EuropaBio response to the EU Study on New genomic techniques Brussels, 29 April 2021

A climate neutral and sustainable European economy needs to be delivered with the support of key technologies such as biotechnology. New genomic techniques (NGTs) are major innovative tools in the biotechnology sector and can provide breakthrough solutions for a healthy planet.

’We are pleased with the Commission’s ambition to accelerate access to advanced, effective and safe tools in the biotechnology sector. Current GMO legislation does not fit the incredible advances in technology and has impacted Europe’s global competitiveness. It’s time for a change that ensures innovation leadership to market, not just in the lab’ says Dr Claire Skentelbery, Director General of EuropaBio.

EuropaBio welcomes that the Commission study recognises the use of NGTs in plants, animals and micro-organisms, in a broad variety of applications.

Within industrial biotechnology and, as the study notes, NGTs can contribute to and are in line with Green Deal objectives. When applied to microorganisms, NGTs provide significant opportunities to create new processes and products and improve existing ones, marking a shift away from the petro-chemical era as we seek to achieve the EU Green transition. A science-based, proportionate, and predictable regulatory approach to current and future biotechnology innovation is key to this achievement.

Healthcare biotechnology is developing an increasing number of advanced therapies for complex genetic diseases. The current disproportionate and outdated GMO regulations affected clinical trials programmes, resulting in delayed access of patients to life-transforming and life-saving treatments. EuropaBio, calls for an exemption by law from the EU GMO rules for the conduct of clinical trials with investigational gene therapies.

‘EuropaBio represents and closely works with companies of all sizes, plus our 19 national and regional associations and their 2500 represented SMEs. The world is moving quickly. Our European SMEs need to have access NGTs in the right regulatory environment, and now is the right time for action if we want our SMEs to be competitive rather than acquired,’ added Dr Claire Skentelbery, Director General of EuropaBio.

We stand ready to contribute to the ongoing dialogue with our broad expertise in genomic techniques as they apply to healthcare and the bioeconomy.

Background information

The Commission study on new genomic techniques was requested by the Council in November 2019, The Council requested the EC to submit a study in light of the Court of Justice’s judgment in Case C-528/16 regarding the status of novel genomic techniques under Union law, and a proposal, if appropriate in view of the outcomes of the study”.