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February 26, 2025

Taming the runaway horse: regulating Ozempic et al

Insight

By Will Marshall, Head of Legal and Risk Management

Taming the runaway horse: regulating Ozempic et al

Barely a day goes by without a new revelation about weight loss medication. This media attention reflects the public clamour to access these revolutionary treatments for obesity. Brand names such as Wegovy, Saxenda, Mounjaro and Ozempic have swiftly become household names.

However, the airtime also reflects growing public and scientific concern. There is widespread unease about unscrupulous marketing and dispensing of the drugs, alongside an increasingly polarised scientific debate. On one hand, studies extol the medication's astonishing healing properties, while on the other, alarming reports emerge of safety risks and potential side effects.

Why are these treatments so popular?

The treatments are in massive demand because anecdotal evidence suggests they work. It is now accepted that GLP-1 Receptor Agonists are incredibly effective in helping people lose weight. Clinical studies have shown impressive results: semaglutide, resulted in 12% larger weight loss than placebo after 68 weeks of treatment, while tirzepatide, a dual GLP-1 and glucose-dependent insulinotropic polypeptide co-agonist, led to 18% weight loss compared with placebo after 78 weeks.

This degree of weight loss brings numerous health benefits, including reduced risk of type 2 diabetes and improved cardiac health, not to mention boosted self-confidence.

Wonder drug or risk to public safety?

Despite their efficacy, concerns have circulated about safety and potential longer-term side effects. Some studies present these treatments as miraculous wonder drugs with benefits beyond weight loss. A recent US study by the journal Nature Medicine based on analysis of 2.5million patient records concluded the medicines could be protective against forty-two different diseases, from Alzheimer's to liver cancer.

Alongside this, a different picture emerges. Reports cite increased hospitalisations, muscle wastage, and osteoporosis. Recent studies raise concerns about serious potential side effects including severe visual problems, gastroparesis (stomach paralysis), increased risk of pancreatic cancer, and increased anxiety and depression.

A regulatory challenge

Current MHRSA Guidance states that the benefits of licensed weight loss injections outweigh the risks, provided they are used for licensed indications. However, these drugs can carry significant potential risks and are not appropriate for everyone.

UK regulators recognise these are serious treatments, and all licensed weight loss injections are prescription only medications (POMs). NHS access is tightly controlled, requiring a BMI of 30+ or 27+ with weight-related health conditions.

These eligibility criteria have led to a bottleneck, and regulators must be alert to corner-cutting. Pressure is acute in two areas: a sharp rise in illegal sales without prescriptions, and unprecedented demand for online pharmacies, which has reportedly soared by 300% for some providers.

Regulatory response

The MHRA's Criminal Enforcement Unit is responsible for preventing illegal sales, recently issuing a public notice urging awareness of fake pharmacy websites. They work with social media platforms to identify illegal sales, with sanctions including removal of posts and suspension of accounts.

The General Pharmaceutical Council (GPhC) has this month released tightened guidance for registered pharmacies providing distance services. The new guidance strengthens safeguards to prevent inappropriate supply of medicines, particularly high-risk medications like weight loss drugs. Requirements include independent verification of patient information before prescribing and emphasise timely two-way communication between prescriber and patient.

Striking the balance

Regulating weight loss medications remains complex. While offering undeniable benefits, their potential risks and illegal distribution require robust oversight. Striking the right balance between availability and safety is crucial in managing this rapidly evolving landscape.

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"The information contained in this article does not represent a complete analysis of the topics presented and is provided for information purposes only. It is not intended as legal advice and no responsibility can be accepted by Altea for any reliance placed upon it. Legal advice should always be obtained before applying any information to particular circumstances."

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