DIY biology dilemma – regulating biohacking

Science kits may have inspired generations of children to become scientists, and those grown up children might be surprised that there may be cause for concern when more people than ever before want to try their hand at some ‘garage biology’.

A few technological advances have changed the game in terms of what can potentially be achieved in someone’s garage. At the top of this list are gene editing technologies, primarily through the use of the CRISPR/cas9 system. The CRISPR/cas9 system is a gene editing system that relies on a guide RNA that can recognise a target DNA sequence in a genome and cause the cas9 protein (or a related enzyme) that it associates with to cut the target DNA. The cut can then be repaired by the cell’s own DNA repair machinery, adding or deleting a piece of genetic material in the process. The technology is flexible, efficient, relatively easy and cheap to implement, which makes it amenable to DIY biology.

One particular aspect of DIY biology that has been picking up speed is the concept of self-improvement using science and technology (sometimes referred to as ‘biohacking’ or ‘grinder’ community). Genetic engineering goes to the core of how the ‘human machine’ functions and new tools to tinker with this incredible machinery did not get lost on the biohacking community.

Biohacking on the world stage

Back in 2017, a series of media stunts put the biohacking phenomenon on the world stage – literally. For example,  on the stage of Synbiobeta, one of the largest synthetic biology conferences in the world, the CEO of a biohacking-promoting startup that sells CRISPR gene editing kits injected himself with a composition designed to increase his muscle mass by disrupting his myostatin gene. The steak-lovers amongst you will be familiar with the Belgian blue cow, which bears a mutation in this gene. Spoiler alert: this did not work. It did however attract some attention, including from the FDA. Other ‘garage biology’ experiments followed.

Regulation in the Golden State

Earlier this summer, the state of California approved a bill that will make it illegal to “sell a gene therapy kit in this state unless the seller includes […] a label on the package containing the gene therapy kit, in plain view and readily legible, stating that the kit is not for self-administration.” It seems that at least in California, gene therapy kits (where gene therapy covers “any administration of genetic material to modify or manipulate the expression of a gene product, or to alter the biological properties of living cells, for therapeutic use”) are now a mass consumer product, and they’ll have to be sold with a safety warning. 

The new California bill does not completely shut down the possibility for biohackers to keep experimenting with adventurous forms of self-improvement (DIY faecal transplants (!) don’t require any genetic engineering), or experiments involving genetic engineering for other uses than self-administration. However, it does arguably represent a first step in the US legislative explicitly trying to address the ‘escape from the lab’ of genetic engineering technologies. It will be very interesting to see whether further steps are taken in the US and elsewhere.

Democratising lab biology

Meanwhile, organisations such as biomakespace in the UK and genspace in the US (to name a few) have been working to provide “community labs” where members can get access to facilities and a community to promote knowledge and innovation in engineering with biology. These spaces encourage a culture of safety and responsibility around the science that is being made, while promoting access to it. In this era where technology is the answer to every question and personalised medicine is a rising theme, our relationship to our biology is changing rapidly. How we handle this paradigm shift as a society will no doubt reveal a lot about which science fiction movie future generations will end up living in.

An IP perspective

The possible growth of a DIY market begs interesting questions in relation to what exactly should be protected. Indeed, the answers to the questions ‘what method/product is performed/sold, by/to who and for what purposes’ may change in ways that are significant since UK law provides exemptions of patent infringement for acts which are done privately and for purposes which are not commercial. This seems far from being a realistic commercial problem at this point, but the idea of having a mini computer in our pockets at all times would have seemed similarly mad 50 years ago.