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Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?

The advertising and promotion of medical products are regulated by article 79 of Decree No. 677 of 1995, which sets out the general rule that prescription medicinal products may be advertised only at scientific or technical events, or in publications addressed to healthcare professionals, and must be consistent with the regulatory information approved by the marketing authorisation holder, particularly regarding indications. The direct promotion of prescription-only medicinal products to patients is prohibited under Colombian legislation, which includes online advertising. When non-advertising information about a prescription medicine is to be provided on the marketing authorisation holder's website, measures are to be taken to avoid information being accessed by patients (article 13 of Decree No. 334 of 2022).

In connection with the advertising of over-the-counter medicines, there are mandatory parameters contained in Resolution No. 4320 of 2004 that must be observed (eg, details of the nature of the medicine, indications, mechanism of action, therapeutic uses, contraindications, side effect risk management, precautions and warnings of drug dependence). Promotional information must be balanced and the benefits of the product must not be overstated.

Marketing authorisation holders are directly responsible for complying with the obligations and prohibitions stated under article 79 of Decree No. 677 of 1995 and under Resolution No. 4320 of 2004. Failure to comply with these obligations can lead to the suspension or cancellation of the marketing authorisation.

In addition, in 2016 and 2019, the Association of Pharmaceutical Research and Development Laboratories and the Pharmaceutical Chamber of the National Business Association of Colombia published their codes of ethics containing guidelines concerning business conduct, promotional and educational activities, and the relationship between the pharmaceutical industry and all relevant actors of the Colombian health system. Self-regulation and the codes bind the pharmaceutical companies that have subscribed to the association agreements.

The advertising and promotion of medical devices are regulated under article 58 of Decree No. 4725 of 2005, which states that promotional scientific information of medical devices must be consistent with the approved information contained within the marketing authorisation, as well as aligned with the scientific evidence available for the product. The benefits cannot be overstated.

This regulation distinguishes between three different types of medical devices depending on their profile risk to human health, in terms of efficacy and security as well as their uses. Categories are determined in Classes I, II and III, with Class I having the lowest level of risk and Class III having the highest level of risk. Class I medical devices may be advertised on mass media (eg, online advertising), taking into account the terms and conditions approved by means of the marketing authorisation. Medical devices and biomedical equipment in Classes IIa, IIb and III, intended for exclusive use by health professionals or prescribed by them, may only be advertised in scientific or technical publications. Notwithstanding the foregoing, the health authority may authorise other means of advertising.

Finally, the National Business Association of Colombia (ANDI) and its Chamber for Medical Devices, which clusters domestic and international manufacturers, importers and suppliers of medical devices, issued its Code of Ethics and Transparency (CET) in 2015, aimed at governing the interactions between medical device companies and healthcare professions as well as organisations that operate, distribute and use medical devices. The CET also sets principles and guidelines on advertising said devices before healthcare professionals and the public, when available. The last update of the CET made by the ANDI Chamber for Medical Devices includes:

The promotion of the products of the industry must be ethical, precise and duly supported. In this sense, clinical trials, scientific research and sponsored clinical studies must be transparent and pursue scientific, not promotional, purposes. In this regard, in the case of market research that is carried out by pharmaceutical companies, it is prohibited to use the information collected as advertising data or promotional material. Additionally, such data cannot be used in such a way as to be misleading because they appear to have origins in scientific studies.

Among other regulations related to promotion and advertising, the CET establishes that all information material for drug promotion must indicate who sponsors or finances it and, when it refers to published studies, it must be faithfully reproduced or offer a clear reference that facilitates its access. Pharmaceutical companies must have clear and written policies for the approval processes of promotional materials and activities. In this sense, each pharmaceutical company will be responsible for:

The recently issued Decree No. 334 of 2022 states that any advertising and promotion are to be consistent with the conditions approved in the health registration. Article 10 specifies that the information and advertising of chemically synthesized medicines, medicinal gases, biological, homeopathic and phytotherapeutic products sold under prescription may only be made in publications whose distribution is restricted and directed exclusively to professionals in medicine and dentistry. Additionally, it is prohibited to provide information, advertising and promotion of prescription medication in mass media and mass dissemination through digital platforms, instant messaging applications and social media.

However, with respect to information and advertising on chemically synthesised, biological, homeopathic and phytotherapeutic over-the-counter drugs, article 12 of Decree No. 334 of 2022 specifies that this must be done in compliance with the regulations issued by the Ministry of Health and Social Protection (MOH) (eg, Decree No. 4320 of 2004). The holders, importers and manufacturers of these products shall inform the National Food and Drug Surveillance Institute (INVIMA) in advance about the advertising pieces and communication media to be used. This publicity will not require prior approval by the MOH.

What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?

Article 106 of Law No. 1438 of 2011 and article 133 of Law No. 1474 of 2011 specifically state that pharmaceutical and medical device companies are not allowed to provide any sort of privilege or gift, in money or in kind, to any player in the healthcare system, including healthcare professionals. Those who infringe this norm may be sanctioned with fines of up to 6,550,935,000 Colombian pesos.

What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?

According to Resolution No. 2881 of 2018, the companies that market medicines or medical devices (ie, transfers of value that are delivered to actors in the health sector) that can be classified in the following categories must be registered.

In the case of natural persons, those that: 

For legal persons, those constituted as: 

However, transfers of value in Colombia are defined as the delivery of goods or services to the aforementioned health sector actors, in forms such as:

In addition, it is mandatory to make a report to the MOH when the sum of the deliveries, in any modality or quantity, to a single recipient exceeds the amount of 1 million Colombian pesos during a six-month period. In that case, the report must include all goods or services delivered.

Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.

In the first instance, INVIMA is in charge of any surveillance and control of a scientific and technical nature. INVIMA works for the protection of the individual and collective health of Colombians through the application of health regulations associated with the consumption and use of food, medicines, medical devices and other products subject to health surveillance. This institute was created by Law No. 100 of 1993.

Additionally, INVIMA is the entity in charge of initiating a sanctioning process in cases that prove an alleged infraction or violation of the health regime according to article 577 of Law No. 9 of 1979 (modified by article 98 of Decree No. 2106 of 2019) Finally, although health regulations contain the preferably applicable norms, the Consumer Protection Regulation contained in article 61 of Law No. 1480 of 2011 could also apply.

In terms of self-regulation, pharmaceutical companies operating in Colombia are mainly affiliated with two entities: the ANDI's Pharmaceutical Chamber and the Association of Pharmaceutical Research Laboratories. These companies have issued codes of ethics that seek to collect good practices of conduct regarding the interactions of companies with actors in the health sector and, particularly, set forth what they consider should be allowed in the field of drug promotion.

Thus, promotional information must be clear, legible, exact, balanced, honest and complete so as to allow the recipient to form his or her own opinion about the therapeutic value of the drug in question. It must be based on an updated evaluation of all relevant and clearly reflected evidence. It should not be confused by distortion, exaggeration, undue emphasis or omission, or in any other way. Any ambiguity should be avoided by all means. Absolute statements such as 'unique' or 'none' should only be used when they are adequately supported by science.

What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?

In the event of a breach of the provisions of any applicable laws, an administrative proceeding will be followed to determine the circumstances of the breach.

Initially, through a health and safety measure, INVIMA may order the suspension of the advertisement violating the norm. If damage had already been caused, according to the administrative proceedings, manufacturers, importers and distributors may be subject to sanctions such as reprimands, fines of up to an amount equivalent to 10,000 daily minimum wages, confiscation of products, suspension or cancellation of marketing authorisation or licences, and temporary or permanent closure of the premises, constructions or services concerned (Law No. 9 of 1979).

Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?

Decree No. 780 of 2016, which incorporated Decree No. 2200 of 2005 and Resolution No. 1403 of 2007, contains regulations for appropriate storage, handling and supply requirements for medicines and medical devices that any pharmaceutical facility should meet.

Prescription medicines can be sold only in pharmaceutical facilities (ie, pharmacies and drug wholesalers). Over-the-counter (OTC) medicines may also be sold in supermarkets provided that the establishment complies with the minimum requirements for guaranteeing the quality of the medicinal products.

Importers of medical devices must obtain a certificate of storage and conditioning capacity for medical devices.

What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?

Online pharmacies are still considered pharmaceutical facilities and are obliged to comply with the requirements contained in Decree No. 2200 of 2005, and in Decree No. 780 of 2016 and Resolution No. 1403 of 2007. In addition, they must also comply with the requirements for the promotion and advertising of prescription drugs (Decree No. 677 of 1995) and over-the-counter drugs (Resolution No. 4320 of 2004).

With the issuance of Decree No. 334 of 2022, the marketing of over-the-counter and prescription drugs as well as phytotherapeutic products through digital platforms was regulated. 

Article 14 specifies that the marketing of chemically synthesised, biological, homeopathic and phytotherapeutic products sold under prescription will be allowed through official websites or digital platforms of pharmacies, provided that they comply with the following:

Finally, regarding the commercialisation of over-the-counter medicines and phytotherapeutic products through websites or digital platforms, marketing will be allowed through official websites or digital platforms of pharmacies, chain stores or department stores, provided that they comply with the following:

What are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?

According to Law No. 1571 of 2015, the Ministry of Health and Social Protection (MOH) has the responsibility, among other things, to maintain a financially sustainable national pharmaceutical policy that includes medicine price controls (for monopolistic or high-cost medicines), unified benefits plans (collective protection plus individual protection), benefits plan exclusions, health technology assessment for the entry into the Colombian market (front door assessment) and centralised purchasing.

Through Decree No. 705 of 2016, the MOH delegated the pricing of medicinal products to the National Pricing Commission for Medicinal Products and Medical Devices (NPCMPMD). The NPCMPMD has structured different methodologies for the calculation of the maximum sales value of high-cost products, including the direct control regime, and for the reimbursement of those products not included in the benefits plan. The NPCMPMD also monitors medicinal product prices reported to the Drug Price Information System by marketing authorisation holders, medicine sellers and buyers. In general, there are two regimes for the price control of medicines:

Maximum prices for medicines under direct control are most commonly determined based on international comparisons (international price referencing (PRI)). However, there are some medicines within direct control whose price is determined by other methodologies not based on PRI. PRI is mandatory and applies to institutional and trade channels. 

Other medicines without PRI but that were the subject of reimbursement in the past had a maximum reimbursement value (VMR) calculated by the government. Although not mandatory (for invoicing), this value is the maximum value that could be reimbursed by the Administrator of Resources of the General System of Social Security in Health (ADRES) or that is considered for maximum capped fee calculations.

Medicines within the benefits plan (collective protection) are covered by a per capita unit, which is transferred from the ADRES to each health maintenance organisation (HMO) per affiliate. Medicines not covered by the capitation payment unit (UPC) were previously reimbursed by the ADRES at a VMR but, as of 1 March 2020, they are paid with a maximum capped fee (paid in advance to each HMO, according to historic reimbursements for therapies not covered by the mentioned UPC). New regulations also established how HMOs should manage said capped values (for technologies considered individual protections, see, for example, Resolution No. 3512 of 2019, Resolution No. 243 of 2019, Resolution No. 205 of 2020, Resolution No. 206 of 2020, Resolution No. 2152 of 2020 and Resolution No. 586 of 2021).

The MOH also has the faculty to establish mechanisms to undertake centralised negotiations and to directly purchase medicines, supplies and devices. The first regulation for centralised purchasing is Resolution No. 1962 of 2017, which establishes the criteria, distribution and supply of medicines for chronic hepatitis C. This practice is likely to be extended to other high-cost medicines.

In addition, a cost-benefit evaluation performed by the Institute of Technology Assessment in Health (IETS) will assign a therapeutic value category to new technologies. The price will depend on health outcomes and a set comparator (ie, standard of care). The methodology for this assessment is included in Decree No. 710 of 2018 and in a draft circular (Circular No. 8 of 2018), which has not been issued yet. Notwithstanding the above, MOH Resolution No. 2152 of 2020 establishes that new chemical entities, before being included within the maximum budget calculation, should be evaluated by IETS and, if it demonstrates utility, IETS would establish a price, and a differential value could be recognised and covered by the said maximum budgets.

In 2022, the National Committee for Medicines Prices, for the first time, controlled the prices for vital unavailable medicines in Circulars No. 11 and 12 of 2022.

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