Is policy keeping up with science and technology breakthroughs?

Science and technology are advancing at a rapid pace. 

Scientists are growing replicas of human organ systems, organoids, in labs to study disease – helping us spot risk genes for certain conditions and understand how viruses harm us. Artificial intelligence (AI) is helping diagnose cancer faster and more accurately. It could even transform primary healthcare in sub-Saharan Africa as a valuable assistant to under-resourced clinicians by supporting decision making, including making diagnosis and treatment plans more efficient. 

These technologies offer drastic improvements for human health, but what’s at stake if these technologies advance unchecked?

Oversight mechanisms span rigid regulations, like laws and legislation, and softer regulatory approaches like guidelines and best practice. Oversight mechanisms are an important step in ensuring science can proceed with confidence. 

Potential misuse of technological developments in neurotechnology, engineering biology, organoids, embryology and AI might seem like science-fiction now, but rapid advancements are telling us we must prepare for this not-so-distant future.

Regulators across the globe are facing an enormous task. Regulate too soon, and you prevent the enormous positive potential these technologies can realise. Regulate too late or not at all and the risks could become a reality.

The key is global collaboration between regulators and developing new, dynamic regulatory solutions that match the pace of technological innovation. A collaborative international community can work to align existing and new laws, rules and frameworks to ensure the science can thrive in a proportional and safe way.

We need policy makers and governments to act. Through our policy and advocacy work in this area, we can create a stronger and more sustainable enabling environment for discovery research that balances scientific progress with ethical and societal implications.

That’s why we commissioned RAND Europe to undertake a first-of-its-kind review of the oversight of emerging technology. We wanted to understand more about what rules, laws, guidelines and frameworks were in place for the following rapidly advancing emerging technologies:

• genomics (in particular engineering biology)
• human embryology
• organoids
• neurotechnology
• artificial intelligence (AI) and data platforms as cross-cutting themes

RAND Europe published two reports. The first is a landscape review, introducing the technology areas, their opportunities and risks. The second covers oversight mechanisms for each area, focusing on the UK, EU, US and internationally, complemented by some deeper-dive case studies.

Below are some key insights from the reports.

Genomics is the study of an organism’s complete set of DNA. Engineering biology, and fields within it like synthetic genomics, create new biological systems or redesign existing ones.

Engineering biology is an emerging and interdisciplinary field, and when applied to the engineering of genes, has the potential to drive innovation in exciting new ways.

Advances in this field could help respond to climate change, allowing us to engineer crops that can survive in high temperatures or make microbes that degrade plastic. Developments in engineering biology can also have harmful applications or be used with malicious intent.

Governments around the world are already taking steps towards ensuring engineering biology is well regulated to avoid misuse, but the current regulatory landscape is fragmented. That means researchers working in this field often navigate a complex labyrinth of different, sometimes conflicting, rules and laws.

The UK Government has taken an experimental approach to exploring how to regulate this field without imposing restrictive sanctions and preventing exciting innovations. It is taking a ‘sandbox’ approach, bringing together regulatory and scientific experts to test ideas for agile regulation in a controlled environment before rolling it out nationally.

To tackle this challenge, the reports recommend developing comprehensive ‘oversight maps’ to help establish networks of interconnected oversight mechanisms. This would support those in the field more effectively navigate the labyrinth of relevant regulations.

Organoids are lab-grown three-dimensional cultures commonly created using stem cells. They can self-organise into structures that mimic organs – even organs as complex as the brain.

The rapid developments in organoid technology mean scientists can test how specific human organs are impacted by diseases and new drugs. This has the potential to help get new drug treatments to market quicker and even create organoids for an individual to design bespoke treatment plans.

But this comes with ethical challenges, particularly for brain or neural organoids. Some scientists are worried that the technology could advance so far that neural organoids theoretically become ‘conscious’.

Organoids are also a relatively new concept and so tend not to have specific rules and regulations, but are governed partially by existing laws created for human cells and tissues. This creates a gap in the regulatory landscape, and one that many fear creates too much space for non-compliance, misinterpretation, or preventing the science from happening at all.

There is also a gap in consent for those donating their cells to research. As stem cells are ‘nonspecialised’ cells at the point of donation, it’s difficult to tell a donor precisely what they could be used for, especially as the science develops in leaps and bounds. Many nations are exploring solutions to this, and the second report covers case studies from Japan, Australia and the Netherlands where different approaches are being trialled to consider consent, risk and ethics. 

Alongside considerations for each emerging technology area, there are also several considerations that cut across all emerging technology areas, recognising that many of the challenges policy makers face are interconnected.

Here are a few highlights:

• Equity must be prioritised: Disparity in access to, representation in, and benefits from emerging technologies can lead to unequal societal and economic outcomes. This undermines the potential these technologies have for inclusive growth and innovation, and it must be considered with the same priority as ethics, safety and security when designing new regulations.
• Working together internationally is essential: Finding common ground for practical and actionable international alignment must be a priority for policy makers to harmonise regulatory practices across borders. Science and research is international, and to aid collaboration and fuel discoveries, policies must consider how everyone can come together globally to ensure technological development is proportionate and ethical.
• Proactively engage the public: Public trust and acceptance are vital for the success of emerging technologies. By engaging the public at the earliest stages, rules and regulations can reflect societal values and needs. More regular public consultations, surveys, forums as well as educational campaigns to inform the public about technologies and their implications are essential.
• Innovative regulation is needed for innovative technologies: Technology is developing rapidly, whereas traditional forms of oversight and regulation tend to move at a slower pace. To effectively manage the complexities and dynamics of emerging technologies, regulation should incorporate adaptive and dynamic practices to foster continuous learning, flexibility and agility in response to advancements.
• Develop comprehensive process maps: Many laws, rules and regulations weren’t designed or intended for the science of today and can make it difficult for scientists to focus on their groundbreaking innovations. The reports propose that developing maps as a guide to help researchers and others would decrease time spent on administration and simplify compliance by making rules, responsibilities and processes clearer.

We hope these reports will provide a valuable resource for policy makers worldwide as we help to shape a healthier future for everyone.