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Written Question
Food Standards Agency
Tuesday 30th January 2024

Asked by: Daniel Zeichner (Labour - Cambridge)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent assessment she has made of the adequacy of the resources provided to the Food Standards Agency to assess food safety applications.

Answered by Andrea Leadsom - Parliamentary Under-Secretary (Department of Health and Social Care)

The Food Standards Agency regularly review their resources across the teams who are responsible for delivering the regulated products service and assessing food safety applications. The teams have expanded since they took over responsibility for the delivery of the service from the European Union in January 2021. However, as highlighted in their most recent Board paper in December 2023, resource pressure remains the main risk to their delivery timetables. In the short-term they are mitigating this risk through continuous improvements that enable the current system to work more efficiently within existing resources. In the longer-term they will bring forward plans for more fundamental reform to streamline the system and reduce the burden on applicants and the regulator, without compromising food safety.


Written Question
Rare Diseases: Drugs
Tuesday 23rd January 2024

Asked by: Daniel Zeichner (Labour - Cambridge)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment her Department has made of the potential impact of the (a) methods and (b) processes used by the National Institute for Health and Care Excellence on access to medicines for patients with rarer diseases since January 2022; and whether this assessment will be reflected in the next Rare Diseases Action Plan for England.

Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)

The National Institute for Health and Care Excellence (NICE) can recommend most rare disease medicines that it appraises through the technology appraisal programme for some or all eligible patients. NICE has no current plans to undertake a modular update of its methods and processes related specifically to rare diseases.

NICE specifically considered treatments for rare diseases during its methods review, and many of the changes introduced in NICE’s updated health technology evaluation manual in January 2022 will benefit treatments for rare diseases. These include the severity modifier, flexibility in uncertainty considerations and the emphasis on a comprehensive evidence base including real-world, qualitative, surrogate and expert evidence. These updates seek to mitigate the barriers faced by rare disease technologies while maintaining an evidence-based, robust and proportionate evaluation approach.

The 2022 England Rare Diseases Action Plan was published following the NICE methods and processes review. The 2022 Action Plan includes actions to capitalise on the changes made to NICE’s methods and processes to ensure that NICE continues to support the rapid adoption of effective new treatments for National Health Service patients with rare diseases. The impact of these changes is being assessed and an update will be provided in the 2024 England Rare Diseases Action Plan.


Written Question
National Institute for Health and Care Excellence: Rare Diseases
Tuesday 23rd January 2024

Asked by: Daniel Zeichner (Labour - Cambridge)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether she has had discussions with the National Institute for Health and Care Excellence on the case for a rarity modifier in its standard technology appraisal programme as part of its modular updates to its methods and processes.

Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)

The National Institute for Health and Care Excellence (NICE) can recommend most rare disease medicines that it appraises through the technology appraisal programme for some or all eligible patients. NICE has no current plans to undertake a modular update of its methods and processes related specifically to rare diseases.

NICE specifically considered treatments for rare diseases during its methods review, and many of the changes introduced in NICE’s updated health technology evaluation manual in January 2022 will benefit treatments for rare diseases. These include the severity modifier, flexibility in uncertainty considerations and the emphasis on a comprehensive evidence base including real-world, qualitative, surrogate and expert evidence. These updates seek to mitigate the barriers faced by rare disease technologies while maintaining an evidence-based, robust and proportionate evaluation approach.

The 2022 England Rare Diseases Action Plan was published following the NICE methods and processes review. The 2022 Action Plan includes actions to capitalise on the changes made to NICE’s methods and processes to ensure that NICE continues to support the rapid adoption of effective new treatments for National Health Service patients with rare diseases. The impact of these changes is being assessed and an update will be provided in the 2024 England Rare Diseases Action Plan.


Written Question
Drugs: Cost Benefit Analysis
Friday 19th January 2024

Asked by: Daniel Zeichner (Labour - Cambridge)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether her Department has had discussions with (a) HM Treasury and (b) the National Institute for Health and Care Excellence on the adoption of a discount rate of 1.5% when assessing the future (a) benefits and (b) costs of medicines to align with the guidance set out in the Green Book.

Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)

The Department of Health and Social Care has had a number of discussions with HM Treasury and the National Institute for Health and Care Excellence (NICE) about the discount rate used in the evaluation of medicines, including as part of the 2022 review of NICE’s methods and processes for health technology evaluation.

Through the methods review, NICE concluded that it was appropriate to maintain the reference case discount rate of 3.5% and has retained the flexibility in its methods for its committees to apply a lower non-reference case discount rate of 1.5% per year for both cost and health effects in exceptional circumstances. The decision on whether a non-reference case discount rate should be applied is taken by NICE’s Appraisal Committees.


Written Question
Meat
Monday 27th November 2023

Asked by: Daniel Zeichner (Labour - Cambridge)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the Food Standards Agency has made an assessment of the potential impact of changing the legal definition of wishbone meat.

Answered by Andrea Leadsom - Parliamentary Under-Secretary (Department of Health and Social Care)

There is no legal definition of wishbone meat. The Food Standards Agency has not made an assessment of the potential impact of introducing such a legal definition.


Written Question
Chronic Fatigue Syndrome: Research
Friday 17th November 2023

Asked by: Daniel Zeichner (Labour - Cambridge)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that funding for biomedical research into myalgic encephalomyelitis (ME) is adequate; and whether he plans to take steps to establish a centre of excellence on ME to (a) promote understanding of and (b) develop effective treatments for that illness.

Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)

The Department funds research through the National Institute for Health and Care Research (NIHR). The NIHR has provided around £4.4 million of programme funding for research on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) since 2011.

Through the NIHR, the Department has co-funded, with the Medical Research Council (MRC) a £3.2 million study called DecodeME into the genetic underpinning of ME/CFS. The study will analyse samples from 25,000 people with ME/CFS to search for genetic differences that may indicate underlying causes or an increased risk of developing the condition. This study aims to increase our understanding of the disease and therefore contribute to the research base on diagnostic tests and targeted treatments for ME/CFS.

The Department and the NIHR has no specific plans to establish a centre of excellence for ME research. The NIHR welcomes funding applications for research into any aspect of human health, including biomedical research for ME/CFS. These applications are subject to peer review and judged in open competition, with awards being made based on the importance of the topic to patients and health and care services, value for money and scientific quality. In all disease areas, the amount of NIHR funding depends on the volume and quality of scientific activity.


Written Question
Novel Foods
Thursday 16th November 2023

Asked by: Daniel Zeichner (Labour - Cambridge)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Answer of 12 December 2022 to Question 105459 on Food: Research, what progress the Food Standards Agency has made in developing dedicated guidance materials for alternative protein companies developing novel foods and processes; and when he plans to publish that guidance.

Answered by Andrea Leadsom - Parliamentary Under-Secretary (Department of Health and Social Care)

The Food Standards Agency (FSA) has prepared an information page for its website that will provide guidance to companies producing cell-cultivated products that wish to apply for regulatory approval. This will be published before the end of November 2023.

This page will outline information about the FSA’s regulated product application service, the regulations that apply to these cell-cultivated products, and information about labelling implications. Alongside this, the FSA has been providing pre-application support to businesses on an individual basis due to the novelty and complexity of this technology. This one-to-one engagement with business and industry has helped to inform and tailor our online guidance which will be available shortly.

The FSA is also considering producing additional regulatory guidance for alternative protein producers as part of its wider aim to support business innovation whilst ensuring that food is safe and what it says it is. In addition to this, a new UK Research and Innovation project was announced on 9 November 2023 that will work on new safety rules for the United States of America, Singapore, United Kingdom and the European Union with a focus on creating standards for cell-cultivated protein.


Written Question
Novel Foods: Regulation
Thursday 16th November 2023

Asked by: Daniel Zeichner (Labour - Cambridge)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to page 20 of his Department's food strategy white paper, published on June 2022, what his planned timetable is for when the Food Standards Agency will review the novel foods regulatory framework.

Answered by Andrea Leadsom - Parliamentary Under-Secretary (Department of Health and Social Care)

The Food Standards Agency (FSA) is committed to maintaining the United Kingdom’s high standards of food and feed safety whilst also working hard to support innovation across the food system. The FSA has a programme of continuous improvement and reform that has been in place since the launch of the Regulated Products Service in January 2021.

In June, the FSA published a summary of the findings of the review of the Novel Foods Regulatory Framework. Following this review, the FSA has focused resource to look at potential future options for more fundamental reform of the food and feed regulatory system. This has included surveying stakeholders across all regulated product regimes to gain their views on potential reforms.

The FSA is in the process of analysing this information to develop reform plans and will provide further detail on these, including timetables, at the public FSA Board meetings in the future.


Written Question
Novel Foods: Regulation
Thursday 16th November 2023

Asked by: Daniel Zeichner (Labour - Cambridge)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to his Department's food strategy white paper, published on June 2022, what steps the Food Standards Agency is taking to help food producers conduct (a) safe and (b) limited tastings of novel food products.

Answered by Andrea Leadsom - Parliamentary Under-Secretary (Department of Health and Social Care)

Under retained EU Regulation 2015/2283, a novel food is only deemed safe to be placed on the market in Great Britain after the Food Standards Agency (FSA) has processed an application for the authorisation of the novel food.

For foods that are still in the research and development phase prior to authorisation guidance issued by the FSA Advisory Committee on Novel Foods and Processes in 2002 confirms that taste trials are permitted as long as they are not conducted for marketing or advertising purposes.


Written Question
Nurses: Migrant Workers
Monday 23rd October 2023

Asked by: Daniel Zeichner (Labour - Cambridge)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the treatment by recruitment agencies of nurses working in social care who were recruited from India.

Answered by Helen Whately - Minister of State (Department of Health and Social Care)

We continue to work closely with partners in the Home Office to share concerns and intelligence related to poor practice in the recruitment and employment of overseas workers in the care sector.

All employers of international health and care staff must follow the Code of Practice for the International Recruitment of Health and Social Care Personnel to make sure staff are recruited ethically and are treated with respect.

In addition, the Home Office’s sponsor licence system places clear and binding requirements and obligations on employers looking to recruit and manage overseas workers. The UK Visas and Immigration body has conducted visits and investigations in the sector, following which sponsors have had their licences suspended pending investigation and then revoked.