Dear colleagues, in recent days I have read the sentence of the Council of State published on several sites, relating to the legitimacy of the regulations issued by the regions on the scientific information of medicines. I don't want to go into the specifics of the sentence, which is very broad and well argued and which clearly explains where and why whoever filed this appeal first in the TAR and then in the supreme court of the Council of State was wrong.
However, some passages should be noted because they are very often misunderstood by many pharmaceutical companies which consider regional regulations as useless frills aimed at limiting their activity.
“ 8.5 Furthermore, always in terms of examining the contents of the individual regional provisions, the complaint involving the alleged illegitimacy of the provision (Article 2 paragraph 4 of the Regional Protocol) according to which the number of individual visits by each scientific representative to individual doctors can be quantified in 4 annual visits for each doctor interested in the prescription. Apart from the conformity of this provision (detected by the Calabrian Tar) with what was approved in the draft guidelines approved by the State-Regions Conference in the session of 20.4.06 (where the adequacy of a choice was proposed which stands between 3 and 5 annual visits), demonstrating the adequacy of such a numerical parameter is its intrinsic rationality and its not unreasonable nature, which places this provision within the legitimate discretionary choices of the regional regulator in a regulatory sector entrusted by the law to its exclusive care (moreover, the regional provision does not exclude that in the face of the need to convey new relevant information on the appropriate use of medicines, the number of annual visits may increase) . Equally not unreasonable, but rather in line with the same need envisaged by the appellant company with regard to respect for the direct doctor-scientific rep relationship, the provision emerges - although contested by the appellant - according to which < as a rule, the ISFs must carry out their activity with doctors alone> . It is first of all a programmatic forecast (as the initial adverbial formula clearly reveals) which if anything, it consolidates, as already mentioned, the seriousness of the approach to scientific information, postulating that in the exercise of the information activity the informant is not accompanied by other subjects, whose presence could evidently discolor the profile of the scientific study on the properties of drugs, to the benefit of their mere commercial promotion.”
“8.9 Lastly, the finding of the inadmissibility due to lack of current harmfulness of the censure relating to the provision, in terms of supervision and control, of a continuous monitoring table for the identification of tools, methods and actions aimed at verifying compliance with the provisions of this provision is impeccable, providing depending on the seriousness of the violation detected, a range of sanctions will be payable by the pharmaceutical company ranging from the suspension of scientific information activity on the regional territory for a certain period of time, to the exclusion from participation in the tender procedures or to the reduction of the free samples that can be delivered to doctors. “
9.” In conclusion, the appeal does not deserve
