Lombardy region. Question from Councilor Carretta: "Establishment of the Regional Table on Scientific Information"

THE UNDERSIGNED REGIONAL COUNCILOR WHEREAS

• article 48, paragraph 21 of the decree-law of 30 September 2003, n. 269, containing “Urgent provisions forfavor the development and for the correction of the trend of the public finances” – converted with law 24 November 2003, n. 326, indicates the mandate of the regions to regulate, in matters of scientific information on drugs, the advertising of drugs to doctors, health professionals and pharmacists, the delivery of free samples, the granting of promotional products of negligible value, as well as the definition 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;
• also in the light of the document “Regional regulation guidelines for scientific information on drugs 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 the Presidents of the Regions and Autonomous Provinces, several Italian regions have set up their own Regional Table on Scientific Information or their own “Working Group on Scientific Information” (such as the Veneto Region with Decree of the Director of the Pharmaceutical, Prosthetics, Medical Devices Department No. 38 of 26 October 2021);
• the legislation on the subject of the Lombardy Region dates back to the DGR 4220 of 2007 containing "Indications on the subject of scientific information on drugs pursuant to Legislative Decree 219/2006 and article 48 paragraphs 21, 22, 23 and 24 of Legislative Decree 269/ 2003 converted with law n. 326/2003” which states «the Regions play a fundamental role in the field of health protection, in particular through the control and supervision of activities of health interest and (..) the protection of public health is also achieved through a control of the 'pharmaceutical activity by promoting correct information on drugs in order to avoid their abuse or misuse";WHEREAS
• correct information is a strategic element for the appropriate and rational choice of drugs and their efficient use in clinical practice;
• it is therefore considered appropriate to promote the efficient, rational and safe use of drugs, parapharmaceuticals and medical devices according to quality, safety and cost-effectiveness criteria, operating with a view to uniformity and equity of access to therapies throughout the region so that patients receive the best possible care:
  • the adoption of uniform operating procedures in all areas of the SSR involved in the scientific information of medicines and medical devices for human use facilitates greater transparency in the relations between prescribing doctors, companies and the Regional Health Service;
  • it is therefore considered appropriate to set up a regional table on scientific information or a "medical-scientific information working group" also in the Lombardy region, a technical-scientific body that makes use of trade associations and professionals with proven experience in the pharmacological, clinical and pharmaco-economic, in order to reconcile the regional needs, of management uniformity of health problems, with the local needs of maintaining the acquired therapeutic specificities, as well as with the aim of significantly improving the use of drugs, parapharmaceuticals and of medical devices in hospitals and in the area, contain costs by developing drug policies in compliance with national regulations and regional indications, as well as providing general guidelines on the proper use of drugs, parapharmaceuticals and medical devices and activating targeted programs to rationalize its prescription;ALSO CONSIDERING THAT
  • also in the light of the recent approval of the regional law n. 22 of 2021 it is considered appropriate to provide for the revision of the regional legislation on scientific information and in any case the establishment of a regional scientific information table;
  • numerous concerns about the lack of regional codification on the subject are collected from the trade associations (including AIISF Lombardia) and it would seem that to date, despite several reminders and requests for the establishment of the aforementioned regional table, no response has been given ;
  • the trade associations (including AIISF Lombardia) also point out the need to include, among the professionals named above, also those who carry out scientific information on parapharmaceuticals and technical-scientific representatives of medical devices, all equally called to post-marketing surveillance of products presented to healthcare professionalsQUESTION THE PRESIDENT AND THE COMPETENT COUNCILOR TO KNOW

  1. the intentions of the Regional Council regarding the revision of the regional legislation on scientific information and the related timing;
  2. if the Lombardy Region intends to set up, as also requested by AIISF Lombardy, its own Regional Table on Scientific Information or its own "Medical-Scientific Information Working Group" (by way of example and not limited to as recently established by the Veneto Region) and the related timing as well as the technical and political assessments to justify the choice.

  Milan, 8 March 2022

  signed by Regional Councilor Niccolò Carretta

   

   

  Mixed Group – Action

  action@consiglio.regione.lombardia.it

  Regional Council of Lombardy – Palazzo Pirelli