General/digital products: EU product compliance: digitalisation and common specifications proposals | Proposal to amend EU regulations on AI rules
Life sciences and healthcare: UK – House of Lords report identifies critical regulatory and supply chain challenges for UK medicines security | DHSC on branded medicines; recommends improvements to legislation; medicines data reporting consult; vaccine regulation response | HRA to align non-clinical trials of investigational medicinal products studies with new clinical trials regulations | CQC: enhanced human rights focus in care settings | EU: European Parliament adopts position on Critical Medicines Act | European Commission consultation on targeted revision of medical devices and in vitro diagnostics regulations
Sustainable products: UK – First UK PFAS plan published | UK government grants partial exclusion for Welsh DRS scheme under UK Internal Market Act | Extended producer responsibility for packaging: new guidance on mergers and transfers of ownership | UK packaging producer responsibility monitoring plan 2026 | Welsh government lays draft regulations amending waste separation requirements | UK REACH – government response to extension to submission deadlines | EU – ESPR on ban of destruction of unsold apparel and footwear, including disclosure and report format requirements | European Commission measures to boost circular economy and plastic recycling
EU product compliance: digitalisation and common specifications proposals
On 27 January 2026, the European Parliament’s Internal Market Committee approved proposals to digitalise EU product compliance and introduce “common specifications” as a fallback mechanism for demonstrating regulatory compliance.
The package adopts a “digital by default” approach, promoting electronic formats for product documentation including declarations of conformity (DoC), instructions and contact details. Key elements include:
The proposals also introduce common specifications that the Commission can adopt exceptionally when harmonised standards are missing or insufficient to demonstrate product compliance.
Parliament is expected to endorse the negotiation mandate during a plenary session in March, with formal trilogue negotiations to follow.
If adopted, businesses may need to invest in digital infrastructure to produce electronic declarations of conformity accessible via QR codes or web links and establish direct digital contact points for communication with authorities, while maintaining the ability to provide paper documentation on request for vulnerable consumers.
Proposal to amend EU regulations on AI rules
The Department for Science, Innovation and Technology has published an explanatory memorandum discussing the EU’s proposed Digital Omnibus on AI.
The EU AI Act does not currently apply in Northern Ireland under the Windsor Framework. However, the UK has been notified by the EU that it considers the AI Act to be within scope of the Windsor Framework to the extent it contains provisions regarding conditions and specifications for the placing on the market of products or relates to the provision of services that may affect the free movement of products.
Any decision to add the AI Act to the Windsor Framework would require an agreement at the EU-UK Withdrawal Agreement Joint Committee. The EU and UK are continuing technical engagement/exchanges of views on the implications for the Windsor Framework, and no decision has yet been made.
House of Lords report identifies critical regulatory and supply chain challenges for UK medicines security
The House of Lords Public Services Committee has published a report warning that medicine shortages are rising, with 73% of pharmacy team members reporting that medicine supply issues are putting patient health at risk in 2025, yet the Department of Health and Social Care (DHSC) cannot confirm whether the number of shortages is rising or falling.
The report finds that the UK’s reliance on a fragile global supply chain, primarily from India and China, means that geopolitical shifts pose significant risks to medicine availability.
The committee calls for three strands of action:
It recommends the government create a public Critical Medicines List based on clinical priority and supply chain vulnerability, publish a comprehensive medicines security strategy, and appoint a Senior Responsible Officer to oversee implementation of supply chain resilience.
For pharmaceutical companies and supply chain stakeholders, the report indicates regulatory pressure will increase on stockpiling requirements, information-sharing obligations, and diversification of manufacturing locations to reduce dependence on single-source suppliers.
DHSC proposes reduction to statutory scheme headline payment percentage for branded medicines
The Department of Health and Social Care is consulting on reducing the statutory scheme headline payment percentage for branded medicines from 24.3% to 16.5% from 1 July 2026 to restore broad commercial equivalence with the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG). The VPAG headline payment percentage for 2026 has been set at 14.5%, with an additional 1% investment programme payment, creating a significant gap with the current statutory scheme rate.
The proposed 16.5% statutory scheme rate represents a one percentage point uplift above the combined VPAG rates, chosen to reflect precedent from previous years and maintain broad commercial equivalence while supporting the partnership between industry and government under the voluntary scheme. Companies that made statutory scheme payments in the first half of 2026 at 24.3% will pay a lower rate of 8.7% from 1 July to 31 December 2026 to achieve a full year average rate of 16.5%.
The consultation also proposes a simplified consultation process for future amendments to the statutory scheme payment percentages. Rather than publishing public consultations on gov.uk, DHSC proposes engaging directly through workshops with pharmaceutical industry trade associations (Association of the British Pharmaceutical Industry (ABPI), Medicines UK, Ethical Medicines Industry Group (EMIG) and BioIndustry Association (BIA)) and patient representatives (CMAC). The consultation closes on 21 April 2026.
DHSC review finds medicines and medical devices legislation fundamentally robust but recommends improvements
The Department of Health and Social Care has published the Medicines and Medical Devices Act 2021: 5 year report evaluating how legislation governing human medicines, veterinary medicines and medical devices has functioned between 11 February 2021 and 11 February 2026, following the introduction of new powers under the Medicines and Medical Devices Act 2021. The review finds that the legislative frameworks continue to safeguard public and animal health effectively, with stakeholders confirming the frameworks are fundamentally robust and fit for purpose.
However, three cross-cutting issues emerged: complexity and fragmentation caused by cumulative amendments over time is making legislation difficult to navigate; heavy reliance on guidance in fast-moving or technically complex areas sometimes results in uncertainty about the legal status of requirements; and procedural rigidity under part 5 of the Act, particularly mandatory consultations and extensive use of the draft affirmative procedure, delays amendments and may not be proportionate.
The review recommends that the government improve clarity and accessibility through consolidation where justified (particularly for medical devices), targeted improvements and strengthened guidance. It also recommends a more proportionate approach to consultation and parliamentary scrutiny of regulatory changes to enhance regulatory agility without compromising oversight or safety, and maintaining awareness of and, where appropriate, harmonising with EU and international frameworks to support supply resilience, innovation and global trade.
DHSC consults on expanding medicines data reporting regime
The Department of Health and Social Care has published its 2025 annual review of the Health Service Products (Provision and Disclosure of Information) Regulations 2018 and is consulting on proposed amendments to strengthen medicines reimbursement, supply oversight and compliance across the UK. The review, covering July 2022 to June 2025, concludes that while the regulations’ objectives remain appropriate, changes are needed to improve NHS reimbursement arrangements, enhance management of medicines shortages and ensure better value for money.
DHSC proposes to broaden mandatory data collection from manufacturers, importers and wholesalers to enable reimbursement prices in the Drug Tariff to be set using supplier sales and volume data for more products, including some Category C medicines. Pharmacy hubs operating under the new “hub and spoke” dispensing model (in force from 1 October 2025) will be required to submit data, and all new products and updates to pack sizes and prices must be notified to ensure accurate reimbursement and up-to-date entries in NHS Business Services Authority (NHSBSA) systems.
To improve availability and value for money, DHSC proposes expanding data requests to include products available both on prescription and for retail sale, particularly where public health risks may arise, and clarifying shortage reporting requirements to remove subjectivity and strengthen market oversight. Compliance changes include updating references from NHS Digital to NHSBSA as the designated data submission portal, formalising reporting via the Discontinuations and Shortages (DaSH) portal, revising penalty arrangements for non-compliance and extending the frequency of statutory reviews from annually to every two years.
HRA to align non-clinical trials of investigational medicinal products studies with new clinical trials regulations
The Health Research Authority (HRA) has confirmed that from 28 April 2026, it will implement procedural changes for non-CTIMP studies to align with the new clinical trials regulations, despite non-CTIMPs remaining outside the scope of those regulations.
The key changes include: adopting harmonised terminology and processes consistent with clinical trials of investigational medicinal products; aligning approval timelines to match the CTIMP framework; and updating research transparency requirements. These changes will apply across all UK jurisdictions and are intended to create greater consistency and proportionality in the regulation of health and social care research.
Additionally, the HRA has published guidance on definitional changes under the new CTIMP regulations, including: replacing “subject” with “participant”; changing “trial site” to “trial location”; revising the definition of “chief investigator”‘; and introducing new defined terms for “notifiable trials” and “non-investigational medicinal products”.
DHSC vaccine regulations response
The Department of Health and Social Care (DHSC) has published its response to the public consultation on proposed amendments to the Human Medicines Regulations 2012 to support ongoing vaccine supply and access across the UK. Following positive feedback, the government confirmed it will proceed with the changes.
The proposal makes several Covid-19-era regulatory flexibilities permanent to create a more resilient UK vaccination system. Regulation 3A will be retained, allowing trained healthcare staff to complete final assembly, preparation and labelling of vaccines without additional manufacturer licences, thereby increasing workforce flexibility. Regulation 19 (4A-4D) will continue, enabling redistribution of Covid-19 and influenza vaccines between NHS providers without a wholesale dealer’s licence.
Additional reforms will extend to community pharmacies, permitting them to deliver vaccinations off-site and prepare vaccines away from registered premises to improve access. The government will also introduce Vaccine Group Directions to replace national protocols and support a broader vaccination workforce.
CQC Update: enhanced human rights focus in care settings
The Care Quality Commission (CQC) has outlined key regulatory changes following the Joint Committee on Human Rights’ 2022 report on protecting human rights in care settings. Providers should prepare for a refined assessment framework, enhanced scrutiny of restrictive practices, and stronger expectations around staff training in human rights-based care.
The CQC is refining its assessment framework following consultation on “Better regulation, better care”, which received over 1,600 responses. A specialist human rights review of sector-specific assessment frameworks is being scoped. Future guidance will include stronger expectations that staff possess the skills and knowledge to deliver rights-respecting care, with explicit references to Care Certificate standards (including the Equality, Diversity and Human Rights standard) and relevant qualifications. It is developing new guidance for inspectors and Mental Health Act reviewers on psychological and cultural restraint, alongside additional guidance on “do not attempt cardiopulmonary resuscitation” (DNACPR) decisions to support inspector judgements. Inspector training is being reviewed to include DNACPR in induction programmes.
Work continues on introducing notification requirements for mental health units when restrictive interventions are used, following the Department of Health and Social Care’s request for further development before implementation. CQC will consider recommendations from the government’s post-implementation review of Regulation 9A (visiting rights) when finalised. The regulator is also moving into phase two of its Anti-Racism Policy and Strategy, which will be informed by a co-produced position statement and action plan developed with staff, providers and people with lived experience.
EU
European Parliament adopts position on Critical Medicines Act
On 20 January 2026, the European Parliament adopted its negotiation position on the European Commission’s proposed Regulation to improve the supply of critical medicines in the EU (Critical Medicines Act) (procedure 2025/102(COD)).
The Parliament’s position, prepared by the Committee on Public Health, supports creating industrial “strategic projects” to modernise and improve manufacturing capacity. It calls for an EU coordination mechanism for national stockpiles and contingency stocks of critical medicines to better anticipate and manage shortages. It also empowers the Commission to decide, as a last resort, on redistributing medicines from one national stockpile to other countries during shortages or supply disruptions.
The proposed regulation aims to reduce dependencies and bolster EU resilience, particularly for medicines and active ingredients with few supplying manufacturers or countries. It complements existing proposals to address medicine shortages, especially the 2023 pharmaceutical reforms.
The Commission adopted the proposal on 11 March 2025. The Parliament, Council and Commission will now enter informal trialogue negotiations under the ordinary legislative procedure. After formal adoption, the regulation will enter into force upon publication in the Official Journal.
European Commission consultation on targeted revision of medical devices and in vitro diagnostics regulations
The European Commission is consulting on a targeted revision of the EU medical devices regulation (MDR) and in vitro diagnostic medical devices regulation (IVDR) following challenging implementation since 2021-2022. Limited notified body capacity, demanding requirements and insufficient manufacturer preparedness have led to risks of device shortages, resulting in transitional periods being extended multiple times with deadlines now ending between December 2027 and 2029.
The initiative aims to reduce administrative burden, enhance predictability and cost-efficiency of certification processes, make conformity assessment requirements more proportionate especially for low- and medium-risk devices, and streamline governance procedures. The Commission expects the changes to reduce burden on manufacturers while preserving high levels of public health and patient safety. The consultation closes on 9 March 2026.
Defra has published the UK’s first-ever plan for PFAS (per- and poly-fluoroalkyl substances) to combat “forever chemicals” – persistent substances used in manufacturing and low-carbon technologies that pose long-term environmental and health risks.
Measures include:
The PFAS plan includes actions taking place throughout 2026 and 2027, with several milestones extending to 2028. The Environment Agency’s PFAS prioritisation map will be available to public sector bodies by the end of 2026, with an interactive website developed by the end of 2027. UK Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) reforms to align with the EU and closest trading partners are targeted for completion by December 2028 along with comprehensive assessment of PFAS contamination in coastal environments by February 2028.
While the government’s plan to start tackling PFAS is to be welcomed, the UK is still some way behind the EU in addressing the problem. The EU has already named or restricted the most harmful PFAS and the European Chemicals Agency is assessing a proposal to ban a further 10,000 different PFAS.
The UK plan sets out broad intentions which includes to understand sources, tighten controls and reduce exposure, but it lacks definitive timelines and does not yet set out how the wider regulatory framework will be shaped.
For businesses, this is a clear reminder that PFAS risk is only moving in one direction. Now is the time to map where PFAS appears in operations and supply chains and to start planning for incoming regulatory changes.
UK government grants partial exclusion for Welsh DRS scheme under UK Internal Market Act
Following the Welsh government’s November 2025 announcement that it was seeking exclusion from the UK Internal Market Act 2020 for its deposit return scheme (DRS), the UK government has now granted a partial exclusion for single-use glass bottles in Wales, to be implemented in legislation at the earliest opportunity.
The exclusion is conditional on Wales committing to launch its DRS for plastic and metal drinks containers on 1 October 2027, ensuring the scheme meets key interoperability criteria with UK-wide schemes (including a single registration and reporting system, reciprocal takeback, consistent logos and the same deposit level), and extending the transitional period for single-use glass to October 2031. During this transitional period, a 0p deposit will apply and no labelling requirements or targets will be in force, providing industry with additional lead-in time.
A joint taskforce will be established under the Resources and Waste Common Framework to oversee interoperability and support smooth implementation of DRS across the UK. The UK government has not agreed an exclusion for Welsh reuse policy at this stage, as the policy remains under development.
Other nations not including glass in their DRS poses the risk of creating a patchwork of rules that is confusing and costly for businesses operating across the UK. It has recently been reported that industry bodies are already commenting on the issues this would cause for businesses and the impact on market access, noting that stock may need to be labelled as “not for sale in Wales”. Businesses should keep abreast of developments on this and start preparing now for the 2027 launch and the planned inclusion of glass in Wales in 2031.
Extended producer responsibility for packaging: new guidance on mergers and transfers of ownership
Defra has published guidance on how mergers and transfers of ownership affect companies registered for extended producer responsibility (EPR) for packaging. The guidance applies when at least one of the companies involved was already registered for EPR.
For mergers, if any of the merged companies was a large producer, the new company is treated as a large producer for the year of the merger and the following year. The new company must register for EPR by the later of the earliest date any merged company would have had to register, or 28 days after the merger. The new company is responsible for all waste disposal fees and administration fees for the assessment year starting 1 April in the year of the merger, including any unpaid fees from previous years.
For transfers of ownership of a brand or business, the new owner must notify the regulator within 28 days and register (or re-register as a large producer if applicable) by the later of the previous owner’s registration deadline or 28 days after the transfer. In the year of transfer and the following two years, adjusted turnover and packaging tonnage figures apply when determining large or small producer status. If the previous owner was a large producer, both parties must submit or resubmit packaging data for four reporting periods covering the 18 months before and after the transfer.
This guidance is important for businesses undergoing corporate restructuring or acquisitions, as failure to notify the regulator and meet adjusted registration deadlines within the specified timeframes could result in non-compliance with EPR obligations and potential enforcement action.
UK packaging producer responsibility monitoring plan 2026
The Environment Agency has published its monitoring plan for 2026 setting out how it will monitor compliance with the Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024 in England. The plan covers producers (including online marketplaces), compliance schemes, reprocessors and exporters.
For producers, the Environment Agency will validate and assess all information and data submitted at registration and each reporting period, monitor progress against recycling obligations, and identify unregistered producers (drop offs and free riders) to bring them into compliance. The agency may carry out additional compliance monitoring including site visits or remote auditing throughout the year. For compliance schemes, monitoring includes assessing submissions, monitoring progress against recycling obligations and risk profiling.
The agency follows an intelligence-led and risk-based approach focusing on businesses posing the biggest risks to the packaging regime and the environment. Where non-compliance is identified, it will work with businesses to bring them into compliance, using enforcement powers where necessary based on the severity of non-compliance, attitude of the offender, and risk posed to the environment and packaging regime. Monitoring activities are funded through cost recovery charges set out in the packaging regulations.
Welsh government lays draft regulations amending waste separation requirements
On 27 January 2026, the Welsh government laid the draft Waste Separation Requirements (Wales) (Amendment) Regulations 2026 before the Senedd, coming into force on 6 April 2026. The draft regulations amend the Waste Separation Requirements (Wales) Regulations 2023, which require non-domestic premises (businesses and public sector bodies) to separate certain recyclables for collection.
The key changes are:
The Welsh government has also laid a draft code of practice providing statutory guidance on the separation requirements, reflecting these amendments. The draft code, consulted on in July 2025, will be finalised once the amendment regulations are made. Those operating in Wales should review these changes ahead of them coming into force.
UK REACH – government response to extension to submission deadlines
On 22 December 2025, Defra published the government response to its July 2025 consultation on proposals to further extend the deadlines for submitting registration information on chemicals to the HSE in the transition from the EU REACH to the UK REACH chemicals regime.
The government has confirmed that it will introduce legislation to:
The government intends to make the legislation in 2026, although the consent of Scottish and Welsh ministers will first be required.
Welsh government consultation on combatting on-the-go packaging waste in Wales
ESPR – delegated regulation setting out derogations on ban of destruction of unsold apparel and footwear
On 9 February 2026, the EU adopted a new delegated regulation under the Ecodesign for Sustainable Products Regulation (ESPR) which sets out the specific circumstances where destruction will still be permitted.
From 19 July 2026, large companies will be prohibited from destroying certain unsold consumer products, specifically unsold apparel, clothing accessories and footwear.
The delegated regulation outlines specific circumstances under which destruction will still be permitted. These include products:
Economic operators must keep documentation for five years after an unsold consumer product subject to a derogation has been destroyed. Examples of this documentation could include: a self-assessment statement that indicates the type of the non-compliance and the applicable Union or national law; where the product is damaged or unfit for purpose, evidence of detailed quality assessment procedures or inspection records; or evidence of the offer for donation.
Businesses will need to review these derogations to ensure they understand what will be excluded from the prohibition that takes effect in July.
ESPR – implementing regulation introducing report format for disclosure requirements of destruction of unsold apparel and footwear
The European Commission has also published the implementing regulation setting out the standardised format for the report on the destruction of unsold consumer products. The format set out in the implementing act will become applicable from February 2027. Information and documentation of discarded unsold products, showing their delivery and reception, including statements from waste treatment operators on the reception and treatment of those products, must be kept for five years. Further, the regulation sets out that the disclosure of information on discarded unsold consumer products does not cover donated products.
The rules on disclosure under the ESPR already apply to large companies. The first disclosure must cover unsold consumer products discarded during the first full financial year after the ESPR entered into force. It entered into force on 18 July 2024, meaning if a company’s financial year runs from 1 January-31 December, it will need to collect its FY 2025 data. This then needs to be reported in the following FY, for this example this would be FY26. Therefore, businesses need to ensure they have collected the relevant data and are ready to report on it.
Businesses should note that while the ban on destruction of unsold consumer goods currently only applies to clothing and footwear, the disclosure obligations apply to all unsold consumer goods placed on the EU market.
European Commission publishes communication and package of measures to boost circular economy and plastic recycling
The European Commission published a communication on 23 December 2025, on accelerating Europe’s transition to a circular economy, focusing on plastic recycling, alongside a package of short-term measures to support the plastics recycling sector in response to declining capacity and international competition challenges. This represents the first step towards the Circular Economy Act, which the Commission will propose later in 2026 after its August 2025 consultation.
Measures include:
The Commission has also launched a consultation on the effectiveness of the Single-Use Plastics Directive ahead of its evaluation and possible scope expansion, closing on 17 March.
