Brazil

Brazil has only just legalised research with human stem cells, after a lbattle in Congress of nearly ten years. The bill, approved in March 2005, authorises the use of stem cells in research and therapy. It allows the use of stem cells up to five days old that cannot be used further in the IVF process and unused embryos that have been frozen for at least three years. Donors must give authorisation. According to estimates, there might be up to 30,000 embryos that meet these conditions in Brazil today.

The use of cloning techniques in order to obtain human embryos is prohibited, whether the objective is therapeutic cloning or human cloning. Genetic engineering in embryos, eggs and sperm is not allowed.

As the approval is recent, Brazil is in the very early stages of research, but keen to go forward and powered by an engaged scientific community. Despite the Federal government's interest, there are no central figures on how many stem cell lines, adult or embryonic, currently exist in Brazil.

On a separate but related matter, it is worth mentioning that assisted reproduction in Brazil is considered to be at a high level, both of development and application.

Brazil is well placed in the area of animal stem cell research. Embrapa (Brazilian Agricultural Research Corporation) has cloned cows and successfully produced bovine, equine and caprine identical twins through embryo bipartition. They are working on GM animals with characteristics such as blood coagulation factors to be used in the production of plasma derived products, for example.

In April 2005, after the bill was sanctioned by President Lula, the Government launched an edict to finance research projects on embryonic stem cells amounting to R$ 11 million (£2.5m), to be split by the ministries of Health and Science & Technology this year. The edict will finance basic and pre-clinical research related to the development of therapeutic procedures using adult stem cells from bone marrow, umbilical cord and embryonic stem cells. The Brazilian Industrial Development Agency (ABDI) and the Ministry of Science & Technology launched 20 edicts in April, including a stem cell programme, worth R$ 2.5 million (£580k). At a state level, the Human Genome Research Centre, which sits within the University of Sao Paulo, is one of the ten centres of excellence with 10-years of guaranteed funding from FAPESP, the São Paulo State Funding Agency. Their work has been divided into two major areas: genomic research and stem cell research.

Another of the FAPESP centres of excellence is the Centre for Cell-based Therapy, which is also part of the University of São Paulo but is located in the upstate campus of Ribeirão Preto. They focus on autologous stem cell transplantation, cord blood transplants, applied to the treatment of hematopoietic malignancies, melanoma and autoimmune diseases, amongst others.

A group formed by members of government and researchers was created to define priority areas for funding and policy. The government has settled on an initial programme (the heart disease project described below), but the group basically decided to see what ideas would arise from the edicts mentioned above before trying to channel resources into specific areas.

The ministries of Health and Science & Technology jointly launched a national study on the efficiency of injecting stem cells to treat heart diseases. Four cardiac pathologies will be researched for three years, nearly 40 institutions are involved and a group of 1,200 people were selected to take part. The Laranjeiras National Cardiology Institute in Rio is conducting the study and the funds being invested are R$ 13 million (£3m).

The Ministry of Health has also revived five umbilical cord blood banks, destining R$ 24 million (£5.6m) to incentive bone marrow donation. The Clinical Hospital of Porto Alegre will host the first public umbilical cord blood bank of the south region of Brazil. The Bank aims to increase the numbers of donors for bone marrow transplant.

The University of Sao Paulo has successfully tested the use of stem cells as a treatment for diabetes. It is the first time that diabetes has been treated through cellular therapy.

At the Human Genome Research Centre, they work with human and animal stem cells. Research is carried out on neuro-muscular diseases, cranio-facial problems and animal models.

Brazil is still at a very early stage regarding human stem cells, but quite advanced in veterinary stem cells, which are important models for research on humans. However, the legal issue is finally being dealt with and the science community is very keen and engaged.

In order to carry out research with stem cells, research groups must submit their projects to their institution's ethics committee, as well as to CONEP (National Council for Ethics in Research), that sits within the Ministry of Health. Now that the Bio-safety bill has legalised stem cell research, work is being carried out on the regulatory details of the law. The Casa Civil - Brazilian equivalent of the Cabinet Office - is in charge of this work and they are discussing details such as how to distinguish an embryo that can or cannot be used in an IVF process. The regulatory framework that will accompany the legislation will also establish the degrees of control over groups carrying out this kind of research, and other important issues. Scientists are closely watching these developments and trying to feed in to the debate. They are especially concerned with restricting access to embryos to carefully selected groups. In all, the regulatory and ethical environment is still in the process of establishing itself, but for that reason, it presents a great opportunity for engagement with the UK (see below).

There is no lack of interest by Brazilian students/researchers. The major problem is the cost of living in the UK. Scholarships offered by the government are meagre and internationally sponsored bursaries are few.

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