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810732

registered interest
date	21/12/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Organs: Donors
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what assessment his Department has made of the potential benefit of measures to support organ donation other than an opt-out system.
tabling member constituency	Congleton
tabling member printed	Fiona Bruce
uin	121077
answer	answer is ministerial correction date of answer 08/01/2018 answer text <p>The last major review of organ donation in 2008 concluded that the case for a change to the law on consent was finely balanced and that other aspects of the systems supporting donation should be developed before any change to the law. Those actions, included in the United Kingdom-wide strategy Taking Organ Transplantation to 2020, have resulted in year on year growth in the number of transplants, seen the number of people on the NHS Organ Donation Register increase by almost five million people over the last five years and, in 2016/17, the highest ever deceased donor rates in England. The Government wants to see rates of transplantation in England amongst the best in the world and is keen to explore all options to increase the availability of suitable organs for transplantation. As part of the consultation on an opt-out system of consent, the Government has invited further evidence to be submitted which could impact on the desired outcome to increase the number of organs for transplant in England. This evidence will be carefully considered before the Government responds.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 08/01/2018 17:14:41 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	3958 label Biography information for Fiona Bruce

809556

registered interest
date	19/12/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Contraceptives: Pregnancy
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, if the Medicines and Healthcare Products Regulatory Agency will review the description in ellaOne packaging that states that if you are already pregnant, it [ellaOne] will not interrupt an existing pregnancy.
tabling member constituency	Congleton
tabling member printed	Fiona Bruce
uin	120214
answer	answer is ministerial correction date of answer 27/12/2017 answer text <p>EllaOne is an ulipristal acetate-containing emergency hormonal contraceptive that is licensed for use within five days of unprotected sexual intercourse or contraceptive failure. It is classified as a female emergency contraceptive; it is not an abortifacient. It exerts its contraceptive action by preventing or delaying ovulation. EllaOne has never been studied as an abortifacient. It is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant. The information provided in each pack of ellaOne clearly informs women and healthcare professionals that it should not be taken by a woman who knows or suspect she is pregnant.</p><p> </p><p>The requirements for medicines labelling are set out within Title V of Council Directive 2001/83/EC. As ellaOne is authorised throughout the European Union the labelling particulars are agreed across all member states by the European Medicines Agency. The Medicines and Healthcare products Regulatory Agency will be liaising with the European Medicines Agency to discuss whether any changes might be desirable within the terms of the marketing authorisation.</p><p> </p><p>As with all other licensed medicines, the Medicines and Healthcare products Regulatory Agency keeps the safety of ellaOne under close review using a wide number of data sources.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 27/12/2017 11:07:57 answering member 4067 label Biography information for Steve Brine
tabling member	3958 label Biography information for Fiona Bruce

809560

registered interest
date	19/12/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Abortion: Northern Ireland
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what assessment he has made of the effect of the extension of the Northern Ireland abortion scheme to include the provision of free travel for Northern Irish women seeking abortion from a certain income bracket will have on the autonomy of the Northern Ireland Assembly.
tabling member constituency	Congleton
tabling member printed	Fiona Bruce
uin	120218
answer	answer is ministerial correction date of answer 22/12/2017 answer text <p>Providing support for travel costs for those who meet financial hardship criteria does not impact on the autonomy of the Northern Ireland Assembly. This scheme does not change the fundamental position that the Abortion Act 1967 does not apply to Northern Ireland. Abortion legislation, and the provision of abortion services in Northern Ireland, are a matter for Northern Ireland.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 22/12/2017 14:10:09 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	3958 label Biography information for Fiona Bruce

809561

registered interest
date	19/12/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Abortion: Private Sector
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what assessment he has made of the effectiveness of the regulation of private abortion clinics.
tabling member constituency	Congleton
tabling member printed	Fiona Bruce
uin	120219
answer	answer is ministerial correction date of answer 22/12/2017 answer text <p>A robust process is in place for regulating independent sector abortion clinics. Independent sector abortion providers must be registered with the Care Quality Commission (CQC) to carry out that regulated activity and have received written approval from the Secretary of State for Health and agree to comply with the Department’s Required Standard Operating Procedures (RSOPs).</p><p> </p><p>The CQC is responsible for ensuring that the requirements under the Health and Social Care Act 2008 are maintained through a system of monitoring and, where appropriate, inspection visits. If a CQC inspection identifies instances of non-compliance with the Health and Social Care Act and Regulations then appropriate regulatory action will be taken. Action will similarly be taken where providers are found not to be acting in accordance with the Abortion Act and RSOPs. This includes reporting any concerns in relation to termination of pregnancy practice to the Department, who then considers the appropriate action to be taken including reporting the matter to the police and/or withdrawing Secretary of State’s approval of the clinic to perform abortions.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 22/12/2017 14:05:45 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	3958 label Biography information for Fiona Bruce

809563

registered interest
date	19/12/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Abortion: Research
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what assessment his Department has made of the potential implications for his policy on abortion of research demonstrating the capacity of foetuses to react to pain.
tabling member constituency	Congleton
tabling member printed	Fiona Bruce
uin	120221
answer	answer is ministerial correction date of answer 22/12/2017 answer text <p>As with other matters of conscience, abortion is an issue on which the Government adopts a neutral stance. It is accepted Parliamentary practice that proposals for changes in the law on abortion come from back-bench members and that decisions are made on the basis of free votes.</p><p> </p><p>The Department does not set clinical practice in abortion services. To support clinical practice, the Royal College of Obstetricians and Gynaecologists has published evidence based guidelines, ‘Fetal Awareness: Review of Research and Recommendations for Practice’, which can be viewed at:</p><p><a href="https://www.rcog.org.uk/en/guidelines-research-services/guidelines/fetal-awareness---review-of-research-and-recommendations-for-practice/" target="_blank">https://www.rcog.org.uk/en/guidelines-research-services/guidelines/fetal-awareness---review-of-research-and-recommendations-for-practice/</a></p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 22/12/2017 14:26:05 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	3958 label Biography information for Fiona Bruce

809565

registered interest
date	19/12/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Abortion: Northern Ireland
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what guidance his Department will issue on cases where, under the extension of the Northern Ireland abortion scheme to provide free travel to women from low-income backgrounds to have abortions in England, women travel from Northern Ireland to England and then change their mind about the procedure.
tabling member constituency	Congleton
tabling member printed	Fiona Bruce
uin	120223
answer	answer is ministerial correction date of answer 22/12/2017 answer text <p>The Government plans to ensure that arrangements for free travel for women travelling to England from Northern Ireland to undergo an abortion reflect the system which applies in England. Women can decide not to proceed with a termination at any time. No attempt will be made to recoup any costs either for the procedure or travel unless clear evidence of fraudulent activity should emerge.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 22/12/2017 14:04:07 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	3958 label Biography information for Fiona Bruce

809566

registered interest
date	19/12/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Pregnancy Remains
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what guidance his Department has issued on the disposal of post-abortive foetuses by hospitals and private clinics.
tabling member constituency	Congleton
tabling member printed	Fiona Bruce
uin	120224
answer	answer is ministerial correction date of answer 22/12/2017 answer text <p>The Human Tissue Authority published guidance on the disposal of pregnancy remains following pregnancy loss or termination in March 2015. The guidance sets out the minimum standard expected for the disposal of tissue following pregnancy loss or termination of pregnancy and applies equally to National Health Service hospitals and independent sector providers. A copy of the guidance can be viewed at:</p><p><a href="https://www.hta.gov.uk/sites/default/files/Guidance_on_the_disposal_of_fetal_remains.pdf" target="_blank">https://www.hta.gov.uk/sites/default/files/Guidance_on_the_disposal_of_fetal_remains.pdf</a></p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 22/12/2017 14:22:56 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	3958 label Biography information for Fiona Bruce

806660

registered interest
date	14/12/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Contraceptives
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what information her Department holds on how many occasions ellaOne, ulipristal acetate 30 mg tablet, has been sold in the UK in 2016.
tabling member constituency	Congleton
tabling member printed	Fiona Bruce
uin	119736
answer	answer is ministerial correction date of answer 21/12/2017 answer text <p>During the time period 1 January 2016 to 31 December 2016, it is estimated that approximately 90,500 tablets of ellaOne 30mg were dispensed against a prescription in pharmacies in the United Kingdom. In addition, it is estimated that there were a further 39,000 tablets of ellaOne 30mg purchased ‘over the counter’ in pharmacies (i.e. without a prescription) in the United Kingdom during the same time period.</p><p> </p><p>This usage data does not capture provision of ellaOne via family planning clinics or stock ordered directly from the manufacturer, via other hospitals or other wholesalers not captured by the database, and therefore some usage for ellaOne will not be included in these figures. For these reasons, the data should be interpreted with caution.</p><p> </p><p>The source of this data is MIDAS Quintiles.</p><p> </p><p>EllaOne is an ulipristal acetate-containing emergency hormonal contraceptive that is licensed for use within five days of unprotected sexual intercourse or contraceptive failure. It is classified as a female emergency contraceptive; it is not an abortifacient. It exerts its contraceptive action by preventing or delaying ovulation. EllaOne has never been studied as an abortifacient. It is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant.</p><p> </p><p>Following a High Court ruling in 2002, emergency contraception is a method of contraception not abortion. The decision confirms the Government’s long held position that a pregnancy begins at implantation and not fertilisation. This judgment means that this position is now established in law and is not a matter of policy.</p><p> </p><p>As with all other licensed medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) keeps the safety of ellaOne under close review using a wide number of data sources. These include reports of suspected adverse drug reactions which include pregnancies; spontaneously provided by health professionals and patients through the ‘Yellow Card scheme’. Other sources of data that the MHRA reviews on a regular basis, and which may include information on safety and/or lack of efficacy or inappropriate use, include periodic safety update reports, renewals and variations to product licences. The MHRA also reviews important published medical literature and the results of any new clinical trials or epidemiological studies as they become available.</p><p> </p><p>As with all marketed medicines, the MHRA will continue to monitor the use of ellaOne. In the event that these monitoring processes identify information that suggest that ellaOne is used outside of its licensed indication, advice will be sought from the Commission on Human Medicines and its expert advisory groups. There are post-marketing regulatory measures in place to ensure that ellaOne is used as safely as possible. These measures include a European Union-wide pregnancy registry which collects data on pregnancy outcomes (including pregnancy maintenance and effects on the foetus or newborn) following exposure to ellaOne for any reason. The registry is available at the following link:</p><p><a href="http://www.hra-pregnancy-registry.com" target="_blank">www.hra-pregnancy-registry.com</a></p><p>Women and healthcare professionals involved in the care of pregnant women are asked to report ellaOne exposed pregnancies to the registry via the ellaOne prescribing information and patient leaflet, as well as via yearly letters sent by the marketing authorisation holder. Abortion clinics in particular are requested to ensure that every pregnant woman is asked whether she has taken emergency contraception and if so, to specify which product.</p><p> </p><p>The world-wide data available to date, including data from the EU pregnancy registry, do not suggest any safety concerns following exposure to ellaOne during pregnancy.</p><p> </p><p> </p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 119739 119740 question first answered 21/12/2017 16:55:09 answering member 4067 label Biography information for Steve Brine
tabling member	3958 label Biography information for Fiona Bruce

806663

registered interest
date	14/12/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Contraceptives
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, if his Department will undertake a review of the potential abortifacient effect of ellaOne, the ulipristal acetate 30 mg tablet; and if he will make a statement.
tabling member constituency	Congleton
tabling member printed	Fiona Bruce
uin	119739
answer	answer is ministerial correction date of answer 21/12/2017 answer text <p>During the time period 1 January 2016 to 31 December 2016, it is estimated that approximately 90,500 tablets of ellaOne 30mg were dispensed against a prescription in pharmacies in the United Kingdom. In addition, it is estimated that there were a further 39,000 tablets of ellaOne 30mg purchased ‘over the counter’ in pharmacies (i.e. without a prescription) in the United Kingdom during the same time period.</p><p> </p><p>This usage data does not capture provision of ellaOne via family planning clinics or stock ordered directly from the manufacturer, via other hospitals or other wholesalers not captured by the database, and therefore some usage for ellaOne will not be included in these figures. For these reasons, the data should be interpreted with caution.</p><p> </p><p>The source of this data is MIDAS Quintiles.</p><p> </p><p>EllaOne is an ulipristal acetate-containing emergency hormonal contraceptive that is licensed for use within five days of unprotected sexual intercourse or contraceptive failure. It is classified as a female emergency contraceptive; it is not an abortifacient. It exerts its contraceptive action by preventing or delaying ovulation. EllaOne has never been studied as an abortifacient. It is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant.</p><p> </p><p>Following a High Court ruling in 2002, emergency contraception is a method of contraception not abortion. The decision confirms the Government’s long held position that a pregnancy begins at implantation and not fertilisation. This judgment means that this position is now established in law and is not a matter of policy.</p><p> </p><p>As with all other licensed medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) keeps the safety of ellaOne under close review using a wide number of data sources. These include reports of suspected adverse drug reactions which include pregnancies; spontaneously provided by health professionals and patients through the ‘Yellow Card scheme’. Other sources of data that the MHRA reviews on a regular basis, and which may include information on safety and/or lack of efficacy or inappropriate use, include periodic safety update reports, renewals and variations to product licences. The MHRA also reviews important published medical literature and the results of any new clinical trials or epidemiological studies as they become available.</p><p> </p><p>As with all marketed medicines, the MHRA will continue to monitor the use of ellaOne. In the event that these monitoring processes identify information that suggest that ellaOne is used outside of its licensed indication, advice will be sought from the Commission on Human Medicines and its expert advisory groups. There are post-marketing regulatory measures in place to ensure that ellaOne is used as safely as possible. These measures include a European Union-wide pregnancy registry which collects data on pregnancy outcomes (including pregnancy maintenance and effects on the foetus or newborn) following exposure to ellaOne for any reason. The registry is available at the following link:</p><p><a href="http://www.hra-pregnancy-registry.com" target="_blank">www.hra-pregnancy-registry.com</a></p><p>Women and healthcare professionals involved in the care of pregnant women are asked to report ellaOne exposed pregnancies to the registry via the ellaOne prescribing information and patient leaflet, as well as via yearly letters sent by the marketing authorisation holder. Abortion clinics in particular are requested to ensure that every pregnant woman is asked whether she has taken emergency contraception and if so, to specify which product.</p><p> </p><p>The world-wide data available to date, including data from the EU pregnancy registry, do not suggest any safety concerns following exposure to ellaOne during pregnancy.</p><p> </p><p> </p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 119736 119740 question first answered 21/12/2017 16:55:09 answering member 4067 label Biography information for Steve Brine
tabling member	3958 label Biography information for Fiona Bruce

806664

registered interest
date	14/12/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Contraceptives: Pregnancy
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, whether his Department plans to conduct controlled studies into the effects of ellaOne in pregnant women; and if he will make a statement.
tabling member constituency	Congleton
tabling member printed	Fiona Bruce
uin	119740
answer	answer is ministerial correction date of answer 21/12/2017 answer text <p>During the time period 1 January 2016 to 31 December 2016, it is estimated that approximately 90,500 tablets of ellaOne 30mg were dispensed against a prescription in pharmacies in the United Kingdom. In addition, it is estimated that there were a further 39,000 tablets of ellaOne 30mg purchased ‘over the counter’ in pharmacies (i.e. without a prescription) in the United Kingdom during the same time period.</p><p> </p><p>This usage data does not capture provision of ellaOne via family planning clinics or stock ordered directly from the manufacturer, via other hospitals or other wholesalers not captured by the database, and therefore some usage for ellaOne will not be included in these figures. For these reasons, the data should be interpreted with caution.</p><p> </p><p>The source of this data is MIDAS Quintiles.</p><p> </p><p>EllaOne is an ulipristal acetate-containing emergency hormonal contraceptive that is licensed for use within five days of unprotected sexual intercourse or contraceptive failure. It is classified as a female emergency contraceptive; it is not an abortifacient. It exerts its contraceptive action by preventing or delaying ovulation. EllaOne has never been studied as an abortifacient. It is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant.</p><p> </p><p>Following a High Court ruling in 2002, emergency contraception is a method of contraception not abortion. The decision confirms the Government’s long held position that a pregnancy begins at implantation and not fertilisation. This judgment means that this position is now established in law and is not a matter of policy.</p><p> </p><p>As with all other licensed medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) keeps the safety of ellaOne under close review using a wide number of data sources. These include reports of suspected adverse drug reactions which include pregnancies; spontaneously provided by health professionals and patients through the ‘Yellow Card scheme’. Other sources of data that the MHRA reviews on a regular basis, and which may include information on safety and/or lack of efficacy or inappropriate use, include periodic safety update reports, renewals and variations to product licences. The MHRA also reviews important published medical literature and the results of any new clinical trials or epidemiological studies as they become available.</p><p> </p><p>As with all marketed medicines, the MHRA will continue to monitor the use of ellaOne. In the event that these monitoring processes identify information that suggest that ellaOne is used outside of its licensed indication, advice will be sought from the Commission on Human Medicines and its expert advisory groups. There are post-marketing regulatory measures in place to ensure that ellaOne is used as safely as possible. These measures include a European Union-wide pregnancy registry which collects data on pregnancy outcomes (including pregnancy maintenance and effects on the foetus or newborn) following exposure to ellaOne for any reason. The registry is available at the following link:</p><p><a href="http://www.hra-pregnancy-registry.com" target="_blank">www.hra-pregnancy-registry.com</a></p><p>Women and healthcare professionals involved in the care of pregnant women are asked to report ellaOne exposed pregnancies to the registry via the ellaOne prescribing information and patient leaflet, as well as via yearly letters sent by the marketing authorisation holder. Abortion clinics in particular are requested to ensure that every pregnant woman is asked whether she has taken emergency contraception and if so, to specify which product.</p><p> </p><p>The world-wide data available to date, including data from the EU pregnancy registry, do not suggest any safety concerns following exposure to ellaOne during pregnancy.</p><p> </p><p> </p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 119736 119739 question first answered 21/12/2017 16:55:09 answering member 4067 label Biography information for Steve Brine
tabling member	3958 label Biography information for Fiona Bruce