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431696

registered interest
date	23/11/2015
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Prescription Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what research his Department has conducted on the disincentives to prescribing off-patent repurposed drugs.
tabling member constituency	Glasgow North West
tabling member printed	Carol Monaghan
uin	17150
answer	answer is ministerial correction date of answer 01/12/2015 answer text <p>The Department has conducted no such research. Current arrangements already allow off-patent drugs to be prescribed for new purposes where this is the most appropriate clinical treatment course for a patient. Prescribing decisions are a matter for the clinical judgement of the prescriber concerned.</p><br /> answering member constituency Mid Norfolk answering member printed George Freeman question first answered 01/12/2015 16:49:32 answering member 4020 label Biography information for George Freeman
tabling member	4443 label Biography information for Carol Monaghan

431698

registered interest
date	23/11/2015
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Prescription Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what steps he has taken to consult clinicians on his policy on access to off-patent drugs.
tabling member constituency	Neath
tabling member printed	Christina Rees
uin	17153
answer	answer is ministerial correction date of answer 01/12/2015 answer text <p>Our policy on generic prescribing has been in place for a number of years. The policy helps ensure that patients can access the medicine that best meets their needs and it has been a key driver in the National Health Service making maximum use of off-patent drugs which are also known as generics. We have the best prescribing rate for these drugs in Europe.</p><br /><p>To support clinicians who may want to prescribe a product off-label for a patient to and improve the flow of research evidence into clinical practice, the Department hosted a Roundtable Event in February 2015. Attendees included the National Institute for Health and Care Excellence, Medicines and Healthcare products Regulatory Agency, Breast Cancer Now and other charities and discussions helped determine those non-legislative measures that could be undertaken. The Government is committed to this work and is holding a further roundtable event with charities.</p><br /> <br /> <br /> <br /> answering member constituency Mid Norfolk answering member printed George Freeman grouped question UIN 17238 question first answered 01/12/2015 16:29:12 answering member 4020 label Biography information for George Freeman
tabling member	4525 label Biography information for Christina Rees

431700

registered interest
date	23/11/2015
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Off-patent Drugs Bill
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, pursuant to the contribution of 6 November 2015 by the Minister for Community and Social Care, Official Report, column 1307, what the evidential basis is for his statement that the provisions of the Off-patent Drugs Bill would be potentially harmful.
tabling member constituency	Glasgow North West
tabling member printed	Carol Monaghan
uin	17208
answer	answer is ministerial correction date of answer 01/12/2015 answer text <p>The current legal framework allows a clinician to prescribe drugs outside their licensed indication where that will best meet the clinical needs of their patient. This clinical freedom is crucial in delivering appropriate healthcare to groups of patients for whom medicines have not historically been licensed, e.g. children. It is also helpful in enabling prescribers to quickly pick up and apply new evidence that will help patients with particular clinical needs. The Off-Patent Drugs Bill would introduce a legal duty to apply for a licence for off-patent drugs where evidence of effectiveness for a new indication becomes available. This will create an expectation that only licensed uses of drugs are acceptable and therefore that off-label use is not appropriate. This would cause unnecessary delays in patients getting the medicines they need by slowing the rapid uptake of new evidence in clinical practice. This is why we believe the proposed legislation could potentially be harmful.</p><br /> <br /> answering member constituency Mid Norfolk answering member printed George Freeman question first answered 01/12/2015 16:45:34 answering member 4020 label Biography information for George Freeman
tabling member	4443 label Biography information for Carol Monaghan

431702

registered interest
date	23/11/2015
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Ovarian Cancer: Blood Tests
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what plans he has to introduce blood tests for the detection of ovarian cancer on the NHS.
tabling member constituency	Strangford
tabling member printed	Jim Shannon
uin	17223
answer	answer is ministerial correction date of answer 01/12/2015 answer text <p>I refer the hon. Member to the answer I gave him on 23 November 2015 to Question <a href="http://www.parliament.uk/business/publications/written-questions-answers-statements/written-question/Commons/2015-11-16/16523/" target="_blank">16523.</a></p><br /> answering member constituency Mid Norfolk answering member printed George Freeman question first answered 01/12/2015 15:16:31 answering member 4020 label Biography information for George Freeman
tabling member	4131 label Biography information for Jim Shannon

431703

registered interest
date	23/11/2015
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Antibiotics: Heart Diseases
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what discussions he has had with the Royal Colleges on the effect of macrolide antibiotics on the risk of heart failure.
tabling member constituency	Strangford
tabling member printed	Jim Shannon
uin	17224
answer	answer is ministerial correction date of answer 01/12/2015 answer text <p>Heart rhythm disturbances are a known potential side effect of macrolide antibiotics. Several observational studies have found a possible association between macrolide antibiotics and heart events. Product information for healthcare professionals and patients includes warnings about the risks of heart rhythm disturbances.</p><br /><p>In 2015, European regulators concluded from a review of all available evidence that the risk of heart events was small. As with all medicines, the Medicines and Healthcare products Regulatory Agency continually monitors the safety of macrolide drugs and will evaluate any new data, seeking independent scientific advice from the Commission on Human Medicines and its Expert Advisory Groups as appropriate, to ensure that the balance of risks and benefits remains positive for this important class of medicines.</p><p><strong></strong></p> answering member constituency Mid Norfolk answering member printed George Freeman question first answered 01/12/2015 16:55:53 answering member 4020 label Biography information for George Freeman
tabling member	4131 label Biography information for Jim Shannon

431709

registered interest
date	23/11/2015
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Prescription Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what steps his Department has taken in the last 12 months to improve access to off-patent, repurposed drugs; and what assessment it has made of the effectiveness of those steps.
tabling member constituency	Swansea East
tabling member printed	Carolyn Harris
uin	17238
answer	answer is ministerial correction date of answer 01/12/2015 answer text <p>Our policy on generic prescribing has been in place for a number of years. The policy helps ensure that patients can access the medicine that best meets their needs and it has been a key driver in the National Health Service making maximum use of off-patent drugs which are also known as generics. We have the best prescribing rate for these drugs in Europe.</p><br /><p>To support clinicians who may want to prescribe a product off-label for a patient to and improve the flow of research evidence into clinical practice, the Department hosted a Roundtable Event in February 2015. Attendees included the National Institute for Health and Care Excellence, Medicines and Healthcare products Regulatory Agency, Breast Cancer Now and other charities and discussions helped determine those non-legislative measures that could be undertaken. The Government is committed to this work and is holding a further roundtable event with charities.</p><br /> <br /> <br /> <br /> answering member constituency Mid Norfolk answering member printed George Freeman grouped question UIN 17153 question first answered 01/12/2015 16:29:13 answering member 4020 label Biography information for George Freeman
tabling member	4480 label Biography information for Carolyn Harris

431710

registered interest
date	23/11/2015
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	NHS: Innovation
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, how the findings of its Innovation, Health and Wealth report, published in December 2011, were taken into account in the terms of reference of the Accelerated Access Review.
tabling member constituency	Denton and Reddish
tabling member printed	Andrew Gwynne
uin	17266
answer	answer is ministerial correction date of answer 01/12/2015 answer text <p>The Accelerated Access Review (AAR), chaired by Sir Hugh Taylor, will make recommendations to government on reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies making our country the best place in the world to design, develop and deploy these products. The terms of the reference for the review focus on faster access to innovations, which may include certain off-patent repurposed drugs, as opposed to the routine availability of medicines or medical technologies.</p><br /><p>Prior to establishing the terms of reference for the AAR, the Department reviewed evaluation reports and met with officials from previous initiatives on the uptake of innovation in the NHS including the Innovation, Health and Wealth report. As a result, building upon the lessons of previous reviews is explicit with the terms of reference of the AAR.</p><br /><p>The AAR has regular meetings with senior officials from NHS England via a steering group as recommendations are being developed. In addition, some staff from NHS England have been assigned to support the review team.</p><br /><p>Sir Hugh is still in the process of developing final recommendations which will be published in spring 2016. In his Interim Report published in October, Sir Hugh sets out a proposition on “galvanising the NHS”. This involves supporting the NHS to adopt innovation, more rapidly through better practical support, stronger incentives and the potential streamlining of local structures.</p><br /><p>The Department reviewed evaluation reports and met with officials from previous initiatives on the uptake of innovation in the NHS prior to establishing the terms of reference for the AAR. It was clear that whilst progress has been made on the uptake of innovation in the NHS there is still much to do. Sir Hugh and the head of the External Advisory Group, Professor Sir John Bell, set out the case for uptake of innovation in the recently published AAR Interim Report.</p><br /><p>The AAR has senior level contact with officials working on Lord Carter’s review of NHS efficiency to ensure that information is shared between the two teams.</p><br /> answering member constituency Mid Norfolk answering member printed George Freeman grouped question UIN 17239 17500 17501 17503 17504 question first answered 01/12/2015 16:58:26 answering member 4020 label Biography information for George Freeman
tabling member	1506 label Biography information for Andrew Gwynne

431711

registered interest
date	23/11/2015
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Prescription Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, whether his Department's Accelerated Access Review will consider issues relating to the routine availability of off-patent, repurposed drugs.
tabling member constituency	Swansea East
tabling member printed	Carolyn Harris
uin	17239
answer	answer is ministerial correction date of answer 01/12/2015 answer text <p>The Accelerated Access Review (AAR), chaired by Sir Hugh Taylor, will make recommendations to government on reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies making our country the best place in the world to design, develop and deploy these products. The terms of the reference for the review focus on faster access to innovations, which may include certain off-patent repurposed drugs, as opposed to the routine availability of medicines or medical technologies.</p><br /><p>Prior to establishing the terms of reference for the AAR, the Department reviewed evaluation reports and met with officials from previous initiatives on the uptake of innovation in the NHS including the Innovation, Health and Wealth report. As a result, building upon the lessons of previous reviews is explicit with the terms of reference of the AAR.</p><br /><p>The AAR has regular meetings with senior officials from NHS England via a steering group as recommendations are being developed. In addition, some staff from NHS England have been assigned to support the review team.</p><br /><p>Sir Hugh is still in the process of developing final recommendations which will be published in spring 2016. In his Interim Report published in October, Sir Hugh sets out a proposition on “galvanising the NHS”. This involves supporting the NHS to adopt innovation, more rapidly through better practical support, stronger incentives and the potential streamlining of local structures.</p><br /><p>The Department reviewed evaluation reports and met with officials from previous initiatives on the uptake of innovation in the NHS prior to establishing the terms of reference for the AAR. It was clear that whilst progress has been made on the uptake of innovation in the NHS there is still much to do. Sir Hugh and the head of the External Advisory Group, Professor Sir John Bell, set out the case for uptake of innovation in the recently published AAR Interim Report.</p><br /><p>The AAR has senior level contact with officials working on Lord Carter’s review of NHS efficiency to ensure that information is shared between the two teams.</p><br /> answering member constituency Mid Norfolk answering member printed George Freeman grouped question UIN 17266 17500 17501 17503 17504 question first answered 01/12/2015 16:58:26 answering member 4020 label Biography information for George Freeman
tabling member	4480 label Biography information for Carolyn Harris

431715

registered interest
date	23/11/2015
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Health: Screening
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 usefulness of self-testing kits for (a) sexually transmitted diseases, (b) fertility, (c) human papilloma virus, (d) blood pressure, (e) bowel cancer and (f) cholesterol.
tabling member constituency	Strangford
tabling member printed	Jim Shannon
uin	17260
answer	answer is ministerial correction date of answer 01/12/2015 answer text <p><strong></strong></p><p>Self-testing and self-sampling kits have an important part to play in the detection of a number of conditions provided they are used in conjunction with advice from a healthcare professional.</p><br /><p>To be placed on the market in the United Kingdom, they must satisfy the necessary requirements of European Union legislation.</p> answering member constituency Mid Norfolk answering member printed George Freeman question first answered 01/12/2015 16:52:56 answering member 4020 label Biography information for George Freeman
tabling member	4131 label Biography information for Jim Shannon

431717

registered interest
date	23/11/2015
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Fertility: Aspirin
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, what discussions he has had with the Royal Colleges on research into the use of aspirin to improve fertility.
tabling member constituency	Strangford
tabling member printed	Jim Shannon
uin	17312
answer	answer is ministerial correction date of answer 01/12/2015 answer text <p>The Department has had no such discussions. The Department's National Institute for Health Research welcomes funding applications for research into any aspect of human health, including the use of aspirin or other treatments to improve fertility. These applications are subject to peer review and judged in open competition, with awards being made on the basis of the importance of the topic to patients and health and care services, value for money and scientific quality.</p><br /> answering member constituency Mid Norfolk answering member printed George Freeman question first answered 01/12/2015 15:23:30 answering member 4020 label Biography information for George Freeman
tabling member	4131 label Biography information for Jim Shannon