Themes | Data & Technology | The Accountability Index

Biotech regulatory gaps

Absence of clear regulatory guidance from bodies like MHRA for genetically engineered (GE) phages and enzymes.

198 items 8 sources 1 inquiry
Source spread

Where this theme appears

This theme appears across 8 independent accountability sources, so the source mix matters as much as the headline total.

2 inquiry recs 5 PFD reports 173 committee recs 2 NAO recs 3 DHR recs 1 PHSO decision

Browse by source

Source-grouped records are useful for tracing where a concern came from. Large sections show the 50 strongest matches for that source; counts still show the full theme total.

8 sources
Inquiry recommendations(2)
Prevention of Future Deaths reports(5)
Victoria Meppen-Walter
27 Feb 2014 · Manchester (North)
Concerns: The coroner raised concerns regarding the availability and regulation of chloroquine, noting the associated risk of misuse.
Overdue
Bradley Cockel
09 Jun 2014 · Essex
Concerns: The coroner noted that a specific drug and some of its chemical compounds were not controlled by legislation at the time of death, with only a partial temporary ban enacted for some compounds later.
Overdue
Grand Canyon
18 Nov 2021 · West Sussex
Concerns: The coroner noted that current regulations do not mandate the fitting of Crash-Resistant Fuel Systems (CRFS) in all rotorcraft, particularly as a retrofit, increasing the risk of post-crash fires. There is also no central register to inform the public whether an aircraft is fitted with CRFS.
Response (Civil Aviation Authority): • The Civil Aviation Authority (CAA) reviewed UK rotorcraft accident data and held meetings with international policy teams. • The CAA is considering retrospective safety proposals for existing UK-registered rotorcraft, … (AI summary)
Response (Civil Aviation Authority): • The Civil Aviation Authority (CAA) stated it would continue to review UK aviation safety data and monitor related developments from EASA Rule Making Task (RMT).0710. • The CAA indicated … (AI summary)
Responded
Jack Knapman
16 Dec 2022 · Northamptonshire
Concerns: The coroner raises concerns about a lack of clarity regarding which government department will be responsible for monitoring and preventing the sale of DNP for human consumption once it is added to the Poisons Act. This lack of clarity could delay an effective response to advertisements for the substance.
Response (Home Office): • The Home Office laid legislation to regulate DNP as a poison under the Poisons Act 1972. • From 1st October 2023, DNP sales to the general public will be … (AI summary)
Responded
Abdul Oryakhel
25 Jun 2024 · Avon
Concerns: The coroner notes a lack of public understanding regarding the dangers of lithium-ion batteries in e-bikes and e-scooters. There are also no British or European standards to control the sale of these batteries and chargers in the UK.
Response (Department of Transport): • The Department for Transport, Home Office, and Office for Product Safety and Standards have published guidance for users on e-cycle and e-scooter battery safety. • Fire and Rescue Services … (AI summary)
Response (OPSS): • OPSS initiated a dedicated programme in early 2023 to address product safety issues in e-bikes and e-scooters, undertaking regulatory interventions and publishing safety information. • OPSS commissioned a research … (AI summary)
Response (West of England Combined Authority): • The Combined Authority's contractor paused the long-term rental service for e-scooters, citing reassessed risks associated with users charging vehicles at home. • The Combined Authority continues to participate in … (AI summary)
Responded
Select committee recommendations(173)— showing 50 strongest matches
#33 — Phage therapy shows AMR promise but faces significant clinical, licensing, and testing barriers.
Public Accounts Committee
Recommendation: Another area of research interest is phage therapy, which involves using viruses as antimicrobials to kill bacteria and is less likely to lead to resistance.84 Dr Partridge told us that in his view phage therapy holds great promise as a …
Response attribution not verified
#9 — Continue implementing Precision Breeding Act and seek exemption in EU SPS negotiations
Environment, Food and Rural Affairs Committee
Recommendation: The Government should continue implementing England’s Precision Breeding Act, actively progress regulatory procedures to bring precision bred plants to market, and seek a targeted exemption for precision breeding in negotiations with the EU on the SPS agreement. (Recommendation, Paragraph 34) …
Response attribution not verified
#8 — EU genomic technology framework delay undermines UK precision breeding advantage
Environment, Food and Rural Affairs Committee
Recommendation: The EU’s forthcoming new genomic technology (NGT) framework could take several years to be finalised, and waiting for alignment between the EU and UK on precision breeding would undermine England’s first-mover advantage and stall the development and release of PBOs. …
Response attribution not verified
#7 — Ensure new EU regulations for GB agriculture incorporate specific climatic and scientific data
Environment, Food and Rural Affairs Committee
Recommendation: The Government should ensure in negotiations that GB will only adopt new EU regulations on PPPs and mycotoxin limits where GB climate, growing conditions and scientific data have been fully considered in their development. It should seek assurances, as a …
Response attribution not verified
#6 — Legislative divergence risks inappropriate EU regulations for GB production systems
Environment, Food and Rural Affairs Committee
Recommendation: Legislative divergence between the UK and EU has occurred given the EU no longer considers GB-specific scientific evidence, such as climatic conditions relevant to mycotoxin formation or the agronomic need for certain plant 34 protection products (PPPs). As such, full …
Response attribution not verified
#36 —
Environmental Audit Committee
Recommendation: New technologies can help to reduce the climate impacts of food production, prevent waste, and grow certain foods domestically for which the UK over-relies on imports. We agree with the Government that this is an exciting area. However, it is …
Response attribution not verified
#27 —
Environmental Audit Committee
Recommendation: The Government should consult on mandatory PFAS disclosures across supply chains within six months, requiring manufacturers and importers to report the presence and purpose of PFAS in products placed on the UK market to support safe handling and disposal. (Recommendation, …
Response attribution not verified
#22 —
Environmental Audit Committee
Recommendation: Whilst PFAS-containing consumer products remain on the market, the Government should introduce interim limits on PFAS levels and require standardised labelling to ensure consumers are fully informed. Implementation should be led by the Department for Environment, Food and Rural Affairs, …
Response attribution not verified
#21 —
Environmental Audit Committee
Recommendation: The Government should set limits on the levels and types of PFAS permitted in food, giving producers, retailers, and regulators a consistent basis for protecting public health. This should include establishing and monitoring 45 limits on PFAS entering the food …
Response attribution not verified
#17 —
Environmental Audit Committee
Recommendation: The Government should invest in long-term research on the health effects of PFAS exposure in the UK population. Within 12 months, it should publish a delivery plan setting out epidemiological studies to assess the cumulative impact of multiple PFAS and …
Response attribution not verified
#16 —
Environmental Audit Committee
Recommendation: While gaps remain in understanding the toxicity of every individual PFAS, the evidence indicates that several PFAS are associated with a wide range of adverse health effects. Studies of highly exposed groups show clearer and more immediate risks, underscoring the …
Response attribution not verified
#15 —
Environmental Audit Committee
Recommendation: The Government should consult on the establishment of an industry-funded mechanism to rapidly assess the properties and risks of newly developed PFAS before they are permitted for use, and invest in the development of 44 safer alternatives. This mechanism should …
Response attribution not verified
#14 —
Environmental Audit Committee
Recommendation: The Government should draw on independent scientific and regulatory expertise in taking a group-based approach for PFAS regulation within three months of the EU’s forthcoming assessment. This should include assessing options for grouping PFAS with similar structures, so that future …
Response attribution not verified
#13 —
Environmental Audit Committee
Recommendation: Without a broad, group-based restriction on PFAS, the Government risks a “whack-a-mole” approach. (Conclusion, Paragraph 56)
Response attribution not verified
#12 —
Environmental Audit Committee
Recommendation: Due to the impracticality of assessing thousands of PFAS one by one, and the risk that new substances emerge faster than they can be evaluated, the UK’s current approach leaves regulators struggling to keep pace with industry innovation. While the …
Response attribution not verified
#11 —
Environmental Audit Committee
Recommendation: Replacing one PFAS with another can perpetuate long-term environmental and health risks and can lead to regrettable substitutions, whereby banned substances are rapidly replaced by chemically similar and potentially harmful alternatives. (Conclusion, Paragraph 54)
Response attribution not verified
#10 —
Environmental Audit Committee
Recommendation: The Government should commission the Health and Safety Executive under UK REACH to bring forward restrictions on PFAS in non-essential consumer products (e.g. food packaging, cookware and school uniforms) without delay and begin a phased restriction from 2027. (Recommendation, Paragraph …
Response attribution not verified
#9 —
Environmental Audit Committee
Recommendation: The Government should adopt an essential-use approach to regulating PFAS, prioritising the rapid restriction of PFAS in non-essential applications. Clearly defined exemptions should be set for essential uses, with time-limited derogations where substitutes are still being developed. (Recommendation, Paragraph 46)
Response attribution not verified
#8 —
Environmental Audit Committee
Recommendation: The Government should reform UK REACH by March 2027 to avoid further delay in restricting PFAS. The Government should set targets at half the statutory maximum timescales and ensure that the Health and Safety Executive has the resources to meet …
Response attribution not verified
#7 —
Environmental Audit Committee
Recommendation: UK REACH must be reformed to enable swifter restrictions on PFAS to ensure the UK can align with emerging evidence to act more quickly on substances of concern. (Conclusion, Paragraph 37)
Response attribution not verified
#1 —
Environmental Audit Committee
Recommendation: PFAS are highly persistent, bioaccumulative chemicals with the potential for long-term environmental and human harm, despite ongoing scientific uncertainties around the toxicity of different PFAS. (Conclusion, Paragraph 22)
Response attribution not verified
#16 —
Science and Technology Committee (Commons)
Recommendation: The Government should consider requiring any manufacturer making genomic tests available to consumers in the UK to register a legal representative in the UK, with responsibility for ensuring that products supplied to consumers in the UK meet all relevant UK …
Response attribution not verified
#3 —
Science and Technology Committee (Commons)
Recommendation: Most manufacturers of genomic tests sold directly to consumers can self-certify the conformity of their products to performance requirements. The Medicines and Healthcare products Regulatory Agency has suggested that this restricts its ability to ensure that genomic tests on the …
Response attribution not verified
#1 —
Science and Technology Committee (Commons)
Recommendation: A range of benefits and concerns have been raised regarding the availability of genomic testing for direct purchase and use by consumers. These apply to all types of genomic tests, but are arguably most acute for tests used for medically-related …
Response attribution not verified
#2 —
Public Accounts Committee
Recommendation: The Department and regulators have been slow to follow best practice in facilitating innovation. The Government’s 2019 White Paper ‘Regulation for the 4th Industrial Revolution’ found that only 29% of businesses believed that government’s approach to regulation facilitates innovation. The …
Response attribution not verified
#18 — Commission ONR to develop proposals for a replacement methodology to SUPDC.
Energy Security and Net Zero Committee
Recommendation: The Government should commission the Office for Nuclear Regulation to develop proposals for a replacement methodology to SUPDC. The ONR could consider the risks posed by different nuclear technologies, recognising that some novel technologies may pose greater or lesser risks …
Response attribution not verified
#7 — Urgently move psychedelic drugs to Schedule 2 to facilitate medical research.
Home Affairs Committee
Recommendation: We welcome the UK Government’s commitment to reducing barriers to researching psychedelic drugs under Schedule 1 to the 2001 Regulations. Pending the outcomes of the ACMD’s ongoing review of Schedule 1 controlled drugs, we recommend the UK Government urgently moves …
Response attribution not verified
#28 —
Environmental Audit Committee
Recommendation: To achieve the diversity needed for a resilient food system, the UK must produce food through a variety of different farming methods spanning a spectrum from a return to more traditional methods, to agroecology, to the latest in cutting edge …
Response attribution not verified
#18 —
Environment, Food and Rural Affairs Committee
Recommendation: As part of reform of the Veterinary Surgeons Act, the government should separate the RCVS’s professional leadership role from any regulatory functions within the veterinary profession, creating a new independent body that can oversee the expanded role of a reformed …
Response status not verified
#17 —
Environment, Food and Rural Affairs Committee
Recommendation: In professions such as medicine and law, regulatory functions have been separated from professional bodies, with oversight vested in independent regulators. Self-regulation is increasingly unsuitable for a profession where vet practices and services are coming under the ownership of corporate …
Response status not verified
#14 —
Environment, Food and Rural Affairs Committee
Recommendation: Reform of the Veterinary Surgeons Act 1966 (VSA) presents an important opportunity to modernise regulation, support a more flexible workforce, and strengthen public confidence. Reform is clearly needed, but it must be carefully designed, with clear definitions of roles and …
Response status not verified
#38 —
Environmental Audit Committee
Recommendation: The Government must commit, within six months, to funding the research and development of non-incineration PFAS destruction technologies through UK Research and Innovation and Innovate UK. (Recommendation, Paragraph 125) 48
Response attribution not verified
#37 —
Environmental Audit Committee
Recommendation: The Government should assess the volume of PFAS containing waste expected from forthcoming restrictions and determine whether UK high- temperature incineration capacity is sufficient. The Government should write to the Committee with its findings and proposed actions within six months. …
Response attribution not verified
#36 —
Environmental Audit Committee
Recommendation: PFAS contamination cannot be addressed without reliable destruction capacity. Current UK incineration capacity is insufficient to treat the increasing volume of PFAS containing waste diverted from landfill, and significant gaps remain in the availability, scalability, and verification of other destruction …
Response attribution not verified
#35 —
Environmental Audit Committee
Recommendation: The Government must publish formally approved guidance for PFAS remediation to provide businesses, local authorities and regulators with the certainty needed to deliver timely, safe and effective remediation. (Recommendation, Paragraph 116)
Response attribution not verified
#34 —
Environmental Audit Committee
Recommendation: The Government should support the development and deployment of scalable, cost-effective PFAS remediation technologies by directing investment through UK Research and Innovation into research, innovation and practical support. (Recommendation, Paragraph 115)
Response attribution not verified
#33 —
Environmental Audit Committee
Recommendation: Industry urgently needs clear direction and Government approval on viable remediation methods so that contaminated materials can be treated safely and at scale. (Conclusion, Paragraph 114)
Response attribution not verified
#32 —
Environmental Audit Committee
Recommendation: Existing PFAS contamination in the environment must be addressed alongside prevention. Even with strong restrictions on future PFAS use, the UK already faces significant legacy contamination. Without action now, this legacy burden will pose long-term risks to public health and …
Response attribution not verified
#31 —
Environmental Audit Committee
Recommendation: The Government should apply the polluter pays principle to prevent ongoing and historic PFAS contamination and consult by March 2027 on establishing a national PFAS Remediation Fund. The Government should: • explore the implications of an emissions levy for PFAS …
Response attribution not verified
#30 —
Environmental Audit Committee
Recommendation: The Government has not applied the polluter pays principle adequately to deter future PFAS emissions nor has it allocated sufficient government funding to tackle the remediation of PFAS in the environment where liable parties cannot be identified. (Conclusion, Paragraph 107)
Response attribution not verified
#29 —
Environmental Audit Committee
Recommendation: Remediating PFAS contamination in the environment is expensive and technically complex. The current regulatory approach that permits continued use of PFAS until harm is proven means that these substances can legally continue to accumulate in the environment, steadily increasing the …
Response attribution not verified
#28 —
Environmental Audit Committee
Recommendation: The Government must set out in its response a timeline to divert PFAS waste from landfill towards safer treatment or destruction technologies to manage increasing volumes of PFAS waste without causing further environmental contamination. (Recommendation, Paragraph 95)
Response attribution not verified
#26 —
Environmental Audit Committee
Recommendation: Lack of supply chain transparency fundamentally undermines the UK’s ability to manage PFAS at end-of-life, leaving councils, waste operators and regulators unable to prevent products with PFAS entering landfill, and leading to further pollution of waterways, soil and the wider …
Response attribution not verified
#24 —
Environmental Audit Committee
Recommendation: The Government should provide full detail, in its response, on how its PFAS monitoring strategy will support enforcement and remediation. This should include a clear explanation of how monitoring results will be used to identify risks, guide remediation activity, and …
Response attribution not verified
#23 —
Environmental Audit Committee
Recommendation: Whilst the PFAS Plan sets out monitoring commitments, it lacks the specificity needed to inform and deliver action. Without clear requirements on what to monitor, the methods to use, and the thresholds for concern, and without adequate funding and laboratory …
Response attribution not verified
#20 —
Environmental Audit Committee
Recommendation: Although the Government has begun setting statutory limits for PFAS in drinking water, which is a welcome step, significant gaps remain in managing and limiting human exposure to PFAS through food and agricultural pathways. (Conclusion, Paragraph 76)
Response attribution not verified
#6 —
Environmental Audit Committee
Recommendation: The Government should make use of existing EU-UK dialogue mechanisms to support UK alignment with EU REACH to avoid unnecessary regulatory divergence. Whilst UK Government may choose a different approach in some areas, without such alignment, UK manufacturers risk accidentally …
Response attribution not verified
#5 —
Environmental Audit Committee
Recommendation: UK REACH, in its current lagging and slow-moving form, risks leaving the UK behind international best practice and limits the Government’s ability to respond swiftly to emerging scientific evidence on PFAS. This increases the likelihood of further regulatory divergence between …
Response attribution not verified
#4 —
Environmental Audit Committee
Recommendation: The Government must act in line with the environmental principles, taking preventative and precautionary action to reduce cumulative PFAS exposure to both people and the environment. We expect the Government to set out in its response how its approach to …
Response attribution not verified
#3 —
Environmental Audit Committee
Recommendation: Voluntary action on PFAS and self-regulation by industry are not sufficient to ensure transparency, accountability or reduce PFAS emissions. (Conclusion, Paragraph 24)
Response attribution not verified
NAO audit recommendations(2)
Independent reviews(11)
Keogh Cosmetic Interventions Review — Rec 19
Manufacturers should inform the MHRA when bringing a new product to the UK market and the MHRA should publish a list of the cosmetic devices available in the UK.
Health & Social Care
Keogh Cosmetic Interventions Review — Rec 16
The EU General Product Safety Directive (GPSD) should be revised so that products used as part of a professional service are no longer exempt from product safety legislation.
Health & Social Care
Keogh Cosmetic Interventions Review — Rec 15
The scope of the EU Medical Devices Directive should be extended to cover all cosmetic implants, including all dermal fillers. UK legislation should be introduced to make fillers a prescription only medical device.
Health & Social Care
Goldacre Review — Rec Open 12
The Medicines and Healthcare products Regulatory Agency should address code sharing and device regulation It is not practical or useful that there should be conflict - or perceived conflict - between code sharing and medical device regulations. The Medicines and Healthcare products Regulatory Agency (MHRA) should deliver absolute clarity to …
Health & Social Care
O'Neill AMR Review — Rec 10
Build a global coalition for real action – via the G20 and the UN 10.1 The G20 group of countries should take leadership on defined aspects of the global response to AMR, particularly work to develop and implement new incentive models to support the development of new antibiotics, diagnostics and …
Health & Social Care
O'Neill AMR Review — Rec 9
Better incentives to promote investment for new drugs and improving existing ones 9.1 Institute a system of 'market entry rewards' to provide lump-sum payments to the successful developers of new antibiotics that meet a specified unmet medical need. In principle, this should be administered and funded on a supra‑national basis, …
Health & Social Care
O'Neill AMR Review — Rec 8
Establish a Global Innovation Fund for early-stage and non-commercial research 8.1 Governments, and public and philanthropic research funding organisations, to collaborate on a global basis to develop a Global Innovation Fund for R&D into new antimicrobials and other related products (including vaccines and diagnostics.) This fund should build on existing …
Health & Social Care
O'Neill AMR Review — Rec 5
Promote new, rapid diagnostics to cut unnecessary use of antibiotics 5.1 In high-income countries, governments, regulators and other health system leaders to support the uptake and use of rapid point-of-care diagnostics in primary and secondary care. Incentives should be considered in high-income countries to facilitate the mandatory use of such …
Health & Social Care
Keogh Cosmetic Interventions Review — Rec 18
There needs to be unannounced inspections of manufacturers of class III and IIb medical devices to ensure production is compliant with the regulations. Reports of such inspections should be made public where possible.
Health & Social Care
O'Neill AMR Review — Rec 6
Promote the development and use of vaccines and alternatives 6.1 Promote the uptake and use of existing vaccines more widely in humans and animals to save lives and reduce unnecessary antibiotic use, including through the work of Gavi or by initiating comparable new initiatives. 6.2 Sustain a viable market for …
Health & Social Care
O'Neill AMR Review — Rec 3
Reduce unnecessary use of antimicrobials in agriculture and their dissemination into the environment 3.1 The G20 and UN, with input from the WHO, FAO and OIE, should lead urgent global efforts to improve the collection and use of surveillance data regarding the use of antibiotics in agriculture, and the emergence …
Health & Social Care
PHSO casework decisions(1)
Domestic Homicide Reviews(3)
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