英国、ゲノム編集の規制緩和はその影響を十分に精査されていないとの判決

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[no-gmo:01850] 英国、ゲノム編集の規制緩和はその影響を十分に精査されていないとの判決

みなさま

ゲノム編集食品に対する規制緩和の不当性を訴えていたイギリスの市民グループより朗報です。イギリスの高等裁判所はイギリス政府によるゲノム編集作物の規制緩和は、その影響が十分考慮されずに決定されたものだと判断しました。具体的にどうしなければならないか、という結論は今後発表されるようです。 以下に自動翻訳にかけたものと原文を送ります。日本語に「精密育種」とありますが、英国での呼び方で、ここにゲノム編集が入ります。（私のは無料の自動翻訳ですが、もう少し上等な自動翻訳をお持ちの方は原文をご利用ください）

 

廣内

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要約

物議を醸してきた「簡略化された」遺伝子編集規則は、高等法院の判決によって混乱に陥った。判決は、政府の助言者が農業大臣に対し、大臣自身の法的権限について誤った助言をしていたと認定したためである。 その結果、政府は、遺伝子編集生物（いわゆる「精密育種（PBO）」）に長年適用されてきた透明性・追跡性・表示・規制監督といった安全策を撤廃することの実際の影響を十分に調査しなかった。

こうした前提で規則を押し通したことは不合理で違法であり、判決によれば、もし大臣が正確な情報を与えられていたなら、特に農業・食品供給網を通過する際の PBO の義務的表示に関して、根本的に異なる判断を下していた可能性がある。詳細は以下をご覧ください。

 

詳細

遺伝子技術（精密育種）規則2025年に関する高等法院判決について

Beyond GMおよび共同申立人らは、本日の高等法院判決を歓迎しました。

裁判所は、政府が遺伝子編集生物（いわゆる「精密育種」またはPBO）の規制緩和を決定する前に、透明性、トレーサビリティ、表示、規制監視に関する長年の保護措置を撤廃することの影響を十分に調査しなかったと認定しました。

主な判決内容
裁判所は特に、Defra農業大臣が、その法的権限の範囲について顧問から誤った助言を受けていたことを認定しました。その結果、大臣は法律上利用可能な権限について誤った理解に基づき、透明性を欠く制度を「推し進めた」ことになります。これは、Beyond GMの法的訴訟の結果として初めて開示された文書によって明らかになりました。

この誤った助言に基づいて大臣が下した決定は、不合理かつ違法であると認定されました。裁判官は、大臣が自身の権限を正しく理解していれば、実質的に異なる選択肢の範囲を検討し、根本的に異なる規制アプローチが合理的に採用された可能性があると結論づけました。

また、司法審査の圧力を受けて裁判で開示された証拠により、政府はすでにPBO種子にはその旨を表示すべきであると認めていることが判明しました。ただし、スーパーマーケットの棚に並ぶ段階を含む全段階での表示義務化については拒否しています。

サプライチェーンへの影響
裁判所は、義務的な表示とトレーサビリティの欠如が、有機および非有機サプライチェーンに重大な追加負担を課すことも認めました。これにより、遺伝子組み換え製品を避けたい農家、食品事業者、消費者、およびEUへの輸出を行うすべての農産物輸出業者にとって、それがより困難かつ高コストになります。

裁判所は、サプライチェーンの透明性に必要なツールを撤廃することの影響は現実のものであり（克服不可能ではないとしても）、大臣の法的理解の誤りにより、規則導入前に十分に検討されなかったと認めました。

食品基準庁の役割
新規則は、PBOに対して通常の食品に適用されない検査を国務大臣が適用することを明確に禁止しています。判決はこれがDefraの監視能力を実質的に弱体化させることを指摘しています。

しかし、食品基準庁（FSA）は、規則が国務大臣にそれを禁じているにもかかわらず、情報を求め、より完全な評価を行う重要な独立した権限を依然として保持していることも指摘されました。これはFSAの独立規制機関としての責任を強化するものです。

有機農業の認定
裁判所はまた、判例として初めて、有機農業は単なる技術基準や認証制度ではないことを認めました。多くの人々にとって、それは独自かつ根本的な価値観、原則、専門的コミットメントを表すものであり、今回の規則によってその維持がより困難になります。

関係者のコメント
Beyond GMディレクター、パット・トーマス氏：

「これは重要な判決であり、遺伝子技術法および規則の成立過程を通じて隠されていたか争われていた様々な問題に明確性をもたらしてくれた裁判所に感謝します。この訴訟は、遺伝子編集技術が良いか悪いかについてのものではありませんでした。政府が遺伝子組み換えPBOの表示とエンドツーエンドのトレーサビリティを撤廃することの影響を十分に調査し、適切な手続きに従ったかどうか、そして議会、ステークホルダー、国民に利用可能な選択肢について正確な情報が提供されていたかどうかについてでした。本日の判決は、そうではなかったことを示唆しています。」

Leigh Day事務弁護士、ジュリア・エリクセン氏（Beyond GM代理人）：

「当事務所の依頼人は、新規則が食品チェーンにおけるトレーサビリティの保護措置を撤廃することで生じる潜在的な問題について長年懸念を表明してきました。本日の判決は、国務大臣がPBOの追跡問題を違法な方法で処理し、有機セクター、消費者、英国およびEU内の貿易への影響に関する懸念よりも商業的利益を優先したことを明らかにしました。裁判所はまた、人々と環境の安全を確保するためにPBOを検査する食品基準庁の役割を有益に明確化しました。」

今後の課題
申立人らは、この判決が、規則を「不可避で確定済みの画期的なもの」として繰り返し特徴づけてきた政府と産業界の姿勢について深刻な疑問を投げかけるものだと考えています。この判決は、規則の基盤となる枠組みが急いで策定され、実質的に不完全であるという異なる現実を露呈しました。

未完成のまま残っている要素には以下が含まれます：

国家植物品種リストの保留中の見直しと、その中でのPBO品種の扱い
PBO種子の表示（裁判の圧力で政府は約束したものの、まだ施行されていない）
国際貿易への影響
分権国家（スコットランド、ウェールズ等）の反対
有意義な共存措置の欠如
英国とEU間の再調整協定からPBOを「除外する」という政府保証の未解決問題
パット・トーマス氏：

「これらの規則が先駆的で堅固であると何年も主張された後、高等法院での二日間の審理とその後の判決は、この枠組みの多くが不完全で、実質的に移行期的であり、したがって変更の対象となることを明らかにしました。政府は厳密さよりもスピードを選びました。バイオテク開発者の負担軽減を、他のすべての関係者への影響を十分に調査する前に優先しました。本日の判決は、これらの選択のコストを浮き彫りにし、国民、農家、食品事業者、有機セクターの懸念が正当であり、十分な検討に値し、規則に反映されるべきであることを明確にしています。」

今後数週間で、裁判所はこの判決を踏まえて規則にどのような対応が必要かを検討します。次のステップに関するさらなる発表は追って行われる予定です。

GOVERNMENT FAILED TO FULLY ASSESS THE CONSEQUENCES OF GENE-EDITING DEREGULATION

A High Court legal challenge led by advocacy group Beyond GM has found that the Government failed to understand the significant consequences – for farmers, businesses, consumers and the organic sector – of removing transparency and labelling for gene-edited crops and foods

Quick summary

The government's controversial new ‘light touch’ gene editing rules have been thrown into chaos after a High Court judgment ruled that government advisors gave the Farming Minister incorrect advice about his own legal powers. This led to a failure to investigate the real consequences of removing longstanding safeguards on gene-edited (so called ‘precision bred’, or PBO) organisms. Pushing the Regulations through on this basis was irrational and unlawful and, according to the judgment, had the Minister been given reliable information, he might have made fundamentally different decisions, particularly around mandatory labelling of PBOs as they pass through the farming and food supply chains.

The judgment notes that the absence of mandatory labelling and traceability within the Regulations places additional significant burdens on organic and non-organic supply chains, making it more difficult and costly for farmers, food businesses and consumers who seek to avoid genetically modified crops and foods derived from them, as well as for those who wish to export food and other agricultural products to the EU.

The judgment also has far-reaching implications for the realignment between the UK and EU as part of the forthcoming SPS negotiations. If the government can achieve its proposed ‘carve out’ of the precision breeding Regulations, the UK farming and food businesses will suffer because proposed new EU rules on gene editing are still more stringent in several areas than those that apply in England. If the carve out is not possible, the UK regime will have to be revised to align with the EU rules.

According to lead claimants in the judicial review, Beyond GM, the judgement means that, for these and other reasons, the current regulatory framework, trumpeted by industry as pioneering, is in effect transitional and temporary and will likely need to be reconsidered.

Full story and notes below

 

Full story

Beyond GM¹ and its co-claimants have welcomed today's High Court judgment on the Genetic Technology (Precision Breeding) Regulations 2025.²

The Court found that the government did not investigate fully the consequences of its decision to deregulate gene-edited (so called ‘precision bred’, or PBO) organisms³ before removing longstanding safeguards relating to transparency, traceability, labelling and regulatory oversight.

In particular, the Court found that the Defra Farming Minister⁴ was wrongly advised about the scope of his legal powers⁵ by his advisors and so “pressed ahead” with a regime lacking transparency based on an incorrect understanding of the powers available to him under the legislation. This was uncovered in documents that were only released as a result of Beyond GM’s legal case. The decisions made by the Minister and based on this wrong advice, were found to be irrational and unlawful. The judge concluded that had the Minister understood his powers correctly, he would have considered a materially different range of options and a fundamentally different regulatory approach might reasonably have been adopted.

Indeed, under pressure from the judicial review, evidence disclosed in Court also showed that government has already conceded that PBO seeds should be labelled as such – though it has refused to go further to ensure labelling at all stages including on supermarket shelves.

The Court also recognised that the absence of mandatory labelling and traceability places additional significant burdens on organic⁶ and non-organic supply chains, making it more difficult and costly for farmers, food businesses and consumers that seek to avoid genetically modified products, as well as for all exporters of agricultural products that seek to export to the EU.

The Court accepted that the consequences of removing the tools necessary for supply chain transparency are real (if not impossible to overcome) and that – because of the Minister’s wrong legal understanding – they were not adequately considered before the Regulations were introduced.

In addition to making it more difficult and costly for consumers and others to avoid PBOs, the new Regulations specifically prohibit the Secretary of State from applying any test to PBOs that would not apply to ordinary food. The Court judgment highlights that this effectively undermines Defra’s own capacity for oversight. It points out, however, that the Food Standards Agency still retains important independent powers to seek information and undertake fuller assessments – even as the Regulations prevent the Secretary of State from doing so. This reinforces the Food Standards Agency’s responsibility as an independent regulator and, according to Beyond GM, serves as a pointed reminder that the Agency's statutory duties are, or should be, distinct from Defra's policy objectives.

The Court also recognised – importantly and for the first time in case law – that organic farming is not merely a technical standard or certification scheme. For many, it represents a distinct and fundamental set of values, principles and professional commitments which the Regulations make much more difficult to maintain.

Pat Thomas, Director of Beyond GM, said:

"This is a significant judgment and we are grateful to the Court for bringing clarity to a range of issues that have remained either hidden or disputed throughout the passage of the Genetic Technology Act and Regulations. This case was never about whether gene editing technology is good or bad. It was about whether the government had followed careful procedures and fully investigated the consequences of removing labelling and end-to-end traceability for genetically modified PBOs, and whether Parliament, stakeholders and the public were being given an accurate picture of the options available. Today's judgment suggests they were not.”

Julia Eriksen, solicitor at Leigh Day, representing Beyond GM, said:

“Our clients have long raised concerns about the potential issues the new Regulations pose by removing traceability safeguards in the food chain. Today’s judgment makes clear that the Secretary of State handled the issue of tracing PBOs in an unlawful way, and prioritised commercial interests over concerns raised about the impact on the organic sector, consumers, and trade within the UK and EU. The Court also helpfully clarified the role of the Food Standards Agency in testing PBOs to ensure people and the environment are safe. We welcome the Court’s findings, and the recognition of the value of the organic and non-GMO food sectors.”

The claimants believe the judgment raises serious questions⁷ about government and industry's repeated characterisation of the Regulations as inevitable, settled and groundbreaking. The ruling exposes a different reality: that the framework underpinning them was rushed and is substantially incomplete.

Amongst the elements of the system that remain incomplete are a pending overhaul of the National Plant Varieties List and how PBO varieties will be represented within that.⁸ While the Court case did put pressure on the government to commit to labelling PBO seeds, this has not been enacted yet.⁹ In addition, international trade implications, devolved nation defiance,¹⁰ the absence of meaningful coexistence measures and government assurances that PBOs will be ‘carved out’ of any realignment agreement between the UK and the EU remain unresolved.¹¹

Pat Thomas said:

"After years of claims that these Regulations were pioneering and rock-solid, the two-day hearing in the High Court and the subsequent Court judgment have exposed that much of the framework remains incomplete, effectively transitional and therefore subject to change. The government chose speed over rigour. It prioritised reducing burdens on biotech developers before investigating fully the consequences for everyone else. Today's judgment highlights the cost of those choices and makes clear that the concerns of the public, farmers, food businesses and organic sector are legitimate, deserve full consideration and should be reflected in the Regulations.”¹¹

In the coming weeks the Court will consider what needs to happen with the Regulations in the light of this judgment. Further announcements regarding the next steps will be made in due course.

The full judgement can be accessed here.

ENDS

More information

Pat Thomas. Director, Beyond GM

pat@beyond-gm.org

 

Leigh Day Press Office
pressoffice@leighday.co.uk

 

Notes for Editors

1 Advocacy group Beyond GM is the UK’s leading independent voice on genetic technologies in food, farming and environment. Co-claimants included two organic farmers and an ethical consumer.

2 The Genetic Technology (Precision Breeding) Regulations were signed into law on 13 May 2025 and became operational on 13 November 2025. They were made under the Genetic Technology (Precision Breeding) Act 2023. They apply only in England.

3 Gene editing/precision breeding is, scientifically, a technique of genetic modification and, therefore produces genetically modified organisms (GMOs). The judgment makes clear that a) existing organic Regulations in the UK and internationally classify these organisms as GMOs; b) under the existing under the Seeds (National Lists of Varieties) Regulations 2001, PBOs are also considered GMOs and c) in Scotland and Wales PBOs are also considered GMOs. The Act and Regulations remove these GMOs from the existing GMO legislation on the contested and hypothetical basis that they “could have” occurred through conventional breeding, and create a newer light touch regulatory regime, which was the focus of the judicial review. Editors should note that neither the Regulations nor the guidance that supports them requires a precedent as proof of the “could have” occurred status.

4 The Farming Minister at the time the Regulations were signed into law was Daniel Zeichner MP

5 The judgement variously refers to the ways the Minister was given “erroneous” and “incorrect” information, was “wrongly advised” and "misdirected" by officials.

6 Since PBOs are legally GMOs under organic legislation, operators are required by law to take all reasonable steps to keep them out of the supply chain.

7 Although not part of the case, during the passage of the Act and Regulations multiple governmental scrutiny committees raised similar issues to those in the judicial review including the Regulatory Policy Committee, the Delegated Powers and Regulatory Reform Committee, the Constitution Committee and the European Scrutiny Committee and the Secondary Legislation Scrutiny Committee.

8 In addition, English PBOs can’t be sold in the UK or into the EU until they pass all the tests for the National Variety list and are added to that list. This process can take years.

9 Labelling PBO seeds will require a new regulation.

10 Scotland and Wales have rejected the Genetic Technology (Precision Breeding) Act and its Regulations;  Northern Ireland is aligned with EU rules.

11 The EU has proposed, but not yet voted on, a new gene editing regulation. This new regime won’t be operational until 2028 and includes several elements that are more stringent than the English regime. If the proposed “carve out” does not happen UK will be obliged to align with these.

12 The judgment explicitly states: "He [the Minister] prioritised the interests of commercial innovators (and the consequential economic benefits of attracting investment into England) notwithstanding the concerns of, and impact on, the organic sector, consumers, and trade with the European Union and with other parts of the United Kingdom." In addition, a) the judgement highlights that the Explanatory Notes to the 2023 Act state the Act was intended "to reduce the regulatory burden and financial barriers in place for researchers and commercial breeders using precision breeding technologies; b) internal government documents and submissions referenced in the judgment highlight the aim to create a "competitive advantage” for UK science and small businesses, drawing investment, expertise and innovation into the UK; and c) the judgment also records that industry stakeholders signalled that mandatory food labelling for PBOs would "deter investment, raise costs to consumers and result in a disadvantage internationally”.