Trends and developments

Legal developments

Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?

Notable trends and recent legal developments in Colombian legislation primarily focus on:

  • centralised purchasing;
  • medicinal price control; and
  • the public registry system for the transfer of value.

Article 71 of Law 1753/2015 authorises the Ministry of Health and Social Protection (MoH) to conduct centralised negotiations and directly purchase medicines, medical supplies and devices. This authorisation is part of a state policy aimed at guaranteeing access to medicines and healthcare services for all citizens. It also contributes to the financial sustainability of the General System of Social Security in Health.

Healthcare service suppliers and buyers must comply with the prices set during centralised negotiations. In addition, Resolution 1962/2017 establishes the criteria for the centralised purchasing, distribution and supply of medicines for chronic hepatitis C. As the treatment of hepatitis C is expensive for the health system, centralised purchasing is conducted through the revolving fund of the Pan-American Health Organisation, to reduce the price of these medicines and facilitate access to them for the wider population.

Please see the response to the question regarding legislative changes for more information about medicinal price control and the recent regulation governing transfers of value directed to healthcare professionals.

Legal framework

Legislation

What is the primary legislation governing medicinal products in your jurisdiction?

The advertisement and promotion of medical products is regulated under Article 79 of Decree 677/1995. This sets out the general rule that medicinal products may be advertised only in scientific or technical events or publications addressed to healthcare professionals and must be consistent with the regulatory information approved by the health registration authority, particularly regarding indications.

Except for over-the-counter medicines, the direct promotion of medicinal products to patients is prohibited under Colombian legislation. In connection with this rule, there are also mandatory parameters, which must be referenced when medicinal products are advertised (eg, 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. Failure to comply with these obligations can lead to the suspension or cancellation of the marketing authorisation.

Regarding the pricing of medicines, mechanisms for establishing maximum prices have existed for over 25 years in Colombia. In the past three years, the Ministry of Health and Social Protection (MoH) has adopted different measures aimed at safeguarding the financial stability of the health system. For example, the National Commission for Drug and Medical Device Prices implemented a method to calculate an international reference price for medicinal products using several relevant markets, selecting a specific percentile and establishing a maximum retail sales price (Circular 03/2017).

Local regulation includes:

  • procedures for the pharmacological and pharmaceutical evaluation of biological medicines in the process of obtaining marketing authorisation to manufacture, import, and commercialise pharmaceutical products (Decree 1782/2014);
  • bioavailability and bioequivalence guidelines (Resolution 1124/2016);
  • manufacturing good practice guidelines (Resolution 1160/2016);
  • the renovation and modification of the sanitary registry (Decree 843/2016);
  • guidelines to comply with the stability standards required for biological products (Resolution 3690/2016);
  • immunogenicity guidelines (Resolution 4490/2016); and
  • criteria for the evaluation carried out by the Technology Assessment Institute to establish the therapeutic value of new medicament and the procedure that must be submitted to the National Food and Drug Surveillance Institute (INVIMA) for the process of obtaining the registration of the commercialisation of medicaments in Colombia (Decree 433/2018).

In addition, the Association of Pharmaceutical Research and Development Laboratories and the Pharmaceutical Chamber of the Colombian Business Association, launched in 2015 and 2016, respectively, have developed their codes of ethics containing guidelines concerning business conduct, promotional and educational activities and the interrelationship of the pharmaceutical industry with all relevant actors of the Colombian health system. Self-regulation and the codes bind the pharmaceutical companies which have subscribed to the association agreements.

Are any legislative changes proposed or expected in the near future?

In the past two years, the government, headed by the MoH, has taken measures to protect the financial stability of the Colombian healthcare system. Specifically, it has:

  • sought to stimulate market competition by facilitating the entry of generic products;
  • initiated compulsory licence (CL) investigations (although it has never granted one); and
  • promoted the rational use of high-cost medicines and therapies.

A 2016 CL investigation into the Novartis Glivec product (imatinib) is particularly illustrative. In this case, the MoH issued a declaration of public interest – a key gateway in the investigation – and used it, not to issue a CL, but to impose a dramatic price reduction (over 50%). Although this practice has since been banned (under Decree 670/2017 and partly as a concession for Colombia’s accession to the Organisation for Economic Cooperation and Development), the case is still serves as a warning to market players.

More recently, through draft Circular 08/2018, the MoH is attempting to establish a method by which the maximum price of a medicinal product is calculated based on the pharmaeconomic value and therapeutic assessment established by Decree 488/2017.

Conversely, the MoH recently issued Resolution 2881/2018, which has created a public registry system for the transfer of value to record any value transfer (eg, stipend, fee or remuneration of any kind) between entities in the pharmaceutical industry and any healthcare system agent (ie, physicians, medical associations or patient associations). Marketing authorisation holders, manufacturers, importers and distributors of medicaments and medical devices must comply with the reporting requirements under the resolution. Failure to comply with the requirements in a timely, reliable and sufficient manner will result in a non-compliance report and/or fines of up to $1.3 million.

Regulation

Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?

The INVIMA is the competent authority for granting marketing authorisations for medicinal products and for the surveillance of manufacturing facilities (ie, it issues good laboratory practice and good manufacturing practice certification). The institute also has the administrative authority to initiate investigations and penalise conduct which the is a violation of sanitary rules. The INVIMA also performs ex ante examination on over-the-counter drug advertising and ex post control on prescription drug advertising.

The MoH has a primary role in formulating and executing public health policy, guaranteeing the application of its decisions in the healthcare system in Colombia and in the drug marketing chain. Therefore, the MoH is mostly active in drug marketing policy, price control (via the National Commission for Medicinal Products Prices) and reimbursement exclusions.

The Institute for Technical Health Assessment is a technical regulatory authority which examines health technologies based on scientific evidence according to different criteria (eg, effectiveness and economic impact (therapeutic value assessment)).

Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?

In addition to the general rules, there are other regulatory regimes, which are applicable to medicinal products covering:

  • competition;
  • consumer protection; and
  • international trade.

With respect to competition rules, the national competition authority (under the Superintendency of Industry and Commerce (SIC)) has the power to investigate and penalise antitrust practice, collusion or any other unfair competition behaviour. Regarding M&A, special rules apply to health service providers. In addition, the SIC will penalise companies failing to report (or quoting incorrect prices) to the price database for prescription medicines.

Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?

No, all medicinal products are regulated in Colombia, including phytotherapeutic, homeopathic medicines and dietary supplements.

Although master formulas and homeopathic products do not require marketing authorisation, they must be manufactured in pharmacies, which must receive good manufacturing practice certification from the INVIMA.

Decree 481/2004 states that ‘vital unavailable’ medicines do not require marketing authorisation. However, their safety and efficacy must be proved through other special requirements.

Supply

Manufacture

What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?

Colombian and foreign drug manufacturers must comply with good manufacturing practice (GMP) under Resolution 3183/1995, which adopted the World Health Organisation (WHO) GMP manual (32nd Technical Report) which is in force until April 2019. In addition, Resolution 1087 contains guidance for performing GMP inspections.

As of April 2019, according to Resolution 1160/2016, drug manufacturers must comply with dispositions contained in Annex 4 of the WHO GMP manual (37th Technical Report). From April 2021 manufacturers of sterile drugs must comply with dispositions contained in Annex 6 of the WHO GMP manual (45th Technical Report).

Decree 549/2001 contains the procedure for assessing GMP, which includes the following steps:

  • the National Food and Drug Surveillance Institute (INVIMA) submits a site master file with a GMP certification request;
  • the INVIMA audits the manufacturing facility (according to the applicable WHO GMP technical reports); and
  • the INVIMA decides whether to grant the GMP certificate.

 

In the case of medicines manufactured abroad, the INVIMA accepts GMP certification issued by high-surveillance regulatory authorities in: Canada, Denmark, France, Germany, Japan, the Netherlands, Norway, Sweden, Switzerland, the United Kingdom and the United States.

What is the fee for obtaining authorisation?

The INVIMA has determined fees on a scale of one to four depending on the location of the manufacturing facility. Fees range from $1,823 to $47,123.

What is the validity period for authorisation?

The validity period for a GMP certificate is three years.

How robust are the standard good manufacturing practices followed in your jurisdiction?

Colombia followed the standard of the WHO 32nd Report until Resolution 1160/2016 was issued. Resolution 1160 introduces requirements contained in the WHO 37th and 45th Technical Reports and will be in force from April 2019.

What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?

If the INVIMA denies GMP certification, the applicant can appeal. However, if the certification is not granted, the local manufacturer cannot manufacture, sell or export the product. Foreign drug manufacturers (with a manufacturing facility in another jurisdiction) lacking GMP certification cannot import or commercialise the product in Colombia.

The INVIMA will revoke a certificate if it detects that GMP has been violated. If this occurs, an administrative investigation by the INVIMA will be performed which can result in:

  • the prohibition of the production and commercialisation of the product when it is produced in Colombia; or
  • the prohibition of the import and trade of the product in Colombia.

The INVIMA can also determine the liability of individuals for the violation of the rules and apply penalties, including:

  • the suspension or cancellation of marketing authorisation or licences; and
  • the closure of the manufacturing facility.

Distribution

How are the distribution and storage of medicinal products regulated?

Good storage practice or good distribution practice certification (according to World Health Organisation standards) are not yet mandatory in Colombia.

However, Resolutions 2200/2005 and 1403/2007 contain dispositions that any pharmaceutical establishment, including drug wholesalers (manufacturers and distributors) and retailers (pharmacies) must comply with certain standards covering the reception, storage, conditioning and transportation of medicines. These dispositions are intended to ensure that the conditions necessary to maintain specifications and guarantee the stability and quality of the medicines are maintained during storage, handling and transportation.

Import and export

How are the import and export of medicinal products regulated?

Any import procedure for a medicinal product must be supported in the marketing authorisation issued by the INVIMA, before any import activity. Similarly, medicinal products manufactured in Colombia, intended for export, must be covered by a free sales certificate issued by the INVIMA.

During import procedures, a virtual validation from the INVIMA will be requested.

Are parallel imports permitted in your jurisdiction?

Not in practice. Parallel imports for pharmaceutical products are effectively banned due to regulatory requirements that prevent a potential parallel importer from importing or commercialising a product based on the same marketing authorisation held by a third party (Decree 677/1995).

Although a parallel importer could seek its own marketing authorisation, the INVIMA requires authorisation from the manufacturer of the product. Although this regulatory barrier was modified by Decree 1313/2010, which permits the import of pharmaceutical products without authorisation from the manufacturer, this option is rarely applied due to a lack of specific regulations aimed at reducing counterfeit, contraband and quality risks that may derive from its application.

Under IP law, parallel imports are permitted in Colombia. Article 54 of Andean Decision 486 establishes an international exhaustion of rights once a product has been introduced into the flow of commerce of any country by the owner or person authorised to do so by the rights holder.

Sale and purchase

What rules govern the dispensing, sale and purchase of medicinal products?

For the case of prescription medicines and hospital pharmacies, Decree 2200/2005 establishes that the dispenser must request a medical prescription, including for tailor-made master formulas. Hospital preparations (eg, sterile preparations, parenteral nutrition and mixtures of oncological medicines) must contain labels containing specific information about the patient.

In addition, for prescription medicines that are dispensed at drug retailers, the dispenser must request a prescription from the physician (particularly for antibiotics and psychiatric drugs) and inform the user about the most important aspects that guarantee the therapeutic effect.

Dispensers are also obliged to ensure that staff comply with professional training standards so that those in contact with patients have the necessary knowledge and skills to perform their duties. Adulterating or modifying a prescription is forbidden, as is recommending the use of other products or inducing patients to buy substitute medications rather than the one prescribed. However, dispensers can offer alternatives provided that they do not alter the following aspects of the medicine:

  • the active ingredient;
  • the concentration;
  • the dosage form;
  • the route of administration;
  • the frequency;
  • the duration of treatment;
  • the quantity; or
  • the prescribed dose.

Over-the-counter medicines may be sold at pharmacies and in retail stores.

Are there any restrictions on the online sale and purchase of medicinal products?

There are no regulations in Colombia which specifically address the online sale and purchase of medicinal products. However, the online sale and purchase of medicinal products – as with any other product in Colombia – must comply with the rules set out in Decree 2200/2005. Article 79 of Decree 677/1997 prohibits the promotion of prescription medicines outside scientific or technical platforms directed at healthcare professionals.

The INVIMA has made significant efforts to block the sale of products and medications that do not meet sanitary and safety requirements on the Internet. In this regard, it has signed various agreements with online sales platforms and the Colombian Chamber of Electronic Commerce. As a result of such efforts, at least 4,000 sales and marketing promotional schemes advertising fraudulent or altered products (eg, dietary supplements and medications) have been withdrawn from online platforms. In addition, the INVIMA recommends that members of the public purchase medication at established pharmacies, rather than online.

Named patient supply

What rules govern named patient supply of pre-launch medicinal products?

Decree 481/2004 governs the named patient supply of pre-launch medicinal products. It states that ‘vital unavailable’ medicines can be imported into the country without a marketing authorisation provided that the medicine:

  • is not in a clinical research phase;
  • is not commercialised in the country or, if it is in commercialised quantities, these are not sufficient to meet market needs; and
  • has no substitutes in the market.

Such imports can be directed to a single patient, a group of patients requiring the same product or used in the case of clinical urgency.

Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in your jurisdiction?

The authorisation procedure for conducting clinical trials in Colombia is regulated by Resolution 2378/2008. To initiate a clinical trial, the party must request approval from the National Food and Drug Surveillance Institute (INVIMA) and fulfil, among others, the following requirements:

  • The party has received an approval letter issued by an INVIMA-registered research ethics committee.
  • The party has received approval from a local health authority confirming that the investigation centre is suitable to provide health services.
  • The party has received a certificate of good clinical practice issued by the INVIMA (valid for five years).
  • The party has in place an insurance policy to cover third-party damages (to cover possible adverse events associated with or attributable to the clinical trial).
  • The party can provide a robust research protocol (including the operation methodology, theoretic framework, justification, results analysis plan and patient data management).

Clinical practices

How robust are the standard good clinical practices followed in your jurisdiction?

The INVIMA bases its regulations and practice on global clinical standards (set by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organisation) and verifies that institutions that carry out research on human beings must comply with the good clinical practice adopted through Resolution 2378/2008. The competence and responsibilities of the ethics committee which issued the approval letter for the research as well as those of the investigator will be assessed in depth. The processes, documentation and registrations associated with the project and of the clinical labs will be also evaluated.

In addition, research centres must follow the dispositions of Resolution 8430/1993, which establish the rules for performing health investigations in Colombia, as well as Resolution 1995/1999, which contains rules for managing clinical records. The personnel responsible for the storage and handling of medicines must comply with the dispositions of Decree 2200/2005 and 1403/2007, which include rules covering pharmaceutical services. In addition, according to Resolution 20764/2011, periodic reports on any adverse events attributable to an investigational drug must be created.

Reporting, disclosure and consent

What are the reporting and disclosure requirements for the results of clinical trials?

Resolution 2378/2008 requires that the results of every clinical trial (both favourable and unfavourable), whether the trial itself is finalised or abandoned, must be reported to the INVIMA.

The principal trial researcher must submit written summaries covering the status of the study to a research ethics committee at least once a year or more frequently if the committee requires it.

The researcher must notify the INVIMA of any significant change that affects the conduct of the trial.

The researcher is responsible for ensuring that the study data is disseminated among the scientific community, regardless of whether the results are favourable, for the therapies under study.

What are the informed consent obligations with respect to clinical trial subjects?

Resolution 8430/1993 establishes that informed consent obligations include providing clinical trial subjects with information on:

  • the investigation objectives;
  • the procedures that will be used;
  • any inconveniences and expected risks;
  • the benefits that may be obtained; and
  • any alternative procedures that could be advantageous for the research subject.

In addition, clinical trial subjects must:

  • receive answers to any questions and doubts;
  • be free to withdraw consent and to stop participating in the study;
  • have patient confidentiality;
  • be provided with updated information obtained during the study;
  • be given medical treatment if any injuries arise as a result of the investigation; and
  • be reimbursed for any additional expenses, which should be covered by the budget of the investigation.

Insurance

What are the insurance requirements for clinical trials?

According to Resolution 2378/2008, to safeguard the fundamental rights of research subjects, civil liability insurance for damage caused to third parties must be put in place. The insured value should be determined according to international standards. In the event that the insurance does not completely cover the damages, the promoter, clinical trial investigator and/or the head of the institution or centre in which the trial was carried out are jointly and severally liable.

Data protection

What data protection issues should be considered when conducting clinical trials?  

Under the Colombian Data Privacy Law (1581/2012), clinical trial data is considered a special data category as it contains health and personal biometric data. The trial subject must sign an informed consent form, which clearly states what data is being collected and for what purpose.

Clinical trial providers must identify:

  • the data that is being processed;
  • who processes the data;
  • where the data is transferred; and
  • any other risks and relevant processes associated with the data.

Marketing authorisation

Authorisation

What is the marketing authorisation procedure for medicinal products in your jurisdiction?

The procedure for obtaining marketing authorisation is regulated by Decree 677/1995 (for chemically synthesised drugs) and Decree 1782/2014 (for biologicals).

Under Decree 677, medicinal products fall under the following categories:

  • new medicines, including:
    • those with an active pharmaceutical ingredient (API), which has not been included in the Pharmacological Code (also known as ‘new chemical entities’); or
    • those with an API which is included in the Pharmacological Code, but the product is related to new associations, fixed dosages, new indications or new pharmaceutical forms; and
  • medicines already included in the Pharmacological Code.

New medicinal products must go through the complete registration process. The process starts with Phase I, which involves a safety and efficacy assessment carried out by the Medicines Review Commission. If successful, the product can be included in the Colombian Pharmacological Code. Following this, Phase II can be completed, which involves a chemistry, manufacturing and controls assessment by the National Food and Drug Surveillance Institute (INVIMA). If the assessment is successful, marketing authorisation can then be granted.

In addition, new products and technologies are subject to a therapeutic value evaluation by the Colombian Institute of Technology Assessment in Health, which will then assign a pricing category.

New versions of medicinal products already included in the Pharmalogical Code (usually generic products) can go directly to Phase II.

Phase I and II assessments usually take 14 to 18 months.

Marketing authorisations are valid for five years from the issuance of the authorisation and may be renewed for the same period on request. The renewal application must be filed at least three months before the expiration of the approval and follows the same procedure as the initial application.

Colombia provides test data protection for new chemical entities (ie, new molecules) for five years from the date of authorisation. In practice, this means that the INVIMA will prevent generic applicants from obtaining a marketing authorisation during a five-year period of exclusivity. New chemical entity applicants must request test data protection when filing for Phase I.

What criteria are considered in granting marketing authorisation?

Phase I The Medicine Review Commission will evaluate the suitability of non-clinical and clinical studies for assessing the safety and efficacy of the new medicinal product.

Phase II Phase II consists of a complete chemistry, manufacturing and controls assessment, which requires:

  • a valid Colombian good manufacturing practice certificate;
  • stability studies in Zone IVB (T°: 30+/-2°C and RH: 75+/-5%); and
  • a valid free sales certificate from the country of origin.

What is the fee for obtaining marketing authorization?

For 2018 the fees for obtaining marketing authorisation from the INVIMA range from $3,500 to $16,000.

What is the validity period for marketing authorisation?

Marketing authorisation is valid for five years.

What are the consequences of failure to obtain marketing authorisation?

All medicinal products require marketing authorisation from the INVIMA to be marketed in Colombia. The main consequence of failing to obtain marketing authorisation is that the product cannot be imported or commercialised in Colombia.

The INVIMA may allow the import or commercialisation of medicinal products without a marketing authorisation in the following exceptional cases:

  • when the Ministry of Health and Social Protection (MoH) or the INVIMA authorises a clinical trial of the product;
  • if a health emergency is declared by the MoH;
  • if the MoH is obliged to provide a pharmaceutical product for an immunisation programme to control diseases affecting public health and such a product is unavailable on the domestic market (Decree 822/2003);
  • if there is a case of named patient supply (‘vital unavailable’ Decree 481/2004); or
  • if the product is a master formula and is manufactured in a pharmacy which fulfils the good manufacturing practice requirements (Decree 0444/2008).

Pharmacovigilance

Monitoring

What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

To ensure the ongoing safety and efficacy of medicinal products, after marketing authorisation has been granted, Colombian legislation provides a reporting procedure concerning adverse events and any other quality issues relating to the use of medicinal products. In this regard, the National Food and Drug Surveillance Institute (INVIMA) requires marketing authorisation holders or pharmaceutical product manufacturers to report adverse events and quality issues to acknowledge the medication profile in such a way that the preexisting factors are identified in time.

Resolution 2004009455 issued by the INVIMA on 28 May 2004 specifies the requirements and frequency with which pharmacological reports must be created under Article 146 of Decree 677. Under this regulation, the marketing authorisation holder and/or the pharmaceutical product manufacturer must adopt a pharmacovigilance programme to ensure the creation of periodic reports about the safety and efficacy of the medicinal product. The reports must be submitted according to the following considerations:

  • Any serious and unexpected adverse event must be reported within 72 hours of its knowledge under the pharmacovigilance programme.
  • Any non-serious or unexpected adverse event must be reported within the last five working days of each bimester.

An ‘adverse event’ is defined in the resolution as an unfortunate medical event that may occur during treatment with a medicinal product. The occurrence of such an event does not necessarily have a causal relationship with the medical treatment or product.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

According to applicable sanitary law, Law 1581/2012 and Decree 1377/2013, in addition to standardised local business practice – and particularly considering that pharmacovigilance programmes may involve sensitive personal data – the personal data (ie, subject names, identification information or disease information) associated with any adverse event or quality issue need not be included when reporting to the relevant authority. These reports are usually made based on a codified number, which does not allow for the transfer of personal data.

Pricing and reimbursement

Pricing

Are there rules governing the pricing of medicinal products in your jurisdiction?

According to Law 1571/2015, the minister of health has the responsibility, among others, to maintain a financially sustainable national pharmaceutical policy, which includes medicine price controls and benefits plan exclusions.

Through Decree 705/2016, the Ministry of Health and Social Protection (MoH) delegated the pricing of medicinal products to the National Commission for Medicinal Products Prices (NCMPP). This includes structuring methodologies for the calculation of the maximum sales value of high-cost products included within the direct control regime and for the reimbursement of those products not included in the benefits plan.

The NCMPP also monitors medicinal product prices reported to the Drug Price Information System by marketing authorisation holders, medicine sellers and buyers.

The MoH also has the authority to establish mechanisms to undertake centralised negotiations and to directly purchase medicines, supplies and devices. The prices resulting from centralised negotiations are fixed for health service suppliers and buyers and cannot be increased. The first regulation for centralised purchasing is Resolution 1962/2017, 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 Institue of Technology Assessment in Health 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 has been included in a recent draft (Circular 08/2018) and its execution by the MoH is currently pending.

Reimbursement

What is the structure for state reimbursement of medicinal product costs?

Each health maintenance organisation is responsible for organising and ensuring user access to the medicines and treatments included in the benefits plan. The health maintenance organisation transfers the payment of each user to the Adminstrator of the Resources of the General System of Social Security in Health (ADRES), which returns a capitation payment unit (UPC) to the health maintenance organisation for each affiliated person. The UPC should be equivalent to the actual value of the benefits plan.

If any user requests the delivery of a drug or medical service that is not provided by the benefits plan, the treating physician must prescribe the medicine or treatment via an electronic platform called MIPRES. Once the non-benefit plan drug is provided, ADRES pays the value of that particular drug or service to the health maintenance organisation or the services provider directly.

Advertising and labelling

Advertising

How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?

The regulation of the advertisement of medicinal products is divided between prescription medicines and over-the-counter medicines.

Prescription medicines All scientific promotional or advertising information regarding prescription medicines must comply with the conditions in the sanitary registry, which is approved by the National Food and Drug Surveillance Institute (INVIMA) and the technical and legal standards provided in Decree 677/1995. The registry titleholders are responsible for taking action when a breach of the regulations occurs.

Article 79 highlights a general rule which stipulates that prescription medicines must be advertised in scientific or technical publications for healthcare professionals only. The article expressly prohibits the advertisement of pharmaceutical products through:

  • press media;
  • broadcast media;
  • television; and
  • mass promotion.

The rule states that all information regarding the product must be consistent with the scientific literature associated with the product or known by the manufacturers, which includes:

  • actions;
  • indications;
  • therapeutic uses;
  • contraindications;
  • side effects;
  • administration risks; and
  • dependence and other cautions and warnings.

Article 79(4) prohibits the advertisement of medicinal products, if the advertisement:

  • contradicts the general norms regarding health, nutrition or therapy education matters;
  • contains partial truths; or
  • imputes, defames, causes injury or is pejorative of other brands, products, services or companies.

Over-the-counter medicines

Over-the-counter medicines can be advertised to the general public provided that the rules under Article 4 of Resolution 4320/2004 are followed, which include the following:

  • guidance on the proper use of the product must be provided;
  • objective information about the product without overstating its properties must be provided;
  • clinical indications must be presented in Spanish using clear language to avoid consumer confusion;
  • sanitary registry information requirements must be complied with;
  • clear and visible captions in audiovisual and print media advertisements must be used; and
  • methods to attract the attention of under-age patients, which induce them to use the product without a prescription, are strictly prohibited.  

In addition to these rules, the Association of Pharmaceutical Laboratories for Research and Development stipulates rules concerning the advertisement of pharmaceutical products in its Code of Ethics, launched in 2015. Article 6.2 of the Code of Ethics states that promotional information must be:

  • clear;
  • legible;
  • accurate;
  • balanced;
  • fair;
  • complete; and
  • based on scientific evidence.

Moreover, the code emphasises that the content of advertisements must include up-to-date information and evidence concerning an assessment of the pharmaceutical product, which should also be reflected in the information provided to healthcare professionals before authorisation by the regulatory authority. The information must not be misleading, be undue or omit any relevant information.

Finally, the National Association of Entrepreneurs of Colombia issued a voluntary self-regulation code – similar to the Code of Ethics – which includes guidelines regarding the advertisement and promotional standard for medicinal products.

Do any special rules apply to online advertising of medicinal products?

There are no specific regulations addressing the online advertisement of medicinal products.

However, Article 79 of Decree 677/1995 provides a general rule which stipulates that pharmaceutical prescription products must be advertised only through scientific or technical publications, which are addressed to healthcare professionals and expressly prohibits the advertisement of prescription medicines through television, broadcast media, the press and general mass-media facilities.

Conversely, over-the-counter medicines may be advertised through mainstream media according to Resolution 4320/2004 – which also applies to online advertisements.

The INVIMA also stipulates that online pharmacies must present medicinal product packaging alongside the product itself (for both prescription and over-the-counter medicines), including the product’s authorised labels and price.

Labelling

What are the packaging and labelling requirements for medicinal products?

According to Decree 677/1997, labels and printed packaging materials must be approved by the INVIMA. Labels and packaging must include:

  • the name of the product and any product trademarks;
  • the name of the product’s manufacturer and manufacturing location;
  • the active pharmaceutical ingredient and its concentration;
  • contraindications;
  • the due date;
  • the batch number;
  • the quantity of the product within the package;
  • any special storage conditions if applicable;
  • the marketing authorisation number; and
  • the following captions:
    • “prescription medicine” (if applicable); and
    • “keep away from children”.

For prescription products, indications must not be included, nor any picture evoking the therapeutic activity associated with the medicinal product.

Leaflets can include any information that is not permitted to be used on labels and packaging.

Packaging and labels in the language of the country of origin are acceptable provided that they include the name of the importer, the product composition, any storage conditions and the marketing authorisation number in Spanish. However, the entire label or packaging material must be approved by the INVIMA.

Prescription information and leaflets (if applicable) must be pre-approved by the Medicine Review Commission.

How is the promotion of off-label use regulated?

Off-label promotion is prohibited under Article 79 of Decree 677/1995. This prohibition is supported by the industry codes which contain regulations applicable to those members of the pharmaceutical industry who have subscribed to such agreements. Marketing authorisation holders are not allowed to conduct promotional activities which refer to indications that are not pre-approved by the INVIMA. Consequently, marketing authorisation holders are responsible for the content of any promotional and advertising materials, and therefore for non-compliance with the relevant promotional rules (ie, penalty fines and the cancellation of marketing authorisation).

Relations with healthcare professionals

Gifts and incentives

What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?

The provision of gifts or the granting of any privileges to healthcare professionals in the context of their professional practice is expressly prohibited if it does not have a legitimate purpose (eg, educational or commercial transaction). This includes cash or cash in kind from:

  • suppliers;
  • pharmaceutical companies;
  • producers; or
  • distributors or traders of medicines, medical supplies, medical devices or medical equipment.

Article 106 of Law 1438/2011 also states that pharmaceutical companies must not provide any gifts or grant any privileges to any individual in the healthcare system, which includes healthcare professionals and physicians. There is no distinction between outpatient or in-patient sectors.

In addition to these rules, the industry code of the Association of Pharmaceutical Research and Development Laboratories establishes some general guidelines to promote healthy competition and the development of promotional strategies consistent with unified ethical criteria. Some of the most relevant provisions regarding the collaboration of the pharmaceutical industry with healthcare professionals include the following:

  • Any drug promotion carried out by the pharmaceutical industry must be based solely on arguments, facts and scientific data.
  • Promotional items or medical samples must not individually exceed a sum equal to 10% of the current legal monthly minimum wage (approximately $20) and must be delivered in minimum quantity, provided that it relates to the work of the healthcare professional who receives it. Such items cannot, under any circumstances, consist of gifts, cash or an equivalent for the personal benefit of the healthcare professional.
  • Healthcare professionals can be hired as consultants and advisers in specific activities (eg, as speakers or at symposiums). The remuneration for such activities must be monetary and correspond with market rates.

Liability

Defect products

How can a liability claim for a defective medicinal product be brought?

Any medicinal consumer can submit a complaint directly to the manufacturer, importer or to the marketing authorisation holder, depending on the individual circumstance.

Good manufacturing practice requires that any quality management systems associated with the medicinal product handle product complaints properly.

In addition, consumers can submit product complaints to the National Food and Drug Surveillance Institute, which will then decide whether to conduct a surveillance inspection and take any corresponding actions.

Civil and criminal remedies are also available.

Which parties can be held liable for a defective medicinal product?

The manufacturer, importer and marketing authorisation holder can be held liable for a defective medicinal product.

Remedies

What remedies are available to successful claimants?

A claimant can file a civil action seeking redress and damages. Actions must be filed before a civil court if damages are sought. The claimant may also file an action of effective warranty before a civil court or a specialised court (eg, the Superintendence of Industry and Commerce) to recover what was paid for the medicinal product or to be provided with a non-defective product.

Exclusion and limitation

On what grounds can liability be excluded?

The defendant can make the following arguments to exclude liability:

  • The existence of external factors beyond its control made the product defective.
  • The product was not defective.
  • The product was not used in accordance with directions or manuals.

Good faith and due diligence alone are normally insufficient to exclude liability.

What preventive steps can be taken to limit liability?

The following preventive steps can be taken to limit liability:

  • include all possible information in a clear and sufficient manner in all material provided to consumers;
  • ensure that waivers are signed by both distributors and consumers if there is a high element of risk associated with using the product; and
  • ensure that a rigorous pharmacovigilance mechanism is maintained.  

Compliance and enforcement

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.

Dishonest practices

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:

  • suppliers;
  • 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.