One of the themes that the Brazilian team of the Social Pharmaceutical Innovation (SPIN) project is exploring through our fieldwork is the value of partnerships between the State and the private sector for developing new drugs to meet the health needs of patients with rare diseases.
In the rare disease field, Partnerships for Productive Development (PDP) have gained prominence in recent years. In the SPIN project, these are being analysed to better understand their application for the development of drugs for rare diseases. Through this research, an in-depth study is being carried out to better understand the benefits of this model, and to identify how this model may be improved to increase its efficacy and applicability.
Currently, PDP are regulated by the Health Ministry Ordinance 2531/2014. This ordinance establishes the guidelines and criteria for defining the list of strategic products for the Brazilian Unified Health System (SUS) and the establishment of Partnerships for Productive Development (PDP). More specifically, the Health Ministry regulates the processes of submission, instruction, decision, transfer, and absorption of technology, as well as the acquisition of strategic products. The regulation of these processes all transpires SUS within the scope of the PDP to allow for the proper monitoring and evaluation of these products.
According to the federal government in Brazil, the Partnerships for Productive Development (PDP) aims to expand access to medicines and health products considered strategic for the Unified Health System (SUS) by strengthening the country's industrial complex. The main objective of this model is to encourage a greater prevalence of national development. Through increased local developed, the costs of acquiring medicines and health products can be significantly reduced. This model focuses particularly on products that are currently imported or represent a high cost for the SUS. Partnerships are carried out between two or more public institutions or private companies which seek to promote national public production. Notably, the development of new technologies is also included in the scope of PDP.
The following are also highlighted as objectives of the PDPs:
• Expanding the population's access to strategic products and reducing the vulnerability of the SUS;
• Reducing productive and technological dependencies;
• Rationalizing the purchasing power of the State through the selective centralization of expenditures in the health area;
• Protect the interests of the Public Administration and society when seeking economy;
• To encourage technological development and the exchange of knowledge;
• Promote the development and manufacture in the national territory of strategic products for the SUS;
• Seek the technical and economic sustainability of the SUS in the short, medium and long terms;
• Promoting structural conditions to increase the country's productive and innovation capacity,
• Contribute to reducing the health industrial complex trade deficit and guarantee access to health;
• To stimulate the development of the public production network in the country and its strategic role for the SUS.
The fact that Ministerial Ordinance regulates it, a normative document that is easy to change and very subject to political contingencies, generates legal uncertainty in the model with significant practical consequences. Consequences could include the cancellation of several PDPs that are in progress in recent years. Cancellations such as these occur for several reasons, but not all of them clear and transparent.
An excellent pharmaceutical social innovation model needs legal certainty, transparency, social control, and institutional stability.
It was in this context, in the search for innovative solutions for public-private partnerships in the field of health, that Bill 1505/2022, authored by Senator Eduardo Gomes, from the Liberal Party, representative of the State of Tocantins, was proposed. It establishes the mechanisms to stimulate the development and strengthening of the Brazilian Economic and Industrial Health Complex (EIHC) within the scope of the National Policy for Technological Innovation in Health and other measures.
Concerning public-private partnerships in pharmaceutical and social innovation, the project encourages strategic alliances between public and private entities. According to the text, strategic alliances "involve companies, ICTs and private non-profit entities focused on research and development activities, which aim to generate innovative products, processes and services and the transfer and diffusion of technology. They may include international technological research networks and projects, technological entrepreneurship actions and the creation of innovation environments, including incubators and technology parks, and the training and qualification of qualified human resources".
These strategic alliances would be consolidated through "strategic solutions" or even "instruments for establishing strategic alliances and technology partnerships within the EIHC to stimulate their development and strengthening”. Among the instruments are, in addition to the PDPs, the Technological Orders in the Health Area; compensation measures in the health area, and other models of strategic alliances and technology partnerships. These alliances and partnerships are empowered to involve technology transfer, development, or co-development of Strategic Solutions for Health, of public interest. Indeed, a legislative review in the pharmaceutical and social innovations field is necessary for Brazil.
The SPIN Brazil team, based on the knowledge already acquired on the application of PDPs in rare diseases in the country, will closely monitor the debates and the progress of Bill 1505/2022 mentioned above to contribute to the construction of effective regulatory models that enable pharmaceutical, social innovation, and improve access for rare patients to these innovations.
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