Market Access Tracker Program

June 2014

Colombia: Market Access Tracker - 2014

Introduction:

Last Updated 9 June 2014
Colombia has the fifth largest pharmaceutical market in Latin America, behind Brazil, Mexico, Venezuela, and Argentina.  The pharmaceutical market in Colombia is expected to enjoy continued growth in the medium-term, making it an attractive market for both global and domestic pharmaceutical manufacturers. Colombia is experiencing growing demand for pharmaceutical products as a result of the country’s positive economic landscape, booming population, and government policies to broaden access to medicines.  A number of successful government policies have expanded access to pharmaceuticals to all strata of the population through increased insurance coverage and an expanded basic drug list from the country’s Mandatory Health Plan (POS). Specifically, social health insurance coverage has grown to 95% of the population, with universal coverage of the population targeted by 2015 by President Santos.  The Santos administration has also worked on tackling a variety of regulatory issues, including reshaping INVIMA’s duties to focus on more efficient pharmaceutical regulation. Colombia’s first HTA agency, IETS, was also established and has been operating since 2012 to evaluate medical technologies on the basis of cost effectiveness, safety, and efficacy; consult on the evaluation of medical technologies with national and international health technology bodies; report on the impact of healthcare services in reducing morbidity and mortality; and developing treatment guidelines. In addition, the new National Pharmaceutical Policy involves drug pricing reform that has focused on reigning in the country’s comparatively high drug prices by enabling the government to take direct control of a more centralized drug pricing system.  As a result, the Colombian Ministry of Health has been able to cut the prices on several hundred of the most expensive drugs in the country since August 2013.  Colombia also has a strong domestic pharmaceutical industry, especially for generics, with government cost-containment efforts driving up demand for lower-cost generics. 

Scope:

Socioeconomic trends: Gross domestic product (GDP); per capita gross national income (GNI).

Demographics: Overall population (projected to 2030); life expectancy at birth (projected to 2030); median age and number of senior citizens (projected to 2030); urban population (projected to 2030).

Healthcare system: Healthcare insurance system; Contributory and Subsidized Schemes; public sector administrative framework; private sector; insurers; and healthcare providers.

Regulatory affairs: Registration process for new drugs and vaccines; clinical trials; pharmacovigilance; manufacturing regulations; regional harmonization; developing biologic and biosimilar regulations.

Intellectual property protection: Patents; data protection; compulsory licensing; counterfeit drugs; Colombia-European Union Free Trade Agreement.

Health technology assessment: Role of the new HTA body - the Instituto de Evaluacion Tecnologica en Salud (IETS). 

Pricing and reimbursement: Selection for pricing and reimbursement under public health insurance; pricing trends; role of INVIMA, reference countries.

Cost containment: Price controls; price caps; margins and discounts; parallel imports.

Healthcare reform: National Pharmaceutical Policy; bioequivalence testing.

Commercialization Outlook: Pharmaceutical market, domestic generic companies; low-cost manufacturing; drug price cuts; lengthy registration process.

Exhibits: 29 data-rich tables and figures.


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Mentioned in this report:

  • Organizations:
  • - Asociación Latinoamericana de Integración (ALADI; Association for Latin American Integration)
  • - Asociacion Farmaceutica Colombiana (AFIDRO; Colombian pharmaceutical association)
  • - Camera Farmaceutica de Comercio (ANDI; Pharmaceutical Chamber of Comemrce)
  • - The Comisión Nacional de Precios de Medicamentos y Dispositivos Médicos (CNPMDM; National Price Commission for Pharmaceuticals and Medical Devices)
  • - Consejo Nacional de Seguridad Social en Salud (CNSSS; National Council of Social Security in Health)
  • - Comision de Regulacion en Salud (CRES; Health Regulatory Commission)
  • - Comité Técnico Cientifico (CTC; Technical scientific committee)
  • - European Medicines Agency
  • - Entidades Promotoras de Salud (EPSs; Health-Promoting Organizations)
  • - Federación Médica Colombiana (FMC; Colombian Medical Federation)
  • - IMS Health
  • - Instituto de Evaluacion Tecnologica en Salud (IETS; Institute for Health Technology Assessment)
  • - International Monetary Fund
  • - Instituciones Prestadores de Servicios de Salud (IPSS; Healthcare Services Delivery Institutions)
  • - Ministerio de Salud y Proteccion Social (MSPS; Ministry of Health and Social Protection)
  • - National Institute for Health and Care Excellence (NICE)
  • - Pan American Health Organization (PAHO)
  • - Partido Social de Unidad Nacional (PSUN; Social Party for National Union)
  • - Pharmaceutical Research and Manufacturers of America (PhRMA)
  • - Pan American Conference on Drug Regulatory Harmonization (CPANDRH)
  • - Superintendencia Nacional de Salud, SuperSalud (SNS; National Health Superintendent)
  • - United Nations Population Division
  • - World Bank
  • - World Health Organization
  • - World Trade Organization
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