Instruments of interest
Draft Aviation Safety (Amendment) Regulations 2024
25.These draft Regulations propose amendments to bring UK aviation safety legislation into alignment with certain International Civil Aviation Organization (ICAO) Standards and Recommended Practices (SARPs), as well as to make corrections. The Regulations would allow commercial air transport operators to use more advanced and efficient fuel planning schemes, aimed at saving fuel and reducing carbon emissions. They would also permit the use of new technology and operational procedures to support take-off and landing under low visibility (all weather operations), to improve safety and increase the resilience of the UK aviation sector during poor weather. Finally, the Regulations would improve mandatory crew training and checking requirements for air operators. The Department for Transport (DfT) expects uptake of advanced fuel planning schemes to be significant, achieving annual net savings to businesses of £7.6 million.
26.We asked the DfT how long the UK has not been aligned with these specific ICAO SARPs; it responded that this varied between 4-12 years, and that although no risks to safety have arisen from the misalignment, UK operators have been at a competitive disadvantage, particularly with EU member states since the EU implemented these standards in 2022. Where a member of the ICAO does not comply with SARPs, it must file a difference. The DfT told us that the UK currently has differences filed against approximately 9% of SARPs, though the majority of these are due to either alignment being in progress, legacy differences inherited from retained EU regulations, the UK having set higher requirements, or the standards not being applicable to the UK. The Department assured us it meets baseline standards and is prioritising implementation based on UK interests, and that outside of the ICAO SARPs, there are no other international agreements relating to aviation safety that the UK has not fully integrated into domestic law.
27.The Civil Aviation Authority (CAA) ran a public consultation on the changes in 2023. The Explanatory Memorandum (EM) notes that the consultation responses were ‘generally supportive’, and outlines some of the points raised by consultees and considered by the CAA. We regret that the full consultation response was not published until two weeks after the instrument was laid.7 Although the consultation outcome was summarised in the EM and the response has now been published, we reiterate that responses to consultations ought to be published alongside the instrument being laid to aid Parliamentary scrutiny, as the Government’s own guidance states.8
Draft Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024
28.These draft Regulations establish a new regulatory framework for medicines manufactured at the point of care (POC) and via modular manufacturing (MM), which is manufacturing in small, portable units. These medicines typically have a very short shelf-life, may be highly personalised and need to be manufactured close to the patient in hospital or community settings. The Medicines and Healthcare products Regulatory Agency (MHRA) says that the current regulatory approach, which is designed for centralised factory-based manufacture, needs adapting for the manufacture of these innovative products and that consultation highlighted strong support for a new framework.
29.A ‘hub and spoke’ model, based on the long-established regulatory approach for the manufacture of blood-derived medicinal products, will name a single control site on the manufacturing licence which will act as the hub for each product. The control site will be subject to routine inspections by the MHRA and will oversee multiple individual manufacturing spoke locations and their activities, ensuring compliance with existing internationally aligned standards for quality, safety and efficacy.
30.According to the MHRA, this new framework tailored for the regulation of products manufactured at the POC will be the first of its kind in the world. Whilst there are currently no POC or MM products on the market, some are at the early stages of clinical trials and the MHRA expects them to become available in “a few years”. Initially, only a small number of patients are expected to benefit from these products, but the MHRA estimates annual benefits to manufacturers of £3.3 million per year on average and says that the new framework “offers a route for manufacturing of innovative and ground-breaking therapeutics that will become available”. The National Institute for Health and Care Excellence (NICE) was consulted throughout the development of the framework and did not raise any concerns; it is expected that NICE will appraise POC and MM products in the same way as other medicines.
Draft Medical Devices (Post-Market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024
31.The instrument proposes stricter post-market surveillance (PMS) requirements for medical devices placed on the market in Great Britain. Medical devices cover a wide range of products such as joint replacement systems and surgical mesh as well as diagnostic devices such as MRI machines. PMS activities involve manufacturers collecting and analysing performance and safety data for medical devices in operation. The changes are being brought forward in response to the Independent Medicines and Medical Devices Safety (IMMDS) Review, which highlighted a need for more robust PMS and better data to minimise risks to patient safety.9 Currently, there are only high-level PMS requirements in legislation which apply only to UKCA (UK Conformity Assessed) marked devices. This has resulted in inconsistencies in how manufacturers perform PMS and impacted the quality of data reported to the Medicines and Healthcare products Regulatory Agency (MHRA).
32.The instrument will increase the scope of devices that must comply with PMS requirements, including CE (European Conformity) marked devices, which make up an estimated 91% of devices registered with the MHRA. In developing these Regulations, the MHRA says it has “taken a pragmatic approach to alignment [with the EU], which prioritises patient safety while supporting global harmonisation across the UK medical device industry”. The regulation of medical devices is reserved and the devolved Governments have confirmed support for these Regulations. In Northern Ireland, EU regulations continue to apply to medical devices under the Windsor Framework.
33.The MHRA estimates benefits of £31 million from reduced medical device incidents over the next ten years. Manufacturers of medical devices face costs of approximately £310 million to set up and maintain PMS systems, though the MHRA say that CE marked devices already comply with similar EU PMS requirements. During the six-month implementation period, the MHRA will issue guidance and communications to manufacturers.
34.We asked the MHRA for an update on the implementation of other recommendations of the IMMDS Review. The MHRA replied:
“The MHRA is currently developing legislation that will bring further improvements to the safety of medical devices by introducing additional measures that must be taken before a product can be put on the market, including introducing unique device identifiers and implant cards, amongst other things.”
7 UK Civil Aviation Authority, ‘All Weather Operations and Fuel/Energy Planning and Management’ (5 November 2024): https://consultations.caa.co.uk/airworthiness-policy-team/all-weather-operations-fuel-energy-planning/ [accessed 5 November 2024].
8 Cabinet Office, Guide to Preparing Explanatory Memoranda (EMs) to Statutory Instruments (2024), p 13: https://assets.publishing.service.gov.uk/media/659fc26b3308d200131fbe32/2024_Guide_to_Preparing_Explanatory_Memoranda_.pdf [accessed 5 November 2024].
9 The Independent Medicines and Medical Devices Safety Review, First Do No Harm: the report of the Independent Medicines and Medical Devices Safety Review (8 July 2020): https://immdsreview.org.uk/downloads/IMMDSReview_Web.pdf [accessed 30 October 2024].