La dolce vita – life in Italy seems to be simply better… and longer. In fact, the country is home to a staggering 22,000 centenarians. But the healthcare system is also starting to show its age, not least since the recent Covid crisis. Discover in our latest blog how a makeover to rejuvenate Italy’s health infrastructure offers promising new market opportunities.

Population

With nearly 61 million inhabitants, Italy is the third-largest economy in the European Union (EU). Life expectancy ranks among the highest in the world: On average, Italians live to be 82.6 years old (even 84 years before the pandemic), compared to 81.8 years in the UK. However, there are major differences within the population. Life expectancy strongly correlates with socioeconomic status and geography. In 2019, women born in the southern region of Campania, for example, lived an average of 2.7 years longer than women born in the northern region of Trento.

About three in four Italian adults report being in good health, compared to only two in four in the UK. At the same time, one in six Italian adults suffers from at least one chronic condition, and this percentage tends to increase with age. Like other Western countries, Italy is also facing the impact of an aging population. In 2023, one in four Italians was 65 or older.

Major health issues among the population include cardiovascular disorders, which account for 35% of all deaths, followed by cancer at 27%. A closer look at specific diseases reveals that ischemic heart disease and stroke were the leading causes of death in 2018 (at 10% and 9%, respectively), followed by lung cancer, which remains the at the top of cancer-related mortality. Relevant health risk factors include tobacco use, physical inactivity and obesity.

Health market

Italy has a universal public health care system that provides all residents with largely free-of-charge access to care in doctors’ offices and hospitals. It is based on the Beveridge model, named after the British social reformer William Beveridge, whose ideas also contributed to the creation of the National Health Service (NHS) in Great Britain. In this system, healthcare is financed and provided by the government through taxes.

Italy’s healthcare system offers free basic care through family doctors and pediatricians and also guarantees every inhabitant the right to receive specialist care, laboratory testing and diagnostics, which is subject to only a small co-payment, called the ticket. Dental care, however, is not covered under the general health scheme, and patients have to pay for it themselves.

At national level, fundamental healthcare is defined by the Servizio Sanitario Nazionale (SSN), Italy’s national health service. Funding and practical implementation, however, is largely the responsibility of the individual regions, their governments and their local health services. This system has led to the development of large disparities across Italy’s 20 regions, resulting in a marked divide between the rich north and the economically weaker south. In southern Italy, in particular, patients are struggling with long waiting times to see a specialist. To avoid waiting, some Italians also use private medical services, and about 11 million Italians have taken out private health insurance to cover the cost. This number, however, is rather low compared to other countries worldwide.

Trends

The Italian government wants to use some of the EU funding package set up to promote post-Covid recovery and has earmarked it for the modernization of the country’s healthcare system. The main goal is to ensure adequate care for its aging population, with an increased focus on the individual needs of each patient.

Italy plans to invest around 15.6 billion euros (approx. 13.6 billion British pounds) from the EU Reconstruction and Resilience Facility (RRF) into the health market. This includes 7 billion euros (approx. 6.1 billion British pounds) for implementing one of the crucial lessons learned from the Covid crisis: avoiding unnecessary hospitalizations. During the pandemic, the uncontrolled mixing of patients with Covid-19 and chronic diseases, among other factors, led to a surge in infections.

Telehealth, digital tools for real-time remote care and ambient assistance solutions to support the elderly and people with disabilities in everyday life will be used to foster autonomy and enable patients to be cared for in their own homes for as long as possible. The government also plans to expand the integration of the fascicolo sanitario elettronico, the electronic patient file, as well as other health records and to manage them centrally on interoperable platforms, instead of dispersed regional solutions.

To this end, 300 million euros (approx. 260 million British pounds) will be invested in technical infrastructure and IT systems for monitoring, simulation and forecasting, such as the early detection of future pandemics. 520 million euros (approx. 450 million British pounds) are set aside for boosting biomedical research, and innovative start-ups, particularly in biopharma, are being supported through investments and tax breaks.

Moreover, Italy plans to invest more than 1 billion euros (approx. 870 million British pounds), also from the EU’s Reconstruction and Resilience Facility, in two procurement rounds until the end of 2024, for the modernization of medical equipment, including MRI machines, linear accelerators, radiological systems and mammography and sonography equipment. This also includes a total of 1.5 billion euros (approx. 1.3 billion British pounds), allocated for the digitalization of urgent care centers.

Legal and regulatory conditions

Prior to the 1978 reform, healthcare in Italy rested primarily on private health insurance, and hospital sponsors were mostly religious charities or university hospitals. The healthcare reform then led to the creation of a regionally organized national health service.

For the distribution of medical devices on the Italian market, which also includes digital platforms and mobile apps used for a medical purpose, they must bear CE marking. The relevant procedure involves a complex registration process with the Italian Ministry of Health. In addition, they can also be entered into a dedicated database, the Repertorio dei Dispositivi Medici, which is a prerequisite for considering the device for the national catalog of reimbursable health products.

When it comes to marketing drug products in Italy, the responsible agency is the Agenzia Italiana del Farmaco (AIFA), which is affiliated with the Ministry of Health. AIFA is responsible for granting authorizations and the entire approval process. It also performs inspections at pharmaceutical production sites and checks manufacturing quality, and it is in charge of monitoring drug safety, indications for use and the reimbursement scheme. Here, too, the regions are actively involved in the pricing and reimbursement negotiations for pharmaceuticals.

EU-wide and international health market

In general, each member state in the European Union (EU) defines its own health policy autonomously. The EU, however, issues relevant directives and regulations as a framework to be integrated into national legislation. A recent example is the MDR, the Medical Devices Regulation (EU) 2017/745, which sets out the requirements for all medical devices distributed in the European single market and requires products to undergo a CE-marking process (declaration of conformity). In Italy, the conformity assessment is also carried out by notified bodies.

For drug products, manufacturers may choose one of two pathways to obtain marketing approval: at the national level (through AIFA) or through the centralized procedure offered by the European Medicines Agency (EMA). The latter has the distinct advantage that a marketing authorization can be obtained for the entire European Economic Area (EU, Iceland and Norway) with just one application, meaning a lot less regulatory complexity for manufacturers.

Internationalization

Internationalization allows Italian hospitals and healthcare services to showcase and explain their services to international patients. The translation of scientific publications and training materials also opens up valuable opportunities in the field of education and development, allowing institutions and healthcare professionals to learn from the experience and best practices of other countries to improve the overall quality of medical care.

Translations are needed throughout the entire lifecycle of medical devices, pharmaceuticals, dietary supplements as well as wellness and lifestyle products. The requirements placed on the translated text differ depending on the audience (authorities, specialists or laypersons), its purpose (regulatory, marketing, patient awareness, etc.) as well as text type and channel. And, in order to meet this wide range of needs and objectives, professional translators must not only have completed extensive training: they must also exhibit a high degree of linguistic sensitivity, experience in the field and comprehensive specialist knowledge.

When patients and consumers are addressed directly, for example, be it in information portals, brochures, social media or blog posts, it is important that the translation is easy to understand. Doctors’ gobbledygook must be avoided, just as long-winding sentences packed with numbers and detailed technicalities. At the same time, the text should be informative and appeal to the reader to instill confidence. For marketing copy, it may even make sense to commission experienced translators with a freer adaptation based on a client briefing.

There are several languages that are particularly important for the Italian market. These include, in addition to the official language Italian, other official regional languages, such as French in the Aosta Valley, German in the Trentino-Alto Adige region, Ladin in several valleys in Upper Italy and Slovenian/Furlan in the county’s northeast. Some regional dialects, such as Sardinian, Sicilian and Occitan, may also play a role for targeting different regions. Significant immigrant languages include Romanian, Arabic (Moroccan) and Albanian.

Summary

Given Italy’s extensive funding plans, which include investments of roughly 20 billion euros (approx. 17.4 billion British pounds) to be made until 2026, and the urgent need for modernization, many segments in the Italian healthcare market are expected to see a favorable development over the near future, including medical technology, digital health, biotech and pharmaceuticals. However, obstacles remain for companies due to regionally fragmented procurement processes, which require local expertise.

Here, translations can be key to ensure the commercial success of a product, while a lack of understanding of local and cultural particularities and of technical know-how can have the opposite effect. Errors or misleading instructions, for example, would be devastating as they put patients and users in danger and expose the company to immense liability risk.

In today’s demanding medical industries, companies need a qualified language service provider at their side to ensure their communication is right on the mark. These experts offer the necessary linguistic and cultural proficiency as well as medical knowledge. An appropriate communication strategy also underscores the company’s quality standards and builds trust in the brand.

References

 

autor_eurotext_100Author: Eurotext Editorial Team

We explain how internationalization works, provide tips for your translation projects and outline some of the technology and processes used. We also report on current e-commerce developments and cover a range of language-related topics.