ABSTRACT

This study was aimed at analyzing the influence of lawsuits on the process of evaluating requests for the incorporation of biological medicines into the Unified Health System (SUS), by the National Committee for Health Technology Incorporation in SUS (Conitec), from 2010 to 2015. The research investigated the performance of Conitec focusing on the analysis of the recommendation of incorporation or not of biological medicines to SUS. The following were used as data collection strategies: document analysis, interviews with members of the Committee, and non-participant observation of the plenary meetings. The data analysis has shown that, although the lawsuits were often part of the plenary discussions, the existence of legal actions is not a decisive factor for the Committee’s decision-making. No evidence of a direct relationship between health lawsuits and the incorporation of biological medicines into SUS was found, as members strictly follow the technology incorporation flow as established by the Law No. 12.401/2011 and by Decree No. 7.646/201. However, the existence of an indirect influence of the phenomenon of health judicialization on the process of incorporation of technologies in SUS became evident when the motivations for the formulation of the law and the rules that regulate the operation of Conitec were analyzed.

KEY WORDS:
Biological products; Health’s judicialization; Unified Health System

Introduction

The technologies used to provide health assistance have been changing quickly in the last years. If on the one hand they bring undeniable benefits, related to the increase in longevity, prevention, disease healing, protection, and health rehab, on the other hand, they bring challenges related to the risks and the costs of their use¹1 Gadelha CAG, Maldonado J, Costa LS, et al. Complexo Produtivo da Saúde: inovação, desenvolvimento e Estado. In: Paim JS, Almeida-Filho N. Saúde Coletiva: teoria e prática. Rio de Janeiro: Medbook; 2014. p. 173-184..

As far as the industry is concerned, there are several production areas involved to meet the health needs. Gadelha and colleagues²2 Gadelha CAG, Barbosa PR, Maldonado J, et al. O Complexo Econômico-Industrial da Saúde: conceitos e características gerais. VPPIS/Fiocruz [internet]. 2010 ago [acesso em 2018 set 26]; 1(1):1-17. Disponível em: http://www.fiocruz.br/vppis/imagens/ceis/Boletim%20Complexo%20Saude%20Vol%201%202010.pdf.
http://www.fiocruz.br/vppis/imagens/ceis... classify the Economic-Industrial Health Complex (Complexo Econômico Industrial da Saúde, Ceis) in three segments: the one with chemical and biotechnology basis; the one with mechanic, electronic and material basis and the segment consisting of health services.

The high investments of the biochemical and biotechnological industry show that the biotechnologies are a great long-term bet, leading several countries to implement industrial policies that are active in the search for innovation in this area³3 Reis C, Pieroni JP, Souza JOB. Biotecnologia para saúde no Brasil. BNDES. 2010; 32:193-230.. The 20th century witnessed an extraordinary development of science and technology, and the convergence of both produced results in several productive sectors, such as that of health, with processes of medicine developments, vaccines, reactants for diagnosis and implants, representing an important advance in the treatment of several diseases⁴4 Malajovich MA. Biotecnologia 2011. Rio de Janeiro: Edições da Biblioteca Max Feffer do Instituto de Tecnologia ORT; 2012.^,55 Pimenta CG. O ambiente institucional da biotecnologia voltada para a saúde humana no Brasil [dissertação]. Brasília, DF: Universidade de Brasília; 2008. 133 p..

The biological medicines are defined as complex molecules of high molecular weight obtained from biological fluids, animal tissues or biotechnological procedures, through the manipulation or insertion of another genetic material or gene mutation due to irradiation, chemical products or forced selection⁶6 Torres-Freire C, Golcher D, Callil V. Biotecnologia em saúde humana no Brasil: produção científica e pesquisa e desenvolvimento. Novos Estudos. 2014 mar; 98:69-93.. Today, the registration of the biological medicines includes seven product categories, such as allergens, monoclonal antibodies, biomedicines, hemoderivatives, probiotics, hyperimmune serum and vaccines⁷7 Brasil. Ministério da Saúde. Agência Nacional de Vigilância Sanitária. Resolução - RDC nº 55, de 16 de dezembro de 2010. Dispõe sobre o registro de produtos biológicos novos e produtos biológicos e dá outras providencias. Diário Oficial da União. 17 Dez 2010..

In Brazil, the perspective of the increase in the demand for health services - together with the challenge of increasing the access of the population to technologies - suggests the existence of a great potential for increasing the use of biotechnology for health²2 Gadelha CAG, Barbosa PR, Maldonado J, et al. O Complexo Econômico-Industrial da Saúde: conceitos e características gerais. VPPIS/Fiocruz [internet]. 2010 ago [acesso em 2018 set 26]; 1(1):1-17. Disponível em: http://www.fiocruz.br/vppis/imagens/ceis/Boletim%20Complexo%20Saude%20Vol%201%202010.pdf.
http://www.fiocruz.br/vppis/imagens/ceis... . Therefore, it is important to establish a stable regulatory environment. The regulation of the development and the incorporation of new technologies into health and, especially of biological medicines, is essential to assure that the production meets the health needs at bearable costs to society.

The decision process related to the incorporation of technologies in the health systems is permeated by the influence of several groups of interests, such as: physicians, institutions that provide health services, financing institutions, policy and service managers, technology producers, patient associations, among others that can play decisive roles in decision-making⁸8 Scheffer MC. Aids, tecnologia e acesso sustentável a medicamentos: a incorporação dos anti-retrovirais no Sistema Único de Saúde [tese]. [São Paulo]: Faculdade de Medicina da Universidade de São Paulo; 2008. 255 p..

A study conducted in Europe⁹9 Schwarzer R, Siebert U. Methods, procedures, and contextual characteristics of health technology assessment and health policy decision making: comparison of health technology assessment agencies in Germany, United Kingdom, France, and Sweden. Int J Technol Assess Health Care. 2009; 25(3):305-314., focusing on England, France, Germany and Sweden, pointed out that the Health Technology Assessment (HTA) has played an increasing role in the health systems in the last years, with the establishment of agencies or programs to assess and incorporate health technologies. Although the countries studied share some purposes, there are differences in the way the HTA agencies and programs are organized, operate and influence decision-making. Despite these differences, all systems face opportunities and challenges related to the involvement and acceptance of the stakeholders¹⁰10 Caetano R, Silva RM, Pedro EM, et al. Incorporação de novos medicamentos pela Comissão Nacional de Incorporação de Tecnologias do SUS, 2012 a junho de 2016. Ciênc. Saúde Colet. [internet]. 2017 ago [acesso em 2018 out 01]; 22(8):2513-2525. Disponível em: http://www.scielo.br/scielo.php?pid=S1413-81232017002802513&script=sci_abstract&tlng=pt.
http://www.scielo.br/scielo.php?pid=S141... .

To regulate the incorporation of technologies in the Unified Health System (SUS), in 2011, by means of the Law No. 12.401¹¹11 Brasil. Ministério da Saúde. Lei nº 12.401, de 28 de abril de 2011. Dispõe sobre a assistência terapêutica e a incorporação de tecnologia em saúde no âmbito do Sistema Único de Saúde SUS. [internet]. 2011 [acesso em 2018 jun 29]. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2011-2014/2011/lei/l12401.htm.
http://www.planalto.gov.br/ccivil_03/_at... , the National Committee for Health Technology Incorporation in the Unified Health System (Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde, Conitec) was established. The Decree No. 7.646¹²12 Brasil. Ministério da Saúde. Decreto nº 7.646, de 21 de dezembro de 2011. Dispõe sobre a Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde e sobre o processo administrativo para incorporação, exclusão e alteração de tecnologias em saúde pelo Sistema Único de Saúde - SUS, e dá outras providências. [internet]. 2011 [acesso em 2018 jun 29]. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2011-2014/2011/decreto/d7646.htm.
http://www.planalto.gov.br/ccivil_03/_at... , of the same year, regulates the law, which mentions the permanent nature of the committee aimed at helping the Ministry of Health (MH) in the attributions related to the incorporation, exclusion or change of health technologies by SUS, as well as in the constitution or change of clinical protocols and therapeutic guidelines¹¹11 Brasil. Ministério da Saúde. Lei nº 12.401, de 28 de abril de 2011. Dispõe sobre a assistência terapêutica e a incorporação de tecnologia em saúde no âmbito do Sistema Único de Saúde SUS. [internet]. 2011 [acesso em 2018 jun 29]. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2011-2014/2011/lei/l12401.htm.
http://www.planalto.gov.br/ccivil_03/_at... ^,1212 Brasil. Ministério da Saúde. Decreto nº 7.646, de 21 de dezembro de 2011. Dispõe sobre a Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde e sobre o processo administrativo para incorporação, exclusão e alteração de tecnologias em saúde pelo Sistema Único de Saúde - SUS, e dá outras providências. [internet]. 2011 [acesso em 2018 jun 29]. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2011-2014/2011/decreto/d7646.htm.
http://www.planalto.gov.br/ccivil_03/_at... .

The increase in public expenses with medicines is partially due to the incorporation of new technologies into SUS. And the latter, on the other hand, may be associated with the phenomena of the judicialization of health. In the last seven years, the MH has spent R$ 4.5 billion to purchase medicines, equipment, dietary supplements and coverage for surgeries and hospital stays from court orders. Most of this amount was used to purchase biological medicines. In 2016, the MH spent R$ 654.9 million in the purchase of only 10 medicines for the treatment of 1,213 people¹³13 Pierro B. Demandas crescentes: parcerias entre instituições de pesquisa e a esfera pública procuram entender a judicialização da saúde e propor estratégias para lidar com o fenômeno. Rev. Pesquisa Fapesp. 2017; 18(252):18-25..

According to the data of the Secretariat of Science, Technology and Strategic Inputs (Secretaria de Ciência, Tecnologia e Insumos Estratégicos, SCTIE) of the MH, the real increase of the expenses with legal actions regarding medicines was of 547% between 2010 and 2016, from R$ 199.6 million to R$ 1.3 billion in 2016. The total expense was R$ 4.8 billion¹⁴14 Brasil, Ministério da Saúde. Relatório de gestão 2016. Brasília, DF: 2017.. It is worth mentioning that, in 2015, half of the twenty most expensive technologies requested to SUS through Court was not registered in the Brazilian Health Regulatory Agency (Anvisa), with emphasis to the requests for biological medicines¹⁵15 Vieira FS. Texto para discussão: Evolução do gasto com medicamentos do Sistema Único de Saúde no período de 2010 a 2016. Rio de Janeiro: Ipea; 2018..

In addition to lawsuits involving especially new and more expensive products, the technological incorporation may be a significant factor for the increase of the public expenses with medicines. A study has reported that, in the period between January 2012 and June 2016, of the 485 submissions to Conitec, 267 (55%) were related to requests for the incorporation of pharmaceutical products. Of 171 requests, 93 medicines (54%) were incorporated¹⁵15 Vieira FS. Texto para discussão: Evolução do gasto com medicamentos do Sistema Único de Saúde no período de 2010 a 2016. Rio de Janeiro: Ipea; 2018..

A research reported that, regarding the greatest public expenses with medicines, in 2016, the following were identified: a biological medicine that was bought due to lawsuits (eculizumab - R$ 376.6 million), two products incorporated to SUS (sofosbuvir16 - R$ 510.5 million; and vaccine against human papilloma virus 17 - R$ 288.4 million), three other biological medicines used mainly to treat arthritis rheumatoid (adalimumab - R$ 621.9 million; etanercept - R$ 322 million, and infliximab - R$ 298.5 million), and hemiderivative (factor VIII18 - R$ 471.5 million)¹⁰10 Caetano R, Silva RM, Pedro EM, et al. Incorporação de novos medicamentos pela Comissão Nacional de Incorporação de Tecnologias do SUS, 2012 a junho de 2016. Ciênc. Saúde Colet. [internet]. 2017 ago [acesso em 2018 out 01]; 22(8):2513-2525. Disponível em: http://www.scielo.br/scielo.php?pid=S1413-81232017002802513&script=sci_abstract&tlng=pt.
http://www.scielo.br/scielo.php?pid=S141... ^,1515 Vieira FS. Texto para discussão: Evolução do gasto com medicamentos do Sistema Único de Saúde no período de 2010 a 2016. Rio de Janeiro: Ipea; 2018..

Several studies have been performed to evaluate the effects of judicialization on health policies¹⁶16 Chieffi AL, Barata RB. Ações judiciais: estratégica da indústria farmacêutica para introdução de novos medicamentos. Rev. Saúde Pública. 2010; 44(3):421-429.

17 Lopes LC, Barberato-Filho S, Costa AC, et al. Uso racional de medicamentos antineoplásicos e ações judiciais no Estado de São Paulo. Rev. Saúde Pública. 2010; 44(4):620-628.

18 Diniz D, Medeiros M, Schwartz IDD. Consequências da judicialização das políticas de saúde: custos de medicamentos para as mucopolissacaridoses. Cad. Saúde Pública. 2012; 28(3):479-489.

19 Vieira FS. Ações judiciais e direito à saúde: reflexão sobre a observância aos princípios do SUS. Rev. Saúde Pública. 2008; 42(2):365-369.

20 Messeder AM, Osorio-de-Castro CGS, Luiza VL. Mandados judiciais como ferramenta para garantia do acesso a medicamentos no setor público: a experiência do Estado do Rio de Janeiro, Brasil. Cad. Saúde Pública. 2005; 21(5):525-34.

21 Torres IDC. Judicialização do acesso a medicamentos no Brasil: uma revisão sistemática [dissertação]. Salvador: Universidade Federal da Bahia, Instituto de Saúde Coletiva; 2013. 86 p.

22 Lisboa ES, Souza LEPF. Por que as pessoas recorrem ao Judiciário para obter o acesso aos medicamentos? O caso das insulinas análogas na Bahia. Ciênc. Saúde Colet. 2017; 22(6):1857-1864.^-2323 Guimarães R. Incorporação tecnológica no SUS: o problema e seus desafios. Ciênc. Saúde Colet. 2014; 19(12):4899-4908.. Researches point out a tendency to divert from the debate about the incorporation of technologies to the world of legal prosecution. In fact, in many countries, the decisions regarding the opportunity of incorporating a technology have increasingly been taken in the discourse and doctrinaire field of Law²⁴24 Machado MAA, Acurcio FA, Brandão CMR, et al. Judicialização do acesso a medicamentos no Estado de Minas Gerais, Brasil. Rev. Saúde Pública. 2011; 45(3):590-598..

In addition, the high number of lawsuits in health has led to the incorporation of some technologies, often high-cost ones, especially by state and municipal health secretariats in several regions in the country. It is worth mentioning that these cases do not deal with the incorporation into SUS as a whole, based on Conitec’s technical recommendation and on the decision of the MH²¹21 Torres IDC. Judicialização do acesso a medicamentos no Brasil: uma revisão sistemática [dissertação]. Salvador: Universidade Federal da Bahia, Instituto de Saúde Coletiva; 2013. 86 p.^,2323 Guimarães R. Incorporação tecnológica no SUS: o problema e seus desafios. Ciênc. Saúde Colet. 2014; 19(12):4899-4908.^,2424 Machado MAA, Acurcio FA, Brandão CMR, et al. Judicialização do acesso a medicamentos no Estado de Minas Gerais, Brasil. Rev. Saúde Pública. 2011; 45(3):590-598..

This article is aimed at analyzing the influence of lawsuits on the recommendation of the incorporation of biological medicines into SUS by Conitec.

Methodology

The influence of the legal decisions on the decision process related to the incorporation of the biological medicines into SUS in the 2011-2015 period was analyzed using the study case as a method. Conitec was taken as the case and the focus of analysis was the recommendation of the incorporation or not of the biological medicines into SUS.

For data production, official documents, semi-structured interviews with Conitec’s members and non-participant observation of the ordinary meetings of the Committee were used as sources of evidence. The documents selected for analysis were: the Law No. 12.401/2011, the Decree No. 7.508/2011, the Decree No. 7.646/2011, the Decree No. 8.065/2013, the Regulation GM/MS No. 152/2006, and official documents produced by Conitec - 44 meeting minutes of the committee, 54 technical reports of incorporation of biological medicines about the technology evaluated showing data on technology, the analysis of scientific evidence, the economic evaluation, the budget impact of the incorporation, Conitec’s decision, public consultation and the final deliberation. In addition, the set of norms regarding the Registration of the Biological Products was checked, and it shows the resolutions regarding biological products published by Anvisa.

Thirteen interviews with 13 members of Conitec were carried out after the interviewees have read and signed the Informed Consent Form. It is worth mentioning that the plenary of the Committee is a forum responsible for issuing the recommendation about incorporation, exclusion or change of technologies in the context of SUS, about the constitution or change of the clinical protocols and the therapeutic guidelines and the Brazilian National Relation of Essential Medicines (Relação Nacional de Medicamentos Essenciais, Rename)²⁵25 Brasil. Ministério da Saúde. Departamento de Assistência Farmacêutica e Insumos Estratégicos. Relação Nacional de Medicamentos Essenciais: RENAME 2017. Brasília, DF: Ministério da Saúde; 2017.. The issues were related to the routines, activities and work organization, and the relationship between the judicialization of biomedicines and Conitec’s decisions.

The non-participant observation of Conitec’s ordinary meetings took place between October 2015 and April 2016. More specifically, the 40th, 42nd and 44th meetings were attended, resulting in a total of 39 hours of observation. To process the empirical material from documents, interviews and observation, the technique of theme-based content analysis was used²⁶26 Bardin L. Análise de conteúdo. Lisboa: Edições 70; 2011.^,2727 Minayo MCS, Deslandes SF. Caminhos do pensamento - epistemologia e método. Rio de Janeiro: Fiocruz; 2010..

Regarding the ethical aspects, it is worth noting that the study was previously submitted and approved by the Research Ethics Committee of the Federal University of Bahia, under the protocol No. 022/2015, in compliance with the Resolution No. 466/2012²⁸28 Brasil. Ministério da Saúde. Conselho Nacional de Saúde. Resolução nº 466 de 12 de dezembro de 2012. Aprova as diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos. Brasília, DF; 2012..

Results

In the period analyzed (2012-2015), 168 medicines were evaluated by Conitec, of which 56 (33%) were biological medicines and 112 (67%) were other types of medicines. Of the 56 biological medicines, 22 (39%) were recommended for incorporation, 26 (47%) were not recommended to be incorporated and 8 (14%) were recommended to be excluded from the official distribution lists of SUS.

Conitec’s members that were interviewed were asked about their perceptions regarding health judicilization and the possibility that the legal demands on Conitec’s final decision have influence on the recommendation of the incorporation or non-incorporation of medicines into SUS, including biological medicines.

The recognition of the health judicialization was verified as a legitimate strategy to safeguard the social rights that may be guaranteed by the Federal Government, among them, the right to healthcare:

According to interviewee 8, health judicialization is twofold. On one hand, there is the ‘good judicialization’, represented by the legal demands of goods, actions or health services, which have to be formally offered by SUS, but, for some reason, are not being offered. According to this interviewee,

On the other hand, there is the ‘damaging judicialization’, when the legal actions require technologies and/or services that are not predicted in the system and that occasionally are not registered at Anvisa. This is damaging, as it involves expenses that are not predicted by the Federal, State and Municipal governments.

According to interviewee 3, the judicialization is usually used to promote an unregulated access or, at least, an easier access to new drugs, a strategy adopted by the pharmaceutical industry to promote the sale of its products. According to interviewee 1, it is common that companies that produce medicines that are judicialized do not demand Conitec’s evaluation, because they know the evidence is not good, the benefits are small and the price is too high. Therefore, it is better for the company to not have Conitec’s evaluation instead of a contrary recommendation, because the judge can eventually consult Conitec and see in the report the reasons why the technology was not incorporated into SUS.

Holding a similar opinion, interviewee 8 states that

In addition, interviewee 3 says:

These statements point to a possible effect of lawsuits in health in Brazil: the creation of a new way to incorporate technologies into the public health system. Indeed, health judicialization has enabled the demandants to have access to health goods and services, which are offered or not by the system.

In a scenario where there are several elements acting as pressure mechanisms on Conitec, all interviewees answered that the legal decisions in health do not influence the decision process of the committee. As interviewees 2, 4 and 10 state respectively:

Some interviewees admit that sometimes the topic ‘health judicialization’ is discussed in the plenary, especially in the evaluation of some technologies that have a high number of legal demands. Others think that Conitec could evaluate the technologies that are objects of lawsuits, until evidence can be provided on them, as stated by interviewee 5:

The case of the analog insulins, for example, observed in the meeting minutes, indicates that there is no influence of health judicialization on Conitec’s work. Despite the deep discussions regarding the judicialization of these insulins and the knowledge of the costs of its provision to the states and municipalities, “the use of the analog insulin is much more a question of the convenience of the use than the patient’s need”²⁹29 Brasil. Ministério da Saúde. Secretaria de Ciência Tecnologia e Inovação. Ata da 17ª Reunião da Conitec: Brasília, DF; 2013.⁽⁸⁾.

Facing the lack of evidence in the studies shown, one of the members of Conitec suggested that the reports that show that the analogs are not superior be sent to the Brazilian National Council of Justice (Conselho Nacional de Justiça, CNJ) to clarify the judges³⁰30 Brasil. Ministério da Saúde. Secretaria de Ciência Tecnologia e Inovação. Ata da 18ª Reunião da Conitec: Brasília, DF; 2013.. In the 20th meeting, the proposal was sent for public consultation with an unfavorable technical report regarding the incorporation of the analog insulin for Diabetes Mellitus into SUS. In addition, in the 24th meeting, the members of the plenary deliberated on the subject and they were unanimous in not recommending its incorporation³¹31 Brasil. Ministério da Saúde. Secretaria de Ciência Tecnologia e Inovação. Ata da 20ª Reunião da Conitec: Brasília, DF; 2013.^,3232 Brasil. Ministério da Saúde. Secretaria de Ciência Tecnologia e Inovação. Ata da 24ª Reunião da Conitec: Brasília, DF; 2014..

Another strong indication that there is no influence of the legal actions, regarding the incorporation of the biological medicines, was the consideration of the proposal of the incorporation of the Infliximab medicine, as mentioned in the following fragment of the meeting minute:

The third indication of the non-direct influence of judicialization on Conitec’s decision is related to the case of Trastuzumab. According to interviewee 1, in the case of the monoclonal antibody, there was a public civil action to incorporate the medicine throughout Brazil, for all the population diagnosed with breast cancer. Therefore, a consent decree was signed with the Court so that Conitec could evaluate this technology before the judge’s final decision. In this case, Conitec’s decision in recommending the incorporation was based on scientific evidence and economic evaluations, as shown in the report on the recommendation of Conitec’s incorporation. For this reason, it was possible to map which groups of the population with breast cancer would have access to the medicine and what would be the requirements to the manufacturer so that the biological medicine could be incorporated into SUS.

According to some interviewees, the fact that Conitec is quite heterogeneous in its composition - the Plenary consists of representatives of seven secretariats of the MH, the Brazilian Federal Medicine Council, the Brazilian National Health Council, the National Council of the Health Secretaries, the National Council of Municipal Secretariats, the Supplementary Health National Agency and Anvisa - which makes the decision-making process more balanced.

The diversity of individuals that are members of the Committee seems to facilitate the decision-making process at Conitec. According to the interviewees, it is exactly the diversity that provides balance and safety to the members of the Plenary, as several issues can be considered and clarified based on the opinion and knowledge of the stakeholders involved in the decision, which was also observed in the meetings.

Another element that can minimize the conflicts of interest of the potential stakeholders and, therefore, legitimate Conitec’s work is the transparency with which the actions are performed (required by the Law No. 12.401/2011 and the Decree No. 7.646/2011)¹¹11 Brasil. Ministério da Saúde. Lei nº 12.401, de 28 de abril de 2011. Dispõe sobre a assistência terapêutica e a incorporação de tecnologia em saúde no âmbito do Sistema Único de Saúde SUS. [internet]. 2011 [acesso em 2018 jun 29]. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2011-2014/2011/lei/l12401.htm.
http://www.planalto.gov.br/ccivil_03/_at... ^,1212 Brasil. Ministério da Saúde. Decreto nº 7.646, de 21 de dezembro de 2011. Dispõe sobre a Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde e sobre o processo administrativo para incorporação, exclusão e alteração de tecnologias em saúde pelo Sistema Único de Saúde - SUS, e dá outras providências. [internet]. 2011 [acesso em 2018 jun 29]. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2011-2014/2011/decreto/d7646.htm.
http://www.planalto.gov.br/ccivil_03/_at... . Thus, the entire process of technology incorporation is of public access and sent to public consultation before the final decision.

Discussion

The analysis of the interviews, meeting minutes and reports, in addition to what was observed in Conitec’s meetings, revealed that, although the existence of legal actions regarding the incorporation of technologies is usually part of the discussions of the plenary, this is not a decisive factor for the Committee’s decision making. On the contrary, this study showed that Conitec’s members follow strictly the flow of technology incorporation regulated by the Law No. 12.401/2011, Decree No 7.646/2011 and by the Committee’s internal regulation.

However, although no evidence of direct influence of lawsuits on Conitec’s decision regarding the incorporation of biological medicines into SUS was found, it became clear that the health judicialization topic is much present in the Committee’s discussions.

Some studies point out the existence of a relationship between the number of lawsuits that require medicines and their incorporation into SUS and conclude that health judicialization, as it has a great interference in the health policies, has been transformed into pressure on the public sector to incorporate drugs¹⁸18 Diniz D, Medeiros M, Schwartz IDD. Consequências da judicialização das políticas de saúde: custos de medicamentos para as mucopolissacaridoses. Cad. Saúde Pública. 2012; 28(3):479-489.^,2121 Torres IDC. Judicialização do acesso a medicamentos no Brasil: uma revisão sistemática [dissertação]. Salvador: Universidade Federal da Bahia, Instituto de Saúde Coletiva; 2013. 86 p.^,2323 Guimarães R. Incorporação tecnológica no SUS: o problema e seus desafios. Ciênc. Saúde Colet. 2014; 19(12):4899-4908..

The findings of this study, which show that there is no direct influence of lawsuits on the decisions of recommendation of incorporation or non-incorporation of biological medicines, can be seen as an evidence that the robust legislation regarding the incorporation of health technologies and its strict observance by the members of Conitec, in the period analyzed, are due to initiatives and behaviors adopted, in a certain manner, as strategies of protection against illegitimate influences that sometimes turn into legal actions.

Thus, Conitec is able to concentrate its attention and base its decisions on the results of the studies on the evaluation of health technology, the analysis of cost-effectiveness and the budget impact, recommending only the incorporation of safe and effective technology into SUS, and with the best cost-effectiveness relationship.

In this sense, it is possible to identify the existence of an indirect influence of the health judicialization on the process of technology incorporation into SUS when the motivations for the law formulation and the rules that regulate how Conitec works are considered and when the concern of Conitec’s decision makers to truly respect the legal norms and avoid the illegitimate influences are identified.

The Health Open Court, called in 2009 by the Federal Supreme Court, has definitely stimulated the approval of the Law No. 12.401/2011, as the necessity of the formalization of the process of technology incorporation into SUS was extensively discussed, which made things more transparent, with the possibility of a greater participation of the SUS users in the decisions³⁴34 Terrazas FV. Novos elementos no cenário da judicialização da saúde: análise das decisões dos Tribunais Superiores. In: Santos L, Terrazas FV. Judicialização da Saúde no Brasil. Campinas: Saberes Editora; 2014. p. 307-330.^,3535 Balestra Neto O. A jurisprudência dos tribunais superiores e o direito à saúde - evolução rumo à racionalidade. Rev. Direito Sanitário. 2015; 16(1):87-111.. This open court was especially aimed at promoting the social participation through the testimony of the authorities and stakeholders, thereby contributing to the development of technical, scientific, management, political and economic issues involved in the legal decisions about health³⁵35 Balestra Neto O. A jurisprudência dos tribunais superiores e o direito à saúde - evolução rumo à racionalidade. Rev. Direito Sanitário. 2015; 16(1):87-111..

Another evidence of influence of the phenomena of health judicialization about the definition of the process of technology incorporation into SUS is related to two initiatives established in 2010 by the Institution.

The first initiative is related to the Recommendation No. 31/2010³⁶36 Conselho Nacional de Justiça. Recomendação nº 31 de 30 de março de 2010. Recomenda aos tribunais a adoção de medidas visando melhor subsidiar os magistrados e demais operadores de direito, para assegurar maior eficiência na solução das demandas judiciais envolvendo assistência à saúde. Brasília, DF [internet]. 2010 [acesso em 2018 nov 13]. Disponível em: http://www.cnj.jus.br/files/atos_administrativos/recomendao-n31-30-03-2010-presidncia.pdf.
http://www.cnj.jus.br/files/atos_adminis... , which guides the courts from all over the country to adopt a series of measures to support judges and other law operators in order to assure a greater efficiency in the solution of the legal demands regarding health law.

The other initiative of the CNJ was the creation of the National Court Forum to ‘monitor and meet the health assistance demands’ and to create concrete measures aimed at the optimization of the procedural routines, as well as the structuring and organization of the specialized court units through the Resolution No. 107³⁷37 Conselho Nacional de Justiça. Resolução nº 107, de 2010. Institui o Fórum Nacional do Judiciário para monitoramento e resolução das demandas de assistência à saúde. [internet]. 2010 [acesso em 2018 jun 29]. Disponível em: http://www.cnj.jus.br/files/atos_administrativos/resoluo-n107-06-04-2010-presidncia.pdf.
http://www.cnj.jus.br/files/atos_adminis... .

In general, the recommendations of the CNJ guide de approximation between the fields of law and health.

In fact, at least partially, because of the recommendations, Conitec has been closer to Court. Therefore, among other strategies, it has promoted actions aimed at providing information for the decision making of the judges. One of these actions is the partnership established between Conitec and the CNJ, which resulted in the creation of a direct channel (conitec@saude.gov.br) to answer the questions of the judges about medicine, product or procedure incorporation into SUS.

Conitec’s 2012-2014³⁸38 Brasil. Balanço Conitec 2012-2014. Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Comissão Nacional de Incorporação de Tecnologias no SUS. [internet] 2014 [acesso em 2018 jun 29]. Disponível em: http://conitec.gov.br/images/Artigos_Publicacoes/BalancoCONITEC.pdf.
http://conitec.gov.br/images/Artigos_Pub... Balance Sheet informs that the responses to the questions from the Federal Prosecution Office and bodies from the Court, regarding the incorporation of technologies into SUS, is a daily job performed by the Executive Secretariat. From January 2012 to August 2014, 701 questions were answered.

Another strategy to get closer to Court is to make the technical reports about health technologies available at Conitec’s site, with the purpose of helping the decisions of the judges. Nowadays, 77 technical reports of several health technologies are available at Conitec’s site (www.conitev.gov.br), 23 of which are about biological medicine. These technical reports have information about medicines and products for health, regarding the availability or not of the technology by SUS, the recommendation or not of its incorporation, the treatment cost, the existence of alternatives in the health public system and the availability or not of the Clinical Protocols and Therapeutic Guidelines for the related clinical situation.

A third initiative undertaken by Conitec to get closer to Court has been the participation of its members in events promoted by the Health Executive Committees, created after CNJ’s recommendation. In addition, Conitec has participated regularly, together with the Legal Consultancy of the MH in several courts in the Federal Prosecution Office and Court to deal with topics about the incorporation of technologies in health.

Because of the complexity of the object of investigation of this study, it was not possible to explore all the possibilities related to the influence of lawsuits regarding biological medicines in the recommendation of their incorporation into SUS by Conitec. Therefore, the conduction of new studies is necessary to try to fill in the following gaps: to follow the incorporation and availability of the biological medicines to SUS users, to evaluate the changes in the Clinical Protocols and in the Therapeutic Guidelines, to update the Rename and to evaluate the deadlines to make the medicine available at SUS. Another possibility of the study is related to the comparison of the number of legal actions in health to require biological medicines to SUS before and after their incorporation into the system.

Conclusions

In the face of the phenomenon of judicialization and its several political, economic, ethical, technical and sanitary aspects, and due to the lack of consensus on the effects of legal actions on the health public system and on the ways of facing the phenomenon among managers, law operators, doctors and the researchers of the topic, as well as due to the market interests behind the legal actions that require health goods and services, we can see that Conitec’s operation is regulated by laws and decrees aimed at protecting the process of incorporation of technologies of illegitimate influences for the incorporation of technologies into SUS, including when they become legal demands. In addition, it is noticeable that Conitec’s members are concerned about following the laws.

Thus, it is possible to conclude that the phenomenon of health judicialization does not influence directly Conitec’s decision-making process aimed at incorporating technologies into SUS, including the biological medicines. However, such phenomenon has indirectly influenced the process of health technology incorporation in the context of SUS, through the elaboration of a solid legal framework by the managers, consisting of laws, decrees and rules, as a way of protecting against the pressure that can be exerted by several interests, including by means of lawsuits.

References

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