The European Commission published a report on 29 April 2021 which reviewed the current legislative framework for the regulation of new genomic techniques (NGTs). The report makes several recommendations and acknowledges the importance of a strong IP and patent strategy to continue the recent surge of innovation in this area, and that the existing framework may not be suitable anymore.
What are new genomic techniques (NGTs)?
NGTs are defined as techniques that are capable of altering the genetic material of an organism and that have emerged or have been developed since 2001 when the current genetically modified organisms (GMOs) legislation was established.
The new report was requested after the decision of the Court of Justice of the European Union in the case C-528/16. This decision upheld the stringent regulatory framework that GMO plants are subject to whilst in the European Union. Many in the plant breeding sector were strongly in opposition to this decision as it was viewed as a missed opportunity for increasing agricultural innovation in the EU.
The report found that techniques, such as CRISPR/Cas9 editing, can contribute to a more sustainable food system through the development of agri-food products. One example is a tomato fortified with gamma-aminobutyric acid, which is already being marketed in North America. However, the report also concludes that the current GMO legislation is not fit for purpose.
In particular, the European Commission appears to have appreciated that the existing framework may not be suitable with regard to the impact of CRISPR/Cas9 techniques in this area. At the moment, the European Union is bound by rules set up in 2001 to address the introduction of GMOs. The report acknowledges that there is considerable interest in research into NGTs both within and outside the EU, but that the current regulatory framework is ambiguously worded and may be stifling innovation by creating uncertainty.
A strong patent system
The report also acknowledges the benefits of a strong patent system in enabling innovation and disseminating knowledge, which is vital for the development and commercialisation of new products. There was some concern from other stakeholders over the complexity of the IP landscape surrounding CRISPR/Cas9 increasing the cost of bringing a new product to market, due to the extensive freedom to operate analysis required. However, stakeholders from the pharmaceutical sector and some EU Member States consider strong patent protection of NGTs as a pre-requisite for innovation due to high R&D costs.
Some stakeholders called for further research to be carried out. This was based on initial concerns regarding the safety and environmental risks linked to unintended adverse effects when NGT products interact with their surrounding environment. However, the report acknowledges that in many cases, experts consider that products derived using NGTs are not expected to present significantly different risks to similar products obtained by more conventional means. The report suggests a flexible approach to assessment of risk will be required on a case-by-case basis, rather than the more restrictive regulatory framework currently in place.
It will be interesting to see whether the European Union takes the opportunity to adopt a more flexible approach in relation to the use of CRISPR/Cas9 techniques for genome alteration or if it maintains its current cautious mindset.
For more information please contact Nick Bassil, or your usual Kilburn & Strode advisor.