The EU Court’s position on CRISPR: a wilful ignorance of progress

4 mins read

By Robin Rönneke Belfrage

Genetically modified organisms (GMOs) constitute a modern political fault line; those opposing it point to both ethical and environmental concerns whereas its proponents emphasise the promises of great gains in areas such as agriculture and medicine. In light of last year’s European Court of Justice (ECJ) ruling on gene editing tools, it is time that Europeans – citizens, scientists and policymakers alike – reappraise the role that gene editing will play in the European Union’s future.

For eighteen years the EU has distinguished itself in the field of GMOs not through innovation and research but its demanding regulatory regime. This approach is not reflected in other scientific powerhouses, most notably the US. The EU has passed strict legislation which prohibits the genetic modification of humans, and rightly so. With regards to humans the risks are far too great, and the ethical dilemmas are incredibly complex. That position is shared among scientists and policymakers. However, in the EU there are draconic restrictions regarding the commercial use of most GMOs. The restrictions are most damaging in agriculture, where relatively small genetic modifications could increase shelf life, resistance to disease, drought, cold snaps or other extreme weather conditions, and the nutritional value of crops. Nonetheless, genetic editing for commercial purposes is limited to technologies that were tried and tested in 2001 when legislation was passed, and that are blunt, inefficient and expensive by modern standards.

Recent development of tools that modify genetic material has been astounding. Biological technology has progressed so far that the relatively new instrument clustered regularly interspaced short palindromic repeats (CRISPR) is so precise that it can edit rather than modify the genetic material. CRISPR uses a protein called Cas 9 found in certain bacteria, which serves as a defense mechanism which traces and removes virus’ genetic material which would otherwise harm the bacteria. Cas 9 can be reprogrammed to track and replace genetic code in other organisms. This makes CRISPR different from previous methods as it is precise down to the level of an individual base pair in the genome, easy to use and access, and it is cheap. However, CRISPR’s place in the EU’s legislation has been unclear as it even if it has been lauded as safe, remains a newly developed technology

The sale of genetically edited produce in the EU is a simultaneously divisive and technical issue. Critics cite risks of modified crops spreading into nature and possibly creating super- weeds or hybrids that imbalance ecosystems. However, safety measures both agricultural or genetic, careful regulation and testing of new crop varieties mitigates such risks, rather than a blanket ban. Moreover, previous progress in research has been possible largely because of the relative novelty of CRISPR, as there until last year has been little clarity on its status in EU-legislation. Political initiative has been left to the ECJ, as has often been done when questions of European integration are gridlocked in the EU-institutions.

On the 25 th of July 2018, the Court delivered a ruling that risks stifling research on CRISPR in the EU and the progress it promises in the foreseeable future. However, such a ruling is not unique, rather it is a key characteristic of the Court’s modus operandi. The ECJ has a far wider jurisdiction compared to most other European constitutional courts. Its judgements not only influence the treaties that form the EU’s constitution, but also a significant number of technical policy areas. Thus, it can influence issues commonly addressed through national politics such as workers’ rights, product standards, or features of higher education systems. The Court’s ruling clarifies and updates existing legislation. In the CRISPR case the Court was asked to examine whether rape flowers genetically engineered to resist certain types of pesticide were safe and if new technologies was tested enough to qualify as a technique with commercial applications. The Court ruled that CRISPR, as it is developed after the date that legislation on GMOs was adopted is untested and its safety unproven. This blocks any use of CRISPR for commercial purposes within the EU.

The ruling on CRISPR is a wet blanket on the research community and risks diverting funding and putting the EU on the back foot in genetic engineering. Far worse the judgement reinforces existing inequalities; research on edited crops is dominated by a few large multinational corporations that prioritise changes tailored to their products. In light of the commercial situation the judgement is all the more unfortunate, since CRISPR is a cheap and accessible and the EU is particularly well suited to deal with markets that show oligopolic charateristics. Because of the Union’s strict competition law, focus on research, and regulatory capacity it might vitalise a sector dominated by a few very large actors. But to assure that outcome politicisation and participation from the citizenry is needed.

Genetic engineering is undoubtedly a technical topic where the benefits might seem small for the average citizen – the kind of topic that should be left to policymakers. But educated input from EU citizens in the dialogue between policymakers and interest groups is necessary to provide the impetus and legitimacy needed to overturn the judgement and revitalise the EU’s policy on gene editing in the foreseeable future. One concrete alternative is to launch a citizen’s initiative to bring CRISPR onto the agenda of the Commission, who can draft legislation overturning the judgement. The risks and rewards of CRISPR’s commercial applications must be discussed, by policymakers, scientists and citizens together, not dismissed by the Court of Justice. If we as citizens manage to foster a debate which is nuanced and evidence based, politicians both in Brussels and national capitals may have a democratically anchored mandate for a policy which acknowledges the potential of genetic engineering and capitalises on the EU’s regulatory strength. Such a scenario entails twin victories, for science and technological progress and for the development of the EU as a democratic polity where the citizen has a voice.

Robin Rönneke Belfrage is a master student in political science with a focus on European questions and the EU, especially law and citizenship issues, and often combined with a penchant for taking a holistic or inter-disciplinary perspective. When not found at a café he spends his time outdoors, either hiking, skiing or kayaking.

Illustration: Sedef Hammarén Catir

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