PEC wants to release payment for blood donation – 03/04/2023 – Health

The Ministry of Health is working to block a PEC (Proposal for Amendment to the Constitution) that allows payment to blood donors and the sale of human plasma to industry.

If approved, the proposal will reduce the powers of the federal state Hemobrás (Empresa Brasileira de Hemoderivados e Biotecnologia) — the only pharmaceutical authorized to use the material for the production of medicines.

Members of the team of the Minister of Health, Nísia Trindade, assess that ending voluntary donation may even increase the health risk and contamination in transfusions.

In addition, they consider that the PEC is an attempt to weaken the state-owned company, as it could direct plasma supply to private pharmaceutical companies, including abroad, and reduce the product available to Hemobrás.

“There is no indication that paid donation improves anything. We have a higher standard than that of the United States, where blood is paid. That is not what improves. It is to encourage donation”, says the secretary of Specialized Care of the Ministry of Health, Helvécio Magellan.

“Today there is absolute quality control, we take the transmission of HIV and hepatitis in transfusions to almost zero, and part [do controle] is due to not commercializing the collection”.

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

The text is being processed by the Senate’s CCJ (Commission on Constitution, Justice and Citizenship), chaired by Davi Alcolumbre (União Brasil-AP). He also signed the suggestion.

Rapporteur for the proposal, Senator Daniella Ribeiro (PP-PB) prepared a favorable opinion for approval. The commission will hold a public hearing on the PEC before voting on the text.

In the project, Trad states that there is a waste of plasma bags in Brazil. The senator cites data from an audit by the TCU (Tribunal de Contas da União) which pointed to a loss of around 600,000 liters, equivalent to 2.7 million donations.

“Another important point is that, with the pandemic, plasma collection fell worldwide, including in the United States of America and in some European countries that are the largest collectors in the world”, says the proposal.

trad said to Sheet that Brazil needs to improve the plasma donation by plasmapheresis, a process in which plasma is removed from the collected blood and a machine returns the red blood cells and other elements to the donor.

Created in 2004, Hemobrás was marked by investigation by the Federal Police about fraud in bidding for works and delays in completing its factory.

But the state-owned company claims that there is no longer a problem of plasma waste, as the product collected in Brazil is once again fractionated abroad and delivered to the SUS.

Hemobrás collects excess 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 now performed in pharmaceutical companies in Europe.

The state-owned company receives the medication back, such as immunoglobulin, and distributes it to meet part of the public network’s demand. The company’s idea is to carry out all the steps in Brazil from 2025 onwards when its factory, located in Goiana (PE), is finished.

The discussion about the PEC takes place at a time when Health has difficulty supplying the SUS with blood products such as immunoglobulin.

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

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

In a note, Hemobrás states that the plasma bags were lost between 2016 and 2020, a period “in which the state-owned company was prevented from exercising its institutional mission”.

During this period, the company that was contracted for fractionation, the French company LFB, lost its Anvisa certification and was unable to handle the Brazilian product. In addition, Saúde decided to take over the management of the plasma and remove powers from the state-owned company.

After resuming management of Brazilian plasma, Hemobrás sent the product back to be fractionated and to supply the immunoglobulin to the SUS. The company, however, still does not meet all the Ministry’s demand.

For secretary Helvécio Magalhães, the Michel Temer (MDB) and Jair Bolsonaro (PL) governments tried to empty Hemobrás. The last government considered putting the company up for sale.

“The discard [do plasma] it was part of the intention of these governments to destroy Hemobrás and the national industry initiative. We have another thought, the pandemic showed that Brazil is vulnerable in the health industrial complex, there was not even a mask available,” he said.

A PEC to be approved needs three-fifths of the votes of each house, in two-round discussions.

“Hemobrás understands that altruistic blood donation is an ironclad clause, thus there is no room for remunerated donation. In recent years, we managed to advance in the entire production process of the blood chain. success of the blood products industry”, said the state-owned company.

In a note, the councils of health secretaries of the states (Conass) and municipalities (Conasems) asked for the disapproval of the PEC, stating that it can “cause great competition for Brazilian plasma and make Hemobrás unfeasible”.

“The big bottleneck today for its full operation is precisely the lack of industrial plasma in Brazil”, say the councils.

The ABHH (Brazilian Association of Hematology, Hemotherapy and Cell Therapy) supported part of the PEC that deals with the authorization of private pharmaceutical companies in the commercialization and fractionation of surplus plasma in Brazil.

“However, regarding the paid donation of plasma for industrial purposes, the ABHH currently issues the opposite position. We understand that the current surplus of plasma from voluntary blood donation is not properly used, corroborating for the non-liberation of this practice in Brazil.”