Orphan Drugs & Rare Diseases
An intro to the legal situation for orphan drugs and rare diseases in Colombia. 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 is the definition of Rare Diseases in your country?
According to the ministry of health and social protection, which is the head of the health sector, rare diseases are those that affect a small number of people compared to the general population and that, due to their rarity, raise specific questions. The rare diseases are life-threatening or long-term debilitating diseases of low prevalence and high level of complexity. Most of them are genetic diseases; others are rare cancers, autoimmune diseases, congenital malformations, or toxic and infectious diseases, among other categories.
2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)
No, the designation of ¨Orphan Drug¨ is not supported on the regulatory framework or at the official health authorities (Ministry of health and social protection and INVIMA) websites. However, that designation is commonly known between the regulatory agency and all the health professionals.
The Specialized Chamber of Medicines and Biological Products of the Review Commission, in minute 27 of 28-10-2008 considers that the terms Orphan Drug and Vital Drug Not Available, essentially have the same connotation. Additionally, the Specialized Chamber said: Orphan Drugs are understood to be those that are destined for the treatment of infrequent diseases or rare diseases.
3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)
The regulatory framework for the authorization of an Orphan Drug is the Decree 481 of 2004 which is the same regulatory framework that applies for Vital Drugs Not Available.
4. Does your country have pro- visions for relaxed clinical trial/ scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?
Yes, considering that these kinds of products are assessed and regulated under a different regulatory framework from other drugs. Furthermore, the Decree 481 of 2004 establishes different requirements for different cases in which an Orphan Drug should be needed such as the authorization of the importation for a specific patient, authorization of importation of Vital Drugs Not Available for exclusive use in urgency cases, or the authorization of importation for more than one patient of Vital Drugs Not Available.
5. Is there an expedited pathway for Orphan Drugs?
The pathway for Orphan Drugs is detailed by the Decree 481 of 2004, which in comparison with the pathways of other drugs can be considered as an expedited pathway.
6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?
No, Colombian jurisdiction does not recognize any foreign marketing authorization.
7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan Drugs?
Yes, Resolutions 205 and 2152 of 2020 are the regulatory frameworks for the reimbursement of Orphan drugs before the ADRES (Administrator of Resources of the General System of Social Security in Health).
8. How are the prices of Orphan Drugs regulated?
The prices of Orphan Drugs are regulated under the methodology developed for the direct price control regime for the drugs that are marketed in the national territory, this methodology is supported on Circular 03 of 2013. Currently, the Ministry of Health published what will be the Circular 012 of 2021 with which the list of medicines subject to the direct price control regime is unified and added, and their Maximum Sale Price is set, in addition to issuing new guidelines related to the regulation of prices of Vital Drugs Not Available.
9. In case of reference price based on a basket of countries, what countries are included?
The countries are: Argentina, Brazil, Chile, Ecuador, Mexico, Panama, Peru, Uruguay, Spain, EEUU, UK, Australia, Canada, France, Norway, Germany and Portugal.
10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?
There are currently no developments concerning Vital Drugs Not Available in Colombia.
11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?
There are currently no proposals for reform to the regulation of Vital Drugs Not Available.