Gene editing requires ‘wide and inclusive’ societal debate, says ethics group

“The debate should be based on democratic principles, take into account present and future generations and include local and European perspectives,” the opinion reads. [SHUTTERSTOCK]

This article is part of our special report Gene editing: The latest developments in the EU.

There is a need for a wide societal debate, including ethical reflection, over new gene-editing techniques, according to a new report from an advisory body for the European Commission, which was welcomed by industry players but accused of missing the mark by environmental campaign groups.

The opinion, released on 19 March by the European group on ethics in science and new technologies (EGE), an independent advisory body to the European Commission, explored the applications of new gene-editing techniques in humans, animals and plants.

It comes following a formal request by the European Commission to examine the ethical issues surrounding novel genome editing techniques across all areas of application.

“As with any groundbreaking technology, high hopes are matched by far-reaching fears,” the opinion reads, highlighting that the issue “urgently requires ethical reflection, debate, and assessment in order to shape the application of the technology and development governance in a way that is in accordance with the fundamental rights and freedoms”.

Rather than focusing on whether the technology is safe enough for use, the opinion aims instead to “draw attention to the importance of nuancing and resisting this framing”.

“What is needed instead is a consideration of the complete decision problem; to take sound, well-reasoned decisions; to look at both the pros and the cons; indeed to consider not just the risks and costs but also the possible benefits, in the widest sense, and the distribution thereof,” it states.

Existing guidance appropriate for gene editing assessment, says EFSA

Genome editing does not pose any additional hazards compared to conventional breeding or other genetic modification methods, meaning that existing guidance is adequate for their assessment, the European Food Safety Agency (EFSA) has concluded.

More cooperation needed

As well as highlighting the need for a wider and more inclusive approach to the debate on new genomic techniques, the report also stressed the need for more cooperative international efforts.

This includes “joint monitoring and learning with regard to both regulatory and scientific developments, and for international engagement towards global governance,” it said.

“The debate should be based on democratic principles, take into account present and future generations and include local and European perspectives,” the opinion reads.

The use of gene-editing technologies has come under increasing scrutiny in the EU over the past few years, following the 2018 European Court of Justice ruling that gene-edited organisms should fall, in principle, under the EU’s GMO directive.

This ruling was widely welcomed by campaign groups and environmentalists, who warn of the wide-ranging ramifications from the use of such a technology, including corporate control of seeds and environmental concerns.

However, proponents argue that gene editing is a sorely needed innovation that would help Europe’s agricultural sector meet the ambitious green objectives set out in the bloc’s flagship food policy, the Farm to Fork strategy, as well as help the EU’s health sector address some of the most devastating genetic diseases.

Its publication comes ahead of a widely-anticipated study on new genomic techniques by the Commission, due at the end of April, which aims to clarify the EU’s position on the technology in light of the 2018 ruling.

EU study to clarify gene editing court ruling further muddies waters

After the European Court of Justice (ECJ) ruling that organisms obtained by new plant breeding techniques (NBTs) should, in principle, fall under the GMO Directive, the Council of the EU has requested a study from the Commission to clarify the situation. But what this means in practice remains unclear.

Europe’s largest biotech association, EuropaBio, welcomed the report, saying that they “strongly support” the group’s call to apply genome editing on the basis of “appropriate and proportionate control, with core values of diversity, respect and responsibility.”

“Genome editing in key applications is a promising next step in research towards beneficial uses in medicine, agriculture and the bioeconomy aimed at addressing some of society’s grand challenges,” they emphasised.

However, other stakeholders were more critical of the opinion.

Green MEP Martin Häusling highlighted that although the report asks “many good questions and makes many useful observations,” the report falls short of adequately addressing them.

“The report appears to take it for granted that all these questions are answered satisfactorily,” he said.

He pointed out, for example, that the opinion highlights that “those who are using the technology must ensure that they are monitoring for unpredicted and unintended events, and act upon them accordingly and without delay”.

“But can the companies involved be trusted to do that? How do we get them to apply these precautions?” he queried.

Likewise, Testbiotech, a non-profit organisation focusing on the independent impact assessment of genetically engineered organisms, criticised the report for presenting conclusions “without sufficient scientific backing”.

“The potential benefits are disproportionately emphasised in comparison to the risks that can be justified from the scientific evidence,” the association said.

EU still reflects over agri-innovation as UK mulls moves forward

While the EU considers the potential role of new innovative techniques to protect harvests from pests and diseases, on the other side of the Channel, the UK is getting ready to open the door to new gene-editing technologies post-Brexit.

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