Products | UK Regulatory Outlook November 2023
Published on 29th Nov 2023
European Parliament and Council adopt negotiating positions on Right to Repair Directive | EMA publishes first electronic product information for human medicines | MHRA launches AI-Airlock
European Parliament and Council adopt negotiating positions on Right to Repair Directive
On 20 November, the European Parliament adopted its position on the Commission's proposal for a Right to Repair (RTR) directive which was first introduced in March 2023 (see this earlier Regulatory Outlook). The RTR proposal does two things: (i) firstly it amends the rights in which consumers have when they are sold defective products to have them repaired; and (ii)secondly it creates a new general obligation on “producers” to repair goods.
The European Parliament's position proposes some quite significant changes to the commission plans regarding right to repair, which will only be implemented if this position is implemented in full. Specifically:
- extend repair obligations for goods which are outside of the SGD guarantee period. The EP's proposal widens the scope of products that these obligations will apply to (bicycles would be added to the initial product groups) and gives the Commission powers to expand the scope of products caught in the future (in light of legislative or market developments).
- If Article 5 obligation to repair applies to a product, producers will need to ensure that spare parts, and repair-related information and tools, are available for at least the expected lifespan of the product.
- Additionally, Producers of products would be prevented from impeding repairs by third parties by contractual, hardware or software techniques, and would also need to allow repairs to be made via original or second-hand spare parts, compatible spare parts, and 3D printed spare parts. The RTR, if amended as proposed, would also prevent producers refusing to service or repair a device that was bought or previously repaired outside their service / distribution networks.
- A fine for non-compliance may be up to 4% of the seller's or the producer's annual turnover in the Member State or Member States concerned.
The Council adopted its position on 22nd November. Changes made to the Commission's original proposal by the Council include not prioritising repair over replacement within a product's legal guarantee, arguing that the consumer should have a choice whether to replace or repair a defective product. The Councils adopted text does not go as far as the European Parliament's and in some instances deviates from that of parliaments text, for instance limiting the requirement on manufacturers to provide information on repair services to those that have a legal obligation to fix defective products.
A differing transposition period has been adopted among all three versions of the proposal. The Commission's proposal outlined a 24 month period, whereas Parliament adopted an 18 month period, and the Council adopted a 30 month period. Therefore the transposition period will depend on the outcome of the inter-institutional negotiations which are scheduled for 7 December, but it seems likely that a middle ground will be reached of the initial 24 month period, which would mean obligations would start to arise from September 2026.
Neither of the current drafts are the final version of the legislation – they constitute the Parliament's and the Council's respective positions for further negotiations between the institutions to reach an agreement on the final version of the text.
For the consumer rights angle of the directive proposal please see the Consumer law section.
EMA publishes first electronic product information for human medicines
The European Medicines Agency (EMA) is currently exploring the use of electronic product information (ePI) with a year-long pilot scheme where companies can create and submit ePIs as part of their regulatory application. Product information of a medicine includes its labelling, package leaflet and summary of a product characteristics. These documents accompany every medicine authorised in the EU and can all be found on a printed package leaflet in the medicine's box and also on the websites of EU regulators.
The published ePIs are for medicines evaluated by the EMA or by the national authorities in the countries taking part in the pilot (Denmark, the Netherlands, Spain and Sweden).
Twenty-five medicines are involved in the pilot. The EMA has now published the first lot of ePI data it has received which can be viewed on the "Product Lifestyle Management Portal". The EMA notes that in future the platform could include functionalities such as automatic update notifications, access to supportive videos or audio content and online adverse reaction reporting tools.
By transitioning to the use of ePI, the EMA stated it should make sharing product information easier, will mean the information can be updated more readily and will be more easily accessible to both healthcare professionals and patients.
The pilot comes to an end in July 2024 and the results will help to integrate the use of ePI across the EU. However, concerns have been raised that ePI should not completely replace paper leaflets and the European Consumer Organisation, BEUC, has warned that certain people could be left behind if this approach is taken.
MHRA launches AI-Airlock
On 30 October 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a new "regulatory sandbox" known as the AI-Airlock, which will provide a regulator-monitored virtual area for developers to generate evidence for their advanced technologies within the current regulatory system.
The MHRA acknowledged that it can be challenging to test AI technologies using traditional trial techniques and the AI-Airlock is designed to provide a collaborative approach to identifying and managing regulatory evidence requirements. This could result in patients benefiting from quicker access to developing technologies. The press release states that the sandbox will allow AI technology to be used in NHS settings (with strict safety controls) before navigating the process of getting regulatory approval. It is due to be launched in April 2024.
UK government's summary of new EU toy safety regulation
As well as providing a high level summary of the changes the regulation will introduce, it highlights that while the requirements for products placed on the GB market will not change, GB manufacturers placing products on the EU market will need to ensure they are comply with the new requirements.
It goes on to outline that the UK's Product Safety review, which concluded on 24 October, will review sector specific legislation, including toys, "to fit within any emerging changes that might be considered for the framework as a whole". The government "will consider the benefits and risks of adopting similar measures as set out in the EU’s proposal" and will take this into account alongside the responses it receives to the consultation.
Government's response to Pro-Innovation Regulation of Technologies Review on advanced manufacturing
Professor Dame Angela McLean (chief scientific adviser to the UK government) has published her Pro-Innovation Regulation of Technologies Review on advanced manufacturing, to which the government has responded.
The review sets out a number of recommendations on regulatory opportunities for advanced technologies, including evolving the existing regulatory framework to safe testing and rollout of electric Vertical Take-off and Landing (eVTOL), accelerating the development of standards for digital twins, and looking to developing repair, reuse and recycling technology. The review includes a caveat that it does not include an exhaustive list of every sub-sector, rather it has focused on areas where regulatory challenges or opportunities are arising.
The government's response outlines what it is doing in these areas, which includes the following:
- The Department for Business and Trade manages the National Digital Twin Programme which it says will work with the British Standards Institute to determine a roadmap and develop standards required for digital twins.
- The government is taking forward the Department for Transport's Future of Flight programme which will, among other things, work with the Civil Aviation Authority to develop regulation for new aviation technologies, and has also funded £300 million to support the development of new technologies, including eVTOL.
- The High Value Manufacturing Catapult is looking to ways in which UK-based manufacturers can design their products to be more sustainable, including designing products for repair, reuse and recycling, as well as helping UK businesses looking to develop new circular materials, technologies and processes.
The government's response provides businesses with some interesting information on what is being done in particular areas to help assist the regulatory framework so that it is fit for these developing technologies.
Agreement reached on new voluntary scheme for branded medicines pricing, access and growth
The government, NHS England and the Association of the British Pharmaceutical Industry (ABPI) have reached an agreement on a voluntary scheme for branded medicines pricing, access and growth (VPAG), which will run for five years from 1 January 2024.
The agreement introduces a new mechanism which will support "lower industry payment rates for more innovative and pioneering branded medicines" and will allow savings that are double those under the current medicine pricing agreement, the voluntary scheme for branded medicines pricing and access (VPAS).
The government and ABHI will review VPAG twice over the five years: once in 2025 and spring 2027. The government's press release states that VPAG should save the NHS £14 billion in medicine costs and that industry will invest a further £400million into the sector to accelerate work on clinical trials, manufacturing and in health technology assessments agencies.
MHRA launches eligibility checking tool for upcoming International Recognition Procedure
In line with its introduction of the International Recognition Procedure (IRP) (see this earlier Regulatory Outlook), the MHRA has launched an online eligibility checking tool which applicants can use to determine whether their marketing authorisation application is suitable for IRP and identify which route to follow, before submitting an IRP application.
The MHRA is encouraging applicants to start using the tool ahead of the IRP becoming fully operational:it is due to go live on 1 January 2024. For businesses looking to place new medicines on the UK market in the new year, the tool will provide helpful guidance as to what route they will follow in order to do so.
Government publish response to Lord O'Shaughnessy review into commercial clinical trials
On 22 November, the Department of Health and Social Care published its response to Lord O’Shaughnessy’s review of commercial clinical trials that was published in May 2023. Following this the government made five headline commitments as an immediate first step, backed by up to £121 million, which were to: to improve the speed of commercial clinical trials; deliver a comprehensive and mandatory national approach to contracting; provide "real-time" data on commercial clinical activity in the UK; establishing a common approach to contacting patients to take part in research and achieving greater data usage for research delivery; and accelerating new and innovative ways to deliver trials.
The government's latest response highlights the significant progress made in commercial clinical research, with performance exceeding pre-pandemic levels. It also, among other things, announces the commencement of a new NIHR Research Delivery Network (RDN) and outlines its role in supporting health and care research delivery. The plan sets out that new performance indicators will be implemented to improve the speed and predictability of commercial research in the NHS.
Autumn statement – life sciences aspects
The Autumn Statement 2023 highlights that "life science is a strength of the UK economy". The statement outlines that £520 million funding will be allocated within the sector from 2025-2026 for transformational manufacturing investments, a Clinical Trials Delivery Accelerator, an Oligonucleotide Manufacturing Centre of Excellence, and AI Life Sciences Accelerator Mission. The introduction of the new VPAG scheme is estimated to save the NHS around £14 billion, and the statement also sets out that "a £400 million fund will also be established by industry to support investment in the UK life sciences ecosystem, including improved clinical trial capacity."
European Parliament adopts position on Packaging and Packaging Waste Regulation
On 23 November, the European Parliament adopted its negotiating position on the proposal for a regulation on packaging and packaging waste regulation. Amendments introduced by the MEPs include introducing specific targets for each Member State to reduce plastic packaging as follows: 10% by 2030, 15% by 2035 and 20% by 2040, this is in addition to the Commission's overall general packaging reduction targets which are 5% by 2030, 10 % by 2035 and 15 % by 2040. This position therefore goes further than that of the Commission as Member States will have to meet both the specific targets for general packaging, as well as the specific targets for plastic packaging, that is if this amendment is brought forward in the finalised version of the proposal.
The Parliament have also introduced a ban on the sale of very light plastic carrier bags as well as restricting the use of certain single use packaging formats, such as hotel miniature packaging for toiletry products and shrink-wrap for suitcases in airports.
As detailed in our Insight, the Commission's proposal outlined that single-use plastic or composite packaging for foods and beverages filled and consumed on premises cannot be used from 1 January 2030 (including disposable plates, cups, bags and trays). This requirement has been deleted by the European Parliament which will be welcomed by food businesses. Other packaging formats that were also included within this provision under the Commission's proposal that have also been axed by Parliament include single-use packaging for fruit and vegetables and single-use sachets and tubs.
Additionally, the European Parliament has introduced provisions banning the use of "forever chemicals" (per- and polyfluorinated alkyl substances or PFAS) and Bisphenol A in food contact packaging from being place on the Union market. This is a new requirement introduced by the European Parliament and if carried forward into the final draft of the proposal will have huge implications on packaging manufacturers who will need to consider alternative packaging materials to use.
In terms of next steps, the Council will now have to adopt its negotiating position. Once the Council has adopted their position, both drafts will constitute the Parliament's and the Council's respective positions for further negotiations between the institutions to reach an agreement on the final version of the text.