UK Law Commission’s Proposals to Tighten Product Liability Law Would Facilitate Pharma and Medical Device Claims

Summary

• In October 2026, the Law Commission of England and Wales published a consultation paper proposing reform of the UK’s product liability regime.
• The existing no-fault, or strict liability, regime would remain, and the proposed reforms would—if implemented—be extensive and claimant-friendly.
• Proposals of particular relevance to life sciences businesses include: (i) explicitly bringing software and AI within scope; (ii) expanding the range of potential defendants; (iii) new principles relating to the assessment of defect; (iv) evidential presumptions to assist claimants; (v) expanding recoverable harm, including to psychiatric harm and preventative measures; and (vi) extending the liability period to 25 years for latent personal injury.
• Taken together, these changes would materially increase litigation risk for life sciences producers and others in the supply chain.
• There are clear echoes of the new EU Product Liability Directive, but also areas of divergence, further complicating the mapping of liability for businesses operating across the UK and EU.
• Responses are due by 14 January 2027, with final recommendations due at the end of 2027.

Background

The current UK product liability rules in Part 1 of the Consumer Protection Act 1987 (CPA) implemented the 1985 EU Product Liability Directive. Some 40 years later—and in light of the recent radical overhaul of the EU framework via the new Product Liability Directive (“new PLD”)—the UK Law Commission was tasked with reviewing whether the CPA remains fit for purpose, particularly in view of emerging technologies and modern supply chains.

The Law Commission is an independent statutory body with the role of reviewing the law and making recommendations to the Government for reform. This review project began in 2025, and in October 2026 the Law Commission published provisional proposals for consultation.

The Law Commission was not tasked with considering whether to adopt the new PLD. However, it had close regard to it, and the paper includes a comparative table as to issues of potential convergence and divergence with its proposals.

The Proposals

The broad structure of strict liability would remain; the proposals are wide-ranging and, if adopted, would be much more claimant-friendly and are likely to have a significant impact on pharmaceutical, medical device and consumer health companies.

Bringing software and AI within scope

The CPA was designed with tangible products in mind, and it is currently unclear whether software is within the scope of product liability law. Under the proposals, the definition of “product” would explicitly extend to software, however supplied, including downloads and software-as-a-service, and to AI systems (with views sought on whether AI models should be products in their own right). Standalone clinical software and digital therapeutics would therefore be in scope, as well as software embedded in or connected with medical devices.

The proposals are broadly consistent with the new PLD, although notably the Law Commission is keen not to blur the line between products and services and does not propose to include services that are interconnected with, or required for, the functioning of a product (so-called “related services”), such as health monitoring services reliant on a physical product’s sensors to track users’ health.

Expanded list of who can be liable

The proposals would expand the list of potential defendants to product liability claims. There is broad convergence with the new PLD, although there are also specific divergences. For example, the new PLD only holds the authorised representative of the manufacturer liable, whereas the proposals would extend to UK authorised representatives of other potential defendants in the supply chain:

• The definition of “producer” (who will still bear primary liability) would be expanded to include “the person who developed the product”, to align with the expanded definition of product.
• “Own brander” liability would be retained but would not be extended to those who request third parties to manufacture products on their behalf unless they also market the product under their own name or trademark (and therefore hold themselves out to be the producer). This is in contrast to the new PLD which expands the definition of “manufacturer” to a person who has a product designed or manufactured.
• Where a producer integrates or connects a component to its product (or this happens within its control), both the producer of the finished product and the producer of the component may be liable, but not where this happens outside the producer’s control.
• Where a product is substantially modified, affecting its safety profile, whether the original producer remains liable as a producer would depend on whether the modification occurred within its control.
• UK authorised representatives would be liable where the producer, own-brander, or importer is established outside the UK.
• Where none of these entities can be identified, liability would fall on fulfilment service providers and then on online marketplaces. Marketplace liability would apply only in certain circumstances, including when: (i) the marketplace’s conduct was a significant factor in making the product available in the UK; (ii) it benefited financially or acted in the course of business; and (iii) it had control over, or a decisive ability to influence, the manufacturing or distribution process.

Defect

The broad test for defect, which currently involves an analysis of the level of safety which the public is entitled to expect in all the circumstances, would remain. However, the Law Commission proposes to introduce a novel, non-exhaustive list of seven principles, to supplement the list of relevant circumstances which courts must consider.

The Law Commission wants to provide additional guidance to courts when applying the test, citing (among other things) challenges in applying the current test to complex products, such as products with digital elements. It gives the example of a medical product using nanotechnology to detect disease biomarkers that produces a false positive, leading to errors in diagnosis and treatment, where it may be “impossible” to determine why the false positive occurred, particularly where the product cannot be extracted or its underlying software, algorithms or AI systems cannot be examined.

New principles

With respect to the new principles, demonstrating any one of them would establish defect, and the Law Commission asks an open question as to whether it should still be open to a defendant to demonstrate that a product was not defective, where a principle is met.

The first four principles cover unusual risks and the information given about a product:

1) Normal and reasonably expected use (i.e., damage beyond what is ordinarily and inherently associated with use, and that could reasonably be expected);

2) Provision of information and acceptance of risk (i.e., insufficient information provided to enable a decision as to whether to accept that risk);

3) Inadequate instructions and warnings to avoid harm; and

4) Presentation of risk (i.e., the warning or risk information did not accurately and clearly convey the nature and seriousness of the risk, downplayed the risk or obscured the risk).

The remaining three principles involve consideration of a product’s risks against its benefits, which the Law Commission terms a “risk-utility analysis”:

5) Avoidability of risk at the time of supply (i.e., whether the risk could reasonably have been eliminated or materially reduced without compromising the product’s benefits, taking cost and feasibility into account);

6) Relationship between risks and benefits (i.e., whether the risk was proportionate to, and justified by, the product’s benefits, unless the risk is so widely known by the public that it is socially acceptable); and

7) Comparison with available alternatives (i.e., when supplied, did the product pose a materially greater risk of damage than other available products which would have provided comparable or greater benefits).

New relevant circumstances

The proposal also includes additional relevant circumstances that courts must consider when assessing defect, including: (i) the manner in which, and the purposes for which, the product has been marketed and presented (including its labelling and instructions); (ii) the specific needs of the group of users for whom it is intended; and (iii) for a product whose very purpose is to prevent damage, any failure to fulfil that purpose.

There is broad convergence with the new PLD here, with one notable exception (which may be of some comfort to life sciences businesses): the Law Commission does not propose to call out as a relevant circumstance “any recall of the product or any other relevant intervention related to product safety”. It considers this to be unnecessary on the grounds that where there has been a recall which is relevant to the risk of harm which eventuated, this would already be taken into account by the court.

Proving defect and causation, including presumptions

Reviewing the case law on the CPA, the Law Commission concludes that the CPA has not fully achieved its “central aim” of alleviating the claimant’s burden of proving fault. It proposes to address this with certain rebuttable presumptions as to fact, as well as with an explicit statutory articulation of the purpose of the regime to guide judges, including that the regime seeks “to mitigate evidential difficulties that might otherwise undermine its operation” (where consistent with the fair allocation of risk), and that part of achieving this is ensuring that persons harmed “can obtain effective compensation without needing to prove fault”.

The new PLD also introduces rebuttable presumptions, but the Law Commission’s approach is more limited, which it considers to be more balanced and proportionate. The Law Commission proposes:

• A rebuttable presumption as to defect where (i) the claimant can show that defect is “arguable”; (ii) that the facts relied on are “not fanciful”; (iii) that the claimant faces “exceptional evidential difficulties due to the limited availability of evidence”; and (iv) provided that the risk is not “so widely known as to be socially accepted”. It gives an example of a product which carries a known risk that has been adequately warned against, where there may be grounds to suspect that the true level of risk is greater than presented, but where statistical evidence to prove that is unavailable, e.g. where the product has been used only for a short period or withdrawn following the introduction of a superior alternative, leaving insufficient data to work with.
• A novel risk-sharing mechanism in cases where the relevant evidence does not exist or cannot be obtained, under which defendants may elect either to accept the alleged defect, with damages starting at 50% of their full value and adjusted up or down, or to try to rebut a presumption of defect, with full damages if they fail.
• A targeted response to perceived difficulties in discharging the burden of proof in technically complex cases. It invites views on a rebuttable presumption of facts relevant to defect and/or causation where a claimant can show that there is an “asymmetry of information in the defendant’s favour” and that it would be “fair” for the defendant to bear the burden of rebutting the presumptions. An example of where such a presumption of fact may be appropriate, according to the Law Commission, is when determining whether a medical device was properly fitted, on the basis that “the manufacturer is likely to possess significantly greater knowledge of the product, its operation and the instructions governing its insertion”.

Recoverable damage - expansions

The recommendations include some significant changes and expansions in relation to recoverable harms:

• Minimum threshold of material harm: The Law Commission proposes introducing a minimum threshold of material harm to a personal injury claim, requiring a claimant to be appreciably worse-off as a result of the injury (to align with UK negligence case law). This will be particularly relevant in cases where a defect causes a physiological change but no symptoms and so, no immediate harm, even though it indicates an increased risk of harm in the future which may or may not materialise. This would confirm that there is no right of action for mere nominal harm or for a condition that is entirely symptomless or has no material impact or adverse consequences.
• Preventative measures would be recoverable: The proposals would also confirm that losses incurred in taking measures necessary to avert a risk of personal injury would also be recoverable, including the cost of preventative medical procedures to replace medical devices. The paper takes the view that the law should incentivise “proactive behaviour that prevents harm from occurring”.
• Psychiatric harm woud be recoverable: Similar to the new PLD, psychiatric harm would be a recoverable harm, on a standalone basis as well as consequential upon physical injury, for both direct and indirect victims. Psychiatric harm must be medically recognised or recognisable (i.e., beyond mere mental distress), and for standalone psychiatric harm cases, the development of the illness must fall within the “natural range of reactions of a person of ordinary fortitude” (borrowing from negligence case law).
• Data destruction or corruption would be recoverable: The Law Commission also recommends that the destruction or corruption of data should be a compensable harm, excluding data leaks, data protection breaches and data used exclusively for professional purposes (extending the position beyond the new PLD to “mixed use” data).

Extension of the 10-year long-stop and defences

The Law Commission proposes that the existing 10-year long-stop, after which claims are extinguished, should be extended, in cases of latent personal injury, to 25 years where it was not possible for the individual to initiate proceedings within 10 years. The Law Commission states that products such as chemicals and pharmaceuticals are “particularly complex” and “the producer is significantly better placed to anticipate and mitigate those long-term risks than the individual consumer.” It also proposes that, where a product is substantially modified after its supply, the 10-year period should “reset” upon each such modification.

With respect to defences, notably:

• The proposal is to retain the development risks defence for all industries (i.e., where the defect could not have been discovered given the scientific and technical knowledge available at the time).
• The Law Commission proposes to clarify the position (consistent with CJEU case law and the position taken by the new PLD) that a defendant cannot avoid liability on the basis that there may be technically “no supply to another” where a defective product has been produced by a service provider for its own use and caused harm in the course of providing a commercial or publicly funded service. The Law Commission states that the NHS and other publicly funded bodies should fall within the ambit of liability and should not be able to avoid liability in this way.

Timing and next steps

The consultation is open until 14 January 2027, and a final report with recommendations is expected in late 2027. Final recommendations from the Law Commission on technical areas are highly influential, although legislating to implement the recommendations would ultimately be a matter for the Government.

Life sciences businesses who wish to make their views known and to try to shape the final recommendations should consider engaging in the consultation.

The Law Commission is also working on a separate project on whether to introduce a consumer class action regime, and the two projects will inevitably overlap.

Our life sciences litigation team acts for pharmaceutical, medical device and consumer health companies in group and collective proceedings in England and Wales and across Europe. Please contact any of the lawyers listed below to discuss the proposals.