The Government has committed up to £520m for life sciences manufacturing, through the Life Sciences Innovative Manufacturing Fund (LSIMF). The scheme launched in October 2024 and will deliver funding until March 2030. Projects focused on Advanced Therapy Medicinal Products (ATMPs) are in scope of the scheme, and we have supported two projects in this sector, totalling £4,335,478 of grant funding. We have other ATMP projects in the pipeline, and expect to make further grant awards soon. We continue to welcome applications from the ATMP sector.

No such discussions have taken place. The Government is committed to ensuring the United Kingdom remains a global leader in the development of advanced therapies, including regenerative medicines, to drive innovation in the National Health Service and deliver life-changing outcomes for patients. The Department continues to work with public sector partners to promote a joined-up ecosystem that will support the development, regulation, and delivery of advanced therapies.

The Government invests in research into regenerative medicine and advanced therapies through UK Research and Innovation. The £42 million UK Regenerative Medicine Platform (UKRMP) aimed at addressing the key translational challenges in regenerative medicine and at bringing innovative regenerative medicine therapies to the clinic. In its second phase, from 2018 to 2024, the UKRMP established three hubs: the Engineered Cell Environment Hub; the Smart Materials Hub; and the Pluripotent Stem Cells and Engineered Cells Hub.

It has not proved possible to respond to this question in the time available before Prorogation. Ministers will correspond directly with the Member.

Regenerative techniques, such as cell therapies, growth factors, and bioengineered scaffolds, can accelerate wound healing, which is particularly valuable in complex or high‑risk surgeries. NHS England maintains an overview of the advanced therapy medicinal products in development and assesses the potential National Health Service impact and the requirements for individual treatments as part of its due diligence, ensuring the NHS is ready to deliver innovative new treatments that secure a positive Medicines and Healthcare products Regulatory Agency licensing decision and National Institute for Health and Care Excellence recommendation.

The Department is committed to turbocharging clinical research and delivering better patient care, to make the United Kingdom a world-leading destination for clinical research including cell and gene therapies such as CAR-T. We are working to fast-track clinical trials to drive global investment into life sciences, improve health outcomes, and accelerate the development of medicines and therapies of the future, including gene therapy treatments.

The Department funded National Institute for Health and Care Research (NIHR) funds research and research infrastructure, which supports patients and the public to participate in high-quality research, across the development pathway.

The NIHR Industry Hub, launched in October 2025, provides a single front door for companies in England, coordinating research infrastructure into one coherent, streamlined offer.

NIHR infrastructure offers innovators access to world-leading expertise, facilities, and support for the delivery of clinical trials, strengthening the UK’s position as a partner of choice for cell and gene therapy studies. The NIHR’s Biomedical Research Centres and Experimental Cancer Medicine Centres support early translational and experimental medicine studies, offering world-leading scientific expertise and clinical capability for complex, early phase, and first-in-human trials, including CAR-T. This helps de-risk development and attract cutting-edge studies to the UK.

NIHR’s Clinical Research Facilities provide specialist environments and the skilled workforce required to deliver these complex therapies safely and efficiently. To improve delivery at scale, the NIHR’s Research Delivery Network and Commercial Research Delivery Centres are established to support rapid and efficient delivery of clinical trials and provide dedicated capacity and capability across the country. This will further enhance the UKs competitiveness by improving the speed and reliability of study setup and delivery.

In addition, the NIHR supported Advanced Therapy Treatment Centres (ATTCs) play a key role in the development of advanced therapy medicinal products clinical trials. By developing national infrastructure, standardising delivery pathways, and supporting centres across a range of geographies, ATTCs help ensure that advanced therapies can be delivered beyond a small number of highly specialised sites.

The Substances of Human Origin (SoHO) Regulation Review Programme launched in 2024 to consider recent changes that the European Union (EU) has made to its SoHO Regulation ((EU) 2024/1938) as well as stakeholder proposals for legislation in this area. It is reviewing patient safety, the intra-United Kingdom and UK-EU supply of SoHO, innovation within the sector, and health inequalities.

A key principle of the review is to maintain compatible high levels of minimum safety and quality standards for blood, blood components, tissues and cells, human breast milk, intestinal microbiota, and blood preparations that are not used for transfusion, to support public health and the movement of SoHO.

A targeted consultation, planned to launch by the end of 2025, will give stakeholders the opportunity to share views and highlight key issues and opportunities. Once the review has concluded a decision will be made about potential changes to legislation.

In addition, recognising the transformative potential of cell and gene therapies, the Department has stood up an advanced therapies co-ordination group to create a joined-up ecosystem that will support the development, regulation, and delivery of cell and gene therapies in the UK.

The Parliamentary Under-Secretary of State for Patient Safety, Women’s Health and Mental Health, Baroness Merron, is the Minister with responsibility for life sciences and innovation, and cell and gene therapies are included in this remit.

In September 2024, the Department stood up an advanced therapies co-ordination group which aims to create a joined-up ecosystem that will support the development, regulation, and delivery of advanced therapy medicinal products in the United Kingdom. This group is chaired at the Senior Civil Service Grade 1 level. We note the recent report from the Cell and Gene Collective, titled Tomorrow’s Science, Today’s NHS, including the ask for a Minister to chair the group, and we will consider the report’s recommendations in due course.

The National Health Service in England is required to fund medicines and treatments recommended by the National Institute for Health and Care Excellence (NICE) as a clinically and cost-effective use of NHS resources. NHS England has undertaken considerable activity to support NICE-recommended CAR-T therapies which are currently commissioned and those that may be available in the future.

There are 3 CAR-T products currently available for four types of blood cancer which have treated over 1,500 people to date: these products were made available via the Cancer Drugs Fund which provides early access to promising new cancer medicines. Two additional CAR-T products are currently being evaluated by NICE.

NHS England uses horizon scanning to see what is coming and has a dedicated team to support the adoption of advanced therapy medicinal products (ATMPs) that are recommended by NICE into the NHS. The team works with a variety of internal and external stakeholders to ensure timely patient access to ATMPs that are on the NICE technology appraisal and highly specialised technology workplan. NHS England regularly engages with clinicians who provide CAR-T therapy in order to ensure that there is sufficient capacity within the service to deliver this.

The UK is a world-leader in the development and manufacture of cell and gene therapies thanks to government investment in innovation and skills, including through the Cell and Gene Therapy Catapult (CGTC).

DSIT also invested £10 million - alongside £10 million from Scottish Enterprise – to support a new Oligonucleotide Manufacturing Innovation Centre of Excellence in Glasgow.

The Vaccine Taskforce provided funding for a state-of-the art CGTC facility in Braintree to accelerate the development and manufacturing of advanced therapies at clinical and commercial scale.

My department also supported CGTC to establish apprenticeships and training programmes to upskill people across the UK.

The government is investing significantly to support manufacturing and delivery of cell and gene therapies.

Since 2021, government has launched three UK-wide capital grant schemes – up to £118 million of funds – to incentivise manufacturing investments, including in advanced therapies. Last year, government announced a further £520 million to increase investment in Life Sciences manufacturing.

The UK is a world-leader in the development and manufacture of cell and gene therapies thanks to government investment in innovation and skills, including through the Cell and Gene Therapy Catapult which also coordinates the Advanced Therapy Treatment Centre network.

Once the final legal text for the Standards of quality and safety for substances of human origin intended for human application and repealing is published, we will fully consider and assess any impact of the revised regulation.

Therapies derived from substances of human origin include those using reproductive and non-reproductive tissues and cells, organs, stem cells, blood, and blood products including plasma. A range of different bodies have responsibility for safety, quality, supply and accessibility.

NHS Blood and Transplant (NHSBT) provides some of the safest products in the world and are regulated by the Care Quality Commission, Human Tissue Authority and Medicines and Healthcare products Regulatory Agency. NHSBT also work closely with the safety policy units of the Advisory Committee on the Safety of Blood, Tissues, and Organs and the Joint Professional Advisory Committee to blood services in the United Kingdom.

The Sustainability and Certainty in Organ Retrieval Programme was established in May 2023, following consultation and engagement with stakeholders across the organ donation and transplantation pathway. The key aim is to make improvements to the pathways with the aim of creating a more sustainable, efficient, and predictable service model.

The Department, NHSBT, NHS England and the devolved administrations are working together to create a long-term domestic supply of plasma for lifesaving medicines. Medicines will be available exclusively to National Health Service patients from early 2025. Additionally, the UK Stem Cell Strategic Forum provides advice on how the UK can develop a stronger and more resilient domestic stem cell supply chain.

The Human Fertilisation and Embryology Authority is the UK regulator for the use of reproductive tissues and cells in fertility treatment and embryo research. This remit includes keeping abreast of all issues relating to quality and safety.

The Department regularly discusses a range of issues with colleagues in NHS England and the National Institute for Health and Care Excellence (NICE) related to patient access to effective new medicines.

NICE has been able to recommend several advanced therapeutic medicinal products for routine NHS use which are now available to NHS patients in line with NICE’s recommendations. No advanced therapeutic medicinal products have been recommended for use through the Innovative Medicines Fund and NICE continues to consider the suitability of medicines for the Fund with individual companies.

Since publication of its updated process and methods for health technology evaluation in January 2022, the National Institute for Health and Care Excellence (NICE) has applied a modifier in its evaluation of two new active substances evaluated through the single technology appraisal process. NICE has been able to recommend both technologies where a modifier has been applied, allowing the National Health Service to adopt innovative new treatments while ensuring value for the taxpayer.

The severity modifier was applied in NICE’s appraisals of regorafenib for previously treated metastatic colorectal cancer [TA866] and bulevirtide for treating chronic hepatitis D [TA896].

The Department regularly meets with the National Institute for Health and Care Excellence (NICE) to discuss a range of issues. NICE’s technology appraisal programme has been proven to be suitable for the assessment of innovative medicines and advanced therapy medicinal products (ATMPs) where companies are able to price their products in a way that represents value to the taxpayer.

NICE has recommended several ATMPs through its technology appraisal programme that are now available to patients in the National Health Service. NICE concluded a review of its methods and processes for health technology evaluation in January 2022 and has introduced changes that ensure that its appraisal processes are suitable for emerging new medicines, including a broader severity modifier and changes to better respond to uncertainty.

No assessment has been made.

The Budget Impact Test is an integral part of the National Institute for Health and Care Excellence (NICE) evaluation process for new interventions, including gene therapies. It assesses the financial implications of introducing a new therapy by considering factors such as patient eligibility, treatment costs, and the impact on National Health Service resources. NICE undertakes a Budget Impact Test for each individual single-dose gene therapy as part of standard NICE process.

The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for the methods and processes that it uses in the development of its guidance. NICE made a number of changes to its health technology evaluation manual in January 2022 following a comprehensive review of its methods and processes, including to clarify its committees’ additional flexibility in considering uncertainty when evidence generation is difficult. NICE’s technology appraisal and highly specialised technology committees are now using the updated health technology evaluation manual for all new evaluations which began after 1 February 2022, including evaluations of cell and gene therapies.

The National Institute for Health and Care Excellence (NICE) evaluates gene therapies through both its technology appraisal programme and its highly specialised technologies programmes as appropriate. NICE’s processes have been proven to be suitable for the evaluation of advanced therapeutic medicinal products (ATMPs) where companies are willing to price their products in a way that represents value to the taxpayer. NICE has recommended 80% of the ATMPs it has evaluated for use by the National Health Service and they are now available for the treatment of NHS patients, including through the Cancer Drugs Fund and managed access agreements negotiated between the NHS and the manufacturer.

Most recently, in April 2023, NICE recommended eladocagene exuparvovec, the first and currently only gene therapy for children with an ultra-rare genetic disorder, aromatic L-amino acid decarboxylase deficiency, enabling its use on the NHS in England.

The Government is committed to supporting access to clinically and cost effective new treatments for National Health Service patients, including for rare, genetic and undiagnosed conditions. The National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing authoritative, evidence-based recommendations for the NHS on whether new medicines represent a clinically and cost-effective use of resources. The NHS in England is legally required to fund treatments recommended by NICE, usually within three months of final guidance. This means that any treatment positively appraised by NICE should be available for clinicians to offer to all their eligible patients.

NHS England has struck commercial agreements with the manufacturers of several cell and gene therapies that have enabled NICE to recommend them for routine NHS use or through the Cancer Drugs Fund. These treatments are now available for the treatment of all NHS patients.

The Innovative Medicines Fund was launched in June 2022 and will allow patients to benefit from early access to the most promising medicines where there is too much uncertainty for NICE to be able to recommend routine funding. This will further support the rapid introduction of effective new medicines for the benefit of NHS patients.

The Department has made no assessment. The National Institute for Health and Care Excellence is responsible for appointing members to its technology appraisal committees. Members reflect the spread of interests and expertise required for the business of the committee and are drawn from the National Health Service, patient and carer organisations, academia, and pharmaceutical and medical devices industries.

Additional experts may be invited to attend to advise the committee on a topic by topic basis to assist in considering and interpreting the evidence.