Guatemala


Introduction

The objective of this document is to present currently available data on pharmaceuticals and health technologies in Guatemala and to identify gaps in data availability pertaining to the Guatemalan health system, medicine, and health technology access.  

Methodology


The list of indicators was prepared by the research team based on relevance and predicted availability of data. The document compiles data from two different sources: PAHO’s internal data that are provided mainly by the country government directly to PAHO are reported in the PAHO data column, while publicly‐available data are found in the Public Data column.  

Search methodology to capture the Public Data involved open internet searches with Spanish and English‐language search terms relevant to each indicator. Data were taken from primary and secondary sources, with a preference for primary sources. When secondary sources cited primary sources, researchers located and cited the corresponding primary source.  

Key data sources identified were departments of the Guatemalan government (Ministerio de Salud Pública y Asistencia Social and Departamento de Regulación y Control de Productos Farmacéuticos y Afines, Instituto Guatemalteco de Seguridad Social, among others), the World Health Organization, and USAID. Data were also included from the CIA, the World Trade Organization, the World Intellectual Property Organization, and academic publications.

Data were hand‐calculated by research staff in cases where component variables were available with which to derive the desired indicator (for example, percentage of adults over age 60).  

Results

Gaps in available information were noteworthy in the research process. Fields in which information was largely unavailable included: pharmacy and radiology human resources; medical technology inventories and regulations; details on the functioning of the National Medicines Regulatory Authority, including adverse drug reaction reporting; and medicines availability and affordability and per capita consumption.  

For other indicators, the lack of recent data was notable: some information on public procurement and essential medicines lists dated from 2002 or 2009, and information on Standard Treatment Guidelines had not been updated since 2010.  


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 15,460,732 (2018)1
C1.2 GDP
C1.3 GDP/Capita (PPP) $8100 (2018)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) 38% public/62 private [52% out of pocket] (2018)3
C1.7 Total Expenditure on Pharmaceuticals per Habitant (USD) 57.05 (2018)4
C1.8 Expenditure on Pharmaceuticals as a percentage (%) of health's total expenditure. 28.00% (2018)5
C1.9 Total Pharmaceutical Expenditure [Public, Private (Out-of-pocket as share of private)] 36/64% public vs private (2018)6
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)
SI Supplementary Indicators
S1 Demographics, economics, market and expenditure
S1.1 Life-expectancy at birth 72.6 years (2018)7
S1.2 Percentage of Adults Aged over 60 years (65 and older) 6.93% (2018)8
S1.3 Percentage of children Aged below 15 years (under 14) 34.50% (2018)9
S1.4 Percentage population served by the public health system:
S1.4.1 % of National public insurance
S1.4.2 % of Social-security 17.50% (2018)10
S1.4.3 % of Private security <5% (2018)11
S1.4.4 Other, please describe
S1.5 National health expenditure as a % of GDP: 6.20% (2018)12
S1.5.1 Public
S1.5.2 Private
S1.6 Total Health Expenditure/Capita (USD Year) 473 (Intl $) (2018)13

References
  • 1: CIA. World Fact Book: Guatemala [Internet]. 2018 [cited 2018 Oct 23]. Available from: https://www.cia.gov/library/publications/the‐world‐factbook/geos/print_gt.html
  • 2: CIA. World Fact Book: Guatemala [Internet]. 2018 [cited 2018 Oct 23]. Available from: https://www.cia.gov/library/publications/the‐world‐factbook/geos/print_gt.html
  • 3: USAID. Guatemala: Health System Assessment 2015 [Internet]. 2015 [cited 2018 Oct 23]. Available from: https://www.usaid.gov/sites/default/files/documents/1862/Guatemala‐HSA _ENG‐FULL‐REPORT‐FINAL‐APRIL‐2016.pdf
  • 4: USAID. Guatemala: Health System Assessment 2015 [Internet]. 2015 [cited 2018 Oct 23]. Available from: https://www.usaid.gov/sites/default/files/documents/1862/Guatemala‐HSA _ENG‐FULL‐REPORT‐FINAL‐APRIL‐2016.pdf
  • 6: USAID. Guatemala: Health System Assessment 2015 [Internet]. 2015 [cited 2018 Oct 23]. Available from: https://www.usaid.gov/sites/default/files/documents/1862/Guatemala‐HSA _ENG‐FULL‐REPORT‐FINAL‐APRIL‐2016.pdf
  • 5: USAID. Guatemala: Health System Assessment 2015 [Internet]. 2015 [cited 2018 Oct 23]. Available from: https://www.usaid.gov/sites/default/files/documents/1862/Guatemala‐HSA _ENG‐FULL‐REPORT‐FINAL‐APRIL‐2016.pdf
  • 7: CIA. World Fact Book: Guatemala [Internet]. 2018 [cited 2018 Oct 23]. Available from: https://www.cia.gov/library/publications/the‐world‐factbook/geos/print_gt.html
  • 8: Instituto Nacional de Estadistica Guatemala. Caracterización República de Guatemala [Internet]. 2017 [cited 2018 Oct 23]. Available from: https://www.ine.gob.gt/sistema/uploads/2014/02/26/L5pNHMXzxy5FFWmk9NHCrK9x7E5Qqvvy.pdf
  • 9: CIA. World Fact Book: Guatemala [Internet]. 2018 [cited 2018 Oct 23]. Available from: https://www.cia.gov/library/publications/the‐world‐factbook/geos/print_gt.html
  • 10: USAID. Guatemala: Health System Assessment 2015 [Internet]. 2015 [cited 2018 Oct 23]. Available from: https://www.usaid.gov/sites/default/files/documents/1862/Guatemala‐HSA _ENG‐FULL‐REPORT‐FINAL‐APRIL‐2016.pdf
  • 11: USAID. Guatemala: Health System Assessment 2015 [Internet]. 2015 [cited 2018 Oct 23]. Available from: https://www.usaid.gov/sites/default/files/documents/1862/Guatemala‐HSA _ENG‐FULL‐REPORT‐FINAL‐APRIL‐2016.pdf
  • 12: WHO. Guatemala. WHO [Internet]. 2018 [cited 2018 Oct 23]; Available from: http://www.who.int/countries/gtm/en/
  • 13: WHO. Guatemala. WHO [Internet]. 2018 [cited 2018 Oct 23]; Available from: http://www.who.int/countries/gtm/en/

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 0.093 (2018)1
C2.2 Number of registered radiologists per 100,000 population 2 total (2018)2
C2.3 Number of registered pharmacists per 10,000 population 0.83 (2018)
SI Supplementary Indicators
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 13 total (2018)3
S2.3 Number of registered radiological technologists per 100,000 population 37 total (including brachytherapy technicians, radiotherapy technicians, and radiology technicians) (2018)4
S2.4 Number of registered nurses per 10,000 population 6 (2018)
S2.5 Number of registered pharmacy technicians per 10,000 population 0.08 (2018)

References
  • 1: WHO Global Observatory for eHealth. Atlas: Guatemala [Internet]. 2015 [cited 2018 Oct 23]. Available from: http://www.who.int/goe/publications/atlas/2015/gtm.pdf
  • 2: de la Torre M. INFORME DE EVALUACIÓN DE LA RADIOTERAPIA ONCOLÓGICA EN GUATEMALA [Internet]. Ciudad de Guatemala, Guatemala; 2011 [cited 2018 Oct 25]. Available from: https://www.paho.org/gut/index.php?option=com_docman&view=download&category_slug=medicamentos‐y‐tecnologias‐ensalud&alias=504‐informe‐guatemala‐final&Itemid=518
  • 3: de la Torre M. INFORME DE EVALUACIÓN DE LA RADIOTERAPIA ONCOLÓGICA EN GUATEMALA [Internet]. Ciudad de Guatemala, Guatemala; 2011 [cited 2018 Oct 25]. Available from: https://www.paho.org/gut/index.php?option=com_docman&view=download&category_slug=medicamentos‐y‐tecnologias‐ensalud&alias=504‐informe‐guatemala‐final&Itemid=518
  • 4: de la Torre M. INFORME DE EVALUACIÓN DE LA RADIOTERAPIA ONCOLÓGICA EN GUATEMALA [Internet]. Ciudad de Guatemala, Guatemala; 2011 [cited 2018 Oct 25]. Available from: https://www.paho.org/gut/index.php?option=com_docman&view=download&category_slug=medicamentos‐y‐tecnologias‐ensalud&alias=504‐informe‐guatemala‐final&Itemid=518

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, since 1995 (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 No (2018)2
C3.3 Are the legal provisions for data exclusivity for pharmaceutical products? (Data Exclusivity) Yes:
"Guatemalan legislation passed in 2000 mandated 15 years of test data exclusivity, a standard well beyond that required by TRIPS" (2018)3
C3.4 Does some kind of relationship exist between the provision of marketing authorization and patent condition of the product presented? (Patent Linkage) Yes:
"DR‐CAFTA mandates the extension of patents beyond 20 years to compensate for “unreasonable” delays in the granting of the patent or marketing approval for the drug, when such delays have been caused by the government." (2018)4
C3.5 Are there legal provisions in order to avoid the extension of a patent? (Evergreening)
C3.6 Is there a public record of patents, accessible to the public?
SI Supplementary Indicators
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? Yes (2018)5
S3.4 Does national legislation have provisions related with the parallel importation? Yes (2018)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

References
  • 1: WTO. Guatemala and the WTO [Internet]. 2018 [cited 2018 Oct 24]. Available from: https://www.wto.org/english/thewto_e/countries_e/guatemala_e.htm
  • 2: Deere C. The Implementation Game: Developing Countries, the TRIPS Agreement and the Global Politics of Intellectual Property [Internet]. [cited 2018 Oct 24]. Available from: https://www.law.ox.ac.uk/sites/files/oxlaw/carolyn_deere.pdf
  • 3: Godoy AS, Cerón A. Changing drug markets under new intellectual property regimes: the view from Central America. Am J Public Health [Internet]. 2011 Jul [cited 2018 Oct 24];101(7):1186–91. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21566033
  • 4: Cerón A, Snodgrass Godoy A. Intellectual property and access to medicines: an analysis of legislation in Central America. Bull World Health Organ [Internet]. 2009 Oct 1 [cited 2018 Oct 24];87(10):787–93. Available from: http://www.who.int/bulletin/volumes/87/10/08‐056010.pdf
  • 5: WIPO. CDIP 5/4 Annex I Provision of Law [Internet]. Available from: http://www.wipo.int/edocs/mdocs/mdocs/en/cdip_5/cdip_5_4‐annex1.doc
  • 6: INTA. A Review of Parallel Import Laws in Latin America [Internet]. INTABulletin. 2015 [cited 2018 Oct 24]. Available from: https://www.inta.org/INTABulletin/Pages/ParallelImportLawsinLatinAmerica_7009.aspx#

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). No (2018)
C4.2 Does a national medicines policy implementation plan exist? No (2018)
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 "El acceso a los medicamentos esenciales y a las tecnologías como parte del
cumplimiento del derecho a la salud, está reconocido en
la constitución o la legislación nacional" (2018)1
C4.4 Official strategy or policy in place for multisource (generics) medicines
SI Supplementary Indicators
S4 Pharmaceutical Policy
S4.1 Is the pharmaceutical policy implementation being regularly monitored/assessed?
S4.2 National Health Policy (NHP) / Law exists. If yes date Yes (2018)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 (2018)
S4.5 Official strategy or policy for prescription by international common denomination (INN) for medicines Yes (2018)
S4.6 Official strategy or policy that allows substitution of generics in the public sector Yes (2018)
S4.7 Official strategy or policy that allows substitution of generics in the private sector Yes (2018)
S4.8 Market share of multi-source medicines (branded and unbranded generic products) by volume and value in public and private sector

References
  • 1: MPSAS and PAHO. Guatemala Perfil Farmacéutico Nacional [Internet]. 2012 [cited 2018 Oct 24]. Available from: https://www.paho.org/hq/dmdocuments/2013/Perfil‐farmaceutico‐GUATEMALA.pdf
  • 2: Ministerio de Salud Publica Asistencia Social Gobierno de Guatemala. Plan Nacional para la salud de todas y todos los guatemaltecos 2008 [Internet]. 2008 [cited 2018 Oct 24]. Available from: http://www.segeplan.gob.gt/downloads/clearinghouse/politicas_publicas/Salud/Plan Nacional Salud.pdf

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, requires co-pay (2018)
C5.2 Median availability of tracer essential medicines in the public sector. Provide percentage (%) 33% for primary care, 25% for secondary care (2018)1
C5.3 Consumption of tracer medicines by DDD (Daily defined dose per 1,000 inhabitants per day):
C5.3.1 Antibiotic (J and J01)
C5.3.2 Antidiabetic (A10)
C5.3.3 Antihypertensives (C02)

References
  • 1: USAID. Guatemala: Health System Assessment 2015 [Internet]. 2015 [cited 2018 Oct 23]. Available from: https://www.usaid.gov/sites/default/files/documents/1862/Guatemala‐HSA _ENG‐FULL‐REPORT‐FINAL‐APRIL‐2016.pdf

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) Dirección General de
Regulación, Vigilancia y
Control de la Salud
(DGRVCS). la competencia, los objetivos y productos objeto de control están indicados en Código de Salud, decreto 90‐97 y sus
actualizaciones Capitulo III, sección I, II, III, IV, V.
Acuerdo Gubernativo 712‐
99 Reglamento para el
Control Sanitario de los
Medicamentos y Productos
Afines Departamento
Medicamentos del
Ministerio de Salud (ARN) (2018)
Departamento de Regulación y Control de Farmacéuticos y Afines (2018)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 (2018) Yes (2018)
C6.3.2 Medical devices Yes (2018)
C6.3.3 Other, Specify -Cosméticos, productos de higiene personal y del hogar;
-Estupefacientes, psicotrópicos y sus precursores;
-Productos fito y zooterapéuticos y similares;
-Plaguicidas de uso doméstico;
-Material de curación;
-Reactivos de laboratorio para uso diagnóstico;
-Materiales, productos y equipo odontológico. (2018)
C6.3.4 Biologicals (e.g. vaccines) Yes (2018)
C6.4 What functions does the NRA perform?
C6.4.1 Registration and Marketing Authorization Yes (2018) Yes (2018)
C6.4.2 Licensing of premises Yes (2018) Yes (2018)
C6.4.3 Market Surveillance and Control Yes (2018) Yes (2018)
C6.4.4 Vigilance Yes (2018) Yes (2018)
C6.4.5 Clinical Trials Oversight Yes (2018) Yes (2018)
C6.4.6 Regulatory Inspection Yes (2018) Yes (2018)
C6.4.7 Laboratory Testing Yes (2018) Yes (2018)2
C6.4.8 NRA Vaccine Lot Release Yes (2018)
C6.5 Number of employees of the National Regulatory Authrity (NRA) with activities at central level
C6.6 Number of medicines with current valid registration Approx 38,000 (2018)3
C6.7 NRA webpage or website Yes (2018) Yes (2018)4
SI Supplementary Indicators
S6 Regulatory Capacity
S6.1 Number of licensed national pharmaceutical manufactures 62 (2018)5
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?

References
  • 1: DRCFPA. Funciones del DRCPFA [Internet]. MPSAS. 2018 [cited 2018 Oct 24]. Available from: http://medicamentos.mspas.gob.gt/index.php/quienes‐somos/funciones
  • 2: DRCFPA. Funciones del DRCPFA [Internet]. MPSAS. 2018 [cited 2018 Oct 24]. Available from: http://medicamentos.mspas.gob.gt/index.php/quienes‐somos/funciones
  • 3: DRCPFA. Registros Sanitarios Vigentes de Productos Farmacéuticos [Internet]. 2018 [cited 2018 Oct 25]. Available from: http://medicamentos.mspas.gob.gt/index.php/consultas/registros‐vigentes
  • 4: DRCPFA. Inicio [Internet]. 2018 [cited 2018 Oct 25]. Available from: http://medicamentos.mspas.gob.gt/
  • 5: DRCPFA. Listado de laboratorios de productos farmaceuticos autorizados [Internet]. 2017 [cited 2018 Oct 25]. Available from: https://medicamentos.mspas.gob.gt/phocadownload/LISTADO%20LABORATORIOS%20FARMACEUTICOS%20AL%20%2007%20 %20DE%20MARZO%202017.pdf

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 Departamento de Compras. Ministerio de Salud Pública y Asistencia Social (2018) IGSS through Contrato Abierto (2018)1
C7.2 Is there a program, system or area responsible for the Quality Assurance for the public procurement mechanism for medicines? Departamento de Compras. Ministerio de Salud Pública y Asistencia Social (2018)
C7.3 Number of licensed retail pharmacies per 10,000 population (Private sector). 4,42 (2018)
SI Supplementary Indicators
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?

References
  • 1: IGSS. Acuerdo No. 7/2012 [Internet]. 2012. Available from: http://www.igssgt.org/ley_acceso_info/pdf/pdf2012/inciso6/acuerdo7_ger2012.pdf

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)
C8.1.2 Part time
SI Supplementary Indicators
S8 Pharmaceutical services
S8.1 Number of hospital pharmacies
S8.2 Number of private pharmacies 6,500 retail pharmacies (2018)1
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)?

References
  • 1: MPSAS and PAHO. GUATEMALA PERFIL FARMACÉUTICO NACIONAL [Internet]. 2012 [cited 2018 Oct 24]. Available from: https://www.paho.org/hq/dmdocuments/2013/Perfil‐farmaceutico‐GUATEMALA.pdf

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. ARTICULO 6. AMBITO DE APLICACIÓN. Esta Ley se aplica en todo el territorio nacional de la República, a las personas individuales o jurídicas, nacionales o extranjeras, así como a las instituciones estatales y entidades descentralizadas,
autónomas o semiautónomas, que realicen cualesquiera de las actividades siguientes: instalar y/u operar equipos generadores de radiaciones ionizantes, irradiar alimentos u otros productos, producir, usar, manipular, aplicar, transportar, comercializar, importar, exportar o tratar sustancias radiactivas, u otras actividades relacionadas con
las mismas. ARTICULO 7.
DEPENDENCIA
COMPETENTE. La Dirección es la Dependencia del Ministerio, competente para nombre del Gobierno, controlar, supervisar, fiscalizar y establecer las condiciones mínimas de seguridad que deben observarse en las actividades indicadas en el Artículo 6º de esta Ley, así como para realizar la investigación, promoción y
desarrollo de las aplicaciones de los radioisótopos y de las radiaciones ionizantes. (2018)
C9.2 Annual number of radiological explorations per 1,000 population
SI Supplementary Indicators
S9 Radiological regulation and Services
S9.1 Radiological Health technologies per 1 million population (public and private sector)
S9.1.1 Linear accelerator 0,41 (2018) 3 machines total (2018)1
S9.1.2 Telecobalt unit (Cobalt-60) 0,06 (2018) 3 machines total (2018)2

References
  • 1: de la Torre M. INFORME DE EVALUACIÓN DE LA RADIOTERAPIA ONCOLÓGICA EN GUATEMALA [Internet]. Ciudad de Guatemala, Guatemala; 2011 [cited 2018 Oct 25]. Available from: https://www.paho.org/gut/index.php?option=com_docman&view=download&category_slug=medicamentos‐y‐tecnologias‐ensalud&alias=504‐informe‐guatemala‐final&Itemid=518
  • 2: de la Torre M. INFORME DE EVALUACIÓN DE LA RADIOTERAPIA ONCOLÓGICA EN GUATEMALA [Internet]. Ciudad de Guatemala, Guatemala; 2011 [cited 2018 Oct 25]. Available from: https://www.paho.org/gut/index.php?option=com_docman&view=download&category_slug=medicamentos‐y‐tecnologias‐ensalud&alias=504‐informe‐guatemala‐final&Itemid=518

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 (2018) Yes, established in 2003:
"En Guatemala el Programa
Nacional de Medicina
Transfusional y de Bancos de Sangre, se estableció por mandato legal en 2003, mediante el acuerdo gubernativo 75‐2003 que consiste en el reglamento de la ley concerniente al tema, aprobada en 1997." (2018)1
C10.2 Are the Hemovigilance (HM) activities legally established (roles and responsibilities) for the HM? No (2018)
C10.3 Total Number of whole blood donations collected during the reporting period (by total blood banks, types of donation and frequency). 135495 whole blood units collected.
5.07% Voluntary blood donations and 94.93% Replacement blood donations. No information reported on frequency. (2018)
1.13 million units from 2008‐2017. 20,379 units in 2017. (2018)2
C10.4 Percentage of donations (whole blood and apheresis) that were screened for TTIs 100.00% (2018)
C10.5 Percentage of RBC units separated and discarded from the total whole blood units 89.59% of RBC units separated from the total whole blood units, and 4.31% of RBC discarded. (2018)

References
  • 1: MSPAS. Acuerdo Ministerial No. 529‐2011. Diario de Centro America. [Internet]. 2011 [cited 2018 Oct 25]. Available from: http://www.mspas.gob.gt/index.php/component/jdownloads/send/148‐bancos‐de‐sangre‐y‐medicina‐transfusional/1338acuerdo‐ministerial‐no‐529‐2011‐creacion‐de‐la‐red‐de‐servicios‐de‐medicina‐transfusional‐y‐bancos‐de‐sangre
  • 2: No Ficcion. Así funcionan los bancos de sangre en Guatemala [Internet]. No Ficcion . 2018 [cited 2018 Oct 25]. Available from: https://www.no‐ficcion.com/project/asi‐funcionan‐los‐bancos‐de‐sangre‐en‐guatemala

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 No (2018)
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. No (2018)
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. No (2018)
C11.4 Does the country have mechanisms that guarantee the availability of medicines for donation and transplant programs No (2018)

References

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 (2018) Yes ‐ IGSS and MSPAS have separate lists. (2018)1
381 medicines on MSPAS list, by active ingredient (2018)3
C12.2 A national Committee on Selection (free of conflict of interests) and Use of Essential Medicines exists. Yes (2018) For MSPAS: Comité de Farmacoterapia Ministerial. (2018)3
For IGSS: Comisión Terapéutica Central (2018)4
C12.3 Is there a procedure for the selection of medicines of the EML publically available? Yes (2018)
C12.4 Was the EML updated in the last 5 years? Yes (2018) Yes for IGSS (2018)5
C12.5 Does a National Essential Priority Medical Devices List exist? If yes, provide the number of medical devices listed No (2018)
C12.6 Existence of a national strategy or plan for the rational use of medicines and other health technologies, with monitoring of results No (2018)
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 No (2018)
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 (2018)
C12.9 Adoption of guidelines and indicators for, at least, good prescribing practices and good pharmacy practices No (2018)
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 (2018)
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) No (2018)
S12.3 Existence of defined standards and procedures for the development or adaptation of clinical practice guidelines No (2018)
S12.4 There are Clinical Guidelines in agreement with EML for most common illnesses No (2018)

References
  • 1: MPSAS. Lista Básica De Medicamentos Ministerio De Salud Pública Y Asistencia Social [Internet]. 2013 [cited 2018 Oct 25]. Available from: http://apps.who.int/medicinedocs/documents/s23202es/s23202es.pdf
  • 3: MPSAS. Lista Básica De Medicamentos Ministerio De Salud Pública Y Asistencia Social [Internet]. 2013 [cited 2018 Oct 25]. Available from: http://apps.who.int/medicinedocs/documents/s23202es/s23202es.pdf
  • 3: MPSAS. Lista Básica De Medicamentos Ministerio De Salud Pública Y Asistencia Social [Internet]. 2013 [cited 2018 Oct 25]. Available from: http://apps.who.int/medicinedocs/documents/s23202es/s23202es.pdf.
  • 4: IGSS. Listado de medicamentos: Presentación [Internet]. 2009 [cited 2018 Oct 25]. Available from: http://www.igssgt.org/images/medicamentos/01_Introduccion_Tabla_de_Contenido.pdf
  • 5: Instituto Guatemalteco de Seguridad Social. Listado de Medicamentos [Internet]. 2018 [cited 2018 Oct 25]. Available from: http://www.igssgt.org/listadomedicamentos.php

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 with exceptions. No VAT on generic pharmaceuticals or antiretrovirals for HIV/AIDS. Ley IVA: Exceptions p. 8, Item 15 (2018)1
C13.2 Importation tax. If yes, what percentage?
C13.3 VAT (value-added tax) If yes, what percentage? 12% (standard), 5% ("regimen pequeño contribuyente" for low‐income people). (2018)2
C13.4 Other. Please, describe
C13.5 Is there an institution responsible for HTA? No (2018) No (2018)
C13.6 Does the country have a legal framework for the use of HTA in decision-making? Specify No (2018)
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. No. Referenced article explains lack of regulation (2018)3
C13.9 Does pricing regulation in the public sector exist? No (2018)
C13.10 Does pricing regulation in the private sector exist? No. DRCPFA (Departamento de Regulación y Control de Productos Farmacéuticos y Afines) regulated prices until 1997, now no regulation. Dirección de Atención y Asistencia al Consumidor makes pricing references but has no regulatory power. (2018)4
C13.11 Name of the body responsible for selection of products for coverage Comisión Terapéutica Central, IGSS (2018)5
C13.13 Percentage individuals with raised blood pressure (SBP>= 140 and/or DBP >= 90 mmHG) currently taking medicines for hypertension 26.70% (2018)6
C13.14 Percentage individuals with raised fasting blood glucose (plasma venous value ≥126 mg/dl) currently on medication for raised blood glucose) 17.8% with impaired fasting glycaemia, defined as capillary whole blood value ≥100 mg/dl and <110 mg/dl (2018)7
C13.15 Opioid consumption in morphine milligrams (mg) per capita/year 1.483 per person (2018)8
S13.1 Percentage patients diagnosed with HIV on treatment 36.00% (2018)9
S13.2 Percentage patients diagnosed with TB concluding treatment course 7.47% (2018)10

References
  • 1: El Congreso de la República de Guatemala. Ley del impuesto al valor agregado: Decreto número 27‐92 [Internet]. 1992. Available from: http://asisehace.gt/media/Ley IVA.pdf
  • 2: El Congreso de la República de Guatemala. Ley del impuesto al valor agregado: Decreto número 27‐92 [Internet]. 1992. Available from: http://asisehace.gt/media/Ley IVA.pdf
  • 3: Babio CQ. 48 precios para un ibuprofeno [Internet]. Plaza Pública. 2017 [cited 2018 Oct 25]. Available from: https://www.plazapublica.com.gt/content/48‐precios‐para‐un‐ibuprofeno
  • 4: Hernández M, Orozco A. Guatemala. Entre 25% y 50% sube costo de medicamentos [Internet]. La Prensa Libre. 2014 [cited 2018 Oct 25]. Available from: http://www.saludyfarmacos.org/lang/es/boletin‐farmacos/boletines/may2014/p2014364/
  • 5: IGSS. Listado de medicamentos: Presentación [Internet]. 2009 [cited 2018 Oct 25]. Available from: http://www.igssgt.org/images/medicamentos/01_Introduccion_Tabla_de_Contenido.pdf
  • 6: WHO. Guatemala Metropolitan Area‐STEPS 2015 Fact sheet [Internet]. 2015 [cited 2018 Oct 25]. Available from: https://www.who.int/ncds/surveillance/steps/STEPS_Guatemala‐Fact_Sheet‐ENG.pdf
  • 7: WHO. Guatemala Metropolitan Area‐STEPS 2015 Fact sheet [Internet]. 2015 [cited 2018 Oct 25]. Available from: https://www.who.int/ncds/surveillance/steps/STEPS_Guatemala‐Fact_Sheet‐ENG.pdf
  • 8: University of Wisconsin. Guatemala Opioid Consumption in Morphine Equivalence (ME) minus Methadone, mg per person [Internet]. 2015 [cited 2018 Oct 25]. Available from: http://www.painpolicy.wisc.edu/sites/default/files/country_files/morphine_equivalence_wo_methadone/guatemala_me.pdf
  • 9: ONUSIDA. Guatemala [Internet]. 2018 [cited 2018 Oct 25]. Available from: http://www.unaids.org/es/regionscountries/countries/guatemala
  • 10: MSPAS. Plan Estratégico Nacional de Control de la TB en Guatemala. http://www.paho.org/hq/dmdocuments/2009/PLAN%20ESTRATEGICO%20NACIONAL%20DE%20CONTROL%20DE%20LA%20TB %20EN%20GUATEMALA.doc