regulation on the procedures for the award and management of local public services of general economic interest, (ii) the rationalisation of State-owned companies, and (iii) the reduction in the use of in-house providing.
The ICA considers it necessary to remove barriers to entry and exit affecting the dynamics of sectoral development. ICA’s proposals cover various sectors: (i) concessions; (ii) retail trade; (iii) free market for the sales of energy; (iv) pension funds; and (v) multiple voting in companies limited by shares.
The regime currently in place in Italy often does not comply with the principles of competition and transparency. Therefore, the ICA deems it necessary, for maritime State concessions for tourist and recreational purposes, to repeal the fifteen-year extension of such concessions, leaving the quantification of the concession fees to the same competitive procedure for the selection of concessionaires, and limiting the use of sub-concessions. With regard to parking concessions for trade in public areas, the ICA recommends applying EU Directive 2006/123 on services in the internal market. In relation to large hydroelectric derivation concessions, the ICA proposes leaving to State regulation the procedures for the awarding of such concessions. The ICA also considers it necessary to rapidly conduct competitive awarding procedures for services that are currently subject to concessions and, with reference to highway concessions, to increase the threshold for the mandatory award through tender. Finally, the ICA advocates speeding up the tender procedures concerning natural gas distribution concessions, through providing incentives to local State entities, eliminating conflicts of interest, simplifying procedures and minimising information asymmetries.
Italy is one of the Member States with the highest level of restrictions in the retail sector. Consequently, the ICA deems it necessary to remove legal obstacles, such as strict regulations and requirements, to the complete liberalisation of retail trade. In particular, reference is made to the existing constraints on the opening of commercial activities, on opening hours and weekly closures of shops and on one-off sales.
Prices in Italy are among the highest in Europe. It is thus necessary to overcome barriers arising from regulation, market inequalities, operational and procedural obstacles, as well as consumer inaction. In particular, the ICA urges allocating to different suppliers the domestic customers and micro-business that are still serviced under the current protection regime. Moreover, the ICA proposes removing the barrier to innovation, such as the obstacles to the deployment of advanced electricity consumption monitoring solutions (smart metering).
The ICA points out that portability of individual positions should be fully ensured, thus avoiding undue constraints or conditions. In this respect, the ICA recommends amending the legislation currently in place by expanding as much as possible the right to choose, whilst removing any undue discrimination on portability.
The ICA urges the repeal of the current rules unduly limiting the exercise of multiple voting shares which act as a disincentive for companies wishing to invest in Italy.
The ICA’s proposals focus on the following sustainability matters: (i) infrastructures for charging electric cars; (ii) separate waste management; (iii) incineration / waste-to-energy plants; and (iv) system charges.
The ICA deems it necessary to ensure that no distortions are created, in the development of the sector, which could compromise its efficient competitive functioning in the future. In particular, attention is devoted to technological neutrality and equipment interoperability, so as to avoid any possible restriction on competition between operators.
Moreover, public administrations should follow, according to the ICA, transparent and non-discriminatory procedures for the allocation of public spaces for the installation of charging stations.
Finally, the ICA proposes that prices for the new services are not based on regulated tariffs.
The ICA recommends amending the regulations so as to: eliminate unjustified discrimination between public and private operators in the management of urban waste; prevent the notion of integrated management of the waste cycle from being misused; exclude the participation of sorting companies from the negotiation of the so-called Framework Agreement.
As per the development of plants for an efficient and competitive management of unsorted waste, the ICA advises a further simplification of authorisation procedures, including the mechanisms for substitute powers in the event of inaction by the public administrations concerned, and the provision of incentives for the parties concerned.
The ICA also proposes adopting policies to encourage rapid infrastructure development in geographical areas that are currently under-equipped (i.e. Central and Southern Italy), in order to achieve a more balanced distribution of waste-to-energy capacity across the country.
In order to improve environmental sustainability in electricity generation, substantial economic incentives have been granted to production from renewable sources, most of which have been financed through the imposition of “general system charges” on electricity end-users.
To ensure greater transparency of electricity prices and adequately manage the financing of renewable sources, the ICA advocates eliminating the system charges in the electricity sector, by gradually and correctly incorporating the financing into the general taxation framework, including the incentives for renewable sources, which could selectively burden the consumption of fossil fuels in heating and transport.
The ICA sets out various proposed interventions concerning the pharmaceutical sector, which pursues the objectives of improving the health of the population, and which has been considerably affected by the policies of public expenditure containment.
With regard to health service, the ICA recommends adopting initiatives to increase the supply of health services and their efficiency by: i) eliminating obstacles that limit private parties’ access to healthcare activities that are not covered by the National Health Service, which is currently bound by the verification of the regional needs for healthcare services; (ii) reforming the accreditation system; (iii) providing for periodic regional selections that are adequately publicised; (iv) ensuring full disclosure on the performance of public and private facilities, so as to allow demand to make an informed choice among the available facilities and thus promoting their efficiency.
As regards pharmaceuticals, ICA’s proposals focus on the promotion of a regulatory framework that: i) facilitates comparability, also in tender procedures, between biological drugs having the same therapeutic indications; ii) allows for an increase in the bargaining power of the Italian Pharmaceutical Surveillance Authority (“AIFA”), with particular reference to drugs that can be included in "non-negotiated" Class C; iii) re-modulates the obligations on wholesalers to stock medicines on the basis of flexible quantitative thresholds based on the demand expressed by the territory, so as to allow more efficient and flexible forms of business organisation, while continuing to ensure the availability of medicines in the territory. Further proposals are also aimed at removing the existing constraints on the procedures for registering generics before the patent protecting the originator expires, and at encouraging the development of galenic medicines.
The ICA considers it necessary to increase competition conditions in accessing health services in private infrastructures. Therefore, it advocates making private individuals’ access to healthcare activities (which are not covered by the National Health Service) not subject to the review of the regional needs for healthcare services.
The ICA also proposes to reform the accreditation system by requiring, instead of a temporary accreditation, a definitive one issued by the Regions for new healthcare facilities or for the start of new activities in existing facilities.
Moreover, the ICA urges that the system for contract arrangements between private companies and the National Health Service operates on a selective, non-discriminatory, regular and transparent basis.
Finally, in the ICA’s view, it is necessary to increase available information regarding the performance of public and private infrastructures, by disclosing the budgets of the Local Health Agencies and of the private infrastructures as well as data on the quality of services.
The ICA first proposes measures to increase competition in public tenders for the purchase of drugs. In particular, it advocates regulating biosimilar drugs having different active pharmaceutical ingredients on the basis of the therapeutic equivalence / overlap criterion. Therefore, the ICA proposes eliminating the prohibition of tendering together biosimilars with different active ingredients but the same therapeutic indications.
Secondly, the ICA considers that it is necessary to strengthen the bargaining power of the AIFA vis-à-vis the pharmaceutical companies, by putting in place a proper system of incentives to quickly conclude the price negotiation and by securing at the same time the therapeutic continuity to patients.
Thirdly, the ICA considers that the objective of timely supplying medicines in Italy can be better pursued on the basis of maximum supply times or flexible quantitative thresholds, instead of fixed stock levels. Indeed the storage obligation currently in place under the law (i.e. 90% of all drugs whose cost is borne by the National Health Service) results in a rigid operativity for wholesalers, thus preventing efficient and flexible forms of business organisation.
Fourthly, the ICA suggest removing the existing constraints on registration procedures for generics before patent expiry (patent linkage). In particular, reference is made to the provision which, by making the inclusion of generics in the National Pharmaceutical Inventory (for the purposes of reimbursement by the National Health System) conditional on the expiry of the patent or supplementary protection certificate of the reference medicinal products, it is possible, through disputes on IP and commercial rights, to delay the market entry of such generics.
Fifthly, with respect to galenics, the ICA proposes removing the obligation for the manufacturer of galenic preparations (i.e. pharmacists) to produce the active ingredient required for the preparation itself, when the industrially produced medicine is also covered by a patent.
The ICA proposes amendments to the Italian competition law, with the threefold aim of increasing the effectiveness of merger control and the fight against cartels, adapting the tools currently available to the challenges of the digital economy and, last but not least, achieving the much awaited harmonisation of the national system with the EU with regard to a number of key provisions.
The following proposals concern (i) the substantive test for concentrations and the efficiency gains; (ii) notification system of concentration (iii) joint ventures; and (iv) calculation of the relevant turnover for banks and financial institutions.
The ICA considers that the 45-day term for the termination of the investigation in the field of merger control is too short to allow the complete analysis of the notified concentration. It is therefore suggested to extend such term to 90 days.
The ICA proposes amending the existing legislation by providing for a rebuttable presumption of economic dependence in commercial relations with a company offering the intermediation services of a digital platform, where the latter plays a decisive role in reaching end-users and/or suppliers, including in terms of network effects and/or data availability.
Strengthening of ICA’s powers to counter the market power of companies operating in several markets
In order to counter distortions of competition more effectively, particularly in markets where a digital platform exists or where there are undertakings which need such platform to gain access to end users or suppliers, the ICA suggests the adoption of a specific provision. That would make it possible to give to certain undertakings the status of undertakings of primary importance for competition in several markets, to which certain particularly distortive conducts of competition may be prohibited, unless the undertaking proves that its conduct is objectively justified.
In particular, ICA’s power to classify undertakings as of primary importance would take into account indications which are capable of highlighting the crucial role that these operators play in the digital economy.
The ICA suggests introducing also in the national legal system the settlement procedure in administrative proceedings conducted by the competition authority resulting in a 20% reduction of the fine imposed on the undertakings which successfully apply and adhere to such procedure.
The ICA considers it appropriate to strengthen its powers to obtain information and documents even outside the investigative procedures, by giving it the power to impose administrative sanctions in case of refusal to or delay in providing the requested information or documents or in case of misleading or incomplete information also where such requests are submitted without opening a formal investigations proceedings.
According to the ICA, the transposition into Italian law of EU Directive 2019/633 on unfair trading practices in business-to-business relationships in the agricultural and food supply chain represents an opportunity to review and rationalise the entire legislation on the subject, with a clear allocation of powers relating to enforcement activities.
In particular, it is suggested that the ICA is identified as the only competent authority in case of breach of the said legislation. Moreover, the implementation of the said Directive should also occur in those cases where rules risk to be an instrument that is difficult to reconcile with the maintenance of adequate competition within the reference markets. According to the ICA, it would also be appropriate to identify more clearly the tools and players through which the necessary aggregation of agricultural supply can be achieved in order to increase the contractual power and competitive capacity of farmers.
As a conclusive set of remarks the ICA refers to its most important past opinions in the economic sectors that are mostly exposed and affected by anticompetitive constraints stemming from unwarranted legislative burdens, namely: professional services; health advertising; urban mobility services; chambers of commerce; pharmacies and para-pharmacies; and postal services.
At present, it is not possible to predict if and when the next Annual Competition Law, which has to take into account the ICA’s proposals above during the preparation of the draft law, will actually be adopted and its entry in force.
Indeed, even though the yearly adoption of the Annual Competition Law is mandatory under Italian law, to date, only one, in 2017, has been ever adopted despite the ICA having submitted four sets of proposals between 2010 and 2014.
[1] According to Italian Law no. 287/1990, the report on ICA’s activities during the preceding year shall be submitted by 31st March of each year. However, this deadline is not applied rigorously, as the previous reports have been submitted in October and July respectively.
[2] Directive 2014/24/EU on public procurement; Directive 2014/25/EU on procurement by entities operating in the water, energy, transport and postal services sectors; Directive 2014/23/EU on the award of concession contracts.