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1010660

	registered interest
	date	20/11/2018
	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	Compulsorily Detained Psychiatric Patients: Bolton
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what assessment he has made of the effect of the interim report of the Independent Review of the Mental Health Act on the rate of detentions under that Act in the NHS Bolton clinical commissioning group area.
	tabling member constituency	Bolton South East
	tabling member printed	Yasmin Qureshi
	uin	193436
	answer	answer is ministerial correction date of answer 22/11/2018 answer text <p>The Independent Review of the Mental Health Act 1983 will report before the end of the year. The Government will consider its findings and respond in due course. The Review will make recommendations to Government for how it should improve the Act, including on improving the protection of people’s rights and considering how detentions might be reduced, but it was not commissioned to have a direct influence on legislation or practice.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 192889 192890 192891 192893 192894 192895 192945 193437 question first answered 22/11/2018 17:39:51 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	3924 label Biography information for Yasmin Qureshi

1010661

	registered interest
	date	20/11/2018
	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	Mental Health Act 1983 Independent Review
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what the timetable is for his Department to respond to the recommendations of the Independent Review of the Mental Health Act.
	tabling member constituency	Bolton South East
	tabling member printed	Yasmin Qureshi
	uin	193437
	answer	answer is ministerial correction date of answer 22/11/2018 answer text <p>The Independent Review of the Mental Health Act 1983 will report before the end of the year. The Government will consider its findings and respond in due course. The Review will make recommendations to Government for how it should improve the Act, including on improving the protection of people’s rights and considering how detentions might be reduced, but it was not commissioned to have a direct influence on legislation or practice.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 192889 192890 192891 192893 192894 192895 192945 193436 question first answered 22/11/2018 17:39:51 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	3924 label Biography information for Yasmin Qureshi

1038039

	registered interest
	date	08/01/2019
	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	Pregnancy Tests
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, if he will make an assessment of the merits in the conclusions of the 2018 report by Professor Carl Heneghan on oral hormones pregnancy tests and the risks of congenital malformations; and if he will make a statement.
	tabling member constituency	Bolton South East
	tabling member printed	Yasmin Qureshi
	uin	206297
	answer	answer is ministerial correction date of answer 11/01/2019 answer text <p>In line with the Government’s commitment to review any new evidence in relation to hormone pregnancy tests, the Commission on Human Medicines is convening a new expert group to conduct an independent scientific review of the publication by Professor Carl Heneghan. In addition, the European Medicines Agency’s Committee for Medicinal Products for Human Use is conducting a review of the paper at European Union level, at the request of the Medicines and Healthcare products Regulatory Agency. Once this paper has been fully considered the findings will be made public.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 11/01/2019 15:18:24 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	3924 label Biography information for Yasmin Qureshi

1105699

	registered interest
	date	27/03/2019
	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	Pregnancy Tests
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what steps he has taken to ensure the (a) impartiality and (b) independence of panels members on the Commission on Human Medicines’ independent scientific review of the publication by Professor Carl Heneghan into hormone pregnancy tests.
	tabling member constituency	Bolton South East
	tabling member printed	Yasmin Qureshi
	uin	237673
	answer	answer is ministerial correction date of answer 04/04/2019 answer text <p>Since publication of the report of the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests (HPTs) the Government has committed to review any important new evidence that arises. In response to publication of the study by Heneghan et al. the Commission on Human Medicines convened an Expert Group to advise on the suitability and robustness of the methodology (including the selection and application of the data quality score) and any clinical implications.</p><p> </p><p>To ensure impartiality none of the members of the Group was involved in the previous review by the Expert Working Group on HPTs. A specific conflict of interest policy was developed and all participants were required to complete and sign a declaration of interests form. Participants were asked to declare personal or non-personal interests in the companies who marketed HPTs or whose predecessors marketed them, current or previous involvement in any studies or reviews on HPTs, the expression in public of a strong opinion about HPTs or any of the companies that produced them, and direct or indirect involvement with, or peer review of, the publication by Heneghan et al. The conflict of interest policy and declarations of participants will be made public in due course.</p><p> </p><p>For complete transparency the meeting was observed by the Chair of the Association for Children Damaged by HPTs, an advocate for those affected by thalidomide, a Lay representative and a representative from the Independent Medicines and Medical Devices Safety Review.</p><p> </p><p>In parallel, the European Medicines Agency is conducting an independent review of the publication by Heneghan et al. Both reviews are ongoing, and we expect the conclusions to be made public within a month of their completion, likely to be May 2019.</p><p> </p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 237674 question first answered 04/04/2019 13:11:53 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	3924 label Biography information for Yasmin Qureshi

1105733

	registered interest
	date	27/03/2019
	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	Pregnancy Tests
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what the timetable is for the publication of the findings of the Commission on Human Medicines’ independent scientific review of the publication by Professor Carl Heneghan into hormone pregnancy tests.
	tabling member constituency	Bolton South East
	tabling member printed	Yasmin Qureshi
	uin	237674
	answer	answer is ministerial correction date of answer 04/04/2019 answer text <p>Since publication of the report of the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests (HPTs) the Government has committed to review any important new evidence that arises. In response to publication of the study by Heneghan et al. the Commission on Human Medicines convened an Expert Group to advise on the suitability and robustness of the methodology (including the selection and application of the data quality score) and any clinical implications.</p><p> </p><p>To ensure impartiality none of the members of the Group was involved in the previous review by the Expert Working Group on HPTs. A specific conflict of interest policy was developed and all participants were required to complete and sign a declaration of interests form. Participants were asked to declare personal or non-personal interests in the companies who marketed HPTs or whose predecessors marketed them, current or previous involvement in any studies or reviews on HPTs, the expression in public of a strong opinion about HPTs or any of the companies that produced them, and direct or indirect involvement with, or peer review of, the publication by Heneghan et al. The conflict of interest policy and declarations of participants will be made public in due course.</p><p> </p><p>For complete transparency the meeting was observed by the Chair of the Association for Children Damaged by HPTs, an advocate for those affected by thalidomide, a Lay representative and a representative from the Independent Medicines and Medical Devices Safety Review.</p><p> </p><p>In parallel, the European Medicines Agency is conducting an independent review of the publication by Heneghan et al. Both reviews are ongoing, and we expect the conclusions to be made public within a month of their completion, likely to be May 2019.</p><p> </p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 237673 question first answered 04/04/2019 13:11:53 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	3924 label Biography information for Yasmin Qureshi

1105850

	registered interest
	date	28/03/2019
	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	Pregnancy Tests
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, how much was spent from the public purse on the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests.
	tabling member constituency	Bolton South East
	tabling member printed	Yasmin Qureshi
	uin	238314
	answer	answer is ministerial correction date of answer 02/04/2019 answer text <p>The Commission on Human Medicines (CHM) advises health ministers on the safety, efficacy and quality of medicinal products. Expert Working Groups of the CHM are comprised of independent experts who work on a voluntary basis and receive reasonable expenses. The Medicines and Healthcare products Regulatory Agency provide a secretariat function to the CHM and its Expert Working Groups. This is included in Agency costs. The Agency is an Executive Agency of the Department and it is established as a Government trading fund, with its work predominantly funded by fees charged to the industry it regulates.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 02/04/2019 16:08:11 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	3924 label Biography information for Yasmin Qureshi

1109206

	registered interest
	date	02/04/2019
	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	Pregnancy Tests
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, whether a meta-analysis was carried out as part of the Commission on Human Medicines' Expert Working Group review into Hormone Pregnancy Tests.
	tabling member constituency	Bolton South East
	tabling member printed	Yasmin Qureshi
	uin	239925
	answer	answer is ministerial correction date of answer 09/04/2019 answer text <p>The Commission on Human Medicines’ Expert Working Group (EWG) review into Hormone Pregnancy Tests (HPTs) was comprehensive, scientifically robust and independent. Based on the totality of the data, the review concluded the available scientific evidence did not support a causal association between the use of HPTs during early pregnancy and birth defects or miscarriage. All evidence considered by the EWG has been published online.</p><p> </p><p>The EWG did not undertake a meta-analysis as part of the review. The EWG examined a large number of epidemiological studies, many of which were conducted under different designs. The EWG considered whether meta-analysis was possible and ultimately concluded that because the studies were so different such an analysis would not be informative. Meta-analysis was also not considered appropriate because the studies were not sufficiently robust and suffered from extensive limitations.</p><p> </p><p>The EWG comprised independent experts from a wide range of relevant specialisms and its report was further scrutinised by the Commission on Human Medicines, the Government’s independent scientific advisory body on the safety of medicines. There are no plans for further peer review of the report. The Government is committed to reviewing any important new evidence that arises.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 239926 question first answered 09/04/2019 11:23:15 answering member 4065 label Biography information for Dame Jackie Doyle-Price previous answer version 112745 answering member constituency Thurrock answering member printed Jackie Doyle-Price answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	3924 label Biography information for Yasmin Qureshi

1109215

	registered interest
	date	02/04/2019
	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	Pregnancy Tests
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what plans his Department has for peer review the report of the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests.
	tabling member constituency	Bolton South East
	tabling member printed	Yasmin Qureshi
	uin	239926
	answer	answer is ministerial correction date of answer 09/04/2019 answer text <p>The Commission on Human Medicines’ Expert Working Group (EWG) review into Hormone Pregnancy Tests (HPTs) was comprehensive, scientifically robust and independent. Based on the totality of the data, the review concluded the available scientific evidence did not support a causal association between the use of HPTs during early pregnancy and birth defects or miscarriage. All evidence considered by the EWG has been published online.</p><p> </p><p>The EWG did not undertake a meta-analysis as part of the review. The EWG examined a large number of epidemiological studies, many of which were conducted under different designs. The EWG considered whether meta-analysis was possible and ultimately concluded that because the studies were so different such an analysis would not be informative. Meta-analysis was also not considered appropriate because the studies were not sufficiently robust and suffered from extensive limitations.</p><p> </p><p>The EWG comprised independent experts from a wide range of relevant specialisms and its report was further scrutinised by the Commission on Human Medicines, the Government’s independent scientific advisory body on the safety of medicines. There are no plans for further peer review of the report. The Government is committed to reviewing any important new evidence that arises.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 239925 question first answered 09/04/2019 11:23:15 answering member 4065 label Biography information for Dame Jackie Doyle-Price previous answer version 112746 answering member constituency Thurrock answering member printed Jackie Doyle-Price answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	3924 label Biography information for Yasmin Qureshi

1111113

	registered interest
	date	10/04/2019
	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	Pregnancy Tests
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 9 April 2019 to Question 239926 on Pregnancy Tests, for what reason previous studies were not considered robust; and what the extensive limitations were.
	tabling member constituency	Bolton South East
	tabling member printed	Yasmin Qureshi
	uin	243382
	answer	answer is ministerial correction date of answer 15/04/2019 answer text <p>The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests considered that the key limitations of previous studies related to the accuracy of recording of what drug was taken by the women; clarity over the timing of administration during pregnancy; adjustment for confounding factors; selection of controls; and the statistical methodology.</p><p> </p><p>The Expert Group used a quality scoring system to evaluate the quality of each individual study according to a set of seven pre-defined quality criteria. The criteria and score agreed by the Expert Working Group for each study are published in Annex 27 of the final report.</p><p> </p><p>The criteria for selecting members of the Expert Working Group were based on the expertise needed to evaluate all aspects of the questions before the Group and the types of data that would need to be assessed. Membership included those with expertise in pharmaco-epidemiology, including perinatal and paediatric epidemiology, medical statistics, embryology, clinical genetics, gynaecology, reproductive endocrinology, toxicology and pharmacology.</p><p> </p><p>The process for selecting members was in line with established policy for expert groups of the Commission on Human Medicines, with the nominations being agreed by the Commission and endorsed by Ministers.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 243383 question first answered 15/04/2019 14:23:24 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	3924 label Biography information for Yasmin Qureshi

1111114

	registered interest
	date	10/04/2019
	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	Hormone Pregnancy Tests Expert Working Group
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what the criteria were for selecting members of the Expert Working Group for Hormone Pregnancy Tests.
	tabling member constituency	Bolton South East
	tabling member printed	Yasmin Qureshi
	uin	243383
	answer	answer is ministerial correction date of answer 15/04/2019 answer text <p>The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests considered that the key limitations of previous studies related to the accuracy of recording of what drug was taken by the women; clarity over the timing of administration during pregnancy; adjustment for confounding factors; selection of controls; and the statistical methodology.</p><p> </p><p>The Expert Group used a quality scoring system to evaluate the quality of each individual study according to a set of seven pre-defined quality criteria. The criteria and score agreed by the Expert Working Group for each study are published in Annex 27 of the final report.</p><p> </p><p>The criteria for selecting members of the Expert Working Group were based on the expertise needed to evaluate all aspects of the questions before the Group and the types of data that would need to be assessed. Membership included those with expertise in pharmaco-epidemiology, including perinatal and paediatric epidemiology, medical statistics, embryology, clinical genetics, gynaecology, reproductive endocrinology, toxicology and pharmacology.</p><p> </p><p>The process for selecting members was in line with established policy for expert groups of the Commission on Human Medicines, with the nominations being agreed by the Commission and endorsed by Ministers.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 243382 question first answered 15/04/2019 14:23:24 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	3924 label Biography information for Yasmin Qureshi