America and China are leading the development of new gene editing technologies via GMO production and bringing CRISPR to the clinic. Why is Europe behind?
Gene editing technologies have revolutionized genetics and mark a new generation in biomedical and agricultural sciences. There’s no limit to possible applications: they’ve grown to include the treatment of human genetic disorders such as cystic fibrosis, autism and cancer; crop modification to produce higher yields and manage climate change; and breeding livestock with specific properties.
But while China and the US are launching groundbreaking human clinical trials with CRISPR/Cas9, Europe seems to remain on the sidelines of the gene editing buzz. The possible reasons may be EU’s distinct political, economic and societal circumstances that have resulted in overly vigilant government regulations of these novel technologies. Can EU Biotech catch up with the global gene editing race?
Gene editing technologies using nucleases such as Zinc Finger Nucleases, TALENs and the latest CRISPR/Cas9 are mechanistically distinguished from the earlier transgenic technologies used to create the largely controversial GMOs. They don’t introduce foreign, usually bacteria-derived DNA to the organism in an unspecific manner. Instead, the modern nucleases cut the DNA strand very precisely at the desired location and then rejoin the together to preserve deletions or insertions of the target genes; the enzymes are then degraded without a trace. Despite the method’s accuracy, it’s not perfect yet as unintentional modifications to the DNA can occur when the repair mechanism is activated.
As the world’s population and average temperature increase, the demand for larger and more nutritious harvests and climate-adaptable crops is also increasing. The application of gene editing technology to agriculture allows for an efficient and accurate mode of genetic manipulation to meet these growing needs. Moreover, gene editing is fundamentally similar to classic breeding methods, so the backlash may seem unreasonable.
With this perspective, the US government has a relatively friendly policy for GMO’s: the regulation of genetically modified plants is not based on the method but rather the product’s properties and intended applications, like whether the novel plant has pest-like properties and how safe it is for its intended use. This policy was established after the commercial potential of biotechnology products became apparent, and the previous more restrictive regulatory approach was dismissed.
On the other hand, European regulatory agencies consider the method key, especially for a novel technology like CRISPR/Cas9. Indeed, because gene editing methods have some off-target events with still unknown consequences, the EU has instituted stricter safety regulations and labeling requirements. Unfortunately, they have barred many products from the market, and the separation of regulatory agencies for the Union and member countries creates additional hurdles.
Consequently, nearly three-quarters of all GM crops are from the US and almost none are from Europe. Novel gene editing products are in danger of being tagged the same way, which would likely hobble research efforts in a race the continent is already losing.
One possible reason for EU’s stringent food and agriculture regulation is economic protectionism dating back to the union’s foundation. This attitude could be rooted in lessons of the Second World War: forming close economic and industrial collaborations between the European economies ensures food availability and aims to prevent new wars in the region.
In a similar vein, food availability and safety requires strict regulation, which is why all stages of food production, including seed acquisition, are kept inside the EU. This policy helps explain why GMOs, produced mainly in the USA, are perceived as a threat to the European food safety and why gene editing technologies may suffer a similar fate in the EU.
Since the EU has not updated the regulatory strategy for gene editing of plants and livestock, human clinical trials in Europe seem unlikely to begin in the near future. The current clinical applications of gene editing technologies in humans are performed ex vivo, including the first CRISPR/Cas9 trials: patient’s own cells are extracted, genetically modified, analyzed for the success of the modification and reinfused back into the patient.
Since no transgenic DNA is introduced into the patient, the risk for a hazardous immune reaction is minimal. In addition, the nucleases will only be present in the body for a short period of time so only the joining step will continue; without the cutting step, off-target effects can be limited. Moreover, previous trials using viral vectors have shown that off-target mutagenesis is unlikely to have ill effects.
While ex vivo gene editing is the simplest application of the novel technology, the prospect of someday using it to edit in vivo is already on the horizon. The process of editing nuclear human DNA, called “human germline modification,” has been the subject of global ethical debate long before gene editing was possible. Critics have argued that gene editing is unethical since the future generations, who will inherit the altered DNA, did not consent to the procedure nor potential adverse effects.
Another worry is that gene editing will resurrect eugenics, harkening back to the attempt to create a Master Race in the early 20th century. Unethical experimentation on humans during WW2 still haunts the collective European consciousness, and these ghosts may weigh too heavily on the ethical debate to allow more liberal gene editing regulation.
Historically, attempts to restrict or direct scientific discovery for ethical or other reasons have negatively impacted humankind in the fields of healthcare, education and general well-being and progress. That said, some regulation of scientific research practices is called for when human rights or public safety is threatened. Finding the middle ground is therefore crucial. Only time will tell whether EU’s overly-cautious approach to gene editing is justified or mistaken that renders its biotech in this field obsolete.