Genetic engineering is advancing at a remarkable pace. What was once limited to theoretical discussions, laboratory experiments and scary sci-fi flicks is increasingly becoming a practical tool for treating disease, improving agriculture and potentially extending healthy human lifespans.
If you find this difficult to wrap your head around, you wouldn’t be the only one. How could it be that we’re living in an age in which we are able to modify genetics in such a way that extends and saves lives?
The thing is, whether we’re ready to accept it or not, we are.
The problem is (among others), while science is moving quickly, regulation appears to be struggling to keep pace. This isn’t exactly unique to the healthtech industry and world of medicine, but it’s fair to say that the implications could be far greater than ever before.
From gene-edited crops and personalised medicine to the possibility of selecting traits before birth, governments are being forced to confront questions that were barely imaginable a decade ago. The challenge isn’t just whether genetic engineering should be regulated, but whether existing systems are capable of governing technologies that are evolving faster than legislation can be written.
Innovation Is Moving Faster Than Regulation
According to the UK Government’s response to its consultation on genetic technologies regulation in 2021, policymakers have been looking to strike a balance between encouraging innovation and maintaining appropriate safeguards. It really is the age-old challenge of keeping research moving while simultaneously ensuring that the safety and security of citizens is still prioritised. Indeed, at the time of this response by the UK Government, officials specifically highlighted the potential benefits of gene editing for the purpose of things like food security, sustainability and agriculture, while acknowledging the need for careful oversight. Essentially, a lot to gain but a lot at risk too.
However, in more recent years (and since medicine and technology have developed further), researchers are beginning to assert that governance frameworks are struggling to keep pace with scientific advances. And it’s nothing new – regulation often (if not mostly) trails behind innovation in a plethora of different industries.
In fact, according to a 2024 paper published in the Journal of Responsible Technology, human genome editing is raising ethical and societal questions that existing regulatory systems were not designed to address. Again, this shouldn’t come as a huge surprise, as the technology continues to evolve, regulators are facing mounting pressure to learn, adapt and try, somehow, to get one step ahead.
Mahendra Balal, Founder of Sovereix, believes governments are already falling behind. “Governments are fundamentally unprepared to regulate the future of genetic engineering because policy cannot match the sheer velocity of commercial biotech innovation.” His concern reflects a broader challenge facing policymakers all around the world, which is simply: how do you regulate technologies that are evolving faster than legislation can be updated?
It’s not a mere oversight that regulation is slower than innovation. It’s an intrinsic part of how the entire system was designed and currently operates – regulation is introduced as a reaction to innovation and new technology. Thus, it cannot possibly move at the same rate (nevermind faster).
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The Risk Of A Global Regulatory Patchwork
One of the biggest obstacles to effective regulation tends to be a lack of international consistency. You’ll have one country following one set of rules and another right nextdoor following an entirely different playbook. But the thing is, innovation doesn’t necessarily adhere to specific borders.
According to research published in Nature Biotechnology, genome-editing regulations vary significantly across countries, creating a fragmented global landscape for researchers and biotech companies. While some governments have adopted relatively flexible approaches, others have imposed much stricter controls.
This creates the possibility that companies will simply move research activities to jurisdictions with fewer restrictions. If you can’t research and develop what you’re interested in within your own borders, just go somewhere it’s legal, right? Balal warns that without international cooperation, countries may inadvertently encourage a form of regulatory competition in which ethical standards become increasingly difficult to enforce, because they could be come a competitive advantage.
The result could be a world in which the future of genetic engineering is shaped not by global consensus, but by whichever countries are willing to impose the fewest limits, and that’s something we ought to be wary of.
Moving Beyond Disease Prevention
Perhaps the most contentious question is where society should draw the line. Many people support the use of genetic engineering to treat or prevent serious diseases, and that one is a little easier to stomach. But the conversation becomes more complicated when discussions turn to selecting specific traits (or intentionally not selecting for them), enhancing abilities or altering characteristics that go beyond medical necessity. And there are so many reasons that this becomes very problematic, very quickly.
According to BBC reporting on advances in reproductive genetics, scientists and ethicists are already debating the implications of increasingly sophisticated genetic screening technologies. While so-called “designer babies” remain largely theoretical, the technologies that could make greater levels of genetic selection possible are steadily advancing. It’s no longe just something that could potentially be possible one day. “One day” is upon us, and we need to figure out what to do about it.
Indeed, Balal argues that regulation should remain focused on disease prevention, warning that enhancement technologies could deepen existing inequalities if access becomes dependent on wealth.
But even so, this still allows room for questioning what is and isn’t defined as a disease or something that ought to be prevented. And this is where significant issues and risks come in.
What’s the Potential Cost Of Moving Too Slowly?
While much of the public debate is centred on the dangers of moving too quickly, many others experts believe that there’s also a risk in excessive caution.
Max Kholin, Co-Founder of GERO, argues that regulators need to consider not only the risks of action, but also the consequences of delay. “One of the greatest ethical risks with therapies targeting aging and its diseases is moving too slowly.”
Kholin believes breakthroughs in genetics could eventually help tackle some of society’s biggest health challenges, including age-related diseases such as Alzheimer’s, cancer and cardiovascular disease. From this perspective, overly restrictive regulation may delay treatments that could improve or extend millions of lives.
Thus, this constant tension, this push and pull between supporting innovation while maintaining public trust and safety, bubbles to the surface once again. The challenge is somehow finding a framework that allows scientific progress without sacrificing ethical oversight. Moving quickly without rushing.
A Global Challenge At Hand
Ultimately, genetic engineering is becoming a global issue that may very well require global solutions.
Researchers collaborate across borders, investment flows internationally and technological breakthroughs rarely stay confined to a single country. Yet, for some reason (nation states and geopolitics), regulation remains largely national.
As a result, many believe that governments may eventually need something closer to an international framework for genetic engineering, particularly as technologies become more powerful and commercially accessible.
Whether policymakers can achieve that level of cooperation remains uncertain, and even if it were possible, it’s reasonable to question how long it may take to implement. What is clear, however, is that the next decade could determine not only how genetic engineering develops, but also who gets to decide its limits. And the latter may indeed be the most important bit of all.
