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Biosafety

New law authorizes research with stem cells and permits marketing of transgenics

ROSI BRASIL / ABRSanctioned by President Luiz Inácio Lula da Silva on March 24, the Law on Biosafety has broadened the prospects for biotechnology in the country: it authorized investigations with embryonic stem cells of human beings and the marketing of genetically modified organisms (GMOs).

Ratified by the President of the Republic, the Congress’ decision is a recognition of the capability of Brazilian researchers for doing science on the frontier of knowledge. The wager on the competence of national research may transform the new law into a tool of technological independence, and, at the same time, guarantee that society will enjoy the results of the investments in science and technology.

The new law will make it possible for at least a dozen laboratories – many of them now carrying out research with stem cells from the bone marrow and the umbilical cord – to start their investigations with embryonic stem cells that, in the future, may indicate ways for treating diseases like Parkinson’s, diabetes and spinal cord lesions, among others. The two lines of research can now count on programmed investments of R$ 28.3 million, according to an announcement by the Minister of Science and Technology, Eduardo Campos.

In the area of transgenics, the researches are more advanced. The prospects are promising, and they lie in the short term. In the next harvest, for example, farmers from all over the country will have access to genetically modified soybean seeds developed by the Brazilian Agricultural Research Corporation (Embrapa), bringing gains in productivity and income. Companies like Monsanto, Bayer Seeds and Syngenta Seeds are also ready to place new products on the market.

Mobilization of researchers
The procedural course of the law through Congress, until its approval, was marked by intense controversy and called for the mobilization of scientists. Patrícia Pranke, a specialist in umbilical cord stem cells, from the faculties of Pharmacy and Medicine of the Federal University of Rio Grande do Sul (UFRGS), for example, went to Brasilia at least twenty times to do, as she says “the work of a little ant”. Along with geneticist Mayana Zatz (see the interview), Marco Antonio Zago, from the Ribeirão Preto School of Medicine and the coordinator of the Cell Therapy Center, and Drauzio Varela, an oncologist, Patrícia took part in public hearings in the Senate and in several encounters with deputies from the Chamber, with the objective of clarifying any of the parliamentarians’ doubts.

The results were worthwhile. “It was the first time that senators, deputies and scientists joined up. We won a holy war”, says Darcísio Perondi (PSDB-RS), who drafted the bill  in the second round of voting in the Chamber.

The voting of the law also took to Brasilia members of the Pro-Life Movement (Movitae in the Portuguese acronym), which brings together entities that represent patients with neuromuscular diseases and their parents. Movitae was created in 2003, when the National Congress was starting the debates on therapeutic cloning, a technique that was left out of the Law on Biosafety. “On the day of the voting, we brought together in the Chamber about 50 people from the four corners of the country”, says Andréa Bezerra de Albuquerque, Movitae’s president, who remained in Brasilia, on the qui vive, until the presidential sanction.

Amongst the patients mobilized by Movitae were six representatives of the Brazilian Muscular Dystrophy Association. They circulated through the corridors of the Chamber, crowded the floor on the plenary session, and, along with researchers and deputies, celebrated the approval of the law. “We asked one of our patients, who is 8 years old, what had pleased him most in Brasilia. And he replied: the victory”, recalls Munira Tenezi Guilhon Sá, the association’s executive director.

The mobilization of the sick touched the President of the Chamber, Severino Cavalcanti (PP-PE).  He had already shown himself to be against the approval of the subject, alleging religious reasons, in spite of the appeals of his daughter Ana Cavalcanti, who is an occupational therapist and state deputy in Pernambuco. “Even before his being elected president of the House, I had already been talking to him, to change his mind”, Ana revealed. Mayana and Patrícia also tried to convince the deputy. “But what moved my father most was the presence of dystrophy victims and their mothers at the entrance to the plenary”, said Ana. Cavalcanti put the proposal for debate, prevented the suspension of the session, defended by the opponents of the project, but withdrew before the end of the voting. Anyhow, the speed with which the Chamber approved the issue surprised the researchers.

Overcoming the Chamber’s resistance, though, was not an easy task. For religious reasons or for lack of information, many deputies feared that, by authorizing research with stem cells, they would be legitimating the cloning of human beings. Others went even further: they suspected they were encouraging abortion. This concern was one of the reasons that led the same plenary to defeat an authorization for research with embryonic stem cells the first time the subject was voted, in February 2004.

Part of the difficulties in the procedural handling of the project, though, has to be credited to its scope. The proposal sent by the Executive Branch to the Chamber, in 2004, sought a definitive solution for the polemics over the planting of Monsanto’s Roundup Ready (RR) soybeans, authorized by the National Technical Biosafety Commission (CTNBio), whose competence was contested by a public civil lawsuit. Amid the juridical imbroglio, there was a shortage of seeds in the domestic market, and the farmers from Rio Grande do Sul bought and planted RR seeds from Argentina. In the absence of a legal framework, the government had to publish a provisional measure to guarantee the harvesting and marketing of the 2002/2003 crop.

The government then set up a commission to draw up a bill, to bring the battle of the transgenic to a conclusion. It joined up the proposal to the embryonic stem cell issue and sent it to the Congress. “We thought that it was odd for the project to join the two together”, Mayana recalls. “The syncretic project was analyzed by a special commission and accompanied closely by researchers and representatives of scientific associations. The opinion of Deputy Aldo Rebelo, of the Communist Party of Brazil, São Paulo – which authorized research with stem cells, therapeutic cloning, and the planting and marketing of transgenics – was already ready to be taken to the plenary when, on the eve of the voting, Rebelo was appointed to a ministry and replaced as the draftsman of the law by Deputy Renildo Calheiros (Communist Party of Brazil, Ceará).

Calheiros prepared his own opinion. He went so far as to consider the possibility of dismembering the project that dealt with different subjects, but, without backing, he changed his mind.  In the first version of the report, he maintained the authorization for research with stem cells, he says. “But every proposal has to be negotiated”, he argues. Faced by the resistance of the evangelical and Catholic benches, in his final report Calheiros vetoed therapeutic cloning and researches with embryonic stem cells.

In the case of the transgenics, he gave way to the pressure of the environmentalists: he limited the competence of the CTNBio to authorizing research, conferring on the Brazilian Institute for the Environment and Renewable Natural Resources (Ibama) and the National Health Surveillance Agency (Anvisa) power to decide about the planting and marketing of GMOs.

The project approved by the Chamber and then sent to the Senate was described as a “juridical Frankenstein” by Carlos Vogt, the president of FAPESP. The Foundation’s Board of Trustees also manifested itself, appealing to the senators to listen to the arguments of the scientific community. Another 13 entities, including the Brazilian Academy of Sciences, positioned themselves in favor of researches with stem cells and against the limitation of the competence of the CTNBio.

The Senate heard researchers, held public hearings, and modified the decision of the Chamber. The report by Senator Ney Suassuna (Party of the Brazilian Democratic Movement, Paraiba), with the endorsement of the scientists, maintained the veto on the therapeutic cloning of embryos, but restored the authorization for researches with stem cells and the power of the CTNBio to decide, in the case of the planting and marketing of transgenics.  Information overcame fear, and the project was approved by a wide margin: 53 votes to 2.

The role of the media
In the Senate’s decision, it is as well to point out, the mobilization of the media had its weight. Before the voting, Rede Globo’s Sunday News program – Fantástico – showed, for three Sundays running, programs from the “How to build a human” series, bought from the BBC in London, which addressed the benefits from using stem cells in the treatment of diseases. The newspaper with the largest circulation in the country, like O Globo, O Estado de S. Paulo and Folha de S.Paulo also manifested themselves, in editorials, against what they described as “obscurantism” and “witchcraft”.

The project, modified, went back to the Chamber, which, in this second round, would only have the power to veto it. The members of the opposition did indeed try to overturn the text’s article 5, which authorized researches with stem cells. With the exception of Prona, Party for the Rebuilding of the National Order, all the parties came out in favor of the text, which was approved by 366 votes to 59. The environmentalists tried to restrict the powers of the CTNBio, but the proposal from the Senate prevailed, with the support of 352 votes against 60.

But it was still early for commemorations. Approved in the two Houses, the draft law on biosafety was forwarded to the Presidential Chief of Staff for an analysis of its merit, constitutionality and legality, before going for the presidential sanction. There was a fear that the president might veto some of the project’s articles, under pressure from Catholics and environmentalists.

The worries were not unfounded: one day after approval, the Ministry of the Environment published a note, reiterating its position against the project: the exclusive and binding power over permitting the planting and marketing of transgenics conferred on the CTNBio by the new law would relegate the public bodies that act in the area of the environment to a secondary role.

The government also received manifestations in favor of the project, like those from FAPESP’s Board of Trustees, which, one week after the approval in the Chamber, on March 10, forwarded a letter to President Luiz Inácio Lula da Silva, asking him to sanction the draft law on biosafety just as approved, “thus laying down the secure foundations, the hopes for a cure and a better quality of life for thousands of people who have experienced and are experiencing the expectations of this great moment”.

In an article published in O Globo, on March 21, Minister Eduardo Campos stated that the permission for researches with stem cells of human embryos represents “the first great step towards the arrival of the country at the frontier of medicine”.  Now, he said: “the important thing is to recover the lost time”. And he noted that, sooner or later, Brazil will have to get itself ready for an even bolder step: authorizing therapeutic cloning. And he made the proviso: “It will be taken when the social and political conditions have matured, representing another landmark in the recognition of the work of Brazilian scientists”.

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