Italian Authority Research Articles

Italian Competition Authority ends antitrust investigation against collecting society with commitment procedure

Italian Competition Authority (Autorità Garante della Concorrenza e del Mercato), decision of 22 March 2017, Case A489 Nuovo Imaie—Condotte anticoncorrenziali (Nuovo Imaie) The Italian Competition Authority and a collecting society settled an Article 102 Treaty on the Functioning of the European Union (TFEU) investigation concerning allegedly abusive business practices, carried out by the latter, by agreeing on a set of commitments offered to resolve the competition problems that exclusionary business practices had given rise to.

Profilazione reputazionale e tutela del lavoratore: la parola al Garante della Privacy

The Italian Data Protection Authority prohibited the activity of employees’ (and users’ in general) profiling implemented by a digital platform with the purpose of elaborating reputational profiles. This decision is the occasion to focus on risks for workers’ dignity, personal identity and privacy resulting from profiling and other automated processing of personal data. The A. points out that “People analytics” activities are likely to breach the prohibition of the collection of belief-related information stated by art. 8, Workers’ Statute. To avoid this risk, new protection techniques “by design” are proposed, taking inspiration from art. 25, EU General Data Protection Regulation.

Life and death in audience development. The exhibition on Pompeii at the British museum, 2013

ABSTRACTValues and orientations of cultural professionals are important to understand the performance of the institutions they manage. While there are striking differences in orientation across countries, their impact has rarely been investigated systematically. This paper offers a case study of a blockbuster exhibition mounted by the British Museum in 2013 using objects loaned by the Superintendence of Napoli and Pompeii. Based on interviews and documentary sources, the study analyzes and explains the perceptions of the Italian professionals with relation to the value and the payoffs of the exhibition, and critically compares these to those of the British Museum. The Italian authority did not recognise the strategic potential of the partnership with the British Museum. Consequently it did not pursue or win any significant gains in the areas of resources, reputation or audience development.

The data protection reform and its impact on the Italian legal system: Between hopes and expectations

The General Data Protection Regulation (GDPR) will be subject to national-level implementation over the next two years, but are we sure this will help pave the way for the creation of a real European digital single market and strengthen individuals’ rights to privacy and data protection? This paper will analyse those aspects of the data protection reform enshrined in the GDPR that can be considered the most important for European businesses, public institutions and national data protection authorities alike. In particular, the focus will be on: (1) the one-stop-shop mechanism; (2) the new rules of consent in the marketing domain; and (3) the role of data protection officers according to the new regulation. Furthermore, considering the need to contextualise such a change in the law of the EU with a more country-specific analysis, the author will also provide a general overview of the possible impact of the reform on the Italian legal system, according to its current laws and regulations and the jurisprudence of the Italian Data Protection Authority.

The Italian pharmaceutical antitrust (r)evolution and its most recent example: the Aspen case

ABSTRACTThe Italian Competition Authority (ICA) has elected the pharmaceutical sector as the field where to expand the boundaries of antitrust enforcement and to develop innovative theories of harm. Pfizer, Roche/Novartis and Aspen are the milestones of this new path. The ICA’s choice is not accidental: pharmaceuticals are primary goods that call for protection, are entrusted to private hands which frequently try to exploit their essential nature and ensure visibility to antitrust enforcement. Aspen is the most recent example of ICA’s approach, reviving the dormant category of excessive pricing and potentially opening up the Pandora’s box of pharmaceutical prices. While the case bears very specific features which limit its precedential value, the ICA’s general attitude vis-à-vis excessive pricing could be easily replicated. The application of the United Brands test in Aspen can be particularly worrisome for pharmaceutical companies, because the ICA is not particularly careful in choosing the correct comparators to assess the excessiveness and unfairness of a given pharmaceutical price. The chances of finding of infringements and fines are particularly increased in case of premium/life-saving products. Furthermore, following Aspen decision, the EU Commission and other authorities have opened excessive pricing proceedings against Aspen, showing the widespread impact of the case.

Surveillance of Clostridium difficile Infections: Results from a Six-Year Retrospective Study in Nine Hospitals of a North Italian Local Health Authority.

Clostridium difficile is an emerging cause of healthcare associated infections. In nine hospitals of an Italian Local Health Authority the episodes of C. difficile infection (CDI) were identified using the data registered by the centralized Laboratory Information System, from 2010 to 2015. CDI incidence (positive patients for A and/or B toxins per patients-days) was analysed per year, hospital, and ward. A number of cases approximately equivalent to the mean of identified cases per year were studied retrospectively to highlight the risk factors associated to CDI and their severity. Nine hundred and forty-two patients affected by CDI were identified. The overall incidence was 3.7/10,000 patients-days, with a stable trend across the six years and the highest rates observed in smaller and outlying hospitals (up to 17.8/10,000), where the admitted patients were older and the wards with the highest incidences (long-term-care: 7.6/10,000, general medicine: 5.7/10,000) were more represented. The mean age of patients in each hospital was correlated with CDI rates. Of the 101 cases selected for the retrospective study, 86.1% were healthcare associated, 10.9% community acquired; 9.1% met the criteria for recurrent case and 23.8% for severe case of CDI. The overall mortality rate was 28.7%. Comorbidity conditions occurred in 91.1%, previous exposure to antibiotics in 76.2%, and proton pump inhibitors in 77.2%. Recurrent and severe cases were significantly associated with renal insufficiency and creatinine levels ≥2 mg/dL. The survey based on the centralized laboratory data was useful to study CDI epidemiology in the different centres in order to identify possible weaknesses and plan control strategies, in particular the reinforcement of staff training, mainly targeted at compliance with contact precautions and hand hygiene.

Collusion in Public Contracts Procurement: Suppliers of School Cleaning Services Fined for Bid Rigging (Italy)

Over the past years the Italian Competition Authority (ICA) has taken an aggressive enforcement stance against bid rigging arrangements. To establish a bid rigging, the ICA is subject to the same evidentiary onus as the European Commission, having to prove anomaly bidding patterns, the lack of alternative plausible explanation for such conducts as wells as contacts and exchange of sensitive information between the colluders. In School Cleaning Services, the ICA found that a consortium of operators and three other firms breached Article 101 TFEU for collusive tendering and imposed fines amounting to the impressive sum of 113 million.

A Study of the Strategies Adopted by Italian Enterprises in China for the Protection of Intellectual Property

Italy is a major manufacturing exporter. The export revenue takes up a significant proportion of its national income to which exported commodities of Italian brands contribute a great deal. This is why the Italian authority has been making continuous efforts to crack down on intellectual property infringement for the protection of Italian exports and ultimately the stability of the Italian economy. Once entering the Chinese market where counterfeit consumer goods go rampant, Italian enterprises have the urge to fight against different kinds of counterfeiting under the intellectual property laws so that the trustworthiness among consumers and the benefits brought by intellectual property rights protection can be maintained.

The Italian Competition Authority Clears a Co-Marketing Agreement for the Commercialization of a Drug Imposing a Number of Commitments on the Parties

The Italian Competition Authority (ICA) has closed by a commitment decision an Article 101 TFEU investigation into a co-marketing agreement. The parties offered to amend the agreement by removing and eliminating the clauses of the agreement that were thought to be conducive to market sharing between the parties. Arguably, the ICA saw that the co-marketing agreements might have pro-competitive effects if they are not price-fixing or market sharing arrangements in disguise.

New limits to the remote monitoring of workers' activities at the intersection between the rules of the Statute and the privacy Code

This paper examines the provisions contained in the new article 4 of the Worker’s Statute that limit the employer’s monitoring powers.After more 40 years, this article is being changed by article 23 of d.lgs. 151/2015 with the purpose to revise the legislation in connection with development of modern technologies.In particular, emphasis is given to the difficult to implement and interpret the law in relation to the scope for employers to control how employees use the internet and emails at work.The new article is analysed in accordance with the rules of Italian Data Protection Code (d.lgs. 196/2003) and the norms laid down by the Italian Data Protection Authority.

The Nonmydriatic Fundus Camera in Diabetic Retinopathy Screening: A Cost-Effective Study with Evaluation for Future Large-Scale Application.

Aims. The study aimed to present the experience of a screening programme for early detection of diabetic retinopathy (DR) using a nonmydriatic fundus camera, evaluating the feasibility in terms of validity, resources absorption, and future advantages of a potential application, in an Italian local health authority. Methods. Diabetic patients living in the town of Ponzano, Veneto Region (Northern Italy), were invited to be enrolled in the screening programme. The “no prevention strategy” with the inclusion of the estimation of blindness related costs was compared with screening costs in order to evaluate a future extensive and feasible implementation of the procedure, through a budget impact approach. Results. Out of 498 diabetic patients eligible, 80% was enrolled in the screening programme. 115 patients (34%) were referred to an ophthalmologist and 9 cases required prompt treatment for either proliferative DR or macular edema. Based on the pilot data, it emerged that an extensive use of the investigated screening programme, within the Greater Treviso area, could prevent 6 cases of blindness every year, resulting in a saving of €271,543.32 (−13.71%). Conclusions. Fundus images obtained with a nonmydriatic fundus camera could be considered an effective, cost-sparing, and feasible screening tool for the early detection of DR, preventing blindness as a result of diabetes.

Incentives to quality and investment: evidence from electricity distribution in Italy

This paper investigates the relationship between output-based incentives for service quality and the use of capital and non-capital resources to meet regulatory targets in the electricity industry. To conduct the empirical analysis we use a dataset collected with the support of the Italian energy regulatory authority, comprising micro data on monetary incentives and physical assets for the largest electricity distribution operator in Italy (86 % of the market). Our results show that physical assets and operational expenditures do affect service quality. Moreover, when we investigate causality in the relationship between incentives to quality and the use of capital and non-capital resources, we find that incentives Granger-cause capital expenditures (and not vice-versa). Finally, our results reveal an asymmetric effect of rewards and penalties on capital expenditures’ decisions across areas with different quality levels. From these findings, we derive several policy implications.

The Italian Guidelines on the Method of Setting Fines. A (Half) Step Towards Transparency and Deterrence

In this paper, we examine the new Italian Guidelines on the method of setting fines for antitrust law infringements in the broader context of Italian antitrust public enforcement. The analysis of the new Guidelines is interesting for at least three reasons. Firstly, in drafting the new guidelines the Italian Competition Authority (ICA) adopted a comprehensive approach, taking into account that the method of setting fines may affect all the other elements of the sanctioning system. Thus, even if the Guidelines deal specifically only with the quantifications of fines, many elements of the new methodology have been designed to affect other important areas of the antitrust enforcement, particularly the leniency programs. Secondly, the new Guidelines clearly witness a shift towards an antitrust enforcement system based on deterrence. Unfortunately, the ICA’s very formal interpretation of the notion of undertaking undermines, if not completely annuls, the efforts towards heavier fines on naked cartels and exclusionary abuses of dominant position. Finally, in choosing the quantification method, the ICA largely followed the 2006 EU Guidelines on the method of setting fines. This should not come as a shock considering that Italian antitrust law closely mirrors Articles 101 and 102 TFEU. It should be pointed out, however, that the ICA resisted to the pleas of many commentators, urging it to follow other more lenient or in any case different national models. We think that, also in light of the allocation principles laid down in the Notice on the cooperation within the network of European Competition Authorities, a high degree of harmonization between the EU and the Italian antitrust sanctioning systems is beneficial to assure a level playing field for companies operating in the Italian markets.

Temperature and salinity effects on cadmium toxicity on lethal and sublethal responses of Amphibalanus amphitrite nauplii

The official protocol of an ecotoxicological assay employing larvae of the crustacean Amphibalanus amphitrite as a model organism has recently been published by the Italian regulatory authority UNICHIM. Such assay is now one of the applicable tests for water quality assessment under Italian law. While specific temperature and salinity values are recommended by ecotoxicology bioassay protocols for test set up, little information is available on response changes in case of parameter variations. In particular, information is totally lacking for this innovative model organism. Under the standard test protocol, 20°C and 37‰ temperature and salinity, respectively, are required to be set in A. amphitrite bioassay. In order to evaluate the environmental relevance of the test, laboratory experiments simulating the effect on larval responses due to variations of temperature and salinity expected in field collected samples were carried out. The effect of temperature and salinity changes on different end-points, involving increasing sensitivity levels, has been investigated, with and without the presence of cadmium nitrate, Cd(NO3)2, as a reference toxicant, to determine the possible interactions between pollutants and environmental parameters fluctuations. Three end-points – mortality, immobilization, and swimming speed alteration – were measured in order to evaluate the impact of a wide range of temperature (5, 10, 15, 20, 25, 30, 35, 40°C) and salinity values (10, 20, 30, 37, 40, 50, 60, 70‰) on response variation after 24 and 48h of exposure. For each parameter, a Non-Effect Range (NER) – namely the limit values within which no effect related to environmental parameter changes is observed – has been defined. For both parameters, NER resulted to be wider for the less sensitive end-points – such as mortality and immobilization – and for shorter exposure time (24h). Later, the same end-points have been evaluated by exposing the same organisms to a reference toxic compound, Cd(NO3)2 (0, 0.2, 0.4, 0.8, 1.6, 3.2mg/L), within the detected NER both for temperature and salinity. LC50 and EC50 values have been calculated for each end-point after 24 and 48h. Cadmium toxicity was shown to decrease at higher salinity values and increase at higher temperatures.Obtained results offer a better bioassay characterization, and the possibility of a more realistic estimation of ecotoxicological assessments performed on field collected samples. Further studies are needed, especially to investigate the effects of simultaneous salinity and temperature changes on end-points.

Building and fuel poverty, an index to measure fuel poverty: An Italian case study

Fuel Poverty is a big challenge for everybody: politicians, decision-makers, technicians, researchers, etc. In Italy, a strategy to solve fuel poverty involves action in order to reduce energy prices, the AEEG (Italian regulatory authority for electricity gas and water) has defined an Assist Tariff for poor people. Fuel poverty depends on family income and energy prices. Building energy performance also influences required energy consumption, and is a contributing cause of fuel poverty. Subsequently, it is possible to introduce a new Fuel Poverty risk Index, correlated to Building Energy Performance: the Building Fuel Poverty index. The Building Fuel Poverty Index (BFP) allows us to quantify how many buildings need direct action and/or just economic incentives.The index should be adopted in order to identify subjects that can afford to pay building energy refurbishment. The paper proposes an index in order to evaluate fuel poverty condition correlated to building energy performance.

"Competition for the field" and pricing regulation: the case of the natural gas distribution in Italy

Recently, looking at the incoming tenders for the new territorial districts in Italy, the Italian energy authority approved the new regulatory regime for the natural gas distribution where the difference between the VIR (residual industrial value) and the RAB (regulatory assets based) is recognized only to the new entrant (disparity of treatment). This article demonstrates that this decision is sub-optimal for firms and consumers. Compared to the situation under parity of treatment (the difference VIR-RAB is recognized for both new entrant and incumbent), the authority’s choice implies distorted results (the less efficient firm would win the tender) and higher final prices for consumers.

Natural geochemical risk in the Pollino Massif: a case-study of chromium

Natural geochemical risk in the Pollino Massif: a case-study of chromium

The Strange Case of Dr. Lucentis and Mr. Avastin. The Italian Competition Authority Fines Roche and Novartis for Collusion

The article aims at retracing the main elements of an antitrust proceedings carried on by the Italian Competition Authority against the Roche and Novartis groups for an alleged infringement of article 101 TFEU. In the antitrust authority's view, as expressed in a formal decision adopted on March 2014, the cartel was set up in order to control the sales of two biotech pharmaceutical products, Avastin and Lucentis, within the Italian relevant market of the drugs used for curing vascular ocular diseases. The article details and discusses the decision, also providing further considerations concerning artificial product differentiation, off-label uses and human rights protection.

Measuring spatial effects in the presence of institutional constraints: The case of Italian Local Health Authority expenditure

Over the last decades spatial econometric models have represented a common tool for measuring spillover effects across different geographical entities (counties, provinces, regions or nations). The aim of this paper is to investigate the issue of measuring spatial spillovers in the presence of institutional constraints that can be geographically defined. In these cases, assuming that spatial effects are not affected by the institutional setting may produce biased estimates due to the composition of twodistinct sources of spatial dependence. Our approach is based on redefining the contiguity structure so as to account for the institutional constraints using two different contiguity matrices: the within matrix, which defines contiguity among units obeying the same institutional setting, and the between matrix, which traces spatial linkages among contiguous units across different jurisdictions. This approach allows to disentangle the two sources of spatial correlation and to easily test for the existence of binding institutional constraints. From the econometric perspective, we extend Lacombe (2004) approach to incorporate the aforementioned institutional constraints in a spatial Durbin model with individual specific slopes, while inference is conducted using a two-way cluster robust variance–covariance matrix controlling for both spatial and time correlations. We apply this methodology to analyze spatial dependence of per-capita public health expenditures in Italyat Local Health Authority level using a balanced panel dataset from 2001 to 2005. Our results show robust evidence of a significant and positive spatial coefficient for the within effect, while the between effect, although significant, is very close to zero, thus confirming the importance and validity of the proposed approach.

The Italian smart grid pilot projects: Selection and assessment of the test beds for the regulation of smart electricity distribution

Nowadays grid connected renewable energy sources have reached a level that was not even conceivable just few years ago with serious concerns on power systems’ stability and security. The Italian TSO and the Italian regulatory authority for electricity, gas and water system (AEEGSI) pioneered this field, and imposed the participation of distributed generation (DG) into voltage and frequency regulation for reducing the risk of loosing significant power generation during frequency transients. Smart grids are the next step towards DG integration. In 2010, the AEEGSI demonstration phase on smart grids was designed according to an input based incentive scheme and a competitive selection process in order to award a limited number of projects. According to AEEGSI resolution ARG/elt 39/10, the selected smart grid demonstration projects did benefit from an extra remuneration of capital cost (a 2% extra WACC in addition to the ordinary return) for a period of 12 years. All projects are now in the rollout phase and the first data are going to be collected from the field in a real world environment. This paper gives a brief description of the projects and adds information about the selection criteria that allowed identifying what are the benefits that the system stakeholders should expect by the innovation of distribution operation and planning. Furthermore, the procedure used to define a regulatory environment suited for smart grids is described. The main idea is to define the fundamentals of a fair and transparent regulation mechanism based on different levels of smartness and on the identification of some suitable indicators that allow the AEEGSI to establish the expected performances of novel smart grids and, consequently, to define penalties and/or rewards for DSOs. With the aid of some examples the role of indicators is showed.Finally, it must be remarked again that the SG projects are in progress and field data are not yet disposable. This is the reason why the numerical simulations reported in this paper have been developed on a reference network that can represent the behaviour of some of the real SG networks relevant to the projects; such simulations have been performed in order to better quantify the benefits that the stakeholders of the system should expect. When the projects will enter the operation phase the field data collected after the new operational approach will be collected and can be used to verify the simulations hypothesis assumed.