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| 5 minutes read

Curtain raised on New Genomic Techniques Regulation

European Commission proposes to ease the regulatory burden for gene-edited plants. But when will it become law, and in what form?

The EU’s New Genomic Techniques (NGT) Regulation made its post-leak appearance last week, in the shape of a draft from the European Commission. The proposed regulation aims to undo the effect of the EU Court of Justice's Confédération Paysanne ruling, which was handed down five years ago this month. Confédération Paysanne determined that organisms derived by DNA editing, for example using CRISPR, should be subjected to the same, super-precautionary EU rules as for those produced by old school "genetic engineering", where a DNA sequence from one organism is spliced into the DNA sequence of another. Sweeping such a significant class of products into the GMO Directive had lead to uproar.

The date of Confédération Paysanne - 2018 - is significant. At that time, the UK had voted to leave the European Union, but had yet to agree on how to do so. As the ruling Conservative Party debated on how to achieve a withdrawal that would achieve its promised benefits, one Prime Minister gave way to another and it was outside 10 Downing Street, in Boris Johnson's first address as Prime Minister, that gene editing made an unexpected appearance. Brandishing the Confédération Paysanne decision as if it were EU policy, Mr Johnson contrasted it with the freedom of the now unshackled UK. Leaving the EU in its contrail, the UK would seize the opportunities of gene editing to become a science superpower. It was a compelling narrative. Scientists and ardent Remainers conceded that here, at least, was a genuine Brexit opportunity. In March 2023, their dreams came true, when the Genetic Technology (Precision Breeding) Act received Royal Assent. The response of the UK media was reminiscent of Charles Haughey's alleged test for rule-making: never mind whether it works in practice, does it work in principle? Accordingly, reporting of the new Act dwelt far more on policy objective (good) than regulatory reality (terrible), with questions about the new law directed to scientists, or possibly regulators, but never, for example, to the lawyers who had advised the Public Bills Committee that it was "staggeringly imprecise" and unworkable. Little, if any, mention was made of the fact that the Precision Breeding Act only applied in the 48 counties of England. That an equivalent Regulation was in fact being cooked up in Brussels simply didn't get reported, even though it would also apply in one country of the UK. If it had been, mention might have been made of the fact that, unlike the English act, the NGT Regulation would create a market of 30 sovereign European states. And Northern Ireland.

But if publication of the NGT Regulation (should it ever find its way into mainstream media) comes as a surprise to those in the UK, it will hardly be remarkable to anyone in Europe. As was well reported on the continent, far from copying the UK's Precision Breeding Act, with which it has much in common, the Commission has been working on the NGT Regulation for longer and with a greater degree of stakeholder and public consultation. Soon after Confédération Paysanne, ministers from across Europe, sitting as the Council of the EU, asked the Commission to undertake a comprehensive investigation into the status of new genomic techniques (NGTs). When it did, the Commission concluded that:

"There are strong indications that the applicable legislation is not fit for purpose for some NGTs and their products, and that it needs to be adapted to scientific and technological progress. It may not be justified to apply different levels of regulatory oversight to similar products with similar levels of risk, as is the case for plants conventionally bred and obtained from certain NGTs."

As the legislative train started to roll, the Commission was asked to submit an impact assessment and, after targeted consultation and public consultation, to propose a new regulation for NGT-produced plants, food and feed: the one published last week. The contents of the proposal are set out very well in this article in the AAAS's Science magazine, so I won't repeat them here. Instead, I'd like to ask what the impact of the NGT is likely to be, given the existence of an English act on the same subject matter.

It turns out that the biggest obstacle to the NGT Regulation becoming law in its present form is the level of democratic scrutiny by MEPs, which will far exceed that of the UK Parliament in connection with the Genetic Breeding Act.

Proposals for green or gene related laws are a big deal in many legislative fora, but especially in the European Parliament, which has the weight of history to contend with. It took a decade for the 1998 Biotechnology Directive to become law, and the very fact that existing EU laws on GMOs have been found wanting by the European Commission and UK government is testament to the level of debate leading up to their enactment. A major difference between the parliaments of Brussels and Westminster concerns vote whipping. In the UK Parliament, the government presents a Bill to Parliament, after which the governing party's "Whips" pressurise its MPs to vote in support of the Bill, irrespective of the wishes of their constituents. But there is no "EU government", just 27 governments delegating drafting responsibility to a joint Commission, which does not whip MPs and has no power to do so. Further, MEPs are not necessarily of the same party as that of their home state's government. There are of course alliances of European parties, but the seven political groups that have emerged do not whip their members. There is one group, however, that stands out for its iron discipline: the Greens. Historically, Green MEPs have played a decisive role in debating and shaping European bioscience laws. But things have changed. Today, the Greens are divided on genetic editing. Some are opposed to edited crops on the, essentially, historical basis that GMOs are an unnatural environmental threat characterised by monoculture and monopoly. But a significant number of Greens support gene editing on the basis that it is not only akin to breeding, but – critically – that it has the capacity to support environmental sustainability, which they consider a far more important objective. The net effect of the Green schism may be to complicate passage of the NGT Regulation, and to make the finished instrument something other than what it is now. However, the Regulation faces a more immediate democratic obstacle: time. With an election for the European Parliament in May next year, not only is composition of the chamber unknown, but the coming into force of the New Genomic Techniques Regulation will, inevitably, be delayed. Add in some time for transitional arrangements, and (like the proposed Regulation  (and here) and Directive (and here) for reforming EU medicines law), the NGT Regulation is unlikely to come into effect before 2027-2028.

In the meantime, alone in Europe, England is able to advance the development of genomically-edited plants. True, English NGT products are cut-off from the nearest and biggest potential market (and even from parts of the UK) by EU laws on genetically modified organisms, but surely that will change when, eventually, those laws are replaced by the NGT Regulation? Not without a mutual recognition agreement, which seems highly unlikely at the present time. As everywhere in Europe, including Northern Ireland, follows the rules of the new NGT market of 30 European states, the much vaunted Precision Breeding Act seems doomed to irrelevance.


biotech, brexit, life sciences, life sciences regulatory