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Pharmaceutical Sales Representatives, the role of the Italian Regions

The Italian Regions have an essential role in the protection of health, by controlling and monitoring any activities regarding health, and promoting appropriate information on drugs, in order to prevent their misuse and ensure public health.

According to article 48 comma 21 of Law 326/2003, the Regions provide to regulate, also by administrative measures:

  1. advertising to doctors, health professionals and pharmacists;
  2. delivery of free samples;
  3. concession of low-value promotional materials;
  4. definition of the methods used by the Italian National Health System professionals to inform Regions about their participation to initiatives promoted or financed by pharmaceutical companies or by companies supplying medical devices for the Italian National Health System.

For this reason, each Region autonomously issued indications on the correct operational methods to carry out the activities of Pharmaceutical Sales Representatives (PSRs) within the Regional Health Service.

Considering that the advertising of a medicine, and consequently scientific information, can only be addressed to health professionals authorised to its prescription or dispensation, pharmaceutical companies interested in this activity are bound to submit a dedicated request to the concerned Regional Directorate to authorise their PSRs, including some information about their sales reps, such as personal data of each sales PSR, the company identification code or of any associated or partner company, a self-certification of the PSR reporting their qualifications, the activity carried out based on an individual full-time working agreement, the name of the scientific responsible person as well as the pharmacovigilance responsible person.

Moreover, in order to access health facilities, PSRs should have an identification card (in some specific cases this should also be stamped by the concerned Regional Directorate) including their picture, indicating the date when their activity at the company started, the therapeutic area and the territory where they carry out their activity (also with reference to the health units).

The responsible Persons of each concerned facility shall identify the suitable areas (such as meeting rooms, doctors’ clinics, department library, etc.) and the time slots when individual or collective/multidiscipline meetings can take place between health professionals and PSRs.

Scientific information activities will not be allowed within the healthcare areas and in the specialists’ clinics during the time dedicated to patients’ examinations.

For each concerned prescriber, each PSR can carry out a limited number of individual visits (reported in the decree of each Region) to single doctors employed by or affiliated to the NHS.

In order to ensure compliance with the provided limitations, pharmaceutical companies shall inform the Italian regions, annually or biannually, about the number of doctors and pharmacists concerned by their scientific information and the average number of visits by the PSRs.

In compliance with the regulation in force and with the principles of professional ethics and transparency, some health facilities felt the need to regulate the access of sales representatives to track their presence, monitor the activities they carry out to prevent any corruption deriving from the relations between sales representatives and health professionals.

In this particular period, the measures to contrast and contain the spreading of the COVID-19 virus in the working environment and the community, along with the provisions already taken in the known decrees by the Italian Prime Minister, some Regions also published a safety protocol or the carrying out of the activity of the pharmaceutical sales representatives, with specific measures, always favouring remote activities.

In the next few months, based on the epidemiologic conditions, any change on the meetings will be considered, still adopting all necessary precautions to minimise the occasions of contagion.

Written by: Francisca Savina