Department ministers and officials regularly meet with a range of organisations, with an interest in securing patient access to new cancer medicines. The National Institute for Health and Care Excellence (NICE) is the body that develops authoritative, evidence-based guidance for the National Health Service on whether new licensed medicines should be routinely funded by the NHS, based on an assessment of their costs and benefits, including medicines for myeloma. The NICE aims to publish guidance on all new medicines close to the point of licensing wherever possible, and has recommended many cancer medicines for NHS use that are now available to NHS patients, including through the Cancer Drugs Fund.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4044", "label" : {"_value" : "Biography information for Andrew Stephenson"} } , "answeringMemberConstituency" : {"_value" : "Pendle"} , "answeringMemberPrinted" : {"_value" : "Andrew Stephenson"} , "dateOfAnswer" : {"_value" : "2024-05-13", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2024-05-13T08:43:01.5Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2024-05-08", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Cancer: Drugs"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for Health and Social Care, what discussions she (a) has had and (b) plans to have with (i) charities and (ii) other organisations working to secure UK access to new drugs for (A) incurable, (B) relapsing and (C) remitting cancers such as myeloma.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4370", "label" : {"_value" : "Biography information for Jess Phillips"} } , "tablingMemberConstituency" : {"_value" : "Birmingham, Yardley"} , "tablingMemberPrinted" : [{"_value" : "Jess Phillips"} ], "uin" : "25238"} , {"_about" : "http://data.parliament.uk/resources/1688273", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1688273/answer", "answerText" : {"_value" : "
Department ministers and officials regularly meet with charities and other organisations working to improve outcomes for patients with cancer, including brain tumours, through access to new medicines.<\/p>
The National Institute for Health and Care Excellence (NICE) makes recommendations on whether all new medicines should be routinely funded by the National Health Service based on an assessment of their costs and benefits and aims to publish guidance as close as possible to licensing. NICE engages with stakeholders, including charities, in the development of its recommendations. NICE is currently developing guidance for the NHS on the use of Vorasidenib.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4044", "label" : {"_value" : "Biography information for Andrew Stephenson"} } , "answeringMemberConstituency" : {"_value" : "Pendle"} , "answeringMemberPrinted" : {"_value" : "Andrew Stephenson"} , "dateOfAnswer" : {"_value" : "2024-02-19", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2024-02-19T09:35:53.283Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2024-02-07", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Cancer: Drugs"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for Health and Social Care, what discussions she (a) has had and (b) plans to have with (i) brain tumour research charities and (ii) other organisations working to secure UK access to (A) Vorasidenib and (B) other new drugs for cancers of unmet need.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/3930", "label" : {"_value" : "Biography information for Caroline Lucas"} } , "tablingMemberConstituency" : {"_value" : "Brighton, Pavilion"} , "tablingMemberPrinted" : [{"_value" : "Caroline Lucas"} ], "uin" : "13599"} , {"_about" : "http://data.parliament.uk/resources/1681620", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1681620/answer", "answerText" : {"_value" : "
In March 2021, the Government published Saving and Improving Lives: The Future of UK Clinical Research Delivery, setting out ambitions to reform clinical research delivery in the United Kingdom. This sets out how we will improve patient access to clinical trials in all areas, including cancer. This, together with the Government response to the O\u2019Shaughnessy review backed by up to £121 million of funding, will help to drive improvements in recruitment to clinical trials and approval processes which lead to quicker study set up. Implementation of our vision for clinical trials brings together stakeholders from across the research system, including industry, and we continue to have regular engagement with industry partners through established forums.<\/p>
The UK\u2019s Cancer Mission, a key element of the Life Sciences Vision, will also bring together industry, academia, and the National Health Service to collaborate and make progress on cancer, including by driving the development and commercialisation of new cancer medicines.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4044", "label" : {"_value" : "Biography information for Andrew Stephenson"} } , "answeringMemberConstituency" : {"_value" : "Pendle"} , "answeringMemberPrinted" : {"_value" : "Andrew Stephenson"} , "dateOfAnswer" : {"_value" : "2024-01-17", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2024-01-17T17:29:10.877Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2024-01-11", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Cancer: Drugs"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for Health and Social Care, what discussions she is having with pharmaceutical organisations on releasing drugs for clinical trials for the treatment of less survivable cancers.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4471", "label" : {"_value" : "Biography information for Rachael Maskell"} } , "tablingMemberConstituency" : {"_value" : "York Central"} , "tablingMemberPrinted" : [{"_value" : "Rachael Maskell"} ], "uin" : "9252"} , {"_about" : "http://data.parliament.uk/resources/1659541", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1659541/answer", "answerText" : {"_value" : "
There is currently no planned timescale for the approval and rollout of the AOH1996 drug through the National Health Service as the Medicines and Healthcare products Regulatory Agency (MHRA) has not granted a marketing authorisation for AOH1996. Should an application be received, the MHRA has a number of licensing pathways available, with the aim of ensuring the products can be made available for patients in the United Kingdom in the shortest time possible and to support and protect public health.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4423", "label" : {"_value" : "Biography information for Will Quince"} } , "answeringMemberConstituency" : {"_value" : "Colchester"} , "answeringMemberPrinted" : {"_value" : "Will Quince"} , "dateOfAnswer" : {"_value" : "2023-09-19", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2023-09-19T12:56:54.957Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2023-09-11", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Cancer: Drugs"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for Health and Social Care, what his Department's planned timescale is for the (a) approval and (b) rollout of the AOH1996 drug through the NHS.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4131", "label" : {"_value" : "Biography information for Jim Shannon"} } , "tablingMemberConstituency" : {"_value" : "Strangford"} , "tablingMemberPrinted" : [{"_value" : "Jim Shannon"} ], "uin" : "198709"} , {"_about" : "http://data.parliament.uk/resources/1653028", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1653028/answer", "answerText" : {"_value" : "
The Medicines and Healthcare products Regulatory Agency (MHRA) is aware that customers who have submitted initial applications and amendments to our Clinical Investigations and Trials team have experienced extended timeframes in some cases, and understands how this unpredictability may be reducing the number of cancer drugs that can transition from a Phase 1 study to MHRA approval. To help improve the predictability of decision making in applications for clinical trials, the MHRA have implemented several actions.<\/p>
The MHRA are looking at novel ways to develop staff capability and expertise. New assessor capacity is being supplemented with an additional fixed-term resource of appropriately experienced and qualified specialists to support the training and supervision of new staff and to help reduce the current backlog. The MHRA has also established links with the Association of the British Pharmaceutical Industry and the BioIndustry Association on clinical trials, to reduce the backlog of delayed applications, which may include applications for cancer drugs. Additionally, they have already reallocated work, and are evaluating queued applications for complexity, to improve the speed of assessment, and are changing processes to take a joined-up risk-proportionate approach.<\/p>
The MHRA is committed to reducing these backlogs so that it makes regulatory decisions in accordance with statutory timeframes for all new fully compliant clinical trial applications received from 1 September 2023. This will enable more cancer drugs to progress from Phase 1 studies to MHRA approval where appropriate.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4948", "label" : {"_value" : "Biography information for Lord Markham"} } , "answeringMemberPrinted" : {"_value" : "Lord Markham"} , "dateOfAnswer" : {"_value" : "2023-07-20", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2023-07-20T16:33:27.783Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2023-07-13", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Cancer: Drugs"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask His Majesty's Government what steps they are taking to ensure that more cancer drugs can transition from a Phase 1 study to Medicines and Healthcare products Regulatory Agency (MHRA) approval.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/2024", "label" : {"_value" : "Biography information for Lord Hunt of Kings Heath"} } , "tablingMemberPrinted" : [{"_value" : "Lord Hunt of Kings Heath"} ], "uin" : "HL9329"} , {"_about" : "http://data.parliament.uk/resources/1644841", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1644841/answer", "answerText" : {"_value" : "
The Innovative Licensing and Access Pathway (ILAP) was launched in January 2021, and has seen strong interest from both small and large companies in a variety of therapeutic settings. Companies who successfully gain an Innovation Passport designation are able to apply for the next step; the Target Development Profile. There are currently 55 cancer drugs that have been awarded an innovation passport as part of the Innovative Licensing and Access Pathway. Eight of these products have accessed the Target Development Profile and a further seven are in progress.<\/p>
Holding an innovation passport is required to apply for Project Orbis. Project Orbis provides a framework for concurrent submission and review of oncology products among international partners, aiming to deliver faster patient access to innovative cancer treatments. 27 innovation passport holders have applied for Project Orbis.<\/p>
Following the McLean report there is ongoing work to ensure enhanced speed and efficiency of ILAP.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4423", "label" : {"_value" : "Biography information for Will Quince"} } , "answeringMemberConstituency" : {"_value" : "Colchester"} , "answeringMemberPrinted" : {"_value" : "Will Quince"} , "dateOfAnswer" : {"_value" : "2023-06-23", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2023-06-23T13:29:04.79Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2023-06-14", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Cancer: Drugs"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for Health and Social Care, which cancer medicines have received (a) an innovation passport and (b) other support under the Medicines and Healthcare products Regulatory Agency\u2019s Innovative Licensing and Access Pathway; and if he will make an assessment of the impact of the pathway on the time taken for innovative treatments to become available to patients.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4828", "label" : {"_value" : "Biography information for Paula Barker"} } , "tablingMemberConstituency" : {"_value" : "Liverpool, Wavertree"} , "tablingMemberPrinted" : [{"_value" : "Paula Barker"} ], "uin" : "189731"} , {"_about" : "http://data.parliament.uk/resources/1644842", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1644842/answer", "answerText" : {"_value" : "
The Medicines and Healthcare products Regulatory Agency (MHRA) does not publish details on applications currently under review as this is considered commercially sensitive information. That said, details of the products approved by the MHRA under Project Orbis are published on the MHRA website available at the following link:<\/p>