Acordos de risk sharing para aquisição de medicamentos pelo governo no abastecimento do SUSanálise jurídica à luz do caso do nusinersena

Resumo

This dissertation proposes to analyze, from a legal point of view, a new contractual arrangement for the acquisition of drugs and respective incorporation into the Unified Health System (SUS, in Portuguese language) through a risk sharing agreement between the Public Administration and the private supplier. The legal analysis starts from a relevant and unprecedented case in Brazil, involving the acquisiton and incorporation of drugs through risk sharing: the nusinersena drug for the treatment of the rare disease Spinal Muscular Atrophy 5q (AME 5q, in Portuguese language), types II and III, to be incorporated by SUS under a pilot project implemented by the Ordinance No. 1,297/2019. The Ordinance No. 1,297/2019 defines the risk sharing agreement for the incorporation of health technologies as the instrument entered into between the Ministry of Health (MoH) and the pharmaceutical company that supplies the drug, due to the uncertainties regarding the cost/effectiveness of the drug in real conditions and the estimated consumption, considering the quantity of pills/doses and the budgetary impact. Therefore, the pilot project proposes that the payment for nusinersena to be acquired by the MoH be linked to specific results and clinical outcomes of patients, in a way that the payment by the entity is only due over those units that effectively reach the expected outcome. The drug's technology is unprecedented and exclusive in the Brazilian public health system because until then what had been available were palliative therapies for the disease. The abovementioned scenario remained until August 2020, when the Ministry of Health, on 8/28/2020, in a meeting with the manufacturer of nusinersena, apparently, due to the need to present greater technical and economic subsidies2 , considered the contractual model as “unfeasible” and the initial arrangement proposed was “frustrated”, requiring the manufacturer to submit a new dossier for incorporation proposing a new risk sharing agreement. Although the model as originally proposed, which is the object of analysis of this dissertation, has not been successful, negotiations with the said company will continue and the Ministry of Health expects to reach the establishment of a risk sharing agreement, even if not on the bases initially outlined. In this sense, the referred pilot project remains in force, however the expectation is that it will get new contours in the future. The discussion around this project and the efforts of the Government - which took it as an innovative and very important initiative - and of the industry, in order to make the model feasible, per se, represent a great gain for society and will continue being the object of such efforts. For this importance, the case deserves to be highlighted and should be studied with the objective of contributing to the dissemination of the theme in Brazil. At the same time, more precisely, on 8/17/2020, the Brazilian Health Surveillance Agency (Anvisa) approved the abeparvoveque onasemnogen (trade name Zolgensma®) - considered the most expensive drug in the world - on an urgent basis due to the severity of the disease -, consistent in a treatment based in gene therapy to correct the genetic mutation that causes the disease, with a single application. Regardless of the abovementioned scenario, the relevance of the topic for public health management, from a legal point of view, is unquestionable. It is known that this type of contractual arrangement based on risk sharing, despite being widely used in the United States of America and Europe, faces great challenges among which can be mentioned: high transaction costs, practical difficulties to measure the results of treatments and lack of information technology and structure for data collection. Additionally to the practical difficulties, the fact is that the risk sharing agreement does not have a legal definition in the Brazilian legal system, nor is it contemplated by the rules of administrative law. The absence of a legal provision of this type of contract does not prevent the implementation of the model in Brazil, however, this situation and the unprecedented project imposes a careful look at the matter and the need for future edition of rules to regulate this type of arrangement. Throughout this dissertation, therefore, some key points related to the feasibility of risk sharing agreements are analyzed in light of the current legal scenario and the relevant case of the incorporation of nusinersena by SUS, to encourage models that expand access to health and pursue better results, simultaneously with greater efficiency in patient care, with the appropriate legal contours.

Ficha do documento

Tipo

Dissertação

Ano

2020

Instituição

Fundação Getulio Vargas

Fonte

Repositório da FGV

Idioma

Português

Acesso

Acesso aberto

Identificador

oai:repositorio.fgv.br:10438/29734

Temas

EconomiaGestão PúblicaAdministração PúblicaTecnologiaSaúde

Palavras-chave

Value-based health careAdministrative agreementRisk sharing agreementRisk sharingAcquisition of drugsIncorporation of health technologyContrato administrativoAcordo de risk sharingCompartilhamento de riscoAquisição de medicamentoIncorporação de tecnologia em saúdeDireitoRisco (Economia)Compras (Serviço público)Medicamentos - ComprasContratos públicosContratos administrativos