Ed.: We respectfully point out to Dr. Petropulacos that what she says referring to paragraph 2 of theArticle 119 of Legislative Decree 219/06, in fact the guidelines approved by the Conference of Regions refer to paragraphs 21, 22, 23 and 24 of the Art. 48 of lawlaw 24 November 2003, n. 326 which reads:
21. Without prejudice to the provisions of articles 1, 2, 3, 4, 5, 6, 9, 11, 12, 14, 15 of legislative decree 30 December 1992, n. 541, the regions provide, also with an administrative provision, to regulate:
a) advertising to doctors, health professionals and pharmacists;
b) delivery of free samples;
c) concession of promotional products of negligible value;
d) definition of the ways in which the operators of the National Health Service notify the regions of their participation in initiatives promoted or financed by pharmaceutical companies and companies supplying medical devices for the National Health Service.
22. The second sentence of paragraph 5 of article 12 of the legislative decree 30 December 1992, n. 541, is deleted. General practitioners and paediatricians of free choice are allowed to participate in conferences and congresses with ECM accreditation of an educational nature on pertinent topics, subject to notification to the competent health facility. A register with the data relating to participation in the events in question is deposited at this facility and these data must be accessible to the Regions and to the drug agency referred to in paragraph 2.
23. In paragraph 6 of article 12 of the aforementioned legislative decree no. 541 of 1992, the words: «he does not communicate his justified opposition» are replaced by the following «he communicates his favorable opinion, having consulted the region where the event is located». In the same paragraph, the words are also deleted: «or, in the case governed by paragraph 2, no later than 5 days before the date of the meeting».
24. In paragraph 3 of article 6, letter b), of the aforementioned legislative decree no. 541 of 1992, the words from: «eight members to» up to: «of health» are replaced by the following: «one member belonging to the Ministry of Health, one member belonging to the Higher Institute of Health, two members designated by the Permanent Conference for relations between the State, the regions and the autonomous provinces".
Therefore, independently of Legislative Decree 542/92, then absorbed in an identical way in Legislative Decree 219/06, the guidelines of the State-Regions Conference of 20 April 2006 have the "characteristics of a normative form" referred to in paragraph 21 of the art. 48 of law 326/03. After all, also in your DGR 2309/16 it is said "Having regard to the document “Guidelines for the regional regulation of scientific information on medicines pursuant to art. 48 paragraphs 21, 22, 23, 24 of Law 24 November 2003, n. 326”, approved on 20 April 2006 by the Conference of Presidents of Regions and Autonomous Provinces“. So it is your own DGR that gives the guidelines of the Regions a legal value and also derives legitimacy from them.
The guidelines explicitly state in art. 2 that "The performance of the activities of the ISFs within the structures of the SSR is ensured and facilitated by the Directions of the aforementioned structures”, we emphasize assured and facilitated, NOT HINDED. It also adds that the work of the ISF must be ensured and facilitated by raising awareness of the availability of doctors.
However, beyond the legal observations, a question arises spontaneously: in addition to the meeting with the ISFs in June 2017 in which all the absurdity of the regional settlement system emerged, how many ISFs have you met to verify the critical issues? or did you only hear the voices of the health companies?
In Resolution No. 919 of 06/18/2018 "planning and financing lines of companies and bodies of the regional health service for the year 2018” in point 2.15.5 Scientific information activities within the Regional Health Service explicitly say “The Health Authorities will have to update the provisions already issued at the local level, in accordance with the regional progress on the matter shared with trade associations”.
The trade association of the ISF is Fedaiisf. We are waiting to be summoned.
Related news: Emilia-Romagna.dgr-2309-2016
