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775928

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Airedale NHS Foundation Trust: Pensions
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government whether a letter of comfort has been given by the NHS Business Authority to the Airedale NHS Foundation Trust to enable NHS staff who transfer to its proposed wholly owned subsidiary company to be able to continue to access the NHS Pension Scheme.
tabling member printed	Lord Hunt of Kings Heath
uin	HL2336
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>The NHS Business Services Authority has not provided a letter of comfort to Airedale NHS Foundation Trust. The Authority has written to Airedale NHS Foundation Trust requesting further information about the proposed transfer but to date this has not been supplied. A letter of comfort can be considered upon receipt of this information.</p> answering member printed Lord O'Shaughnessy question first answered 02/11/2017 14:48:52 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	2024 label Biography information for Lord Hunt of Kings Heath

775947

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what assessment they have made of the 2.5 per cent level of serious adverse events in clinical trials of Gardasil and Gardasil 9; and whether this represents an acceptable level of risk for patients.
tabling member printed	The Countess of Mar
uin	HL2355
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>Safety data from the clinical trials of Gardasil and Gardasil 9 vaccines were thoroughly reviewed by the European Medicines Agency (EMA) as part of the licensing process of the vaccines. A serious adverse event (SAE) in a clinical trial is any untoward medical occurrence in a study subject and does not necessarily have a causal relationship with the treatment.</p><p>The overall proportions and types of SAEs reported in the Gardasil, Gardasil 9 and placebo or comparator groups were comparable, indicating that most were not related to the vaccines. The EMA authorised Gardasil and Gardasil 9 vaccines for use on the basis that the benefits of vaccination outweighed the possible side effects. The potential side effects of Gardasil and Gardasil 9 vaccines are listed in the product information.</p><p> </p><p>As with all vaccines and medicines, the safety of human papillomavirus (HPV) vaccines has remained under continual review in the post-licensing period. At least three million girls have been vaccinated so far in the United Kingdom, with tens of millions more worldwide. Thorough reviews undertaken by health authorities across the world have found no evidence to support a link between HPV vaccine and the development of chronic illnesses, and concluded that the balance of benefits and risks remains favourable.</p> answering member printed Lord O'Shaughnessy question first answered 02/11/2017 14:52:32 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

775948

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what assessment they have made of the 3.3 per cent of patients presenting with new medical conditions potentially indicative of autoimmune disorders in clinical trials of Gardasil and Gardasil 9.
tabling member printed	The Countess of Mar
uin	HL2356
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>Safety data from the clinical trials of Gardasil and Gardasil 9 vaccines were thoroughly reviewed by the European Medicines Agency (EMA) as part of the licensing process of the vaccines. A serious adverse event (SAE) in a clinical trial is any untoward medical occurrence in a study subject and does not necessarily have a causal relationship with the treatment. SAEs potentially indicative of an autoimmune disorder were evaluated in the Gardasil and Gardasil 9 vaccine clinical trials. The rates of autoimmune disorders were similar to that seen in the placebo or comparator groups, indicating that they were not related to the vaccines. The EMA authorised Gardasil and Gardasil 9 vaccines for use on the basis that the benefits of vaccination outweighed the possible side effects. The potential side effects of Gardasil and Gardasil 9 vaccines are listed in the product information.</p><p> </p><p>As with all vaccines and medicines, the safety of human papillomavirus (HPV) vaccines has remained under continual review in the post-licensing period. At least three million girls have been vaccinated so far in the United Kingdom, with tens of millions more worldwide. Thorough reviews undertaken by health authorities across the world have found no evidence to support a link between HPV vaccine and the development of chronic illnesses, and concluded that the balance of benefits and risks remains favourable.</p> answering member printed Lord O'Shaughnessy question first answered 02/11/2017 14:58:12 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

775949

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government why the Medicines and Healthcare products Regulatory Agency record individual symptoms relating to suspected adverse reactions to human papilloma virus vaccines instead of correlating those reported for each individual patient so that a complete picture of the patient’s condition is formed.
tabling member printed	The Countess of Mar
uin	HL2357
answer	answer is ministerial correction date of answer 01/11/2017 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) encourages anyone to report a suspected adverse reaction to a vaccine or medicine through the Yellow Card Scheme. A Yellow Card report is not proof of a side effect occurring, but a suspicion by the reporter that the vaccine or medicine may have been the cause. Such reports are kept under continual review to identify potential new risks.</p><p> </p><p>All information provided in the report such as signs, symptoms or diagnoses are recorded by the MHRA. The full information included in a Yellow Card report is reviewed by the MHRA as this gives the most complete picture for evaluation. If required, the MHRA may follow up for more information.</p> answering member printed Lord O'Shaughnessy question first answered 01/11/2017 12:56:29 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

775950

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government how many reports of suspected adverse reactions to human papilloma virus vaccines have been followed up with individual patients.
tabling member printed	The Countess of Mar
uin	HL2358
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) encourages anyone to report a suspected adverse reaction (ADR) to a vaccine or medicine through the Yellow Card Scheme. A Yellow Card report is not proof of a side effect occurring, but a suspicion by the reporter that the vaccine or medicine may have been the cause. Such reports are kept under continual review to identify potential new risks.</p><p> </p><p>Follow up procedures for Yellow Card reports are in place and are designed to ensure that relevant information is sought where it is missing and could help with the evaluation of a report and associated safety signals.</p><p> </p><p>The MHRA has received 780 reports of suspected ADRs to human papilloma virus (HPV) vaccines directly from United Kingdom members of the public up to 20 October 2017. Of these, 278 (35%) have been followed up for further clinical details. This does not include reports for which detailed information had already been provided by the reporter and thus did not require further MHRA follow up.</p> answering member printed Lord O'Shaughnessy question first answered 02/11/2017 14:53:10 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

775951

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
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 October (HL1965), on what evidence the enhanced pharmacovigilance relating to human papilloma virus vaccines was based.
tabling member printed	The Countess of Mar
uin	HL2359
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>In evaluating vaccine and medicines safety, the Medicines and Healthcare products Regulatory Agency (MHRA) takes account of all available sources of evidence. The enhanced form of pharmacovigilance for human papillomavirus vaccine was based primarily on the evaluation of Yellow Card reports alongside data from the Clinical Practice Research Datalink. As part of routine pharmacovigilance, the MHRA also takes account of information contained in periodic safety update reports from the marketing authorisation holders, any ongoing safety studies, any information from other worldwide health authorities and evidence from published medical literature.</p> answering member printed Lord O'Shaughnessy question first answered 02/11/2017 14:50:53 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

775954

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Travel: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what consultation they have undertaken on proposals to remove the free provision of travel vaccinations.
tabling member printed	Baroness Masham of Ilton
uin	HL2362
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>The Government has not undertaken any consultation on proposals to remove free provision of travel vaccination. However, on 21 July 2017, NHS England started a three month consultation on guidance for clinical commissioning groups (CCGs) entitled <em>Items which should not routinely be prescribed in primary care: A Consultation on guidance for CCGs. </em>A copy of the consultation is attached<em>.</em></p><p> </p><p>The consultation document contains a section on travel vaccines. This sought to ensure that travel vaccines that are not currently commissioned in the National Health Service are not administered by the NHS for the purposes of travel in error. This relates to hepatitis B, Japanese encephalitis, meningitis ACWY, yellow fever, tick-borne encephalitis, rabies and BCG.</p><p> </p><p>The consultation closed on 21 October. NHS England is currently analysing the responses it has received and will publish the final guidance in due course, which will ensure that, among other things, the principles of best practice on clinical prescribing are adhered to.</p><p> </p><p>In this consultation document, NHS England asked Public Health England (PHE) to conduct a review of travel vaccines currently available on the NHS to assess their appropriateness for prescribing on the NHS. This relates to diphtheria/tetanus/polio, typhoid, hepatitis A and cholera.</p><p> </p><p>PHE has not yet started this review. It will be an initial assessment of the need and value of a more in-depth look at travel vaccination policy. The public health implications of any potential policy change will be a key consideration.</p><p> </p><p><strong> </strong></p> answering member printed Lord O'Shaughnessy grouped question UIN HL2363 question first answered 02/11/2017 14:54:58 answering member 4545 label Biography information for Lord O'Shaughnessy attachment 1 file name Consultation Items not routinely prescribed in primary care FINAL1809.pdf title Consultation on prescribing
tabling member	1850 label Biography information for Baroness Masham of Ilton

775955

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Travel: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what assessment they have made of the implications for public health of the proposal to remove the free provision of travel vaccinations for diphtheria, polio and tetanus, typhoid, hepatitis A and cholera; and whether this will create a particular risk for people travelling to India, Pakistan and Bangladesh.
tabling member printed	Baroness Masham of Ilton
uin	HL2363
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>The Government has not undertaken any consultation on proposals to remove free provision of travel vaccination. However, on 21 July 2017, NHS England started a three month consultation on guidance for clinical commissioning groups (CCGs) entitled <em>Items which should not routinely be prescribed in primary care: A Consultation on guidance for CCGs. </em>A copy of the consultation is attached<em>.</em></p><p> </p><p>The consultation document contains a section on travel vaccines. This sought to ensure that travel vaccines that are not currently commissioned in the National Health Service are not administered by the NHS for the purposes of travel in error. This relates to hepatitis B, Japanese encephalitis, meningitis ACWY, yellow fever, tick-borne encephalitis, rabies and BCG.</p><p> </p><p>The consultation closed on 21 October. NHS England is currently analysing the responses it has received and will publish the final guidance in due course, which will ensure that, among other things, the principles of best practice on clinical prescribing are adhered to.</p><p> </p><p>In this consultation document, NHS England asked Public Health England (PHE) to conduct a review of travel vaccines currently available on the NHS to assess their appropriateness for prescribing on the NHS. This relates to diphtheria/tetanus/polio, typhoid, hepatitis A and cholera.</p><p> </p><p>PHE has not yet started this review. It will be an initial assessment of the need and value of a more in-depth look at travel vaccination policy. The public health implications of any potential policy change will be a key consideration.</p><p> </p><p><strong> </strong></p> answering member printed Lord O'Shaughnessy grouped question UIN HL2362 question first answered 02/11/2017 14:54:58 answering member 4545 label Biography information for Lord O'Shaughnessy attachment 1 file name Consultation Items not routinely prescribed in primary care FINAL1809.pdf title Consultation on prescribing
tabling member	1850 label Biography information for Baroness Masham of Ilton

775970

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Cancer: Analgesics
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government whether one possible outcome of NHS England’s consultation, Items which should not be routinely prescribed in primary care: consultation on guidance for CCGs, may be a limit imposed on the pain management treatments prescribed within NICE guidelines for cancer patients.
tabling member printed	Lord Porter of Spalding
uin	HL2378
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>NHS England’s consultation on draft guidance for clinical commissioning groups on a range of items that should not routinely be prescribed in primary care ended on 21 October. The draft guidance seeks to ensure that the National Health Service is able to secure best value from its use of medicines and therefore focuses on areas of prescribing that have been found to be unsafe, ineffective or where there are more cost effective alternatives.</p><p> </p><p>We would not want to pre-empt any outcome following NHS England’s careful analysis of the responses it has received.</p> answering member printed Lord O'Shaughnessy question first answered 02/11/2017 14:49:44 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	4555 label Biography information for Lord Porter of Spalding

775971

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Hepatitis: Drugs
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government whether they intend to review run rates for Operational Delivery Networks providing treatment for hepatitis C, in the light of current variations in the level of demand in relation to capacity.
tabling member printed	Baroness Randerson
uin	HL2379
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>NHS England will keep the run rates for each Operational Delivery Network (ODN) under review, as in 2016/17, taking into account available data on estimated need and performance across the Networks.</p><p> </p><p>NHS England has a Commissioning for Quality and Innovation scheme in place for hepatitis C virus, which provides a substantial opportunity for hospitals to earn additional income for success, rather than any financial penalties. All hospitals who deliver between 90% and 100% of the planned rates of expansion receive the additional payment. In 2016/17, no ODN exceeded their run rate.</p> answering member printed Lord O'Shaughnessy question first answered 02/11/2017 14:59:03 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	4230 label Biography information for Baroness Randerson