{ "format" : "linked-data-api", "version" : "0.2", "result" : {"_about" : "http://eldaddp.azurewebsites.net/answeredquestions.text?tablingMemberPrinted.=Naomi+Long&min-questionFirstAnswered.=2014-06-25T12%3A50%3A20.8318635Z", "definition" : "http://eldaddp.azurewebsites.net/meta/answeredquestions.text?tablingMemberPrinted.=Naomi+Long&min-questionFirstAnswered.=2014-06-25T12%3A50%3A20.8318635Z", "extendedMetadataVersion" : "http://eldaddp.azurewebsites.net/answeredquestions.text?tablingMemberPrinted.=Naomi+Long&min-questionFirstAnswered.=2014-06-25T12%3A50%3A20.8318635Z&_metadata=all", "first" : "http://eldaddp.azurewebsites.net/answeredquestions.text?tablingMemberPrinted.=Naomi+Long&_page=0&min-questionFirstAnswered.=2014-06-25T12%3A50%3A20.8318635Z", "hasPart" : "http://eldaddp.azurewebsites.net/answeredquestions.text?tablingMemberPrinted.=Naomi+Long&min-questionFirstAnswered.=2014-06-25T12%3A50%3A20.8318635Z", "isPartOf" : "http://eldaddp.azurewebsites.net/answeredquestions.text?tablingMemberPrinted.=Naomi+Long&min-questionFirstAnswered.=2014-06-25T12%3A50%3A20.8318635Z", "items" : [{"_about" : "http://data.parliament.uk/resources/176526", "AnsweringBody" : [{"_value" : "Department for International Development"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/176526/answer", "answerText" : {"_value" : "

We welcome the leadership of the EU on the humanitarian response in CAR and on programmes linking relief, recovery and development. The UK is not a current contributor to the EU Trust Fund in CAR. The UK has committed £33 million in humanitarian funds to CAR and CAR refugees since July 2013, funding a range of NGOs and UN agencies to provide protection, water, health and food security.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/55", "label" : {"_value" : "Biography information for Sir Desmond Swayne"} } , "answeringMemberConstituency" : {"_value" : "New Forest West"} , "answeringMemberPrinted" : {"_value" : "Mr Desmond Swayne"} , "dateOfAnswer" : {"_value" : "2015-02-04", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2015-02-04T17:09:04.013Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "20"} , "answeringDeptShortName" : {"_value" : "International Development"} , "answeringDeptSortName" : {"_value" : "International Development"} , "date" : {"_value" : "2015-01-28", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Central African Republic"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for International Development, what assessment she has made of the effectiveness of the Bekou Trust Fund to date; and whether she plans to contribute to it.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/3920", "label" : {"_value" : "Biography information for Naomi Long"} } , "tablingMemberConstituency" : {"_value" : "Belfast East"} , "tablingMemberPrinted" : [{"_value" : "Naomi Long"} ], "uin" : "222369"} , {"_about" : "http://data.parliament.uk/resources/176528", "AnsweringBody" : [{"_value" : "Department for International Development"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/176528/answer", "answerText" : {"_value" : "

DFID regularly monitors the security and humanitarian situation in CAR. High levels of violence continue across the country, and a million people have been displaced since December 2013. The security situation impacts not only communities but humanitarian workers. The Office for the Coordination of Humanitarian Affairs (OCHA) has reported 142 security incidents directed at humanitarian workers since January 2014 and 18 humanitarian workers killed. In 2014 DFID provided £18 million to the ICRC, UN agencies and international NGOs to support communities who have suffered from the violence in CAR.<\/p>

<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/55", "label" : {"_value" : "Biography information for Sir Desmond Swayne"} } , "answeringMemberConstituency" : {"_value" : "New Forest West"} , "answeringMemberPrinted" : {"_value" : "Mr Desmond Swayne"} , "dateOfAnswer" : {"_value" : "2015-02-04", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2015-02-04T17:11:24.37Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "20"} , "answeringDeptShortName" : {"_value" : "International Development"} , "answeringDeptSortName" : {"_value" : "International Development"} , "date" : {"_value" : "2015-01-28", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Central African Republic"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for International Development, what her assessment is of the implications of the current security situation in the Central African Republic for the delivery of humanitarian assistance in that country.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/3920", "label" : {"_value" : "Biography information for Naomi Long"} } , "tablingMemberConstituency" : {"_value" : "Belfast East"} , "tablingMemberPrinted" : [{"_value" : "Naomi Long"} ], "uin" : "222421"} , {"_about" : "http://data.parliament.uk/resources/175252", "AnsweringBody" : [{"_value" : "Foreign and Commonwealth Office"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/175252/answer", "answerText" : {"_value" : "

The UK actively pushes for the release of all political prisoners in Burma. The most recent official figures from the government of Burma suggest that 27 political prisoners remain in prison, having dropped from over 2,000 in 2011. However these figures are contested, and a leading local non-government organisation \u2013 the Assistance Association for Political Prisoners (Burma) \u2013 suggest that as of January there are 160 political prisoners with another 203 facing trial.

Clearly, the UK is very concerned by the increase in political prisoners witnessed over the last year. Officials from our Embassy in Rangoon meet regularly with members of civil society on this issue, and we continue to raise our concerns with the government of Burma at Ministerial level. I raised our concerns over political prisoners with Deputy Foreign Minister Thant Kyaw in June 2014. Most recently, the Minister of State at the Home Office, my right hon. Friend the Member for Hornsey and Wood Green (Ms Featherstone), raised this issue directly with the Minister for the President\u2019s Office, U Soe Thein, during her visit to Burma this month. We continue to lobby on individual cases. We also raise our concerns publicly in our Annual Report on Human Rights and in multilateral fora such as the UN General Assembly, where the UK co-sponsored a Resolution last year that called for the unconditional release of all political prisoners.<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/1408", "label" : {"_value" : "Biography information for Lord Swire"} } , "answeringMemberConstituency" : {"_value" : "East Devon"} , "answeringMemberPrinted" : {"_value" : "Mr Hugo Swire"} , "dateOfAnswer" : {"_value" : "2015-01-27", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2015-01-27T16:48:27.457Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "16"} , "answeringDeptShortName" : {"_value" : "Foreign and Commonwealth Office"} , "answeringDeptSortName" : {"_value" : "Foreign and Commonwealth Office"} , "date" : {"_value" : "2015-01-22", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Burma"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for Foreign and Commonwealth Affairs, what steps his Department has taken in response to the increase in the number of political prisoners in Burma in the last year.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/3920", "label" : {"_value" : "Biography information for Naomi Long"} } , "tablingMemberConstituency" : {"_value" : "Belfast East"} , "tablingMemberPrinted" : [{"_value" : "Naomi Long"} ], "uin" : "221704"} , {"_about" : "http://data.parliament.uk/resources/173936", "AnsweringBody" : [{"_value" : "Northern Ireland Office"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/173936/answer", "answerText" : {"_value" : "

It remains my view that the Inquiry chaired by Sir Anthony Hart is the best forum to consider the allegations surrounding Kincora.<\/p>

<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/1500", "label" : {"_value" : "Biography information for Theresa Villiers"} } , "answeringMemberConstituency" : {"_value" : "Chipping Barnet"} , "answeringMemberPrinted" : {"_value" : "Mrs Theresa Villiers"} , "dateOfAnswer" : {"_value" : "2015-01-20", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2015-01-20T12:35:11.383Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "21"} , "answeringDeptShortName" : {"_value" : "Northern Ireland"} , "answeringDeptSortName" : {"_value" : "Northern Ireland"} , "date" : {"_value" : "2015-01-15", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Child Sexual Abuse Independent Panel Inquiry"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for Northern Ireland, whether it remains her policy that the Historical Institutional Abuse Inquiry chaired by Sir Anthony Hart is the most appropriate place where all allegations surrounding Kincora should be examined.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/3920", "label" : {"_value" : "Biography information for Naomi Long"} } , "tablingMemberConstituency" : {"_value" : "Belfast East"} , "tablingMemberPrinted" : [{"_value" : "Naomi Long"} ], "uin" : "220898"} , {"_about" : "http://data.parliament.uk/resources/173937", "AnsweringBody" : [{"_value" : "Northern Ireland Office"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/173937/answer", "answerText" : {"_value" : "

It remains my view that the inquiry chaired by Sir Anthony Hart is the best forum to consider the allegations surrounding Kincora.<\/p>

As you may be aware the Attorney General for England and Wales has written to the Chairman of the Inquiry and provided an undertaking in the usual format about the admissibility and use of evidence given by a witness who co-operates with the Inquiry. This undertaking covers any offences arising under the Official Secrets Act.<\/p>

<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/1500", "label" : {"_value" : "Biography information for Theresa Villiers"} } , "answeringMemberConstituency" : {"_value" : "Chipping Barnet"} , "answeringMemberPrinted" : {"_value" : "Mrs Theresa Villiers"} , "dateOfAnswer" : {"_value" : "2015-01-20", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2015-01-20T12:37:25.013Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "21"} , "answeringDeptShortName" : {"_value" : "Northern Ireland"} , "answeringDeptSortName" : {"_value" : "Northern Ireland"} , "date" : {"_value" : "2015-01-15", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Child Sexual Abuse Independent Panel Inquiry"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for Northern Ireland, if she will include Kincora Boys' Home in the independent inquiry into historical child sex abuse, established by the Home Office, in order to allow potential witnesses not to be constrained by the Official Secrets Act.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/3920", "label" : {"_value" : "Biography information for Naomi Long"} } , "tablingMemberConstituency" : {"_value" : "Belfast East"} , "tablingMemberPrinted" : [{"_value" : "Naomi Long"} ], "uin" : "220899"} , {"_about" : "http://data.parliament.uk/resources/173683", "AnsweringBody" : [{"_value" : "Department for International Development"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/173683/answer", "answerText" : {"_value" : "

DFID has already disbursed £5 million of the £20 million early recovery assistance that we pledged at the Gaza Reconstruction Conference. The UK was also the first donor to support the temporary Gaza Reconstruction Mechanism which is facilitating the import of construction materials into Gaza, and, in close co-ordination with our EU partners and the Office of the Quartet Representative, we continue to press the Government of Israel to lift restrictions and facilitate the entry of aid into Gaza.<\/p>

<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/55", "label" : {"_value" : "Biography information for Sir Desmond Swayne"} } , "answeringMemberConstituency" : {"_value" : "New Forest West"} , "answeringMemberPrinted" : {"_value" : "Mr Desmond Swayne"} , "dateOfAnswer" : {"_value" : "2015-01-21", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2015-01-21T17:02:34.15Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "20"} , "answeringDeptShortName" : {"_value" : "International Development"} , "answeringDeptSortName" : {"_value" : "International Development"} , "date" : {"_value" : "2015-01-14", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Palestinians"} , "houseId" : {"_value" : "1"} , "legislature" : [{"_about" : "http://data.parliament.uk/terms/25259", "prefLabel" : {"_value" : "House of Commons"} } ], "questionText" : "To ask the Secretary of State for International Development, what steps the Government is taking to work with partners in the region to ensure that sufficient aid for reconstruction reaches Gaza following the recent conflict.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/3920", "label" : {"_value" : "Biography information for Naomi Long"} } , "tablingMemberConstituency" : {"_value" : "Belfast East"} , "tablingMemberPrinted" : [{"_value" : "Naomi Long"} ], "uin" : "220672"} , {"_about" : "http://data.parliament.uk/resources/173684", "AnsweringBody" : [{"_value" : "Department of Health"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/173684/answer", "answerText" : {"_value" : "

Since the launch of the Early Access to Medicines Scheme in April 2014, three Promising Innovative Medicine (PIM) designations have already been granted. By 9 January 2015 there had been 428 downloads of the PIM designation form and 187 downloads of the scientific opinion form, which indicates the high level of interest in the scheme.<\/p>

<\/p>

<\/p>

<\/p>

The Early Access to Medicines Scheme already has a number of incentives for pharmaceutical companies. The PIM designation provides an early indication that a product may be a possible candidate for the Early Access to Medicines Scheme and is of particular value to smaller companies because it will act as a signal to potential investors. At the next stage of scientific review, the Medicines and Healthcare products Regulatory Agency will consider the evidence and can issue an Early Access to Medicines scientific opinion. This opinion will support the prescriber to make a decision with the patient on using this medicine, when still unlicensed or used off-label. Earlier clinical use of new innovative medicines will also provide valuable real world data to companies for use in subsequent health technology appraisal processes.<\/p>

<\/p>

<\/p>

<\/p>

We committed to review the Early Access to Medicines Scheme when we launched the scheme in April 2014. Through the Innovative Medicine and Medical Technologies Review we will also be taking forward a major review over the coming months to make recommendations to Government on opportunities to accelerate access for National Health Service patients to innovative medicines, devices and diagnostics.<\/p>

<\/p>

<\/p>

<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4020", "label" : {"_value" : "Biography information for George Freeman"} } , "answeringMemberConstituency" : {"_value" : "Mid Norfolk"} , "answeringMemberPrinted" : {"_value" : "George Freeman"} , "dateOfAnswer" : {"_value" : "2015-01-20", "_datatype" : "dateTime"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2015-01-20T14:53:16.883Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health"} , "answeringDeptSortName" : {"_value" : "Health"} , "date" : {"_value" : "2015-01-14", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Drugs: Licensing"} , "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, persuant to the Answer of 5 January 2015 to Question 218547, if he will adapt the Early Access to Medicines Scheme to better accommodate off-patent indications of drugs, by creating incentives for pharmaceutical companies to submit applications to the scheme.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/3920", "label" : {"_value" : "Biography information for Naomi Long"} } , "tablingMemberConstituency" : {"_value" : "Belfast East"} , "tablingMemberPrinted" : [{"_value" : "Naomi Long"} ], "uin" : "220673"} , {"_about" : "http://data.parliament.uk/resources/170101", "AnsweringBody" : [{"_value" : "Department of Health"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/170101/answer", "answerText" : {"_value" : "

In June 2013 the National Institute for Health and Care Excellence (NICE) issued an updated clinical guideline on familial breast cancer which includes recommendations on the use of tamoxifen and raloxifene outside their licensed indications for the prevention of cancer in specific groups of women at high and moderate risk of breast cancer.<\/p>

<\/p>

<\/p>

<\/p>

NICE\u2019s clinical guidelines represent best practice and we expect commissioners to take their recommendations into account when designing services and making commissioning decisions for their healthcare population.<\/p>

<\/p>

<\/strong><\/p>

<\/p>

Our assessment is that, as NICE has already provided guidance on the use of tamoxifen and raloxifene, there would be little value in NICE separately appraising these drugs for the prevention of breast cancer and we have had no discussions with NICE on this issue.<\/p>

<\/p>

<\/p>

<\/p>

<\/p>

<\/p>

<\/p>

<\/p>

<\/strong><\/p>

<\/p>

<\/p>

<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4020", "label" : {"_value" : "Biography information for George Freeman"} } , "answeringMemberConstituency" : {"_value" : "Mid Norfolk"} , "answeringMemberPrinted" : {"_value" : "George Freeman"} , "dateOfAnswer" : {"_value" : "2014-12-17", "_datatype" : "dateTime"} , "groupedQuestionUIN" : {"_value" : "218463"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2014-12-17T17:20:27.857Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health"} , "answeringDeptSortName" : {"_value" : "Health"} , "date" : {"_value" : "2014-12-12", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Breast Cancer: Tamoxifen"} , "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, what discussions his Department has had with the National Institute for Health and Care Excellence about a technology appraisal for tamoxifen in the chemoprevention indication.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/3920", "label" : {"_value" : "Biography information for Naomi Long"} } , "tablingMemberConstituency" : {"_value" : "Belfast East"} , "tablingMemberPrinted" : [{"_value" : "Naomi Long"} ], "uin" : "218545"} , {"_about" : "http://data.parliament.uk/resources/170102", "AnsweringBody" : [{"_value" : "Department of Health"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/170102/answer", "answerText" : {"_value" : "

In developing our response to the Bill, we have taken advice from a number of cancer clinicians including breast cancer specialists and from officials at the National Institute for Health and Care Excellence, the Medicines and Healthcare products Regulatory Agency, and taken account of views expressed by other stakeholder organisations.<\/p>

<\/p>

<\/p>

<\/p>

<\/p>

<\/p>"} , "answeringMember" : {"_about" : "http://data.parliament.uk/members/4020", "label" : {"_value" : "Biography information for George Freeman"} } , "answeringMemberConstituency" : {"_value" : "Mid Norfolk"} , "answeringMemberPrinted" : {"_value" : "George Freeman"} , "dateOfAnswer" : {"_value" : "2014-12-17", "_datatype" : "dateTime"} , "groupedQuestionUIN" : {"_value" : "218462"} , "isMinisterialCorrection" : {"_value" : "false", "_datatype" : "boolean"} , "questionFirstAnswered" : [{"_value" : "2014-12-17T17:11:40.23Z", "_datatype" : "dateTime"} ]} , "answeringDeptId" : {"_value" : "17"} , "answeringDeptShortName" : {"_value" : "Health"} , "answeringDeptSortName" : {"_value" : "Health"} , "date" : {"_value" : "2014-12-12", "_datatype" : "dateTime"} , "hansardHeading" : {"_value" : "Drugs: Licensing"} , "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, how many breast cancer clinicians he spoke to directly when developing his policy on the Off-patent Drugs Bill.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"} , "tablingMember" : {"_about" : "http://data.parliament.uk/members/3920", "label" : {"_value" : "Biography information for Naomi Long"} } , "tablingMemberConstituency" : {"_value" : "Belfast East"} , "tablingMemberPrinted" : [{"_value" : "Naomi Long"} ], "uin" : "218546"} , {"_about" : "http://data.parliament.uk/resources/170103", "AnsweringBody" : [{"_value" : "Department of Health"} ], "answer" : {"_about" : "http://data.parliament.uk/resources/170103/answer", "answerText" : {"_value" : "

Off-patent drugs are those whose patent period has expired and consequently manufacturers may make available generic or non-branded versions of the products.<\/p>

<\/p>

<\/p>

<\/p>

An \u201coff-label\u201d medicine is any medicine prescribed outside the terms of its licence (as set out in the prescribing information in the Summary of product Characteristics). Medicines legislation permits prescribers to prescribe a product outside the terms of its licence where they judge it to be in the best interests of the patient to address a medical need. For example to prescribe for a different use or to different category of patients but in doing so the prescriber takes personal responsibility for the treatment, inform the patient(s) of the licensing status of the product and obtain consent from the patient for its use.<\/p>

<\/p>

<\/p>

<\/p>

The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will provide a scientific opinion on the benefit/risk balance of the medicine, based on the data available at the time of the EAMS submission. The scheme is voluntary and as such the MHRA is dependent on companies submitting potential products that may fulfil the EAMS criteria.<\/p>

<\/p>

<\/p>

<\/p>

In the government response to the public consultation, it was confirmed that off-label supply of existing medicines would be eligible for the scheme, but only if they meet the EAMS criteria. Thus companies can submit an application to the EAMS for a new indication for an already marketed drug (which may be off patent).<\/p>

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