Judicialization and right to health in Brazil: a trajectory of matches and mismatches

Vieira, Fabiola Sulpino

doi:10.11606/s1518-8787.2023057004579

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Comment • Rev. Saúde Pública 57 • 2023 • https://doi.org/10.11606/s1518-8787.2023057004579 copy

Judicialization and right to health in Brazil: a trajectory of matches and mismatches

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ABSTRACT

This study discusses the impacts of judicialization on the guarantee of the right to health in Brazil and the need to reassess the role of the Judicial system in its protection. We used evidence from the technical-scientific literature and information on the budgetary-financial execution and the acquisition of medicines from the Brazilian Ministry of Health to substantiate the arguments. In 2019, lawsuits consumed 25.2% of the resources of the Specialized Component of Pharmaceutical Care, 21% for 10 medicines. Although the Judicial promotes this right when the State fails to ensure access to medicines incorporated into the Brazilian Unified Health System (SUS), this system compromises access to medicines of the population with the determinations of acquisition of non-incorporated products. The Judicial needs to guide its control over compliance with constitutional and legal precepts in public policies, especially in fiscal policy, given its impact on the financing of the SUS.

Health’s Judicialization; Access to Essential Medicines and Health Technologies; Equity in the Resource Allocation; Unified Health System; Right to Health

Year	Judicialized medicines		10 medicines with the greatest budgetary impact
Year	Number of items	Total expenditure (R$ of 2020)	Name	Incorporation	Indication	Expenditure on the item (R$ of 2020)	Expenditure on ten medicines (R$ 2020)	% of spending on the ten medicines in the total spending
2016	676	1,436,444,910	1. eculizumab 10 mg/ml	2018 (Ordinance no. 77, of 12/14/2018)	Paroxysmal nocturnal hemoglobinuria	717,149,490	1,307,172,609	91.0
			2. galsulfase 1 mg/ml	2018 (Ordinance no. 83, of 12/19/2018)	Mucopolysaccharidosis type VI	145,918,651
			3. elosulfase alfa 1 mg/ml	2018 (Ordinance no. 82, of 12/19/2018)	Mucopolysaccharidosis type IVA (Morquio Syndrome A)	107,462,354
			4. galsulfase 2 mg/ml	2017 (Ordinance no. 62, of 12/19/2017)	Mucopolysaccharidosis type II	83,442,677
			5. alfagalsidase 1 mg/ml	Not incorporated (decision not to incorporate Ordinance no. 56, of 11/23/2020)	Fabry disease	80,920,978
			6. ataluren 250 mg	Not incorporated (no evaluation by Conitec)	Duchenne Muscular Dystrophy	55,633,789
			7. agalsidase beta 35 mg	Not incorporated (decision not to incorporate Ordinance No. 56, of 11/23/2020)	Fabry disease	37,717,391
			8. metreleptin 11.3 mg	Not incorporated and without registration with Anvisa	Congenital or acquired generalized lipodystrophy	32,054,438
			9. lomitapide 10 mg	Not incorporated (no evaluation by Conitec)	Familial hypercholesterolemia	23,927,105
			10. human C1 esterase inhibitor 500 IU	Not incorporated (no evaluation by Conitec)	Hereditary angioedema type I and II	22,945,735
2017	508	1,085,490,298	1. eculizumab 10 mg/ml	2018 (Ordinance No. 77, of 12/14/2018)	Paroxysmal nocturnal hemoglobinuria	296,462,726	981,720,251	90.4
			2. galsulfase 1 mg/ml	2018 (Ordinance No. 83, of 12/19/2018)	Mucopolysaccharidosis type VI	176,252,001
			3. elosulfase alfa 1 mg/ml	2018 (Ordinance No. 82, of 12/19/2018)	Mucopolysaccharidosis type IVA (Morquio Syndrome A)	101,093,948
			4. alfagalsidase 1 mg/ml	Not incorporated (decision not to incorporate Ordinance No. 56, of 11/23/2020)	Fabry disease	100,592,156
			5. ataluren 250 mg	Not incorporated (no evaluation by Conitec)	Duchenne Muscular Dystrophy	84,746,590
			6. idursulfase 2 mg/ml	2017 (Ordinance No. 62, of 12/19/2017)	Mucopolysaccharidosis type II	61,684,075
			7. agalsidase beta 35 mg	Not incorporated (decision not to incorporate Ordinance No. 56, of 11/23/2020)	Fabry disease	54,882,175
			8. ataluren 1000 mg	Not incorporated (no evaluation by Conitec)	Duchenne Muscular Dystrophy	39,848,443
			9. alpha-glucosidase 50 mg	2019 (Ordinance No. 48, 10/16/2019)	Pompe disease	33,258,882
			10. metreleptin 11.3 mg	Not incorporated and without registration with Anvisa	Congenital or acquired generalized lipodystrophy	32,899,255
2018	332	1,495,905,549	1. eculizumab 10 mg/ml	2018 (Ordinance No. 77, of 12/14/2018)	Paroxysmal nocturnal hemoglobinuria	478,746,855	1,364,024,905	91.2
			2. galsulfase 1 mg/ml	2018 (Ordinance No. 83, of 12/19/2018)	Mucopolysaccharidosis type VI	164,038,893
			3. idursulfase 2 mg/ml	2017 (Ordinance No. 62, of 12/19/2017)	Mucopolysaccharidosis type II	124,079,026
			4. nusinersen 2.4 mg/ml	2021 (Ordinance No. 26, of 6/1/2021)	Spinal muscular atrophy 5q type II, diagnosed up to 18 months of age	124,045,961
2018	332	1,495,905,549	5. elosulfase alfa 1 mg/ml	2018 (Ordinance No. 82, of 12/19/2018)	Mucopolysaccharidosis type IVA (Morquio Syndrome A)	112,287,809	1,364,024,905	91.2
			6. alfagalsidase 1 mg/ml	Not incorporated (decision not to incorporate Ordinance No. 56, of 11/23/2020)	Fabry disease	105,496,952
			7. ataluren 250 mg	Not incorporated (no evaluation by Conitec)	Duchenne Muscular Dystrophy	100,947,361
			8. ataluren 1,000 mg	Not incorporated (no evaluation by Conitec)	Duchenne Muscular Dystrophy	55,002,927
			9. agalsidase beta 35 mg	Not incorporated (decision not to incorporate Ordinance No. 56, of 11/23/2020)	Fabry disease	53,825,639
			10. alpha-glucosidase 50 mg	2019 (Ordinance No. 48, 10/16/2019)	Pompe disease	45,553,481
2019	284	1,004,114,249	1. eculizumab 10 mg/ml	2018 (Ordinance No. 77, of 12/14/2018)	Paroxysmal nocturnal hemoglobinuria	467,571,795	950,325,051	94.6
			2. elosulfase alfa 1 mg/ml	2018 (Ordinance No. 82, of 12/19/2018)	Mucopolysaccharidosis type IVa (Morquio Syndrome A)	190,076,099
			3. alfagalsidase 1 mg/ml	Not incorporated (decision not to incorporate Ordinance No. 56, of 11/23/2020)	Fabry disease	105,003,061
			4. nusinersen 2.4 mg/ml	2021 (Ordinance No. 26, of 6/1/2021)	Spinal muscular atrophy 5q type II	87,703,893
			5. galsulfase 1 mg/ml	2018 (Ordinance No. 83, of 12/19/2018)	Mucopolysaccharidosis type VI	54,288,525
			6. metreleptin 11.3 mg	Not incorporated and without registration with Anvisa	Congenital or acquired generalized lipodystrophy	21,533,960
			7. eteplirsen 50 mg/ml	Not incorporated and without registration with Anvisa	Duchenne Muscular Dystrophy	8,324,480
			8. sebelipase alfa 2 mg/ml	Not incorporated (no evaluation by Conitec)	Lysosomal acid lipase deficiency	6,308,632
			9. brentuximab vedotin 50 mg	2019 (Ordinance No. 12, of 3/11/2019)	Hodgkin’s lymphoma cd30+	5,976,991
			10. mercaptamine 75 mg	Not incorporated and without registration with Anvisa	Nephropathic cystinosis	3,537,616
2020	678	592,320,679	1. eculizumab 10 mg/ml	2018 (Ordinance No. 77, of 12/14/2018)	Paroxysmal nocturnal hemoglobinuria	220,640,260	484,460,069	81,8
			2. ataluren 250 mg	Not incorporated (no evaluation by Conitec)	Duchenne Muscular Dystrophy	107,559,900
			3. clozapine 100 mg	2015 (Ordinance No. 3, of 3/9/2015) and 2016 (Ordinance No. 22, of 5/31/2016)	Bipolar affective disorder and psychosis associated with Parkinson’s disease	42,825,048
			4. metreleptin 11.3 mg	Not incorporated and without registration with Anvisa	Congenital or acquired generalized lipodystrophy	36,465,099
			5. alpha-glucosidase 50 mg	2019 (Ordinance No. 48, 10/16/2019)	Pompe disease	19,945,651
			6. ataluren 1,000 mg	Not incorporated (no evaluation by Conitec)	Duchenne Muscular Dystrophy	19,580,225
			7. ataluren 125 mg	Not incorporated (no evaluation by Conitec)	Duchenne Muscular Dystrophy	15,212,043
			8. mercaptamine 75 mg	Not incorporated and without registration with Anvisa	Nephropathic cystinosis	10,014,300
			9. sebelipase alfa 2 mg/ml	Not incorporated (no evaluation by Conitec)	Lysosomal acid lipase deficiency	8,655,498
			10. cerliponase alfa 30 mg/ml	Under analysis by Conitec	Neuronal ceroid lipofuscinosis type 2	3,562,045

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E-mail: revsp@usp.br

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[1] Correspondence: Fabiola Sulpino Vieira SEPS 702/902, Edifício Brasília 50 Torre B, 5º andar, Pétala C 70.390-025 Brasília, DF, Brasil E-mail: fabiola.vieira@ipea.gov.br