Such registry seeks the transparency of public information regarding payments made by the pharmaceutical industry to health sector actors, particularly those made to prescribing physicians, with the purpose of establishing regulations and public policies about such subject matter.
Who is obliged?
Industry related with medicines, medical devices and diagnostic reagents. Holders of Marketing Authorizations are included, as well as manufacturers, importers, distributors, and trade associations representing the same. Additionally, Colombian corporations shall report payments made by their parent companies, subsidiaries or affiliates abroad in favor of payees of payments in Colombia.
What items are subject to reporting?
Payments made carried out directly or indirectly to the following shall be reported: prescribers, health entity workers, those in charge of health products purchases, whoever leads health educational matters in educational entities, those covering matters relating to health in communication media, professional organizations of the health sector, scientific associations, health-related professional associations, educational institutions, patient organizations, NGOs, Benefit Plans Administration Enterprises, health services providers, communication media.
What is the frequency for submitting the report?
This report shall be submitted every semester through a technological platform administered by the Ministry of Health denominated Information Exchange Platform (PISIS, for its Spanish acronym, Plataforma de Intercambio de Información), and shall remain registered in the platform during the three months following the due date of the corresponding reporting period.
What is subject matter of being reported?
Delivery of money, goods or services. Namely, the delivery of food and beverage supplies, financing of activities such as travel, transportation, lodging, travel expenses, financing of clinical studies and health-related research, supply of software licensing and registration in databases, financing for registration of any academic activity, financing for organizing any academic activity, financing of scientific publications, financing for patient’s programs, delivery of promotional information, medical samples, and payment of fees for rendering of services.
As from when?
The first mandatory report shall be submitted within the first quarter of year 2020, including transfers made as from July, 2019.
What matter is not subject of being reported?
Value transfers made to persons with which a labor relationship exists; those destined for developing market studies; the supply of software licensing necessary for the operation of a biomedical team.
Which are the minimum amounts to be reported?
Transfers exceeding a minimum legal monthly wage in force ($COP 781,242) delivered to the same receptor within a six-month period.
Exceptionally, for the cases of food, beverages and delivery of promotional objects, only transfers exceeding the unitary amount of three minimum legal daily wages in force ($COP 78,000.oo)
Are there any sanctions?
Noncompliance of the reporting obligation shall give place to the sanctions defined under Articles 116 and 132 of Law 1438 / 2011, namely fines of up to 5,000 minimum legal monthly wages in force $COP 3,906,210,000.oo.
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