AnimalhealthEurope welcomes the One Health approach taken by the European Commission in the recently proposed Biotech Act, to include the development of veterinary biotechnology products and services.

The EU rules governing veterinary medicines (Regulation 2019/6) already aimed to reduce administrative burden and support the improved availability of animal health products across Europe and across species, and this new proposal goes a step further. Innovations, such as biologicals derived from living sources, and medicines containing genetically modified organisms will not be subject to additional assessments – other than those for licensing veterinary medicines – which will greatly support further investment in innovative solutions to protect animal health and welfare. The proposal also brings indispensable clarity about the non-GM status of animals treated with such innovative medicines.

Another innovation boost comes from the potential to extend data protection by an additional year for veterinary medicines developed by means of biotechnology processes to diagnose, treat or prevent zoonotic diseases, leading to companies potentially increasing investments in this field. This is also in line with the One Health approach, where protecting animal health, in turn protects public health.

Roxane Feller Director General of AnimalhealthEurope commented:
“The Biotech Act offers a welcome additional step forward to reduce administrative burden for our highly innovative animal health sector. The new concept of regulatory sandboxes creates a safe space for new animal health technologies, methods, or products to be tested, marketed, or used under regulators’ supervision which will allow for real-world learning and flexible rules that do not stifle innovation.”

There were also some minor positives in the newly published Omnibus on Food and Feed. Although the omnibus does not include simplification of the veterinary medicines Regulation 2019/6, there is a move towards digitalising labelling for medicinal feed additives, and an easing of the obligation to renew feed additive marketing authorisations every 10 years. Updating the surveillance of bovine spongiform encephalopathy (BSE) and risk mitigation requirements in accordance with science is also a welcome move to bring this is line with the latest evidence available.