5. Provision of services
he Ministry of Health is the main institution responsible for public health at the national level. Immunization and screening programmes are considered to be priorities. In addition to the mandatory and voluntary routine immunization programmes, pap tests, mammography and colorectal screening are offered free of charge to target populations nationally.
Primary care services are delivered by health districts, the operative branches of local health authorities. Over the last 15 years, there have been attempts to reorganize the delivery of primary care, with the objective of moving from the traditional model of GPs and other health professionals working in single practices to an integrated care model that connects different health-care professionals and bridges the gap between frontline staff and patients, though change has been slow.
Inpatient care is provided through a network of accredited public and private hospitals, with GPs and paediatricians (who usually treat children up to the age of 6 or if parents so wish, up to the ages of 14–16) playing a gatekeeping role. In recent years there has been a progressive increase in Accident and Emergency Department (AED) admissions, some of which are due to inappropriate use by patients (e.g. for minor illnesses or prevention interventions that could have been treated by primary care physicians) for which co-payments of €25 are imposed (see above).
Medicines are grouped into three main classes: Class A are essential medicines that are reimbursable (but require a co-payment that varies by region) and include those indicated for the treatment of severe, chronic or acute illnesses. Class C includes non-reimbursable pharmaceutical products (though some regions opt to offer some reimbursement). Class H includes pharmaceutical products delivered only within hospitals. To contain pharmaceutical expenditure, the 2012 Spending Review reduced the budget for drugs used in non-hospital settings from 13.3% of total health-care expenditure to 11.35% in 2013. However, in the last decade, the cost of pharmaceuticals delivered by hospitals has significantly increased due to new expensive products and the delivery by hospital pharmacies of products that are then used outside hospital settings.
With regard to mental health care, the 1978 Basaglia Law marked the switch from institutional care to community mental health services. Subsequently, specific departments of mental health have been established within local health authorities. A priority remains closing the gap between the northern and southern regions with regard to the provision and quality of services, which remains a major challenge.
Health-care delivery to vulnerable or excluded groups has undergone a recent change in policy. After several years without specific regulations, legislation has now been defined to guarantee that immigrants (both legal and temporarily undocumented) are eligible to receive the same public health-care services that are available to Italian citizens.
The central issue with health service delivery is the heterogeneity of regional arrangements. In general, northern and central regions appear to keep pace with institutional, organizational and professional developments aligned with best international practices and in line with central government orientations, while southern regions appear to lag behind. The gaps between northern and southern regions mainly reflect socioeconomic and cultural factors that are far beyond the health-care system. However, it is also likely that decentralization policies introduced in the last two decades have not favoured the homogeneity of regional systems as they have provided opportunities for improvement to the best institutionally equipped regions while leaving southern regions with less central support to cope with more difficult social contexts.
5.1 Public health
The main institution responsible for public health at the national level is the Ministry of Health, which undertakes a stewardship role and sets the general policies targeting health improvement and prevention. Public health policies are implemented by the regions through their Departments of Health and ASLs, the remits of which include protection of the population’s health, health promotion, preventing diseases and disability, and improving quality of life. The main areas of activity are: public hygiene, occupational health, food and nutrition and veterinary health care.
5.1.1 Communicable diseases control programmes: vaccinations
The reduction or elimination of the burden of vaccine-preventable diseases is considered a priority of the public health service. The routine immunization programme includes diphtheria, tetanus (DT) and poliovirus (oral poliovirus vaccine – OPV) vaccinations, which have been mandatory by law since the early 1960s for all newborns under 24 months. The hepatitis B vaccine was added in 1991, introducing universal vaccination of infants and children (up to 12 years of age). Vaccinations against pertussis, measles, mumps, rubella, Haemophilus influenzae type b (Hib), meningococcal C and pneumococcal meningitis, chickenpox and human papillomavirus (HPV) are non-mandatory vaccinations but are recommended by the Ministry of Health. Compulsory and recommended vaccinations are included in the benefit package and are provided free of charge for all Italian and foreign children living in the country.
Regions are in charge of organizing and implementing their own vaccination strategy, based on the National Vaccination Plan (NVP). In 2012 a new NVP – NVP 2012–2014 – was released, which emphasizes the right to vaccination, defines the specific objectives to be reached for the population and certain risk groups and sets the standards for vaccination coverage (Ministero della Salute, 2012b). ASLs and the Ministry of Health are responsible for implementing the activities outlined in the plan. Childhood vaccinations are routinely provided through a well-established and organized network of public facilities and are usually administered by specific departments within ASLs. Moreover, primary care paediatricians are the key contacts for counselling and information; they verify that children have received vaccinations and can administer vaccines themselves.
To evaluate the efficacy of vaccination programmes, national and sentinel surveillance systems are used to collect data and provide information on the incidence of infectious diseases and vaccination coverage. SIMI is the statutory notification system, administered by the National Institute of Health, in collaboration with the Ministry of Health. Remarkable progress has been achieved in terms of coverage rates for the compulsory vaccinations, reaching an average of 96% and meeting the target of 95% set by the NVP, in accordance with WHO guidelines. With regard to the recommended vaccinations for measles, mumps and rubella (MMR), coverage (89.9%) has increased significantly over the last 10 years, even if further efforts are needed to meet the target of 95% and a certain degree of heterogeneity still persists, at both the regional and local level (Table5.1).
In March 2018 Giovanni Rezza, the head of the Infectious Diseases Department of Italy's Istituto Superiore di Sanità (ISS), released the first, preliminary data on the impact of the so-called Lorenzin Law, approved by the Italian Parliament on July 2017, which made ten vaccinations compulsory and free of charge for all children aged 0-16 (ie. polio, hepatitis B, tetanus, measles, Haemophilus influenzae Type B, diphtheria, mumps, rubella, pertussis (whooping cough) and varicella (chicken pox), the last only for children born in or after 2017).
"We have over 95% of children vaccinated for the six-in-one vaccine [covering diptheria, tetanus, pertussis, polio, Hib disease (Haemophilus influenzae type b) and hepatitis B], so the threshold that makes it possible to have collected immunity has been reached. In addition, thanks to the implementation of Lorenzin’s Law, we've had an increase of about 6% for the measles [vaccine] so we are close to that threshold in this case too” – Rezza said (ANSA, 2018).
Beatrice Lorenzin is the Italian Minister of Health who decided to make vaccinations a compulsory pre-requisite for registering children in school. Awareness was raised by public health experts when the average rate of children vaccinated for the six-in-one vaccine dropped below 93% in the first half of 2017.
The Law requires all nurseries and pre-schools (public and private) to notify the local ASL (Health Authority) when parents fail to present the necessary vaccination documents within ten days of the cut-off dates (Library of Congress, 2017). In March 2018, it was estimated that around 30,000 children were not in compliance with the Law (ANSA, 2018). In cases of non-compliance ASLs can request a meeting with parents to discuss the matter and establish a vaccination plan for their child. If parents still refuse they can be issued with a fine of between 100 and 500 Euros.
Most of the vaccines described in the Law (haemophilus influenzae B, pertussis, measles, mumps, rubella, chickenpox, meningococcal C and B) were previously just recommended but have now become mandatory.
The new measures have been interpreted as a reaction against the many anti-science behaviors and theories that have led to a decrease in population coverage in Italy.
At European level, the Italian Law is becoming a benchmark for other countries and EU institutions to counter the increase in cases of infectious diseases that are preventable through vaccination. In July 2017, soon after Lorenzin’s Law, the French Prime Minister Édouard Philippe announced that a series of vaccinations would also become mandatory for French children by 2018. Vaccinations included under this mandate would cover polio, pertussis, measles, mumps, rubella, hepatitis B, Haemophilus influenza bacteria, pneumococcus and meningococcus C (Lowe, 2017).
In addition, at EU level, the European Commission is proposing that Member States should agree on a set of joint measures, in the form of a Council Recommendation on vaccine preventable diseases, accompanied by a Commission Communication on the policy rationale for acting together in this area, thus giving Member States flexibility and the possibility to taking into account their history, practices and particular cultural challenges (European Commission, 2018).
ANSA (2018) Vaccine goal achieved, 95% coverage – ISS. ANSA News, 12 March, 2018. http://www.ansa.it/english/news/2018/03/12/vaccine-goal-achieved-95-coverage-iss-3_f73aff94-cde5-4430-b1f9-fe89d5248b44.html
European Commission (2018) Fact Sheet: EU cooperation on vaccine preventable diseases, April 26, 2018. http://europa.eu/rapid/press-release_MEMO-18-3458_en.htm
Library of Congress: Global Legal Monitor (2017). Italy: Vaccinations for Children Made Mandatory, 13 June 13, 2017. http://www.loc.gov/law/foreign-news/article/italy-vaccinations-for-children-made-mandatory/
Lowe J (2017) Child Health: Vaccinations For 11 Diseases Mandatory In France Starting in 2018, Newsweek, 5 July, 2017),. http://www.newsweek.com/france-vaccinations-compulsory-632060.
The new National Immunization Plan 2017-2019 (Piano Nazionale Prevenzione Vaccinale 2017-2019) was approved at the State-Regions Conference on 19th January 2017. A previous agreement had been signed at the end of 2015, but its approval was hampered by concerns over its financial sustainability and by the parallel development of Italy’s new benefits package (LEAs). Finalizing the LEA, which is deeply interweaved with the immunization plan to ensure successful and homogeneous implementation of the vaccination schedule across the regions, has been quite a complex process and its final approval was deferred several times until it was successfully passed on 12 January 2017.
The new immunization plan provides a renewed vaccine schedule to achieve the maximum possible protection based on current demographic and epidemiological needs. In addition to securing free-of-charge vaccinations for specific age groups and populations at risk, a top priority of the Plan is to eradicate measles, polio and rubella. Furthermore, it supports the empowerment of citizens with regard to understanding the social value of immunization, highlights the responsibilities of health care professionals to provide updated evidence-based education, and fosters the collaboration between national institutions and scientific bodies in research and technological developments.
In addition to the vaccines already included in the previous plan (covering the period 2012-2014) which included diphtheria, tetanus, poliomyelitis, hepatitis B, haemophilus influenzae B, pertussis, pneumococcus, measles, mumps, rubella, meningococcal C in newborns, HPV at age of eleven and influenza in individuals aged 65 and over), the new plan:
- Introduces Meningococcal B, rotavirus and chickenpox vaccines in newborns
- Extends HPV vaccination to 11-year-old males
- Introduces tetravalent anti-meningococcal and inactivated poliovirus booster doses for adolescents
- Foresees anti-pneumococcal and anti-zoster vaccinations in 65-year-olds
The Ministry of Health estimates that the National Health Service will need to invest €100 million in 2017, €127 million in 2018 and €186 million in 2019 for overall implementation, mostly related to purchasing the vaccines.
In terms of vaccination strategies, Italy is also facing the historical challenge against many anti-science behaviors and theories that have led to a decrease in population coverage. Therefore, the government recently approved a decree that introduces 12 compulsory vaccines for the enrollment of 0-6-year-old children in the school system, ie. in nurseries and pre-schools. Most of the vaccines described in the decree (haemophilus influenzae B, pertussis, measles, mumps, rubella, chickenpox, meningococcal C and B) were previously just recommended but have now become mandatory. Furthermore, parents refusing to comply with the vaccination schedule without medical reasons will be fined .
This decision emerges from the experiences of different countries, where mandatory vaccinations have already proved their efficacy. For example, in the US state of California the proportion of students attending kindergarten who have received all required vaccines rose to 95.6% after they were made compulsory (the highest coverage reported for the current set of immunization requirements for kindergarten), with a 5.2% increase in two years . In 2012 in Europe, 14 countries have at least one compulsory vaccination included in their programs .
- Decreto del Presidente del Consiglio dei Ministri 12 gennaio 2017. Definizione e aggiornamento dei livelli essenziali di assistenza, di cui all'articolo 1, comma 7, del decreto legislativo 30 dicembre 1992, n. 502. GU n.65 del 1832017 Suppl. Ordinario n. 15
- Ministry of health. Change after the law decree about vaccination. Available at: http://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=2951. Accessed 27th May 2017.
- 2016-2017 Kindergarten Immunization Assessment – Executive Summary, California Department of Public Health, Immunization Branch, available at: http://www.igienistionline.it/docs/2017/21california.pdf
- Haverkate et al. Mandatory and recommended vaccination in the EU, Iceland and Norway: results of the VENICE 2010 survey on the ways of implementing national vaccination programmes. Euro Surveill. 2012 May 31;17(22). pii: 20183
5.1.2 Occupational health
Driven by EC Directives, the occupational health sector has made significant progress in recent years. The Italian Occupational Health and Safety Act (Legislative Decree 81/2008) provides the legal framework, setting out the rights and duties of all parties in the workplace and harmonizing previous legislation. Due to spending cuts, in 2010 the National Institute for Occupational Safety and Prevention (ISPESL) was absorbed within the Italian Workers’ Compensation Authority (INAIL). This organization is responsible for the administration of the compulsory insurance scheme related to work/industrial accidents and occupational illnesses. Public funds are the main source of funding and are set through the National Health Fund, along with additional finance that can be provided by the regions and the European Commission. In all workplaces where workers can be exposed to specific risks an occupational health specialist must be appointed by law for medical check-ups of employees and education information activities.
5.1.3 Screening programmes
Since 2001, the government has adopted a series of measures to promote the widespread and uniform adoption of screening policies and guiding principles at the national level. Secondary cancer prevention has been included in the benefit package. To improve screening coverage and following the EU’s recommendation on cancer screening (December 2003), several plans have been developed with the aim of strengthening the diffusion of active programmes: National Health Plan (2003–2005), National Screening Plans (2004–2006 and 2007–2009) and National Prevention Plan (2005–2007). Moreover, Law 138/2004 contains a commitment to reduce the gap between the target and the screened population, allocating €50 million.
Important progress in the extension of screening programmes has been made in recent years (for example, see Fig5.1) Cervical pap tests, mammography and colorectal screening are offered free of charge to target populations nationally. For cervical cancer the pap test is offered every three years to women aged 25–64, in accordance with EU guidelines. Mammography screening is offered every two years to women aged 50–69. As for colorectal screening, current guidelines recommend two screening tests: the majority of programmes use the faecal occult blood (FOB) test in populations aged 50–69/74, while others (mainly those in the Piedmont and Veneto regions) have adopted flexible sigmoidoscopy (FS) once in a lifetime (or with a frequency of at least 10 years) in patients aged 58 or 60. The screening programmes are regulated and organized at the regional level through the ASLs, which actively invite the target population to have preventive tests (mammography, pap test, FOB test) free of charge. Participation in screening programmes is voluntary and several indicators are calculated to monitor screening invitations and uptake, which impacts on the efficacy of programmes in reducing cancer mortality. The National Centre for Screening Monitoring (Osservatorio Nazionale Screening) was created in 2002 and was charged by the Ministry of Health with monitoring and promoting screening programmes nationwide.
5.1.4 Smoking bans
It is worth mentioning that, as a major national public health measure to reduce the prevalence of tobacco usage, the introduction of a general ban of smoking in all public and working places was implemented in 2012. This ban, approved by parliament after a long history of attempts, was implemented rapidly (Mele & Compagni, 2010).
In 2013-2014 the recorded coverage rates for “compulsory vaccinations” were below the minimum levels recommended by the World Health Organization - that is, at least 95% for infants under 2 years of age. A slight decrease is also evident for some recommended vaccination rates, such as Hib (-0.6%) and Pertussis (-1.1%). More worryingly, major variations have been recorded for vaccine coverage of Measles, Mumps, Rubella (-4.0%) and meningococcal C conjugate (-2.5%). Furthermore, in the elderly population over 65, flu coverage rates have not reached minimum levels (75%) set by the National Vaccine Prevention Plan.
Osservatorio Nazionale sulla Salute nelle Regioni Italiane (2016) Rapporto Osservasalute 2015. Available at: www.osservasalute.it
In February 2016, new legislation implementing European Directive 2014/40/UE on the sale of tobacco and tobacco products came into force. The purpose of the new legislation is to guarantee a high level of protection for human health, particularly for young people, through the implementation of European and domestic legislation aimed at preventing tobacco addiction. The legislation regulates such matters as the ingredients, composition, and emission levels of cigarettes, as well as the labeling and manufacturing of tobacco products. There are severe penalties (imprisonment and fines) for manufacturers and importers who violate its provisions.
Decreto Legislativo 12 gennaio 2016, n. 6 Recepimento della direttiva 2014/40/UE sul ravvicinamento delle disposizioni legislative, regolamentari e amministrative degli Stati membri relative alla lavorazione, alla presentazione e alla vendita dei prodotti del tabacco e dei prodotti correlati e che abroga la direttiva 2001/37/CE. (16G00009) http://www.gazzettaufficiale.it/eli/id/2016/01/18/16G00009/sg
The Italian Ministry of Health has just approved the first National Prevention Plan for Hepatitis B (HBV) and Hepatitis C (HCV) with an emphasis on the latter. The Plan’s objective is to ensure uniformity of treatment across the country, in light of new therapies available against HCV, by setting diagnostic and therapeutic care standards and defining a unique diagnostic and therapeutic pathway. As a first step, the Plan calls for the development of epidemiological studies to understand the spread of the viruses across the country, particularly as incidence rates differ between the north and south. In addition, the Plan envisages the implementation of screening programs for groups considered at risk and promotes the development of health-economic studies to estimate the impact of new therapies.