THE FUNDAMENTALS OF LIFE
On being unapologetically pro-regulation
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
To truly unlock the promise of AI for health, we must build robust regulatory systems that protect patients, build trust and strengthen oversight
H istory is littered with 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 examples of poorly regulated medical innovation gone wrong, from early batches of tainted polio vaccines to the
Bilal Mateen, chief AI officer, PATH
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Health: A Political Choice – The Future of Health in a Fractured World
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