The Regulatory Question Bomb

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A monthly podcast series from Life Science Law, taking a deeper dive into the regulatory developments shaping the pharmaceutical, biotech and wider life sciences industries. Moving beyond the headlines, our series will explore the key developments from our monthly Regulatory Updates, bringing practical insights, expert opinion and commentary from experienced industry lawyers.

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The Regulatory Question Bomb Ep 1 - Weight Loss Jabs, Indirect Promotion and AI Governance

30 min 8 sec

Our new monthly lawcast series, The Regulatory Question Bomb, looks in more depth at the key developments from our regulatory updates and provides practical opinion and commentary from our most experienced industry lawyers. In this first episode, Wendy is joined by Rebecca, who researches and writes our monthly regulatory update. They discuss two stories from last month’s edition: the MHRA’s summer rulings on online pharmacies promoting weight loss injections to the public, and the governance questions raised by AI adoption across the NHS. The episode is relevant to legal, compliance and regulatory professionals who work on medicines promotion or oversee the use of AI in their business. Overview The discussion starts with the rules on advertising prescription-only medicines under the Human Medicines Regulations 2012. Wendy and Rebecca then look at how the MHRA’s recent cases show that a company can promote to the public without ever naming a product. They cover indirect references, a pre-licence campaign and an off-label promotion case, and ask whether enforcement risks becoming a cost of doing business. They also explain how the MHRA, the ABPI and the PMCPA fit together. The second half turns to AI. NICE wants to scale AI across the NHS while the NCSC is warning about the cyber risks of agentic AI, and the speakers discuss what that means for governance. Key Points The fundamentals still apply: A medicine can’t be advertised before it’s licensed, prescription-only medicines can’t be promoted to the public, and any claims must be consistent with the SPC. Promotion can be indirect: Symptom-led content, before and after imagery, and “ask about our weight management programme” messages can promote a medicine without naming it. Past customers are still the public: The MHRA confirmed that people are still members of the public even if they’ve shown interest in a service or been prescribed a medicine before. Sanctions have teeth: Repeated breaches can lead to mandatory pre-vetting, escalation and, in the worst cases, criminal prosecution and personal liability. AI governance is lagging behind adoption: Businesses are moving quickly on AI, but oversight of which tools are in use, and who signed them off, hasn’t always kept up. Key Takeaways What counts as an indirect reference When only a few products offer a particular treatment, mode of action or claim, talking about that treatment can point to a specific medicine. The test is whether the content is likely to lead someone to ask for a prescription-only medicine by name. Pre-licence and off-label promotion In the Voy case, social media posts built demand for an unauthorised weight loss product with a “new dawn is coming” teaser and a pre-sale waiting list, without naming a brand. In the Kenalog case, a licensed medicine was promoted for an unlicensed use, hay fever. Different rules apply to each, but both were clear breaches. Where risk appetite meets the line Much of the work in pharma is finding nuanced wording that keeps material on the right side of the line, but some companies knowingly take the risk anyway. Both agree that patient safety must be the deciding question for any material. This first episode shows that the foundations of medicines advertising law are being tested in new ways, from indirect social media content to the push for AI-driven efficiency. Clear rules, strong governance and a focus on patient safety are still the best protection. You can read last month’s full regulatory update, and previous editions, on the Regulatory Updates page of our Knowledge Centre. Have a question or perspective on this topic? We’d be interested to hear your thoughts. Share your comments using the form below and join the conversation.

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