Countries in Central America have not determined the regulatory status of gene and stem cell therapy. There is little research and no products in development.
Products/Research
None
Regulatory Timeline
None
NGO Reaction
None
Additional Resources
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.
| 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 |
†Proposed: No Unique Regulations: Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.
| 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 |
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.
