By Marcel Kuntz*
The so-called gene (or genome) editing techniques are already massively used in biological science laboratories to generate valuable knowledge. They also promise great advancements in various applied fields. However, many are worried after the European Court of Justice (ECJ) issuing a ruling last year saying organisms obtained by mutagenesis (the simplest use of gene editing, sometimes indistinguishable from natural mutations) should be considered as GMOs.
Consequently, the EU’s GMO directive could create a new impediment for innovation, just like what happened to classical transgenesis.
The public debate over gene editing often focuses on “New Plant Breeding Techniques” which are a group of innovations that can increase the speed of plant genetic improvement. However, in the current regulatory context, a number of breeding companies are considering relocating their advanced mutagenesis breeding programs outside Europe “if nothing is done to change EU rules”.
A growing influx of patented inventions involving gene editing
However, gene editing is not limited to plants. To shed light on the diversity of potential applications, we have compiled and analyzed all patents filed on inventions involving a CRISPR type of mutagenesis, which has become the most popular tool for gene editing, using so-called molecular scissors (the most famous being CAS9). We choose to examine patents since if a laboratory decides to file a patent application it means that it considers its invention to be promising for practical use, or at least of strategical importance.
Our landscape of CRISPR (CAS 9 and other “scissors”) patenting, recently published in Nature Biotechnology, collected more than 2000 patents and reveals a great diversity of applications in the medical, industrial, or agricultural fields, and of actors (both public and private). In the medical field, 100 diseases are concerned by these inventions, including 131 patents against cancer and 112 against viral diseases.
The EU has the Precautionary Principle while China and the USA own the patents
Strikingly, a novel geopolitical balance of forces has emerged in this crucial biotechnological field. As is known, laboratories in the USA played a pioneer role in the original invention, and laboratories in this country remain leaders in technical improvements and in the medically applied sector. However, China is now taking the lead in the industrial and agricultural (plants and animals) sectors. China overtook the USA as early as 2016 in the total number of CRISPR patents per year.
No less striking is the fact that the number of CRISPR patents originating from Europe trails far behind the USA and China. We explain the strong position of China by massive investments of course, but also by a deliberate strategy of power, which sadly is absent in the EU.
To say it bluntly, the EU has the Precautionary Principle while China and the USA have the patents! Europe suffers from a “cultural” reluctance to file patents and from its inability to overcome the GMO controversy. The weakened position of Europe is also observed for gene editing patents in relation to public health (which is not a controversial biotechnological field as is the agricultural one).
How can Europe avoid vassalisation by other economical empires?
As the current EU Health Commissioner Vytenis Andriukaitis has said: “we need a new legal regulatory framework for these new techniques”. In this context, a coalition of 14 EU member states are calling on the next European Commission to update EU GMO laws. The Commission’s Scientific Advice Mechanism (SAM) also recommended revising the existing GMO directive in order to “reflect current knowledge and scientific evidence, in particular on gene editing and established techniques of genetic modification” .
The SAM’s proposition for an “evidence-based, implementable, proportionate and flexible” regulation is not different from our own suggestions in 2016, which included a plea for a product-oriented regulatory system, in agreement with dozens of scientists and academies. Importantly, “product” should not be understood as the DNA construct, but as the final product which goes on the market.
In other words, what we need is not some kind of surgical improvements of the current GMO directive, which is based on the method used to obtain a biotechnological product. This would inevitably lead to a nonsensical regulatory burden on new biotechnologies.
It has to be recognized that the GMO directive, and the whole “GMO” concept, were dire mistakes and have contributed to destroy entire promising fields of biotechnologies in Europe and in many other regions of the world, with no benefit for health and environment (just the opposite actually!)
More many years, scientists have attempted, in vain, to alert political authorities about the negative consequences of the current regulatory burden on biotechnology. As part of a consortium over 13 European countries, we could document, with figures in support, that the current anti-GMO political situation in Europe is an impediment to research in order to address agricultural challenges in the future. This is simply not a sustainable path.
Neither is to let USA and China becoming the exclusive producers of biotech innovation. It is not a “robust response to the EU court’s ruling” that is needed, but an urgent double change of paradigm: a more scientific approach of regulation, and on the other hand a strategical vision of biotechnology for Europe.
*A researcher at the French Centre national de la recherche scientifique
**First published in euractiv.com
By: N. Peter Kramer
