A Proposed Amendment to the Constitution (PEC), presented by senator Nelsinho Trad (PSD-MS), which provides for the authorization of the paid collection and sale of blood plasma, is being processed in the Federal Senate.
PEC 10/2022 is in the Constitution, Justice and Citizenship Committee (CCJ) of the upper house of the National Congress and has divided the opinion of senators by proposing to change the section of the Federal Constitution that prohibits “all types of commercialization” of “organs , human tissues and substances for transplantation purposes” or in the “collection, processing and transfusion of blood and its derivatives”.
In the justification presented to his fellow senators, Trad cites the Federal Audit Court (TCU) and the Public Ministry (MP) to justify the thesis that thousands of plasma bags are wasted in Brazil.
“In fact, since 2017, according to the TCU and the MP, 597,975 liters of plasma have been lost in the country, which is equivalent to the material collected in 2,718,067 blood donations”, says the senator.
Proposal divides the Senate
Daniella Ribeiro (PSD-PB), project rapporteur, welcomed amendments to the PEC that authorize the commercialization of human plasma for laboratory use, development of new technologies, national and international production of blood-derived medicines.
The senator wants the project to meet the demand of the biotechnology sector and reduce dependence on the import of medicines that serve hemophiliac patients and other diseases related to blood clotting.
According to Daniella, Hemobrás, the state-owned company responsible for processing and distributing blood products and the only company authorized to do this in the country, is unable to meet the population’s demand.
“There is no reason for the country not to open the market to the private sector, as long as the SUS is preferably the first to be served”, stated the senator.
The proposal divides opinions in the Senate and was considered by the CCJ, which was scheduled for Wednesday (13), postponed. Daniella and also parliamentarians against the text asked for more time to analyze the merits and talked about seeking a consensual text.
“Experts have warned that this PEC represents a serious threat to the entire national blood policy, as it creates a dangerous precedent by allowing the commercialization of a vital blood component. This would make us regress to dark times, like the 70s, when the poorest and most vulnerable sold blood, an undignified and inhumane practice”, declared senator Paulo Paim (PT-RS).
Ministry of Health: Private initiative must submit to public regulation
A CNN heard from the Ministry of Health about the PEC that polarized the CCJ. The ministry views the proposal with caution and opposes “the remuneration, compensation or commercialization of blood or plasma collection”.
“This would disrupt the national blood policy, a global reference for its excellence and ability to serve all Brazilians”, states the Ministry in a statement.
The section of the PEC that talked about paying for collection has already been discarded from the text that will be recommended in the rapporteur’s opinion. In the report, Daniella signaled the presentation of another project that regulates the issue.
The department headed by Nísia Trindade does not oppose the entry of the private sector into the processing and commercialization of human plasma, but imposes the caveat that its actions should prioritize service to the SUS, be subject to regulation by the Public Power, and be limited to transport , storage and processing of plasma.
“By working in the logistics and production stages, together with Hemobrás, companies can contribute to increasing capacity and promoting the development of the sector in Brazil, generating employment and income, without harming the public interest and national autonomy.”
Who corroborates this point of view is the Brazilian Association of Hematology, Hemotherapy and Cellular Therapy (ABHH). Wanted by CNNthe entity stated in a statement that it approves the change that includes the private sector in the commercialization of industrial fractionation of surplus human plasma, but makes reservations regarding paid collection.
“We understand that the current surplus of plasma from voluntary blood donations is not properly used, corroborating the non-release of this
practice in Brazil”, says the note.
Positioning of Hemobrás
Hemobrás, accused of being unable to meet the national demand for the PEC rapporteur, issued a note summarizing its position on the proposal. The company advocates expanding its operations and greater integration of public and private blood banks so that SUS demands can be met more effectively.
For her, there is no guarantee that the entry of the private sector will, in fact, result in gains for the national market or greater effectiveness in the blood supply. Hemobrás states that plasma prices would be regulated by the international market, which is currently characterized by a scarcity of the material — which would increase prices charged by the private sector.
The state-owned company also defends the allocation of R$795 million in investments from PAC-Saúde for its blood products factory with the aim of expanding its production capacity and supplying the SUS.
Rebutting the author of the text, senator Nelsinho Trad (PSD-MS), Hemobrás says that it “never wasted plasma” and accused the private sector of offering resistance in making the surplus item available.
“There is no plasma left in Brazil and in the world, what exists are public blood centers that need to be strengthened and private blood therapy services need to pass on the plasma in accordance with the law”, states the note.
In a note, the National Health Council (CNS) reinforced its position against the approval of the Plasma PEC.
The text states that the CNS has already sent a document to the Senate’s CCJ in which the Council expresses its opposition to private activity in the collection and processing of human plasma and also the commercialization of blood.
The recommendation, according to the CNS, also highlights the importance of promoting and strengthening the National Coordination of Blood and Blood Products (CNSH), a body of the Ministry of Health responsible for implementing the hemotherapy and hematological care policy, in accordance with Law No. 10,205/ 2001 (Blood Law).
“It is worth highlighting that the Federal Constitution prohibits all types of commercialization of human organs, tissues and substances. The PEC amends article 199 of the Constitution, which provides for the conditions and requirements for plasma collection and processing to allow this to be done by the private sector. Currently, the collection and processing of blood content is the responsibility of the Brazilian Blood Derivatives and Biotechnology Company (Hemobrás)”, reinforces the text.
*With information from CNN
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