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172723

	registered interest
	date	08/01/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	IVF
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government, further to the Written Statement by the Parliamentary Under-Secretary of State for Public Health, Jane Ellison, on 17 December 2014 (HC Deb, col. 96WS), what concerns were raised by the expert panel convened by the Human Fertilisation and Embryology Authority (HFEA) regarding the possibility of carryover of a small percentage of abnormal mitochondrial DNA (mtDNA) from the affected oocyte or zygote as a result of close associations between mtDNA and the karyoplast; what additional consideration the HFEA’s expert panel gave to replicative advantage of some mtDNA variants skewing the proportions in subsequent development as a result of a mitochondrial bottleneck; whether they can therefore guarantee that no females born following spindle-chromosomal complex transfer or pronuclear transfer would ever transmit the disease to subsequent generations; if not, whether serial nuclear transfer would minimise this risk; and why serial nuclear transfer is precluded by Regulations 3(c) and 6(c) of the Draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, which prevent any further "alterations in the nuclear or mitochondrial DNA".
	tabling member printed	Lord Alton of Liverpool
	uin	HL4043
	answer	answer is ministerial correction date of answer 22/01/2015 answer text <p>We are advised by the Human Fertilisation and Embryology Authority (HFEA) that the issues raised by the noble Lord are discussed at various points in the Expert Panel’s 2014 report, as follows:</p><p> </p><p> </p><p> </p><p>- mitochondrial DNA carryover at sections 3.7.2 to 3.7.11;</p><p> </p><p>- nuclear-mitochondrial interactions at sections 3.7.15 to 3.7.20; and</p><p> </p><p>- points relating to replicative advantage and mitochondrial bottleneck are widely discussed throughout section 3.</p><p> </p><p> </p><p> </p><p>The Panel’s report is attached.</p><p> </p><p> </p><p> </p><p>The HFEA has also advised that the Expert Panel it convened concluded that, following Maternal Spindle Transfer or Pronuclear Transfer, the risks of mitochondrial disease in the next generation will be low. Further details can be found in section 3 of the Panel’s 2014 report.</p><p> </p><p> </p><p> </p><p>Serial nuclear transfer is not a term or process connected with mitochondrial donation. Therefore, serial transfer is not something the Expert Panel has considered.</p><p> </p> answering member printed Earl Howe question first answered 22/01/2015 16:49:38 answering member 2000 label Biography information for Earl Howe attachment 1 file name HFEA Panel's Report.pdf title HFEA's Panel Report
	tabling member	738 label Biography information for Lord Alton of Liverpool

173028

	registered interest
	date	12/01/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Antimicrobials: Drug Resistance
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 31 December (HL3763) concerning antimicrobial resistance, how they will consult industry and recruit the group investigating interim issues; and how they will investigate pricing and reimbursement arrangements before the conclusion of the O'Neil review.
	tabling member printed	Baroness Manzoor
	uin	HL4100
	answer	answer is ministerial correction date of answer 26/01/2015 answer text <p>The group to explore how to address interim issues pending the independent Review on Antimicrobial Resistance’s conclusion has not yet been established. Departmental officials have been working with relevant industry trade bodies, which will nominate industry participants in the group. Any discussion of the pricing and reimbursement of newly launched antibiotics or soon-to-be launched antibiotics will need to be framed in a way which does not pre-empt the conclusions of the Review, which is now underway.</p><p> </p> answering member printed Earl Howe question first answered 26/01/2015 12:26:06 answering member 2000 label Biography information for Earl Howe
	tabling member	4289 label Biography information for Baroness Manzoor

172991

	registered interest
	date	12/01/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	IVF
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 18 November 2014 (HL2644), whether they will place in the Library of the House a full copy of the correspondence between members of the expert panel convened by the Human Fertilisation and Embryology Authority and the Zhang research group, as referenced by the Parliamentary Under-Secretary of State for Public Health, Jane Ellison, in her letter to Lord Alton of Liverpool dated 30 October 2014; and if not, what was the evidential basis for the relevant statements in that letter.
	tabling member printed	Lord Alton of Liverpool
	uin	HL4063
	answer	answer is ministerial correction date of answer 26/01/2015 answer text <p>The Human Fertilisation and Embryology Authority (HFEA) has advised that the correspondence the Expert Panel member had with the research group does not add any more information to what had already been outlined in the relevant abstract, by John Zhang et al, published in Fertility and Sterility, Vol. 80, Suppl. 3, September 2003, which makes it clear the complications related to the multiple pregnancy and that the fetuses were found to be genetically normal. The Panel confirmed with the research group that it did not publish any further detail or follow up to this study, so the Panel has taken the view that there is nothing further for it to consider in relation to this case. For this reason, there is no ‘data concerned’.</p><p> </p><p><strong> </strong></p><p> </p><p>The HFEA has also advised that the member of the Expert Panel corresponded with one of the authors of this abstract in his capacity as a Panel member, not on behalf of the HFEA. This correspondence was shared with the other Panel members. The Expert Panel is independent of the HFEA and does not act of its behalf.</p><p> </p> answering member printed Earl Howe grouped question UIN HL4228 question first answered 26/01/2015 12:16:50 answering member 2000 label Biography information for Earl Howe
	tabling member	738 label Biography information for Lord Alton of Liverpool

172992

	registered interest
	date	12/01/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Human-animal Hybrid Embryos
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government, further to the Written Answers by Viscount Younger of Leckie on 12 November 2013 (WA 113) and by Earl Howe on 22 January 2014 (WA 129), whether the generation of any human admixed embryos as defined under section 4A(6)(a) to (c) of the Human Fertilisation and Embryology Act 1990 would constitute genetic modification; and if not, why not.
	tabling member printed	Lord Alton of Liverpool
	uin	HL4064
	answer	answer is ministerial correction date of answer 26/01/2015 answer text <p>The Human Fertilisation and Embryology Authority (HFEA) advises that the creation of human admixed embryos is permitted by the Human Fertilisation and Embryology Act 1990, as amended, solely for the purposes of research allowed by the Act. These embryos cannot continue to be used in research after 14 days or the appearance of the primitive streak, whichever is the earlier, and must be discarded.</p><p> </p><p> </p><p> </p><p>The HFEA does not believe that discussion of genetic modification, as it might be considered to apply to the creation of human admixed embryos, can usefully add to the debate on the definition of genetic modification in humans.</p><p> </p> answering member printed Earl Howe question first answered 26/01/2015 12:18:30 answering member 2000 label Biography information for Earl Howe
	tabling member	738 label Biography information for Lord Alton of Liverpool

173519

	registered interest
	date	13/01/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Pregnancy: Sodium Valproate
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government, following the findings of the European Medicines Agency review of Valproate in pregnancy, and the past issue of the availability of information to patients, why the new instructions from the European Medicines Agency have not become mandatory.
	tabling member printed	Baroness Masham of Ilton
	uin	HL4101
	answer	answer is ministerial correction date of answer 26/01/2015 answer text <p>Sodium valproate has been authorised since the early 1970’s for the treatment of epilepsy. It was known at the time of licensing that valproate was associated with an increased risk of birth defects and it was authorised for the treatment of women of childbearing potential only where other treatments were ineffective. The authorised product information (Summary of Product Characteristics or SPC and Patient Information Leaflet or PIL) contain warnings about the risks associated with use in pregnancy.</p><p> </p><p> </p><p> </p><p>The Medicines and Healthcare products Regulatory Agency (MHRA) initiated a Europe-wide review of the risk of developmental disorders in October 2013 following publication of studies which provided further information on the magnitude and nature of the risk of developmental disorders in children born to mothers who took valproate in pregnancy. The Europe-wide review, led by the United Kingdom and the Netherlands, was completed in November 2014 and MHRA is working to fully implement the conclusions of that review which are binding in all Member States. There will be a mandatory requirement for all manufacturers to update the valproate SPC and PIL with strengthened warnings and in addition new educational materials will be provided to healthcare professionals and patients.</p><p> </p> answering member printed Earl Howe grouped question UIN HL4102 question first answered 26/01/2015 12:28:03 answering member 2000 label Biography information for Earl Howe
	tabling member	1850 label Biography information for Baroness Masham of Ilton

173520

	registered interest
	date	13/01/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Pregnancy: Sodium Valproate
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government whether they intend to issue an apology for the failure to inform female patients of the dangers of Valproate in pregnancy and the harm caused to children as a result.
	tabling member printed	Baroness Masham of Ilton
	uin	HL4102
	answer	answer is ministerial correction date of answer 26/01/2015 answer text <p>Sodium valproate has been authorised since the early 1970’s for the treatment of epilepsy. It was known at the time of licensing that valproate was associated with an increased risk of birth defects and it was authorised for the treatment of women of childbearing potential only where other treatments were ineffective. The authorised product information (Summary of Product Characteristics or SPC and Patient Information Leaflet or PIL) contain warnings about the risks associated with use in pregnancy.</p><p> </p><p> </p><p> </p><p>The Medicines and Healthcare products Regulatory Agency (MHRA) initiated a Europe-wide review of the risk of developmental disorders in October 2013 following publication of studies which provided further information on the magnitude and nature of the risk of developmental disorders in children born to mothers who took valproate in pregnancy. The Europe-wide review, led by the United Kingdom and the Netherlands, was completed in November 2014 and MHRA is working to fully implement the conclusions of that review which are binding in all Member States. There will be a mandatory requirement for all manufacturers to update the valproate SPC and PIL with strengthened warnings and in addition new educational materials will be provided to healthcare professionals and patients.</p><p> </p> answering member printed Earl Howe grouped question UIN HL4101 question first answered 26/01/2015 12:28:03 answering member 2000 label Biography information for Earl Howe
	tabling member	1850 label Biography information for Baroness Masham of Ilton

173537

	registered interest
	date	13/01/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Medicine: Education
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government, further to the Written Answers by Earl Howe on 24 October 2014 (HL2125 and HL2126) and 1 July 2013 (WA 191–2), why the review of medical and dental student intakes recommended by the Health and Education National Strategic Exchange for 2014, which was to be led by Health Education England, did not take place; and why, in its absence, they reconsidered the policy of reducing student intake.
	tabling member printed	Lord Laird
	uin	HL4119
	answer	answer is ministerial correction date of answer 26/01/2015 answer text <p>Health Education England (HEE) plans to undertake a review of the medical student intake in 2015 in the context of the HEE Strategic Framework 15, the HEE Workforce Plan for England 2015-16, and the recently published NHS England Five Year Forward View.</p><p> </p><p> </p><p> </p><p>Working with the Chief Dental Officer for England, HEE took the decision to recommend a reduction in the 2014 student dental intake by 10%. This was in response to a number of issues including detailed analysis supplied by the Centre for Workforce Intelligence that highlighted key changes in the improvement in dental health within England and the need for NHS England to ensure it had available the appropriate workforce to meet the needs of the service going forward.</p><p> </p> answering member printed Earl Howe question first answered 26/01/2015 12:46:52 answering member 2000 label Biography information for Earl Howe
	tabling member	2479 label Biography information for Lord Laird

172722

	registered interest
	date	08/01/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	IVF
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 6 February 2014 (WA 76) and the Written Statement by the Parliamentary Under-Secretary of State for Public Health, Jane Ellison, on 17 December 2014 (HC Deb, cols 96–7WS), whether an enucleated embryo being unable to survive without nuclear DNA necessarily implies that both steps of the different processes described in Regulations 4 and 7 must be completed in their entirety in order to generate the permitted egg or embryo referred to in Regulations 3(a) and 6(a) respectively of the Draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015; and if not, whether they will describe how individual eggs or embryos that have been enucleated might be used directly in infertility treatment as egg P or embryo P.
	tabling member printed	Lord Alton of Liverpool
	uin	HL4042
	answer	answer is ministerial correction date of answer 22/01/2015 answer text <p>Enucleated eggs and embryos are, in themselves, non-viable and, therefore, cannot be used for the treatment of infertility. The different processes used to generate a permitted egg or embryo, referred to in Regulations 4 and 7, will be completed in their entirety.</p><p> </p> answering member printed Earl Howe question first answered 22/01/2015 11:50:59 answering member 2000 label Biography information for Earl Howe
	tabling member	738 label Biography information for Lord Alton of Liverpool

173538

	registered interest
	date	13/01/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	General Practitioners
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 24 October 2014 (HL2125 and HL2126), what plans they have to address the current shortage of general practitioners; whether they will review their decision to reduce the number of students entering medical school this year; and whether they intend to rely on foreign medical graduates coming to this country to fill vacancies for the foreseeable future.
	tabling member printed	Lord Laird
	uin	HL4120
	answer	answer is ministerial correction date of answer 26/01/2015 answer text <p><em>There are more than 1,000 more general practitioners (GPs) now working and training in the National Health Service than from the position in September 2010, the most recent figures after the General Election – these data are published once a year in September. The next census as at 30 September 2014 will be published in March 2015.</em></p><p> </p><p><em> </em></p><p> </p><p><em>Transforming Primary Care </em>set out the intention to make available around 10,000 primary and community health and care professionals by 2020, in support of the shift in how care will be provided. Bringing forward substantial numbers of new GPs through training is a key part of this, and Health Education England’s (HEE) mandate commitment will increase the total number of GPs available by 5,000.</p><p> </p><p><em> </em></p><p> </p><p><em>In order to understand the needs of the primary care workforce of the future, HEE has commissioned an independent review. On 10 December 2014, HEE announced that Professor Martin Roland, Professor of Health Services Research, University of Cambridge, will Chair the Primary Care Workforce Commission. </em></p><p> </p><p><em> </em></p><p> </p><p><em>The work was commissioned by HEE at the request of the Secretary of State for Health, due to the future health and care system requiring greater emphasis on community, primary and integrated services, and to ensure that we have the primary care workforce to meet the changing needs for healthcare, therefore it will focus on: </em></p><p> </p><p><em> </em></p><p> </p><p><em>- </em><em>patient and population need; </em></p><p> </p><p><em>- </em><em>emerging models of care to respond to the population need; </em></p><p> </p><p><em>- </em><em>maximising new skill sets; and</em></p><p> </p><p><em>- </em><em>education and training. </em></p><p> </p><p><em> </em></p><p> </p><p><em>HEE are currently implementing a number of projects to support recruitment into practice. This includes a pre-GP year pilot in five Local Education and Training Boards that provides targeted educational development for those expressing interest in general practice, and the launch of a primary and community care programme.</em></p><p> </p><p> </p><p> </p><p>HEE plan to undertake a review of the medical student intake in 2015 in the context of the HEE Strategic Framework 15, the HEE Workforce Plan for England 2015-16, and the recently published NHS England Five Year Forward View.</p><p> </p> answering member printed Earl Howe question first answered 26/01/2015 13:00:07 answering member 2000 label Biography information for Earl Howe
	tabling member	2479 label Biography information for Lord Laird

173011

	registered interest
	date	12/01/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Cancer: Screening
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government what steps they are taking to ensure that patients in England have access to cancer-related molecular testing.
	tabling member printed	Lord Hunt of Kings Heath
	uin	HL4083
	answer	answer is ministerial correction date of answer 26/01/2015 answer text <p><em>Improving Outcomes: a Strategy for Cancer</em> (Department of Health, 2011) did include a specific commitment to develop a commissioning and funding structure which would enable the efficient delivery of high quality molecular diagnostic testing through centres of excellence. The first phase of this work included the establishment of the Human Genomics Strategy Group (HGSG). NHS England drew upon the work of the HGSG, specifically the report <em>Building on our Inheritance; Genomic technology in healthcare</em> (2012), in the production of the proposed genetics laboratory service specification.</p><p> </p><p> </p><p> </p><p>Since 2011, the field of genetic medicine and genomics has progressed rapidly with many molecular tests now available locally. Further work is underway to better understand the specific responsibilities of NHS England as a direct commissioner of specialised services, clarify the legacy arrangements of how such tests are currently commissioned and ensure alignment with the National Tariff payment rules. This may highlight the need to develop specific commissioning policies, or undertake other commissioning interventions, that will support the continued diffusion of such technology across the National Health Service.</p><p> </p><p> </p><p> </p><p>Molecular diagnostics for cancer is the responsibility of a range of commissioners, and historically many of these tests have been funded in a number of different ways including by industry (i.e., have been free to the NHS). The legacy work may highlight a need for NHS England to undertake commissioning interventions, which could include the development of specific commissioning policies or pricing work.</p><p> </p><p> </p><p> </p><p>Funding for these molecular tests is complex. At this stage, the earliest opportunity for changes to be made to the National Tariff, should such action be thought to be necessary, is now 2016-17 with consultation on any proposals being launched in summer 2015.</p><p> </p><p> </p><p> </p><p>In the meantime, NHS England is currently consulting on a new service specification for the genetic/genomic laboratory services which is its direct commissioning responsibility. A procurement process will take place following the consultation. The consultation, including the proposed service specification, can be accessed at:</p><p> </p><p> </p><p> </p><p><a href="https://www.engage.england.nhs.uk/consultation/genomic-laboratories" target="_blank">https://www.engage.england.nhs.uk/consultation/genomic-laboratories</a></p><p> </p><p> </p><p> </p><p>The Department is not aware of any such targets for introducing and funding diagnostics testing. NHS England do not agree that there has been reduced access to molecular testing for cancer, but accept that there has always been variation.</p><p> </p><p> </p><p> </p><p>The Department holds NHS England to account for achieving its objectives in a number of ways. The Mandate to NHS England, published by the Department, sets out its core objectives. NHS England must publish an annual business plan, and report on progress against its objectives at the end of each year. At the end of each year, the Secretary of State also publishes an assessment of NHS England’s performance. The Secretary of State holds regular accountability meetings with NHS England based on an assessment of performance against the Mandate and its wider functions.</p><p> </p> answering member printed Earl Howe grouped question UIN HL4084 HL4085 HL4086 HL4087 question first answered 26/01/2015 12:24:07 answering member 2000 label Biography information for Earl Howe
	tabling member	2024 label Biography information for Lord Hunt of Kings Heath