Brazil: Therapeutic / Stem Cell

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

Genes and Science’s FAQ on gene editing
Library of Congress summary of Brazilian gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities

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.

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 Status	Rating
Determined: No Unique Regulations*	10
Lightly Regulated	8
Proposed: No Unique Regulations†	6
Ongoing Research, Regulations In Development	5
Highly Regulated	4
Mostly Prohibited	2
Limited Research, No Clear Regulations	1
Prohibited	0

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
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / Region	Therapeutic	Germline	Human Rating
Japan	8	8	8
Brazil	4	0	2
Canada	4	0	2
Russia	10	5	7.5
Argentina	5	1	3
Israel	8	2	5
Australia	4	0	2
China	8	4	6
US	4	0	2
Chile	4	1	2.5
New Zealand	4	0	2
Ukraine	10	5	7.5
Central America	1	1	1
Paraguay	1	1	1
Uruguay	1	1	1
India	4	0	2
UK	4	4	4
Mexico	8	0	4
EU	4	0	2

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

Gene Drive 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 Status	Rating
Determined: No Unique Regulations*	10
Lightly Regulated	8
Proposed: No Unique Regulations†	6
Ongoing Research, Regulations In Development	5
Highly Regulated	4
Mostly Prohibited	2
Limited Research, No Clear Regulations	1
Prohibited	0

Lightly Regulated: Gene drives regulated through existing biotechnology laws.

*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.

Gene Drives:

Genetic engineering technology used to transmit a characteristic throughout a wild population. For example, it can be used to develop mosquitoes that only have female offspring. If released into the wild, these mosquitoes would breed with wild malaria-carrying mosquitoes and over time would eliminate the population. Scientists are interested in using this technology to help eradicate disease-carrying insects and control invasive species, but questions about how gene drives will be directed and controlled are still being fleshed out.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / Region	Gene Drives	Gene Drive Rating
Japan	1	1
Brazil	8	8
Canada	8	8
Russia	1	1
Argentina	1	1
Israel	1	1
Australia	4	4
China	1	1
US	4	4
Chile	1	1
New Zealand	4	4
Ukraine	1	1
Central America	1	1
Paraguay	1	1
Uruguay	1	1
India	1	1
UK	2	2
Mexico	1	1
EU	2	2

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which agriculture products and processes are approved or in development and their regulatory status. The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs.

Agriculture 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 Status	Rating
Determined: No Unique Regulations*	10
Lightly Regulated	8
Proposed: No Unique Regulations†	6
Ongoing Research, Regulations In Development	5
Highly Regulated	4
Mostly Prohibited	2
Limited Research, No Clear Regulations	1
Prohibited	0

Lightly Regulated: Some or all types of gene editing are regulated more strictly than conventional agriculture, but not as strictly as transgenic GMOs.

*Determined: No Unique Regulations: Gene-edited crops that do not incorporate DNA from another species are regulated as conventional plants with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene-edited crops that do not incorporate DNA from another species would no require unique regulations beyond current what is imposed on conventional breeding.

Crops/Food:

Gene editing of plants and food products. Research and development has mostly focused on disease resistance, drought resistance, and increasing yield, but more recent advances have produced low trans-fat oils and high-fiber grains.

Animals:

Gene editing of animals, not including animal research for human drugs and therapies. Fewer gene edited animals have been developed than gene edited crops, but scientists have developed hornless and heat-tolerant cattle and fast-growing tilapia may soon be the first gene edited animal to be consumed.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / Region	Food / Crops	Animals	Ag Rating
Japan	8	8	8
Brazil	10	10	10
Canada	8	8	8
Russia	5	5	5
Argentina	10	10	10
Israel	10	5	7.5
Australia	8	8	8
China	5	5	5
US	10	4	7
Chile	10	1	5.5
New Zealand	4	4	4
Ukraine	1	1	1
Central America	6	6	6
Paraguay	10	10	10
Uruguay	6	6	6
India	6	6	6
UK	2	2	2
Mexico	1	1	1
EU	2	2	2
Colombia	10	1	5.5

Global gene editing regulatory landscape

The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs. Regulations across 34 countries where transgenic or gene edited crops and animals are commercially allowed (as of 12/19) are guided in part by two factors:

(1) Cartagena Protocol on Biosafety [https://bch.cbd.int/protocol/]

Whether the country has ratified the international agreement that took effect in 2003 that aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from biotechnology that may impact biological diversity, also taking into account potential risks to human health. It entered into force for those nations that signed it in 2003. It applies the ‘precautionary approach as contained in the Rio Declaration on Environment and Development. The US, Canada, Australia and Chile and the Russian Federation have not signed the treaty.

(2) Product v process

Whether regulations are based on the genetic process used to create the trait (conventional, mutagenesis, transgenesis, gene editing, etc.) or the final product.Transgenic crops and animals (aka GMOs) are product regulated in many countries including the US and Canada, while the EU, India, China and others regulate based on how the product is made. There is almost an equal number of countries with product- and process-based regulations. It’s not clear how much this distinction matters. It’s somewhat true that countries with product-based regulation have more crops approved and the approval process is more streamlined, but there are contradictions. For example, Brazil and Argentina have emerged as GMO super powers using different regulatory concepts, while there is no GMO commercial cultivation in Japan, North Korea, and the Russian Federation, which employ product-based regulations. How this will effect gene editing regulations is also unclear. For example, Japan, which has no commercialized GMOs, is emerging as a leader in the introduction of gene edited crops.

A Public Resource Compiled by the

Brazil: Therapeutic / Stem Cell

Highly Regulated

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

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.

European Union

Brazil

New Zealand

United States

Australia

Canada

China

United Kingdom

Israel

Argentina

Japan

Mexico

Russia

Chile

Uruguay

Paraguay

India

Africa

Ukraine

Southeast Asia

Central America

Colombia

Norway

Ecuador

Africa

Argentina

Australia

Brazil

Canada

Central America

Chile

China

Colombia

Ecuador

European Union

India

Israel

Japan

Mexico

New Zealand

Norway

Paraguay

Russia

Southeast Asia

Ukraine

United Kingdom

United States

Uruguay

Human / Health Gene Editing IndexCompare Regulatory Restrictions Country-to-Country

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