Medical regulation in Italy
Structure and nature of medical regulation Italy has a regionally-based national health service (Servizio Sanitario Nazionale – SSN).
At a regional level, the organisation of public healthcare provision is the responsibility of the respective regional administration. Medical regulation and the bodies involved in this are governed by state laws. Regulations, administrative actions and formal acts are all implemented by the provincial medical associations who carry out regulatory and administrative functions at a regional level. Some key Acts regulating the medical profession are: the Civil Code (Art. 2229); Law no. 233 of 13 September 1946; Law no. 1378 of 8 December 1956; Law no. 409 of 24 July 1985; and Law no. 471 of 31 October 1988.
The main organisations involved in medical regulation are the Ministry of Health, the Italian regions and independent provinces, the medical associations (given the federal system in Italy, there are more than 100, one for each province), and their national umbrella organisation, the National Federation of Medico-Surgical and Dental Orders (Federazione Nazionale degli Ordini dei Medici-Chirurghi e degli Odontoiatri – FNOMCeo). Although numerous bodies are involved in medical regulation, it is the provincial associations and the FNOMCeo that are of central importance.
The Ministry of Health establishes the fundamental principles, and self-regulatory activities are performed under the supervision of the ministry, which is assisted in many of its activities by the Istituto Superiore di Sanità. A commission within the ministry (Commissione Nazionale per la Formazione Continua) is responsible for the elaboration of the programme for continuous medical education (Educazione Continua in Medicina – ECM). Given the federal structure of Italy, the regions and independent provinces are responsible for applying the fundamental principles established by the ministry at a national level. Italian law delegates central regulatory and administrative functions to the regional medical associations which are responsible for keeping the register of doctors up to date, establishing the code of conduct, and disciplining their members. At national level these activities are coordinated by the umbrella association, FNOMCeo. Medical education (along with all university-related issues) is the responsibility of the Ministry of Education (Ministero dell’Istruzione, dell’ Università e della Ricerca) (more on this below). Responsibilities do overlap on occasion; for example, hospitals have disciplinary authority over their staff, including doctors, and medical associations have disciplinary authority over doctors registered with them. However, there seem to be mechanisms in place to foster collaboration, and FNOMCeo stresses that it has good relations with the other bodies involved in the medical regulatory process in Italy.
Registration and licensing process According to a WHO report 74 the Ministry of Health is responsible for the licensing of doctors, while registration and disciplinary matters are carried out by the medical associations. According to the report: There is one licence to practise issued by the Order following approval of qualifications by the Ministry (which delegates this to the Universities). The University issues Specialist Diplomas which must be registered with the Order. Applications are made in the first instance to the Ministry of Health and then to the appropriate Provincial Order for Registration. The licence issued is valid for the whole of Italy, not only for the province in which the person in registered. The licence is issued on a permanent basis, with no time limit attached to it. For Italian nationals evidence of the following needs to be provided when applying to an association for registration and authorisation to practise:
• Italian citizenship;
• civil status (full entitlement to civil rights and privileges); Certificate of professional good standing;
• University or other appropriate institution diploma of completion of medical studies, state examination and internship period;
• Ministerial approval of certificates of medical training and status relevant to entitlement to practise;
• Certificate of residence in the area of the relevant provincial order.
People trained in other EU countries are entitled to register to practise medicine in Italy; the right to practise is in accordance with the relevant European Directives that have been incorporated in Italian Laws nos. 217/78 and 409/85. In addition to the documents required of Italian citizens, those trained in other EU member states must provide a certificate of registration as a doctor in the country from which they came as well as a certificate of professional good standing issued in that country. For non-EU nationals the following documentation is required:
• Birth certificate;
• Certificate of nationality or equivalent document;
• Certificate of civil status;
• Extract from the legal record;
• Evidence of professional qualifications (diplomas etc.).
Documents issued by the national competent authorities of the applicant must be authorised by the Italian consular or diplomatic services and endorsed by the Ministry of Foreign Affairs (Art 7 DPR 221/50). Nationals of countries with which Italy has bilateral agreements need to provide evidence of Italian language proficiency through an interview organised by FNOMCeo. EU applicants are not required to prove language proficiency. There is no process of revalidation within the medical profession in Italy. Once doctors obtain their medical degrees and are registered with their respective association they are not subject to any additional regulatory processes until they retire.
Standards & ethics
Although implementing and monitoring disciplinary procedures is the responsibility of the individual provincial medical associations, the Codice Deontologico (Code of Ethics) is established at a national level by the FNEMCeo. The latest version was published in 2006. The code includes principles regarding doctors’ relationships with patients, doctor-patient confidentiality, the quality of medical care, a doctor’s duty regarding organ donation, abortion and the prolongation of life, assisted reproductive treatment, clinical experiments (also on animals), and other issues. Each provincial association is responsible for ensuring that registered doctors uphold the standards of professional conduct set out in the code. In cases of alleged malpractice or any misconduct that might have a bearing on the standing of the medical profession (including private conduct), it is the responsibility of the association to pursue disciplinary proceedings. The Code of Ethics sets out the doctor’s obligation to: • Protect life; protect the physical and psychological wellbeing of the individual; and alleviate pain while respecting the freedom and dignity of the patient, without consideration of gender, age, ethnicity, religion, nationality, social condition, and ideology, in peace and war times; • Support and promote preventative medicine, healthy work practices and individual and public health; • Promote efficacy of treatment, as well as the non-discriminatory access to, availability, use of and quality of treatments; • Provide health assistance in urgent cases, and offer support to the respective authority in the event of a catastrophe; • Uphold confidentiality with respect to patient information and within the limits of the law (confidentiality with respect to patient information does not end with the death of the patient); • Take into account the dignity of his/her professional status, and obtain informed consent from the patient if applying non-conventional treatments; • Comply with data-protection regulations relating to personal data and sensitive data; • Ensure the safety of patients and prevent clinical risk; • Not abuse his professional status; • Not perform euthanasia; • Update his/her knowledge and participate in continuous training; • Not take on tasks beyond his/her professional knowledge and capacity; • Respect fundamental human rights; • Avoid conflicts of interest. This is just a selection of obligations mentioned – the code lists more, and provides further information on the standards of good conduct. Failure to abide by the principles established by the code constitute a disciplinary fault as specified in the general statutes of the FNEMCeo and are dealt with by the provincial medical association.