The concept of creating whole new life forms from artificial material sounds like something from a sci-fi movie. Yet the advancing field of synthetic biology is very real, and brings its own legal concerns with it.
In 2005, scientists from a government laboratory in Atlanta, Georgia in the USA, successfully recreated the Spanish flu virus. It’s the same virus that killed an estimated 50 million people in 1918.
Senior Lecturer in the Faculty of Law, University of Technology Sydney, David Leary says researchers around the world had good reason to be alarmed. Security fears stemming from the implications of such advancements in synthetic biology have opened up a whole new cause for concern.
“You’ve probably heard of genetically modified organisms (GMOs); but the technology that allowed scientists to recreate Spanish influenza is something completely new,” explains Leary. “GMOs were about genetically altering an organism; for example, manipulating a species of wheat that could tolerate salty soil or needs less water.
“Instead of manipulating something that already exists in nature, the fundamental preface to synthetic biology is taking the building blocks of life and creating a whole new life form. It’s an area open to breakthroughs for beneficial purposes, such as a cure for malaria or next generation biofuels.”
But there are dangers too. With the applications of synthetic biology only just beginning to be understood, Leary has been looking at the potential risks such breakthroughs pose, and whether existing laws and regulations around biotechnology apply.
“There’s been no detailed study by lawyers as to whether existing regulation effectively manages these risks or not. This project will be the first study of the regulatory framework for synthetic biology under Australian and international law.
“My research is trying to work out what’s going on and to come up with some ideas on where we need to regulate, or do we need to regulate, and look at how we move forward. We’ve got quite a robust regulatory regime for dealing with gene technology already. However, we’re now moving into synthetic biology and questions are emerging as to whether current legislation adequately manages the risks posed by this new field.”
With the ‘playing God’ consequences of synthetic biology raising social, ethical and moral concerns, on a more serious public safety level it also raises bioterrorism and biosafety threats.
“If a newly-created organism is intentionally or unintentionally released into the wild, what would these new life forms do to existing biodiversity? We already have concerns about naturally created alien-invasive species that come from other parts of the world and end up destroying eco systems. A good example is the foreign crown-of thorns-starfish on the Great Barrier Reef, which feeds on coral. If we now introduce totally new life forms into the environment we simply still do not know what will happen.”
Just as the synthetic recreation of the Spanish flu by scientists poses health concerns if it ever managed to escape, Leary points out the dangers of a ‘hacker mentality’ taking hold.
“When we talk about hackers in a computer context, they do it just to prove that they can. With the availability of DNA sequence data and molecular biology techniques on the internet, along with the fact that specially synthesised DNA can easily be purchased, it’s not inconceivable that someone could engineer a virus or other life form to cause havoc. Or worse still, to be used in a terrorist attack. There is currently little oversight around these possible threats.”
The issues surrounding synthetic biology have come to the attention of the Convention on Biological Diversity (CBD), dedicated to promoting sustainable development and signed by over 150 government leaders at the 1992 Rio ‘Earth Summit’.
“They had a long debate more than 10 years ago about GMOs and the risk to biodiversity. The response was initially a moratorium and strict regulation placed on the field trials of GMOs domestically, and on an international level the enforcement of the Cartagena Protocol on Biosafety – a treaty governing the movements of GMOs across international borders,” explains Leary.
“The CBD is quite an interesting body of law. Every meeting held by diplomats each year has a part dedicated to emerging issues. In the last few years there’s been a debate at these meetings asking whether we need to look at how we regulate synthetic biology as an emerging issue in the context of the biodiversity convention. Do we need another protocol, like we have with the Cartagena Protocol? Or will the Cartagena Protocol suffice?
“What has been problematic, though, is that some countries who are already investing in research and technology in this field don’t want it to get on the agenda at the UN. They don’t want restrictions on their economic development.”
Outside the CBD, the possible risk of synthetic biology for terrorist uses has also been discussed within the confines of the Biological Weapons Convention, and to a lesser extent, the Chemical Weapons Convention. Both these international treaties were designed to stop the spread of weapons and technology used for biological and chemical warfare.
“Three to four years ago they set up a working group to look at what these new technologies mean for existing international treaties that regulate the import and export of biological weapons technology. They’re looking at that largely behind closed doors, trying to work out how to best respond to what is a complex problem.
“It’s not just a matter of ‘someone’s developed this new living form, let’s ban its import and export’. With synthetic biology effectively working at the DNA level, or even smaller than that, you’re talking about different things that could be used, in theory, to develop weapons.”
The challenge for regulators and policy makers is to come up with legislation that balances security and safety risks while still facilitating research.
“How do you differentiate between those building blocks of life being sent across international borders for scientific research, and being sent across international borders for terrorist purposes? You can’t. How does that feed into the quarantine and customs regulations in particular countries? And what gaps are there in the regulation of synthetic biology under international environmental law?
“I don’t know what the answers are yet, but I am keen to find out.”
Source: University of Technology Sydney