Asked by: Naomi Long (Alliance - Belfast East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, persuant to the Answer of 5 January 2015 to Question 218547, if he will adapt the Early Access to Medicines Scheme to better accommodate off-patent indications of drugs, by creating incentives for pharmaceutical companies to submit applications to the scheme.
Answered by George Freeman
Since the launch of the Early Access to Medicines Scheme in April 2014, three Promising Innovative Medicine (PIM) designations have already been granted. By 9 January 2015 there had been 428 downloads of the PIM designation form and 187 downloads of the scientific opinion form, which indicates the high level of interest in the scheme.
The Early Access to Medicines Scheme already has a number of incentives for pharmaceutical companies. The PIM designation provides an early indication that a product may be a possible candidate for the Early Access to Medicines Scheme and is of particular value to smaller companies because it will act as a signal to potential investors. At the next stage of scientific review, the Medicines and Healthcare products Regulatory Agency will consider the evidence and can issue an Early Access to Medicines scientific opinion. This opinion will support the prescriber to make a decision with the patient on using this medicine, when still unlicensed or used off-label. Earlier clinical use of new innovative medicines will also provide valuable real world data to companies for use in subsequent health technology appraisal processes.
We committed to review the Early Access to Medicines Scheme when we launched the scheme in April 2014. Through the Innovative Medicine and Medical Technologies Review we will also be taking forward a major review over the coming months to make recommendations to Government on opportunities to accelerate access for National Health Service patients to innovative medicines, devices and diagnostics.
Asked by: Naomi Long (Alliance - Belfast East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, which Off-patent drugs will be considered under the Early Access Scheme.
Answered by George Freeman
Off-patent drugs are those whose patent period has expired and consequently manufacturers may make available generic or non-branded versions of the products.
An “off-label” medicine is any medicine prescribed outside the terms of its licence (as set out in the prescribing information in the Summary of product Characteristics). Medicines legislation permits prescribers to prescribe a product outside the terms of its licence where they judge it to be in the best interests of the patient to address a medical need. For example to prescribe for a different use or to different category of patients but in doing so the prescriber takes personal responsibility for the treatment, inform the patient(s) of the licensing status of the product and obtain consent from the patient for its use.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will provide a scientific opinion on the benefit/risk balance of the medicine, based on the data available at the time of the EAMS submission. The scheme is voluntary and as such the MHRA is dependent on companies submitting potential products that may fulfil the EAMS criteria.
In the government response to the public consultation, it was confirmed that off-label supply of existing medicines would be eligible for the scheme, but only if they meet the EAMS criteria. Thus companies can submit an application to the EAMS for a new indication for an already marketed drug (which may be off patent).
Asked by: Naomi Long (Alliance - Belfast East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what discussions his Department has had with the National Institute for Health and Care Excellence about a technology appraisal for tamoxifen in the chemoprevention indication.
Answered by George Freeman
In June 2013 the National Institute for Health and Care Excellence (NICE) issued an updated clinical guideline on familial breast cancer which includes recommendations on the use of tamoxifen and raloxifene outside their licensed indications for the prevention of cancer in specific groups of women at high and moderate risk of breast cancer.
NICE’s clinical guidelines represent best practice and we expect commissioners to take their recommendations into account when designing services and making commissioning decisions for their healthcare population.
Our assessment is that, as NICE has already provided guidance on the use of tamoxifen and raloxifene, there would be little value in NICE separately appraising these drugs for the prevention of breast cancer and we have had no discussions with NICE on this issue.
Asked by: Naomi Long (Alliance - Belfast East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, how many breast cancer clinicians he spoke to directly when developing his policy on the Off-patent Drugs Bill.
Answered by George Freeman
In developing our response to the Bill, we have taken advice from a number of cancer clinicians including breast cancer specialists and from officials at the National Institute for Health and Care Excellence, the Medicines and Healthcare products Regulatory Agency, and taken account of views expressed by other stakeholder organisations.
Asked by: Naomi Long (Alliance - Belfast East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what recent discussions he has held with disability campaigners on securing compensation from Grünenthal for people affected by thalidomide; and if he will make representations to his German counterpart on that matter.
Answered by Norman Lamb
I met with the Thalidomide Trust on 23 June 2014 and subsequently wrote to Manuela Schwesig, Federal Minister of Family Affairs, Senior Citizens, Women and Youth, on behalf of all four UK Governments asking if she would meet with the Trust.
Asked by: Naomi Long (Alliance - Belfast East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what estimates he has made of the variation in survival rates for pancreatic cancer patients between (a) UK regions and (b) the UK and other European countries.
Answered by Jane Ellison
The latest analysis of pancreatic cancer survival suggests that:
- According to a recent National Cancer Intelligence Network (NCIN) data briefing, pancreatic cancer one-year survival is improving in each of the countries of Great Britain. There is little difference in one-year survival between the countries in Great Britain.
- A recent paper in the Lancet looking at EUROCARE5 data showed variation between countries in five-year pancreatic cancer survival. Whilst the European mean was 6.9%, figures for the United Kingdom were as follows: England 4.7%, Wales 5.4%, Scotland 3.4%, Northern Ireland 3.0%.
- According to the NCIN UK Cancer e-atlas, the UK one-year survival rate for pancreatic cancer was 18.0%. However, there was regional variation in one-year survival rates across cancer networks in England, ranging from 14.0% to 25.6%.
Asked by: Naomi Long (Alliance - Belfast East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what steps his Department plans to take to address the low uptake of the pancreatic cancer e-learning module among GPs.
Answered by Jane Ellison
The e-learning module ‘Pancreatic Cancer: early diagnosis in general practice’ was developed and is promoted by the Royal College of General Practitioners (RCGP) in partnership with the charity Pancreatic Cancer Action.
We understand that the module has had 3,550 users and that compared to other e-learning modules launched in 2012, this module is performing well. Since the launch of the module in October 2012, the RCGP has promoted the e-learning module through its usual communication channels including Chair of RCGP Council’s weekly message; membership and faculty newsletters; promotion on the RCGP website and; promotion via RCGP social media channels.
The module can be accessed from the RCGP website at
Ministers also promote the availability of the module by reference to it in debates and correspondence.
Asked by: Naomi Long (Alliance - Belfast East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, how many of the NHS trusts involved in the Sign up to safety campaign have a policy of stocking medicines for the treatment of Parkinson's disease in their emergency medications cupboards.
Answered by George Freeman
Following publication of the National Institute for Health and Care Excellence (NICE) guidance that people with Parkinson's disease should have their medication given at appropriate times and should be allowed to self-administer if necessary, the National Patient Safety Agency issued a rapid response report (RRR) on omitted and delayed medicines on 24 February 2010, (NSPA/2010/RRR009) Reducing harm from omitted and delayed medicines in hospital, which applies to the National Health Service in both England and Wales. A copy of this report has already been placed in the Library, and a copy is available at:
www.nrls.npsa.nhs.uk/resources/patient-safety-topics/medication-safety/?entryid45=66720&p=2
Under the Health and Social Care Act 2008, all providers of regulated activities, including care homes have to register with the Care Quality Commission, the independent regulator of health and adult social care providers in England, and meet a set of requirements of safety and quality. One of these requirements relates to the management of medicines and requires that a provider protects service users against the risks associated with the unsafe use and management of medicines.
NHS England’s Safer Medication Practice Team in Patient Safety, is finalising an e-learning package to help reduce omission and delay in the administration of medicines, including for Parkinson’s disease. This package will be available for all health professionals who prescribe, dispense and administer medicines in hospitals. It aims to increase awareness of the frequency of incidents and harm that are associated with omitted and delayed medicine doses in hospital and describes safer practice
In addition, in March 2014, a joint NHS England and The Medicines and Healthcare products Regulatory Agency Patient Safety Alert, ‘Improving medication error incident reporting and learning’, was issued. A copy of this has been placed in the Library and is available at:
www.england.nhs.uk/wp-content/uploads/2014/03/psa-med-error.pdf
This alert directs NHS and independent sector organisations to identify medication safety officers by 19 September 2014. They will be empowered to champion and facilitate local learning from patient safety incidents, including those that arise from omissions and delay of medicines for Parkinson’s disease. A National Medication Safety Network is to be established for discussing potential and recognised safety issues and identifying trends and actions to improve the safe use of medicines. The network will also work with new Patient Safety Improvement Collaborative, that will be set up later this year
NHS England does not hold information on the number of NHS trusts that are involved with the Sign up to Safety campaign or the number of trusts who have a policy of stocking medicines for the treatment of Parkinson’s disease in their emergency medicines cupboards.
The NPSA RRR referred to above, identified medicines used to treat Parkinson’s disease as critical medicines. Although emergency medicine cupboards are not mentioned directly in the RRR, NHS organisations have to review and where necessary make changes to systems for the supply of critical medicines within and outside of hours to minimise risks related to omitted or delayed doses of medicines.
Asked by: Naomi Long (Alliance - Belfast East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what steps his Department has taken to improve compliance in (a) hospitals and (b) care homes with the National Institute for Health and Care Excellence guidelines that people with Parkinson's disease should have their medication given at appropriate times and should be allowed to self-administer if necessary.
Answered by George Freeman
Following publication of the National Institute for Health and Care Excellence (NICE) guidance that people with Parkinson's disease should have their medication given at appropriate times and should be allowed to self-administer if necessary, the National Patient Safety Agency issued a rapid response report (RRR) on omitted and delayed medicines on 24 February 2010, (NSPA/2010/RRR009) Reducing harm from omitted and delayed medicines in hospital, which applies to the National Health Service in both England and Wales. A copy of this report has already been placed in the Library, and a copy is available at:
www.nrls.npsa.nhs.uk/resources/patient-safety-topics/medication-safety/?entryid45=66720&p=2
Under the Health and Social Care Act 2008, all providers of regulated activities, including care homes have to register with the Care Quality Commission, the independent regulator of health and adult social care providers in England, and meet a set of requirements of safety and quality. One of these requirements relates to the management of medicines and requires that a provider protects service users against the risks associated with the unsafe use and management of medicines.
NHS England’s Safer Medication Practice Team in Patient Safety, is finalising an e-learning package to help reduce omission and delay in the administration of medicines, including for Parkinson’s disease. This package will be available for all health professionals who prescribe, dispense and administer medicines in hospitals. It aims to increase awareness of the frequency of incidents and harm that are associated with omitted and delayed medicine doses in hospital and describes safer practice
In addition, in March 2014, a joint NHS England and The Medicines and Healthcare products Regulatory Agency Patient Safety Alert, ‘Improving medication error incident reporting and learning’, was issued. A copy of this has been placed in the Library and is available at:
www.england.nhs.uk/wp-content/uploads/2014/03/psa-med-error.pdf
This alert directs NHS and independent sector organisations to identify medication safety officers by 19 September 2014. They will be empowered to champion and facilitate local learning from patient safety incidents, including those that arise from omissions and delay of medicines for Parkinson’s disease. A National Medication Safety Network is to be established for discussing potential and recognised safety issues and identifying trends and actions to improve the safe use of medicines. The network will also work with new Patient Safety Improvement Collaborative, that will be set up later this year
NHS England does not hold information on the number of NHS trusts that are involved with the Sign up to Safety campaign or the number of trusts who have a policy of stocking medicines for the treatment of Parkinson’s disease in their emergency medicines cupboards.
The NPSA RRR referred to above, identified medicines used to treat Parkinson’s disease as critical medicines. Although emergency medicine cupboards are not mentioned directly in the RRR, NHS organisations have to review and where necessary make changes to systems for the supply of critical medicines within and outside of hours to minimise risks related to omitted or delayed doses of medicines.
Asked by: Naomi Long (Alliance - Belfast East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what steps the new NHS safety action team plans to take to reduce avoidable harm resulting from delays or omissions in medication for hospital patients with Parkinson's disease.
Answered by George Freeman
Following publication of the National Institute for Health and Care Excellence (NICE) guidance that people with Parkinson's disease should have their medication given at appropriate times and should be allowed to self-administer if necessary, the National Patient Safety Agency issued a rapid response report (RRR) on omitted and delayed medicines on 24 February 2010, (NSPA/2010/RRR009) Reducing harm from omitted and delayed medicines in hospital, which applies to the National Health Service in both England and Wales. A copy of this report has already been placed in the Library, and a copy is available at:
www.nrls.npsa.nhs.uk/resources/patient-safety-topics/medication-safety/?entryid45=66720&p=2
Under the Health and Social Care Act 2008, all providers of regulated activities, including care homes have to register with the Care Quality Commission, the independent regulator of health and adult social care providers in England, and meet a set of requirements of safety and quality. One of these requirements relates to the management of medicines and requires that a provider protects service users against the risks associated with the unsafe use and management of medicines.
NHS England’s Safer Medication Practice Team in Patient Safety, is finalising an e-learning package to help reduce omission and delay in the administration of medicines, including for Parkinson’s disease. This package will be available for all health professionals who prescribe, dispense and administer medicines in hospitals. It aims to increase awareness of the frequency of incidents and harm that are associated with omitted and delayed medicine doses in hospital and describes safer practice
In addition, in March 2014, a joint NHS England and The Medicines and Healthcare products Regulatory Agency Patient Safety Alert, ‘Improving medication error incident reporting and learning’, was issued. A copy of this has been placed in the Library and is available at:
www.england.nhs.uk/wp-content/uploads/2014/03/psa-med-error.pdf
This alert directs NHS and independent sector organisations to identify medication safety officers by 19 September 2014. They will be empowered to champion and facilitate local learning from patient safety incidents, including those that arise from omissions and delay of medicines for Parkinson’s disease. A National Medication Safety Network is to be established for discussing potential and recognised safety issues and identifying trends and actions to improve the safe use of medicines. The network will also work with new Patient Safety Improvement Collaborative, that will be set up later this year
NHS England does not hold information on the number of NHS trusts that are involved with the Sign up to Safety campaign or the number of trusts who have a policy of stocking medicines for the treatment of Parkinson’s disease in their emergency medicines cupboards.
The NPSA RRR referred to above, identified medicines used to treat Parkinson’s disease as critical medicines. Although emergency medicine cupboards are not mentioned directly in the RRR, NHS organisations have to review and where necessary make changes to systems for the supply of critical medicines within and outside of hours to minimise risks related to omitted or delayed doses of medicines.