Senate Committee approves plasma PEC – 10/04/2023 – Balance and Health

The CCJ (Committee on Constitution, Justice and Citizenship) of the Senate approved this Wednesday (10), by 15 votes to 11, a PEC (Proposed Amendment to the Constitution) that allows the commercialization of blood plasma.

The text authorizes the collection, processing and sale of plasma in Brazil by private companies. This liquid part of the blood is used in treatments, research and manufacturing of blood-derived medicines.

The Ministry of Health is pressing to block the proposal. The PEC will still be evaluated by the Senate plenary and the Chamber.

The possibility of paying blood donors was one of the most controversial topics among senators. Rapporteur of the proposal at the CCJ, senator Daniella Ribeiro (PP-PB) states that the text does not provide for remuneration.

Government members and parliamentarians who oppose the proposal, however, believe that the PEC would open up space for this type of payment. This is because payment could be included in the law that would regulate the plasma collection and use process.

The PEC report approved by the commission states that a law “will provide for the conditions and requirements for the collection, processing and commercialization of human plasma by the public and private sector.”

The text also says that plasma can be used in laboratories, developing new technologies and producing medicines “intended to preferentially provide for the SUS”.

To be approved, in addition to passing through committees, a PEC needs three-fifths of the votes in the Senate and the Chamber, in two-round discussions.

Before the vote, the Minister of Institutional Relations, Alexandre Padilha (PT), said that the proposal cannot guarantee the sanitary control of national blood banks.

“It is true marketing vampirism, authorizing private companies to suck the blood of the Brazilian population and transform it into a product to be sold, with the idea that with this sale, they could buy products to treat their private patients,” said Padilha.

Today only the federal state-owned company Hemobrás (Brazilian Blood Derivatives and Biotechnology Company) is authorized to use plasma collected in Brazil for the production of medicines.

The Ministry of Health argues that the sale of plasma could reduce the national supply of blood products, as the product made with blood collected in Brazil could be sold abroad.

Members of Nísia Trindade’s team still believe that ending voluntary collection could make blood available for cases that require, for example, transfusions more scarce.

“Today there is absolute quality control, we have brought HIV and hepatitis transmissions in transfusions to almost zero, and part [do controle] is due to not commercializing the collection”, he told Sheetin April, the Secretary of Specialized Care of the Ministry of Health, Helvécio Magalhães.

The text divided the government base, receiving support from PSD senators.

Senators Marcos do Val (Podemos-ES), Plínio Valério (PSDB-AM), Efraim Filho (União-PB), Flávio Bolsonaro (PL-RJ), Carlos Portinho (PL-RJ), were in favor of Daniella Ribeiro’s report. Rogério Marinho (PL-RN), Nelsinho Trad (PSD-MS), Angelo Coronel (PSD-BA), Otto Alencar (PSD-BA), Sérgio Petecão (PSD-AC), Lucas Barreto (PSD-AP) and Ciro Nogueira (PP-PI), Laércio Oliveira (PP-SE) and Hiran (PP-RR).

The votes against the report were senators Eduardo Braga (MDB-AM), Renan Calheiros (MDB-AL), Marcelo Castro (MDB-PI), Weverton (PDT-MA), Alessandro Vieira (MDB-SE), Veneziano Vital do Rêgo (MDB-PB), Professor Dorinha (União Brasil-TO), Magno Malta (PL-ES), Fabiano Contarato (PT-ES), Rogério Carvalho (PT-SE) and Augusta Brito (PT-CE).

The councils of health secretaries of states (Conass) and municipalities (Conasems), in addition to Fiocruz, also ask for the PEC to be rejected.

Presented by senator Nelsinho Trad (PSD-MS), PEC 10/2022 received signatures from 26 other senators from parties from left to right. Two of President Luiz Inácio Lula da Silva’s (PT) ministers signed the proposal: Alexandre Silveira (Mines and Energy) and Carlos Fávaro (Agriculture).

“Does not exist [previsão de] remuneration [a doadores de sangue e plasma] in the reported project. Whoever says this is misleading colleagues”, said Trad this Wednesday (4).

In a separate vote, which received support from part of the government, senator Marcelo Castro (MDB-PI) suggested releasing the participation of the private sector in plasma processing, as long as it is authorized by the Ministry of Health and to supply the SUS “as a priority”. . This text was not evaluated.

Created in 2004, Hemobrás was marked by an investigation by the Federal Police regarding fraud in construction tenders and delays in completing its factory, located in Goiana (PE).

The state-owned company collects surplus plasma from blood centers, that is, that is not used in transfusions, treats the product and sends it for fractionation. This last step, which serves to isolate plasma components, is currently carried out in pharmaceutical companies in Europe.

The PEC cites the waste of plasma bags as a justification for the change in the Constitution. The state-owned company claims that there is no longer any loss of plasma, as the product obtained from collections made in Brazil has once again been fractionated abroad.

After this fractionation, the state-owned company receives the medicines back, such as immunoglobulin, and distributes them to meet part of the SUS demand.

The discussion about the PEC occurs at a time when Health is having difficulty supplying the public network with blood products.

The Ministry of Health states that the state-owned company delivers 30% of the blood products offered in the SUS. The plan is to produce 80% of these products at Hemobrás in 2025, the year in which the government hopes to complete the company’s factory.

The new PAC (Growth Acceleration Program) foresees investments of around R$900 million in the Hemobrás manufacturing park and in the qualification of the blood collection network in Brazil.

In recent years, Health has made purchases of more than R$300 million for medicines not registered by Anvisa (National Health Surveillance Agency), made with foreign plasma.

This medication is used to treat several diseases, including HIV and immunodeficiencies. Since 2018, the government has accumulated frustrated purchases and disputes in court and in the TCU over immunoglobulin.