Health services framework and competent authoritiesHealthcare bodies
Describe the bodies and their responsibilities (public and private sector) concerned with the delivery of healthcare and appropriate products for treatment.
The provision of health services is headed by public and private entities, such as:
- the Administrator of Resources of the General System of Social Security in Health (ADRES) whose specific objective is the adequate management of financial resources for the System and to implement the respective controls;
- health maintenance organisations (HMOs): health-promoting entities that are responsible for the affiliation and the registration of the affiliates, and the collection of their contributions, by the delegation of ADRES. Their basic function is to organise and guarantee the provision of the health benefits plan to affiliates. They can operate within the contributive or the subsidised regime; and
- healthcare provider institutions (IPS): for example, hospitals, clinics and doctors that provide healthcare services to the affiliates and beneficiaries within the parameters and principles indicated in the law.
Additionally, the following entities are responsible for the inspection, monitoring and control of the entities involved in the health system:
- Ministry of Health and Social Protection (MoH), which is in charge of the general management of the General System of Social Security;
- National Health Superintendency, which is in charge of the inspection, surveillance and control of all those involved in the Colombian social security system; and
- territorial, departmental, district and municipal entities, which are responsible for advancing actions aimed at the promotion and care of collective health, as well as inspection, surveillance and control. They also administer the subsidised regime and own public hospitals.
Finally, the National Food and Drug Surveillance Institute (INVIMA) is responsible for monitoring products such as medicines and medical devices. The INVIMA verifies that local manufacturers comply with good manufacturing practices (GMP) (for medicine producers), technical sanitary conditions (for medical device producers) and conditioning and storage conditions (for importers of medical devices), and also issues health registrations (marketing authorisation (MA)) that allow manufacturers and distributors to market regulated products in the country.Competent authorities for authorisation
Identify the competent authorities for approval of the marketing of medicinal products and medical devices. What rules apply to deciding whether a product falls into either category or other regulated categories?
The INVIMA is the competent authority for granting MAs for medical devices and medicinal products, and for the surveillance of manufacturing facilities (eg, by issuing good laboratory practice and GMP certifications). The institute also has the administrative authority to investigate and punish conduct that violates sanitary rules. The INVIMA also examines over-the-counter (OTC) drug advertising and the control of prescription drug advertising.
Products monitored by the INVIMA are classified according to the definitions provided by regulatory law, for example:
- medical devices, defined as a medical device for human use: any instrument, apparatus, machine, software, biomedical equipment or other similar or related article, whether used alone or in combination, including its components, parts, accessories and software necessary for its proper application, proposed by the manufacturer for use in:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, prevention, monitoring, treatment, alleviation or compensation for an injury or disability;
- investigation, replacement, modification or support of the anatomical structure or physiological process;
- diagnosis of pregnancy and conception control;
- care during pregnancy, birth or thereafter, including newborn care; and
- disinfection or sterilisation of medical devices; and
- medicines: defined in Colombian legislation as ‘pharmaceutical preparation containing active pharmaceutical ingredients (API), with or without excipients, in a determined pharmaceutical dosage form, employed for the relief, diagnosis, treatment, cure or rehabilitation of an illness. Packaging, labels and containers are integral components of the medicine since they warrant its quality, stability and appropriate use.’
Describe the general legislative and regulatory framework for approval of marketing of medicinal products and medical devices.
Local regulation includes:
- Decree 677 of 1995, which contains disposition for the issuance of MAs for medicinal products (Phase I: pharmacological evaluation and Phase II: chemistry, manufacturing and controls (CMC) evaluation);
- Decree 1782 of 2014, which includes procedures for the pharmacological and pharmaceutical evaluation of biological medicines;
- Resolution No. 1124 of 2016, which provides bioavailability and bioequivalence guidelines;
- Resolution No. 1160 of 2016, which provides good manufacturing practice guidelines;
- Decree 843 of 2016, which provides for renovation and modification of MAs;
- Resolution No. 3690 of 2016, which provides guidelines on compliance with the stability standards required for biological products;
- Resolution No. 2514 of 1995 containing the current guidelines for the development of stability studies of medicinal products (and amended by Resolution No. 3157, which will be in force by 2022);
- Resolution No. 4490 of 2016, which contains immunogenicity guidelines for the registration of biological medicines;
- Decree 2085 of 2002, which provides regulatory test data protection in the form of a five-year exclusivity term for new chemical entities;
- Decree 4725 of 2005, which contains disposition for the risk classification and issuance of MAs for medical devices;
- Decree 582 of 2017 containing disposition for the automatic amendments of MAs for medical devices;
- Decree 1030 of 2007 and Resolutions Nos. 4396 of 2008 and 2968 of 2015, which contain mandatory technical sanitary conditions for the manufacture of medical devices;
- Resolution No. 4002 of 2007 contains dispositions for the adequate storage and conditioning of medical devices. All importers must obtain a certificate of storage and conditioning capacity (CCAA) from the INVIMA; and
- Decree 710 of 2018, which is awaiting an administrative proceeding to enter into force, contains the criteria for the evaluation carried out by the Technology Assessment Institute in establishing the therapeutic value of any new medicament, and the procedure that must be submitted to the INVIMA for the process of obtaining an MA for the commercialisation of medicines in Colombia.
Clinical practiceApplicable rules
What legislation controls and which rules apply to ethics committee approval and performance of clinical trials in your territory for medicinal products and medical devices?
Resolution No. 13437 of 1991 regulates hospital ethics committees and adopts the ‘Decalogue of Patients’ Rights’. This rule defines the confirmation process for committee members, their functions and some operating mechanisms, including the obligation of sending the minutes of their meetings to the MoH.
Resolution No. 2378 of 2008 adopts GMPs for institutes that undertake medical research with pharmaceutical candidate compounds in humans.
Resolution No. 8430 of 1993 establishes the scientific, technical and administrative standards for clinical trials of medical devices.
The essential aspects that an ethics committee must comply with include elements that ensure the fulfilment of its responsibility with society as well as the fundamental rights of the participating subjects.
The rules for ethics committee approval are provided in the Technical Annex that is an integral part of Resolution No. 2378 of 2008.
The INVIMA is responsible for evaluating the clinical research protocols that are carried out in the country, monitoring the investigations, and issuing the GMP certificate to the IPS that carries out clinical investigations.
For clinical trials of medications in humans, the party must request approval from the INVIMA. This evaluation is performed by a specific area named the Clinical Research Group. The requirements for requesting evaluation are contained in the Guide for the Presentation of Research Protocols, and include the following:
- an approval letter issued by an INVIMA-registered research ethics committee;
- approval from a local health authority confirming that the investigation centre is suited to providing health services;
- a GMP certificate issued by the INVIMA (valid for five years);
- an insurance policy to cover third-party damages (to cover possible adverse events associated with or attributable to the clinical trial);
- a robust research protocol (including the operation methodology, theoretic framework, justification, results from analysis plan and patient data management); and
- consent and insurance.
Clinical trials of medical devices must be approved first by the ethical committee of the IPS where the trial will be conducted, and then by the INVIMA Medical Devices Reviewing Commission. The requirements for requesting evaluation are contained in the ‘Presentation Format and Evaluation Protocols for Medical Clinic Research and Other Technologies’ guidelines, and include:
- approval from a local health authority confirming that the investigation centre is suited to providing health services;
- a letter of application for approval of the research protocol;
- problem formulation;
- research summary;
- theoretical framework;
- medical device information and safety tests;
- details of hypothesis, objectives and methodology;
- ethical considerations;
- project management details; and
- bibliographic references (Vancouver standards).
What requirements exist for reporting the commencement of a trial and its results to the competent authorities or the public?
According to Decree 2378 of 2008, any clinical study must be registered with the INVIMA, which is qualified to make verifications when necessary. Additionally, favourable or unfavourable results of each clinical investigation must be reported to this authority. In practice, clinical investigators make periodic reports indicating when the study began and their main results; if the trial has not commenced, an explanation of the reasons for this must also be reported. At the same time, the INVIMA must make quarterly reports to the MoH, with a copy of the results of clinical studies once they have been completed.
Since 2018, the INVIMA has made public the database of clinical studies carried out in Colombia since 2014, in a standardised format that allows the analysis, consultation and monitoring of the same.Consent and insurance
Are there mandatory rules for obtaining trial subjects’ consent to participate? Must sponsors arrange personal injury insurance to a particular limit?
Resolution No. 8430 of 1993 establishes that informed consent obligations include providing clinical trial subjects with information on:
- investigation objectives;
- procedures that will be used;
- inconveniences and expected risks;
- benefits that may be obtained; and
- alternative procedures that could be advantageous for the research subject.
Also, 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.
According to Resolution No. 2378 of 2008, to safeguard the fundamental rights of research subjects, civil liability insurance for the damage caused to third parties must be put in place. The insured value should be determined according to international standards. If the insurance does not completely cover the damages, the promoter, clinical trial investigator or the head of the institution or centre in which the trial was carried out are jointly and severally liable.
Marketing authorisationTime frame
How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?Medicinal products
New medicinal products must go through the complete registration process. The process starts with Phase I, also called pharmacological evaluation, which involves a safety and efficacy assessment carried out by the Medicines Reviewing Commission (MRC). The Phase I fee for a chemical synthesis medicine is approximately US$3,100, and for biological medicines in general is US$14,300 (vaccines have a specific cost of approximately US$20,000). The MRC takes approximately four to five months to issue a decision, if no requirements are made during this phase. If successful, the product can be included in the Colombian Pharmacological Code. Following this, Phase II can be started, which involves CMC assessment by the INVIMA. If the assessment is successful, an MA can then be granted. The Phase II fee for a chemical synthesis medicine ranges from approximately US$3,900 to US$4,800, and for biological medicines is US$3,900 (for vaccines, the fee is approximately US$4,680).
The INVIMA takes approximately eight to 17 months to grant an MA for medicinal products already included in the Pharmacological Code.
Generic versions of products included in the Code only need Phase II assessment. The time taken for Phase I and Phase II assessment in 2019 varied from 14 to 20 months. An MA is valid for five years.Medical devices
MAs for low risk (Classes I and IIa) medical devices are issued automatically (within a maximum of one week). MAs for high-risk medical devices (Classes IIb and III) extended to 300 days in 2019.
Products that have not obtained an MA in other countries, or whose risk classification is not clear, may have to request a prior evaluation from the Medical Devices Reviewing Commission.
An MA is valid for 10 years. The corresponding fee for an MA is approximately US$900.Protecting research data
What protection or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?
Decree 2085 of 2002 provides for regulatory test data protection (TDP), for a five-year term from the grant of the MA. In practice, this prevents generic applicants from receiving an MA during this term.
According to Decree 2085 and INVIMA Circular DG 005-03 of 2003, which regulate regulatory data protection in Colombia, the requirements for obtaining data exclusivity are:
- the new chemical entity, understood as APIs that have not been included in the Pharmacological Code, must be specified;
- non-disclosed non-clinical or clinical data, supporting safety and efficacy of the new drug contained within the dossier, must be declared; and
- the considerable effort made by the originator to obtain the undisclosed information must be declared and demonstrated.
Since 2002, TDP had been automatic and relatively straightforward to obtain, and the practice of the INVIMA was to automatically and summarily reject generic MA applications for products still covered by the TDP protection term. However, since 2018, the INVIMA’s practice has reflected cracks in the system, signalling that effective TDP protection is at risk.Freedom of information
To what extent and when can third parties make freedom of information applications for copies of research data submitted by applicants for authorisation to market medicinal products or medical devices?
The information provided within an MA application, specifically the pharmacological dossier, is not public. Although a third party is allowed to file a freedom of information application, the authority may and will only provide general information regarding the filing date and the applicant. No research data will be provided by the INVIMA.Regulation of specific medicinal products
Are there specific rules for approval, and rewards or incentives for approval, of particular types of medicinal products, such as traditional herbal and homeopathic products, biologicals and biosimilars, controlled drugs, orphan drugs and those for paediatric use?
Decree 1156 of 2018 contains specific dispositions for approval of phytotherapeutic medicines (including traditional medicines). For the manufacture, production, import, export, processing, packaging and sale of phytotherapeutic medicines, a sanitary registration must be issued by the INVIMA. This sanitary registration is issued per product, and is valid for 10 years, renewable for equal periods. The time taken to review an application is usually eight months.
Homeopathic medicines, developed in pharmaceutical laboratories duly certified by a homeopathic medicine GMP, require a sanitary registration issued by the INVIMA for their production, import, export, packaging, sales, distribution and commercialisation, as per the fulfilment of the requirements established in Decrees 3554 of 2004 and 1861 of 2006. As with phytotherapeutic products, the validity of a homeopathic registration is 10 years, renewable for equal periods. The time taken to review an application is usually eight months.
Resolution No. 1478 of 2006 regulates the control, monitoring and surveillance of import, export, processing, synthesis, manufacturing, distribution, dispensing, purchase, sale, destruction and use of controlled substances and medicines containing them and over those subject to state monopoly.
Regarding incentives, Decree 1782 of 2014 includes an ‘accelerated pathway’ for biosimilar molecules that have had a prolonged and safe presence in the market. However, this incentive has not been widely employed in practice, due to problems with perceived security issues.Post-marketing surveillance of safety
What pharmacovigilance or device vigilance obligations apply to the holder of a relevant authorisation once the product is placed on the market?
To ensure the ongoing safety and efficacy of medicinal products after MA has been granted, Colombian legislation provides a reporting procedure concerning adverse events and any other quality issues relating to their use. In this regard, the INVIMA requires MA holders or pharmaceutical product manufacturers to report adverse events and quality issues to acknowledge the medication profile in such a way that the pre-existing factors are identified in time.
Resolution No. 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 MA holder or the pharmaceutical product manufacturer must adopt a pharmacovigilance programme to ensure the creation of periodic reports on 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; and
- any non-serious or unexpected adverse event must be reported within the last five working days of each two-month period.
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.
Resolution No. 4816 of 2008 regulates the national techno-surveillance programme.
The reports of adverse events or incidents occurring during the use of a medical device 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 techno-surveillance programme; and
- any non-serious or unexpected adverse event must be reported within eight working days after each trimester.
What authorisations are required to manufacture, import, export or conduct wholesale distribution and storage of medicinal products and medical devices? What type of information needs to be provided to the authorities with an application, what are the fees, and what is the normal period of validity?Medicinal products
Manufacturers must comply with GMP and provide a certificate issued by the competent authority from the country of origin or otherwise request the INVIMA to issue one. GMP certificates from the following countries are accepted by INVIMA: Canada, Denmark, France, Germany, Japan, the Netherlands, Norway, Sweden, Switzerland, the United Kingdom and the United States, or from countries that have signed mutual recognition agreements with these countries.
Manufacturers located in different countries must request a visit from the INVIMA to certify GMPs. Local manufacturers must also be certified by the INVIMA. Importers, distributors and wholesalers must comply with dispositions on storage and handling of medicines contained in Decree 2200 of 2005 and Resolution No. 1403 of 2007.
The applicable fee to obtain GMP certification from the INVIMA depends on the location of the manufacturing facility, whether the product to be manufactured is a biologic and whether the facility also manufactures the API. The fees range from US$6,700 to US$41,333.Medical devices
Foreign manufacturers are not obliged to provide a GMP certificate, but it is expected they comply with all conditions guaranteeing the quality of medical devices. There are no regulations on GMPs for local manufacturers of medical devices. Said local manufacturers must comply with the technical sanitary conditions for medical devices that are applicable to their specific products and that can be taken from Decree 1030 of 2007 and Resolutions Nos. 4396 of 2008, 2968 of 2015 and 4002 of 2007 (ISO 13485 is also taken as reference). Importers of medical devices must obtain a CCAA issued by the INVIMA.
In addition, wholesalers and distributors must comply with dispositions on storage and handling of medicines and medical devices contained in Decree 2200 of 2005 and Resolution No. 1403 of 2007.Sanctions
What civil, administrative or criminal sanctions can authorities impose on entities or their directors and officers for breach of the requirements concerning controlled activities?
The MoH, INVIMA and the sectional and district health departments have sanctioning authority over MA holders of medicines or medical devices for failing to comply with the requirements established in the law for the commercialisation of these products. These entities will sanction MA holders through mechanisms such as sanitary safety measures that consist of preventing the commercialisation of a product while its safety is re-evaluated. Manufacturers that fail to comply with the technical regulations can also be sanctioned.
Sanctions provided by the law include reprimands, the imposition of fines, confiscation of products, cancellation of the MA and the respective licence, and temporary or permanent closure of the establishment. Regarding criminal sanctions, if a potential crime is identified in the sanctioning process, the authority must inform the Attorney General’s Office.Exemptions
What, if any, manufacture and supply of medicinal products is exempt from the requirement to obtain an approval to market?
In general, there is no medicinal product exempt from the requirement to obtain an MA. It is a mandatory requirement for all medicinal products regardless of their components or manufacturing method to comply with the requirements of Decree 677 of 1995.
However, master formulas (phytoterapeutic, homeopathic or medicinal product for an individual patient) do not require an MA. They must be manufactured in pharmacies, certified in GMP by the INVIMA.
Decree 481 of 2004 states that ‘vital unavailable’ medicines (VUMs) (eg, named-patient supply) do not require an MA. However, their safety and efficacy must be proved through other special requirements.
Certain medical devices do not require MAs. The MoH and the INVIMA have included tailor-made orthopaedic, dental and traumatological products in this exemption.Parallel trade
Are imports allowed into your jurisdiction of finished products already authorised in another jurisdiction, without the importer having to provide the full particulars normally required to obtain an authorisation to market? What are the requirements?
Parallel imports are permitted in Colombia. Article 54 of Andean Decision 486 of 2000 establishes an international exhaustion of rights once the product has been introduced into the flow of commerce of ‘any country’ by the owner or another person authorised by the right holder or with economic ties to that patent owner.
Two persons shall be considered to have economic ties when one of the persons is able to exercise a decisive influence on the other, either directly or indirectly, with respect to the exploitation of the patent or when a third party is able to exert that influence over both persons.
In practice, parallel imports for pharmaceutical products are practically non-existent due to regulatory requirements that prevent a potential parallel importer from obtaining an MA for the patent holder’s product (see Decree 677 of 1995). However, this regulatory barrier was modified by Decree 1313 of 2010, which authorises parallel imports for pharmaceutical products without authorisation from the manufacturer (normally the patent holder). This regulation, even though in force, is not usually applied due to lack of specific regulation aimed at reducing counterfeit, contraband and quality risks that may derive from its application. Nevertheless, this Decree was clearly aimed at promoting price reductions.
What are the main requirements relating to variation of authorisations for medicinal products and medical devices?
There are two types of variations of MA for medicinal products:
- significant modifications: these require a procedure consisting of updating the MA information issued by the INVIMA. The review process for this level of modication requires further study and, subsequently, the decision is issued by reasoned resolution. Technical and legal studies can take two to four months; and
- traditional or automatic non-significant modifications: these require a procedure consisting of updating the technical or legal information of the MA within a file, which is generated automatically and with subsequent review of the documentation that supports compliance of the requisites required according to the case. This procedure may take 20 business days.
MAs for medical devices cannot be modified when there is a significant change in the medical device that may affect its safety and effectiveness or when the modification implies changes to the design, chemical composition of the material, source of energy or manufacturing processes. Other variations of MAs can be requested and issued automatically within 20 days.Renewal
What are the main requirements relating to renewal of authorisations for medicinal products and medical devices?
MA renewals are issued following the same procedure as the product’s initial authorisation, which means complete technical (CMC) and legal evaluations must be performed.
However, if the product, its labelling and the manufacturing procedures have not changed, the MA holder may apply for an automatic renovation under Decree 843 of 2016 (for medicinal products) or Decree 582 of 2017 (for medical devices). The request for renewal must be filed with the INVIMA three months prior to the expiry of the MA.
Any request for renewal of an MA that was not submitted within the prescribed period will be processed as a new application. If the respective MA has expired without the renewal application being submitted, the MA is cancelled and the corresponding product may not be imported into the country, or manufactured, as appropriate. If there are stocks in the market, the INVIMA will grant the interested parties a period to dispose of them, which may not exceed six months. If, after this period, there are still products on the market, the INVIMA will order their final disposal in accordance with the provisions of the Decree.Transfer
How easy is it to transfer the existing approvals or rights to market medicines and medical devices? How long does this take in general?
Transfers of MAs for medicinal products or medical devices may be requested only by the MA holder and require:
- assignment contract signed by the assignor (former MA holder) and the assignee (new MA holder);
- certificate of incorporation of the former and new MA holders;
- authorisation issued by the manufacturer to the assignor to perform the assignment; and
- payment of a fee of approximately US$186 by the MA holder.
This procedure can be automatic and takes approximately 20 days.
RecallDefective and unsafe products
What are the normal requirements for handling cases of defective or possibly unsafe products, including approvals required for recall and communication with health professionals?
Any medicinal consumer can submit a complaint directly to the manufacturer, importer or to the MA holder, depending on the individual circumstance. Local GMPs require that the company responsible for the product in Colombia has a quality management system in place to handle product complaints properly and to manage a recall, if necessary.
In addition, consumers can submit product complaints to the INVIMA, which will then decide whether to conduct a surveillance inspection and take any corresponding actions.
Also, upon receiving any indication (from the MA holder or from another source) that the product has been altered or fraudulent or presents a failure of quality, performance or safety, the INVIMA may decide to perform a joint analysis (with the MA holder and other involved authorities) and advise whether a recall is necessary. Alternatively, if there is an imminent sanitary risk, the INVIMA may immediately publish a sanitary alert on its website informing the HMOs and consumers of the prohibition of marketing the products, and, when appropriate, that a recall is ongoing. The manufacturer or MA holder may also directly advise its clients of the situation.
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 is regulated under article 79 of Decree 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 (HCPs), and must be consistent with the regulatory information approved by the healthcare registration authority, particularly regarding indications. The direct promotion of prescription-only medicinal products to patients is prohibited under Colombian legislation (this prohibition includes online advertising). When information of a prescription medicine is to be provided via a website, measures are to be taken to avoid information being accessed by patients.
In connection with advertising of OTC medicines, there are mandatory parameters contained in Resolution No. 4320 of 2004, which 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.
MA holders are directly responsible for complying with the obligations and prohibitions stated under article 79 of Decree 677 and of Resolution No. 4320 of 2004. Failure to comply with these obligations can lead to the suspension or cancellation of the MA.
In addition, in 2016 and 2019, the Association of Pharmaceutical Research and Development Laboratories (AFIDRO) and the Pharmaceutical Chamber of the National Business Association of Colombia (ANDI) published 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 that have subscribed to the association agreements.
The advertising and promotion of medical devices is regulated under article 58 of Decree 4725 of 2005, which states that promotional scientific information of medical devices must be consistent with the approved information contained within the MA, as well as aligned with the scientific evidence available for the product. The benefits that its uses may offer 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 MA. 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 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 HCPs, as well as organisations that operate, distribute and use medical devices. This CET also sets principles and guidelines to advertise said devices before HCPs and the public, when available. The Chamber is currently working to update the CET, which among other things, is seeking to enhance the prohibition to directly sponsor HCPs to attend academic events and to improve transparency by means of the creation of an external tribunal of ethics to acknowledge violations of self-regulation and the requirement to publish said cases. The update will most probably be in force by the end of 2019.Inducement
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 HCPs. Those who infringe this norm may be sanctioned with fines of up to US$1.5 million.Reporting transfers of value
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?
Resolution No. 2881 of 2018, issued by the MoH on 6 July 2018, creates a Public Registry System for the transfer of value (ToV) carried out between the pharmaceutical and medical devices industry towards healthcare system agents (ie, physicians, medical associations, patient organisations). The provision specifically determines that MA holders, manufacturers, importers and distributors of medicaments and medical devices are bound to comply with said report depending on whether the ToV exceeds a limit set over US$300 (approximately) on an annual basis. The reports will be biannual (January to June and July to December). The first report corresponds to the ToV made in the second part of 2019, and must be completed within the first quarter of 2020. Failure to comply with said report in a timely, reliable and sufficient manner would result in fines of up to approximately US$1.3 million.
Enforcement of advertising rulesEnforcers
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.
The INVIMA is the entity in charge of operating inspection, surveillance and control over medicinal products, whether OTC or prescription-only, and medical devices in Colombia, including how they are advertised.
The Advertising Group of the INVIMA Department of Health Registries approves advertisement requests and also performs inspection, surveillance and control of advertising material that has already been circulated.
In addition, in 2016 and 2019, AFIDRO and the ANDI launched 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 that have subscribed to the association agreements. Decisions made by the external tribunal of ethics and AFIDRO have been published since 2018.Sanctions
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 sanitary safety measure, the INVIMA may order the suspension of the publicity violating the sanitary 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 up to an amount equivalent to 10,000 daily minimum wages, confiscation of products, suspension or cancellation of MAs or licences, and temporary or permanent closure of the premises, construction or service concerned (Law No. 9 of 1979).
Pricing and reimbursementPricing
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 Minister of Health 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), benefits plan exclusions, health technology assessment for the entry into the Colombian market (front door assessment) and centralised purchasing.
Through Decree 705 of 2016, the MoH delegated the pricing of medicinal products to the National Commission for Medicinal Products Prices (NCMPP). The Commission has structured different 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 MA holders, medicine sellers and buyers.
In general, there are two regimes for price control of medicines:
- surveilled freedom, which allows sellers to determine the price of their product, but said prices must be periodically reported and are monitored by the NCMPP; and
- government direct control regime, which includes most high-cost medicines and the government sets a maximum sales price.
Maximum prices for medicines under direct control are most commonly determined based on international comparisons; however, there are some medicines within the direct control whose price is determined by other methodologies not based on international referencing.
In addition, most controlled prices apply for inclusion in the institutional channel (when products are paid with public resources); however, there are some cases where the controlled price also applies for the commercial channel (eg, drugstores, pharmacies).
Medicines within the benefits plan are covered by a per capita unit, which is transferred from the ADRES to each HMO per affiliate. Those medicines and therapies not included within the benefits plan must be reimbursed by ADRES. Recently, the MoH issued different regulations for the management of said reimbursements and established maximum values for some of these non-benefits plan therapies.
The MoH also has the authority 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 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 draft circular (Circular 08/2018) but has not been issued yet.
Off-label use and unlicensed productsOff-label use
May health professionals prescribe or use products for ‘off-label’ indications? May pharmaceutical companies draw health professionals’ attention to potential off-label uses?
MA holders may not provide information regarding off-label uses to HCPs according to Decree 677 of 1995, which states that drug advertisements cannot contain information or event suggestions about indications different from those approved in MAs.
On the other hand, Ruling T-1214 of 2008 issued by the Constitutional Court of Colombia, stated that the scope of the MA granted by the healthcare authority cannot be interpreted as an exclusionary criterion on the suitability of medicines. Physicians may prescribe medicines for uses not approved within the MA, according to the competence granted to them in relation to the duty to prescribe the necessary treatment according to the health status of their patients.
There is also a specific list of ‘off-label’ uses authorised by the MoH.Unlicensed products
What rules apply to the manufacture and importation and supply to healthcare providers of unlicensed medicines or medical devices?
VUMs can be imported or manufactured without a licence (MA issued by the healthcare authority). These are mostly prescribed to patients suffering from an orphan disease recognised in Colombia (which are listed within Resolution No. 5265 of 2018), or correspond to medicines not commercialised in the country.
Decree 481 of 2008 allows the importation and manufacture of VUMs for an individual patient, a specific group of patients or a clinical emergency without the need for a prior MA, thus allowing for faster market entry, provided that the following conditions are met:
- the API has already proven its safety and efficacy in other countries and is not under clinical research;
- the drug is not being marketed or in insufficient supply in the country; and
- there is no therapeutic substitute for the drug.
Specific requirements for VUM authorisation are discussed below.
For an individual patient, the INVIMA requests:
- medical prescription fulfilling requirements from Decree 2200 of 2005 (article 17) , duly signed by the treating physician and including his or her professional registration number;
- application containing the name of the patient and identification, justifying the need for the treatment;
- summary of the clinical record; and
- payment of the official fee (tariff code 4002-24).
The authorisation to import a VUM for an individual patient may take from eight to 15 working days.
For a clinical emergency, the INVIMA requests an application explaining the urgency, preferably providing the clinical information (as complete as possible) and payment. The VUM import authorisation for emergency cases is issued within three to four working days.
According to Decree 481, the Medicines Review Commission (MRC) at the INVIMA may authorise the import of VUMs for groups of patients. The application must contain:
- justification of the quantities of the VUM needed. This import will be authorised for a maximum of three to six months of treatment. Documentation supporting the number of patients is helpful;
- certificate of incorporation of the entity requesting the import authorisation;
- WHO certificate for the pharmaceutical product; and
- certificate of analysis.
This authorisation may take from 15 days to two months to be issued.
However, during the VUM import application assessment, the MRC may require the applicant to submit an application for pharmacological evaluation first, which may take up to four months.Compassionate use
What rules apply to the establishment of compassionate use programmes for unlicensed products?
Decree 481 allows the importation and manufacture of VUMs (including orphan medications for rare diseases or for clinical emergencies whose use may include compassionate use) for an individual patient, a specific group of patients or a clinical emergency without the need for a prior MA, thus allowing for faster market entry, provided that the following conditions are met:
- the API has already proven its safety and efficacy in other countries and is not under clinical research;
- the drug is not being marketed or in insufficient supply in the country; and
- there is no therapeutic substitute for the drug.
Medicines under clinical research cannot be used to treat patients in Colombia (unless they are employed within an approved clinical trial in the territory).
Sale and supplyRegulation
Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?
Decree 2200 of 2005 and Resolution No. 1403 of 2007 contain dispositions on the 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 (pharmacies, drugstores, drug wholesalers). OTC medicines may also be sold in supermarkets as long as the establishment complies with the minimum requirements for guaranteeing quality of the medicinal products.
Importers of medical devices must obtain a CCAA for medical devices.Online supply
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 2200 of 2005 and Resolution No. 1403 of 2007. In addition, they are also obliged to comply with the requirements for promotion and advertising of prescription drugs (Decree 677 of 1995) and OTC drugs (Resolution No. 4320 of 2004).
Update and trendsForthcoming legislation and regulation
Is there any current or foreseeable draft legislation or other rules that will affect the regulation of pharmaceuticals and medical devices? What is likely to change, and what steps need to be taken in preparation?Forthcoming legislation and regulation31 Is there any current or foreseeable draft legislation or other rules that will affect the regulation of pharmaceuticals and medical devices? What is likely to change, and what steps need to be taken in preparation?
Further regulations on medicine prices are expected. For example, specific guidelines on how HMOs should manage capped values for medicines not included in the benefits plan are to be established.
The Front Door Regulation (cost-benefit assessment for price suggestion against a comparator) has already been issued; however, this Regulation is not yet in force because of ongoing administrative proceedings
Further regulations on medicine prices are expected (eg, inclusion of new products in the direct control, update of the controlled prices of medicines that are not calculated according to the international referencing methodology and new prices for VUMs).
Finally, regarding TDP, the INVIMA’s practice has reflected cracks in the system since 2018, signalling that effective TDP protection is at risk. Specifically, the INVIMA is applying a new expansive interpretation of an exception in Decree 2085 of 2002 whereby TDP is rejected if the molecule is considered similar to a previously protected one. Appeals have been filed and judicial review has also been requested.
Additionally, the INVIMA recently agreed to review a generic application relying on a bibliographic dossier based on publicly available information. The INVIMA has argued that generic applicants may obtain an MA if there was sufficient publicly available information before the innovator applied for its Colombian MA. This openly contradicts a legal position agreed to in 2003 between the Ministries of Health and Trade.