Since then, the regulatory framework has continued to evolve. Now, the journey to get new medicines to market is long, requiring multiple phases in the clinic, continual monitoring and independent assessment. Generating the evidence to hit regulatory milestones requires an enormous amount of investment, but it is vital to understanding if they are safe let alone if and how new treatments work, which informs future research. The regulations, in demanding rigorous testing and reliable evidence, help to drive innovation rather than dampen it.
And for any political leaders who fear AI regulation will stunt their economies, it’s worth noting that the pharmaceutical industry remains one of the most profitable in the world.
Best-laid plans
The thalidomide disaster, which catalysed these regulatory changes, was not the result of a grand conspiracy or an industry-wide deception. The manufacturer thought the drug was safe and believed it would help many women manage their morning sickness, but the scandal exposed serious failures in how medicines were tested. With such lax regulations, even well-intentioned companies can cause harm.
This is particularly relevant in the AI industry, where the actions of the technology can diverge from the intentions of the company, as we’ve seen from the many incidents this year of AI agents going rogue and hacking into things they shouldn’t. Indeed, policymakers are currently grappling with a difficult question: who do you hold accountable for a technology that has a mind of its own?
The answer cannot rely on trusting companies to get everything right. The pharmaceutical industry shows that we need independent assessment and continual monitoring to keep the public safe. AI will require its own regulatory framework, but the principle is the same: you do not have to choose between progress and safety. Rather, it is only by ensuring the safety that you can deliver the progress promised by the AI revolution.
Hopefully we will not have to wait for another disaster to force regulators into action. They better be quick – life moves pretty fast.
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