In terms of setting the guidelines for contemporary genetics, modern laws can sometimes seem as antiquated as the Magna Carta. In 2001, the European Union adopted key policies that govern the use of genetically modified organisms (GMOs) in agriculture — but that was more than a decade before the CRISPR technique, a more efficient, cheaper method of gene editing, rose to prominence. On Jan. 18, the advocate general to the European Court of Justice, Michal Bobek, issued a preliminary opinion regarding the interpretation and classification of new and evolving gene-editing techniques, such as CRISPR, as they relate to the European Union's stringent GMO regulations. The bloc is currently waiting for a court decision on the matter, but the possibility of legislative change has given hope to agricultural biotechnology companies and researchers that their techniques, which can increase crop yields and alter the specific properties of organisms, may soon obtain a modicum of approval on a continent that has long taken a dim view of such activity.
Time to Widen the Loophole?
Bobek issued his opinion in response to a motion for clarification from French agricultural unions regarding regulations in EU policy and the French Constitution. In 2001, the European Union's policymakers did not specifically foresee the advent of CRISPR, but they did open a loophole in the legal framework by permitting "mutagenesis exceptions" — that is, exceptions for the altering of the genetic makeup of a living organism through either natural or unnatural processes. More than a decade and a half later, Bobek's opinion and other discussions about the semantics of the "mutagenesis exception" have given hope to companies in Europe that are eager to use and ultimately profit from gene-editing technology.
The judge's opinion for the court, however, does not call for full separation between genetic editing and the current definition of genetic modification, which entails inserting the genetic material of one organism into another. Instead, Bobek states that gene-editing techniques can benefit from the mutagenesis exception if they do not involve the use of recombinant nucleic acid molecules. Bobek's opinion effectively separates transgenesis, the insertion of foreign genetic material into a plant or animal, from types of genetic editing that do not use such practices. For academic laboratories and companies that use gene-editing techniques to alter the properties of plants through the deletion of portions of DNA without inserting foreign material, this distinction could eventually limit costly regulatory hurdles in introducing such a plant to the market.
The opinion also charts a potential path for the adoption of new regulations. According to Bobek, when the European Commission passed the legislation in 2001, it never sought to regulate mutagenesis techniques on a continentwide basis, but effectively delegated that responsibility to individual nation-states. Therefore, any ruling based on the Bobek opinion could lead different practices regarding gene editing to emerge in different EU states. France would likely be the most resistant to permitting the use of gene-edited crops, while Greece and the United Kingdom (for as long as it is required to abide by EU guidelines) would likely be the most receptive. But despite the possible legislative breakthrough, technical patent rulings in EU courts against the Broad Institute, the key patent holder in the United States for CRISPR technology, indicate that biotech companies may be required to lease multiple patents to engage in such gene editing. Nevertheless, there is hope in the industry that potential clarification on EU regulations — currently some of the strictest in the world, making it difficult for academics and smaller biotech companies to introduce a product to the market due to high costs — will not apply to new products that were developed using technology like CRISPR.
Weighing the Options
As the European Court of Justice deliberates, other jurisdictions around the world are also grappling with the potential regulatory changes that may come from advances in genetic technology. The United States, for example, has traditionally taken a more lenient view on GMOs and has thus far exempted gene-edited compounds from GMO regulations on a case-by-case basis. Though the country has not yet passed official legislation on the matter, the U.S. Department of Agriculture (USDA) submitted a proposal in January 2017 to differentiate the techniques — only to revoke the proposal 10 months later. Still, recent USDA decisions, including the approval of a CRISPR-edited mushroom that turns brown more slowly, suggest that a loose regulatory structure will prevail in the near future.
Australia, another major agricultural producer, is also wrestling with the prospect of new regulations. Current rules on genetic modification encompass any artificial alteration of a plant or animal and subject products to significant regulation and extra development cost, although legislators are currently evaluating whether to differentiate between the types of modification. In China, too, the development of domestic biotechnology has become a key imperative for Beijing, and the country's scientists remain on the cutting edge in the use of the technology.
The actions of Europe, Australia and the United States indicate that much of the world will seeks to distinguish between the genetic editing of plants and animals and traditional, transgenic GMOs (and the reputation they have acquired). Such a distinction would permit a more rapid incorporation and dissemination of such products — be it a mushrooms that retain their color longer or grains that boast enhanced nutrient levels — to reach markets faster and with lower costs. The evolution of this single technology's relationship with policy is just one example of the push and pull between emerging, potentially disruptive technologies and policy that is constantly playing catch-up. As policy comes into line with today's reality, the door for potential business opportunities is opening in some of the most unexpected places.