Very recently, I wrote an article on whether regulators can enforce weight loss drug laws. I didn’t expect to be writing another piece on the same subject so soon, but the Health and Social Care Committee (HSCC) has just published the second report from its inquiry into “Food and Weight Management”.
One of the things the HSCC looked at was “the regulatory landscape” and it “explored the capacity of the regulatory system to tackle illegal and counterfeit GLP-1s”.
Read more: From a lawyer: Can regulators enforce weight loss drug laws?
The Medicines and Healthcare products Regulation Agency’s (MHRA) deputy director of criminal enforcement and head of the criminal enforcement unit Andy Morling gave evidence that the MHRA “did have the capability and capacity to tackle the illegal trade” and “in relation to social media, his team actively patrolled the internet for examples of illegal activity and worked with social media companies to remove offending accounts”.
He said the medicines watchdog “relied heavily on public reporting to identify issues”, and acknowledged that “the ‘whack-a-mole’ nature of the approach” reflected “the nature of the territory and the sheer volume and speed at which these things can be posted”.
Read more: Weight loss management services must be ‘overhauled’, say MPs
Is the MHRA complacent about its capability and capacity? Much of the focus seems to be on social media and not on websites.
It is interesting to compare what the MHRA witness said with a recent High Court case brought by Novo Nordisk, the manufacturers of Wegovy, against all the UK’s main internet service providers (ISPs) including BT, EE, Virgin Media, Sky, TalkTalk and Plusnet.
Read more: Around £2m of fake weight loss jabs seized in MHRA raid
The case was not brought in a criminal court, but in a civil court. Novo’s case was that Viogen Pharma, Pharma-Labs, Leo Labs and The Steroid Supplier were advertising on their websites unlicensed and counterfeit semaglutide.
They were targeting UK consumers. Novo argued that this advertising breached its intellectual property rights.
“Large numbers deceived”
Novo asked the judge to grant an injunction that would require the ISPs to block the offending websites. This was the first time in English legal history that a court order of this kind had been sought in relation to the supply of counterfeit and unlicensed prescription-only medicinal (POM) products.
The judge referred to evidence that “large numbers of UK consumers are being deceived into thinking that they are purchasing a licensed and genuine source of semaglutide when they are not”.
Read more: First oral weight loss drug ads banned by watchdog
He observed that this deception was supported by messages from the website operators that they are a “pharmaceutical company you can trust” – as seen on the Viogen website home page – and whose products are “certified by the WHO-GMP, and fully compliant with … UKMHRA” – as seen on the Viogen website frequently asked questions page.
The judge was also influenced by the fact that the advertising and offering for sale of unlicensed POMs is a criminal offence under the Human Medicine Regulations 2012. The injunction was granted.
“Joined-up action plan”
A significant feature of the case is what prompted Novo to bring it in the first place. The MHRA had tried and failed to take down the Viogen website, so it wrote to Novo to ask for help. Compare the MHRA’s inability to take down a website with the evidence it gave to the HSCC.
As it happens, the HSCC doesn’t seem to have found the MHRA’s evidence convincing. Its conclusion was:
“While we acknowledge the ongoing efforts to tackle the illegal trade of GLP-1s, we remain concerned that the regulatory system is inadequately equipped to keep up with the scale of demand for GLP-1s, or flexible enough to deal with changes such as patent expiry and the availability of tablets. There are already examples of harm to people who have accessed illegal GLP-1s online, and we are concerned that these will increase as availability and demand for these products increases. The MHRA seems to be playing catch up, rather than proactively addressing this challenge, particularly with social media.”
The HSCC recommended that the government must “review the capacity and capability of the MHRA” and say whether it considers the MHRA is “sufficiently resourced to address the illegal trade in GLP-1s”.
Read more: GPhC takes action against two major weight loss pharmacies
It also called for a “joined-up action plan” for dealing with illegal trade in GLP-1s and access to them through social media, so “clear areas of responsibility” can be set up.
Injunctions in civil courts can be an effective weapon because ISPs can be relied on to obey them. But the Novo case suggests that the MHRA should have the power to ask ISPs to take down offending websites without having to ask a manufacturer to bring court proceedings.
David Reissner is chair of the Pharmacy Law & Ethics Association