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827924

registered interest
date	22/01/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Radioisotopes
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 18 January (HL4659), whether, after exit from the EU, the licensing regime for medical isotopes will be the responsibility of the Medicines and Healthcare Products Regulatory Agency (MHRA) even where those isotopes are manufactured outside the UK; and if so, how the MHRA will ensure the safety of manufacture outside the Euratom framework.
tabling member printed	Lord Warner
uin	HL4974
answer	answer is ministerial correction date of answer 05/02/2018 answer text <p>Medical isotopes may be either medicinal products or medical devices regulated according to the appropriate legislation. The system of regulation after exiting the European Union depends on agreements reached as part of current negotiations, however, the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to be responsible for the regulation of such products placed on the market in the United Kingdom.</p><p>Medical isotopes or radiopharmaceuticals that are medicinal products are regulated in accordance with the laws applicable to all medicines. Currently there are products regulated nationally by national competent authorities (such as MHRA) or centrally by the European Medicines Agency (EMA). National competent authorities have a shared role in the licencing of centrally authorised products.</p><p>If required as a result of the terms of the EU exit, the MHRA will regulate products licenced nationally and those that would have been authorised via the centralised route including verification of compliance with good manufacturing practice.</p><p>Currently medical isotopes that are medical devices are regulated in accordance with the laws applicable to medical devices implementing directives 93/42/EEC, 98/79/EC and 90/385/EEC.</p><p>The three directives do refer to EURATOM requirements but these aspects are covered in the UK by other organisations such as the Department of Health and Social Care, the Department for Business, Energy and Industrial Strategy, the Health and Safety Executive and the Environment Agency under the relevant UK legislation.</p><p>The new European medical device regulations (2017/745 and 2017/746) are in force and are due to apply from May 2020 for medical devices and May 2022 for In Vitro Diagnostic medical devices. Again, these refer to EURATOM requirements but these aspects are similarly covered in the UK by other organisations.</p><p>The situation after exiting the EU depends on any agreements reached but is likely that the other Government agencies mentioned above will continue to be responsible for those aspects currently covered by the EURATOM legislation.</p> answering member printed Lord O'Shaughnessy question first answered 05/02/2018 12:38:17 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1732 label Biography information for Lord Warner

827925

registered interest
date	22/01/2018
answering body	Department for Business, Energy and Industrial Strategy
answering dept id	201
answering dept short name	Business, Energy and Industrial Strategy
answering dept sort name	Business, Energy and Industrial Strategy
hansard heading	Radioisotopes
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 18 January (HL4659), which body or bodies in the UK will be responsible for setting and enforcing the standards for the safe use, disposal and transportation of medical isotopes after exit from the EU; and how will that body, or those bodies, ensure that the necessary upgrades in standards in those areas currently secured through EU directives are maintained in the UK after exit day.
tabling member printed	Lord Warner
uin	HL4975
answer	answer is ministerial correction date of answer 29/01/2018 answer text <p>The safety and security of radioactive materials is a top priority for the Government. The UK already has robust domestic legislation in place to ensure that the keeping, movement and use of radioactive sources is tightly regulated, whether on nuclear sites or in hospitals. The UK’s regulatory regime is based on international regulatory requirements for sources informed by the International Atomic Energy Agency (IAEA). Following our withdrawal from the EU and Euratom, the UK will continue to meet its international obligations in full and ensure that UK law and regulatory oversight continues to deliver the highest standards of safety, in line with the relevant international frameworks.</p> answering member printed Lord Henley question first answered 29/01/2018 15:51:59 answering member 2616 label Biography information for Lord Henley
tabling member	1732 label Biography information for Lord Warner

827926

registered interest
date	22/01/2018
answering body	Department for Business, Energy and Industrial Strategy
answering dept id	201
answering dept short name	Business, Energy and Industrial Strategy
answering dept sort name	Business, Energy and Industrial Strategy
hansard heading	Radioisotopes
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 18 January (HL4659), which body will discharge the framework-setting role currently performed by Euratom with regard to the safe manufacture, transport, use and disposal of medical isotopes.
tabling member printed	Lord Warner
uin	HL4976
answer	answer is ministerial correction date of answer 29/01/2018 answer text <p>The safety and security of radioactive materials is a top priority for the Government. The UK already has robust domestic legislation in place to ensure that the keeping, movement and use of radioactive sources is tightly regulated, whether on nuclear sites or in hospitals. The UK’s regulatory regime is based on international regulatory requirements for sources informed by the International Atomic Energy Agency (IAEA). The UK will continue to meet its international obligations in full and ensure that UK law and regulatory oversight continues to deliver the highest standards of safety, in line with the relevant international frameworks.</p><p>Medical radioisotopes are also subject to European medicines regulation which establishes a licensing regime and controls on the quality of materials, as well as manufacturing and distribution processes within Europe. In the UK human medicines are subject to national human medicines legislation which transposes the requirements of the European regulatory regime. This regime is enforced by the Medicines and Healthcare Products Regulatory Agency (MHRA) and will continue to do so after our withdrawal from the EU.</p> answering member printed Lord Henley question first answered 29/01/2018 15:58:58 answering member 2616 label Biography information for Lord Henley
tabling member	1732 label Biography information for Lord Warner

820688

registered interest
date	11/01/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	NHS: Standards
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government whether they plan to incorporate access targets from the NHS Constitution into the performance ratings of NHS Trusts that are produced by the Care Quality Commission.
tabling member printed	Lord Warner
uin	HL4658
answer	answer is ministerial correction date of answer 24/01/2018 answer text <p>The Care Quality Commission (CQC) has provided the following response:</p><p>The CQC already reports on access targets under the key inspection question: ‘are they responsive to people’s needs’. The CQC runs analysis on these indicators to support its monitoring, inspection and ratings of this key question.</p> answering member printed Lord O'Shaughnessy question first answered 24/01/2018 13:10:48 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1732 label Biography information for Lord Warner

820689

registered interest
date	11/01/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Radioisotopes
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what arrangements are currently in place for ensuring (1) the safety and quality of medical isotopes used by the NHS when they leave production centres in mainland Europe, and (2) the safe handling of such isotopes following arrival in the UK; and what role Euratom plays in delivering those arrangements.
tabling member printed	Lord Warner
uin	HL4659
answer	answer is ministerial correction date of answer 18/01/2018 answer text <p>Radio pharmaceuticals (medical isotopes) used for diagnostic procedures are human medicines and are the subject of European medicines regulations which sets out a licensing regime and includes controls on the quality of materials used and processes followed during manufacture and the way they are distributed within Europe.</p><p> </p><p>In the United Kingdom, human medicines are subject to national human medicines legislation which transposes the requirements of the European regulatory regime.</p><p> </p><p>As a form of radioactive material, medical radioisotopes are covered by the European atomic energy community (Euratom) Treaty framework. However, they are not classified as special fissile material so they are not covered by the safeguards provisions of that Treaty.</p><p> </p><p>The use and disposal of medical radioisotopes are governed by a set of standards established in domestic legislation (and regulated by domestic regulators) that have in some cases been informed by Euratom standards.</p><p> </p><p>The UK already has robust, domestic regimes in place for the safety, security, transport, use and disposal of nuclear and radioactive materials – including medical radioisotopes – throughout their lifecycle. These regimes will remain in place as the UK leaves Euratom, ensuring we exit with certainty, clarity and control.</p><p> </p><p>In addition, relevant Euratom and European Union safety and transport legislation Directives have already been, or are in the process of being, transposed into UK law before the UK’s withdrawal. The EU Withdrawal Bill will convert all European law, including that made under the Euratom Treaty, as it stands at the moment of exit into UK law.</p><p> </p> answering member printed Lord O'Shaughnessy question first answered 18/01/2018 12:22:06 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1732 label Biography information for Lord Warner

820541

registered interest
date	10/01/2018
answering body	Department for Education
answering dept id	60
answering dept short name	Education
answering dept sort name	Education
hansard heading	Out-of-school Education: Hackney
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government, further to the Written Answer by Lord Agnew of Oulton on 5 January (HL4335), what evidence they have for the statement that “there are far fewer unregistered schools than many had believed to be the case”, in the light of a recent report by the London Borough of Hackney Scrutiny Commission which stated that between 1,000 and 1,500 Charedi boys were in unregistered schools in that Borough; and what assessment they have made of Hackney Council’s findings in this regard.
tabling member printed	Lord Warner
uin	HL4622
answer	answer is ministerial correction date of answer 24/01/2018 answer text <p>The evidence for the government’s statement is in Her Majesty’s Chief Inspector’s annual report, attached, published in December 2017, which includes statistics about the work of Ofsted’s unregistered schools team. Over an 18 month period, the Ofsted team looked into many possible settings but determined that only 38 of them had been operating as unregistered schools, and secured that, as at August 2017, 34 of those 38 settings ceased operating illegally.</p><p> </p><p>We are aware of the recent findings in the Borough of Hackney, which refer to between 1,000 – 1,500 Charedi boys in out-of-school settings in that borough. The report made clear that these were yeshivas, offering religious teaching, in settings that do not meet the criteria to register as independent schools, but were operating as out-of-school settings.</p><p>The government’s Counter Extremism Strategy, published in 2015, set out plans to introduce a new system of oversight for out-of-school settings which teach children intensively, including part-time religious settings. We undertook a call for evidence to learn more about the range of settings, and to determine the potential scope and impact of introducing a regulatory system.</p><p> </p><p>As well as considering the views of those that responded to the call for evidence, the department has been working with a range of stakeholders to strengthen our understanding of these settings, which vary considerably in their characteristics and the activities and education they offer. We will make an announcement on the outcome shortly.</p><p> </p><p>It is Ofsted, rather than local authorities, that have powers in relation to unregistered schools, to collect evidence to support prosecutions. The department and Ofsted operate a joint team on unregistered schools and work together closely on all relevant issues, including on the extent of Ofsted’s powers, which are always kept in view.</p> answering member printed Lord Agnew of Oulton grouped question UIN HL4624 question first answered 24/01/2018 14:21:00 answering member 4689 label Biography information for Lord Agnew of Oulton attachment 1 file name Ofsted_Annual_Report_2016-17_Accessible.pdf title Ofsted Annual Report 2016/17
tabling member	1732 label Biography information for Lord Warner

820542

registered interest
date	10/01/2018
answering body	Department for Education
answering dept id	60
answering dept short name	Education
answering dept sort name	Education
hansard heading	Out-of-school Education
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government, further to the Written Answer by Lord Agnew of Oulton on 5 January (HL4335), what steps they are taking to ensure that the 34 unregistered schools that ceased to operate as a result of Ofsted action will not re-establish themselves elsewhere, given that no operators of the illegal closed schools were prosecuted.
tabling member printed	Lord Warner
uin	HL4623
answer	answer is ministerial correction date of answer 24/01/2018 answer text <p>In most cases, proprietors voluntarily complied with the law following the inspection by Ofsted, either by closing completely or by reducing their operation to a lawful part time provision. Some settings also went on to register as independent schools, so that they could legitimately re-open or increase their hours to full-time. Ofsted carries out further inspections without notice where it has reasonable cause to believe that an unregistered independent school continues to operate, either at the same premises or if it has re-established elsewhere. The Ofsted team draws significantly on local knowledge, from the local authority and other sources, on where such settings may be operating. The Department for Education/Ofsted joint team works together closely on all these issues. This remains a high priority for both the government and Ofsted.</p> answering member printed Lord Agnew of Oulton question first answered 24/01/2018 14:18:45 answering member 4689 label Biography information for Lord Agnew of Oulton
tabling member	1732 label Biography information for Lord Warner

820543

registered interest
date	10/01/2018
answering body	Department for Education
answering dept id	60
answering dept short name	Education
answering dept sort name	Education
hansard heading	Out-of-school Education
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government whether they will consider extending the definition of a school to cover part-time religious settings and expand the powers of entry, inspection and enforcement for local authorities to deal with unregistered schools in the light of recent findings in the London Borough of Hackney of the problems caused by such schools.
tabling member printed	Lord Warner
uin	HL4624
answer	answer is ministerial correction date of answer 24/01/2018 answer text <p>The evidence for the government’s statement is in Her Majesty’s Chief Inspector’s annual report, attached, published in December 2017, which includes statistics about the work of Ofsted’s unregistered schools team. Over an 18 month period, the Ofsted team looked into many possible settings but determined that only 38 of them had been operating as unregistered schools, and secured that, as at August 2017, 34 of those 38 settings ceased operating illegally.</p><p> </p><p>We are aware of the recent findings in the Borough of Hackney, which refer to between 1,000 – 1,500 Charedi boys in out-of-school settings in that borough. The report made clear that these were yeshivas, offering religious teaching, in settings that do not meet the criteria to register as independent schools, but were operating as out-of-school settings.</p><p>The government’s Counter Extremism Strategy, published in 2015, set out plans to introduce a new system of oversight for out-of-school settings which teach children intensively, including part-time religious settings. We undertook a call for evidence to learn more about the range of settings, and to determine the potential scope and impact of introducing a regulatory system.</p><p> </p><p>As well as considering the views of those that responded to the call for evidence, the department has been working with a range of stakeholders to strengthen our understanding of these settings, which vary considerably in their characteristics and the activities and education they offer. We will make an announcement on the outcome shortly.</p><p> </p><p>It is Ofsted, rather than local authorities, that have powers in relation to unregistered schools, to collect evidence to support prosecutions. The department and Ofsted operate a joint team on unregistered schools and work together closely on all relevant issues, including on the extent of Ofsted’s powers, which are always kept in view.</p> answering member printed Lord Agnew of Oulton grouped question UIN HL4622 question first answered 24/01/2018 14:21:00 answering member 4689 label Biography information for Lord Agnew of Oulton attachment 1 file name Ofsted_Annual_Report_2016-17_Accessible.pdf title Ofsted Annual Report 2016/17
tabling member	1732 label Biography information for Lord Warner

809638

registered interest
date	19/12/2017
answering body	Attorney General
answering dept id	88
answering dept short name	Attorney General
answering dept sort name	Attorney General
hansard heading	Out-of-school Education: Prosecutions
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government, further to the Written Answer by Lord Keen of Elie on 6 November (HL2408), whether there have been no prosecutions for operating unregistered schools because no cases have been put to the Crown Prosecution Service, or for evidential reasons.
tabling member printed	Lord Warner
uin	HL4333
answer	answer is ministerial correction date of answer 05/01/2018 answer text <p>The offences under sections 96 and 97 of the Education and Skills Act 2008 came into force, as they relate to independent schools, on 5 January 2015. Since that date two cases have been referred to the Crown Prosecution Service for early investigative advice following which investigations were discontinued. Two further cases have been referred to the Crown Prosecution Service for a charging decision. In both of these latter cases the evidential test under the Code for Crown Prosecutors was not met.</p><p> </p> answering member printed Lord Keen of Elie question first answered 05/01/2018 12:56:41 answering member 4538 label Biography information for Lord Keen of Elie
tabling member	1732 label Biography information for Lord Warner

809639

registered interest
date	19/12/2017
answering body	Department for Education
answering dept id	60
answering dept short name	Education
answering dept sort name	Education
hansard heading	Ofsted: Security
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what steps they are taking to protect the Chief Inspector of Schools and her staff and offices in the light of threatened attacks following Ofsted's criticism of faith-based schools.
tabling member printed	Lord Warner
uin	HL4334
answer	answer is ministerial correction date of answer 05/01/2018 answer text <p>It is imperative that Her Majesty’s Chief Inspector and her staff feel able to carry out their responsibilities and report their findings without fear or favour. The Cabinet Office sets security policy for government, which all departments, including Ofsted, follow. Any concerns that Her Majesty’s Chief Inspector or her staff have regarding their personal safety or building security would in the first instance, be discussed with the police who would consider the nature of any threats, provide appropriate security advice and recommend any further measures.</p> answering member printed Lord Agnew of Oulton question first answered 05/01/2018 14:55:45 answering member 4689 label Biography information for Lord Agnew of Oulton
tabling member	1732 label Biography information for Lord Warner