On 3 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 (21 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 (27 and 28 June, respectively). This projection is based on data made available daily by the Department of Civil Protection from 24 February to 17 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 19 May (number 34) 2020 and its latest amendments of 28 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 10 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 26 April 2020, the Prime Minister unveiled the containment measures of the so-called “Phase 2”, aimed at gradually lifting restrictions starting from 4 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 8 June, 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 28 April2020), 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 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 13 February 2021, new Prime Minister Mario Draghi presented his government program to the Senate on 17 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.
The state of emergency ended on 31 March 2022. Law Decree No. 24 of 24 March 2022 set out urgent provisions to bridge the measures preventing the circulation of COVID-19 after the conclusion of the state of emergency. The Ministry of Health has been identified as the competent administrator for the continuation and coordination of ordinary interventions.
During April 2022, it remained compulsory to wear FFP2 masks in the following places: planes, trains, buses, other public transportations, event halls and other confined spaces. This was modified so that from 1 May 2022 the use of masks remained mandatory until 15 June for: local and long-distance public transport, indoor sports events and competitions, indoor shows, health, social and social welfare facilities and schools (until the end of the school year).
Green passes obtained after vaccination, certificates of recovery from COVID-19 or negative tests are required to access specific places and certain activities at national level. The new decree also updated the provisions relating to mandatory vaccination and relative categories such as health care professionals, military and security staff and education personnel. Management of COVID-19 cases in schools became less strict. The activities of the Special Unit for Continuity of Care (USCAs) for the management of home care and COVID-19 Tests were extended until 31 May 2022.
Provisions relating to quarantine obligations for the infected and relative health surveillance continue to be applied. Close contacts with a positive case must undergo self-monitoring requirements.
Emergency regulation concerning privacy
Once the State of Emergency was declared on 31 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 31 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.
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specifically, after receiving the formal consent from the Italian Data
Protection Authority, article 5 of the Civil Protection’s Order of 3
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 9 March 2020 number 149
underlined the temporary nature of such provision.