Policy Change and the National Essential Medicines List
Development Process in Brazil between 2000 and 2014: Has the
Essential Medicine Concept been Abandoned?
Claudia G. S. Osorio-de-Castro
1,
*, Thiago B. Azeredo
2
, Vera L. E. Pepe
3
, Luciane C. Lopes
4
, Sueli Yamauti
4
, Brian Godman
5,6,
* and
Lars L. Gustafsson
5
1
Department of Pharmaceutical Policy and Pharmaceutical Services, Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation,
Rio de Janeiro, Brazil,
2
Medicines Use and Surveillance Observatory, School of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro,
Brazil,
3
Department of Health Administration and Planning, Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation, Rio de
Janeiro, Brazil,
4
Pharmaceutical Science Graduate Course, University of Sorocaba, Sorocaba, Brazil,
5
Division of Clinical Pharmacology,
Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden and
6
Strathclyde Institute of Pharmacy and Biomedical
Sciences, University of Strathclyde, Glasgow, UK
(Received 17 August 2017; Accepted 27 October 2017)
Abstract: Brazil has had a National Essential Medicines List (EML) since 1964. From 2000 to 2010, five consecutive evidence-
based editions were produced, building on the essential medicine concept. In 2012, the government changed course to establish a
new paradigm, introducing adoption of new medicines as the main aim within the recommendation process. The objective of the
article was to report efforts to develop Brazil’s national EML, policy changes from 2000 to 2014, discussing results, challenges
and perspectives. Brazilian EML history and development process were collected from legislation, minutes, reports and legal
ordinances, from 2000 to 2014. The Brazilian EML and the WHO Model Lists were compared using the Anatomical Therapeutic
Chemical system. Overlap between lists was verified, and linear trends were produced. Type of membership, inclusion criteria,
procedures, flow and listed medicines varied greatly between the selection committees acting before and after 2012. Paradigm-
changing legislation aiming at linking list compliance to public financing in 2012 produced (i) greater importance given to politi-
cal and administrative stakeholders, (ii) increasing trends in number of medicines over the years, (iii) decrease in use of WHO
Model List as a reference and (iv) substitution of an essential medicines list review and update process by an adoption decision
output. Other issues remained unchanged. Insufficient efforts for list implementation, such as lack of physician education, pre-
sented consequences to the health system. Substantial efforts were made to produce and update the list from 2000 to 2014. How-
ever, continuous and intense health litigation disproves process outcome effectiveness.
Since the late 1970s, the essential medicine concept has guided
health systems to adopt rational therapeutic choices of medici-
nes in clinical practice. Essential medicines lists (EMLs) are a
necessary strategy to foster cost-effective therapy, rational use
of medicines and evidence-based learning in health systems
[1,2]. However, worldwide trends show that essential medicines
lists are succumbing to new postulates related to rapid uptake of
new medicines and the WHO Model List is no exception [3].
Protection of individuals and health systems from financial bur-
dens are viewed as key to essential medicine characterization
and policy in many countries [4–7], but is especially challeng-
ing in middle- and low-income countries [8].
In Brazil, the Federal Constitution grants health as a right
and regulates, through policies, that public institutions take
responsibility to ensure that essential health services are
provided to all Brazilians (http://www.planalto.gov.br/ccivil_
03/Constituicao/Constituicao.htm/July 2017) [8]. Universal
access, comprehensive care, equity and public control of the
Brazilian Health System are policy landmarks (http://www.pla
nalto.gov.br/ccivil_03/leis/L8080.htm/July 2017) [8]. Federal
and regional governments must uphold patients’ individual
rights, while coping with the financial pressures from the
introduction of technological innovations [9,10]. While
expanding access to new medicines, lack of their timely deliv-
ery by local governments, market pressures and less than
rational prescribing have caused increasing numbers of judicial
demands based on the right to new treatment options [2,11].
The rising costs of new medicines have increased healthcare
expenditures across countries (http://www.oecd.org/els/health-
systems/49105858.pdf/July 2017) [8,12,13], with growth rates
in Brazil matching other countries, in the last 15 years
[14,15].
Since 1964, Brazil has a national EML, known as
‘Rename’,(Relac
ß
~
ao Nacional de Medicamentos Essenciais).
With the introduction of the National Medicines Policy (http://
bvsms.saude.gov.br/bvs/saudelegis/gm/1998/prt3916_30_10_
1998.html/July 2017) [8] in 1998, Rename became the angular
strategy for managing medicines’ supply and utilization. A
Rename evidence-based edition was launched in 2000 after
18 years without a coherent list review process [16]. Follow-
ing this, states and municipalities also began drafting Rename-
based lists. In 2001, for the first time, a Brazilian EML
Author for correspondence: Claudia G. S. Osorio-de-Castro, Depart-
ment of Pharmaceutical Policy and Pharmaceutical Services, Sergio
Arouca National School of Public Health, Rua Leopoldo Bulhoes
1480, Oswaldo Cruz Foundation, Brazil (e-mail: claudia.osorio@ensp.
fiocruz.br).
*Guarantors of the paper. I affirm together with Brian Godman that
the manuscript is an honest, accurate and transparent account of the
activities being reported and that no important aspects of the various
activities have been omitted.
© 2017 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society)
Basic & Clinical Pharmacology & Toxicology, 2018, 122, 402–412 Doi: 10.1111/bcpt.12932
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