Products | UK Regulatory Outlook March 2023
Published on 28th Mar 2023
EU bring in proposals for right to repair | MHRA publish proposals for new clinical trials regulatory framework | Spring Budget 2023 – UK chancellor announces a new regulatory model
EU bring in proposals for right to repair
The European Commission has (on 22 March 2023) published its proposal for a Directive on common rules promoting the repair of goods which aims to increase the repair and reuse of defective products to promote sustainability.
Within the legal guarantee, the proposal makes a direct amendment to the Sale of Goods Directive for sellers to prioritise repair where it is cheaper than replacing the product. This means that consumers no longer have a choice about whether to repair or replace – rather a repair must be offered to consumers, unless this would be more expensive than a replacement.
Outside of this legal guarantee, the directive introduces the following measures to facilitate repair when the legal guarantee has expired:
- Obligation to repair – producers (that is, manufacturers) will be obligated to repair goods, upon a consumer's request, that fall outside the liability of the seller. This obligation does not arise for products that are impossible to repair. This obligation will apply to producers established both inside and outside the Union in relation to goods placed on the Union market.
- Information on obligation to report – producers need to inform consumers of their obligation to repair products and provide information on the repair services in an easily accessible, clear and comprehensible manner (for example, through the online platform – see below).
- Information needs to be provided to consumers to find suitable repairers in their area via an online repair platform. Each Member State will have to have at least one online platform.
- Introduction of a European Repair Information Form, which will help consumers compare different repair services based on key aspects, such as price, duration of repair or availability of a replacement product during repair. This form can be requested from the producers and also other repairers like the seller or independent repairers, or by searching via the online repair platform.
The directive will apply to consumer goods (any tangible movable item) and applies to any defect that may occur in those goods.
The proposal provides that Member States will have two years to implement the directive into national law, so while these changes will not be coming into force imminently, it is important for businesses to understand the direction of travel and start discussions about how this shift of focus to repair would be achieved.
The proposal will now be subject to the ordinary legislative procedure, which means they will be transmitted to the co-legislators, the European Parliament and the Council for adoption.
MHRA publish proposals for new clinical trials regulatory framework
The government has published its response to the consultation on the regulation of clinical trials in the UK, setting out a number of reforms of the framework. The measures introduced are hoped to streamline and accelerate clinical trials in order to "find innovative ways to bring new treatments to patients faster and more effectively."
Among the measures proposed are a number to ensure transparency within clinical trials, with the new framework introducing a legal mandate to register the trial in a World Health Organization public register.
The legislation will also bring in a requirement to publish a summary of results within 12 months of the end of the trial and sharing trial findings with participants. Additionally, clinical trial applications will need to be completed within 30 days, in general, with a maximum 10 days for a decision to be granted once the MHRA has received any final information.
The Association of the British Pharmaceutical Industry has welcomed the new proposals and in its response Richard Torbett, ABPI Chief Executive, said: “It’s great to see the MHRA taking forward these important changes to UK clinical trials regulation centred on patient safety and the benefits of participating in research. The reforms are a significant step forward for UK clinical trials and come at a crucial time for industry clinical research in the UK."
Spring Budget 2023 – UK chancellor announces a new regulatory model
In his recent spring Budget, chancellor Jeremy Hunt announced reform to the UK's regulation of medicines and medical technologies. In a bid to position the UK as a global hub for innovative products, the Medicines and Healthcare products Regulatory Agency (MHRA) will get additional funding to accelerate access to new products and manufacturers will be able to leverage approvals from overseas regulators.
The chancellor has outlined how funding will change the role of the MHRA, stating that it will receive an extra £10 million over the next two years to put in place "the quickest, simplest, regulatory approval in the world for companies seeking rapid market access" for innovative medical products.
The rapid approval of medicines approved in other jurisdictions will also be introduced, with the Budget confirming that the MHRA is "exploring partnerships with trusted international agencies, such as in the US, Europe and Japan to provide simple, rapid approvals for medicines and technologies that have received their approval from 2024".
In the House of Commons, the chancellor went further, stating that the MHRA would move to a new model to allow "often near automatic sign-off for medicines and technologies" that have already been approved by regulators in jurisdictions such as the US, Europe and Japan.
In addition, from 2024, the MHRA will introduce a new approval process for the most "impactful" innovative medicines and devices, examples being cancer vaccines and AI therapeutics for mental health. This is hoped to accelerate patient access to treatments and build on the success associated with the UK's rapid approval of Covid-19 vaccinations. See our Insight for more.
Call for evidence and inquiry launched on the Windsor Framework
On 17 March, the UK European Affairs Sub-Committee on the Protocol on Ireland/Northern Ireland published an inquiry and call for written evidence on the Windsor Framework (see our previous Regulatory Outlook). The Committee will examine the economic, political, legal and constitutional implications of the Framework and is seeking views on issues including: the customs procedures and movement of goods; the impact of the Windsor Framework on the application of EU rules in Northern Ireland; and whether issues around provision of medicines to Northern Ireland are resolved. The deadline to submissions is 4pm on Tuesday 2 May 2023 and you can respond here. The committee will also hear oral evidence from 22 March.
EU PFAS restriction proposal
The European Chemicals Agency (ECHA) last month announced details of a proposal which would restrict around 10,000 per- and polyfluoroalkyl substances (PFASs). The restriction will be on the manufacture, placing on the market and use of PFASs.
Most recently, on 22 March the ECHA launched a six month open consultation on the proposal for those who wish to provide their views. Comments are to be made by 25 September 2023, you can respond here.
An online information session is also being run on 5 April 2023 to explain the restriction process and to help those interested in participating in the consultation. More details on this can be found here.
This proposed restriction on PFASs is set to be one of the largest ever on chemical substances in the EU and so it is important your business follows this for further developments. Whilst the European Commission is not expected to make a decision on the PFAS ban until 2025, it is important that your business is familiarises itself with the proposal as actions may need to be taken further down the line, such as reducing PFAS and looking for alternatives.
In the UK, PFAS have been in the media recently. The Health and Safety executive (HSE) is looking to whether and to what extent the UK should phase out and eventually ban the use of PFAS. The HSE is expected to publish its recommendations this spring and we expect the review to conclude that restrictions on the use of PFAS is necessary and could come in during the course of 2024, subject to relevant grace periods.
European Council adopts regulation extending transitional periods for certification of medical devices
On 7 March, the European Council adopted the proposal to extend the transitional provisions put forward by the European Commission on medical devices (MDR) and Regulation (EU) 2017/746 in vitro diagnostic medical devices (IVDR) to extend the transitional provisions for certain medical devices.
This amending legislation will extend the MDR transition periods, delaying the full implementation of the MDR and IVDR, and removes the sell-off date provision in MDR and IVDR in an attempt to avoid device shortages.
For producers of medical devices this means they have until 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices to meet the legal requirements.
The regulation came into force on 20 March.
The UK government has announced that the MHRA is looking at what the implications of these revisions are for acceptance of CE marked medical devices on the GB market. That would include certificates valid under the latest EU’s revised transitional arrangements, if they are adopted as proposed. As announced in October 2022, there are plans to extend acceptance of the CE marking in GB which will be put into law in the coming months and the government will be publishing guidance on this as soon as possible (see our Insight for more). However, as it stands, until the legislation is updated the standstill period during which CE marking is accepted in GB ends on 30 June 2023. Industry will be hoping that the government formalises the extension to the period in which CE marking is accepted as soon as possible.
Artificial Intelligence and Digital Regulations Service launches
The NHS Health Research Authority has launched the Artificial Intelligence and Digital Regulations Service website. The service is a partnership between the Health Research Authority, National Institute for Health and Care Excellence, Care Quality Commission, and the MHRA. The website aims to clearly set out the information and guidance that developers and adopters need to follow to develop safe, innovative technologies in health and social care. This includes advice on legal requirements, best practice guidance for the development and adoption of AI and digital technologies.
The platform helpfully indicates which regulatory requirements are mandatory and which are best practice, bringing greater clarity to what is required of developers of medical and non-medical devices. The guidance for developers is all publicly accessible. To access regulations for adopters, you will need to sign up and create an account with the site.
MHRA recall and withdraw medicines containing cough suppressant pholcodine in the UK
Following a review conducted by the Commission on Human Medicines (CHM), the MHRA has, as a precaution, recalled and withdrawn all pholcodine-containing medicines.
The CHM review found that pholcodine-containing medicines may increase the risk of the very rare event of anaphylaxis, in particular when exposed to neuromuscular blocking agents (NMBA). NMBAs are used to relax the muscles during general anaesthesia for some surgical procedures.
The MHRA has instructed healthcare professionals to stop supplying the product immediately and to quarantine remaining stock. It also notes that patients should check through medicines to see whether pholcodine is a listed ingredient and if patients undergo general anaesthesia in the next 12 months, they should notify their anaesthetist that they have taken pholcodine-containing products before they have surgery.
My safety: toys and electrical products
The Office for Product Safety and Standards is leading a new campaign to raise awareness about potential hazards to adults and children associated with toys and electrical products. The campaign posters, which will be on social media platforms such as Facebook, Instagram and Twitter, concentrate on three main messages:
- Consumers should be aware that not everything advertised on an online platform is sold by that platform.
- They should search ‘product recalls’ on GOV.UK to see if any problems have been identified with a potential purchase.
- And if they think they have bought an unsafe product they should report it
This new campaign aims to encourage consumers to be wary of where they are purchasing their products from, ensuring they are buying them from safe reliable sources. So whilst aimed at consumers, this campaign provides businesses placing toys on the market with a timely reminder that the safety standards of toys must be met.
Defra reminds businesses of their obligation as EPR reporting requirements come into force
On 28 February, the extended producer responsibility (EPR) reporting requirements, as set out in the Packaging Waste (Data Reporting) (England) Regulations 2023 (SI 2023/219) came into force.
Alongside these, the Department for Environment, Food & Rural Affairs (Defra) published a reminder to businesses that supply household packaging and meet the required threshold of their obligations to collect information on the amount and type of packaging they have supplied during 2023. The first reports must be submitted from 1 October 2023.
The requirements applies to producers with an annual turnover of £2 million that handle more than 50 tonnes of packaging each year and requires them to report twice a year, starting on 1 October 2023, with data on the amount and type of packaging they supply.
The Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2023 will be introduced to establish the packaging EPR regime in full later in 2023. They will revoke and replace the 2023 data regulations by including equivalent data collection provisions.
New government guidance has also recently been published on how to structure packaging data submissions, and includes information about the different types of data that needs to be submitted and the codes that need to be used.
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Advertising and marketing
Bribery, fraud and anti-money laundering
Employment and immigration
Environmental, social and governance
Fintech, digital assets, payments and consumer credit
Health and safety
Sanctions and Export Control