Updated: Feb 28, 2022
Due to the need for established measures to limit health expenditures, Health Technology Assessment (HTA) was created as a field of practice in the early 1970s, when the emergence of the computed tomography (CT) scanners became a public health issue due their very high cost per unit of more than US$ 300,000,(World Health Organization, 2011).
Since then, the HTA paradigm has expanded substantially aiming to systematize scientific evidence on given health technology, including the analysis of the social, ethical and economic implications of its national use (Jonsson ; Banta, 1999). The hope has been to positively guide the process of making the political decision of incorporation of health technologies (Yuba, Novaes; de Soárez, 2018).
Thus, the HTA process is regulated by each country and the decision of political incorporation should also be made nationally, since it will depend on the specific context in which the social ethical, organizational, professional, and economic aspects evaluated will be inserted (World Health Organization, 2011).
Until 2006, the process of incorporating technologies into the Brazilian public health system called Sistema Único de Saúde – SUS (Unified Health System) was not standardized in the country. This situation changed with the establishment of the Comissão de Incorporação de Tecnologias – Citec (Commission for the Incorporation of Technologies) which was subordinated to the Ministry of Health, and whose mission was to conduct the process of incorporating technologies considering social aspects and management of the SUS.
Although this initiative has been important for the institutional advancement of the subject, it did not prevent the growth of lawsuits based on the constitutional right to health that guarantees access to medicines and medical procedures – a phenomenon described as "judicialization of health" (Aith, Bujdoso, Nascimento ; Dallari, 2014).
Faced with this judicialization of health the Supremo Tribunal Federal – STF (Federal Supreme Court) organized a public hearing in 2009, motivated by the repeated judicial decisions that determined the public supply of medicines. This public hearing was meant to discuss the adoption of immediate measures for the incorporation of technologies within the scope of action of the SUS (Aith, Bujdoso, Nascimento ; Dallari, 2014).
As a result of this initiative by the Judiciary, Law 12,401 was enacted in 2011, which created the HTA agency in Brazil: the Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde – Conitec (National Committee for Health Technology Incorporation). The creation of Conitec worked to replace Citec in advising the Ministry of Health on policies regarding the incorporation of health technologies (Yuba, Novaes ; de Soárez, 2018).
From the perspective of the studies developed by our SPIN Project, we are discussing whether such an initiative could be considered a case of social pharmaceutical innovation (even if it is permeated by important obstacles narrated below)?
Inspired by international HTA agencies, Conitec reports must necessarily be based on proven scientific data and economic data that will support economic assessments and budget impact. Thus, from a theoretical perspective, at least, one can attest to the scientific autonomy of the agency to advise the political decision-making of incorporation of the Ministry of Health.
Despite that, in October 2021, during a collegiate meeting, Conitec discussed whether or not to use the so-called "Covid Kit";, composed of medications such as hydroxychloroquine, on patients with Covid-19. Surprisingly, in the vote there was a technical tie due to the position of members of the Ministry of Health who contradicted the Ministry's own opinion, which demonstrated the ineffectiveness of those drugs against the disease (Cordovil-Oliveira, 2021).
What to expect, then, from an agency, whose HTA reports suffer clear political interference from the Ministry of Health itself? According to Cordovil-Oliveira (2021), this raised public suspicion that Conitec's decision-making process suffers from a lack of independence, transparency, and legitimacy. Because of this, the prospects for users of the Brazilian health system, and especially for those with rare diseases, are bleak (Cordovil-Oliveira, 2021). In addition to the currently existing model of HTA being focused on prevalent diseases (Souza, Krug, Picon; Schwartz, 2010), the incipient participation of patient organizations in technical-scientific processes of decision-makers highlight the lack of representativeness of people with rare diseases in the political process of HTA.
In the Brazilian scenario, therefore, patients with rare diseases must continue to litigate in court for the equitable distribution of health resources. We argue here that this does not refer to the phenomenon called judicial activism, but in fact to the exercise of the counter majority function by the Brazilian Supreme Court.
Political obstacles to social pharmaceutical innovation such as the one mentioned here are the object of study of our SPIN project that will produce recommendations for the improvement of national HTA regulations in favor of positive and equitable strengthening of health systems, especially in developing countries such as Brazil.
Aith, F., Bujdoso, Y., do Nascimento, P. R.; Dallari, S. G. (2014). The principles of universality
Sanitário, 15(1), 10-39.
Cordovil-Oliveira, Cláudio (2021). Falta de independência da Conitec é apontada na CPI da Covid. Academia de Pacientes, Rio de Janeiro.
Jonsson, E.; Banta, D. (1999). Management of health technologies: an international view.
BMJ, 319(7220), 1293.
Souza, M. V. D., Krug, B. C., Picon, P. D.; Schwartz, I. V. D. (2010). High cost drugs for rare diseases in Brazil: the case of lysosomal storage disorders. Ciência & Saúde Coletiva, 15, 3443- 3454.
World Health Organization. (2011). Health technology assessment of medical devices.
Yuba, T. Y., Novaes, H. M. D.; de Soárez, P. C. (2018). Challenges to decision-making processes in the national HTA agency in Brazil: operational procedures, evidence use and recommendations. Health Research Policy and Systems, 16(1), 1-9.