TY - JOUR
T1 - Policy Change and the National Essential Medicines List Development Process in Brazil between 2000 and 2014
T2 - Has the Essential Medicine Concept been Abandoned?
AU - Osorio-de-Castro, Claudia G.S.
AU - Azeredo, Thiago B.
AU - Pepe, Vera L.E.
AU - Lopes, Luciane C.
AU - Yamauti, Sueli
AU - Godman, Brian
AU - Gustafsson, Lars L.
N1 - Funding Information:
Health Council and the National Physician’s Council, the States’ Health Secretaries National Council, the Municipalities’ Health Secretaries National Council, the National Health Agency and the National Health Surveillance Agency. The Conitec Secretariat: officials from the Department of Health Technology (DGITS). Partners (institutional): healthcare institutions, universities, Health Technology Assessment (HTA) networks.
Funding Information:
The corresponding author is endowed with a Brazilian National Research and Development Council fund (number 304975/2016-8). No writing assistance was utilized in the production of this manuscript. The corresponding author is endowed with a Brazilian National Research and Development Council fund (number 304975/2016-8). Details of author contributions include the following: Claudia Garcia Serpa Osorio-de-Castro, Thiago Botelho Azeredo, Luciane Cruz Lopes and Vera L?cia Edais Pepe participated in the study design including the analysis of Brazilian policies, drafting and revising the manuscript. Claudia Garcia Serpa Osorio-de-Castro, Thiago Botelho Azeredo, Vera L?cia Edais Pepe, Luciane Cruz Lopes and Sueli Yamauti provided critical input regarding the development of the national EML in Brazil including the various processes and stages. Brian Godman and Lars L. Gustafsson were involved in final drafting and critically revising the manuscript. All authors read and approved the final manuscript.
Funding Information:
1Department of Pharmaceutical Policy and Pharmaceutical Services, Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil, 2Medicines Use and Surveillance Observatory, School of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil, 3Department of Health Administration and Planning, Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil, 4Pharmaceutical Science Graduate Course, University of Sorocaba, Sorocaba, Brazil, 5Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden and 6Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK
Funding Information:
Funding The corresponding author is endowed with a Brazilian National Research and Development Council fund (number 304975/2016-8).
Funding Information:
Conitec membership is dual. The Plenary Committee is composed by members from the seven MoH secretariats, the National Health Council and the National Physician’s Council, the States’ Health Secretaries National Council, the Municipalities’ Health Secretaries National Council, the National Health Agency and the National Health Surveillance Agency. The Conitec Secretariat is composed exclusively by officials from the DGITS. The Secretariat prepares the technical documentation and invites partners for research and drafting of reports and reviews. The Plenary Committee members make recommendation based on their reports, but the final decision, after public consultation or public audience, belongs to the MoH’s SCTIE Secretary.
Funding Information:
Author for correspondence: Claudia G. S. Osorio-de-Castro, Department 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.
Publisher Copyright:
© 2017 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society)
PY - 2018/4
Y1 - 2018/4
N2 - 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 political 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, presented consequences to the health system. Substantial efforts were made to produce and update the list from 2000 to 2014. However, continuous and intense health litigation disproves process outcome effectiveness.
AB - 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 political 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, presented consequences to the health system. Substantial efforts were made to produce and update the list from 2000 to 2014. However, continuous and intense health litigation disproves process outcome effectiveness.
UR - http://www.scopus.com/inward/record.url?scp=85037370662&partnerID=8YFLogxK
U2 - 10.1111/bcpt.12932
DO - 10.1111/bcpt.12932
M3 - Article
C2 - 29117642
AN - SCOPUS:85037370662
SN - 1742-7835
VL - 122
SP - 402
EP - 412
JO - Basic and Clinical Pharmacology and Toxicology
JF - Basic and Clinical Pharmacology and Toxicology
IS - 4
ER -