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Brazil: Therapeutic / Stem Cell

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Highly Regulated

Gene therapy is permitted but highly regulated and research is ongoing.

In 2019, a measure was approved by the Brazilian Health Regulatory Agency (Anvisa) to regulate gene therapy as a drug and to establish specific criteria for clinical studies using gene therapy. Because the measure clarified the approval process for gene therapy research, it is expected to increase gene therapy research being conducted. Additional legislation is expected to be finalized later this year, which will include specific regulations outlining how to file applications for registration of new gene therapy drugs.

Gene therapies are regulated by Anvisa, which is responsible for clinical trial oversight, approval, and inspections for drugs registered in Brazil. Prior to 2019, it was unclear whether gene therapy products would be regulated as drugs or as human tissues. In 2019, the agency approved RDC #260, which establishes gene therapy as a drug and created the regulatory framework for advanced cell therapies including gene therapy. No gene therapies have been approved or registered yet.

Products/Research

  • Prostate cancer in mice: In 2019, researchers at the São Paulo State Cancer Institute (ICESP) used gene therapy to destroy tumor cells upon injection into mice with prostate cancer and to make tumor cells more sensitive to chemotherapy drugs. More studies will be conducted before clinical trials in humans begin.
  • Fungal infections: Researchers used stem cell therapy to treat patients with a genetic mutation that causes them to be more susceptible to fungal infections.
  • Heart disease: Researchers conducted clinical trials to test gene therapy to reduce symptoms of refractory angina, a coronary artery disease.
  • Head and neck cancer: Researchers at the University of Sao Paulo tested gene therapy as a treatment for advanced head and neck carcinoma.

Regulatory Timeline

2019: Anvisa approves RDC #260, which establishes specific criteria for gene therapy research and development and opens the door for more gene therapy research.

2018: Anvisa approves RDC #214, which establishes regulations for clinical research using human cells.

2012: The National Health Council passes CNS Resolution #466, which provides a general framework for human research ethics.

1995: Brazil passes Law No. 8.974, which establishes safety and inspection requirements for genetic engineering in agriculture and humans. The aim is to protect human, animal and plant health as well as the environment. It establishes which manipulation methods would be prohibited.

NGO Reaction

None

Additional Resources

 

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which human / health products and processes are approved or in development and their regulatory status.

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Human / Health Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Gene and stem cell therapies regulated with minimal restrictions and requirements.
*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.

Therapeutic:
Gene editing of adult human cells, including gene therapy and stem cell therapy, that is used to treat and cure disease. Recent breakthroughs include CAR T-cell therapy, which uses patients’ own immune cells to treat their cancer.
Germline:
Gene editing of the human embryo or germline that results in genetic changes that are passed down to the next generation. This type of gene editing is the most controversial because changes are inherited and because it could theoretically be used to create “designer babies”. A Chinese scientist announced in 2018 that he had successfully edited twins that were brought to term. International backlash from the announcement has resulted in China and other countries working to clarify regulations on germline gene editing.

Rating by Country / Region
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Country / RegionTherapeuticGermlineHuman Rating
Japan888
Brazil402
Canada402
Russia1057.5
Argentina513
Israel825
Australia402
China846
US402
Chile412.5
New Zealand402
Ukraine1057.5
Central America111
Paraguay111
Uruguay111
India402
UK444
Mexico804
EU402