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Italy: New Law on Clinical Trials of Medicines and Reorganization of Health Professions Enters into Force

(Apr. 12, 2018) On February 15, 2018, a new law on clinical trials of medicines came into effect in Italy. (Law No. 3 of January 11, 2018, on the Delegation of Power to the Government over Clinical Trials of Medicines as well as on Provisions for Reorganizing the Health Professions and on the Health Directorate at the Ministry of Health) (Law No. 3), GAZZETTA UFFICIALE (G.U.) (Jan. 31, 2018) (in Italian).) The new Law directs several government ministries to issue regulations for the full implementation of the new provisions. (La legge Lorenzin (n. 3/2018) è in Gazzetta ed è in Vigore dal 15 Febbraio: Nasce Ufficialmente la Fnopi. Ecco Cosa Cambia [The Lorenzin Law (n. 3-2018) Is in the Gazzette and Effective on February 25: The Fnopi is Officially Born: This Is What Changes], FNOPI (Mar. 31, 2018).)

Clinical Trials of Medications for Human Use

The new Law delegates powers to the government to amend the existing legislation on clinical trials of medications for human use, introducing specific references to gender medicine and pediatric patients. (Law No. 3, art. 1(1).) To that effect, the Law creates a national coordinating center of territorial ethics committees for clinical trials of medicines for human use and medical devices. (Id. art. 2(1).)

Application and Dissemination of Gender Medicine Guidelines

The Law directs the Health Ministry to approve a plan for the dissemination and application of gender medicine guidelines throughout the country, focusing on the prevention, diagnosis, and treatment of illnesses taking into account differences arising from gender. (Id. art. 3(1).) The plan must promote biomedical, pharmacological, and psychosocial research. (Id. art. 3(2)(b).)

Reorganization of Healthcare Professionals’ Associations

In addition to regulating clinical trials of medicines, the Law reorganizes healthcare professionals’ associations into geographical districts according to the following professions: surgeons and dentists, veterinarians, pharmacists, biologists, physicists, chemists, nursing professionals, obstetrics, health technicians on medical radiology, and technical health professionals in the areas of rehabilitation and prevention. (Id. art. 4(1).) All health professionals must register in their respective health associations and are bound by the associations’ administrative and ethical rules. (Id. art. 5(1).)

National Federations of Health Administrations

According to the new Law, territorial associations are integrated into national federations based in Rome, which assume the representation of the respective professions with regard to national, European, and international institutions. (Id. art. 7(1).) National federations are composed of a president, national council, central committee, registry commission, and board of auditors. (Id. art. 8(1).)

Creation of the Field of Socio-Health Professions and Other Health Professions

In order to reinforce the protection of health, the Law creates the field of socio-health professions. (Id. art. 5(1).) A decree of the President is to determine the profile of this new health professional order. (Id. art. 5(2).) The Law also recognizes the osteopathic and chiropractic health professions. (Id. art. 7(1).) The Ministry of Health is charged with defining the educational requirements for the granting of college degrees in the areas of osteopathy and chiropractic. (Id. art. 7(2).) The professions of chemist and physicist are also recognized by the new Law, and a national federation of chemists and physicists is established. (Id. art. 8(1).) Likewise, the health professions of biologist and psychologist are recognized, as are their respective national federations. (Id. art. 9(1)–(3).)

Extension of Insurance for Health Professionals

The new Law provides that the existing health insurance fund for damages arising from health liability as established in Law No. 24 of March 8, 2017, on the Safety of Care and of the Assisted Person, and Concerning the Professional Responsibility of Health Professionals (G.U. Mar. 17, 2017 (in Italian)) must now provide access to health professionals who perform their services independently. (La Legge Lorenzin, supra.)

Malpractice in Health Professions

The new Law sets a fine of €10,000–50,000 (about US$12,356–61,777) for malpractice in health professions that require special authorizations issued by the state. (Law No. 3, art. 12(1).) Materials used for the commission of the crime are also to be confiscated. (Id.) Third parties used to commit the crimes are also subject to imprisonment for three to 10 years. (Id. art. 12(2).) Aggravating circumstances include medical malpractice causing injury to persons who are hospitalized in health facilities or in residential or semiresidential social health facilities. (Id. art. 14(1).) Manslaughter caused by medical malpractice is now punishable by imprisonment from three to 20 years. (La Legge Lorenzin, supra.)

Specialized Medical Instruction and Training of Non-EU Physicians

The Ministry of Health is to approve new regulations concerning the insertion of non-EU physicians into the Italian national health structure. (Id. art. 15(1).) A decree of the Ministry of Health may temporarily authorize non-EU physicians to participate in training or professional update initiatives carried out in Italy involving the development of clinical activities at hospital facilities, university hospitals, or institutes for recovery and scientific cures. (Id. art. 15(2).) Authorizations require compliance with specific criteria and may not last longer than two years. (Id.) Existing provisions on professional practice by non-EU physicians in Italy are repealed. (Id.)