Advanced Therapy Medicinal Products

Department of Health and Social Care written question – answered at on 21 February 2024.

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Photo of Baroness Ritchie of Downpatrick Baroness Ritchie of Downpatrick Non-affiliated

To ask His Majesty's Government what steps they are taking to enhance the safety, quality, supply and accessibility of therapies derived from substances of human origin.

Photo of Lord Markham Lord Markham The Parliamentary Under-Secretary for Health and Social Care

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.

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