FOI release
Counterfeit Medicines
Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.
Case reference FOI2026/00982
Received 31 August 2026
Published 13 October 2026
Request
I am making this request under the Freedom of Information Act 2000. I am seeking recorded information about MHRA's duty, track record and statutory powers concerning counterfeit and unlicensed medicines generally, and the unlawful substitution of licensed prescription medicines with non-MA products. 1. MHRA's duty to protect patients from counterfeit and unlicensed medicines The Novo Nordisk case shows a single manufacturer having to secure, through its own civil litigation, protection that patients might reasonably expect their medicines regulator to provide. Please provide recorded information setting out MHRA's statutory duty, objectives or public task in relation to protecting patients from counterfeit and unlicensed medicines generally — not limited to any single manufacturer's products — including the relevant legislative basis (e.g. under the Human Medicines Regulations 2012) and any published statement of MHRA's role in this area. 2. MHRA's own enforcement efforts and why they have had limited success The judgment in Novo Nordisk A/S & Anor v British Telecommunications Plc & Ors [2026] EWHC 1094 (Ch) records that “the MHRA's own efforts at closing down infringing websites have met with limited success”. Please provide any recorded information explaining what those efforts consisted of, why they have had limited success, and any internal review, assessment or lessons-learned exercise concerning this. 3. MHRA's response to the Novo Nordisk precedent for counterfeit medicines generally Please provide any recorded information — including business cases, internal assessments, correspondence, minutes or strategy documents — concerning whether MHRA intends to pursue, seek or support a court-ordered website-blocking mechanism covering counterfeit and unlicensed medicines generally, rather than leaving this protection to depend on individual manufacturers bringing their own litigation product by product. 4. MHRA's statutory powers against counterfeits and unlawful substitution The Novo Nordisk order demonstrates that website-blocking against counterfeit and unlicensed medicines is achievable through the courts. Please provide recorded information setting out what statutory powers MHRA itself holds — as opposed to relying on individual manufacturers' civil litigation — to prevent, disrupt or take enforcement action against: (a) the sale and supply of counterfeit or falsified medicines; and (b) the sale, supply, prescribing or dispensing of health/food supplements and other products without a UK marketing authorisation where they are used in place of, or presented as equivalent to, licensed prescription-only medicines. 5. Enforcement track record, 2021–2025 Against the background of the Novo Nordisk judgment's finding that “the MHRA's own efforts at closing down infringing websites have met with limited success”, for each calendar year 2021–2025, where recorded, please provide the number of enforcement actions taken by MHRA against: (a) websites or sellers of counterfeit or falsified medicines; and (b) suppliers or sellers of non-MA products used as substitutes for licensed prescription medicines — together with the nature of the action taken (e.g. website takedown request, seizure, prosecution, warning) and the outcome, where recorded. 6. Cross-agency work and future plans Following the Novo Nordisk judgment and the limitations of MHRA's own efforts that it identified, please provide any recorded information about work planned or under way, in conjunction with other bodies (e.g. GPhC, NHSBSA, police, Trading Standards, ISPs), to address counterfeit medicines and the unlawful substitution of licensed medicines with non-MA products during 2026–2030. 7. Chain of accountability — MHRA, ISPs and patient harm Where a patient is harmed by a counterfeit or unlicensed medicine bought online, accountability arguably extends along a chain: MHRA's own statutory duty and powers to prevent access to the product; the ISP or hosting provider that supplies the platform enabling the sale, and which derives commercial benefit (e.g. hosting fees, advertising revenue) from doing so; and the counterfeiter itself. Please provide any recorded information setting out MHRA's own assessment or policy position on how responsibility is distributed across this chain, including whether MHRA considers ISPs and hosting providers to bear any statutory or regulatory responsibility for illegal medicine sales conducted through their platforms, and whether MHRA has ever sought — through litigation, regulatory referral or otherwise — to hold an ISP or hosting provider to account for hosting such sales. I am seeking recorded information rather than asking MHRA to create new information or provide an opinion. Where the precise information requested is not held, please provide the closest equivalent information held. Where information is withheld, please identify the relevant FOIA exemption and provide the remainder where reasonably practicable. If any part of this request would exceed the appropriate cost limit, please identify the relevant part and provide the information that can be supplied within the limit so that I may refine the request.
Response
See attached
Documents
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