Brazil: Germline / Embryonic

PROHIBITED
Germline gene editing is specifically banned, but regulation is lacking.

Germline gene editing is banned by a resolution and a law. The CNS Resolution #340, finalized in 2004, allows human genetic research on somatic (adult) cells only. In 2005, Law No. 11.105 was passed, which bans genetic engineering in “human germinal cells, human zygotes and human embryos”. However, the law primarily focuses on regulating genetically modified crops and does not specify enforcement or punishment for germline gene editing.

Human gene editing is regulated by the National Biosafety Technical Commission (CTNBio), which sets and enforces rules for GMO research, and by the National Committee for Ethics in Research, which is responsible for human research ethics.

Products/Research

None

Regulatory Timeline

2015: Federal Council of Medicine (CFM) Resolution #2121 passes, which allows research using discarded human embryos from assisted reproduction processes, but there is no specific mention of gene editing.

2012: The National Health Council passes CNS Resolution #466, which provides a general framework for human research ethics and requires that all research must be evaluated by an ethics committee.

2005: Brazil establishes the National Biosafety Technical Commission (CTNBio) under Law No. 11.105 to set rules for laboratories and establish authorization procedures for GMO research and to provide for the punishment of administrative violations and criminal offenses. The law bans genetic engineering in human germinal cells, human zygotes and human embryos.

2004: The National Health Council passes CNS Resolution #340, explicitly banning germline gene editing

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 countries (eg. Brazil, US) or regions (eg. European Union) to find what agricultural products or therapies are approved or in development and their regulatory status.

Hotspots Background

EUROPEAN UNION

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

BRAZIL

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

NEW ZEALAND

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

UNITED STATES

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

AUSTRALIA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 

Gene Drives

 

CANADA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

CHINA

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives

 

UNITED KINGDOM

 

Agricultural Gene Editing
- Crops / Food
- Animals

 

Human Gene Editing
- Therapeutic / Stem Cell
- Germline / Embryonic

 
 

Gene Drives