The pharma anti-counterfeiting playbook has a new tactic in the form of website blocking injunctions. This comes with thanks to Novo Nordisk, owner of the well-known OZEMPIC and WEGOVY brands. This is a first-of-its kind injunction in the pharmaceutical space, but builds on the established jurisdiction of the court to grant such injunctions in an ever-growing list of circumstances.

A blocking injunction is a court order directed at intermediaries, typically internet service providers (ISPs), such as BT, Virgin Media, Sky. Rather than pursuing the operator of a website, the court requires the ISP to prevent access to it. These injunctions are not a takedown mechanism. They are an access control tool. Users in the UK are prevented from accessing the injuncted websites. 

Website blocking injunctions as a remedy exist to combat the digital reality that infringers are often not identifiable or operate outside of the jurisdiction. Whilst the intermediaries are not responsible for the underlying wrongdoing, they are best placed in the digital ecosystem to thwart access to unlawful content.

A Novel Evolution for Blocking Orders

Novo Nordisk’s injunction is a watershed moment: 

1. First UK website blocking injunction targeting illicit online pharmacies (IOPs) and the sale of medicines.
2. Confirmed that blocking injunctions extend to criminal and regulatory wrongdoing.
3. The application for the injunction was supported by the Medicines and Healthcare products Regulatory Agency (MHRA); a fantastic example of private-public partnership in the combatting of counterfeiting.

Despite the above novelties, this decision now raises more questions than it answered. 

The Illicit Online Pharmacies Epidemic

An estimated 30,000+ illicit online pharmacies are thought to be operational at any given time. This figure does not account for the endless stream of medicines being offered on social media platforms. This case blocks a handful. 

The court has definitively established, in Cartier and Nintendo, that it is imbued with the power to grant such injunctions in cases outside of copyright and intellectual property rights. Now, the court has accepted criminal offences as the basis for obtaining a blocking order. 

Once the question on standing was answered in the affirmative for Novo Nordisk to assert the criminal wrongdoing of the defendants, the court inevitably made short thrift of the proportionality issue on the basis 

1. the websites offer prescription medicines to customers without a prescription, 
2. the websites did not have regulatory authorisation to sell semaglutide, the active ingredient in Novo Nordisk’s GLP-1 products, and 
3. the websites did not in fact appear to be authorised to sell prescription medicines of any kind. This meant there was no real risk of overblocking.

Furthermore, the court gave strong weight on the need to protect the public from the harms caused by IOPs selling counterfeit and unlicensed product. At para 41:

I accept that there are very serious risks to patients from these falsified products and it was made clear that preventing the UK public from being exposed to falsified and dangerous medicinal products was the Applicants' primary aim in bringing this claim.

And at para 46ii)

There is a real and pressing need for ongoing remedies of this kind, given the wider commercial and public health context of counterfeiting of semaglutide products (see above). Blocking will protect the public from dangerous medicinal products and assist in protecting the value of NN's rights and its considerable investment in developing and promoting useful medicines.

The question remains how are the public protected from the 30-odd-thousand illicit online pharmacies which pose very serious risk?

A Shot in the Arm for Lawmakers

Novo Nordisk have discharged their duty to protect patients. The MHRA played their part by extra-judicial measures and in supporting the blocking injunction application. The collaboration between brand owner and MHRA is a shining example of how public-private partnerships can be leveraged for effective anti-counterfeiting to remove unlawful, harmful products from the market. 

This win serves as a signal that not only is there more to be done to combat the scourge of illicit online pharmacies selling falsified medicines, but that there’s a clear way forward: administrative website blocking. This would be a version of a website blocking order but granted through the relevant regulator, namely MHRA, rather than going through the courts. 

A carefully designed procedure with sufficient safeguards empowering the MHRA to administer the wholesale restricting of access to the UK market of illicit online pharmacies would drastically reduce a large catalogue of harmful products from being purchased and consumed by the public. Given the court has found there is no material risk of overblocking, there is no reason why administrative blocking could not fairly balance the need to remove illicit medicines from online with freedom of expression and due process. 

Any move towards administrative blocking requires considerable consultation. During this time the MHRA needs to be better resourced as the internet remains awash with falsified medicines. Without an endless docket of injunction applications with the court, patients will remain at risk. Despite a string of recent successes***, the MHRA is woefully underfunded. Analysis from the OECD has estimated the illicit market for falsified medicines in the multi-billion-pound range, and increasing. And it’s a hugely profitable form of illicit trade with relatively lower risks compared to the illegal drug trade e.g. sale of cocaine, heroin etc.

The Novo Nordisk decision has proved blocking injunctions should now be another tool in

the pharma anti-counterfeiting playbook. It has also put a spotlight on how its been left entirely to the pharmaceutical industry to protect the public from falsified medicines. Its time for a thorough legislative review to tackle the online falsified medicines epidemic, with better funding for the MHRA and administrative website blocking orders high on the priority list.

[i] Similar injunctions are available across other jurisdictions.

[ii] Overblocking describes the situation in which a website or content is blocked which goes beyond what is deemed proportionate in order to effect the order.