First published in our Biotech Review of the year – issue 8.

Of course, this is a rather reductive summary; for the full story we will need to jump back three years.

In 2018, the gene editing world was aghast when the EU Court of Justice decided in Confédération paysanne[1] to include GE organisms within the definition of GMO under the EU GMO (Deliberate Release) Directive (GMO Directive)[2]. The effect of the decision remains highly ironic: organisms whose genes are modified by exquisitely precise processes are heavily regulated, while those modified randomly are exempt[3]. The decision offended in other ways, ignoring the warning of the court’s legal advisor to leave law-making to lawmakers[4].

That September, leading UK scientists called upon Cabinet Minister Michael Gove for a UK response[5], which he pronounced a Brexit opportunity. The following Summer, the new Prime Minister, Boris Johnson, used his maiden speech to Parliament to declare that Brexit would ‘liberate the UK’s extraordinary bioscience sector’ from Europe’s anti-GM rules, and the following May, the All Party Parliamentary Group on Science & Technology in Agriculture proposed that the UK definition of GMO under the Environmental Protection Act 1990 (derived from EU law) be restricted to ‘the insertion of viable, heritable, foreign DNA’, which ‘would at a stroke remove around 90% of gene editing applications from the scope of GM regulation.’

The Secretary of State responded, describing GE as ‘a more targeted form of conventional plant breeding’, but adding that the government ‘would not propose changing at all the regulatory framework on GMOs.’ Although a gene editing amendment[6] did appear in the Agriculture Bill[7], it was subsequently withdrawn[8] with the promise of a consultation[9] instead, a DEFRA spokesperson stating the government’s opinion that ‘organisms produced by… gene editing should not be subject to genetic modification regulation if the changes to their DNA could have occurred naturally or through traditional breeding methods.’

Crucially, though, the UK is far from alone in seeking to reform GMO regulation. In the EU, the clamour for change is coming from an unexpected quarter and, as we shall see, is being intensified by the COVID-19 pandemic.

GMO Regulatory Reform in the EU

Across the Channel, EU States had been waiting for a Commission policy on new breeding techniques long before Confédération paysanne. Rather than twiddle its thumbs, Sweden chose not to regulate some GE Arabidopsis plants on the basis that introducing DNA from another species and editing a plants’ existing DNA are very different processes. Because most GE applications do not involve the former, any interpretation that subjected them to GM rules would severely restrict the choice of crops that EU farmers could grow. Although its position was blocked by the Court’s decision, Sweden and others objected that the judges had failed to define which techniques were captured by the term used by the court, ‘directed mutagenesis’, which never explicitly referred to editing. The case had concerned herbicide-tolerant seed varieties, but how broadly should it be applied? It wasn’t even clear how GE-restrictions could be enforced[10]. Despite claims by Greenpeace, there is no such thing as a GE crop test[11].

Subsequently, in November 2018, the European Commission’s Group of Senior Scientific Advisers publicly responded[12] that scientific knowledge and recent technical advances had rendered the GMO Directive unfit for its intended purpose, while a European Citizens’ Initiative named Grow scientific progress, following in its wake, demanded a review of the regulation[13].

Momentum built

In July 2020, EU-SAGE[14] published an open statement on behalf of its 132 European research institute members, recommending the EU to endorse GE for the welfare of its citizens, on the basis that it offers ‘a more efficient selection of crops that are climate resilient, less dependent from fertilizers and pesticides’ which would ‘help preserve natural resources.’ In the same month, the Conseil Européen des Jeunes Agriculteurs (CEJA[15]), representing around two million young European farmers, expressed frustration at the Commission’s ‘Farm to Fork’ plan to make Europe’s food system the global standard of sustainability, complaining that if they were to achieve F2F’s goal of switching 25% of agricultural land to organic farming and reducing fertilizers use by 30 per cent, they would need access to GE products[16].

An unlikely champion?

By now, support had come from a surprising source: the most senior members of the Green Party of Europe’s most GMOconservative state, Germany, who had just endorsed the view of the Commission’s Senior Advisors[17]. ‘Current GMO regulation no longer corresponds to the current state of science’, they stated: ‘the decisive factor is not the technology but the result’. Strikingly, the Greens emphasised that ‘it is not enough to describe a technology as ‘more natural’ or ‘safer’ if there is no concrete evidence to support it… In agriculture, biodiversity can be damaged just as much by organic products as by genetic engineering,’ which, they wrote ‘has fundamentally changed in the last ten years.’ Sustainability required re-appraisal of new technologies, said the scientific Greens, warning that regulatory costs impeded competition and the emergence of more environmentally-friendly start-ups[18].

Meanwhile, the SARS-Co-V-2 pandemic had struck, and Germans discovered that a homegrown company was preparing to produce the first COVID-19 vaccine. Not just any vaccine, but the world’s first mRNA vaccine. To expedite availability of mRNA vaccines, the European Parliament adopted[19] a ‘temporary’ regulation[20], a press release explaining that ‘Some COVID-19 vaccines and treatments already being developed may be defined as GMOs[21]. As national requirements to assess the environmental risks of clinical trials on medicinal products that contain or consist of GMOs vary considerably across member states, a derogation from these rules is needed to avoid significant delay in developing lifesaving vaccines[22].’

The following month, opening a GE debate in the Bundestag[23] by referring to the imminent release of BioNTech’s mRNA vaccine, Dr Volker Wissing[24] highlighted the genetic technology linking medicine and food production. Rather than restricting GE research, said Dr Wissing, Germany should encourage it, ‘if only to remain a competitive export nation.’ A Green Party motion along traditional lines was dismissed, but within the Party, opinions were dividing. Its scientific wing now had backing from over 150 independent academics for a policy proposal that expressed openness to a ‘factbased assessment of new genetic engineering processes’, and another group also showed a change of heart.

As approval of the first mRNA vaccines approached, the pressure to permit GE organisms grew across Europe. In October, a report on GE crop regulation by the European Federation of Academies of Science and Humanities had issued a direct appeal to EU leaders in Europe[25]. Warning of the dangers of failing to reform Europe’s GM laws, the Federation declared that, ‘in the circumstances, doing nothing does not seem to be an option.’ The same month, when approving the ‘Farm to Fork’ scheme, EU Agriculture ministers, called for ‘new and innovative techniques to boost sustainable food production, as long as they are shown to be safe for humans, animals and the environment’, – a clear reference to GE agricultural products.

Where are we now?

As citizens impatiently await their mRNA vaccination[26] – a product with robust efficacy data[27], a safety record that grows jab by GM jab, and the prospect of saving the lives of millions – today may not be a good time to be anti-GM.

Is the EU likely to move GMO regulation to a more scientific basis? In an age of concerted disinformation in which populist parties expressly devalue scientific expertise and consciously sow distrust, this would be a remarkable turn of events. But in the pandemic’s battle between frauds[28] and facts, there can only be one winner. As GMOs vindicate themselves in fighting the global challenge of infectious disease, rules that hobble their capacity to combat the challenges of food security, energy and climate look increasingly out of place.

As a first step, might expert regulators be given the power to classify products as GMOs if they incorporate transgenes, but not if their DNA has merely been edited and they pose no realistic risk to humans, animals and the environment? We may find out in April, when the European Commission reports to the Council on the impacts of new genomic techniques and the effect of Confédération paysanne[29].

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[1] https://curia.europa.eu/juris/liste.jsf?language=en&num=C-528/16
[2] Directive 2001/18. (Implemented in the UK in the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (SI 2002/2443) https://www.legislation.gov.uk/uksi/2002/2443/contents/made
[3] https://www.labiotech.eu/regulatory/gmo-regulations-europe/
[4] http://curia.europa.eu/juris/document/document. Para 149.
[5] http://www.cpm-magazine.co.uk/wp-content/uploads/2018/09/180903-MichaelGove-letter.FINAL_.pdf
[6] https://www.theyworkforyou.com/lords/?id=2020-07-28b.204.0
[7] https://geneticliteracyproject.org/2020/07/30/gene-editing-amendment-to-ukagriculture-bill-withdrawn-delaying-farmer-access-to-crispr-crops/ The [Act passed 11 November 2020.
[8] https://www.euractiv.com/section/agriculture-food/news/uk-gene-editingamendment-withdrawn-but-government-commits-to-consultation/
[9] https://consult.defra.gov.uk/agri-food-chain-directorate/the-regulation-of-genetictechnologies/
[10] Despite Greenpeace claims, there is no such thing as a GE crop test. https://twitter.com/methylcytosine/status/1303225481009991680?s=20
[11] https://consult.defra.gov.uk/agri-food-chain-directorate/the-regulation-of-genetictechnologies/
[12] https://op.europa.eu/en/publication-detail/-/publication/a9100d3c-4930-11e9- a8ed-01aa75ed71a1/language-en/format-PDF/source-94584603
[13] The petition closed in July 2020. https://www.growscientificprogress.org/
[14] European Sustainable Agriculture through Genome Editing network.
[15] https://www.ceja.eu/home
[16] https://www.euractiv.com/section/agriculture-food/news/young-farmers-need-atoolbox-as-broad-as-possible-to-achieve-farm-to-fork-goals/
[17] https://www.gruene.de/artikel/neue-zeiten-neue-antworten-gentechnikrechtzeitgemaess-regulieren
[18] “New times, new answers: regulating GM law in a contemporary way”
[19] July 2020. Parliament voted via the urgent procedure 505 votes to 67 in favour of the derogation, with 109 abstentions.
[20] In accordance with the Commission’s COVID-19 Vaccine Strategy.
[21] https://www.europarl.europa.eu/news/en/press-room/20200706IPR82731/parliament-to-allow-covid-19-vaccines-to-be-developed-more-quickly
[22] https://ec.europa.eu/health/human-use/advanced-therapies/gmo_investiganional_en
[23] https://www.bundestag.de/dokumente/textarchiv/2020/kw47-de-gentechnik-806836
[24] Minister of Economics, Transport, Agriculture and Viticulture in RhinelandPalatinate (FDP Party).
[25] https://allea.org/wp-content/uploads/2020/10/ALLEA_Gen_Editing_Crop_2020.pdf
[26] EMA approval of BioNTech/Pfizer’s mRNA vaccine by EMA: 21 December 2020.
[27] Phase III data shows 95% effectiveness of Pfizer BioNTech (link) and 94.1% (with 100% efficacy against severe COVID-19) from Moderna
[28] https://www.acsh.org/news/2020/12/27/fraud-doctor-andrew-wakefield-now-lying-about-covid-rna-vaccine-15240
[29] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019D1904&from=EN%20;%20https://ec.europa