The COVID-19 pandemic has the weaknesses of healthcare systems significantly more evident and has highlighted the importance of investments in research, development, and innovation (R, D&I). Thus, new agreements centring on health have emerged in the discourse of social and governmental actors for the “post-pandemic” world. However, these discourses still lack greater integration into the challenges of pharmaceutical innovation.
According to the UNESCO Science Report, around 80% of countries invest less than 1% of GDP in research and development (R&D). Substantial increases in R&D investments is recommended in the face of the growing crises. Further, investments are critical in order to balance the power dynamics with countries such as the United States and China, which accounted for nearly two-thirds (63%) of the increase in science spending between 2014 and 2018.
Contrary to this recommendation, Brazil undergoes successive budget cuts within strategic bodies that finance research. Data from 2021 indicated that the Brazilian Ministry of Science, Technology, and Innovation only received 16% of the 2013 budget (ANDRADE, 2021). Another aggravating factor is the approval of Constitutional Amendment No. 95/2016, which created a “Public Expenditure Ceiling” for primary expenditures until 2036 (FERREIRA, 2021), increasing the underfunding of the Brazilian public health system.
In this context, an interesting phenomenon in Brazil is a reluctance of public managers and civil servants to sign any document that could compromise them politically or individually through the control bodies and the Department of Justice. This includes the acquisition of new treatments or investments in public-private partnerships for pharmaceutical R, D&I.
These factors make it difficult for the population to access disruptive pharmaceutical innovations, such as cell and gene therapy products. Cell and gene therapies have shown rapid growth in the market since 2017. These innovative therapies are more complex forms of R, D&I, which can often target patients with rare diseases.
Still, due to their high cost, access to these technologies depends on legal tracks in many cases. The United States Food and Drug Administration has promised to approve between 10 and 20 new cell and gene therapy products per year by 2025 (YILDIRIM e KOCABA, 2021), which will amplify societal pressures for access, but will also have significant budgetary impacts. In this sense, the Pharmaceutical Innovation Pacts can be powerful narratives for mobilising the public and private sectors to cooperate on issues of this nature (DE VROEY, 2020). Therefore, we understand that the Pharmaceutical Innovation Pacts must include, at least, the following topics:
Qualified debates in public discourse on the challenges of pharmaceutical R, D&I.
Promotion of transparency and social participation mechanisms in public-private partnerships, respecting industrial secrecy.
Modernization of norms and partnership instruments for pharmaceutical R, D&I.
Increase in R&D funding and priority in incorporating pharmaceutical innovations developed in Brazil.
The Social Pharmaceutical Innovation (SPIN) project proposes to seek new models of R, D&I for unmet medical needs. We hope that the SPIN model can accelerate the processes of pharmaceutical innovation through the mobilisation of different social actors. Further, the construction of innovative public policies would facilitate access to treatment and strengthen public health systems.
References
ANDRADE, R.O. Revista Pesquisa Fapesp. Ciência à míngua. N° 304, junho de 2021 Available in : https://revistapesquisa.fapesp.br/ciencia-a-mingua/
DE VROEY, Anouk. (2020) A new health innovation pact can make European health systems resilient and sustainable. Available in: https://www.janssen.com/emea/blogs/new-health-innovation-pact
FERREIRA, B.P. & GONDINHO, B. (2021). Consequências da EC95/2016 para o SUS frente ao envelhecimento populacional: revisão de literatura. JMPHC | Journal of Management & Primary Health Care | ISSN 2179-6750, 12(spec), 1-2 https://doi.org/10.14295/jmphc.v12.1070
YILDIRIM, S., KOCABA, F. Gene Therapy Products Reached to Market by 2021. Gene Editing. (2021) 02: Pages 1-21. Available in: https://web.archive.org/web/20211229190815id_/https://genediting.net/files/genediting/7772bacb-d6c6-4187-98c6-e3f022d45781