Seven years after the approval of Law 24/2017, known as Gelli-Bianco, which is credited with having given a fundamental reformist turning point to the matter of health responsibility in Italy, on March 1st it was published in the Official Journal the expected implementing decree provided for by article 10 paragraph 6 of the Gelli-Bianco Law. This and the future of Law 24 will be discussed during the conference which will be held tomorrow, Tuesday 14 May, at 3.00 pm, in Rome, in the Refectory Hall of Palazzo San Macuto in the presence of the vice president of the Chamber, Anna Ascani, and the Minister of Health Orazio Schillaci, the president of the Higher Institute of Health, Rocco Bellantone and the general director of Agenas, Domenico Mantoan. With this conference – we read in a note – the Italia in Salute Foundation intends to continue the discussion with the institutions and create a space for in-depth analysis with the many subjects involved in the debate.
The recently published decree – explains the Foundation – is a fundamental piece missing from the full implementation of law 24 which, in regulating the matter of healthcare safety and healthcare liability from scratch, introduced, among the innovations characterizing the reform, precisely the the obligation to cover the risks related to the exercise of healthcare professions and activities. In fact, the provision of healthcare liability insurance coverage establishes, at least in theory, the definitive securing of the clinical risk system, as designed by the reform law and characterized by its dual protective vocation: of potential perpetrators, on the one side and, of the patients, on the other. Protecting healthcare personnel means guaranteeing better care for citizens.
The ‘Implementing Regulation’ in article 2 defines the minimum requirements for insurance policies for public and private health and socio-health structures and for those practicing health professions, the general conditions of operation of the so-called ‘similar measures’ for direct assumption of risk, the rules for the transfer of risk in the case of contractual takeover of an insurance company as well as the provision in the balance sheet of the structures of a risk fund and a fund constituted by the accrual reserve of compensation relating to reported claims, in implementation of article 10, paragraph 6, of law 8 March 2017, n. 24.
“Just as Law 24/2017 is not just a law on healthcare liability, Decree 232/2023 is not just an insurance decree – states Maurizio Hazan, lawyer and president of the Italia in Salute Foundation – Both move along the entire supply chain ‘useful’ health risk from its recognition, to its prevention, to its best management, to the promotion of responsible management of calculated risks, to their neutralization and to the remedies in case of adverse events, which, despite the precautions, inevitably occur verify.
Law 24 has indicated the way to move from the concept of health responsibility to that of responsible healthcare, this is because “health responsibility” creates human and economic costs. Responsible healthcare reduces them by bringing the therapeutic alliance back on track and strengthening a system based on prevention. Ministerial Decree 232/2023, always in the logic of ‘better safe than sorry’, requires the adoption of continuous clinical risk governance processes and the establishment of funds to cover the risks and costs relating to claims already reported, further defining the path traced by law 24 is better.
“In 2017 the Gelli law was born from the strong need to guarantee first and foremost the safety of patient care – observes Federico Gelli, director of Health, welfare and social cohesion of the Tuscany Region – but also to remedy two problems: the enormity of legal disputes that swamped the Italian courts, there were around 30 thousand cases every year, and the use and abuse of defensive medicine. The professionals, called to respond personally, defended themselves with unnecessary tests and requests, increasing the costs of the public health system by many billions of euros. The rule – he continues – marked an important turning point in terms of deflation of litigation as confirmed by the data published in 2023 by Eurispes following research carried out together with the XIII Section of the Court of Rome. I also see an important step in the recent reform of the Penal Code which provides that the professional is liable only for gross negligence. For the future – concludes Gelli – I would be in favor of the establishment of a public health fund, on the French model, to compensate patients when there is no proven responsibility on the part of professionals and healthcare facilities”.
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