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European Union: Germline / Embryonic

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Prohibited

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

Germline gene editing for clinical purposes is banned, but it is unclear whether this ban applies to germline gene editing research. Germline editing is regulated by the EU Commission, the European Medicines Agency (EMA) and the Federation of European Academies of Medicine (FEAM). In 2014, the EU Clinical Trials Regulation banned any gene therapy clinical trials which result in modifications to the germline, but did not specify whether non-clinical research is permitted or banned. 15 of 22 Western European nations have additional regulations banning human germline engineering.

The regulatory and ethical guidelines for gene therapy across the EU are guided by the 2000 EU Charter of Fundamental Rights and the 1997 Convention on Human Rights and Biomedicine (Oviedo Convention) of the Council of Europe. The EU Charter of Fundamental Rights, Article 3, prohibits “eugenic practices, in particular those aiming at the selection of persons.” Ratified by 29 of the 47 European states, Oviedo requires that any therapy modifying the human genome “may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.” Critically, Oviedo requires “public debate” on the ethical and scientific implications of gene editing.

There is considerable confusion as to Oviedo’s restrictions on research. Genome editing for therapeutic or preventive purposes, in which the modification of the descendant’s genome is not the aim but is incidental to the process, might still be in accordance with Oviedo. It provides for the freedom of scientific research, subject to the protection of human rights, which it is believed protects the right for researchers to do germline editing as part of pure research. Yet, while Oviedo allows research on human embryos in vitro, Article 18.2 prohibits the creation of human embryos for research. Therefore, the recent experiments reporting genome editing of human embryos in the US, Japan, China or other countries to erase a heritable disease are not allowed.

Eighteen European countries have not ratified or signed the regulations, including Italy, Sweden, UK, Germany, Austria, Russia, and The Netherlands, in part because of the limits it puts on embryo research.

After a Chinese scientist altered the DNA of human embryos that were carried to term, many European researchers joined an international call in 2019 for a global moratorium on all clinical uses of germline editing. Some European research societies published a consensus statement condemning the acts of the Chinese scientist.

Products/Research

None

Regulatory Timeline

2018: Germany’s Citizens’ Delphi Germline Therapy project at Karlsruhe Institute of Technology (KIT) calls for the loosening of bans on germline gene editing research in Germany.

2017: Council of Europe (PACE) of 47 member States recommends forbidding establishing pregnancies from genetically modified gametes or human embryos, and urges member States that have not yet ratified the Ovideo Convention to do so.

2017: The European Society of Human Reproduction and Embryology (ESHRE) and European Society of Human Genetics (ESHG) develop recommendations for human germline gene editing.

2017: France amends its Civil Code prohibiting ‘the violation of the integrity of the human species and any eugenic practice aimed at the selection of persons.’

2014: EU Clinical Trials Regulation is passed, which bans germline gene therapy clinical trials.

2007: EU Commission Regulation on advanced therapy medicinal products finalized, which outlines the procedure for gene therapy approval.

2001: Directive on medicinal products for human use finalized.

2000: EU Charter of Fundamental Rights, which has primacy over domestic law, establishes a ‘respect for human dignity’ as the key principle in guiding human genome editing regulations.

1997: European Convention on Human Rights and Biomedicine (Oviedo Convention) passed the first and only legally binding treaty on bioethics. 29 of the 47 member States issued regulations that the human genome can be modified only for “preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.”

1990: Germany’s Embryo Protection Act bans pre-implantation diagnostics except in cases involving a high risk of serious genetic diseases “to identify an abnormality that would be highly likely to lead to still-birth or miscarriage.”

1988: European Medical Research Council first declares a formal stance against germline gene therapy.

NGO Reaction

Many European ethics committees and other organizations argue that germline gene editing is potentially dangerous and could lead to irreversible harm. They endorse a continued ban on clinical applications, at least until more research is done to understand the technologies behind germline gene editing. Others oppose it on ethical grounds, believing that gene editing would allow the selection against children with (or at risk of) certain genetic diseases, thereby stigmatizing humans and allowing for a eugenic expansion of definitions of “healthy,” “disease”, and “disability.” Many other researchers believe the restrictions, which date back almost two decades, need updating to include the kind of non-clinical gene editing research now regularly undertaken in the US and other countries. The Ethics Council of the Max Planck society argued in a discussion paper in 2019 that the health of patients would need to be monitored over several decades to rule out side effects in future generations.

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
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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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