Supreme Court Justice Celso de Mello says that this was the most important decision handed down by the Federal Supreme Court/STF in the last one hundred years of the Court’s history. On the afternoon of May 29, the eleven Supreme Court justices authorized the on-going research studies into embryo stem cells, when they rejected the Request for Unconstitutionality/ADIN lawsuit filed by former Attorney General Cláudio Fonteles against one of the articles of the Biosafety Law (No. 11105). Six of the justices stated that the lawsuit lacked grounds. The other five justices, even though they did not declare the law unconstitutional, stated reservations which, to a greater or lesser extent, might have limited scientific activity. But dissenting opinions were in the minority.
By handing down this historic decision, the Supreme Court voiced its official support of research into embryo stem cells in Brazil. These studies had been put on hold due to the uncertainty caused by the said lawsuit. “This decision lifted the sword that was being held over our heads,” says geneticist Lygia da Veiga Pereira, who expects to obtain the first Brazilian strain of a special type of cell in her laboratory at the University of São Paulo (USP). Embryo stem cells can generate different body tissues – such as skin, bones or neurons. They have drawn the interest of researchers and people worldwide because they represent hope in the treatment of serious health problems that cannot be treated with standard drugs. The production of a Brazilian strain of embryo stem cells is an important step forward for Brazilian science. “It will provide the country with independence and Brazil will no longer have to depend on importing strains produced abroad,” says Lygia, who has been engaged in this mission since 2005, together with Stevens Rehen, from the Federal University of Rio de Janeiro (UFRJ). “I kept on going, because I had faith that the Supreme Court would be sensible,” she adds.
This is not a simple task. The development of a strain means that cells have to be extracted from an embryo in its initial stage of development and have to be reproduced in a laboratory, making sure that they do not lose their most interesting characteristics, namely, their pluripotency, the capacity to reproduce other cells of the body. By using an innovative technique – whereby human embryo cells are cultivated under human fibroblasts -, Lygia and Rehen have already generated a Brazilian strain, but the results have not been entirely successful. Now they intend to repeat the experiment by adopting the classical method used around the world, whereby these cells are cultivated over mice fibroblasts. “These will be all right for research purposes, but not for treatments,” Lygia explains. She intends to pass on the technique to other laboratories as soon as the technique is fully understood.
“This is a new learning experience,” says physician Antonio Carlos Campos de Carvalho, a researcher at the National Cardiology Institute and at UFRJ, where he also works with imported strains of human embryo stem cells. Carvalho and four other teams from UFRJ have been trying, since 2005, to obtain specific kinds of mature cells suitable of use in repairing damaged tissue. “Thanks to the STF decision, we will now be able to include students in master’s and PhD programs to work on these projects,” says Carvalho.
Geneticist Mayana Zatz, who led the movement to do away with the ban on stem cell research, says that embryo stem cells have huge therapeutic potential. “But we have to be patient: nobody knows when and which diseases will actually be treated,” she warns. “Researchers are already working on imported and Brazilian embryo stem cells – because there was no ban on this kind of research. But nobody was investing in research, because nobody knew if it would be interrupted. Now researchers will follow these steps: submit projects, obtain funding, conduct the research,” says Mayana. The researcher pointed out that STF approval does not mean that research with adult stem cells will slow down; adult stem cells can be extracted from various organs, but they are not as versatile as the embryo ones. “Research with adult stem cells will bring short-term results, while research into embryo stem cells will allow us to treat a wider range of diseases,” she stated.
Sérgio Rezende, Minister of Science and Technology, pointed out that stem cell research studies, that have enjoyed Federal Government support since 2004, might produce their first results in 2009. So far, these projects have been granted some R$ 24 million. “We have a long way to go before we get the first real results. But one must point out that these research studies seek to provide answers to such major problems as spinal cord injuries, diabetes and genetic diseases,” the Minister explained.
Research with embryo stem cells is provided for in the National Biosafety Law, passed in March 2005 (see cover story in Pesquisa FAPESP nº 110). The ban on using embryos was lifted, but there are some restrictions: researchers are only allowed to use embryo stem cells from surplus embryos left over from in vitro fertilization processes – and only if the embryos cannot be used for reproduction purposes or have been frozen for at least three years. The cloning of embryos – which theoretically could generate tailor-made cells and tissues to treat intervals – is banned.
A legal deadlock surfaced as soon as the new law went into effect. In May 2005, the then Attorney General, Cláudio Fonteles, filed the Adin at the STF. He challenged Article 5 of the law, which concerns the use of embryos stored in human reproduction clinics (see Pesquisa FAPESP nº 113). In Fonteles’ opinion, these provisions clashed with the protection conferred upon human lives by the Constitution. The lawsuit led to the first public hearing ever in the history of the Brazil’s Supreme Court (see Pesquisa FAPESP nº 135). At the initiative of the case’s reporting judge, Supreme Court Justice Carlos Ayres Britto, the STF brought together 22 scientists who went to Brasília to debate the following issue: when does life begin? The decision on this issue will begin on March 5, with the reading of the opinion of Justice Ayres Britto, who challenged the argument presented by Fonteles. “To remain silent on the matter and not allow people to regain their normal lives – does this not seem like an inhuman way of denying help?” Britto asked. The then Chief Justice of the Supreme Court, Ellen Gracie, voiced the same opinion as that of the reporting judge, but the session was interrupted because of a request from Justice Carlos Alberto Menezes Direito, who asked to review the issue. The Supreme Court reconvened on May 28.
Justice Direito, who is a member of the Union of Catholic Legal Scholars of Rio de Janeiro, stated in his opinion that the extraction of stem cells should be conditioned to the non-destruction of the frozen embryo. Justices Ricardo Lewandowski, Eros Grau, Gilmar Mendes and Cezar Peluso also issued opinions that put limits on research. But the reporting Justice’s opinion prevailed, with the support of Justices Marco Aurélio Mello, Ellen Gracie, Celso de Mello, Cármen Lúcia and Joaquim Barbosa, who voted to lift the ban on research studies under the terms of the Biosafety Law, with no restrictions.