12 June 2023 | Policy Analysis
The National Oncology Plan 2023–2027The Ministry of Health is the main institution responsible for public health at the national level. It 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 local health authorities, the remits of which include protection of the population’s health, health promotion, preventing diseases and/or disability and improving quality of life. The main areas of activity are public hygiene, occupational health, food and nutrition, and veterinary health care.
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 infants under 24 months. The hepatitis B vaccine was added in 1991, introducing universal vaccination of infants and children up to 12 years of age. In July 2017, a national law added vaccinations against pertussis, haemophilus influenzae type b1, measles, rubella, mumps and chickenpox, to make a total of 10 compulsory vaccines (D’Ancona et al., 2019). All compulsory vaccinations are fully covered by the SSN.
In Italy, regions oversee the organization and implementation of their own vaccination strategy based on the National Vaccine Prevention Plan (Piano Nazionale Prevenzione Vaccinale, PNPV) (Ministero della Salute, 2017a). The latest PNPV was published in 2017 and was originally valid until 2019, but its validity was extended to the end of 2021 due to the COVID-19 pandemic.[12] This plan aims to reduce/eliminate vaccine-preventable diseases by identifying effective and homogeneous strategies to be implemented on a national scale. The PNPV was designed taking into consideration the European Vaccine Action Plan 2015–2020, which constitutes a response to the Global Vaccine Action Plan 2011–2020 developed by WHO. Local health authorities and the Ministry of Health are responsible for the implementation of activities outlined in the plan. In Italy, childhood vaccinations are routinely provided through a well established and organized network of public facilities and are usually administered by specific departments within local health authorities. Moreover, primary care paediatricians are the key contacts for counselling and information regarding vaccines; 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. For this purpose, a National Vaccine Registry was created in September 2018. It ensures the correct evaluation of vaccine coverage, monitoring nationally consistent vaccine implementation and providing information to national and international bodies.
Despite remarkable progress in terms of coverage rates for some compulsory vaccinations (reaching an average of 95% and meeting the target of 95% set by the PNPV), some challenges persist, as measles–mumps–rubella (MMR) coverage still remains half a point below the 95% threshold recommended by WHO (although it increased 5 percentage points between 2011–2017). Further, a certain degree of heterogeneity is still present for different vaccines both at the regional and local levels. For example, coverage for the OPV in Abruzzo is 97.4%, while it is 91.1% in Sicily and 81.1% in the Autonomous Province of Bolzano (Ministero della Salute, 2020d).
In response to the COVID-19 pandemic, Italy rolled out a vaccination campaign from December 2020, first for priority groups such as health workers and the elderly, and then extending to the general population for primary and booster inoculations throughout 2021–2022. The vaccination plan has been carried out under the supervision of the regions and the COVID-19 Emergency Commissioner (see Chapter 2) utilizing a range of facilities, including designated vaccination centres and administered by GPs, nurses, paediatricians and other specialists, dentists and pharmacists who have undergone the necessary training.
Driven by European Commission Directives, the occupational health sector has made significant progress since the introduction of the Italian Occupational Health and Safety Act 2008 which provides the legal framework, setting out the rights and duties of all parties in the workplace and harmonizing previous legislation. The Ministry of Labour and Social Policies is the responsible national authority for health and safety at work. Other institutions also collaborate with the Ministry. These include INAIL, which aims to reduce workplace injuries, protect workers performing hazardous jobs, insure workers, facilitate the return to work of people injured at the workplace, and the National Labour Inspectorate, established in 2015 with the overall responsibility for monitoring compliance of health and safety laws. Additionally, the Standing Advisory Committee for Health and Safety at Work evaluates issues concerning health and safety at work, validates good practice, and establishes standard risk assessment procedures (Ministero del Lavoro e delle Politiche Sociali, 2022).
Funding for occupational health in Italy is achieved primarily through central public funds, along with additional finance which can be provided by the regions and the European Commission. According to INAIL data, the social costs directly associated with work-related accidents in Italy account for €45 billion every year, with more than 700 000 work-related accidents reported yearly, 900 of which are fatal. 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.
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. Among these, secondary cancer prevention has been included in the national benefits package (LEAs). The National Screening Observatory (Osservatorio Nazionale Screening, ONS), founded in 2001, currently offers cervical Pap tests, mammography and colorectal screening free of charge for the target populations.
To improve screening coverage, and following the EU’s recommendation on cancer screening in December 2003, several plans were developed with the aim of strengthening the diffusion of active programmes: these include the NHP (2003–2005), National Screening Plans (2004–2006 and 2007–2009) and the National Prevention Plan (2005–2007). In addition, Law 138/2004 was introduced, containing a commitment to reduce the gap between the target and the screened population, allocating €50 million for this purpose.
Screening programmes are regulated and organized at the regional level through the local health authorities, which actively invite the target population (mammography, Pap test, faecal occult blood (FOB) test). Participation in screening programmes is voluntary and several indicators are calculated to monitor screening invitations and uptake, which impacts the efficacy of programmes in reducing cancer mortality. The ONS was created in 2002 and was charged by the Ministry of Health with monitoring and promoting screening programmes nationwide. According to its report in 2019, the development of organized screening programmes continues, even if gaps still exist between the central, northern and southern regions. Data also show that screening has increased in absolute numbers from 2017 to 2018, with more than 14 million invitations, 6.3 million tests, and between 80–90% of the Italian population of target age being invited for mammography and cervical screening, as well as 75% for colorectal cancer (Osservatorio Nazionale Screening, 2019).
Breast cancer is the most prevalent cancer among women in Italy, and mammography screening reached a coverage rate of 84% between 2008 and 2018 for women between 50–69 years old. However, there is still a large difference (40 percentage points) between the southern and northern regions. Mammography screening is offered every two years to women aged 50–69, while some regions are piloting tests for a wider age group, between 45–74 years old (Ministero della Salute, 2021e).
Cancer of the colon and rectum has the second- and third-highest cancer prevalence rates, respectively, in both women and men. Current guidelines recommend two colorectal cancer screening tests: most programmes use the FOB test in peolpe aged either 50–69 or 50–74, 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 (Zorzi et al., 2015; Ministero della Salute, 2021f). In 2018, nearly 6 million citizens aged 50–69 years were invited for the FOB test; 68 893 aged 58 years for the FS test; and 214 679 between the ages of 70 and 74 years for the FOB test. However, data point to differences between regions in terms of target population being invited to screening tests. North-central regions were well above 80% in 2018, while southern regions stood at just above 40% (Osservatorio Nazionale Screening, 2020).
The coverage for cervical cancer screening has grown overall between 2011 and 2018, mainly due to the increase of invitations for HPV screening, while Pap tests have decreased. For cervical cancer, the Pap test is offered every three years to women aged 25–30, and the HPV test (HPV-DNA test) is offered every five years to women aged 30–64 years. Regional differences are still present, but they are less stark (Ministero della Salute, 2021g).
On 26 January 2023, the National Oncology Plan 2023–2027 was adopted following the agreement reached during the State–Regions Conference. The plan aligns with the Europe’s Beating Cancer Plan and sets out various objectives and strategic guidelines to be implemented by the Italian regions and autonomous provinces. One of the key goals of the plan is the completion of the National Cancer Registry and the Regional Cancer Registry Network. These cancer registries not only facilitate monitoring and surveillance of oncological diseases but also provide valuable information for healthcare planning, evaluating the effectiveness of preventive measures, and assessing access, quality, and appropriateness of care.
In terms of primary prevention, the focus is on promoting healthy lifestyles within various living environments, ranging from schools to workplaces. Special attention is given to combating smoking, reducing harmful alcohol consumption, promoting physical activity, and encouraging healthy eating habits.
Adopting the One Health approach, the plan aims to enhance sustainable mobility, improve air quality, and implement interventions to prevent and reduce harmful environmental (indoor and outdoor) and anthropogenic exposures that adversely affect health.
Another crucial aspect involves strengthening efforts to increase vaccination coverage against infectious agents known to cause cancer, such as the papillomavirus and hepatitis B virus.
Regarding secondary prevention, the COVID-19 health emergency has led to a decrease in organized screening programs. Therefore, the National Oncology Plan emphasizes the need to reinforce these programs, making use of the new Community Health Centres outlined in the National Recovery and Resilience Plan and regulated by Ministerial Decree 2022/77. The plan aims to expand the age groups targeted for mammography and colorectal screening and promote early identification of individuals at family-hereditary risk through dedicated clinical pathways. Additionally, alongside health promotion and prevention activities, the plan supports increasingly home-based care integrated with hospital and community services. This integration is achieved through the rationalization of care processes and the use of multiprofessional teams that can provide remote services. The plan emphasizes the importance of clinical pathways organized according to the (hospital) Hub & Spoke model to ensure comprehensive patient care at all stages. It is essential to implement these pathways across all regions within the Oncology Networks, ensuring equitable access to care and involving patient associations.
The National Oncology Plan also places great emphasis on research advancements related to personalized prevention and early cancer detection. This includes exploring omics research, diagnostic imaging technologies, and therapeutic technologies. The document also highlights the need for digital transition, planning the implementation of various telemedicine services in home settings. Technological modernization in oncology is given special attention, not only focusing on the renewal of diagnostic equipment but also ensuring the availability of well-trained medical specialists and non-medical healthcare professionals. The development of platforms for recording, integrating, and analyzing clinical, genomic, imaging, and treatment data to enhance diagnostic and therapeutic processes is also encouraged.
Recognizing the importance of training and communication, the plan proposes interventions to provide training on care models, technological innovations, and the essential aspects of humanization and respect for individuals. Finally, the National Oncology Plan underscores the significance of raising awareness and engaging the general population through information campaigns aimed at empowering citizens and enhancing health literacy concerning prevention, research, and oncology care.
Decreto Ministeriale 23 maggio 2022, n. 77. Regolamento recante la definizione di modelli e standard per lo sviluppo dell’assistenza territoriale nel Servizio sanitario nazionale.
In January 2003, a law to ban smoking indoors was introduced, with exceptions for: 1) private dwellings which are not open to the public; and 2) places reserved for smokers and marked as such. The ban also extended to all education and training establishments, as well as hospitals and scientific research laboratories (Law 3/2003, art. 51). After the law came into force in January 2005, Italy became the first country in the EU to ban indoor smoking to improve the health of the population (Laurendi et al., 2007), setting up a model for this effective public health intervention (see Box5.1). Recent data show that nationally: 1) the number of daily smokers aged 14 years and over decreased from 23.8% in 2005 to 19% in 2020; 2) sales of tobacco products decreased by 32% between 2004 and 2018; and 3) the perception of compliance with the smoking ban in 2020 was 91.9% for public places and 93.9% for workplaces. However, smoking rates among 15-year-old boys and girls, who are under the legal age for smoking, remain high (24.8% in boys, 31.9% in girls) (Ministero della Salute, 2020e).
Box5.1
Other measures related to smoking are now also being addressed by cities, as in the case of Milan, which in January 2021 introduced a new smoking ban in the city to stop cigarette smoking in outdoor spaces, including public transport stops, parks, dog walking areas and cemeteries. The fines for those who do not comply range from €40 to €240 (Il Sole 24 ORE, 2021).
Electronic cigarettes and a new generation of inhalation-without-combustion (“heat-not-burn”) products are classified in Italy as tobacco-related products and are regulated. Manufacturers or importers must also submit an annual report to the competent authority. The cross-border sale of e-cigarettes is prohibited, as is the sale to minors (under 18 years). According to a European School Survey Project on Alcohol and Other Drugs (ESPAD) poll, e-cigarette use has grown in popularity among teenagers, with 13% of 15- and 16-year-olds reporting using them in 2019. This percentage is similar to the EU average (14%) (OECD/European Observatory on Health Systems and Policies, 2021). E-cigarette advertising is currently prohibited in the country (LD 6/2016).
Starting from 1 January 2021, the tax duty on products containing e-liquids with nicotine was raised to 15%, with subsequent increases of 5 percentage points each year until 2023 (rising to 20% in 2022 and 25% in 2023). Nicotine-free e-liquids are also subject to a new tax of 10% in 2021, 15% in 2022, and 20% in 2023. As of December 2020, the Customs and Monopoly Agency in Italy reported 19 569 notified e-cigarette products in the country (Camera dei Deputati, 2020; ECigIntelligence, 2021).