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Polemical law

Project restricts power of the CTNBio, bans therapeutic cloning, and mobilizes scientists

ADVANCED CELL TECHNOLOGYBill on Biosafety bans therapeutic cloning with embryonic stem cellsADVANCED CELL TECHNOLOGY

The biosafety bill, No. 2401, of 2003, which ought to replace the current legislation and define clear rules for researching and marketing genetically modified organisms (GMOs), has set fire to the debate in the country about transgenics. The text approved in the Chamber of Deputies, on February 5, and which is now making its way through the Federal Senate, creates the Biosafety Information System which will manage activities that involve transgenics, and the Development of Biotechnology for Family Farmers Incentive Fund, aimed to fund projects in biotechnology and genetic engineering implemented by public institutions, which are an improvement on the current legislation. But it is polemical in at least two aspects: it attributes to a council of ministers the last word on the marketing of genetically modified organisms, and it bans research with stem cells for therapeutic ends.

With regard to the first controversial aspect, the scientists want the National Technical Biosafety Commission (CTNBio) to be the sole and definitive instance for assessing both research into and marketing of transgenics.  “It is fundamental for national development that research spawning from the public institutions be swiftly incorporated into our productive sector, under the penalty of Brazilian society not reaping the fruits of the investments in science and technology in Brazil”, say the representatives of 13 scientific entities, among which the Brazilian Academy of Sciences, in a letter forwarded to the senators on February 18.

FAPESP’s Board of Trustees has also manifested itself. In a document handed to the president of the Senate, José Sarney, by its scientific director, José Fernando Perez, the Foundation appeals to the members of parliament for them to listen to the accredited representatives of the scientific community, in order to transform the text of the law into a tool for the progress and technological independence, thus avoiding irreparable damage to the mechanisms for generating knowledge and wealth” (see the full text on page 20). The scientific community also reacted negatively to the ban of research with stem cells for therapeutic purposes.  “The texts of bill that deal with research with embryonic stem cells are particularly alarming as to the effects on public health”, states the document drawn up by the 13 entities.  “Cell therapy with embryonic stem cells may mean hope in the treatment of 5 million persons, the majority children and youngsters. We do not defend the production of embryos for this purpose, but of using those that are discarded in fertility clinics.”  The entities are also requesting that the CTNBio should have the legitimacy to be last decision body on this issue.

Legal clash
Brazil has had a Law on Biosafety (No. 8974) since 1996, which attributes competence to the CTNBio – created by a provisional measure in August and linked to the Ministry of Science and Technology –, to establish technical standards and to issue conclusive opinions regarding biosafety.  The competence of the CTNBio to issue opinions about environmental safety, though, has been contested by lawsuits based on the Environmental Law, which, it is argued, confers this authority on the Ministry of the Environment.  On account of this legal clash, the 1998 opinion of the CTMBio was suspended, which waived the genetically modified soybeans from Monsanto from the Environmental Impact study, before being released for planting.

This still ongoing battle has created a juridical limbo that has halted research activities and obliged the publication of three provisional measures to authorize the harvesting of the Monsanto soybean crop, in the state of Rio Grande do Sul. The government then decided to set up a commission made up of nine ministers and commanded by the Civil Cabinet Office to analyze the question of biosafety and formulate a new law to put an end to the polemics over transgenics.

The bill from the executive was sent to the Chamber of Deputies in October last year.  Over three months, a special commission – which had as its chairman Deputy Aldo Rebelo (PCdoB – SP,Communist Party of São Paulo) –, accompanied closely by researchers and representatives of scientific associations, modified the original text.  On the eve of the voting, Rabelo took up the Ministry of Political Coordination and Institutional Affairs and was replaced in the chair by Deputy Renildo Calheiros (PCdoB – PE , Communist Party of Pernambuco), who, under pressure from environmentalists and the evangelist caucus, modified the project.  “The result was a juridical Frankenstein”, in the assessment of Carlos Vogt, FAPESP’s president.

Rebelo’s report put research under the tutelage of the CTNBio and attributed to a National Biosafety Council – made up of 15 ministers – the last word about the economic timing of marketing transgenics.  Both in the case of research and of marketing, it would be up to the CTNBio to assess risks and identify activities that were potentially dangerous and that could be harmful to human health. Calheiros modified the text to “enhance the technical role” of the commission, as he explains in his report.  On the project approved, it is made clear that the CTNBio retains its autonomy to decide on research projects, while it is up to the Brazilian Institute of the Environment and Renewable Resources (Ibama) to license the polluting activities identified by the commission.  In article 11, item XXIII, the project states that “in the case of a previous favorable conclusive technical opinion on biosafety in the ambit of the research activity, the CTNBio will send the respective process to the bodies and entities referred to in article 13, for them to fulfill their responsibilities”.  Article 13 defines the functions and responsibilities of the registering and supervising bodies and entities connected to the Ministry of Agriculture, Livestock and Supply; the Ministry of Health; the Ministry of the Environment; and the Special Secretariat for Aquaculture and Fishing.

But, as far as marketing is concerned, the text is not so elucidative.  In the same article, in item XXIII, paragraph 4, the project lays down that “in the case of a favorable conclusive technical opinion on biosafety in the ambit of the activity of commercial use, the CTNBio will send a copy of the opinion to the National Biosafety Council, for it to fulfill its responsibilities”. And, in article 13, paragraph 1, the project says that “after a favorable manifestation from the National Biosafety Council”, as a result of a specific analysis and the pertinent decision, it will be up to the competent body of then Ministry of the Environment, in this case Ibama, to license and issue authorization and registration, to supervise and to monitor products and activities that involve GMOs and their derivatives to be released into the ecosystem”, in a maximum period of 120 days.  This period, though, will be suspended “during the drawing up of the studies or preparation of clarifications by the entrepreneur”.

This lack of clarity with regard to the competence of the CNTBio, from the scientists’ viewpoint, makes one suppose that the commission’s opinion will only be definitive when it is contrary to releasing the GMOs.  If it is favorable, the opinion will have to be submitted to the ministerial council, to be ratified or otherwise. The text also “allows the interpretation” that the evaluation of the risk to the environment and to health made by the Technical Commission may not be accepted Ibama or by the National Health Surveillance Agency (Anvisa), according to Reginaldo Minaré, a lawyer who is a specialist in biotechnology. “Ibama or Anvisa will be able, each in its own field of activity, to call for more studies on the biosafety of the activity or product with its origins in genetic engineering, since, according to the text, these requirements will be made after the favorable manifestation of the ministerial council”, he foresees.

For the Ministry of the Environment (MMA), there is no doubt in the project. “The text approved gives Ibama powers to question in the National Biosafety Council opinions of the CTNBio regarding the sales of GMOs. The institute may ask for Environmental Impact Studies when it considers that commercial planting may damage the environment”, informs MMA’s communication service on the website.  On the same site, the Minister of the Environment, Marina Silva, commemorated the results.  “This was not an exclusive work of the Ministry of the Environment. Everything was coordinated by the Civil Cabinet Office, in such a way that it was possible to reach a suitable bill, according to the understanding of the government, of the majority of the members of parliament, and of a good part of the civil society and of the scientific community.”  To judge from the reaction of the scientific community, the “majority” does not include a good number of researchers.

“This result was a surprise”, says Aluízio Borem, of the Brazilian Academy of Science, and also a member of the Brazilian Genetics Society and the Brazilian Biotechnology Society. Since 1998, researchers have been awaiting an end to the conflict between the Ministry of the Environment and the CTNBio, to carry on with such strategic projects as, for example, the one on a virus-resistant bean developed by the Brazilian Agricultural Research Corporation (Embrapa). “The delay has been irreparable”, regrets Elíbio Rech, a researcher from Embrapa.

The expectation with new law was great. But despite the text giving a differentiated treatment to scientific research – an old request from researchers –, it transfers the legal obstacles to marketing, neutralizing any advances that may have been achieved with research, as it will block the transfer of technology to agribusiness. “Ibama does not have the competency for this analysis. They are ecologists and not molecular biologists. A proof of this is that the institute asked for a socioeconomic survey of the population settled in a radius of 3 kilometers, for Embrapa to be able to test the planting of the bean in an area of 10 square meters”” Borem explains. “We are in the face of a backward step with grave consequences for agribusiness.  If genetic research cannot be transferred to the productive sector, the country will not make headway”, adds Marcelo Menossi, from the Biology Institute of the State University of Campinas.

Strategic competency
“Brazil has acquired a competency in this strategic area of research that has great potential for generating socioeconomic opportunities. The government needs a legislation that is not inhibitive for this project, which is fundamental for the development of new companies”, comments Perez, of FAPESP. The prospect of facing up to new hurdles for the commercial licensing of products is worrying companies as well.The São Paul Sugarcane, Sugar and Alcohol Producers’ Cooperative (Copersucar), for example, has now, with the endorsement of the CTNBio, field-tested sugarcane that is resistant to the glyphosate herbicides, in partnership with Monsanto, and to Bt, together with Syngenta. “We have products that could be marketed, but we have been waiting for a legal definition up until today”, says Eugênio Cérsar Ulian, who manages biotechnology for Copersucar.  Faced by the new law, the company may interrupt a study with a sugarcane gene identified as responsible for its flowering, implemented in a partnership with the College of Philosophy, Sciences and Literature of the University of São Paulo (USP), in Ribeirão Preto, with the objective of increasing the productivity of the crops.  “No company researches for the sake of researching”, Ulian explains.

The representatives of the scientific community are proposing to the Senate changes in the text, accrediting the CTNBio as the “sole and definitive instance” for judging the scientific nature of the issue, and that their opinions have as their topics not merely the research activities, but marketing as well. The Ministry of the Environment, they argue, may manifest itself on the subject, in the ambit of the commission itself , which will be made up of 27 doctors, 12 of which “specialists of renowned technical and scientific learning” and 15 representatives of the ministries and the civilian entities.

In the assessment of Esper Cavalheiro, who presided the National Council for Technological Research and Development (CNPq) and the CTNBio, the commission “always had the conditions” for assessing whether a given manipulation may cause damage to health or to the environment. “When they claim that environmental impact studies cannot be judged by scientists, I ask them: Then who should they be judged by? Why should scientists submit their opinion to other scientists who are not on the commission?” says he.

Another controversial point of the project concerns the ban of research with embryonic stem cells. The evangelical caucus in the Chamber, made up of 55 deputies, went so far as to threaten to vote against the project, unless there was a veto on the manipulation of human embryos for the purposes of therapeutic cloning, provided for in Rebelo’s report. They won support from Catholic members of parliament, expanding the quorum to 120 deputies, and even from the National Conference of the Bishops of Brazil (CNBB), which sent representatives to Congress. The result lies in the 5th article of the project: “The following are prohibited: any procedure of genetic engineering on living organisms, or the handling in vitro of natural or recombinant DNA/RNA, carried out without being in accordance with the standards provided for in this law; genetic manipulation in germinal human cells and in human embryos; human cloning for reproductive purposes; production of human embryos intended to serve as available biological material; intervention in human genetic material in vivo, except if approved by the competent authorities, to the end of carrying out a procedure with the purpose of diagnosing, preventing, and treating diseases and their complications, and therapeutic cloning with pluripotent cells.

“Existence as a human being begins with the fusion of the ovule with the spermatozoid.  The embryo is already a life.  We are talking about a religious principle”, is the justification given by Deputy Henrique Afonso, of the Evangelical Parliamentary Front.  For Marco Antonio Zago, from USP’s Ribeirão Preto School of Medicine and the coordinator of the Cell Therapy Center, one of the ten Research, Innovation and Diffusion Centers (Cepids) maintained by FAPESP, the Chamber’s concern is mistaken. “The debate ought to be about what to do with human embryos frozen in clinics”, he suggests. In the assessment of Mayana Zatz, the coordinator of the Human Genome Studies Center – another Cepid – there has been a muddle between the concepts of reproductive cloning, therapeutic cloning, and cell therapy with stem cells. “Reproductive cloning, which would be the attempt to produce a copy of an individual, really ought to be condemned and prohibited”, she points out.

But therapeutic cloning, a technique for transferring the cell nucleus, is just one of the methods for getting stem cells for cell therapy or regenerative medicine. The result of this “muddle” can bring serious losses for research, and put Brazil in the position of depending on importing technology from countries that authorize this sort of investigation.  “We will have to buy this cell abroad, and lose the chance of training personnel who could develop these strains.  It is a landmark in limiting the progress of science in the country”, foresees Lygia da Veiga Pereira, from USP’s Human Genome Studies Center.

Progenitor cells 
Stem cells are progenitor cells that maintain the capacity for differentiating the countless tissues of the human body, Mayana Zatz explains. They can be obtained by the nuclear transfer technique or therapeutic cloning – as has just been announced by the group of South Korean scientists (see page 22) – from an umbilical cord or from embryos.

Using therapeutic cloning or nuclear transfer, Mayana details, it is possible to transfer the nucleus of one person’s cell – from the skin, for example – to an ovule without a nucleus, and this new ovule, in theory, would become capable of producing any tissue of that person in the laboratory, without any risk of rejection. Therapeutic cloning would make it possible, for example, to reconstitute the bone marrow of a paraplegic, or replace the cardiac tissue of someone who has had a heart attack.

This technique, though, could not be used in victims of genetic diseases, since all the cells would have the same defect.  Hence the importance of the researches with stem cells.

There are stem cells in several tissues of children and adults, but in a small quantity. “We do not know yet which tissues they are capable of differentiating themselves into”, Mayana observes. The blood from the umbilical cord is also rich in stem cells, but scientists likewise do not know what the potential for differentiation is of these cells into different tissues. “If researches show that the umbilical cord stem cells will be capable of regenerating tissues or organs, this will, without a doubt, be the most important source for getting them”, Mayana says. In this case, it would be necessary to observe the compatibility between the donor and the receiver, and to create a public umbilical cord bank. If these researches fail to bring the result hoped for, the alternative will be the use of embryonic stem cells that, according to Mayana, are certainly pluripotent, that is, they have the capacity for differentiating themselves into any one of the human tissues.  They can be obtained by means of nuclear transfer – as the Koreans have demonstrated – or from embryos of a poor quality, which would not have the potential for generating a life. “It is fundamental for our legislation to approve this kind of research, because they may, in future, save countless lives.”

Letter from FAPESP to the senators 

Law on Biosafety
Obstacles to scientific and technological research 

The Board of Trustees of the State of São Paulo Research Foundation (FAPESP), meeting on 11/02/04, manifests its great concern with the terms of the Law on Biosafety recently approved by the Chamber of Deputies and presently under discussion in the Senate of the Republic.

In the terms in which it was approved, the law will create serious obstacles to scientific research and to technological development in a sector in which the transfer of technology, from its discovery to its application, is extremely rapid.

In this area, of strategic importance for economic and social development, as well as for national sovereignty, Brazil has conquered a competency equivalent to that of the most advanced countries, a competency that can be turned into a great benefit for the population in the food, agriculture and livestock, and health industry.

FAPESP’s Board of Trustees appeals to members of parliament to listen to the accredited representatives of the scientific community, so as to transform the text of the law into an instrument of progress and technological independence, thus avoiding irreparable damage to the mechanisms for generating knowledge and wealth.

São Paulo, February 11, 2004
Carlos Vogt – President