The Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to substantially increase its criminal enforcement capacity, signalling a stronger focus on investigating and prosecuting unlawful activity involving medicines and medical devices.

The commitment forms part of the regulator’s newly published Strategy 2030, which sets out its priorities for the coming years.

For businesses operating across the pharmaceutical, healthcare and medical-device sectors, the announcement is significant. The strategy is a policy document and does not itself create new criminal offences or investigative powers. It does, however, signal an intention to devote greater resources to criminal investigations and enforcement.

Businesses should therefore consider not only whether their activities comply with the relevant regulatory requirements, but also how they would respond if concerns were to develop into a criminal investigation.

A significant expansion of criminal enforcement

The MHRA’s Strategy 2030⁠ sets out a programme intended to strengthen patient safety, support innovation and modernise the regulator’s approach to medicines and medical devices.

A particularly important commitment is the intention to substantially increase criminal enforcement capacity to investigate, disrupt and prosecute illegal activity.

The MHRA also intends to strengthen its engagement with online marketplaces and social media platforms to address the availability of illegal medical products.

These commitments reflect the increasing complexity of medicines and medical-device supply chains, particularly where products are manufactured, marketed or distributed through online channels.

The strategy does not specify precisely how many additional investigators will be recruited or when the expansion will be completed.

Nevertheless, the direction of travel is clear: criminal enforcement will form an important part of the MHRA’s regulatory priorities.

What powers does the MHRA already have?

Medical devices placed on the Northern Ireland market are subject to a distinct framework under the Northern Ireland Protocol and Windsor Framework. The MHRA has powers to investigate suspected breaches of the legislation within its remit.

The Human Medicines Regulations 2012⁠ establish requirements governing the manufacture, importation, distribution, sale and supply of medicinal products.

Depending upon the circumstances, suspected breaches may give rise to criminal offences, including those relating to unauthorised medicinal products, prescription-only medicines and failures to comply with applicable licensing requirements.

The MHRA can investigate suspected offences and use applicable statutory powers of entry, inspection, sampling and seizure. Warrants may be obtained in specified circumstances, and criminal proceedings may follow where the evidential and public-interest tests are met.

The legal position will depend upon the particular product, the activities undertaken and the statutory provisions engaged.

Importantly, not every regulatory breach will necessarily result in criminal prosecution. The appropriate enforcement response will depend upon the nature and seriousness of the suspected conduct.

How can a regulatory investigation become a criminal matter?

Businesses may initially become aware of MHRA concerns through correspondence, requests for information, inspections or enquiries about particular products or supply arrangements.

Depending upon the circumstances, those enquiries may develop into a criminal investigation.

Investigators may seek evidence concerning product classification, manufacturing arrangements, procurement, importation, distribution, marketing and financial transactions.

Individuals may also be invited to attend interviews under caution where criminal offences are suspected.

For businesses, an investigation can create immediate commercial and reputational difficulties, even before any decision is made about prosecution.

It is therefore important to establish at an early stage the nature of the investigation, the powers being exercised and the potential legal exposure of both the business and individuals involved.

Careful consideration should also be given to the preservation of relevant documents, communications and financial records.

The financial consequences of an MHRA investigation

The potential consequences of an MHRA investigation are not limited to regulatory sanctions or criminal prosecution.

The agency has accredited financial investigators who can exercise powers under the Proceeds of Crime Act 2002⁠.

Depending upon the circumstances and the powers available to the investigator, an investigation may involve financial enquiries, cash seizure, Account Freezing Orders (AFOs), restraint proceedings or other asset-recovery measures.

Under Part 5 of POCA, the relevant enforcement officer may apply to the magistrates’ court for an AFO. The court must be satisfied that there are reasonable grounds for suspecting that money held in the relevant account is recoverable property or intended for use in unlawful conduct, together with the other statutory requirements.

A criminal conviction is not required before such an order can be made.

The consequences for a business can be substantial.

The freezing of funds may interfere with its ability to pay employees, suppliers and other operating expenses, potentially creating serious financial difficulties while an investigation remains ongoing.

Importantly, the making of an AFO does not establish criminal wrongdoing or determine that the money is ultimately liable to forfeiture.

Businesses facing such proceedings may need to consider the evidence demonstrating the legitimate source of funds, the basis of the underlying transactions and whether grounds exist to challenge or vary the order.

Online activity and supply chains under scrutiny

Another notable feature of the MHRA’s strategy is its intention to work more closely with social media platforms and online marketplaces.

The increasing availability of medicines and medical devices through digital channels presents particular enforcement challenges, including the identification of suppliers and the tracing of products through complex distribution networks.

Businesses involved in importing, distributing or selling regulated products should ensure that they understand the applicable requirements.

This includes establishing the regulatory status of products, checking that suppliers hold any required authorisations and maintaining an appropriate audit trail.

The fact that a product is readily available through an online marketplace does not establish that it can lawfully be imported, marketed or supplied in the relevant UK market.

Businesses should also be mindful of the separate restrictions governing the advertising of prescription-only medicines to members of the public.

What should businesses do now?

The publication of Strategy 2030 provides an opportunity for businesses to assess whether their existing compliance arrangements are appropriate.

Particular consideration should be given to:

• Product classification: Understanding whether products fall within medicines or medical-device legislation and identifying the applicable regulatory requirements.
• Licensing and authorisations: Ensuring that the necessary permissions are in place for manufacturing, importation, wholesale distribution or supply.
• Supply-chain due diligence: Establishing the legitimacy of manufacturers, distributors and other commercial partners.
• Advertising and marketing: Reviewing promotional material for compliance with applicable medicines advertising restrictions.
• Record keeping: Maintaining appropriate records relating to procurement, distribution, sales and financial transactions.
• Investigation readiness: Ensuring that businesses understand how to respond to regulatory enquiries, inspections and the exercise of investigative powers.

For organisations operating across multiple regulatory regimes, it may also be important to consider how an MHRA investigation could interact with other regulators or enforcement agencies.

A clear statement of regulatory intent

The MHRA’s commitment to substantially increasing criminal enforcement capacity is an important indication of its future priorities.

Although the strategy does not itself change the law, a better-resourced enforcement function may have significant practical implications for businesses operating in regulated markets.

The prospect of greater investigative capacity reinforces the importance of proactive compliance and an effective response when concerns first arise.

Businesses should not wait until an investigation becomes a criminal matter before considering their legal position.

Understanding the relevant regulatory requirements, maintaining appropriate records and obtaining advice at an early stage can make a material difference when responding to enforcement action.