Counterfeit pharmaceuticals: innovative strategies for combatting global health threats in the UK

Charlotte Tillett
Stevens & Bolton, Guildford
charlotte.tillett@stevens-bolton.com

Jessica Gregson
Stevens & Bolton, Guildford
jessica.gregson@stevens-bolton.com

Introduction

The pharmaceutical industry is one of the UK’s leading industrial sectors, contributing around £15bn in gross value added (GVA) to the economy each year and responsible for around 70,000 jobs,^[1] underscoring its significant role in the economy and the importance of maintaining its integrity. The UK has a robust regulatory framework; however, like most countries, it faces challenges in regard to combatting counterfeit pharmaceuticals and the health threats that they present.

The rise of online pharmacies has exacerbated the challenges faced by providing more routes for products to reach consumers and opening ‘loopholes’ with the additional jurisdictional challenge, resulting in some suppliers circumventing the stringent regulatory requirements they would otherwise be subject to. The issue in terms of online sales is particularly pronounced for younger generations, who are more inclined to make online purchases, with the Medicines and Healthcare products Regulatory Agency (MHRA) reporting that nearly half (44 per cent) of UK adults aged between 18 and 30 have bought medicine or medical products online.^[2] Additionally, drug shortages in the UK, such as the recent shortages of attention deficit hyperactivity disorder (ADHD) medication, have driven people to seek alternative ways to obtain their medication. All of these factors create a favourable environment for counterfeiters.

Innovative strategies and technologies

The approach in the UK is multifaceted, comprising different methods, including technologies, public awareness campaigns and collaboration. Pharmaceutical companies are likely implementing or developing innovative measures to combat counterfeit medicines, although these efforts are not exclusive to the UK and remain largely unpublicised.

Authentication technologies

Authentication technologies, such as serialisation, blockchain and AI, play a crucial role in ensuring the integrity of pharmaceuticals; however, the UK’s use of technology is comparatively limited when considered in relation to other jurisdictions. This is especially true since the UK Medicines Verification System was disconnected in December 2024, following the UK’s withdrawal from the European Union, the subsequent disapplication of the EU Falsified Medicines Directive (Directive 2011/62/EU) in Great Britain and introduction of the Windsor Framework.

Disconnection of the UK Medicines Verification System

The UK Medicines Verification System (UKMVS) was part of the broader European Medicines Verification System (EMVS), designed to prevent falsified medicines from entering the legal supply chain and ensure patient safety. The EMVS was borne from the EU Falsified Medicines Directive and corresponding safety features, which were implemented through delegated regulation. Simply put, the UKMVS and EMVS enabled the authentication of medicines by scanning a unique data matrix code printed on a medicinal product pack against a database. In January 2021, the government stated that a consultation into a falsified medicines scheme for the UK was expected ‘within 12 months of the royal assent’ of the Medicines and Medical Devices Act 2021, which was granted on 11 February 2021.^[3] However, a consultation is still yet to begin, as of the date of this article.

The use of AI

AI has been deployed by the MHRA, which regulates medicines, medical devices and blood components for transfusion in the UK, and is at the forefront of efforts to combat counterfeit pharmaceuticals in the UK. For example, the MHRA has collaborated with eBay to leverage AI in combatting counterfeit pharmaceuticals. This partnership led to the seizure of illegal medicines worth over £30m in 2023.^[4] The AI algorithms effectively detected and prevented the sale of more than half a million unregulated prescription and over-the-counter medicines.

Companies can also engage service providers that utilise AI to prevent illegal sales of their medicines, including counterfeits. AI can help to identify and prioritise online intellectual property (IP) infringements. For less obvious infringements, human review is typically required, but AI can be an efficient way to reduce the number of potential infringements requiring human review. Additionally, enforcement actions can be automated through the application of such technology.

Public awareness campaigns

The MHRA actively encourages both individuals and businesses, such as pharmacies, to conduct thorough due diligence on pharmaceuticals to verify their legitimacy before purchase. To educate consumers about the dangers of counterfeit medicines, the MHRA has launched various public awareness campaigns, including the #FakeMeds^[5] campaign. This initiative provides tools and resources to help the public avoid fake and substandard medical products, empowering them with the knowledge to identify signs of falsification and make informed decisions about their healthcare purchases.

The MHRA’s ‘Yellow Card’ scheme^[6] is another critical component of public engagement. This scheme collects information about suspected safety concerns around any healthcare product, which could include products causing side effects, defective, falsified or fake healthcare products. Anyone can report issues via the Yellow Card website or app, contributing to a safer pharmaceutical environment.

Collaboration and partnerships

Combatting counterfeit pharmaceuticals is a global issue, so collaboration and partnerships between various jurisdictions are essential. Operation Pangea^[7] is a prime example of an international initiative targeting the illegal internet trade in medical products through, among other things, intelligence sharing and coordinated transnational law enforcement operations. Instigated by the MHRA in April 2006, this operation has evolved into the largest internet-based enforcement action of its kind. It is now coordinated by International Criminal Police Organisation (INTERPOL), who work in conjunction with the MHRA’s Criminal Enforcement Unit, the World Customs Organisation (WCO), the Permanent Forum on International Pharmaceutical Crime (PFIPC), the Heads of Medicines Agencies Working Group of Enforcement Officers (WGEOs), the European Union Agency for Law Enforcement Cooperation (Europol) and the Pharmaceutical Security Institute (PSI). The operation is supported by the Center for Safe Internet Pharmacies (CSIP) and private sector companies. As of October 2023, Operation Pangea had seized over 25 million illegally traded medicines and devices seized in the UK valued at more than £84m.

Conclusion

While the UK has implemented several measures to combat counterfeit pharmaceuticals, the current strategies adopted lack significant innovation. The reliance on traditional methods like public awareness campaigns and reporting hotlines highlight the need for more advanced and proactive solutions, and the MHRA’s collaboration with eBay was a good start. Continued collaboration and the development of new strategies will be essential to overcoming the evolving threats posed by counterfeit medicines.

Notes