Regulatory, Pricing and Reimbursement
Need to know about regulation, pricing and reimbursement in Colombian pharma? Read on! Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99.
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
Jurisdiction over drugs, biologicals and medical devices is centralized at the Colombian National Food & Drug Surveillance Institute, better known as INVIMA. This is a decentralized agency of the Ministry of Health, created in 1993. More information available at invima.gov.co.
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
The regulatory framework for the authorization of drugs, biologicals and medical devices is framed through Decree 677/95 (chemical synthesis), Decree 1484/12 (biologicals) and Decree 4725/05 (medical devices). Each field has additional regulations:
- Law 1751/2015, regulated by Decree 780/2016, provides the general national framework on health rights and duties in Colombia;
- Resolution 3951/2016, establishes the reimbursement procedure at the Fund of Solidarity and Assurance (FOSYGA) for supplying medicines, medical services and health benefits not included in the Health Benefits Plan; (FOSYGA was substituted in its functions by the Administrator of the Resources of the General System of Social Security in Health (ADRES), this occurred since August 1, 2017 as established by law 1753 of 2015.
- Price control over drugs and medical devices is determined under the National Commission of Medicines and Medical Devices’ scope (CNPMD) according to Law 1438/2011, Decree 1071/2012 and Decree 705/2016. The CNPMD annually assign a reference price for all medicinal products marketed in the country. This price is considered a regulatory tool to establish the price for each commercial presentation of the medicinal product. A product will enter on a direct control system (price control fixed) if: I) It presents a retail price higher than the reference price of the corresponding homogeneous group and/or II) The class of products do not form a homogeneous group, with at least three or more references of the product.
3. What are the steps to obtaining authorization to develop, test, and market a product?
It is mandatory to obtain a marketing authorization (MA) or health registration to manufacture, sell, import or export a drug product. Requirements and procedures depend on the product, its background, indications of use and risks.
3.A. STEPS TO OBTAINING MARKETING AUTHORIZATION OF NEW DRUG PRODUCTS:
Usually, the marketing authorization for a new medicinal product may take from between 9 months to 12 or 20 months depending on the product supporting information. In practice, INVIMA takes more time than the legally established limits.
3.B. STEPS TO OBTAINING A MARKETING AUTHORIZATION FOR PRODUCTS INCLUDED IN OFFICIAL PHARMACOLOGICAL REGULATIONS
Usually, the marketing authorization for drug products included in Official Pharmacological Regulations may take from 4 months to 9 or 12 months depending on the product supporting information. In practice INVIMA takes more time than the legally established limits.
4. What are the approximate fees for each authorization?
|GOVERMENT FEES IN USD FOR MARKETING ATHORIZATION FOR A:|
|Drug Product included in the Pharmacological Code||3,200|
|Good Manufacturing Practice Certificate||5,100|
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
Every five years. Renewals shall be applied for no later than the third month prior to the expiration date.
6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
- If it is an innovator or new drug product, the authorization process takes longer because the scientific and technical information is completely new. Besides, there is no worldwide data about safety nor efficacy.
- It if is a generic or a drug product is listed on an Official Pharmacopeia, the authorization process will be shorter because the technology is sufficiently demonstrated. This rule applies equally for both local and foreign-owned manufacturers.
- For products of biological origin there are no generics, and biosimilars may take as long as the innovator, but depending on the type of molecule and its size, INVIMA may allow abbreviated routes that may expedite the process.
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
There is no specific regulation for combination drug or biological products. The only regulation is established under Decree 4725/05 for medical devices + drug products. According to what is set in this Decree, combination products will be ruled according to their main indication or function. If it has a pharmacological action, then it will be ruled under drugs regulations. If the main indication or function is to work as a device and the role of the drug is more of an accessory, then the product will be ruled under medical device dispositions.
8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the expectations and requirements of the US Food and Drug Administration (US FDA) or the European Medicines Agency (EMA)?
Compliance with regulation is monitored and evaluated by local authorities through periodical inspections scheduled by the authority or upon complaints received anonymously or from third parties.
9. What is the potential range of penalties for noncompliance?
Penalties include fines of up to USD 100,000 at the discretion of INVIMA. If the investigation is passed up to the Superintendence of Industry and Commerce, penalties are much higher and can reach up to USD 500,000. As to inducement, penalties of fines may be imposed up to USD 130,000.
10. Is there a national healthcare system? If so, how is it administered and funded?
Colombia has a Social Security System with national healthcare coverage which is regulated by the National Government through the Health Ministry. Colombian citizens benefit from the healthcare system by being affiliated to the system, either under the contributory (private) or subsidized (public) regime.
11. How does the government (or public) healthcare system function with private sector healthcare?
The Social Security System functions as follows:
- Contributory Regime (private sector): Refers to all affiliates paying or contributing to the system through a legal fixed monthly fee (as employees or independents). Besides the contributor, relatives in the first degree of consanguinity may be enrolled as beneficiaries: wife/husband and children under 18. In some special cases (people economically dependent on the contributor) children, parents and relatives up to the third degree of consanguinity may be included.
- Subsidized Regime (public sector): All citizens who are unemployed and/or pertaining to levels 1 and 2 of the Sisben (a census/survey classifying the poverty levels of affiliates). The subsidized regime includes the affiliates’ families.
12. Are prices of drugs and devices regulated and, if so, how?
Price control over drugs and medical devices is determined under the National Commission of Medicines and Medical Devices’ scope (CNPMD) according to Law 1438/2011, Decree 1071/2012 and Decree 705/2016. The CNPMD annually assigns a reference price for all medicinal products marketed in the country. This price is considered a regulatory tool to establish the price for each commercial presentation of the medicinal product. A product will enter on a direct control system (price control fixed) if: i) It presents a retail price higher than the reference price of the corresponding homogeneous group and/or ii) The class of products do not form a homogeneous group, with at least three or more references of the product.
13. How are drugs and devices used by patients paid for? What roles do public and private payers play?
Resolution 3951/2016 establishes a procedure for reimbursement at the Fund of Solidarity and Assurance (FOSYGA), for supplying medicines, medical services and health benefits not included in the Health Plan Benefits. The Health Benefits plan is intended to cover the health needs of the majority of the Colombian population, according to epidemiological studies performed in order to know which the most usual diseases are.
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
Drugs and devices are dispensed by Health Promotion Entities (EPS), hospitals or healthcare professionals directly. Dispensers are compensated through FOSYGA.
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
First, they must comply with all regulations applying to reception, storage, transport, distribution and dispensing of drug products. Additionally, they must register at the Special Registry of Health Service Providers.
Products authorized for sale under Rx conditions can only be sold in chemist’s stores and drugstore-pharmacies. The professional must ask for the prescription document before dispensing the medicine and should verify the prescription requirements.
It is forbidden for drugstores to have free samples in their store or to have empty packages of pharmaceuticals. In case a person or a company finds that a drug store has medical samples and is selling them, the interested party may start legal action against the establishment to prevent this legal infringement. In any case, they must provide accurate, verifiable, sufficient and clear information to patients as required in accordance with the drug product, indications, warning or precautions.