Title I - PROVISIONS OF THE CODE
CHAPTER II - Interaction with Healthcare Professionals and Organizations
12. PHARMACEUTICAL COMPANY PERSONNEL
12.1. Pharmaceutical company personnel that interact with Healthcare Professionals in the course of their work must be appropriately prepared, by or in the name of the company in which they are employed, with sufficient scientific knowledge to present information on the company's medicines in an accurate and responsible manner.
12.2. They must conduct their work in a responsible manner, respecting current legislation and ethical rules, as well as the provisions of this Code.
12.3. No inducement or subterfuge may be used to gain an interview. No amount of money may be offered or paid in order to gain an interview.
12.4. Employees must ensure that the frequency, time and duration of visits to Healthcare Professionals, administrative staff and health authorities or similar, as well as the manner in which they are performed, do not cause any inconvenience.
12.5. When coordinating and conducting interviews, reasonable measures must be taken at all times to ensure that they do not lead to confusion about the identity of the employee or the company he/she represents.
12.6. Any information received from the professionals visited that is relevant to the use of medicines must be reported to the pharmaceutical company’s scientific department, especially indicating any side-effects reported by the professionals visited.
12.7. At each visit, the current summary of product characteristics for each medicine presented must be provided or made available to the person visited, if requested, accompanied by information on the different pharmaceutical forms and dosage, its prescribing and dispensing conditions, information on price, the conditions of reimbursement by the National Health System, where applicable, and whenever possible, the estimated cost of treatment.
12.8. Companies must adopt effective methods and monitor that pharmaceutical company personnel involved in the preparation, approval or provision of promotional material, or information intended for Healthcare Professionals, are informed and comply at all times with the provisions of this Code and the rules applicable to advertising and promotion of medicines.
In addition, they must adopt effective measures and monitor that the interactions of their employees with Healthcare Professionals and Patient Organizations comply with the provisions of this Code and applicable rules at all times.
12.9. Pharmaceutical company personnel that interact with Healthcare Professionals in the course of their work must have sufficient training to disclose the characteristics of medicines. Each company is responsible for periodically ensuring (through tests, additional training, teamwork, etc.) that their personnel’s training is appropriate.
12.10. The same rules will apply to pharmaceutical company personnel who interact with pharmacy offices in the course of their work, respecting both current legislation on this matter as well as ethical rules and provisions of this Code in the area they work.
12.11. Each company should appoint at least one employee or manager with sufficient qualifications who will be responsible for internal oversight of compliance with the Code. Supplementary Rules will explain the basic principles and mechanisms of internal monitoring that all companies must respect. In all cases, the existence of persons responsible for internal supervision does not exempt the company’s senior officers from responsibility.
Below, the Supplementary Rules develops articles 12.8 and 12.11 with the objective of making it clear that companies must have an appropriate internal system for monitoring compliance with the Code. In this regard, it does not intend to impose any model, as it must respect different corporate cultures and existing working procedures. Instead, it simply ensures that the procedures exist in writing and they fulfill the purposes for which they were conceived.
12.8. In order to verify their compliance, pharmaceutical companies must provide the Code of Practice Surveillance Unit with the company's internal procedures that guarantee appropriate training in matters relating to the Code.
12.11. Companies must have internal monitoring procedures that are appropriate for verifying that their activities are in compliance with the Code.
The role of the Compliance Officer or the person responsible for communicating Events, studies or services (articles 33.4, 34.4 and 35.4 of the Code) is understood in a broad sense and may be a single person, several persons or a Committee that jointly decides how activities are to be performed and that compliance with the Code is internally verified. As such, the Compliance Officer may or may not be the same as other figures anticipated in the Code, such as the scientific department responsible for reviewing the materials (art. 9 of the Code) or the person responsible for Events communication (art. 33.4 of the Code).
It is convenient for committees, policies or internal procedures to incorporate the participation of different departments (Marketing-Sales, Medical, Records, Legal, Financial-Administrative) in such a way that the company ensures that the activities have appropriate support and oversight from different perspectives.
The procedures must be formalized in writing and the company must provide a copy of these to the Code of Practice Surveillance Unit, if requested in the course of their oversight work, as well as the name(s) of the Compliance Officer(s). The information provided to the Code of Practice Surveillance Unit will be considered confidential and may only be used for the purposes for which it was submitted.
The procedures must, at the least, address approval of promotional materials and organization and/or funding or sponsoring of conferences, scientific meetings, provision of samples, conduction of studies, formalization of agreements with third parties and Healthcare Professionals, as well as training of company personnel. The procedures must also provide appropriate means for ensuring that subcontractors and providers used to perform activities are aware of and respect the rules of the Code and that they commit to cooperate with the Code of Practice Surveillance Unit.
Companies will include modules or programs of information and updates of the Code in their internal communication and training plans, especially in those directed toward personnel involved in promoting medicines and those who interact with Healthcare Professionals and/or Patient Organizations.