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Ddl Lorenzin is law. The new rules on clinical trials, on gender medicine, harsher penalties to abusiveness

On 22 December 2017, the DENL Lorenzin was definitively approved in the Senate for the clinical trials of medicines as well as provisions for the reorganization of the health professions and for the health management of the Ministry of Health.

"This bill, which I presented almost 5 years ago - the Minister recalls - has had a very long gestation in Parliament and introduces very important measures for health and for 1 million people who work there".

"The law - underlines the Minister of Health - provides for new rules on clinical trials, on gender medicine, harsher penalties on health care and against those who abuse health facilities for the elderly and the disabled, and then we tackle the reform after 70 years of the professional health professions also recognizing new professions such as osteopaths and chiropractors.In the provision are also established new professional orders for nurses, midwives, medical technicians of medical radiology and technical health professions, rehabilitation and prevention".

Below are the main changes in the c.d. "Ddl Lorenzin".

The new provisions, adapting the Italian regulations to the new European legislation (EU Regulation 536/2014) provide for the reorganization and reduction of existing ethics committees. In fact, a National Coordination Center for Ethical Territorial Committees for clinical trials on medicinal products for human use and on medical devices is envisaged, with the task of coordinating, guiding and monitoring the evaluation activities of ethical aspects related to experimentations . It is also envisaged the identification, through a subsequent ministerial decree, of a maximum number of forty territorial ethics committees (compared to over 100 currently existing) of which at least one for each region, and the recognition of three national ethical committees, one of which reserved for experimentation in the pediatric field.
These provisions go in the direction of the need to acquire greater international competitiveness in the field of clinical trials, which, thanks to the significant reduction in the number of ethics committees and thanks to the role of support and supervision assigned to the newly established national coordination center , will be able to rely on certain times for their analysis from an ethical point of view, as well as a unit rate, which is parameterized to the mere costs of managing the analysis itself.

The new provisions transform the current colleges of health professions and their national federations into orders of the same professions and their national federations. To the already existing orders of the doctors-surgeons, the veterinarians and the pharmacists, are added the orders of the nursing professions, of the profession of obstetrician and of the medical technicians of medical radiology and of the technical sanitary professions, of the rehabilitation and the prevention.Contestually the discipline relating to the internal operation of the Orders, dating back to 1946, and provisions are introduced to improve the functionality of the bodies, to clarify the tasks performed, enhancing, in particular, the public and deontological function, as well as to encourage internal participation by members.

The bill rewrites the procedure for the recognition of new health professions, thus establishing a potentially open system. This procedure, which will pass for the scientific-technical opinion of the Higher Health Council, will require the agreement at the Permanent Conference for relations between State, Regions and Autonomous Provinces. As part of this procedure, a simplified path is set for osteopaths and chiropractors, whose identification is already established by law, while the path to definitive recognition passes through the agreement in the Conference that will define the scope of activity, the functions, the criteria for evaluating professional experience and the recognition of equivalent qualifications related to these professions.
With the MIUR decree, in agreement with the Minister of Health, the educational system of university training will also be defined.

The law establishes that supervision of these professions, and the related orders, passes from the Ministry of Justice to the Ministry of Health. Also to these orders will apply, therefore, the new provisions related to the internal operation of the Orders, modified by the Decree.

It intervenes on the offense of illegal practice of the profession, to insert an aggravating circumstance when the offense concerns a health profession and to provide in such cases the mandatory confiscation of the assets used to commit the crime. And in particular, when it comes to real estate, they are transferred to the heritage of the municipality where they are sites, to be used for social and welfare purposes.

An aggravating circumstance is added to the penal code (Article 61) for crimes against the person committed to the detriment of persons hospitalized in health facilities or in residential or semi-residential social or residential structures, or in socio-educational structures.
Health Executives of the Ministry of Health
The current regulations concerning the role of the Health Directorate of the Ministry of Health are modified: on the one hand, a single level of the aforementioned role is established, and on the other hand, the legal and economic institutions provided for the management extend to the Ministry's health managers. health service of the National Health Service.