In Europe, the deliberate release of genetically modified organisms (GMOs) for trials and marketing are regulated by EC Directive 2001/18/EC, this applies to plants and genetically modified microorganisms (GMMs). When assessing applications to release GMOs regulators must be satisfied that any potential risks associated with the release have been properly assessed. EC Directive 2001/18/EC provides a clear framework to guide regulators in making their assessments, and criteria for assessment of risks to human health and the environment are a very important part of this. In the UK, Defra is responsible for the regulation of the release of GMOs.
Whilst the use of genetic modification in the production of crop plants is well known in the UK, Europe and worldwide, genetic modification techniques are also used in the production of medicines for both humans and animals. Broadly speaking, GM medicines fall into four categories: gene therapy, vaccination, the direct action of a genetically modified microorganism in a target area, and drug delivery. This is a rapidly developing field, as a quick search on the internet will show, bringing up many references to peer-reviewed and commercial publications.
Techniques for the development of GM medicines and new products for human and veterinary uses are moving very quickly. Defra must continue to regulate this area effectively. To do this, it needs to be aware of developments, trends and changes in the medium to long-term future that could have an impact on its ability to act effectively and efficiently. This project will combine a review of evidence from existing literature, regulatory and commercial sources, with expert consultation to identify new techniques, products and product/technique scenarios that are likely to emerge in the future. The potential emerging risks that might be associated with these scenarios will also be explored, again through consultation with experts. The work will be delivered using innovative horizon scanning and other 'futures techniques' to systematically anticipate, identify and prepare for new or changing risks associated with GM medicines. Workshops will be held with invited key experts using recognised techniques that capture and quantify their beliefs about the likelihoods of the scenarios identified, and the impact of any risks. These outputs will be used to identify whether the future product scenarios identified are likely to present regulatory challenges for Defra, and whether any amendments might be needed to enable appropriate regulatory assessment and management of products for which Defra may see applications in the future.
The research will place Defra at the forefront of awareness of emerging techniques and products in the field of GM medicines, and their potential risks to human health and the environment. The approach will be systematic, transparent and evidence based and benefiting from input from a wide range of independent experts. It will also be transferrable should Defra wish to use it again in the future.