Use the Lexology Navigator tool to compare the answers in this article with those from other jurisdictions.
Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
Title VIII of Decree 677/1995 provides controls, procedures and applicable penalties for non-compliance with laws governing medicinal products. Article 104 contains administrative penalties which can be imposed on marketing authorisation holders or product manufacturers for non-compliance, including:
- the suspension or cancellation of the corresponding licence registration;
- the temporary or definitive closure of the establishment or pharmaceutical laboratory;
- fines of up to 10,000 times the current legal minimum wage; and
- the confiscation and/or destruction of products.
In addition, both the Association of Pharmaceutical Research and Development Laboratories (AFRIDO) and the National Association of Colombian Indsutries industry codes contain enforcement measures and applicable penalties under a compliance control procedure carried out by an ethics tribunal. Under the procedure, offenders may be subject to:
- moral sanctions, including written warnings and specific action requests seeking to avoid non-compliance in the future;
- pecuniary sanctions, including fines from 20 to 100 times the current legal minimum wage (in Colombian pesos), depending on the seriousness of the non-compliance; and
- legal sanctions, if a complaint is made before the National Food and Drug Surveillance Institute or other authorities.
From an antitrust standpoint, the Superintendence of Industry and Commerce (SIC) ensures the protection of unfair competition laws and antitrust practices and can impose penalties of up to $25 million for companies and $700,000 for individuals.
Finally, according to Article 132 of Law 1438/2011, the SIC can impose fines of up to 5,000 times the current legal monthly minimum wage for violation of the price control regime on any natural or legal entity, agent or actor involved in the production, distribution, marketing and other intermediation of medicines, medical devices or goods related to the health sector.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
Article 17 of the Health Statutory Act (Law 1751/2015) prohibits the provision of gifts or the granting of any privileges to healthcare professional in the context of their professional practice if it does not have a legitimate purpose (eg, educational or commercial transaction). This includes cash or cash in kind from:
- pharmaceutical companies;
- producers; or
- distributors or traders of medicines, medical supplies, medical devices or medical equipment.
Article 28 of the Anti-corruption Act states that it is a criminal act to commit fraud or exert undue influence over an official employee with the purpose of obtaining an economic benefit. Such a violation is punishable with a four to eight-year prison sentence and fines of up to $4,448 (relevant as of 2016).
Article 29 of the Anti-Corruption Act states that it is a crime for a government official or an individual in public office to obtain for themselves or for another party an unjustified increase in their assets. Such a violation is punishable with a nine to 15-year prison sentence and fines of up to $5,448 (relevant as of 2016).
Article 106 of Law 1438/2011 also specifically prohibits pharmaceutical companies from providing gifts or granting privileges to healthcare professionals.
The Anti-bribery Act (Law 1778/2016, Resolution 100-002657 and Circular 100-03/2016) defines the scope of transnational bribery in Colombia.
Finally, the AFRIDO Code of Ethics contains useful guidelines concerning business conduct and specifically the relationship between the pharmaceutical industry and healthcare professionals. Section 6(f) of the code provides guidelines for specific scenarios in regard to interaction with healthcare professionals. Article 5.1.4 of the code states that pharmaceutical companies must avoid interaction with third parties whose resources come from illegal activities and must conduct due diligence to avoid this occurring. To this end, they should require third parties to disclose all of their business relationships in order to confirm that they are not subject to penalties or investigations for corruption or money laundering.
Click here to view full article.