When philosopher George Santayana said more than a century ago that those who do not learn from history are doomed to repeat it, he could have been predicting the European Union and its approach to genetically modified (GM) organisms.
As we report in a News story, the EU is dragging its feet over a legal ruling that could affect research and innovation for years to come. At stake is the use of gene-editing tools such as CRISPR–Cas9, which are revolutionizing biology. These techniques should theoretically trigger few safety alarms, yet they may be snared by the onerous legislation that has already added layers of bureaucracy to research involving conventional genetic engineering, and has slowed the cultivation of GM crops almost to a standstill in many nations.
The new tools can be applied to create mutations that could have occurred naturally, and leave no trace of foreign genes in the product. Accordingly, the US Department of Agriculture has ruled in several cases that the products do not have to be regulated as GM organisms.
The European Commission is yet to send the same signal. In fact, it could decide that such products are governed by the existing cumbersome rules — its 2001 directive on the deliberate release of GM organisms into the environment. That would be a disaster for research.
The commission represents the interests of 28 member states, which are deeply divided on issues of genetic modification. But it needs to make clear — soon and with no room for misinterpretation — that work with these new techniques is important and does not necessarily need to be regulated in the same way as the previous generation of GM crops.
The precise and efficient gene-editing tools insert a gene that can create tiny, targeted mutations in an organism’s own genome. These mutations can permanently change the function of a host gene, change its sensitivity to environmental cues or switch it off entirely; the foreign gene can then be bred out.
The core legal issue is whether the 2001 directive applies to all products of genetic engineering, or only to organisms that have been altered in a way that could not occur naturally. Clauses in the directive mention both.
Non-governmental organizations that are hostile to genetic engineering say that the directive is about the process by which products are created. But legal analyses conducted in the past year by several member states — including Germany, which has been opposed to conventional GM crops — concluded that it is fundamentally about the products themselves.
“Letting a court decide a political issue is a poor option.”
The commission’s own legal analysis, being handled behind firmly closed doors, is the one that will count. But the result has been repeatedly delayed, spreading immense uncertainty in the scientific community.
It is now promised before the end of March. Why is it taking so long?
The commission has strongly hinted that the matter will ultimately be settled in court. Its decision, when it comes, is bound to annoy parties on one side, which may then sue. The possibility that a decision that releases many gene-edited products from GM regulation could be overturned by a court will add to the community’s uncertainty.
There is some history here, and it should not be repeated. The commission tried, and failed, to resolve the lengthy disagreement over conventional GM crops by getting the European Court of Justice to rule on whether member states should be required to allow cultivation of such crops deemed safe by EU regulatory authorities. The court ruled that they should, but some countries banned it anyway. In a messy compromise, the EU now allows individual states to opt out.
The commission may be calculating that the reaction to a court ruling could be different this time, as a result of member states signalling their willingness to consider gene-edited products to be non-GM.
But letting a court decide a political issue is a poor option. It could take years. Even a positive verdict could rebound by reinforcing the narrative in some countries that the technology is being forced upon them. And it does not convey a positive message about legislation, which is supposed to reflect the will of the people.
The commission should indicate that the spirit of the 2001 directive does not cover the impact of the new gene-editing tools, and should give them an appropriate green light — with encouraging enthusiasm. If the exact wording of the 2001 directive gives room for doubt, then it should be updated to reflect a world in which new science has long overtaken the old.
Whatever the decision, the uncertainty must be lifted to allow research to proceed, and quickly.
- Journal name:
- Date published: