Guillermo Sanchez Vanegas, MD, MSc PhD, Executive Director, Institute of Health Technology Assessment in Bogota, Colombia
According to a recent report published by the Organization for Cooperation and Economic Development (OCED), health coverage indicators show a remarkable breakthrough, reaching a level in which more than 97% of the population is insured, a situation where the country is technically known as being universally covered, and that contrasts with the 1991 figures, where only 1 in 6 citizens had some form of health insurance (1).
On the other hand, it is worth noting that according to a recent study from the Bank of the Republic, Colombia has gone from having out-of-pocket expenses greater than 50% in 1993, to a level of 15.9% in 2015, a figure that is well below the Latin American average (36.7%) and that is also less than the world average (20.4%) (2).
These advances in the Colombian health care system generate institutional challenges in order to ensure that the population has access to health care technologies that have proven to be safe and effective in a sustainability scenario. It is in this context that Colombia made strides in public policies and strategies to rationalize the expense, ensuring equitable and timely access to technologies that have shown benefits for the population through scientific evidence. This interest was reflected in the health care reform carried out in 2011, signed through Law 1438 (Chapter V, Article 92) where it was authorized by the former Ministry of Social Protection to create the Institute of Health Technology Assessment (3). After this legislature, the Inter-American Development Bank, in the context of an institutional strengthening project to support the processes of health care priority setting in Colombia, produced a document called “Recommendation for Structuring an Institute of Health Technology Assessment : The Case of Colombia”, which presented, based on an international benchmarking exercise in the Colombian health care system, a series of recommendations for the government on how to design and implement the Health Technology Evaluation Institute. The vast majority of the recommendations proposed were accepted and implemented once the agency began its work. The creation of a national institute dedicated to health technology evaluation was a clear sign of having understood the need to incorporate in health care decision making, technical judgment based on solid scientific evidence, that carry a sense of legitimacy from the social point of view.
In November 2012 after a complex process, the Institute of Health Technology Assessment (IETS) was finally launched, which to date has developed 148 health technology assessments, including medications (81%), diagnostic tests (14%), procedures (3%), and devices (2%). While institutionalizing the health technology assessment, IETS has been a key player in the national development process of clinical practice guidelines, where it has accompanied the development of more than 40 guidelines and developed 10 “in-house” national guidelines.
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Within three years of work, IETS has contributed to helping key players in the system know and understand the role of the health technology assessment, in the context of informed decision making and its value as a strategy to increase the capacity of discernment of the government body. Also, technology assessments and clinical practice guidelines have been essential to update the mandatory health plan (MHP) and adjust the payment unit for training (PUT). However, challenges for the country and IETS, insofar as technology assessment is concerned are the order of the day and at this time are linked to two key milestones for the health of the country: Statutory Law 1751 of 2015 (4) and the National Development Plan 2014-2018 (5).
Article 15 of the Statutory Law, states that: “The system shall ensure the basic right to health through the provision of services and technologies, structured on a holistic conception of health that includes its promotion, prevention, administration, care of the illness and rehabilitation from its after-effects.” (4). The same article also states that they may not use public resources to finance services or technologies that meet the following criteria:
- That they have as a principal purpose a cosmetic or sumptuary purpose not related to the recovery or maintenance of the functional or vital training of persons.
- That there is no scientific evidence regarding its safety and clinical efficacy.
- That there is no scientific evidence regarding its clinical effectiveness.
- That its use has not been authorized by the competent authority.
- That it is in the experimentation
- They have to be provided
According to Law 1751, services or technologies that comply with these criteria should be explicitly excluded by the Ministry of Health.
This Law reinforces the basic role of technology assessment and makes it clear that for the Colombian population, an institution like IETS is key to ensuring the basic right to health, through solid processes from a methodological point of view, which contributes to the legitimate construction of the yes or no. Against this ongoing challenge, in the last three years, the Institute has been working on strengthening methods, defining processes and increasing its present capacity to meet the country’s demands.
The second milestone that I want to note is the National Development Plan 2014-2018 and specifically Article 72 which challenges that: “The assessment that the Institute of Health Technology Assessment (IETS) performs on medications and medical devices defined by the Ministry of Health and Social Protection (MSPS) and the price that this ministry determines based on that evaluation, shall be required for the issuance of the corresponding health registry and/or its renewal by the National Institute for Drug and Food Surveillance (Invima). The process for determining price mentioned in this article is completed simultaneously with the health registry process at Invima.”(5)
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This new legislation reaffirms the role that IETS has and shall have relating to access of the population to technologies with evidence on effectiveness and safety, at a reasonable cost for the Colombian society, in a way that ensures the basic right to health. It is worth noting that IETS has the challenge of maintaining standards that Invima already has for obtaining health care registry by interested parties, and it is expected that the related processes maintain the same time periods enforced until now. Mechanisms, procedures, definitions, and the regulation process of Article 15 are subject to inter-institutional work in progress, with the participation of the Ministry of Health and Social Protection, Invima, the Ministry of Finance, the National Planning Departments, IETS, academia, and other related key players.
Based on the stated context, we see that in the country the need to institutionalize and strengthen health technology assessment is understood, and in that sense, Colombia has been advancing with firm steps, articulating legal support, with the infrastructure required in responding to challenges that arise from efficient use of health technology. Despite advances, we are aware of the current challenges and those ahead. It is important to continue working on consolidating high level technical equipment, strengthening relations between academia and scientific societies, and the technology assessment agency, and ensuring necessary resources so that the technology assessment maintains a high technical-level standing and independence that confers legitimacy. Finally, despite the challenges, we are optimistic about the support that technology assessment, and specifically IETS, can provide to make progress towards the triple goal–care, health and cost― (6), providing high-quality evidence so that Colombians can access effective, safe, and quality medicine based on scientific evidence, supporting the sustainability of the system and contributing to the preservation of the universally achieved coverage.
- OECD Reviews of Health Systems: Colombia, 2016. Available from: http://www.oecd.org/countries/colombia/oecd-reviews-of-health-systems-colombia-2015-9789264248908-en.htm.
- Pérez G, Silva A. Una mirada a los gastos de bolsillo en salud para Colombia (A look at pocket expenses in health for Colombia) | Banco de la República (banco central de Colombia) (Bank of the Republic (central bank of Colombia)). Banco de la República, 2015.
- Ley 1438 Reforma Del Sistema De Seguridad Social En Salud (Law 1438 From the Social Safety System in Health), (2011).
- Ley Estatutaria (Statutory Law) 1751, (2015).
- Ley 1753 de 2015: Plan Nacional de Desarrollo (National Development Plan) 2014-2018 “Todos por un nuevo país (All for a new country)”. (2015).
- Berwick DM, Nolan TW, Whittington J. The Triple Aim: Care, Health, and Cost. Health Affairs. 2008-05-01;27(3):759-69. en.