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biosafety

Campaign for knowledge

Researchers mobilize themselves against draft law that restricts research with stem cells and power of the CTNBio

Scientists from all over the country are mobilized in defense of the researches of stem cells that, they bet, have the potential for saving millions of lives. They also do not have any doubts that the investigations with genetically modified organisms (GMOs) carried out at research institutes offer alternatives that reduce costs and increase the competitiveness of Brazilian agriculture. They want this knowledge to be rapidly incorporated by the productive sectors and shared with society. To do so, they propose that the National Technical Biosafety Commission (CTNBio) should be the only and definitive instance for assessing the risks of researching and producing transgenics, so as to speed up the licensing of products and to consolidate private sector interest.

The fate of the investigations with stem cells and the future of researches with transgenics depend on the vote of 81 senators. They have to ratify, or otherwise, the bill on Biosafety approved by the Chamber of Deputies that prohibits the use of embryonic stem cells for therapeutic purposes and leaves room for the CTNBio’s decisions on the marketing of transgenics to be contested by other instances of the government and judged by a council made up of ministers, postponing indefinitely the licensing of products.

Strategic research
The mobilization of the researchers is justified. Stem cells are progenitor cells that keep the capacity for differentiating themselves in numerous human tissues. They can be obtained by means of nuclear transfer or therapeutic cloning, using umbilical cord or embryos. Therapeutic cloning would, for example, make it possible to reconstitute the spinal cord of a paraplegic. But a person’s own cells cannot be used on victims of genetic diseases. Hence the importance of the researches. There are stem cells in children’s and adults tissues and in the blood from the umbilical cord. But scientists still do not know these cells potential for differentiating into different tissues. If the research brings no result, the alternative will be the use of embryonic stem cells, known to be totipotent, that is, capable of differentiating themselves into any one of the human tissues.

The biotechnology of plants and animals likewise opens up enormous possibilities of development for agriculture and livestock raising – with strategic gains for a country on whose list of exports ten agricultural products stand out – since it makes it possible to improve the quality and the resistance of products and reduce production costs.For these reasons, and also because Brazil has internationally recognized competence in the two areas of research, the scientists’ expectation is that the project will be modified.

“What we want is authorization to use embryonic stem cells for a therapeutic purpose, getting them from discarded frozen embryos, either because they were abandoned by their parents over three years ago, or because they do not have the quality for implants, nor any chance of being transformed into a life”, explains Mayana Zatz, from the University of São Paulo (USP) and the coordinator of the Human Genome Studies Center – one of the ten Research, Innovation and Diffusion Centers (Cepids) maintained by FAPESP. “What we want to be banned is reproductive cloning, the production of embryos for the purpose of research, the genetic manipulation of embryos and their marketing”, clarifies Patrícia Pranke, a specialist in umbilical stem cells, from the colleges of Pharmacy and Medicine of the Federal University of Rio Grande do Sul (UFRGS).

Mayana and Patrícia, alongside Marco Antonio Zago, from the Ribeirão Preto School of Medicine and the coordinator of the Cell Therapy Center, another Cepid funded by FAPESP, and Drauzio Varella, an oncologist and research director of the São Paulo University (Unip), have taken the front line in the defense of researches in the genomic sphere. They defended this perspective of research in a public hearing promoted by the Social Affairs (CAS) and Education commissions of the Senate, on June 2.

Varella went so far as to compare stem cells to “a tissue factory” that may represent for the 21st century a revolution similar to the discovery of antibiotics in the 20th century. The arguments, in their assessment, seem to have had an effect: Senator Lúcia Vânia (PSDB-GO), the president of the Social Affairs Commission, commented that the debate was “profitable and useful” for the parliamentarians to be able to decide on the matter.On June 23, it was the turn of the specialists in biotechnology and researchers from the Brazilian Agricultural Research Corporation (Embrapa) to argue in favor of the socioeconomic benefits of the production of transgenics.

Francisco Aragão, from Embrapa, proved to the senators that Brazil is qualified to use biotechnology with responsibility, and Aluízio Borém, the president of the Brazilian Plant Improvement Society, defended the genetic manipulation of plants. “Transgenic varieties may bring a significant socioeconomic contribution to the country, and an environmental one as well, just as is now happening in other countries”, Borém claimed.The arguments presented won a weighty reinforcement: a week before, the Food and Agricultural Organization (FAO), of the United Nations, published a report in which it recognizes that biotechnology is the great promise for developing countries.

The report’s finding is that, in the developing countries where transgenic crops have been introduced, the small farmers have had economic gains and reduced the use of toxic agrochemicals. “Transgenic crops have brought great economic benefits to farmers in some areas of the world in the last seven years”, says the report. In the case of GMOs, the FAO recommends a case-by-case assessment that takes into consideration the potential benefits and risks of transgenic crops, individually.For Elíbio Rech, a researcher from Embrapa who also took part in the public hearing, “the senators now have a clear view of the importance of the use of biotechnology for producing food in a country that has agriculture as its main export item”.

Regulatory landmark
A possible approval in the Senate of the text sent by the Chamber, without alterations, besides prohibiting researches in the area of genomics and restricting laboratories in their investigations in biotechnology , may bring serious losses to Brazil, reckons Leila Oda, the president of the National Biosafety Association (Anbio) in an interview for the FAPESP Agency. “The text, particularly in relation to the decision-making , makes scientific research inviable.” The project, she says, has managed to mix together the two possible forms of regulatory models that there are in the world. “Some countries have opted for a multidisciplinary chamber, like CTNBio itself.

In others, the processes pass case by case, through several decision-taking bodies.” The text that is being analyzed by the Senate provides for the actions involving GMOs passing through the CTNBio, and then through the ministries, which creates an unnecessary excess of red tape. If it is approved, the law is going to suspend over 200 biosafety certificates issued by CTNBio that are in force. “The decisions made in the commission, when they do not show any scientific novelties that jeopardize safety, need to be validated”, Leila explains.

The senators also heard, from the president of CTNBio himself, Jorge Guimarães, that it is essential for the commission to have the autonomy for making decisions of a definitive nature to allow researches and to decide about marketing a product or otherwise. “I am convinced that, if CTNBio does not have sufficient institutional freedom, we will continue in the same situation as today, that is, with restrictions on the release of projects, in spite of there having been analyzed with care and rigor”, stated Guimarães to Senate Agency.

The sharing of the power of decision of CTNBio, a technical commission, with two areas of government, the Brazilian Institute for the Environment and Renewable Resources (Ibama) and the National Health Surveillance Agency (Anvisa), should cause a strong impact on investments by biotechnology companies in the country, foresees Eduardo Emrich, the president of the Biominas Foundation. “Nobody is going to invest with uncertainty, which is very bad when we know we have the competency for competing with other countries and at a moment when we are trying to raise the sector up again.”

Biominas and the Minas Gerais State Federation of Industries (Fiemg) were signatories of a Manifesto for Science, made public during International Biotechnology Congress II, in Minas, in which they call for a clear regulatory landmark to be established with regard to biosafety, defining “precisely” the prerogatives and responsibilities of the various government bodies involved in the area of biotechnology. “The industry and the scientific and academic sectors foresee serious difficulties in developing research with genetically modified organisms, should this wording be maintained for the bill. As it is, the proposal will bring about a downturn in investments for new studies, since it may make it inviable to release transgenic products commercially”, the document runs.

Besides the pressure from researchers and businessmen, the senators are going to examine the article that limits the power of CTNBio under the weight of a decision of the Federal Regional Court (TRF) of Brasilia, which after two years of silence decided, by two votes to one, that the commission has constitutional competence to decide on the introduction of GMOs into the environment. “When risks are identified, it is then that Ibama may ask for environmental impact studies (EIA-Rima)”, explains Reginaldo Minaré, a lawyer specialized in biotechnology. The competence of CTNBio was placed under suspicion by the Consumer Defense Institute (Idec) in 1998, straight after the commission had released the commercial planting of Monsanto’s RR soybeans. The TRF’s decision may still be contested.

Confused debate
The strange coupling together of debates on two distinct areas of research, genomics and biosafety – albeit both related to strategic investigations at the frontier of knowledge – must be credited to the Chamber of Deputies, which, on the eve of the voting on the matter, inserted into the draft law of Biosafety of GMOs a prohibition of investigations with stem cells. “The two subjects are totally different”, recognizes Walter Colli, the chair professor of biochemistry at the Chemistry Institute of the University of São Paulo (USP), pondering, however, that in the present circumstances it is best to carry out a joint debate. In the Senate, there were those who proposed, in the ambit of the Law on Biosafety, a divorce between the two materials. But prudence prevailed. “If we dismember the debate, the stem cell issue will be postponed, running the risk of getting lost from sight”, Mayana fears. The best way out, the scientists concluded, was to support the mess brought about and plead with the senators not to separate the two proposals of the bill.

In the Senate, the climate is one of caution. In spite of the polemics aroused by the debate, up until the end of June – one week from the date planned for the parliamentary recess – no senator had presented any amend to the bill approved by the Chamber. An agreement was sought that would allow the leaders to close ranks around a replacement for the draft law approved by the Chamber of Deputies. If the bill on Biosafety is altered, the matter goes back to the Chamber for fresh voting.

Senator Tasso Jereissati, for example, already had ready – and reserved – an amendment to the draft law that provided for the inclusion of a paragraph in article 5 of the law – about the prohibition of researches – that excludes from the “prohibition” the obtaining of stem cells, “for the purposes of research or treatment of diseases and lesions, from embryos produced for reproduction, by fertilization in vitro”, provided that these cannot be used for reproduction, have not been implanted, and “have been frozen for over three years”, provided that the biological parents consent. It also foresees the consent of the biological parents for the use of embryos fertilized in vitro, not implanted and frozen. Jereissati’s text bans reproductive cloning, the production of embryos to be used exclusively in research, and trading in them. The amendment was drawn up with the advice of researchers from the Human Genome Studies Center and Patrícia Pranke.

Obscurantism and witchcraft
While the researchers were doing their peregrination through the Senate, the last few weeks saw an intense mobilization by the media around the voting of the draft law on Biosafety, above all as far as concerns the prohibition of researches with stem cells. The popular Sunday news show Fantástico at Globo TV showed, on three consecutive Sundays, from May 30, a program from the series How to build a human, purchased from the BBC of London, focusing on the benefits of the use of stem cells in the treatment of diseases. The BBC series has 16 chapters in all, but Fantástico’s editors opted to begin with the subject that at that moment was being discussed by society and the scientific community, according to Globo Communication Center.

The program of June 13, for example, had the participation of Mayana and Varella. It showed the prospects for this research, provided that adult cells are used, covering stem cells extracted from the umbilical cord and those from embryos. “But, in Brazil, Congress has still not approved the therapeutic use of stem cells from embryos”, Fantástico clarified.The printed media was more incisive, particularly in the editorials.

The one in O Globo, of May 27, stated that the bill on Biosafety is “a veritable model of obscurantism”. The editorial of O Estado de S.Paulo, on June 1, warned: “Witchcraft cannot beat science in the Senate as well”; and the Folha de S.Paulo, also in an editorial, published on June 7, was now betting that the senators are going to modify the project. “But a possible modification by the senators would take the text back to the Chamber, where the influence of the evangelical lobby is particularly strong, and is responsible for the victory of obscurantism”, it warned.

Imported material
While they await the outcome of the debates, the researches continue. At the end of June, USP’s Human Genome Studies Center imported a lineage of embryonic stem cells for the United States. The material was donated by a group of researchers from Harvard University that is carrying out researches with stem cells, sponsored by private enterprise. In the United States, the use of official resources in this line of investigation is prohibited. The senators, though, are now mobilizing themselves to alter this situation. “The polemical part, which is the destruction of the embryos, has been done there”, says researcher Lygia da Veiga Pereira. The material will be used in the comparison of different kinds of embryonic cells. “We have been working in this line of investigation since 1999, when we established a lineage of embryonic cells from mice”, she says.

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