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Written Question
Agriculture: Genetic Engineering
Thursday 2nd February 2023

Asked by: Lord Taylor of Warwick (Non-affiliated - Life peer)

Question to the Department for Environment, Food and Rural Affairs:

To ask His Majesty's Government what recent discussions they have had with the governments of EU member states regarding the use of gene editing in agriculture.

Answered by Lord Benyon - Minister of State (Foreign, Commonwealth and Development Office)

Government officials have ongoing discussions with EU member states. In November last year, officials from Defra, and from the Food Standards Agency, took part in a global regulators meeting, organised by the US Food and Drug Administration Mission to Europe, which included representatives from EU Member States.

This covered regulatory approaches to biotechnology, including gene editing in agriculture. Since then, Defra officials have met with Netherlands officials to discuss gene editing.


Written Question
Genetic Engineering: Scotland
Wednesday 29th June 2022

Asked by: Jerome Mayhew (Conservative - Broadland)

Question to the Scotland Office:

To ask the Secretary of State for Scotland, what recent discussions he has had with Cabinet colleagues on the potential merits of allowing gene editing in Scotland.

Answered by Alister Jack - Secretary of State for Scotland

It is the UK Government's ambition for the whole of the UK to benefit from the cutting edge technology that the development of gene edited plants offers.

Agriculture and the legislation of gene edited plants is a devolved matter and the Genetic Technology (Precision Breeding) Bill currently extends to England only. However, we are keen that all parts of the UK have the ability to unlock the potential of these technologies and are having ongoing discussions on the proposed policy changes with the Devolved Administrations. We have also invited them to join us in bringing forward this legislation and this invitation remains open as the Bill continues its passage through Parliament.


Written Question
Genetic Engineering
Thursday 17th March 2022

Asked by: Lilian Greenwood (Labour - Nottingham South)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of (a) the number of cell and gene therapies expected to come to the UK market in the next 10 years and (b) the capacity and infrastructure requirements of advanced therapy treatment centres in (i) Nottingham and (ii) elsewhere in the UK to deliver those treatments.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Life Sciences Vision and the Life Sciences Industrial Strategy set out an ambition to accelerate the adoption and uptake of cell and gene therapies in the United Kingdom. The Accelerated Access Collaborative’s early stage programme includes advanced therapy medical products (ATMPs).

As part of this programme, the National Institute for Health Research’s Innovation Observatory has undertaken horizon scanning over five years which has identified ATMPs until 2026. The United States Food and Drug Administration anticipates that by 2025, it will approve approximately 10 to 20 cell and gene therapy products per year, which is consistent with horizon scanning estimates provided to the National Health Service.

There are a number of providers which already offer ATMPs in England. To date, no specific assessment has been made for treatment centres in Nottingham. As ATMPs advance in clinical development, NHS England and NHS Improvement will consider how these products could be incorporated into existing clinical pathways. This would include assessments of potential capacity and infrastructure requirements prior to formally commissioning the relevant ATMP service. The capacity and infrastructure requirements of providers to offer ATMPs will depend on the individual products they are commissioned to deliver. Capability to deliver ATMPs is also considered and takes into account expertise in treating the condition which the therapy is intended to treat.


Written Question
Genetic Engineering
Thursday 28th October 2021

Asked by: Chris Green (Conservative - Bolton West)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how many gene and cell therapies have been appraised by NICE through a Single Technology Appraisal; and what category of recommendation made in each of those cases was (a) recommended, (b) optimised, (c) Cancer Drugs Fund, (d) not recommended and (e) only in research.

Answered by Edward Argar - Minister of State (Ministry of Justice)

As of October 2021, the National Institute for Health and Care Excellence (NICE) has published technology appraisals guidance on seven gene and cell therapies. The following table shows NICE’s recommendation for each cell and gene therapy.

Technology

Categorisation

Talimogene laherparepvec

Optimised

Holoclar (ex vivo expanded autologous human corneal epithelial cells containing stem cells)

Optimised

Holoclar (ex vivo expanded autologous human corneal epithelial cells containing stem cells)

Only in Research

Autologous chondrocyte implantation using chondrosphere

Optimised

Tisagenlecleucel

Recommended (Cancer Drugs Fund)

Darvadstrocel

Not recommended

Axicabtagene ciloleucel

Recommended (Cancer Drugs Fund)

Tisagenlecleucel

Recommended (Cancer Drugs Fund)


Written Question
Rare Diseases: Genetic Engineering
Tuesday 27th July 2021

Asked by: Jim Shannon (Democratic Unionist Party - Strangford)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the UK Rare Diseases Framework, whether he has had discussions with NICE on concerns arising from the first gene therapy for a rare disease to go through NICE's appraisal process having been rejected.

Answered by Jo Churchill - Minister of State (Department for Work and Pensions)

We have had no specific discussions. The National Institute for Health and Care Excellence (NICE) is responsible for developing its recommendations independently and in accordance with its methods and processes. NICE has recommended a number of cell and gene therapies through its technology appraisal programme and these treatments are now available to National Health Service patients in line with NICE’s recommendations.


Written Question
Genetic Engineering
Monday 26th July 2021

Asked by: Feryal Clark (Labour - Enfield North)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential for gene therapy technologies to help tackle health inequalities in (a) communities affected by specific hereditary conditions and (b) the general population.

Answered by Edward Argar - Minister of State (Ministry of Justice)

Gene therapies have the potential to treat hereditary and non-hereditary diseases that are a cause of long-term health conditions and poor quality of life. The Government supports research, development and adoption readiness of advanced therapy medicinal products, including gene therapies, through the Advanced Therapy Treatment Centre network, which is hosted by the Cell and Gene Therapy Catapult. The Department has also invested over £9 million in NHS Blood and Transplants’ Clinical Biotechnology Centre which manufactures recombinant proteins and gene therapy products for use in clinical trials enabling access for patients to the latest therapies.


Written Question
Retinitis Pigmentosa: Genetic Engineering
Monday 28th June 2021

Asked by: Jim Shannon (Democratic Unionist Party - Strangford)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he has undertaken any research on the potential effectiveness of gene therapy in treating pigmentosa.

Answered by Edward Argar - Minister of State (Ministry of Justice)

The National Institute for Health Research (NIHR) contributes to retinitis pigmentosa research, including potential gene therapies. In the past five years, there have been five projects related to the condition directly funded through NIHR programmes and 22 studies supported by the NIHR’s infrastructure.

In October 2019, the National Institute for Health and Care Excellence (NICE) recommended voretigene neparvovec, an adeno-associated virus vector-based gene therapy, for treating inherited retinal dystrophies caused by RPE65 gene mutations. NICE has two additional pieces of guidance on potential gene therapies for retinal conditions currently in the development and proposal stages.


Written Question
Genetically Modified Organisms
Thursday 18th March 2021

Asked by: Baroness Bennett of Manor Castle (Green Party - Life peer)

Question to the Department for Environment, Food and Rural Affairs:

To ask Her Majesty's Government what assessment they have made of the compatibility of any changes to the regulation of genetic engineering in food and farming in England with the UK–EU Trade and Cooperation Agreement.

Answered by Lord Goldsmith of Richmond Park

All consultation responses will be taken into account and analysed regardless of type. Free text responses will be analysed using well-established methodology from social sciences for the analysis of qualitative data, in line with standard practice for the analysis of public consultations. All views are being considered, whether or not they use technical language, and no weighting will be applied to more technical responses.

Prior to its publication, the Gene editing (GE) explainer document was reviewed by Defra’s Chief Scientific Adviser and Defra’s communications team. This ensured that the information was scientifically accurate and pitched so that a lay person could understand it.

We are gathering views and evidence on trade as part of the our consultation process. We will continue to monitor and respond to the approach taken in the EU to the regulation of GMOs.

Defra officials have regular ongoing discussions with Scottish and Welsh Government counterparts about the regulation of genetically modified organisms. These discussions are considering the impact of any potential changes to the regulation of genetic engineering in food and farming in England.

Owing to the application of Union law to Northern Ireland by virtue of the Northern Ireland Protocol, GE organisms will in Northern Ireland continue to be considered as GMOs and regulated as such.


Written Question
Genetically Modified Organisms
Thursday 18th March 2021

Asked by: Baroness Bennett of Manor Castle (Green Party - Life peer)

Question to the Department for Environment, Food and Rural Affairs:

To ask Her Majesty's Government what discussions they have had with (1) the Scottish, and (2) the Welsh, Government about the impact of any changes to the regulation of genetic engineering in food and farming in England on the maintenance of existing regulations relating to genetic modification in those countries; and what assessment they have made of any such change on (1) frictionless trade with Northern Ireland, and (2) the functioning of the Protocol on Ireland/Northern Ireland.

Answered by Lord Goldsmith of Richmond Park

All consultation responses will be taken into account and analysed regardless of type. Free text responses will be analysed using well-established methodology from social sciences for the analysis of qualitative data, in line with standard practice for the analysis of public consultations. All views are being considered, whether or not they use technical language, and no weighting will be applied to more technical responses.

Prior to its publication, the Gene editing (GE) explainer document was reviewed by Defra’s Chief Scientific Adviser and Defra’s communications team. This ensured that the information was scientifically accurate and pitched so that a lay person could understand it.

We are gathering views and evidence on trade as part of the our consultation process. We will continue to monitor and respond to the approach taken in the EU to the regulation of GMOs.

Defra officials have regular ongoing discussions with Scottish and Welsh Government counterparts about the regulation of genetically modified organisms. These discussions are considering the impact of any potential changes to the regulation of genetic engineering in food and farming in England.

Owing to the application of Union law to Northern Ireland by virtue of the Northern Ireland Protocol, GE organisms will in Northern Ireland continue to be considered as GMOs and regulated as such.


Written Question
Genetically Modified Organisms
Thursday 18th March 2021

Asked by: Baroness Bennett of Manor Castle (Green Party - Life peer)

Question to the Department for Environment, Food and Rural Affairs:

To ask Her Majesty's Government what assessment was made of the content of the Gene editing explainer, published in January, prior to its publication as a supporting document for the consultation by the Department for Environment Food and Rural Affairs The regulation of genetic technologies which opened on 7 January.

Answered by Lord Goldsmith of Richmond Park

All consultation responses will be taken into account and analysed regardless of type. Free text responses will be analysed using well-established methodology from social sciences for the analysis of qualitative data, in line with standard practice for the analysis of public consultations. All views are being considered, whether or not they use technical language, and no weighting will be applied to more technical responses.

Prior to its publication, the Gene editing (GE) explainer document was reviewed by Defra’s Chief Scientific Adviser and Defra’s communications team. This ensured that the information was scientifically accurate and pitched so that a lay person could understand it.

We are gathering views and evidence on trade as part of the our consultation process. We will continue to monitor and respond to the approach taken in the EU to the regulation of GMOs.

Defra officials have regular ongoing discussions with Scottish and Welsh Government counterparts about the regulation of genetically modified organisms. These discussions are considering the impact of any potential changes to the regulation of genetic engineering in food and farming in England.

Owing to the application of Union law to Northern Ireland by virtue of the Northern Ireland Protocol, GE organisms will in Northern Ireland continue to be considered as GMOs and regulated as such.