Synthetic biology (or "SynBio") is the engineering, construction, or redesigning of natural biological units (such as cells, genomes, or proteins) and processes to produce synthetic derivatives with new abilities or properties (and ultimately to fulfil new scientific and/or useful purposes).
SynBio is increasingly used in pharmacological production (e.g. the wholly synthetic mRNA COVID vaccines, drugs that induce insulin secretion in diabetics, or stem cells that generate blood of a certain type) or to meet sustainability targets (e.g. producing plant-based 'meat', cultivating resilient crops, or synthesising sustainable nitrogen-fixing fertilisers).
The law & SynBio
It is a widely-held view that there is a considerable risk of regulation not keeping up with developments in technology. The SynBio sector is no different. It is currently governed by a patchwork of laws and regulations that apply to biotechnology more broadly – as opposed to being addressed by a single piece of legislation. The array of SynBio or GMO-related legislation includes the following:
- All work activities, including those concerned with genetic modification and synthetic biology, are covered by the Health and Safety at Work etc Act 1974 ("HSW Act") and relevant regulations, including the Control of Substances Hazardous to Health Regulations 2002 and Genetically Modified Organisms (Contained Use) Regulations 2014. The HSW Act, together with the Regulations, are concerned with the prevention of harm to both human health and the environment that arises from 'contained use' involving genetically modified micro-organisms, animals and plants. A person responsible for the contained use must ensure that a suitable and sufficient assessment of the risks is carried out.
- The UK Genetic Technology (Precision Breeding) Act 2023 is a recent framework in the UK for the risk, release and marketing of precision bred plants and animals, including food derived from such. Precision breeding is a type of genetic technology and is considered by some to be essential to ensuring food security in the UK. 'Precision breeding' is defined as 'gene editing' (not gene modification). As a consequence of this Act, precision bred plants and animals have been removed from the regulatory system for genetically modified organisms (GMOs). As stated in the Queen's speech in May 2022, the Act's aims are to “encourage agricultural and scientific innovation” in the UK and that “legislation will unlock the potential of new technologies to promote sustainable and efficient farming and food production.” Controversially, there are no labelling requirements mandated for precision bred products under the Act – this has led to debate about consumer protection and whether this results in potentially misleading information (or no information at all) on the front of pack labels.
- Under the National Security and Investment Act 2021, it is a legal requirement to notify the government about acquisitions in 17 sensitive areas of the economy, one of those being synthetic biology. Likewise, a person is also required to submit a mandatory notification to the government if the target company carries out activities in relation to "advanced materials" (which includes a number of metals, polymers, nanotechnology and advanced composites).
- The Anti-terrorism, Crime and Security Act 2001 includes measures to prevent the misuse of pathogens and toxins that could be used in bioterrorism. This is a (fairly genuine) concern that the SynBio sector will need to deal with to inhibit the potential for creation and use of harmful organisms.
- The Patents Act 1977 governs the patenting of inventions in the UK, including those related to SynBio, provided that they: (1) meet the criteria of being new, involving an inventive step, and being capable of industrial application; and (2) have not been deemed a not patentable invention (e.g. DNA and human embryonic stem cells, as mentioned below).
- If SynBio is used to develop new medicines, the Human Medicines Regulations 2012 sets out a comprehensive regime applying to the authorisation, manufacture, and marketing of these products.
- Although SynBio is not specifically mentioned, we expect both the Environmental Protection Act 1990 (which seeks to protect the environment by implementing controls and fines to reduce air pollution, carbon emissions, and harmful waste disposal practices) and the Environment Act 2021 (which includes a new legally binding target on species abundance for 2030 and establishes the Office for Environmental Protection) to monitor any negative impacts on releasing SynBio products and processes into the environment.
Key legal issues and other considerations
Determining what can be patented in SynBio is complex and, unsurprisingly, the issue of ownership/protection of intellectual property rights is one of the key issues facing this area of innovation. As mentioned above, to be patentable, an invention must be: (1) novel; (2) inventive/non-obvious; and (3) have utility or industrial applicability. Litigation in the USA and Europe has questioned the patentability of DNA and the Patents Act 1977 (at paragraph 3 of Schedule 2A) sets out a number of biotechnological inventions that are not patentable. Specifically: use of human embryos for industrial or commercial purposes is not patentable; the human body, at the various stages of its formation and development (including any part or all of a gene sequence) is not patentable; neither is any (natural) variety of animal or plant, or any essential biological process for the production of animals or plants; processes for cloning human beings is also not patentable. Therefore, whilst biological methods of producing an organism are not patentable, there has been a separate (and ongoing) debate as to whether the organisms resulting from these methods are patentable.
Likewise, there is the issue of biosafety and biosecurity and associated regulation. Key considerations include appropriate containment, any potential "dual use" (i.e. whether it is used for harmful purposes as well as beneficial), and the tension of balancing innovation with public safety and environmental protection. From a sustainability/environmental protection perspective, Jevons Paradox (also known as the "rebound effect") proposes that an increase in efficiency will generate an increase in resource consumption, rather than a decrease. To the contrary, if SynBio systematically increases the availability of substances in nature, then the impact may be positive. From an ethical perspective, whether SynBio products have the implications of modifying or creating life, regulators and those in the SynBio sector will need to balance the risks and benefits, while also potentially taking into account moral or ethical beliefs on the matter.
Lastly, but importantly, there may need to be a complex assessment of liability – and the determination of that liability in the event of loss. Insurance companies will need to turn their mind to the ability to insure (and to what extent) SynBio products.
Conclusion
Under the UK Science and Technology Framework, of which engineering biology is one of the five critical technologies for the UK, the Government’s vision is "to have a broad, rich engineering biology ecosystem that can safely develop and commercialise the many opportunities to come from the technology and the underlying science." SynBio is, undeniably, a huge growth area and focus in the UK. However, its use brings with it a number of legal, scientific, ethical, and environmental considerations.