Following the outcome of the national election on 4 July 2024, on 17 July 2024, King Charles III gave a speech to the UK Parliament in which, as directed by the new Government, he outlined the key points of its legislative and policy agenda.
The agenda includes a Product Safety and Metrology Bill. Some form of legislation to address UK product regulation was expected in order to take account of market developments and new technologies, such as online selling and AI. We set out below a brief summary of the Bill.
Product Safety and Metrology Bill
Since Brexit, the agenda had apparently been set by other governmental priorities, including an ideological attachment to divergence from the EU legislation and attempts to square this with the ongoing connection of Northern Ireland to the EU.
In the background document, the new Government outlines the content and purpose of the new Product Safety and Metrology Bill, acknowledging that
"The majority of the UK's product safety and metrology framework is derived from EU law developed over the past four decades."
They say that
"As technology and regulation continues to develop, we need new powers to address current or future threats and hazards, and ensure a continued supply of safe goods on our market and so this Bill will enable us to make the sovereign choice to mirror or diverge from updated EU rules, so that we can maintain high product safety while supporting businesses and economic growth."
Importantly, it is said the Bill will ensure
"...that the law can be updated to recognise new or updated EU product regulations, including the CE marking, where appropriate to prevent additional costs for businesses and provide regulatory stability."
This marks a significant departure from the previous regime's policy, indicating a theoretical readiness to align with the EU. This willingness to align is couched in cautious technocratic terms however, and it is noteworthy that the Bill will
"also ensure the UK can end recognition of EU product regulations."
The guiding principle for aligning or not aligning is said to be "the best interests of UK businesses and consumers".
What does this mean in practice?
The detail of what types of products the Bill will cover is not fully spelt out. There is a reference to "nearly all manufactured products." Toys, fireworks, cosmetics and machinery, as well as batteries and e-bikes, get specific mentions. It seems likely that the types of products affected will include most consumer products covered in legacy EU regulations either by general product safety legislation or sector-specific harmonised legislation, including that which provides for CE marking in the EU.
Medicines and medical devices?
Whether medical devices (which are covered by CE marking) and medicines will be included in the scope of this Bill is not completely clear. Since there is no mention of either product category, on balance this seems unlikely. The indications from the background document are that it has been principally informed by discussions with the central government product safety and metrology regulator, the Office for Product Safety and Standards (OPSS).
However, it is possible that the Bill could grant powers to amend medical device legislation. The Bill can plausibly be understood as indicative of a general shift in approach that is likely to impact on such specialised product areas as medicines and medical devices in due course, even if they are not within scope of the forthcoming Bill. It may be a good time for the Life Sciences industry to assess whether it is worth revisiting submissions e.g. on any Government consultations, as they may now find the Government less opposed to practical solutions that involve alignment with EU regulation.
Alignment with EU general product safety and product liability legislation?
Some commentators have suggested that alignment with new EU product legislation is likely, including the EU General Product Safety Regulation (EU) 2023/988 (EU GPSR) due to come into force in the EU in December 2024 and the revised EU Product Liability Directive (PLD) likely to come into force in the next few years. It will at least be necessary for the Bill to grant powers to amend product regulations to include software as a product and take account of AI. But, if the new Government follows through on its stated pragmatic approach, then the extent of alignment with the EU legislation will depend on whether such alignment is seen as cost effective and likely to be welcomed by UK businesses and consumers. Alignment with EU GPSR is perhaps likely, although this will merit careful thought as EU GPSR is a more complex piece of legislation than the current General Product Safety Directive 2001/95/EC (GPSD) – implemented in the UK by the General Product Safety Regulations 2005 (UK GPSR). As drafted, EU GPSR does not quite function as a general product safety 'backstop' in the same way as the GPSD, and it removes some products such as medicines and chemicals wholly or partially from scope.
The new EU PLD contains some new harmonising provisions that will impact upon the approach of national courts in some potentially significant ways that are apparently intended to make it easier for claimants to succeed in establishing liability and causation. While the UK product liability regime (based on the 1985 EU Directive) needs updating to take account of technological progress, it is less clear that it is necessary to align in all respects with the new EU PLD. The extent of such alignment will depend upon whether the new Labour Government considers it in the interests of UK businesses and consumers. Trade unions and claimant lawyers, some of whom are affiliated with the Labour Party, may support alignment. Industry and insurers will need to consider where their interests lie and provide reasoned feedback on any proposals in this area.
Conclusion
As ever, the devil will be in the detail, but there are encouraging signs that the forthcoming product legislation is likely to be pragmatic and responsive to reasoned concerns, rather than being informed by any prior commitment to either diverging from or aligning with the EU.
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