The rise of counterfeit drugs and medical products is a global problem. Even with the global pharmaceutical industry backing efforts to tackle the problem, the scale is difficult to comprehend. As many as 10.5% of medicines in middle to low income countries could be counterfeit or substandard drugs, according to estimates by the World Health Organization (WHO). If this is accurate, it could represent a spend of $30bn (USD) in countries that are already facing economic distress. In 2023, Operation Pangea - a collaboration between Interpol, the Medicines and Healthcare products Regulatory Agency (MHRA), and 89 countries around the world - seized more than 15.5 million doses of illegally traded medicines, with a value of over £30m.

This indicates significant growth, but the problem has been ongoing for many years. There were more than 1,112 reports to the Global Surveillance and Monitoring System for substandard and falsified medical products (GSMS) from 2013-2017, from more than half of the world's countries. These included counterfeit medicines in every category from painkillers to lifestyle products - although antibiotics and antimalarial products were the most common reports. Recent efforts to bring counterfeiters to justice have seen the closure of 113,000 illegal online pharmacies selling fake medicines, and the seizure of 3,000,000 medical products and devices in the UK alone.

Unfortunately, the biggest challenges relate to the supply chain. Fake pharmaceuticals are difficult to identify and trace as they travel around the world, which makes it hard to determine where they were manufactured or who is selling them. There are several stages within the pharmaceutical supply chain where counterfeit medicines and devices can enter and this means there is a risk to legitimate pharmacies and suppliers of getting caught up. While the recent escalation of police efforts to stem the growth of counterfeit drugs are welcome, they also mean there is a risk of innocent parties facing harsh sentences for their unintentional involvement.

• https://iris.who.int/bitstream/handle/10665/326708/9789241513425-eng.pdf
• https://www.gov.uk/government/news/illegal-medicines-worth-more-than-30-million-seized-in-the-uk-in-2023
• https://www.gov.uk/government/news/over-3-million-medicines-and-devices-seized-in-uk-as-part-of-global-crackdown

Here, the experts in counterfeiting law at JMW Solicitors explain the scale of the problem and the potential public health risk, the police efforts that are aiming to curb the spread of counterfeits, and the ways that pharmacists and others within the supply chain can protect themselves.

How big is the counterfeit medicines problem?

The scale of the counterfeit medicines problem around the world is far larger than many people imagine. As noted above, the World Health Organization's estimates indicate that as many as one in ten medical products in low income and middle income countries is either "substandard" or "falsified". The WHO defines substandard and falsified medicines as follows:

• Substandard medicines are authorised products that do not meet the necessary quality standards or specifications as determined by law or medical evidence.
• Falsified medical products are any products that intentionally mislead consumers about what they are, their ingredients, or who made them.

While this does not only include counterfeit drugs, the mechanisms that develop and supply falsified medicines are the same as those delivering substandard products, which means that the approach to stopping them must include a combined effort.

In 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) reported evidence that Brexit was affecting medicine supply chains. The UK's withdrawal from the EU in 2020 meant that the bloc's Falsified Medicines Directive, which launched in February 2019, would no longer. In the ten months prior to Brexit, 44.7 million medicine packs were dispensed in the UK, of which none were found to be counterfeits. After the directive ceased to apply, but its systems were still in use, around 15,500 counterfeit medicine packs were found in the country’s authorised medicines supply chain over a period of around two years. The authorisation system no longer exists and has not been replaced. Millions of pounds' worth of counterfeit and substandard medicines are on the UK market and, extrapolating this out across other high income countries shows that even outside of the developing world, the problem is an urgent concern.
The health, social and economic consequences of this are significant. The WHO modelled data on pneumonia in children from 0 to 5 years of age in low and middle income countries. Using that data, the WHO calculated that 72,430 childhood pneumonia deaths globally could be caused by substandard and falsified antibiotics that had reduced antibiotic activity. While this is the most likely scenario, it also estimated that if entirely counterfeit drugs were used, with no active ingredients or antibiotic activity, this would increase to an estimated 169,271 annual deaths. Antibiotics and antimalarial medicines were the most common among those reported as substandard or falsified to the GSMS, which is likely to disproportionately affect developing countries.

• https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products
• https://pharmaceutical-journal.com/article/news/more-than-15000-falsified-medicines-found-in-uk-supply-chain-over-past-two-years
• https://iris.who.int/bitstream/handle/10665/331690/9789241513432-eng.pdf

If fraudulent medicines are not stopped from reaching the market and continue to grow at their current pace, the risk of a global health crisis could grow dramatically. Global authorities must partner with each other, with pharmaceutical companies and other actors in the pharmaceutical sector, and with regulators like the European Medicines Agency, to develop a comprehensive solution.

The World Health Organization approach

The WHO has been concerned about this growing problem for more than a decade, and set up its Global Surveillance and Monitoring System for substandard and falsified medical products in 2013. This is an initiative to improve the detection, reporting, and response to cases of substandard and falsified medical products with a comprehensive and globally standardised approach.

The system provides a platform for countries to report incidents of substandard and counterfeit medical products, and collect data from sources including national regulatory authorities, health professionals, and the public. This data can then be analysed to understand the scope and impact of substandard and falsified medicines, and to develop ways to mitigate risks or, ultimately, tackle the illegal medicine trade. This information is used to monitor trends, identify emerging issues, enable timely interventions, and prioritise resource allocation and regulatory actions.

The GSMS has been a success, although low income countries and those in conflict zones have had more difficulty implementing it, which has made reporting and data inconsistent. Even so, the systematic review of risks has supported countries around the world to build their capacity to detect and respond to substandard products and counterfeit medicines. Because it functions as a central hub for information exchange, it also fosters collaboration and coordination in combating substandard and falsified medical products.

The need for global collaboration

The global cooperation enabled by the GSMS can be seen in the police response to counterfeit medicines and products, which has taken on an increasingly global angle in recent years. This is necessary in part because of the spread of the counterfeit drugs industry. Many of the counterfeit products reaching the UK market are made in Europe, and because of the lack of border restrictions imposed by countries in the Schengen Area, it is difficult to determine the origins of the products even when they are detected. Other countries have similar challenges in tracking the illegal import of these products, not least because they are indistinguishable from genuine medicines in many cases.

Further, the sites where these products are manufactured are often remote and can be transported relatively easily. Simply finding where these counterfeit pharmaceutical manufacturers are based and where the products are coming from can be a significant and resource-intensive challenge that requires global collaboration. Enforcement is also difficult - if facilities are not taken down simultaneously, a raid provides a warning opportunity for other groups or operations to pack up and move elsewhere before they can be tracked. On the other hand, coordinating large-scale operations to take down organised crime gangs across many borders and in remote locations can be difficult even when countries can rely on the standardisation and collaboration protocols within the GSMS.

This is not to say that addressing the problem is impossible. Both Interpol and Europol coordinated large-scale operations to seize and destroy substandard and falsified medicines before they could enrich fraudsters or potentially cause harm to unsuspecting consumers. Operation Pangea's past efforts have involved 193 police officers, customs agents and health regulatory authorities from more than 100 countries, and led to the seizure of more than $53 million (USD) in fraudulent medicines and medical products. In total, 393 people were arrested around the world.

In 2021, more than three million medicines and medical devices were seized by UK officers working as part of Operation Pangea - a haul worth over £9 million. The UK also shut down or blocked access to 113,000 illegally operating websites. Operation Pangea XVI, which took place in October 2023, led to a further 72 arrests worldwide, the shutdown of 1,300 websites and the seizure of substandard and falsified medicines worth more than $7m (USD).

This targeted approach aims to tackle the illicit prescription drugs trade across the entire supply chain, by taking down manufacturers who are producing them, the online pharmacies carrying them to market, and the organised criminal gangs fuelling the process.

While operations this large are needed to support the ultimate goal of protecting patient safety and removing counterfeit drugs from the market, there are steps that every actor in the pharmaceutical industry should take to try to address the problem. Those who provide pharmaceuticals to end users - such as pharmacists - have a responsibility to check that medicines are legitimate before dispensing them. If they fail to do so, there is a significant risk of them being held responsible for any adverse effects, or being caught up in these global law enforcement operations.

Legal considerations for pharmacists

Pharmacists and any other businesses that supply drugs in the UK must be alert to the risk of fake medicines, given the scale of the problems and the persistent challenges involved in tackling the problem at the highest levels. The government has issued guidance for pharmacists, with information on everything from spotting fake packaging to the due diligence checks that you should make before buying from drug companies or third parties.

Pharmacists can also consider the following measures to avoid selling, purchasing, or dispensing counterfeit pharmaceutical products. This is the best way to avoid any risk of being engaged in an investigation, and to minimise the potential health impact of supplying drugs with the wrong (or no) active ingredient.

• https://europol.europa.eu/media-press/newsroom/news/online-sale-of-fake-medicines-and-products-targeted-in-operation-pangea-ix
• https://www.gov.uk/government/news/over-3-million-medicines-and-devices-seized-in-uk-as-part-of-global-crackdown
• https://www.interpol.int/News-and-Events/News/2023/Global-illicit-medicines-targeted-by-INTERPOL-operation

Your first commitment should be to the guidelines set by the MHRA, which regulates the safety, quality, and efficacy of medicines and medical products. While the Falsified Medicines Directive no longer applies in the UK, it still contains best practices that pharmacists can follow and certain regulatory requirements that still apply. The removal of the legal obligation for pharmacists to verify medicines through serial codes, anti-tampering devices or other identifiers means that there is more responsibility to manually verify the source and authenticity of a medicine before dispensing it.

The best approach is to purchase pharmaceuticals only from licensed and reputable wholesalers and conduct thorough due diligence before entering into agreements with new suppliers. Check that wholesalers have the appropriate authorisations to distribute medicines in the UK and verify their credentials with the MHRA.

To further minimise risk, maintain detailed records of all purchases, sales, and stock movements, and regularly audit stock to identify any discrepancies that could indicate the presence of counterfeit products. Store medicines in a secure environment and restrict access to authorised personnel only. This helps prevent the introduction of counterfeit products into supply chains.

Train staff to recognise the signs of counterfeit products, such as unusual packaging, unfamiliar suppliers, and discrepancies in the appearance of medicines. Have them inspect medicines for any signs of tampering, discrepancies in labelling, or poor-quality packaging. In cases where the packaging of counterfeit medicines differs from the genuine product, this can be the quickest way to remove them from the market. Explain to staff the protocols for reporting suspected counterfeit products to the MHRA.
If you are concerned about compliance or your legal position regarding an investigation into counterfeit medicines, speak to the Business Crime and Regulatory team at JMW Solicitors. Our experts have a wealth of experience in this area and can advise you on minimising your risk of trading in counterfeit products, or represent you during an investigation and any legal proceedings that follow. To learn more about how we can help, call us on 0345 872 6666 or use our online enquiry form to request a call back.