Products | UK Regulatory Outlook September 2024

Jump to: General / digital products | Product sustainability | Life Sciences and Healthcare

General / digital products

Draft Product Regulation and Metrology Bill published

On 4 September, the draft Product Regulation and Metrology Bill was published and had its first reading in the House of Lords. It is scheduled to have its second reading on 8 October 2024. The bill allows for the creation of product and metrology regulations aiming to make it easier for the government to update the relevant legislation, as well as allowing for alignment with EU standards.   

The bill is broad in scope in terms of the products it applies to, defining products as a "tangible item that results from a method of production". In its current form, the bill does not apply to intangible products, such as AI systems, but the regulations which can be introduced may include requirements relating to a products components, which includes intangible items, such as software.

A key aspect of the bill is that the new regulations can outline that a product can meet relevant product requirements by meeting specified provisions in relevant EU law. This means the government will be able to decide whether to align or diverge from new or updated EU rules.

Some of the other key points from the bill are as follows:

• Responsibilities within supply chain – the regulations may impose obligations on: manufacturers, those who market a product (such as distributors and retailers) in, or import a product to, the UK and a person who controls access to, or contents of, an online marketplace or an intermediary. It adds that this is not an exhaustive list and requirements may be placed on others carrying out activities in relation to a product.
• Cost Recovery – the regulations may include mechanisms for recovering costs incurred by the authorities detailing who is liable and the charge conditions.
• Enforcement – the bill provides for both criminal and civil sanctions to be included in the regulations and also allows for authorities to accept undertakings to secure compliance with the regulations.
• Excluded products - the draft bill does not apply to: food, feed stuff, plants, fruit and fungi, plant protection products, animal by-products, products of animal origin, aircrafts, military equipment, medicines and medical devices.

The bill also includes provisions in regards to the creation of metrology regulations which gives powers for regulations to be made about:

• the units of measurement that must be used to express quantities (whether of goods or other things);
• how units of measurement are to be calculated, determined, or must and may be referred to; and
• the quantities in which goods may or must be marketed.

CE marking extended for construction products

The government has confirmed that the use of the CE mark on construction products can  continue to be used beyond the current deadline of June 2025. Construction products were one of the product categories that fell outside the indefinite extension of CE marking recognition. Rushanara Ali, the secretary of state for building safety and homelessness, set out in her written statement that the government will extend the period of recognition of CE marking for construction products and added that "any subsequent changes to the recognition of CE marking would be subject to a minimum 2-year transitional period".

BSI PAS 7770: energy-related consumer products

The Office for Product Safety and Standards (OPSS) has sponsored the new PAS 7770. Publicly available specifications are often referred to as “fast-track standards”, and PAS 7770 sets out how manufacturers and designers can assess a product’s environmental impact across its entire life cycle, from raw material extraction through to end of life. This PAS provides guidance on the measurement and reporting of the environmental performance of energy-related consumer products, such as household appliances, consumer electronics and toys, and aims to assist businesses navigate existing sustainability standards.

PAS 7770 considers the environmental implications of how products are made, bought, used, and disposed of. This includes the use of recycled materials for manufacturing, reuse, repair, reconditioning or refurbishment, upgrading, upcycling, recycling, increasing product durability and lifespan, and waste prevention and reduction. Issues covered in the guidance include product functionality and product user safety that might be introduced as a result of replacing or repairing product parts and also includes the information that should be provided to consumers, such as in regards to reuse options and maintenance information. PAS 7770 will be a helpful tool to those businesses looking to reduce their products' lifetime environmental impact. The PAS is free and can be downloaded here.

Courts consider whether a time-limited subscription to a SaaS application also counts as a 'sale of goods'

The Court of Justice of the EU, in Computer Associates UK Ltd v The Software Incubator Ltd (Case C-410/19) [2021], ruled that obtaining a perpetual licence to download and use software is considered a sale of goods.

LivePerson, which offers a SaaS product called LiveEngage, hired Kompaktwerk to market this software. Kompaktwerk claimed it was a commercial agent under the Commercial Agents (Council Directive) Regulations 1993 and sought compensation after their arrangement ended. It argued that Software-as-a-Service (SaaS) is similar to traditional software purchases and should follow the CJEU decision in Computer Associates.

LivePerson countered that SaaS does not involve a "sale of goods" but rather an ongoing service. Judge Christopher Hancock KC agreed with LivePerson, ruling that:

• A "sale" involves a permanent transfer of the seller's interest in the product. SaaS customers only get a limited, renewable licence, akin to a rental, not a sale.
• SaaS involves the provision of services rather than the sale of goods, as customers access software hosted on the provider's servers. The judge said the "heart of the product was the service to which the customer subscribed".
• The key documents were the contracts, and factual disputes did not change the conclusion on the "sale of goods" issue.

This indicates that the UK might be diverging further from the EU's stance on whether software is a product. The Product Liability Directive and the General Product Safety Regulation suggest that the EU would likely take a different view and would probably consider the Computer Associates judgment as applicable to time-limited subscriptions as well.

EU

European Parliament approves revised Product Liability Directive

On 18 September 2024, the European Parliament plenary approved the new EU Product Liability Directive. The Council now needs to approve it, after which it will be published in the Official Journal of the European Union and Member States will have two years to transpose the new directive into national law.

The new directive represents the biggest reform to the civil liability framework for defective products since the introduction of the first Product Liability Directive in 1985. See our infographic for more on the changes being implemented.

European Parliament adopts Cyber Resilience Act

On 18 September 2024, the European Parliament plenary approved the legally revised text of its first reading position. The Council is expected to formally adopt the regulation without further amendments, after which it will be published in the Official Journal of the European Union.

The Cyber Resilience Act's rules will be phased in over a three-year period to give manufacturers sufficient time to adapt to the significant new obligations. See our Insight for more on the changes being introduced.

Product sustainability

UK

Defra publishes initial illustrative base fees under EPR

On 15 August, Defra published its initial illustrative base fees for different materials for 2025/26 to be imposed through the new extended producer responsibility (EPR) scheme. The proposed fees range from between £130 and £330 a tonne for glass to between £410 and £665 a tonne for fibre-based composites. These figures are the first estimate and the government will publish refined illustrative figures in September 2024. The exact fee rates for the first year of EPR will not be known until after 1 April 2025 (after the deadline for reporting data).

The fees payable are for year one and do not include regulator charges or costs associated with meeting packaging recycling targets. The guidance also notes that from the second year of EPR (2026), fees will be modulated in a bid to reduce the amount of unsustainable packaging being placed on the market. Information will be published on the types of packaging that will be subject to these modulated fees in autumn 2024.

Following the publication of these fees, there has already been backlash from the glass industry as to how high the fees are for glass. Defra has responded to these calls saying that it will be looking again to the way it calculates fees for glass and emphasises that the figures are likely to change.

EPR guidance updated to reflect dates and deadlines for reporting 2024 and 2025 data

The extended producer responsibility guidance on packaging data has been updated to reflect dates and deadlines for reporting 2024 and 2025 data as follows:

Large organisations

If businesses have all the data under the new rules for 2024, they should report it in 2 batches:

• report data for 1 January to 30 June from 9 August 2024 (deadline to report: 1 October 2024)
• report data for 1 July to 31 December from January 2025 (deadline to report: 1 April 2025)

If businesses do not have all the data required under the new rules, they should still report in two batches. In England, Scotland and Wales:

• businesses should not report any data relating to packaging supplied between 1 January and 30 March 2024;
• they should report data collected under the new rules from 1 April to 30 June – do this from 9 August 2024 and before 1 October 2024; and
• report their 1 July to 31 December data from 1 January 2025

The environmental regulators will use the data submitted to calculate the 3 missing months (January, February and March 2024).

All the data they submit must follow the new rules for data from 2024. The deadlines for reporting are:

• 1 October 2024 to report for January to June 2024.
• 1 April 2025 to report for July to December 2024.

Small organisations must collect data for 2024 and report this by 1 April 2025.

Businesses in scope must ensure that they have submitted the relevant data by 1 October 2024 and are then collecting the correct data ahead of the next deadline in April 2025.

Government not to implement recycling labels under extended producer responsibility

It has been reported this month that the government is telling businesses the mandatory recycling labelling requirements under EPR, that were to be introduced in April 2027, will no longer be required from that date. Originally, under the scheme, businesses were to be required to place the OPRL Recycle Label on its packaging from April 2027. However, reports suggest the government has stopped plans to impose this as the EU considered it was not consistent with its labelling plans.

Scottish consultation on charging for single-use disposable cups

The Scottish government has launched a consultation on the introduction of a national mandatory 25p charge on single-use disposable beverage cups. The powers granting the Scottish government to implement this charge was provided for in the Circular Economy (Scotland) Act 2024.

Views are being sought on the proposals which include:

• a charge of at least 25p on all single-use beverage cups when an individual buys a drink of any kind, including through a loyalty scheme, to maximise coverage and ensure the charge is easily understood;
• the application of the charge regardless of cup material, including biodegradable materials or bio-based plastics;
• exemptions from the charge when a drink is free, for instance in non-retail settings such as hospitals and care homes;
• retailers would be able to retain reasonable implementation costs from the charge, in line with the approach taken for the single use carrier bag charge; and
• net proceeds of the charge to be used for the advancement of environmental protection or improvement, or other purposes that are similar.

The consultation closes on 14 November 2024 and the Scottish government are aiming to implement the charge by the end of 2025.

EU

Right to Repair Directive enters into force

The Right to Repair Directive entered into force on 31 July 2024. Member States will need to bring into force laws, regulations and administrative provisions to comply with the directive by 31 July 2026. Please see our Eating Compliance for Breakfast webinar recording and relevant slides on the directive.

Life sciences and healthcare

UK

NHS report provides potential areas of reform

The publication of Lord Darzi's report on the NHS looks to a number of areas which have contributed to the current state of the NHS, which Darzi states "is in serious trouble". Areas of concern which the report looks to include the following, and while the detail on proposed regulatory reform is yet to be seen, both this report and the government's response outlining that long term reform will be put into place, indicate that reform of these areas could be on the horizon:

Digital transformation - Lord Darzi compares how technology has revolutionised many aspects of daily life, whereas the NHS remains in the early stages of digital transformation. The last decade could have been a golden era for embracing technologies that shift the model from "diagnose and treat" to "predict and prevent". Lord Darzi advocates integrating advanced digital solutions into the healthcare system.

What to watch out for: regulatory reform in line with the MHRA's roadmap, leading to new medical device regulations expected in 2025.

Clinical trials - The UK is ranked fourth in the number of clinical trials initiated in 2021. However, Lord Darzi notes the need to simplify and expedite the process for establishing trials in the UK, pointing to the O'Shaughnessy review that recommended simplifying and speeding up the process for establishing clinical trials to maintain the UK's competitive edge.

What to watch out for: the UK government has recognised the need to reform regulations over establishing clinical trials.

Health data - The NHS holds extraordinarily rich datasets that are largely untapped. Lord Darzi explains how these datasets could revolutionise clinical care, service planning, and research. Investment in information technology has predominantly focused on acute hospitals, meaning that investment is needed in technology in community-based services and other providers.

What to watch out for: updated guidance from the NHS Health Research Authority on the use of patient data in research

AI - Lord Darzi notes the potential for AI to transform patient care: from discovering new treatments to automating routine processes. With its vast datasets and the UK's position as a global AI hub, the NHS could lead this transformation, benefiting patients nationwide. Lord Darzi argues for a fundamental shift towards technology adoption.

What to watch out for: the development by the MHRA of its AI strategy (published in April), particularly guidance and regulations over accountability and governance

Windsor Framework - supplying medicines into Northern Ireland

Changes to the supply of medicines from Great Britian to Northern Ireland (NI) being introduced under the Windsor Framework (WF) come into force on 1 January 2025. Amending regulations and further guidance has recently  been published ahead of this implementation.

The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 amend the Human Medicines Regulations 2012 to implement the arrangements relating to the supply of medicines from Great Britain to Northern Ireland (NI) as set out in the Windsor Framework agreement, including the provision of two categories of UK-wide marketing authorisation. The regulations come into force on 1 January 2025.

Under the WF, medicinal products that previously required EU-wide authorisation must now be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) according to UK law. This allows all types of medicines to be supplied with a single licence and pack for the entire UK.

The 2012 Regulations have been amended to include two categories of UK-wide marketing authorisation (Categories 1 and 2), depending on whether the product would have fallen under the centralised EU procedure. This eliminates the need for separate packs for Northern Ireland and Great Britain. The 2012 Regulations still allow for marketing authorisations limited to Northern Ireland, but no longer for Great Britain. Additionally, the WF removes the EU law requirement for medicines packaging to include a bar code for an EU-wide database.

Wholesalers and manufacturers guidance following agreement of the Windsor Framework

New guidance has been published to support manufacturers and wholesalers implement the requirements under the WF for those medicines supplied to NI. This guidance is intended to be read in conjunction with the labelling and packaging guidance and associated Q&As. The WF will ensure that human medicines can be approved and licensed on a UK-wide basis by the MHRA.

From 1 January 2025, to be placed on the UK market, all medicines must be labelled as "UK Only" to ensure they do not move into any part of the EU or European Economic Area. The guidance adds that joint packs between the UK and EU will no longer be possible.

Pharmacovigilance following agreement of the Windsor Framework

The MHRA has published guidance on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the WF. These changes will be implemented from 1 January 2025.  The guidance notes that pharmacovigilance requirements will remain broadly in line with current requirements. However, there will be aspects of pharmacovigilance which will be impacted depending on whether the product is Category 1 or 2 and the guidance provides information on these different requirements. Businesses should review this guidance to determine how pharmacovigilance is impacted in relation to their products.