- Latest Updates:
- 26/02/2021: Update on Easing of measures (transition measures): Governance by Antonio Giulio de Belvis, Giovanni Fattore, Alisha Morsella, Gabriele Pastorino, Andrea Poscia, Walter Ricciardi, Andrea Silenzi
- 26/02/2021: Update on Governance by Antonio Giulio de Belvis, Giovanni Fattore, Alisha Morsella, Gabriele Pastorino, Andrea Poscia, Walter Ricciardi, Andrea Silenzi
The GOVERNANCE of the health system with regard to COVID-19 relates to pandemic response plans and the steering of the health system to ensure its continued functioning. It includes emergency response mechanisms, as well as how information is being communicated, and the regulation of health service provision to patients affected by the virus.
On 3rd April 2020, the National Health Institute (ISS ) confirmed that there had been a decrease in the transmission of the virus, implying that mitigation measures are working and confirming the positive impact of social distancing. Due to the different intensity of exposure and to differences in regional responses to the epidemic, Italy will not see an end to the emergency all at once. On 20th April 2020, the National Observatory on Health in the Italian Regions released a timeline estimating the earliest date in which it will be possible to register zero new cases for each region, according to which Basilicata and Umbria will be the first (21st April) followed by Molise, Sardinia and Sicily, in the following week. The majority of regions will then gradually exit as May progresses, whereas Marche and Lombardy will have to wait the longest (27th and 28th June, respectively). This projection is based on data made available daily by the Department of Civil Protection from 24th February to 17th April 2020 and on the lockdown measures that have been implemented nationwide and shows how the next stage of dealing with the crisis ought to occur gradually and at with different timing among regions.
During the first week of April 2020, some considerations were made as to what to expect once complete lock-down is over and the country moves on to the second phase, gradually lifting restrictions. Although the outcome of the discussion between the ISS, the government and the Scientific and Technical committee will be disclosed once technical opinions are formalized, Health Minister Roberto Speranza outlined the future strategy to re-open productive activities and industries in an interview released on 5th April 2020. The plan focuses on developing a viral map of the country by resorting to nationwide screening and technology-intensive case tracking through an app that traces movements and contacts, which also gives access to key telemedicine and digital health services.
COVID-19 hospitals will be kept in place to address future waves of patients, however measures will be taken to strengthen local and community healthcare, further distancing the National Health System from a hospital-centred model. Indeed, the very high infection rates among medical personnel (8,920 healthcare professionals infected by 30th March 2020) have shown Italy, and other countries, the importance of limiting patient access to hospitals, except when absolutely necessary.
Through the ‘Relaunch Decree’ of 19th May (n° 34) 2020 and its latest amendments of 28th June, for example, it was established that in the years 2020 and 2021 the Ministry of Health will coordinate a series of activities to promote the integration between social and health services. This will be done by activating structures for health promotion, prevention and rehabilitation of the most fragile categories of people. The initiatives will involve local institutions, voluntary associations and non-profit third sector entities. Projects must include intervention methods that favour the shift from institutionalized to home care. This shift will be supported by an increase of the National Health Fund by EUR 20 Million in 2021 to finance GP internships.
Furthermore, strategies will have to be developed to minimize the risk of household transmission, protect health and social workers and prioritize the protection of the frailest citizens, such as the elderly in retirement homes. Social distancing measures might need more restrictive legal measures if necessary, and recommendations to optimize the use of available diagnostics and PPE will need reinforcing.
On 10th April 2020, it was decided that the two main pillars of Phase 2 would be the institution of a Committee of 19 experts in social and economic matters, and a protocol for safety in the workplace.
On the evening of April 26th 2020, the Prime Minister unveiled the containment measures of the so-called “Phase 2”, aimed at gradually lifting restrictions starting from 4th May 2020. The Prime Minister also announced that the Ministry of Health is working on the elaboration of specific epidemiological parameters to build “safety thresholds” on the basis of which ad hoc local lockdowns will be imposed (see Transition measures: Physical distancing, and Transition measures: measures in other sectors.
According to the latest Report elaborated by the Scientific and Technical Committee for the planning of Phase 2, if Italy were to completely lift lockdown, a second peak in the number of infected would occur on June 8th, with an expected demand of 151 000 intensive care beds, reaching 430 000 by the end of the year.
The Committee’s directives recommend keeping R0, the “basic reproduction number” (indicating how many people each positive case is likely to infect) below 1, as values even slightly above (for example in the range between 1.05 and 1.25) would significantly impact the health system, highlighting that the room for manoeuvre is very narrow. Currently maintained between 0.5 and 0.7 (as of April 28th 2020), R0 would jump to 2.25 should all lockdown measures be interrupted. After simulating a total of 92 predictive models, the Committee’s report shows that the only economic activities that the country can afford to activate are manufacturing and construction plus all commercial trading related to the first two, with the imperative that social distancing and hygiene safety measures are respected. Following this route leads to an estimated R0 of 0.69 and a decrease in the number of ICU admissions. Reopening bars and restaurants would create too much social interaction which, according to the forecast models, would lead to a rise of R0 above 1. This would occur even if the population group over 65 (47% more susceptible to contagion) were to be excluded. For the same reason, the government has chosen not to reopen schools, which would lead to an increase of 50,000 cases needing ICU by the end of the year. On the other hand, allowing people to pay visits to family members maintains the basic reproduction number below 1. The Committee, who was not in favour of this concession, has also underlined that, up to now, there is still limited scientific evidence concerning the effectiveness of using masks for the general population.
In hindsight, it appears that the management and transitioning of the pandemic led to a proliferation of decrees, laws, regulations and administrative acts, that created a ‘legislative jungle’. FB&Associati, an Italian advocacy company, has calculated that in phase I only, the central state has issued some 200 legislative acts, and the regions have issued a total of 593 regional acts. A review of the legislation produced during the pandemic underlined that, while some regions reinforced national policies adopted at national level, in some cases such acts were not fully coherent with national decisions, creating governance challenges in the management of the pandemic.
As established by Prime Ministerial Decree n.126 of 17 May 2020, Regions and Autonomous Provinces are authorized to define escalation/de-escalation methods and timings for transitioning to post-lockdown phases. To support this process, the Ministry of Health and the National Health Institute (ISS) have released new guidelines ("Prevention and response to COVID-19: strategies and plans for the autumn-winter transition phase”) and set up a monitoring system for the weekly assessment of health services’ risk and resilience, whose data is shared with the Regions and jointly evaluated by Ministry of Health, ISS Regional experts. These guidelines guide Regional decision-making by providing four distinct transmission scenarios in the autumn-winter period:
- SCENARIO 1: localized transmission (outbreaks) substantially unchanged compared to July-August 2020, with many Regions at low or moderate risk; however, with possible high-risk contexts at sub-regional level.
- SCENARIO 2: sustained and widespread transmissibility (many Regions with moderate to high risk levels) but manageable by the health system in the short-medium term.
- SCENARIO 3: sustained and widespread transmissibility (many Regions with high risk levels) manageable by health system in the medium term.
- SCENARIO 4: uncontrolled transmissibility with criticalities in the health system in the short term.
For each of these, related measures and approaches to escalation and de-escalation are further detailed.
After the institution of a new government on 13th February 2021, new Prime Minister Mario Draghi presented his government program to the Senate on 17th February. With regards to public health governance, three areas have been addressed as priorities for the upcoming months:
- Resuming normal school activities;
- Accelerating vaccination campaigns, also by increasing as much as possible the number of public and private facilities able to administer vaccines;
- Reforming the healthcare system as a whole, with the intent of shifting towards a local-care based model, strengthening and redesigning out-of-hospital care and creating a strong network of basic services (community homes, community hospitals, counseling centers, mental health centers, proximity centers against health poverty).
Essential institutional resources to pursue these objectives will be the Department of Civil Protection and the armed forces as well as numerous volunteers.
Emergency regulation concerning privacy
Once the State of Emergency was declared on 31st January 2020, Civil Protection ordinances and decree laws, constitutionally recognized as the fundamental to the emergency regulation infrastructure, are characterized by their exceptional nature and their derogatory scope outside the principles and institutions of the country’s ordinary legal system. Since 31st January 2020, the Department of Civil Protection has adopted various ordinances limiting fundamental rights in an effort to contain the epidemic for the safety and health of its citizens.
More specifically, after receiving the formal consent from the Italian Data Protection Authority, article 5 of the Civil Protection’s Order of 3rd February declared that to optimize personal data flows, the Civil Protection Service is authorized to process personal data even if sensitive or judicial, if strictly necessary. If essential to contain the pandemic, such data can also be disclosed to public and private entities. Subsequently, article 14 of decree law 9th March 2020 n° 149 underlined the temporary nature of such provision.
- National Observatory on Health in the Italian Regions, Press Release 20th April 2020 https://www.osservatoriosullasalute.it/wp-content/uploads/2020/04/new-19-aprile-Definitivo-CS-COVID-19-Osservatorio.pdf
- Decree 26th April 2020 n° 108 - “Additional implementing provisions for Law-decree N° 6 of 23rd February 2020, regarding Urgent measures to contain and manage the epidemiological emergency due to COVID-19, applicable to the entire national territory”
- Law Decree 19th May 2020, n. 34 - Urgent measures in the field of health, support for work and the economy, as well as social policies connected to the epidemiological emergency caused by COVID-19. [Available at https://www.gazzettaufficiale.it/eli/id/2020/05/19/20G00052/sg]
- Amendments to Law Decree 19th May 2020, n. 34 of 28th June – [Available at http://www.quotidianosanita.it/allegati/allegato8651425.pdf]
- Ministero della Salute. “Linee di indirizzo per la progressiva riattivazione delle attività programmate considerate differibili in corso di emergenza da COVID-19”. Giugno 2020. [Available at: https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2020&codLeg=74374&parte=1%20&serie=null]
- ALTEMS. Instant REPORT#18: 03 Settembre 2020 [Available at: https://altems.unicatt.it/altems-instant%20report%2018.pdf]
- Prevenzione e risposta a COVID-19: evoluzione della strategia e della Salute, Istituto Superiore di Sanità; 2020 [Available at: https://www.iss.it/documents/20126/0/COVID+19_+strategia_ISS_ministero+%283%29.pdf/e463c6e7-6250-109c-1c74-d2f8262f5056?t=1602672178859
Pandemic Preparedness and Response plans
Following the WHO 2005 recommendations in response to the outbreak of the Asian Avian Influenza A/H5N1 virus, in 2007 Italy formulated a National Plan for Preparedness and Response to an Influenza Pandemic structured in six phases, detailing objectives and actions to be taken at each step, including guidelines for the formulation of coordinated regional operative plans. The national guidelines and action plans are released and meant to be periodically updated by the National Centre for Disease Prevention and Control (CCM). The aim is to identify, confirm and report cases in a timely manner, minimize the risk of transmission and limit morbidity and mortality - overall reducing the impact of the pandemic on health and social services. Included advice outlines: ensuring adequate training for personnel, guaranteeing up-to-date and well-timed information for decision-making, reporting on the efficiency of undertaken interventions and epidemiological surveillance. Key actions include the implementation of prevention and control measures (public health measures, prophylaxis with antivirals, vaccination) and guaranteeing treatment and assistance to those in need.
Responding to the need for a new Pandemic Preparedness Plan that was fit for purposed for the COVID-19 emergency on 25 January 2021, the State-Regions Conference ratified the agreement on the document "National strategic operational plan for the preparation and response to an influenza pandemic (PanFlu 2021 - 2023). The Plan was published on 29th January 2021 with the approval of the National Institute Against Accidents at Work (INAIL), the National Health Council and the National Health Institute. The new plan (http://www.salute.gov.it/imgs/C_17_pubblicazioni_3005_allegato.pdf) is based on two main pillars:
- Preparedness: in public health emergencies, this includes planning, coordination, timely diagnosis, evaluation, investigation, response and communication, needed to minimize risk of infection and mitigate impact.
- Readiness: as intended by WHO recommendations, the Plan contains actionable strategies for the responses established in the Preparedness pillar.
Notwithstanding the availability, on paper, of an Influencza National Plan, Italy was hit by what is considered its biggest crisis since World War II in only a few weeks. At first, the magnitude of the COVID-19 threat was not easily recognizable, making real-time crisis-averting decisions harder to take. Apart from its general principles, the operative framework of the Influenza National Plan (eg. defining roles and timing of actions) was not followed.
On 22nd January 2020, the government started issuing some precautionary measures, such as airport controls for citizens coming from Wuhan, body temperature measurements and, eventually, blocking all flights to and from China. On 5th February, the Department of Civil Protection instituted the Scientific and Technical Committee, which is composed of about twenty members and plays a key role in the central government’s decision-making process. The Committee has evolved and changed over these months, integrating new experts from time to time in relation to specific needs. Its purpose is to provide guidance based on scientific evidence during the emergency phase and during the gradual social and economic recovery phase.
Once the first positive cases were verified, the government accelerated efforts by declaring a six-month State of Emergency on 31st January, to create a fast-track for actions against the spreading of the disease. This date marked the beginning of a cascade of measures taken on behalf of the central government, based on evaluations by the Scientific and Technical Committee. In the following days, the coordination of interventions and conduct of rescue and assistance to address the emergency was assigned to the Department of Civil Protection. The National Surveillance System, on the other hand, is coordinated by the ISS and oversees the daily gathering of data from regions and from ISS’s National Laboratory for SARS-CoV-2.
It is important to note that in a country with such a decentralized health system (Italy is often described as having “21 different healthcare systems”) there have been rapid changes in health governance in order to face the national threat represented by the COVID-19 outbreak. The extraordinary character of the pandemic, in fact, legitimized state intervention and the activation of the Department of Civil Protection to support regions in the procurement of pharmaceuticals, medical devices, human resources and infrastructure, in tight collaboration with the ‘Extraordinary Commissioner’, nominated on 18th March. According to Italian legislation, in urgent or extraordinary situations, the government can decide to centralize - or increase - administrative authority to a chosen delegate, for a fixed period. In this case, the role of “Extraordinary Commissioner for the implementation and coordination of measures to contain and combat the epidemiological emergency COVID-19 ", was assigned to the CEO of Invitalia, the national Agency for inward investment and economic development. While, in normal circumstances, regions enjoy a great deal of autonomy in decision-making, central government decisions cannot be derogated by regional and local bodies, especially when they are issued through legislative decrees, unless they result in more restrictive measures. It does appear that regional governments and the central government are currently engaged in preliminary consultations and information flows before the central government or the Ministry of Health issue new actions.
Notwithstanding the increased role of the central government, regions still retain decision- making autonomy regarding the delivery and organization of health services, such as whether to conduct COVID-19 tests on the regional entire population. Such decisions, however, must be adequately motivated in terms of clinical efficacy and taken on the basis of available regional resources. This means that different regions have been trying different policy responses. A prominent example is the different approaches taken by the Lombardy and Veneto regions. Aside from being the two regions most affected by the crisis, these two neighbouring regions also possess a similar socioeconomic profile. They have both imposed social distancing measures and retail closures, but Veneto has applied a more proactive strategy aimed at containment. It performed tests on asymptomatic cases at a very early stage and then traced potential positives. Once someone was found to be infected, their families and neighbours were tested in turn or, if testing kits were not available, they were quarantined. Home care and diagnoses are also strongly emphasized (for example, when possible, samples are collected at home) and healthcare and essential workers are specifically monitored. Lombardy, proportionally to its population, has conducted half the number of tests performed in the Veneto region and has focused only on symptomatic cases; it is undertaking less tracing, home care and monitoring healthcare workers.
Another example is the regional measures on face masks adopted in Lombardy. National guidelines follow WHO recommendations and impose their utilization only on health professionals and Covid-19 positive patients. Further, the ISS has consistently highlighted that there is little scientific evidence regarding the effectiveness of having the entire population use them in an attempt to prevent infection. However, Lombardy’s governor has issued an ordinance that makes wearing protection over mouth and face mandatory, starting from 5th April.
- Ministry of Health, 2006. National plan for preparedness and response to an influenza pandemic http://www.salute.gov.it/imgs/C_17_pubblicazioni_511_allegato.pdf
- Council of Ministers’ Resolution, 31st January 2020 - “Declaration of a state of emergency due to health risk linked to the insurgence of pathologies deriving from transmissible viral agents” www.gazzettaufficiale.it/eli/id/2020/02/01/20A00737/sg
- Polillo R. Dieci proposte per rilanciare il nostro Servizio Sanitario di Roberto Polillo, Quotidiano Sanità. Banchieri G, Vannucci A. COVID19 – Review n.25 del 09.04.2020 https://www.ilfattoquotidiano.it/2020/04/27/coronavirus-azzolina-scuole-chiuse-un-dolore-ma-aprirle-rischia-di-vanificare-gli-sforzi-ma-abbiamo-ok-per-maturita-in-classe/5783051/