A well-functioning health system offering universal health coverage to their citizens requires equitable access to health services, and technologies, such as medicines, vaccines, and devices. Several countries in the Americas have declared universal health coverage of their population; however, medicines are often financed out-of-pocket as they are not included in the benefit package.
The World Health Organization in conjunction with its regional offices, have provided information on the performance of pharmaceutical systems within health systems. For example, WHO performed surveys in order to gather information on key performance indicators of health systems including the pharmaceutical system. The support of the regional offices has allowed countries to assess their own pharmaceutical systems. Previous Pan American Health Organization (PAHO) country profiles included regional and sub-regional level information on pharmaceutical system performance. The South-East Asia Regional Office (SEARO) published their country profiles in 2017. Similarly, in 2018 the West Pacific Regional Office in conjunction with the Organization for Economic Cooperation and Development (OECD) published theirs.
The goals of this document is to gather data of Colombia’s health and pharmaceutical system in efforts to describe system structures and processes, generate evidence on system performance, inform stakeholders on system performance, allow identification of effective policies and programs, and promote efficient resource allocation. This document will be an input for the larger project that aims to develop a country profile that includes a dashboard, descriptive text, a full reference list and underlying source data pertaining to the indicator list.
Pre-defined indicators were organized by the research team and were divided into 13 domains. Data for these indicators was gathered through open internet searches from primary and secondary search engines such as Google and Google Scholar using Spanish and English-language terminology. For example, the term ‘Licencia Obligatoria’ was used to obtain information on the national compulsory licensing, ‘Extensión Bolar’ for Bolar Extention, and ‘extensión del término de protección de las patentes’ was used to identify legal provisions for the extension of a patent. Primary sources include Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Ministerio de Salud (MINSALUD) and Ventanilla Única de Comercio Exterior (VUCE) while secondary sources include the World Bank, World Trade Organization, and the World Health Organization (WHO). Key data sources include the World Bank, Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Ministerio de Salud (MINSALUD), as well as the World Health Organization (WHO). PAHO’s internal data provided by Colombia’s government directly to PAHO has also been included.
Gaps in information was noted for Standard Treatment Guidelines, Procurement and Reimbursement of Pharmaceuticals, Medical Device Regulation and Management, Regulatory Infrastructure in Radiological Safety, and in Blood Services. Most of the data provided by PAHO is similar to the public data found; however, some information did vary such as the number of medicines with current valid registration and the number of blood units collected during the reporting period.
Assessing health and pharmaceutical systems require background information on the size of the population, its demographics and economics, the pharmaceutical market size and the expenditure on health and pharmaceuticals. These key data are parameters that define the requirements that a system has to meet in terms of population coverage and availability of resources.
The percentage of pharmaceutical expenditure out of total health expenditure provides a useful indication on the relative investment in pharmaceuticals compared to other components. The variation on per capita spending on pharmaceuticals between countries is due to differences in the share of generic medicines, prices and consumption pattern among other factors. Benchmarking pharmaceutical expenditure per capita can help identifying inefficiencies in spending. Very low pharmaceutical expenditure per capita can indicate a gap in pharmaceutical service delivery and result in higher morbidity and mortality.
|C1||Demographics, economics, market and expenditure||PAHO data||Public data|
|C1.1||Population in thousand||49,070,000 (2017)1||49,070,000 (2017)1|
|C1.3||GDP/Capita (PPP)||6,302 (2017)2||6,302 (2017)2|
|C1.4||GINI index for income distribution (source: World Bank)|
|C1.5||Total pharmaceutical market in USD|
|C1.5.1||Percentage of market share by value produced by domestic manufacturers (%)|
|C1.5.2||Percentage of market share by value of imported pharmaceutical products (%)|
|C1.6||Composition of Total Health Expenditure [Public, Private (Out-of-pocket as share of private)|
|C1.7||Total Expenditure on Pharmaceuticals per Habitant (USD)|
|C1.8||Expenditure on Pharmaceuticals as a percentage (%) of health's total expenditure.||12.00% (2010)3||12.00% (2010)3|
|C1.9||Total Pharmaceutical Expenditure [Public, Private (Out-of-pocket as share of private)]|
|C1.10||Key legislation-health general (E.g. Health Act/Codex)|
|C1.11||Key legislation-pharmaceuticals and other Health Technologies (E.g. Pharmaceutical/Drug Act/Codex)|
|S1||Demographics, economics, market and expenditure|
|S1.1||Life-expectancy at birth||74 (2017)4||74 (2017)4|
|S1.2||Percentage of Adults Aged over 60 years (65 and older)||8.00% (2017)1||8.00% (2017)1|
|S1.3||Percentage of children Aged below 15 years (under 14)||23.00% (2017)1||23.00% (2017)1|
|S1.4||Percentage population served by the public health system:||96.60% (2015)5|
|S1.4.1||% of National public insurance|
|S1.4.2||% of Social-security|
|S1.4.3||% of Private security|
|S1.4.4||Other, please describe|
|S1.5||National health expenditure as a % of GDP:||7.20% (2014)6|
|S1.6||Total Health Expenditure/Capita (USD Year)||852.81 (2015)1||852.81 (2015)1|
- 1: World Bank Group. Country Profile [Internet]. 2018. p. 2018. Available from: http://databank.worldbank.org/data/views/reports/reportwidget.aspx?Report_Name=CountryProfile&Id=b450fd57&tbar=y&dd=y&inf=n&zm=n&country=COL
- 2: The World Bank. GDP per capita ( current US $ ) [Internet]. The World Bank Website. 2018. p. 1–10. Available from: http://data.worldbank.org/indicator/NY.GDP.PCAP.CD
- 4: Bank W. Country Profile [Internet]. 2018. p. 2018. Available from: http://databank.worldbank.org/data/views/reports/reportwidget.aspx?Report_Name=CountryProfile&Id=b450fd57&tbar=y&dd=y&inf=n&zm=n&country=COL
- 3: World Bank Group. Current health expenditure (% of GDP) | Data [Internet]. The World Bank Website. 2018. p. 1–19. Available from: https://data.worldbank.org/indicator/SH.XPD.CHEX.GD.ZS
- 5: OECD (2017), Health at a Glance 2017: OECD Indicators, OECD Publishing, Paris. http://dx.doi.org/10.1787/health_glance-2017-en
- 6: The World Factbook — Central Intelligence Agency [Internet]. [cited 2018 Nov 13]. Available from: https://www.cia.gov/library/publications/the-world-factbook/geos/co.html
Human resources are one of the six building blocks of the health system. Pharmacy workforce comprises professionals charged with the final custody of medicines, before they are dispensed to patients, as well as ensuring the proper use and administration of medicines. They also be active in the regulation, manufacturing and procurement of medicines.
Currently, there is no recommendation of the number of pharmacists or pharmacy technicians per capita. However, very low numbers of trained human resources per capita in the pharmaceutical sector can indicate gaps in the delivery capacity of the system.
|C2||Human Resources for health||PAHO data||Public data|
|C2.1||Number of physicians per 1,000 population||1.8 (2014)1||1.8 (2014)1|
|C2.2||Number of registered radiologists per 100,000 population||200 (2011)2||200 (2011)2|
|C2.3||Number of registered pharmacists per 10,000 population||1.59 (2016)3|
|S2||Human Resources for health|
|S2.1||Number of registered medical physicists per 100,000 population|
|S2.2||Number of registered radiation oncologists per 100,000 population|
|S2.3||Number of registered radiological technologists per 100,000 population|
|S2.4||Number of registered nurses per 10,000 population||10.8 (2014)4|
|S2.5||Number of registered pharmacy technicians per 10,000 population|
- 1: World Bank Group. Country Profile [Internet]. 2018. p. 2018. Available from: http://databank.worldbank.org/data/views/reports/reportwidget.aspx?Report_Name=CountryProfile&Id=b450fd57&tbar=y&dd=y&inf=n&zm=n&country=COL
- 2: Amaya Lara L, Beltrán Villegas A, Chavarro D, Romero G, Matallana MA, Puerto S. Estudio de disponibilidad y distribución de la oferta de médicos especialistas , en servicios de alta y mediana María Alexandra Matallana Gómez Autores. Cendex. 2013
- 3: Cassiani SHB, Hoyos MC, Barreto MFC, Sives K, da Silva FAM. Distribución de la fuerza de trabajo en enfermería en la Región de las Américas. Rev Panam Salud Publica. 2018;42:e72. https://doi.org/10.26633/RPSP.2018.72
- 4: Cassiani SHB, Hoyos MC, Barreto MFC, Sives K, da Silva FAM. Distribución de la fuerza de trabajo en enfermería en la Región de las Américas. Rev Panam Salud Publica. 2018;42:e72. https://doi.org/10.26633/RPSP.2018.72
Balancing incentives for innovation and manufacturing medicines with affordability of medicines has been a challenge globally. The flexibilities of the World Trade Organization (WTO)’s Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) allow countries protecting public health, including access to medicines. The existing of provisions for the flexibilities in national legislative framework provide relevant information on the country’s ability to enact public health protection.
|C3||Innovation and Intellectual Property Management||PAHO data||Public data|
|C3.1||Is the country a member of the World Trade Organization?||Yes (2018)1|
|C3.2||With reference to the flexibilities and safeguards (TRIPS) contained in national legislation: are there flexibilities related to the Bolar Extension? Specify||Yes (2012)2|
|C3.3||Are the legal provisions for data exclusivity for pharmaceutical products? (Data Exclusivity)||Yes (2013)3|
|C3.4||Does some kind of relationship exist between the provision of marketing authorization and patent condition of the product presented? (Patent Linkage)|
|C3.5||Are there legal provisions in order to avoid the extension of a patent? (Evergreening)||Yes (2011)4|
|C3.6||Is there a public record of patents, accessible to the public?|
|S3||Innovation and Intellectual Property Management|
|S3.1||Key legislation-intellectual property and data protection|
|S3.2||Key legislation-innovation for health|
|S3.3||With reference to the flexibilities and safeguards (TRIPS) contained in national legislation: are there flexibilities related to the compulsory licensing provisions that can be applied for reasons of public health?||Will grant licenses to third parties when the patent is not being exploited by its owner or when it abuses its dominant position in the market (2005)5|
|S3.4||Does national legislation have provisions related with the parallel importation?||Parallel imports have been allowed in Colombia according to Decision 486, which is the mandatory IP law for the whole Andean Community setting forth the st (2000)6|
|S3.5||Is it part of the State of any free trade agreement / partnership / customs union of bilateral or multilateral agreement, which has a chapter on intellectual property?|
|S3.6||Are there guidelines or procedures in the country that incorporate the public health perspective in the process of evaluating pharmaceutical patent applications? (for example, guidelines for the evaluation of patent applications, prior consent procedures|
- 1: World Bank Group. Current health expenditure (% of GDP) | Data [Internet]. The World Bank Website. 2018. p. 1–19. Available from: https://data.worldbank.org/indicator/SH.XPD.CHEX.GD.ZS
- 2: INVIMA. RESPUESTAS INSTITUCIONALES A PREGUNTAS FRECUENTES Entrada en Vigor del Tratado de Libre Comercio con Estados Unidos Instituto Nacional de Vigilancia para Alimentos y Medicamentos INVIMA Mayo de 2012 [Internet]. 2012. Available from: https://www.asonatura.com/files/NOTICIAS DEL TLC CON USA.pdf
- 3: B. MSE. Legislative Background of the FTA between Colombia and the US: Intellectual Property on the pharmaceutical market. EAFIT [Internet]. 2012;4(1):16–40. Available from: http://publicaciones.eafit.edu.co/index.php/ejil/article/view/2110
- 4: Propiedad Industrial 2020 [Internet]. Ministerio de Comercio, industria y turismo. 1993. Available from: http://www.sic.gov.co/recursos_user/documentos/publicaciones/Libro_PI_2020/files/libro propiedad industrial 2020.pdf
- 5: Redaccion El Tiempo. REGLAMENTAN LICENCIAS OBLIGATORIAS DE PATENTES - Archivo Digital de Noticias de Colombia y el Mundo desde 1.990 - eltiempo.com [Internet]. El Tiempo. 2001 [cited 2018 Nov 11]. Available from: https://www.eltiempo.com/archivo/documento/MAM-489737
- 6: Controlled Parallel imports of pharmaceuticals and medical devices [Internet]. Moeller. 2013. p. 8–11. Available from: https://www.moellerip.com/controlled-parallel-imports-of-pharmaceuticals-and-medical-devices/
Laws and policies are the basis for good governance in the pharmaceutical sector. A national pharmaceutical policy is the explicit commitment of the government towards different policy objectives related to pharmaceuticals. It provides a guidance for action for all actors involved in the pharmaceutical sector. An implementation plan for the policy defines the responsibilities, measurable goals and timeframes of each actor and those overseeing the implementation. The implementation plan should also include the plan for reporting and independent assessment of the implementation progress.
The use of generic medicines and biosimilars is an important opportunity to increase the efficiency of the pharmaceutical sector spending. Policies to promote the use of generics are a corner stone to guide the government and other institutions to implement generic medicines strategies.
|C4||Pharmaceutical Policy||PAHO data||Public data|
|C4.1||National Medicines and other Health Technologies Policy official document (s) exists. (medicines, blood etc). If yes, please write the year of the most recent document (s).||Yes (2016)1|
|C4.2||Does a national medicines policy implementation plan exist?||Yes (2018)2|
|C4.3||Is access to essential medicines/technologies a part of the fulfillment of the right to health, is it recognized in the constitution or is it part of national legislation? If yes to any of these three please provide details|
|C4.4||Official strategy or policy in place for multisource (generics) medicines|
|S4.1||Is the pharmaceutical policy implementation being regularly monitored/assessed?||Yes (2016)|
|S4.2||National Health Policy (NHP) / Law exists. If yes date||Yes (2017)2|
|S4.3||National Good Governance Policy or transparency framework for governmental institutions and officials exists. If yes, please specify the year.|
|S4.4||Implementation of a functional system of surveillance and control of advertising or inaccurate or unethical information about medicines and other health technologies||Yes (2016)3|
|S4.5||Official strategy or policy for prescription by international common denomination (INN) for medicines||Yes (2016)3|
|S4.6||Official strategy or policy that allows substitution of generics in the public sector||Yes (2016)3|
|S4.7||Official strategy or policy that allows substitution of generics in the private sector||Yes (2016)3|
|S4.8||Market share of multi-source medicines (branded and unbranded generic products) by volume and value in public and private sector|
- 1: Ministerio De Salud Social YP. Resolucion numero 006408 de 2016 [Internet]. 006408 2016. Available from: https://www.minsalud.gov.co/Normatividad_Nuevo/Resolución 6408 de 2016.pdf
- 2: Ministerio de la proteccion social. 2003. Available from: http://apps.who.int/medicinedocs/documents/s18068es/s18068es.pdf 2. MINSALUD. Circular no. 16 de 2018 [Internet]. 2018. Available from: https://www.minsalud.
- 3: Indicadores Regionales de Uso Racional de Medicamentos y otras TS
Access to medicines in one of the intermediate performance goals of a functioning pharmaceutical system. Benchmarking the consumption of medicines across countries with similar epidemiological profiles is useful to indicate possible over- or underutilization of medicines. It is also useful to potentially indicate the increased risk of the development of antimicrobial resistance in the case of antibiotics.
Access to essential medicines should not depend on the financial means of individuals or households and should be guaranteed as a basic right.
|C5||Access of medicines||PAHO data||Public data|
|C5.1||Access to medicines on the National EML is guaranteed without any payment at the point of care, service or dispensing of the medicines.||No (2012)1|
|C5.2||Median availability of tracer essential medicines in the public sector. Provide percentage (%)|
|C5.3||Consumption of tracer medicines by DDD (Daily defined dose per 1,000 inhabitants per day):|
|C5.3.1||Antibiotic (J and J01)|
- 1: Huertas Vega NR. Perfil Farmacéutico de la República de Colombia [Internet]. 2012. Available from: http://www.who.int/medicines/areas/coordination/pscp_colombia.pdf?ua=1
Regulation is focused on ensuring efficacy, quality and safety of medicines through their life-cycle. Collaboration between countries can increase efficiency and promote human resource capacity building. Countries in the Americas have invested in strengthening regulatory authorities but more work needs to be done.
The Global Benchmarking Tool has been developed to objectively and systematically evaluate regulatory systems across the globe. Indicators in this section are taken from the Global Benchmarking Tool to align with best practice in the field of evaluation of regulatory systems.
|C6||Regulatory Capacity||PAHO data||Public data|
|C6.1||Legislation identifies the institutions involved in regulatory system medicines and other health technologies, their responsibilities, functions, roles and powers. Please, provide the name(s) of the NRA(s)||INVIMA. ley 9 de 1979 por la cual se dictan medidas sanitarias, se establecen las competencias del Gobierno Nacional y del Ministerio de Salud o la entidad que este delegue,el Invima y las entidades territoriales (personas jurídicas, de derecho público, quecomponen la división político-administrativa del Estado, gozando de autonomía en la gestiónde sus intereses. Son entidades territoriales los departamentos, municipios, distritos y losterritorios indígenas y eventualmente, las regiones y provincias) relacionadas con la regulación de medicamentos y otros productos competencia del Invima. La legislación colombiana sí establece la creación del Invima a través de la Ley 100 de 1993, la cual en su artículo 245, crea el Instituto Nacional de Vigilancia de Medicamentos y Alimentos Invima, como un establecimiento público delorden nacional, adscrito al Ministerio de Salud, con personería jurídica, patrimonio independiente y autonomía administrativa, cuyo objeto es la ejecución de las políticas en materia de vigilancia sanitaria y de control de calidad de medicamentos, productos biológicos, alimentos, bebidas, cosméticos, dispositivos y elementos médico-quirúrgicos, odontológicos, productos naturales homeopáticos y los generados por biotecnología, reactivos de diagnóstico, y otros que puedan tener impacto en la salud individual y colectiva. (2016)1|
|C6.2||Has the NRA been evaluated by Regional or Global Benchmarking Tool? If yes, has it achieved level 3 of functionality?|
|C6.3||What category of medicinal products does the NRA regulate? Specify|
|C6.3.1||Pharmaceuticals of chemical synthesis||Yes (2016)2|
|C6.3.2||Medical devices||Yes (2016)2||Yes (2015)3|
|C6.3.3||Other, Specify||Yes (2016)2|
|C6.3.4||Biologicals (e.g. vaccines)||Yes (2016)2|
|C6.4||What functions does the NRA perform?|
|C6.4.1||Registration and Marketing Authorization||PRAIS (2016)1|
|C6.4.2||Licensing of premises||PRAIS (2016)1|
|C6.4.3||Market Surveillance and Control||PRAIS (2016)1|
|C6.4.5||Clinical Trials Oversight||PRAIS (2016)1|
|C6.4.6||Regulatory Inspection||PRAIS (2016)1|
|C6.4.7||Laboratory Testing||PRAIS (2016)1|
|C6.4.8||NRA Vaccine Lot Release||PRAIS (2016)1|
|C6.5||Number of employees of the National Regulatory Authrity (NRA) with activities at central level||1,275 (2017)4|
|C6.6||Number of medicines with current valid registration||14,636 (2017)4||15,177 (2018)5|
|C6.7||NRA webpage or website||Yes (2018)4|
|S6.1||Number of licensed national pharmaceutical manufactures|
|S6.2||Number of import permits of medicines granted in the last year|
|S6.3||Are there legal provisions that categorize according to the risk to medical devices?|
- 2: Ley 100 de 1993 [Internet]. 1993. Available from: http://www.secretariasenado.gov.co/senado/basedoc/ley_0100_1993.html
- 3: Ministerio de salud y protección social. Decreto 1782 de 2004 Manual de BPM de medicamentos biologicos y se establece el instrumento para su verificación. 2015;44
- 4: MINSALUD I. Informe de Gestion 2017 [Internet]. 2017 [cited 2018 Dec 20]. Available from: https://www.invima.gov.co/images/pdf/nuestra-entidad/Gestion/InformesdeGestion/Informe_dic_2017.pdf
- 5: Listado Código Unico de Medicamentos [Internet]. INVIMA. 2012. p. 6–11. Available from: https://www.invima.gov.co/index.php?option=com_content&view=article&id=806&Itemid=429
- 1: PAHO W. Regional Platform on Access and Innovation for Health Technologies [Internet]. [cited 2018 Dec 21]. Available from: http://prais.paho.org/en/featured-links/
The goal of an efficient procurement is to ensure the acquisition of the adequate quantities of a quality assured medicines at an affordable price. Achieving this goal can improve access to medicines. Country collaborations in different steps in the procurement process can promote efficiency including negotiation, information exchange and bulk procurement.
Distribution systems have the goal to ensure a steady supply of pharmaceuticals and other health goods. Distribution of goods is an additional costs to the end price patients or the system have to pay. Hence, it is important to design systems that protect the goods from damage and losses, delivery the right quantities at the right time at the lowest cost possible. Assessing procurmenet and supply chain performance is needed on an ongoing basis. The indicators in this section are well established and are routinely used to assess global supply chains.
|C7||Procurement and Supply Chain Management||PAHO data||Public data|
|C7.1||Agency/agencies responsible for public procurement for medicines and medical devices. Please specify||Secretaría General. Ministerio de Salud y Protección Social (2018)1|
|C7.2||Is there a program, system or area responsible for the Quality Assurance for the public procurement mechanism for medicines?||Area de Operaciones MS y INVIMA (2018)1|
|C7.3||Number of licensed retail pharmacies per 10,000 population (Private sector).||2,770 (2012)3||Droguerias- 12,411 Farmacias-droguerias-178 (2011)2|
|S7||Procurement and Supply Chain Management|
|S7.1||Number of entities legally authorized to import pharmaceutical products.|
|S7.2||Number of distributors or their agents authorized to operate|
|S7.3||Number of wholesalers licensed|
|S7.4||Is there regulation for sale of pharmaceutical products via the Internet that limited to registered and authorized mail-order pharmacies or other authorized entities?|
- 1: MINSALUD. Comisión Nacional de Precios de Medicamentos y Diapositivos Médicos [Internet]. 2017. p. 24. Available from: http://www.sic.gov.co/sites/default/files/files/reglamentos
- 2: Rocío N, Vega H. PERFIL FARMACÉUTICO DE LA REPÚBLICA DE COLOMBIA [Internet]. 2012 [cited 2018 Oct 26]. Available from: http://www.who.int/medicines/areas/coordination/pscp_colombia.pdf
- 3: https://www.who.int/medicines/areas/coordination/pscp_colombia.pdf (for # of pharmacies and population)
Services that the provided by pharmacists or trained pharmacy staff include among other tasks dispensing, health promotion, screening for diseases, administrating medicines and ensuring safe storage and quality supply of medicines.
A system that delivers pharmaceutical services requires adequately trained staff as well as the legal framework at establishes standards for the delivery of medicines. For instance, dispensing of medicines can only be done under the supervision of a trained health professional. Retail stores with medicines dispensing units require an onsite pharmacist to be present throughout the hours of its operation.
The number of private and public pharmacies including hospital pharmacies per inhabitants is an indicators to assess the capacity of a system to provide pharmaceutical services. Information of type of services provided by pharmacies indicates the locations where population can access healthcare.
|C8||Pharmaceutical services||PAHO data||Public data|
|C8.1||Are ther legal provisions that require the presence of the pharmacist in all public and private pharmacies/drug stores?|
|C8.1.1||Full time (Pharmacy working hours)|
|S8.1||Number of hospital pharmacies|
|S8.2||Number of private pharmacies|
|S8.3||Are there any follow-up program of NCD for patients at pharmaceutical care/pharmacies for at least two diseases (e.g. HIV, diabetes, hypertension)?|
Conventional diagnostic radiology (basic and specialized), interventional radiology, sonography, radiation therapy, and diagnostic and therapeutic nuclear medicine are currently playing an essential function in clinical health care processes. These services cover a wide range of clinical applications, from the diagnosis and monitoring of very common diseases and situations with a high incidence, such as respiratory diseases, traumas, digestive disorders, control of pregnancy and breast disorders, etc., to more complex diseases such as tumors, AIDS, central nervous
system conditions, or cardiovascular diseases. International standards also require that countries have a national regulatory infrastructure for radiation safety and protection of patients, health workers and the public in general.
|C9||Radiological regulation and Services||PAHO data||Public data|
|C9.1||Do legal provisions exist that establish the functions and responsibilities of the National Regulatory Authority for radiological safety to protect patients, workers, public, and the environment.||Yes. En la Ley 9 de 1979, que se encuentra vigente, enuncia en el artículo 152: “El Ministerio de Salud deberá establecer las normas y reglamentaciones que se requieran para la protección de la salud y la seguridad de las personas contra los riesgos derivados de las radiaciones ionizantes y adoptar las medidas necesarias para su cumplimiento”. La Resolución No 2400 de 1979 del Ministerio de Trabajo y Seguridad Social en el Capítulo V, Art. 97 a 109, establece condiciones para el control de factores de riesgo derivados de la exposición a Radiaciones Ionizantes. Se trata de un Reglamento destinado exclusivamente a la protección de Trabajadores referido a todas las fuentes de Radiación Ionizante. Corresponde destacar que en la actualidad las funciones del entonces Ministerio de Trabajo y Seguridad Social se encuentran incluidas en el Ministerio de Protección Social (2011)1|
|C9.2||Annual number of radiological explorations per 1,000 population||210 (1984)2|
|S9||Radiological regulation and Services|
|S9.1||Radiological Health technologies per 1 million population (public and private sector)|
|S9.1.1||Linear accelerator||1,340 (2018)3|
|S9.1.2||Telecobalt unit (Cobalt-60)||0.55 (2018)3|
- 1: Ministerio de Protección Social 2) Misión OIEA/OPS de evaluación Autoridad Reguladora Colombia. http://www.saludcapital.gov.co/Normo/jur/ley_009_de_1979.pdf
- 2: United Nations Scientific Committee on the Effects of Atomic Radiation. Sources and effects of ionizing radiation. UNSCEAR 2000 report to the General Assembly, with scientific annexes. Vienna: UNSCEAR; 2000.
- 3: DIRAC (DIrectory of RAdiotherapy Centres). Available from: http://wwwnaweb.iaea.org/nahu/dirac/default.shtm
Universal access to safe blood for transfusions is based on self-sufficiency in blood and blood products through voluntary unpaid donation of blood, improvements in the quality of donated blood, maximization of adequate use of blood, strengthening of human resources.
In addition to the technical aspects, it is necessary for states to ensure the allocation of resources according to national blood safety objectives and plans, reorganize and integrate blood services networks in accordance with the needs of the national health system. That they develop and manage health surveillance, and promote and manage Hemovigilance and risk management, along the chain of transfusion.
Finally, obtaining relevant information through specific indicators allows strengthening the management of information to visualize and determine if there is a sufficient, timely, accessible and safe blood supply, and how this supply is linked to the country's morbidity and mortality.
|C10||Blood regulation and services||PAHO data||Public data|
|C10.1||Is there a specific law that regulates the promotion of donation, processing, storage, use of blood and health surveillance?||Yes (2016)1|
|C10.2||Are the Hemovigilance (HM) activities legally established (roles and responsibilities) for the HM?||Yes (2016)1|
|C10.3||Total Number of whole blood donations collected during the reporting period (by total blood banks, types of donation and frequency).||817,003 (2016)1||830,000 (2017)2|
|C10.4||Percentage of donations (whole blood and apheresis) that were screened for TTIs||100.00% (2016)1|
|C10.5||Percentage of RBC units separated and discarded from the total whole blood units||98.69% of RBC units separated from the total whole blood units, and 7.26% of RBC discarded (2016)1|
- 1: Organización Panamericana de la Salud. "Suministro de sangre para transfusiones en los países de Latinoamérica y del Caribe, 2016". En proceso de publicación.
- 2: MINSALUD. The Challenge is to Increase Blood Donation in Colombia - According to the National Institute of Health only 220 , 000 nationals donate blood in the country . 2018.
The transplant of organs, tissues and cells has become a worldwide practice that can prolong life and improve its quality. Advances in ablation, preservation, transplant and immunosuppression techniques have improved the effectiveness, cost-effectiveness and cultural acceptability of transplants with the consequent increase in demand for these practices. Today it is possible to perform solid organ transplants such as kidney, liver, heart, lung, pancreas, small intestine and cornea mainly, and also treat other events leukemias, severe burns, traumatic accidents and surgical treatment, with the use of cell and tissue transplantation , these treatments have become an effective therapy that saves lives and improves the quality of life of many people. However, despite the great scientific developments and the advances that can be seen in some countries, the capacities for transplants in the different health systems of the Region of the Americas are heterogeneous.
Therefore, having basic information about these transplant therapies allows us to propose a baseline that allows the monitoring of the strategy and plan of action on donation and equitable access to the transplantation of organs, tissues and cells 2019 - 2030 recently. promoted by PAHO, also to know and follow the behavior of equitable and quality access to transplants of organs, tissues and cells in the countries.
|C11||Transplants||PAHO data||Public data|
|C11.1||Does the country have a national organization of transplants with structure, competencies and financing according to the essential responsibilities of the donation and transplant system||Yes (2017)1|
|C11.2||Does the country have a National single registry for the entire health system (public and private), of waiting patients (waiting list), coordinated by the governing body.||Yes (2017)1|
|C11.3||Does the country have documents that establish technical-scientific criteria for the donation, processing and allocation and distribution of organs, tissues and cells.||Yes (2017)1|
|C11.4||Does the country have mechanisms that guarantee the availability of medicines for donation and transplant programs||Yes (2017)1|
- 1: PAHO'S Proposal of Strategy and Action Plan for Donation and Equitable Access to Transplantation of Organs, Tissues and Cells, 2019 - 2029.
Appropriate use of medicines is necessary to achieve health benefits and protect populations from harm cause by medicines. Additionally, inappropriate use of medicines wastes resources. Inappropriate use of medicines include: overuse (using medicines that are unnecessary), underuse (the absence of medicines when they are effective), the wrong use (medicines are not in line with best clinical evidence or wasting resources).
Management tools to promote appropriate use of medicines are formularies or essential medicines lists, standard treatment guidelines and health technology assessments, among others. The development of these tools needs to follow a defined process that is publically available and that manages conflicts for interest if present.
Advertisement of medicines can provide distorted information about medicines that can result in harmful use of medicines. Surveillance of advertisement by regulatory bodies is relevant to prevent harm.
|C12||Rational Use of Medicines and other Health Technologies||PAHO data||Public data|
|C12.1||Does a National Essential Medicines List (EML) exist? If yes, provide the number of medicines on the EML by active ingredient||Yes (2012)1|
|C12.2||A national Committee on Selection (free of conflict of interests) and Use of Essential Medicines exists.||Yes (2012)1|
|C12.3||Is there a procedure for the selection of medicines of the EML publically available?||Yes (2012)1|
|C12.4||Was the EML updated in the last 5 years?|
|C12.5||Does a National Essential Priority Medical Devices List exist? If yes, provide the number of medical devices listed||No (2017)2|
|C12.6||Existence of a national strategy or plan for the rational use of medicines and other health technologies, with monitoring of results||No (2016)3|
|C12.7||Incorporation of medicines and other health technologies of the public sector through an official mechanism that includes the selection according to the criteria of Health Technologies Assessment||Yes (2016)3|
|C12.8||Is there a functional system of surveillance and control of advertising or inaccurate or unethical information about medicines and other health technologies?||Yes (2016)3|
|C12.9||Adoption of guidelines and indicators for, at least, good prescribing practices and good pharmacy practices||No (2016)3|
|S12.1||Existence of a current national and functional program of communication and dissemination of independent information on the rational use of medicines and other health technologies||No (2016)3|
|S12.2||Existence of official systems for monitoring the safety of medicines and other health technologies (national functional systems of at least two of the following: pharmacovigilance, technovigilance, haemovigilance)||Yes (2016)3|
|S12.3||Existence of defined standards and procedures for the development or adaptation of clinical practice guidelines||Yes (2016)3|
|S12.4||There are Clinical Guidelines in agreement with EML for most common illnesses||Yes (2016)3|
- 1: PSPC. Available at: http://www.who.int/medicines/areas/coordination/pscp_colombia.pdf?ua=1
- 2: PAHO Review (unpublished)
- 3: Indicadores Regionales de Uso Racional de Medicamentos y otras TS
Many medicines are considered essential goods which means that their prices are less influenced by demand. Measuring medicines prices can be challenging but is important to understand affordability which is a key dimension of access. Governments can influence markets that set prices through control of markups or eliminating tariffs and taxes. Governments are often buyers of large quantities of medicines which means that they can effectively negotiate prices and share information with other national or international buyers to increase their power.
Health technology assessments (HTAs) play an important part in the selection of medicines for reimbursement. An HTA consists of a systematic evaluation of the properties, effects, and/or impacts of medicines, devices and other technologies for health. Many countries in the Americas have developed institutional capacity to carry out HTAs to support the selection of technologies for their health systems. However, much needs to be done to improve quality and efficiencies in technology selection for health systems. Country collaborations in this area are vital to reduce costs of conducting HTA.
Treatment coverage is one of the most relevant outcome measures to assess a functioning pharmaceutical system. It is a core indicator of many vertical disease programs such as HIV and TB. Since non-communicable diseases are the top cause of mortality worldwide assessing treatment coverage for common diseases such as hypertension and diabetes is critical in addition to HIV and TB.
|C13||Pricing, Procurement, Health Technology Assessment (HTA) and coverage||PAHO data||Public data|
|C13.1||Are taxes imposed on pharmaceuticals?||Yes (2014)4|
|C13.2||Importation tax. If yes, what percentage?|
|C13.3||VAT (value-added tax) If yes, what percentage?|
|C13.4||Other. Please, describe|
|C13.5||Is there an institution responsible for HTA?||Instituto de Evaluacion Tecnologica en Salud Evaluacion (2018)1|
|C13.6||Does the country have a legal framework for the use of HTA in decision-making? Specify||Yes (2017)2|
|C13.7||Public procurement of medicines is determined by the products selected according to HTA or other evidence-based criteria|
|C13.8||Agency/agencies that sets medicine prices exists. If yes, name.||Comisión Nacional de Precios de Medicamentos y Dispositivos Médicos (2018)3||Comisión Nacional de Precios de Medicamentos y Dispositivos Médicos (2017)5|
|C13.9||Does pricing regulation in the public sector exist?|
|C13.10||Does pricing regulation in the private sector exist?||Yes (2016)5|
|C13.11||Name of the body responsible for selection of products for coverage|
|C13.13||Percentage individuals with raised blood pressure (SBP>= 140 and/or DBP >= 90 mmHG) currently taking medicines for hypertension||23.90% (2010)6|
|C13.14||Percentage individuals with raised fasting blood glucose (plasma venous value ≥126 mg/dl) currently on medication for raised blood glucose)||4.00% (2010)6|
|C13.15||Opioid consumption in morphine milligrams (mg) per capita/year||15.19 (2015)7|
|S13.1||Percentage patients diagnosed with HIV on treatment||54.00% (2017)8|
|S13.2||Percentage patients diagnosed with TB concluding treatment course||79.00% (2014)9|
- 4: Rocío N, Vega H. PERFIL FARMACÉUTICO DE LA REPÚBLICA DE COLOMBIA [Internet]. 2012 [cited 2018 Oct 26]. Available from: http://www.who.int/medicines/areas/coordination/pscp_colombia.pdf
- 1: Instituto de Evaluacion Tecnologica en Salud [Internet]. [cited 2018 Dec 21]. Available from: http://www.iets.org.co/
- 2: Lessa F, Caccavo F, Curtis S, Ouimet-Rathé S, Lemgruber A. Strengthening and implementing health technology assessment and the decision-making process in the Region of the Americas. Rev Panam Salud Publica. 2017;41:e165. https://doi.org/10.26633/RPSP.2017.165
- 3: Minsalud. Listado de medicamentos con precio controlado y/o de referencia [Internet]. [cited 2018 Dec 21]. Available from: https://www.minsalud.gov.co/salud/MT/Paginas/listado-de-medicamentos-con-precio-controlado.aspx
- 5: Comisión Nacional de Precios de Medicamentos y Diapositivos Médicos [Internet]. 2017. p. 24. Available from: http://www.sic.gov.co/sites/default/files/files/reglamentos tecnicos/Control_de_precios/Circular_Externa_001_de_2017_Medicamentos.pdf
- 6: Factores de riesgo para enfermedades crónicas en Santander: Método STEPwise. Observatorio de Salud Publica de Santander. 2011. 172 p.
- 7: University of Wisconsin: Pain and Policy Studies Group. Colombia Opiod consumption in Morphine Equivalence (ME) minus Methdone, mg per person [Internet]. 2015. Available from: http://www.painpolicy.wisc.edu/sites/default/files/country_files/morphine_equivalence_w
- 8: The World Factbook — Central Intelligence Agency [Internet]. [cited 2018 Nov 13]. Available from: https://www.cia.gov/library/publications/the-world-factbook/geos/co.html
- 9: Plan Estrategico “Hacia el fin de la Tuberculosis” [Internet]. Vol. 2015, MINSALUD. 2016. Available from: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/INEC/INTOR/Plan-estrategico-fin-tuberculosis-colombia-2016-2025.pdf