Asked by: Stephen Morgan (Labour - Portsmouth South)
Question to the Department for Environment, Food and Rural Affairs:
To ask the Secretary of State for Environment, Food and Rural Affairs, what steps his Department is taking to prepare for another potential outbreak of bovine spongiform encephalopathy in the UK.
Answered by Mark Spencer - Minister of State (Department for Environment, Food and Rural Affairs)
The measures to be followed in the event of suspicion of BSE are set out in UK legislation, and the Animal and Plant Health Agency (AHPA) are well prepared to carry out the necessary actions. In the rare event that BSE is suspected, whole farm movement restrictions are applied by APHA who then trace cohorts (animals that shared feed with the affected animal during its first year of life) and any of its offspring born in the last two years.
In the event of the suspect case testing positive for BSE, its cohorts and offspring are then humanely culled, samples are taken from the brain stem for testing and the carcases are then destroyed, with the owners of the culled animals receiving compensation. While it not believed that BSE can be transmitted by mother to offspring during pregnancy ('vertical transmission') these animals are culled, along with cohorts, on a precautionary basis.
The APHA also carry out a rolling national feed audit which inspects and takes samples at various stages of the animal feed chain. This includes checks for prohibited processed animal proteins in samples of feeding stuffs intended for farmed animals. If feed is non-compliant, APHA inspectors look at the cause of contamination and make a decision based on the risk. Depending on the severity, feed may have to be removed from the market, and cattle exposed to it may be restricted or killed.
We remain vigilant to the threat posed by BSE and have a comprehensive surveillance programme in place to monitor the level of BSE over time and check on the continued effectiveness of our BSE controls. More detail on this is set out in Defra’s latest TSEs annual report here:
https://www.gov.uk/government/publications/monitoring-programme-for-tses-annual-report-2021-and-2022.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they intend to have any discussions with the National Institute for Health and Care Excellence about employing additional flexibility for rare condition medicines to take into consideration the implications of having a small population and potentially more expensive medicines.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department regularly meets with the National Institute for Health and Care Excellence (NICE) to discuss a range of issues including access to and availability of medicines. NICE’s methods and processes for health technology evaluation have been proven to be suitable for medicines for rare diseases where companies price their products responsibly, and NICE introduced a number of changes to its methods and processes in 2022 that ensure that its processes are appropriate to the evaluation of emerging new technologies.
NICE also operates a highly specialised technologies programme for the evaluation of a small number of medicines for the treatment of very rare diseases. As of 31 March 2024, NICE has recommended 88% of medicines licensed for the treatment of rare diseases for some or all of the eligible patient population, which is comparable to NICE’s approval rate for all medicines.
The Innovative Medicines Fund, building on the success of the Cancer Drugs Fund, provides a mechanism for consistent and transparent managed access process for companies offering promising non-cancer medicines at a responsible price. The Fund has already provided early access for National Health Service patients to several innovative new treatments, including for patients with rare diseases such as graft-versus-host disease and Wolman disease.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they plan to hold discussions with the National Institute for Health and Care Excellence about its appraisal system to ensure it is sufficiently flexible to respond to treatments and medicines for rare diseases.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department regularly meets with the National Institute for Health and Care Excellence (NICE) to discuss a range of issues including access to and availability of medicines. NICE’s methods and processes for health technology evaluation have been proven to be suitable for medicines for rare diseases where companies price their products responsibly, and NICE introduced a number of changes to its methods and processes in 2022 that ensure that its processes are appropriate to the evaluation of emerging new technologies.
NICE also operates a highly specialised technologies programme for the evaluation of a small number of medicines for the treatment of very rare diseases. As of 31 March 2024, NICE has recommended 88% of medicines licensed for the treatment of rare diseases for some or all of the eligible patient population, which is comparable to NICE’s approval rate for all medicines.
The Innovative Medicines Fund, building on the success of the Cancer Drugs Fund, provides a mechanism for consistent and transparent managed access process for companies offering promising non-cancer medicines at a responsible price. The Fund has already provided early access for National Health Service patients to several innovative new treatments, including for patients with rare diseases such as graft-versus-host disease and Wolman disease.
Asked by: Lord Oates (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what contingency planning, if any, they have conducted to anticipate the spread of tropical virus transmission to the United Kingdom.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The outbreak of an emerging infectious disease is a categorised risk, in the 2023 National Risk Register. Working closely with the Department and NHS England, the UK Health Security Agency (UKHSA) has a programme of work in place to plan and respond to this risk.
The UKHSA continues to monitor the global epidemiology of infectious diseases, to inform the assessment of risk to the United Kingdom’s population. Routine surveillance is carried out for a range of viral infections that may be acquired overseas. Data on some of these infections is published in the annual Travel-associated infections reports. Information collated from these various sources are routinely reviewed and assessed through the relevant UKHSA Horizon Scanning Group, with appropriate public health actions proposed to mitigate any threats.
The Rare and Imported Pathogens Laboratory has a small serological study, partnering with NHS Blood and Transplant and at-risk groups, to look for evidence of exposure to Usutu, West Nile, and tick-borne encephalitis viruses. The Medical Entomology and Zoonoses Ecology group study vector distribution, and look for the presence of tropical and other viruses in relevant arthropod species in an ongoing surveillance programme. The Animal and Plant Health Agency has a programme of surveillance in wild birds and mammals. The Department of Health and Social Care, the UKHSA, and the Department for Environment, Food and Rural Affairs published a national contingency plan for invasive mosquitoes that may spread vector-borne diseases, such as dengue, Zika and chikungunya.
Asked by: Toby Perkins (Labour - Chesterfield)
Question to the Department for Environment, Food and Rural Affairs:
To ask the Secretary of State for Environment, Food and Rural Affairs, how many hectares of plantations on ancient woodland sites have had licences granted for clearfell and replanting with non-native trees in the last five years.
Answered by Rebecca Pow - Parliamentary Under-Secretary (Department for Environment, Food and Rural Affairs)
The Forestry Commission is the regulator for the legal felling of trees in England under the provisions in the Forestry Act. Most felling licences issued require felled trees or areas of woodland to be replaced by replanting or allowed to regenerate. The exception to this is a thinning licence, where sufficient woodland cover is retained so as not to require restocking.
When considering a felling licence application the Forestry Commission will judge the proposals against the UK Forestry Standard, the government’s approach to sustainable forestry. This is available on GOV.UK at https://www.gov.uk/government/publications/the-uk-forestry-standard. This standard encompasses the impacts on biodiversity and recognises the importance of priority habitats and species. This is why a felling licence also includes advice and guidance on additional issues a landowner needs to take into account.
The restocking conditions in a felling licence are put in place to help meet the aims of the management of the site through good silvicultural practice. While the Forestry Commission does advise on a suitable species mix there are no provisions in the Forestry Act to mandate the source of trees and whether they are native or non-native.
The guide to Managing England’s woodlands in a climate emergency, advises to manage ancient woodlands in a manner which conserves important biodiversity and heritage features. Greater diversification of species and origin of stands is advised, with a focus on southerly provenances of native species. Due to the unknown nature of acceleration of climate change, management intervention may need to be more frequent in order to preserve these rare habitats effectively. This is available on GOV.UK at https://www.gov.uk/government/publications/managing-englands-woodlands-in-a-climate-emergency.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many prescriptions for amitriptyline, imipramine and atomoxetine were issued in each year since 2014; how many Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA has received for each of these drugs in each year since 2014; and whether they will ensure that persistent sexual dysfunction is listed as a side effect in the patient information leaflets for each these drugs.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Over the next year, the Medicines and Healthcare products Regulatory Agency (MHRA) plans to review the risk of sexual dysfunction and whether these side effects persist for all antidepressants marketed in the United Kingdom. As a result of the review product information will be updated, as necessary, and consideration will be given to whether additional risk minimisation measures are needed.
The following table shows the total number of items in each calendar year between 2014 and 2023, as well as January 2024:
Calendar Year | Amitriptyline Hydrochloride | Atomoxetine Hydrochloride | Imipramine Hydrochloride |
2014 | 11,851,704 | 118,843 | 174,731 |
2015 | 12,404,537 | 125,680 | 167,072 |
2016 | 12,943,138 | 130,731 | 164,645 |
2017 | 13,256,893 | 134,785 | 156,555 |
2018 | 13,532,567 | 138,160 | 150,526 |
2019 | 13,975,389 | 141,907 | 151,889 |
2020 | 14,468,134 | 146,346 | 137,284 |
2021 | 14,930,177 | 158,339 | 123,450 |
2022 | 15,226,816 | 174,894 | 115,360 |
2023 | 15,662,619 | 178,150 | 108,197 |
January 2024 | 1,370,670 | 15,334 | 9,072 |
Data Source: NHS Business Services Authority Open Data Portal, PCA data
The MHRA has received a total of 38 Yellow Card reports of sexual dysfunction related reactions suspected to be associated with amitriptyline, atomoxetine, and imipramine. Of these, 8 were for amitriptyline, 21 for atomoxetine, and 2 for imipramine.
‘Persistent sexual dysfunction’ does not represent a specific medical condition.
The following table shows a summary of these side effects listed in the product information:
| Common (may affect up to 1 in 10 people) | Uncommon (may affect up to 1 in 100 people) | Rare (may affect up to 1 in 1,000 people) |
amitriptyline | erectile dysfunction, libido decreased |
|
|
imipramine | disturbances of libido, impotency or abnormal ejaculation |
|
|
atomoxetine | libido decreased, ejaculation disorder, erectile dysfunction, male genital pain | Ejaculation failure | Priapism |
Asked by: Kim Leadbeater (Labour - Batley and Spen)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps she is taking to (a) support research for and (b) raise awareness of Ornithine Transcarbamylase Deficiency.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Department funds research into rare diseases such as ornithine transcarbamylase deficiency through the National Institute for Health and Care Research (NIHR). Over the last five years, NIHR infrastructure has supported 13 research awards on ornithine transcarbamylase deficiency. Raising awareness of rare diseases such as ornithine transcarbamylase deficiency among healthcare professionals is a priority of the 2021 UK Rare Diseases Framework, and the 2024 England Rare Diseases Action Plan.
Asked by: Andrew Lewer (Conservative - Northampton South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to support effective routes to market for precision medicines for (a) motor neurone disease and (b) other rare diseases in the UK.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
Should the Medicines and Healthcare products Regulatory Agency (MHRA) receive a marketing authorisation application (MAA) or applications, the MHRA will consider the drug with regards to quality, safety, and efficacy. The MHRA has procedures in place to consider drugs as part of an accelerated pathway. This is possible as part of national access collaboration, and international recognition. The MHRA would be able to consider motor neurone disease and other rare disease treatment products, under any of the procedures for the benefit of patients.
Asked by: Henry Smith (Conservative - Crawley)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to help improve genomics testing for bowel cancer patients.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
A National Health Service testing programme is helping to diagnose thousands of people with a genetic condition, Lynch Syndrome, that increases the chance of developing certain cancers including bowel cancer. The national programme ensures all people diagnosed with bowel cancer are offered genomic testing, with a diagnosis for Lynch Syndrome not only helping to guide more personalised cancer treatment but enabling their families and relatives to be offered testing too. Relatives who receive a diagnosis of Lynch Syndrome can be referred to genetic services to discuss regular testing options to help catch any cancers as early as possible, as well as to consider preventive options such as taking aspirin or undergoing risk-reducing surgery.
Genomic testing in the NHS in England is provided through the NHS Genomic Medicine Service (GMS) and delivered by a national genomic testing network of seven NHS Genomic Laboratory Hubs (GLHs). The NHS GLHs deliver testing as directed by the National Genomic Test Directory (NGTD) which outlines the full range of genomic testing offered by the NHS in England including tests for 3,200 rare diseases and over 200 cancer clinical indications, including both whole genome sequencing (WGS) and non-WGS testing. The NGTD sets out the eligibility criteria for patients to access testing as well as the genomic targets to be tested and the method that should be used, including testing for bowel cancer patients.
The NHS GMS cancer genomic testing strategy has facilitated a move to a consolidated laboratory network through the seven NHS GLHs delivering more extensive panel testing using cutting edge high throughput Next Generation Sequencing (NGS) technology. For patients, including those with bowel cancer, this technology enables testing for a larger number of genetic variations to give a more precise diagnosis, identify biomarkers to target treatment and opportunities to access innovative medicines, and can support enrolment into molecularly stratified clinical trials.
Testing is available for all eligible patients across the whole of England. Individuals should discuss with their healthcare professional (for example, their general practitioner or other healthcare professional if they are already being seen in a relevant service) whether genomic testing is appropriate for them. Their healthcare professional will then make a decision whether to refer the individual either directly or via an NHS clinical genomics service or other relevant clinical speciality for genomic testing following clinical review of their and their family’s medical history if known, and the relevant genomic testing eligibility criteria.
The 17 NHS Clinical Genomic Services (NHS CGSs), commissioned by NHS England, deliver a comprehensive clinical genomic and counselling service that directs the diagnosis, risk assessment and lifelong clinical management of patients of all ages and their families who have, or are at risk of having, a rare genetic or genomic condition. As part of the NHS CGS, the patient and their family will access diagnosis, and management relevant to their particular condition, but also receive support and guidance so that they are able to understand their condition, its implications, and their options in relation to reproduction, screening, prevention and clinical management.
Asked by: Peter Dowd (Labour - Bootle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when the National Institute for Health and Care Excellence next plans to review the entry criteria for its highly specialised technologies programme for the evaluation medicines to treat very rare diseases.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The National Institute for Health and Care Excellence plans to review the criteria for determining whether a medicine should be routed to its highly specialised technologies programme later this year.