Products | UK Regulatory Outlook June 2024

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UK general election 2024: product regulation aspects

Focusing on the manifestos and statements of Labour and the Conservatives ahead of the UK general election on 4 July 2024, below are the main themes of what could be on the horizon for product regulation following the formation of a new government:

Both parties intend to continue with the introduction of legislation to phase out smoking and restrict the sale of vapes. As the Tobacco and Vapes Bill fell away during the "wash-up" period, new legislation (which may be a very similar to the previous Bill) will need to be introduced and start the legislative process from the beginning.

With regard to the deployment of deposit return schemes (DRS), the Conservative manifesto outlines its intentions to proceed with DRS, continuing on from the progress made. While the Labour manifesto does not explicitly refer to DRS, it does state that Labour is "committed to reducing waste by moving to a circular economy" which we suspect, due to the progress already made on DRS, would include continuing with the implementation of the scheme.

Both the Labour and Conservative parties aim to leverage AI in healthcare—Labour's priority is stated to be to enhance and quicken diagnostic accuracy, particularly using AI-powered scanners for early cancer detection. The Conservatives have pledged to increase frontline care time for medical staff, offering "new digital health checks" to prevent strokes and heart attacks. With each manifesto highlighting regulatory change to offer faster approvals for medical tech, this is expected to be a key area for the incoming government. See our Insight for more on the implications of the general election for the life sciences and healthcare sector.

Labour has proposed the establishment of a new Regulatory Innovation Office (RIO) to modernise regulations and accelerate approval processes while also enhancing cross-regulatory collaboration. A prior announcement emphasised the RIO's role in expediting clinical trial applications and improving patient access to advanced treatments, hinting at the idea that its initial focus will be on the MHRA's operations.

Labour has confirmed that there will be no return to the EU single market, the customs union, or freedom of movement. This is also the intention of the Conservatives.

However, in an interview with the Financial Times on 16 June, shadow chancellor Rachel Reeves said that the Labour Party would look to improve the UK's trading relationship with Europe, specifically targeting regulatory alignment for chemicals and "a better deal" for workers in the City of London. Whichever party wins, we will have to see how the new government deals with further divergence and product regulatory issues once it enters into power.

General / digital products

EU

Commission adopts implementing regulations on product recall notices and the Safety Gate Portal

The European Commission has adopted an implementing regulation which sets out the template for written recall notice required under Articles 35 and 36 of the General Product Safety Regulation (GPSR). The template recall notice is set out in the annex to the Recall Notices Regulation and will also be published on the Commission's website. Businesses placing products on the EU market will need to ensure that that this template is used when conducting recalls once the GPSR enters into force on 13 December 2024.

Additionally, the Commission also adopted an implementing regulation which establishes an interoperable interface of the Safety Gate Portal. This will enable online marketplaces to link their interfaces with the portal, as required by Articles 22(6) and (7) of the GPSR.

Product sustainability

EU

Council of the EU adopt right to repair

The Council of the EU has formally adopted its position on the right to repair directive (see previous Regulatory Outlook for more on the position). The legislation now needs to be signed by the President of the European Parliament and the President of the Council before published in the Official Journal of the European Union and will enter into force on the twentieth day following publication.

Member States endorse ban of Bisphenol A in food contact materials

On 12 June, Member States endorsed a proposal from the Commission to ban Bisphenol A (BPA) in food contact materials. The ban will be formally adopted following “a scrutiny period by the European Parliament and the Council”, entering into force at the end of 2024. The press release notes that limited exceptions will apply where there are no safe alternatives. The ban will mainly apply to the use of BPA in packaging, such as the coating used on metal cans. The use of BPA in consumer articles such as reusable plastic drink bottles, water distribution coolers or other kitchenware will also be banned. There will be a transition period between 18 to 36 months which will be agreed by the EU institutions.

Council of the EU adopt position on amendments to Waste Framework Directive 

On 17 June, the Council of the EU adopted its position on the amendments to the waste framework directive in regard to food and textile waste. The Council agrees with the Commission's proposal to introduce extend producer responsibility (EPR) schemes for textiles within 30 months after the directive comes into force (the European Parliament has proposed this be 18 months). The Council's position also sets out that Member States can require higher fees for companies following "fast fashion" industrial and commercial practices. The Council has also included a provision to allow Member States to exempt social economy entities (including charities, social enterprises and foundations) from certain reporting requirements.

Now that the Council has adopted its approach, negotiations with the European Parliament (who adopted its position earlier this year, see this Regulatory Outlook) can begin during the new legislative cycle in July.

Council adopts formal position on Green Claims Directive

Please see ESG.

Imports and exports of electrical and electronic waste in the EU

The European Commission has launched a consultation on amendments to the Basel Convention to bring all imports and exports of hazardous electrical and electronic waste within the convention's scope. The Basel Convention controls the transboundary movements of hazardous wastes and their disposal. The parties to the convention now wish to add electrical and electronic waste in order to encourage the safe management. These changes will be incorporated into EU law, notably the EU Waste Shipment Regulation.

The amendments will enter into force from 1 January 2025.After this date, both hazardous and non-hazardous e-waste transboundary movements will be subject to the Prior Informed Consent Procedure (PIC) according to the Basel Convention.

These changes will apply to all parties to the convention, including the EU and its Member States.

The Commission will take feedback into account when finalising this initiative and feedback can be given until 3 July 2024.

Life sciences and healthcare

UK

CMA launches market investigation into the UK vet sector

After consulting on a proposal to make a market investigation reference into UK veterinary services for household pets, which followed a review into the sector (see this Regulatory Outlook), the CMA has published the consultation responses alongside its decision to make a market investigation reference.

The market investigation will enable the CMA to further investigate its concerns and assess in detail whether certain features of the market are having an adverse effect on competition and therefore on consumers. A market investigation will also allow the CMA to address the issues with appropriate remedies.

Possible remedies include making recommendations to the government, for example, suggesting changes to the regulatory framework, which was a key theme from respondents to the consultation, who argued that the regulatory framework needed reform as it is no longer fit for purpose.

Other potential remedies include making the provision of certain information to consumers obligatory, imposing maximum prescription fees and ordering the sale or disposal of a business or assets.

The CMA has also published guidance for consumers on choosing a vet practice and the appropriate treatment for their pets.

The statutory timetable for a market investigation is 18 months, meaning that the CMA would be required to deliver its final report, including any proposed remedies, by 22 November 2025.

NHS launch consultation on integrated, rules-based medical technology pathway

NHSE and the National Institute for Health and Care Excellence (NICE) have launched a consultation on their proposals for an integrated, rules-based medical technology (medtech) pathway. The proposal is based around the following principles:

• Principle 1 – the pathway should be supported by evidence-based advice and guidance from the NICE, focused on technologies with the greatest impact on patient outcomes and the most compelling cases for clinical and cost-effectiveness.
• Principle 2 – the pathway requires a lifecycle approach to support new, early-stage technologies as well as driving greater value from existing technologies in widespread use.
• Principle 3 – the pathway should lead to automatic identification of funding to support routine commissioning and adoption for clinically and cost-effective and affordable technologies.
• Principle 4 – the pathway should support the transformation of clinical pathways and services.
• Principle 5 – the pathway should drive up the quality and use of evidence, helping tackle ethnic and unfair biases in medtech

The consultation closes on 15 August 2024 and the new pathway will be piloted later in the year, although this may be subject to change in light of the upcoming general election.