On being unapologetically pro-regulation
History is littered with examples of poorly regulated medical innovation gone wrong, from early batches of tainted polio vaccines to the global roll-out of faulty metal-on-metal hip implants. These failures caused real harm, but they also catalysed real change – tighter vaccine regulation, stronger post-market surveillance and more rigorous standards.
However, for much of the world, especially in Africa, those guardrails came slowly and remain fragmented. That is changing. After more than a decade of investment, we are approaching the emergence of a robust regulatory ecosystem in Africa, one that is continent-wide and capable of operating independently. Underpinned by the African Medicines Agency, this system brings the technical muscle to evaluate and hold to account critical medical innovations, while ensuring that high-quality medicines, diagnostics, vaccines and other interventions reach the people who need them most.
This is not just a bureaucratic achievement; it is a pivotal step towards regulatory equity, opening up the enormous economic and scientific potential for Africa and African manufacturing. It challenges the implicit assumption that emerging economies must accept weaker safety standards as the price of access or rely on others for their regulatory approvals.
That is why it is especially concerning to see a growing chorus questioning whether the same high standards should apply to artificial intelligence. To be pro-regulation of artificial intelligence in health has somehow become provocative.
It must not be.
A pro-innovation regulatory ecosystem
The current push for ‘pro-innovation regulation’ suggests that oversight and progress are opposing forces, as if ensuring safety means stifling creativity. That is a false and dangerous dichotomy. Regulation is not the enemy of innovation. In fact, effective regulation is an essential foundation for innovation.
A shrewd regulatory framework does not just provide clarity and certainty – it drives investment. Businesses and, more importantly, science thrive when rules are clear, fair and consistently enforced, which, at the same time, builds public trust. Far from being a drag, well-crafted oversight weeds out unsafe or ineffective solutions early and paves the way for high-quality innovations to succeed.
The problem we face in AI for health today is not overregulation but underpowered regulators. Many agencies tasked with protecting patients simply lack the expertise, funding, political backing or teeth to do their jobs. This leads to ineffective oversight, a lack of trust and an inability to nurture rapidly evolving science and research and development ecosystems. Ironically, supporting regulators is the fastest path to the pro-innovation regulatory ecosystem that so many desire.
Putting people before platforms
Of course, some will still argue that a strong regulatory stance risks stifling bold ideas. But regulation is not about fetishising rules or bureaucratic box ticking. It is about protecting lives and preserving the integrity of health care. If a more robust regulatory regime for AI slows down or, worse still, halts some innovations, we must be mature enough to say that is okay. In truth, that is the point when pseudo-innovations offer little benefit or carry unacceptable risks. In a field laden with snake oil salesmen, a robust regulatory infrastructure and well-resourced regulators are our best defence.
In the current fractured global governance context, choosing regulation is a deliberate act. It is a choice to prioritise human well-being over short-term techno-economic gains. A choice to learn from past mistakes, rather than repeat them. Over time, that choice will save far more lives than the perceived bureaucracy costs. And although regulation may not be as attention-grabbing as a flashy new app, it is the foundation that allows real innovation to thrive in all countries and endure. It is what transforms potential into public good.
So, yes, I am unapologetically pro-regulation. If that makes some uncomfortable – those who would rather move fast and break things – so be it. Because in health, what breaks is not just a product or platform. It’s people. And no apology is needed for insisting they come first.
