Policy responses for Italy - HSRM

Italy


Policy responses for Italy

3. Providing health services effectively

The section on PROVIDING HEALTH SERVICES EFFECTIVELY describes approaches for service delivery planning and patient pathways for suspected COVID-19 cases. It also considers efforts by countries to maintain other essential services during periods of excessive demand for health services.

3.1 Planning services

With the ‘Relaunch Decree’ of 19th May n° 34 and its latest amendments of 28th June, regions are allowed to authorize pharmacies to distribute medicines for Covid-19 which would be usually provided in hospitals to patients being treated at home.

COVID-19 vaccine agreement: regulating and monitoring access to experimental treatments

On 3rd June, France, Germany, Italy and the Netherlands joined forces with potential developers of a Covid-19 vaccine with the aim of manufacturing vaccines in Europe. A few days later, on 13th June, the Italian Ministry of Health signed a contract with the pharmaceutical company AstraZeneca for the supply of up to 400 million doses of a vaccine to be destined to the entire European population. The testing process is already at an advanced stage and is the result of collaboration between the University of Oxford and IRBM Science Park SpA, an Italian company that operates in the fields of molecular biotechnology, biomedical science and organic chemistry and which, in the past, has already developed the Italian anti-ebola vaccine. The experimental phase for the Covid-19 vaccine is expected to end in autumn with the distribution of a first portion of doses.

Sources:
- https://www.ilsole24ore.com/art/vaccino-italo-inglese-ministro-speranza-firma-l-accordo-400-milioni-dosi-AD4MgfX
- http://www.comune.pomezia.rm.it/IRBM
- https://www.government.nl/latest/news/2020/06/03/france-germany-italy-and-the-netherlands-working-together-to-find-a-vaccine-for-countries-in-europe-and-beyond
- 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]

On 1st March the Ministry of Health issued a circular requiring all regions to take action according to following recommendations/rules:
• Increase by 50% the number of intensive care beds
• Increase by 100% the number of beds in pneumology and infectious diseases wards (these beds should be equipped with adequate assisted pulmonary ventilation systems)
• Mainly use private contractors (private hospitals accredited with the NHS) for non COVID-19 patients; however, in Lazio and Lombardy, private contracted hospitals increased their capacity also for COVID-19 patients
• Re-allocate health professionals according to the internal re-organizations and provide a short training program if required

In the regions with higher infection rates hospitals were designated as COVID-19 hospitals (e.g., Sacco Hospital in Milan). In general, Covid-19 hospitals only admit patients and try to discharge or transfer patients who are not infected. Hospitals that continue to see non-Covid-19 patients must design a triage system to differentiate physical spaces for suspected Covid-19 patients.

Primary care physicians are assumed to be the first point of contact for patients with COVID-19 symptoms. If patients are not critical, they are asked to remain at home and to be taken care by their GP or medical continuity services (medical services for the hours in which GPs are not on duty). Patients are invited to stay at home and not to visit their GPs. GPs either visit their patients or manage them by telephone or skype. Some media report that many GPs in Lombardy and in other area where the incidence of Covid-19 is very high cannot cope with the demand and they often lack basic protection devices (masks and gloves). In general, an increase in the use of telephone and other devices as an alternative to physical visits has been reported.

There is a national designated telephone helpline (1500). In addition, each region has its own helpline that gives more specific information. Some municipalities have activated additional helplines (e.g., for supporting daily life for frail people).

REGULATING AND MONITORING ACCESS TO EXPERIMENTAL TREATMENTS
For the duration of the emergency, the Italian Medicines Agency (AIFA) has activated a simplified procedure to ease, regulate and monitor access to potentially useful pharmaceuticals and treatments in the fight against COVID-19 and the website provides a continuously updated list of drugs that are being experimented (https://www.aifa.gov.it/sperimentazioni-cliniche-covid-19).  On 4th April, ISS highlighted that since 17th March, AIFA evaluated 53 proposals for experimental clinical trials of which 8 were also approved by the ethical committee.  Patient recruitment has already begun. 
By 8th May, AIFA’s Scientific and Technical committee has approved seven clinical studies in Lazio, four in Lombardy and in Emilia Romagna, two in Veneto and one in Piedmont, in Tuscany, in Campania and in Umbria, for a total of 21 trials. Of these, six are managed by for profit promoters and the remaining 15 by not-for-profit agencies.

Source
- https://www.aifa.gov.it/informazione-continua-sui-farmaci
- ALTEMS Covid-19 working group - Instant REPORT#6: 8 Maggio 2020  - Analisi dei modelli organizzativi di risposta al Covid-19, available at https://altems.unicatt.it/altems-6REPORT%20ALTEMS.pdf