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Ukraine: Germline / Embryonic

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Ongoing Research, Regulations In Development

Germline gene editing research is being conducted, but no regulations specifically address germline gene editing for research or clinical purposes.

Ukraine has no explicit regulations directly addressing the germline gene editing of embryos for research or clinical purposes. However, a form of germline gene editing is being used in clinics to help women who are infertile have a baby.

Mitochondrial replacement therapy (MRT), popularly known as ‘three-parent IVF’, was developed to help women avoid having a baby with certain mitochondrial genetic diseases but can also help women whose IVF treatments have failed have a baby. The UK is the only country that has officially approved the procedure.

A fertility doctor in Ukraine reportedly has used MRT in numerous successful births since May 2017. He says he has received approval for a five-year research program from health authorities although he has not registered the trial with the European clinical trial database. The doctor has reportedly worked with patients from Sweden, Britain, Brazil, Israel and perhaps other countries, and is marketing he procedure in the United States, where it is illegal.

In 2002, Ukraine signed the Council of Europe’s Oviedo Convention, which bans interventions and modifications in the human germline and prohibits the creation of human embryos for research, but Ukraine never ratified the treaty.

Products/Research

  • Mitochondrial replacement therapy: A fertility doctor in Kyiv, Ukraine reportedly has used MRT, popularly known as ‘three-parent IVF’, in multiple births since 2017.

Regulatory Timeline

2002: Council of Europe’s 1997 Oviedo Convention signed, which bans all interventions and modifications in the human germline and the creation of human embryos for research. Ukraine has not ratified the convention.

NGO Reaction

The US-based Center for Genetics and Society, which is opposed to MRT, has called the doctor’s research program “troubling” and a “slippery slope”. Some scientists, such as Dietrich Egli, a professor of developmental biology at Columbia University Medical Center, have called this work “pioneering”. A U.S. National Academy of Sciences panel concluded in 2015 it could be ethical to attempt the procedure to help women carrying mitochondrial disorders, which can be fatal, to have healthy children, and should be encouraged.

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

Swipe right/left if all columns aren't visible

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
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

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