{ "format" : "linked-data-api", "version" : "0.2", "result" : {"_about" : "https://eldaddp.azurewebsites.net/answeredquestions.text?uin=HL3346", "definition" : "https://eldaddp.azurewebsites.net/meta/answeredquestions.text?uin=HL3346", "extendedMetadataVersion" : "https://eldaddp.azurewebsites.net/answeredquestions.text?uin=HL3346&_metadata=all", "first" : "https://eldaddp.azurewebsites.net/answeredquestions.text?_page=0&uin=HL3346", "hasPart" : "https://eldaddp.azurewebsites.net/answeredquestions.text?uin=HL3346", "isPartOf" : "https://eldaddp.azurewebsites.net/answeredquestions.text?uin=HL3346", "items" : [{"_about" : "http://data.parliament.uk/resources/1696589", "AnsweringBody" : [{"_value" : "Department for Education"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1696589/answer", "answerText" : {"_value" : "

Of the 55 independent residential special schools, five are identified as requiring improvement by Ofsted. One further school met the standards since the previous answer was provided. These schools are The Forum School, Wilds Lodge School, Pioneer TEC, The Fitzroy Academy and The Grange Therapeutic School. Nine schools offer under 20 residential placements, eight schools offer 20 to 40 residential placements, and 38 schools offer residential placements for over 40. None are approved for a single child only.<\/p>

<\/p>

When the department registers an independent school, it establishes who the proprietor will be, and runs suitability checks on the proprietor. The proprietor is ultimately responsible for the operation of the school. The proprietor is included on the register of independent schools. The department does not record the ultimate beneficial owner of the school. The registered proprietor of each of the 55 independent residential special schools is shown in the attachment provided titled \u2018Table of Independent Residential Special Schools\u2019.<\/p>

<\/p>

Of the 26 residential maintained special schools, six are identified as requiring improvement by Ofsted. These schools are Holly House Special School, Barndale House School, Greenbank School, Kings Mill School, Lindsworth School and Lexden Springs School. One school offers under 20 residential placements, three schools offer 20 to 40 residential placements, and 23 schools offer residential placements for over 40. None are approved for a single child only.<\/p>

<\/p>

Of the 33 residential non-maintained special schools (NMSS), three are identified as requiring improvement by Ofsted. This number has increased by one since the previous answer provided as the department has identified an additional NMSS that is listed on the register of schools as a further educational college rather than a school. These schools are St Vincent\u2019s School, New College Worcester, and Breckenbrough School. No schools offer under 20 residential placements, one school offers 20 to 40 residential placements, and 32 schools offer residential placements for over 40. None are approved for a single child only.<\/p>

<\/p>

Of the 34 residential special academy and free schools, four require improvement according to Ofsted. One school no longer offers residential placements since the previous answer provided. These schools are Brompton Hall School, Langham Oaks, Pencalenick School and Charlton Park Academy. No schools offer under 20 residential placements, two schools offer 20 to 40 residential placements, and 32 schools offer residential placements for over 40. None are approved for a single child only.<\/p>

<\/p>

Historical data does not allow a comparison to be made on Residential Special Schools compared to 2010 and 2015. Data for recorded school types is available in the department\u2019s data releases, which is included in the attached documents titled \u2018Index of Tables\u2019 and \u2018Table of School Characteristics\u2019.<\/p>

<\/p>

Local authorities must ensure there are sufficient school places for all pupils, including those with special educational needs and disabilities. Residential provision may be the right way to meet the needs of some children and young people, but it places them at greater risk by removing them from their families and local support networks. While there will always be a small group of children who require more intensive round-the-clock care alongside their education or healthcare in a residential setting, this should be less necessary as the department better meets children\u2019s needs in mainstream schools and non-residential special schools and provide more early and intensive support for families.<\/p>

<\/p>

Individual schools are responsible for ensuring they can meet the needs of the children and young people they educate. All residential special schools are required to follow and are inspected against the residential special schools\u2019 national minimum standards (NMS). These standards can be found on the GOV.UK website: https://assets.publishing.service.gov.uk/media/647f53155f7bb700127fa5c9/Residential_special_schools_national_minimum_standards.pdf<\/a>.<\/p>

<\/p>

Amongst other things, the NMS set out the importance of suitably qualified and trained staff, along with a requirement for care staff to have at least a relevant Level 3 qualification. Part D, \u2018Health and Wellbeing\u2019, provides comprehensive standards to ensure staff are meeting pupils\u2019 needs, including ensuring pupils have access to appropriate support services. Children and young people in residential special schools away from home are entitled to access local health services in the same way as all children and young people are. Some providers also offer and commission their own clinical expertise and support for children in their residential special schools. Additionally, the National Autism Trainer Programme, funded by NHS England and led by Anna Freud provides a co-produced autism Train the Trainers approach that has been offered free of charge for staff working in residential special schools and colleges to better support them to understand the needs and experiences of autistic children and young people.<\/p>

<\/p>

Children and young people may only be placed in a special school if they have an Education, Health and Care (EHC) plan. If the placement is no longer suitable for the child or young person, the local authority responsible for the EHC plan will need to review it and consider amending it, following the statutory processes set out in the Children and Families Act 2014.<\/p>

<\/p>

In the meantime, local authorities have a duty to arrange suitable education for any pupil of compulsory school age who, because of illness, exclusion, or other reasons, would not get a suitable education without such provision. This education must be full time, unless a pupil\u2019s medical needs mean that full-time education would not be in their best interests.<\/p>

It is up to local authorities to determine the most appropriate alternative provision for a child, but they should take into account the views of the pupil, their parents and other professionals.<\/p>

<\/p>

The department has published statutory guidance on alternative provision, which local authorities must have regard to. The guidance is available on the GOV.UK website: https://www.gov.uk/government/publications/alternative-provision<\/a>.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4703", "label" : {"_value" : "Biography information for Baroness Barran"} } , "answeringMemberPrinted" : {"_value" : "Baroness Barran"} , "attachment" : [{"_about" : "http://data.parliament.uk/resources/1696589/answer/attachment/1", "fileName" : {"_value" : "HL3342 HL3343 HL3344 HL3345 HL3346 HL3347_table_of_Independent_Residential_Special_Schools.xlsx"} , "title" : "Table of Independent Residential Special Schools"} , {"_about" : "http://data.parliament.uk/resources/1696589/answer/attachment/2", "fileName" : {"_value" : "HL3342 HL3343 HL3344 HL3345 HL3346 HL3347_index_of_tables.xlsx"} , "title" : "Index of Tables "} , {"_about" : "http://data.parliament.uk/resources/1696589/answer/attachment/3", "fileName" : {"_value" : "HL3342 HL3343 HL3344 HL3345 HL3346 HL3347_table_of_school_characteristics.xlsx"} , "title" : "Table of School Characteristics"} ], "dateOfAnswer" : {"_value" : "2024-04-03", "_datatype" : "dateTime"} , "groupedQuestionUIN" : [{"_value" : "HL3342"} , {"_value" : "HL3343"} , {"_value" : "HL3344"} , {"_value" : "HL3345"} , {"_value" : "HL3347"} ], "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2024-04-03T14:49:04.26Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "60"} , "answeringDeptShortName" : {"_value" : "Education"} , "answeringDeptSortName" : {"_value" : "Education"} , "date" : {"_value" : "2024-03-18", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Boarding Schools: Special Educational Needs"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask His Majesty's Government, further to the Written Answer by Baroness Barran on 11 March (HL2772, HL2773, HL2811), what arrangements they have in place to ensure that the 148 residential special schools mentioned in that answer have ready access to psychiatric and clinical psychology services to meet the clinical needs of their residents, especially those with complex autism.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/1732", "label" : {"_value" : "Biography information for Lord Warner"} } , "tablingMemberPrinted" : [{"_value" : "Lord Warner"} ], "uin" : "HL3346"} , {"_about" : "http://data.parliament.uk/resources/1542052", "AnsweringBody" : [{"_value" : "Northern Ireland Office"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1542052/answer", "answerText" : {"_value" : "

The Government is acutely aware of the pressures facing the health service in Northern Ireland. The absence of a functioning Executive is exacerbating the severe challenges that the healthcare system in Northern Ireland is facing.<\/p>

People in Northern Ireland deserve locally-elected decision-makers who are working for them to address these important issues. That is the best way to progress the necessary long term solutions to healthcare and make best use of the substantial UK Government funds announced in the Autumn Statement which will see the budget to the Northern Ireland Executive increase by £650m over two years.<\/p>

In the absence of an Executive, the Secretary of State for Northern Ireland outlined to Parliament on Wednesday 9 November, and which I shared with the House on 14 November, his intention to introduce legislation to enable Northern Ireland Departments to maintain delivery of all vital public services including health and social care.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4581", "label" : {"_value" : "Biography information for Lord Caine"} } , "answeringMemberPrinted" : {"_value" : "Lord Caine"} , "dateOfAnswer" : {"_value" : "2022-11-23", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2022-11-23T15:04:00.103Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "21"} , "answeringDeptShortName" : {"_value" : "Northern Ireland"} , "answeringDeptSortName" : {"_value" : "Northern Ireland"} , "date" : {"_value" : "2022-11-14", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Health Services and Social Services: Northern Ireland"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask His Majesty's Government what assessment they have made of the impact the absence of the Northern Ireland Health Minister will have on the delivery of health and social care services in Northern Ireland this winter; and what steps they intend to take to ensure the safe delivery of critical services.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4216", "label" : {"_value" : "Biography information for Lord Empey"} } , "tablingMemberPrinted" : [{"_value" : "Lord Empey"} ], "uin" : "HL3346"} , {"_about" : "http://data.parliament.uk/resources/1362692", "AnsweringBody" : [{"_value" : "Foreign, Commonwealth and Development Office"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1362692/answer", "answerText" : {"_value" : "

This is a matter for the US Government. The UK's position on Jerusalem is that the status of Jerusalem should be determined in a negotiated settlement, and ultimately the shared capital of both states.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4210", "label" : {"_value" : "Biography information for Lord Ahmad of Wimbledon"} } , "answeringMemberPrinted" : {"_value" : "Lord Ahmad of Wimbledon"} , "dateOfAnswer" : {"_value" : "2021-11-05", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2021-11-05T13:40:20.437Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "208"} , "answeringDeptShortName" : {"_value" : "Foreign, Commonwealth and Development Office"} , "answeringDeptSortName" : {"_value" : "Foreign, Commonwealth and Development Office"} , "date" : {"_value" : "2021-10-22", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Jerusalem: USA"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask Her Majesty's Government what assessment they have made of the proposal by the government of the United States of America to reopen their consulate in East Jerusalem.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/2018", "label" : {"_value" : "Biography information for Lord Hylton"} } , "tablingMemberPrinted" : [{"_value" : "Lord Hylton"} ], "uin" : "HL3346"} , {"_about" : "http://data.parliament.uk/resources/1189829", "AnsweringBody" : [{"_value" : "Department of Health and Social Care"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/1189829/answer", "answerText" : {"_value" : "

As of 15 May, over 13,000 businesses have contacted the Government with offers of help on supplying personal protective equipment (PPE). Many are related to the manufacture of PPE for the National Health Service and care sectors, a vast majority of which we are taking forward, predominantly from United Kingdom based companies but also including multinational companies. Some offers were not progressed due to financial and capability considerations.<\/p>


The Department engages directly with potential manufacturers to qualify and prioritise the opportunity, based on availability of and access to raw supplies, lead-times to manufacture, and other commercial considerations. Product prototypes are submitted to a Technical Product Review process, to ensure they meet essential health, safety and quality standards for PPE. Financial due diligence and fraud prevention measures are also undertaken, after which the Department can contract with the manufacturer.<\/p>

<\/p>

Lord Deighton is leading the Government\u2019s efforts to secure sufficient PPE and ensure this gets to where it is needed. He is also driving forward coordination of the end-to-end process design and manufacture of new domestic PPE supplies. As at 15 May, the Department has entered into contract and placed orders with eight manufacturers to provide millions of items of PPE products to the National Health Service and carers. The volumes will increase in the coming weeks.<\/p>

<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4708", "label" : {"_value" : "Biography information for Lord Bethell"} } , "answeringMemberPrinted" : {"_value" : "Lord Bethell"} , "dateOfAnswer" : {"_value" : "2020-05-27", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2020-05-27T11:47:09.76Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health and Social Care"} , "answeringDeptSortName" : {"_value" : "Health and Social Care"} , "date" : {"_value" : "2020-04-21", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "NHS: Protective Clothing"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask Her Majesty's Government whether all suppliers and potential providers of personal protective equipment within the UK have been used by the NHS.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/1796", "label" : {"_value" : "Biography information for Lord Taylor of Warwick"} } , "tablingMemberPrinted" : [{"_value" : "Lord Taylor of Warwick"} ], "uin" : "HL3346"} , {"_about" : "http://data.parliament.uk/resources/792394", "AnsweringBody" : [{"_value" : "Department for Transport"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/792394/answer", "answerText" : {"_value" : "

In 2016 Atkins, on behalf of the Department for Transport, undertook analysis on the business case for electrification and other route enhancements of the Midland Main Line route from Bedford north to Corby, Leicester, Nottingham and Sheffield. A copy of this is in the House library; Chapter 3 (pp 17-24) has the required timings for those journeys.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4584", "label" : {"_value" : "Biography information for Baroness Sugg"} } , "answeringMemberPrinted" : {"_value" : "Baroness Sugg"} , "dateOfAnswer" : {"_value" : "2017-12-04", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2017-12-04T17:32:49.293Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "27"} , "answeringDeptShortName" : {"_value" : "Transport"} , "answeringDeptSortName" : {"_value" : "Transport"} , "date" : {"_value" : "2017-11-20", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Railways: Sheffield"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask Her Majesty's Government, in preparation for the re-letting of the East Midlands Train franchise, what estimate they have made of the overall journey times for (1) a bi-mode train, and (2) an electric alternative, between London and Sheffield.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/2483", "label" : {"_value" : "Biography information for Lord Bradshaw"} } , "tablingMemberPrinted" : [{"_value" : "Lord Bradshaw"} ], "uin" : "HL3346"} , {"_about" : "http://data.parliament.uk/resources/638595", "AnsweringBody" : [{"_value" : "HM Treasury"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/638595/answer", "answerText" : {"_value" : "

The Government maintains close and constructive links with charity sector representatives and is in regular dialogue with the sector. HM Revenue and Customs has set up an outreach team which is particularly focused on responding to the needs of smaller charities.<\/p>

This team regularly makes visits to small charities and has provided face-to-face presentations to over 650, raising awareness and helping charities to receive support through the Gift Aid Small Donations Scheme, as well as the full range of available tax reliefs to which they are entitled.<\/p>

<\/p>

Amounts claimed under the Gift Aid Small Donations Scheme since 2013 are £6 million in 2013/14, £21 million in 2014/15 and £26 million in 2015/16. Figures for 2016/17 are not currently available.<\/p>

<\/p>

The costs of administering the Gift Aid Small Donations Scheme and instances of malpractice are not available as they are included in the figures for the wider Gift Aid scheme, and cannot be separately extracted.<\/p>

<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/57", "label" : {"_value" : "Biography information for Lord Young of Cookham"} } , "answeringMemberPrinted" : {"_value" : "Lord Young of Cookham"} , "dateOfAnswer" : {"_value" : "2016-12-02", "_datatype" : "dateTime"} , "groupedQuestionUIN" : [{"_value" : "HL3347"} , {"_value" : "HL3348"} , {"_value" : "HL3349"} ], "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2016-12-02T14:18:07.357Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "14"} , "answeringDeptShortName" : {"_value" : "Treasury"} , "answeringDeptSortName" : {"_value" : "CaTreasury"} , "date" : {"_value" : "2016-11-18", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Gift Aid Small Donations Scheme"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask Her Majesty\u2019s Government how much money has been claimed under the Small Charitable Donations Act 2012 in each year since 2013.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/2501", "label" : {"_value" : "Biography information for Baroness Barker"} } , "tablingMemberPrinted" : [{"_value" : "Baroness Barker"} ], "uin" : "HL3346"} , {"_about" : "http://data.parliament.uk/resources/426407", "AnsweringBody" : [{"_value" : "Department for Transport"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/426407/answer", "answerText" : {"_value" : "

Road safety education includes a range of interventions including educational courses and publicity campaigns.<\/p>

The Department funds the THINK! road safety publicity campaign. We evaluate the campaign to ensure it is effective, that we continually improve performance; and that we ultimately deliver value for money for the taxpayer.<\/p>

Prior to each campaign we set communication objectives and key performance indicators. We measure progress against these by running surveys with our target audience before and immediately after the campaign. We have seen positive shifts in key performance indicators for the majority of our campaigns. All of our recent campaign evaluation reports are published on gov.uk[1]<\/sup><\/sup>.<\/p>

In the long run, positive changes in key performance indicators on campaigns such as speeding, drink driving and seatbelts have correlated with fewer drivers exceeding the speed limit, fewer accidents involving drink driving and higher seatbelt wearing rates; and ultimately to fewer road casualties.<\/p>

Publicity campaigns are part of the solution to reduce road casualties and work best when used alongside enforcement and engineering interventions. Due to the multiple factors affecting casualties (weather, road conditions, traffic levels, the economy etc.) it is difficult to demonstrate a causal relationship with a specific intervention. However, in 2012 the department commissioned an independent agency to evaluate the impact drink drive campaigns have had on casualties. They used econometric modelling to estimate that over a 30 year period, drink drive communication campaigns have saved almost 2,000 lives and prevented over 10,000 serious injuries[2]<\/sup><\/sup>.<\/p>

In 2013, the Transport Research Laboratory published[3]<\/sup><\/sup> a review and synthesis of evidence on the effectiveness of pre-driver education and training for those under 17 years of age which was undertaken for the Coalition Government. The findings showed that very few interventions had been robustly evaluated and that the evidence base around pre-driver interventions was weak. The Government recently commissioned an evidence base review, to build on existing work, to help us to understand the effectiveness of a range of pre- and post-test behavioural and technological interventions for young drivers. The Government is currently also funding an evaluation of the effectiveness of speed awareness courses.<\/p>

[1]<\/sup><\/sup> https://www.gov.uk/government/collections/think-communication-activity<\/p>

[2]<\/sup><\/sup> https://www.gov.uk/government/publications/drink-drive-30-years-of-communication<\/p>

[3]<\/sup><\/sup> https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/249282/novice-driver-research-findings.pdf<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4210", "label" : {"_value" : "Biography information for Lord Ahmad of Wimbledon"} } , "answeringMemberPrinted" : {"_value" : "Lord Ahmad of Wimbledon"} , "dateOfAnswer" : {"_value" : "2015-11-17", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2015-11-17T12:47:08.653Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "27"} , "answeringDeptShortName" : {"_value" : "Transport"} , "answeringDeptSortName" : {"_value" : "Transport"} , "date" : {"_value" : "2015-11-05", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Roads: Safety"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask Her Majesty\u2019s Government what assessment they have made of the effectiveness of road safety awareness educational programmes in reducing accidents.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/3801", "label" : {"_value" : "Biography information for Lord Browne of Belmont"} } , "tablingMemberPrinted" : [{"_value" : "Lord Browne of Belmont"} ], "uin" : "HL3346"} , {"_about" : "http://data.parliament.uk/resources/167245", "AnsweringBody" : [{"_value" : "Department of Health"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/167245/answer", "answerText" : {"_value" : "

Products used in direct-to-consumer testing services providing health-related information are regulated as in vitro<\/em> diagnostic medical devices and are subject to European Union legislation that sets out minimum standards of safety and quality. The testing service itself is not subject to this legislation, only the products.<\/p>

<\/p>

<\/p>

<\/p>

Manufacturers of in vitro<\/em> diagnostic medical devices are required to register with the competent authority in the country where they are placing the device on the market. In the United Kingdom this is the Medicines and Healthcare products Regulatory Agency (MHRA). In this registration a manufacturer declares that their devices are safe and meet all of the relevant requirements of the legislation including having evidence to support their performance claims. For some higher risk devices a manufacturer has to have its product checked before it is placed on the market. Such checks are undertaken by third-party conformity assessment bodies called notified bodies.<\/p>

<\/p>

<\/p>

<\/p>

The role of the MHRA is to ensure that all medical devices placed on the UK market are compliant with the relevant legislation and to enforce this legislation on behalf of the Secretary of State. The MHRA fulfils this role by monitoring notified bodies (for higher risk devices) and operating the UK medical device vigilance system, which involves assessing and responding to safety concerns involving devices.<\/p>

<\/p>

<\/p>

<\/p>

The MHRA does not have a role in assessing the additional costs or benefits of devices to the National Health Service and so has not done so in the case of the service offered by 23andMe.<\/p>

<\/p>

<\/p>

<\/p>

Furthermore, under existing EU legislation, testing services are regulated in the country where the test is being performed. The tests offered by 23andMe are performed in laboratories that are based in the United States of America and as such are covered by US legislation.<\/p>

<\/p>

<\/p>

<\/p>

The Government has advised that no test will be 100% reliable, that 23andMe should be used with caution and that the information provided by 23andMe should not lead consumers to make any changes of medical significance, such as changes to medication, without first consulting their healthcare professional. If consumers need more information about the conditions listed in their results then they can visit the NHS Choices website for more information.<\/p>

<\/p>

<\/p>

<\/p>

The MHRA discussed the 23andMe Personal Genome Service with the US Food and Drug Administration (FDA) and shared information under the confidentiality commitment that is in place between the two agencies.<\/p>

<\/p>

<\/p>

<\/p>

The MHRA also held discussions with 23andMe prior to them launching their product in the UK. In those discussions, 23andMe explained that the product being offered in the UK is different to their US product in that many of the drug responses, inherited conditions and genetic health risks that were of concern to the FDA have been removed. 23andMe also presented results of surveys with UK-based consumers of their existing service that demonstrated that 4% of people had a specific conversation with their general practitioner (GP) as a result of their test results but it is not known how many GP visits led to National Health Service treatment.<\/p>

<\/p>

<\/p>

<\/p>

In the context of those discussions, the MHRA also agreed with 23andMe that they would take part in an enhanced surveillance program. Such a program involves regular sharing of safety information that might not otherwise meet the threshold for reporting to the competent authority. This will allow the MHRA to have a more in depth look at the performance of the test in use and if this highlights any regulatory or safety issues then they will consider further action.<\/p>

<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/2000", "label" : {"_value" : "Biography information for Earl Howe"} } , "answeringMemberPrinted" : {"_value" : "Earl Howe"} , "dateOfAnswer" : {"_value" : "2014-12-16", "_datatype" : "dateTime"} , "groupedQuestionUIN" : [{"_value" : "HL3343"} , {"_value" : "HL3344"} , {"_value" : "HL3345"} , {"_value" : "HL3347"} , {"_value" : "HL3348"} ], "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2014-12-16T14:44:44.437Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health"} , "answeringDeptSortName" : {"_value" : "Health"} , "date" : {"_value" : "2014-12-02", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "DNA: Screening"} , "houseId" : {"_value" : "2"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25277", "prefLabel" : {"_value" : "House of Lords"} } ], "questionText" : "To ask Her Majesty\u2019s Government what are the minimum standards required for a personal genome service to be approved by the Medicines and Healthcare Products Regulatory Agency.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/4286", "label" : {"_value" : "Biography information for Lord Mendelsohn"} } , "tablingMemberPrinted" : [{"_value" : "Lord Mendelsohn"} ], "uin" : "HL3346"} ], "itemsPerPage" : 10, "page" : 0, "startIndex" : 1, "totalResults" : 8, "type" : ["http://purl.org/linked-data/api/vocab#ListEndpoint", "http://purl.org/linked-data/api/vocab#Page"]} }