Has the EU lost its way on gene-editing?

http://ipkitten.blogspot.com/2019/09/has-eu-lost-its-way-on-gene-editing.html
A year ago, this Kat reported on the surprise ruling by the CJEU that organisms obtained by gene-editing should be considered genetically modified organisms (GMOs). The consequence of this ruling was that gene-edited food products became subject to the stringent regulatory requirements laid down by the GMO Directive (Directive 2001/18/EC) (IPKat post here). 

The CJEU decision was met with dismay by European research institutes and agri-tech industry. The EU has been criticized for not basing its policy on the scientific evidence. The EU is also notably at odds with other major agri-tech markets, including the U.S. and Japan. As highlighted in a recent report from the EU’s own testing laboratories, scientists are also currently unable to reliably distinguish gene-edited plant products from natural products. The EU is therefore incapable of enforcing the GMO Directive as applied to gene-edited products imported from outside the EU, putting its own agri-tech industry at an even greater disadvantage.

Out of step with science and the rest of the world

Marking the anniversary of the CJEU decision, 120 research institutes from around Europe (including the University of Cambridge and the Max Plank) released a statement, under the heading “give CRISPR a chance”, arguing that EU regulations no longer correctly reflect the current state of scientific knowledge:

There are no scientific reasons to consider genome-edited crops differently than conventionally-bred varieties that have similar alterations. Plants that have undergone simple and targeted genome edits by means of precision breeding and which do not contain foreign genes are at least as safe as varieties derived from conventional breeding techniques…

The consequence of the ECJ ruling is that the use of precision breeding techniques like CRISPR are becoming the privilege of a select group of large multinational companies to exploit it in large cash crops. Consequently, the inability to market genome edited crops in Europe will cause a chilling effect on the investments in R&D in the European breeding sector. The result will be that the further development of beneficial varieties in a faster and much more directed way will be halted in Europe, while the rest of the world embraces the technology.

Notably, the EU’s position is in contrast to that of the U.S., Japan, China, Brazil and Australia. Earlier this year, for example, Japan followed the U.S.’s example by concluding that gene edited food products need not be subject to safety screening (provided that the gene-editing techniques satisfy certain criteria).

The GMO Directive can not be enforced for gene-edited products

It has recently become apparent that enforcement of the new stringent requirements for gene-edited products in the EU may not be possible. EU member states are under an obligation to test for unauthorized GMO release in the EU and for the presence of GMOs in imported food, animal feed and seeds (Regulation (EC) 882/2004, and Regulation (EU) 2017/625). This testing is carried out by the European Network of GMO Laboratories (ENGL). The CJEU ruling that gene-edited organisms fall under the GMO umbrella, required EU testing laboratories to also test for gene-edited organisms.

However, ENGL have recently confirmed that developing methods to detect unauthorized gene editing may be a challenge (ENGL report). Testing for the presence of gene-editing is not as straightforward as testing for the presence of traditional genetic modification. GMO cloning techniques generally involve the insertion of large sections of foreign DNA into an organism’s genome. The presence of this foreign DNA can be easily detected. Gene-editing, by contrast, may involve editing of only one or two single residues in an organisms DNA. It is difficult to identify these changes as being artificial as opposed to the result of natural variation.

In its recent report ENGL confirmed that:

validation of an event-specific detection method and its implementation for market control will only be feasible for genome-edited plant products carrying a known DNA alteration that has been shown to be unique. Under the current circumstances, market control will fail to detect unknown genome-edited plant products.

Attacked on all fronts

In the meantime, the European agri-tech industry is also in limbo with regards to the patent eligibility of plants produced by essentially biological processes (i.e. natural breeding techniques). The EPO President has recently referred the issue (again) to the Enlarged Board of Appeal (EBA) (IPKat post here). The majority of legal experts are of the opinion that the EBA should consider the referral inadmissible. If the EBA were to find the referral inadmissible, this would maintain the disparity between the opinions of the EBA and Boards of Appeal, and that of the Administrative Council and the EU Commission. The EU agri-tech industry therefore faces attacks on multiple fronts. The President of the EPO seems determined to ensure plant products produced by natural breeding methods should not be patentable, whilst the EU requires that gene edited food products should be subject to stringent regulation.

Gene-editing patents

The predominant gene-editing technique, CRISPR/Cas-9, has been the subject of high-profile patent disputes, both in the U.S. and Europe (IPKat post here). The main players in the field are the Broad Institute and The University of California, Berkeley. However, the CRISPR patent field is growing ever more complex. Thousands of CRISPR patent applications have been filed, by hundreds of organisations. In order to simplify licensing requirements for CRISPR, there were calls for a CRISPR patent pool. However, its seems that these calls have lessened significantly within the European agri-tech industry, following the CJEU ruling on gene-editing. Industry experts and insiders have reported a significant decrease in CRISPR innovation in Europe since the ruling, making the need for CRISPR IP agreement less pressing.

The impact of Brexit

If the UK leaves the EU with no-deal (as is looking depressing likely…), the UK will of course be no longer subject to the GMO Directive. On his first day in office Boris Johnson bombastically promised to “liberate the UK’s extraordinary bioscience sector from anti-genetic modification rules”.

However, the value of the UK going it alone on gene-editing regulation without the rest of the EU 27 is doubtful. The EU is the UK’s largest export market for plant and animal products. The UK agri-tech industry may be as significantly damaged by an inability to export to the EU as it is by stringent GMO regulations. If the UK wished to influence EU policy on GMO’s, would it not have been more productive to keep its seat around the table? As it is, it seems the UK will have to sit on the sidelines and hope that the EU will listen to the scientists and industry experts and rethink the gene-editing regulations.
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