Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what information his Department holds on analyses of the causes of medicine shortages in the UK.
Answered by Caroline Dinenage
Medicines supply problems can occur for a number of reasons due to manufacturing difficulties, regulatory problems and problems with the supply of raw materials, or from issues which are related to the distribution of the product. The manufacture of medicines is complex and highly regulated, and materials and processes must meet rigorous safety and quality standards, so difficulties can arise for various reasons.
The Department is responsible for the security of supply of medicines and ensuring continued access to medicines for all patients is a key priority. There is a team within the Department, which deals specifically with medicine supply issues arising both in the community and hospitals and receives regular information from the pharmaceutical industry about impending medicine supply issues. It works closely with the Medicines and Healthcare products Regulatory Agency, the pharmaceutical industry, NHS England and others operating in the supply chain to help prevent shortages and to ensure that the risks to patients are minimised when they do arise.
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what guidance has been given to the NHS on responding to freedom of information requests on contingency planning for the UK leaving the EU; and whether that guidance is published.
Answered by Stephen Hammond
The Freedom of Information Act 2000 provides a right of access to a wide range of information held by public authorities, including the National Health Service.
The Parliamentary and Public Accountability Agreements Protocols in place between the Department and its arm’s length bodies cover best practice for responding to Freedom of Information (FOI) requests. This includes consulting with the Department where necessary and sets out that the Department’s FOI team will provide informal, impartial advice on relevant legislation and duties. However, the decision as to whether a request falls under a relevant exemption and whether or not the information should be released remains with NHS England and Improvement.
The Department expects to publish the latest Protocol for Public and Parliamentary Accountability on GOV.UK in due course.
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will confirm that Serious Medicines Shortage Protocols will not be appropriate for epilepsy treatments and that will be included in published guidance on Serious Medicines Protocols.
Answered by Caroline Dinenage
A Serious Shortage Protocol is an additional tool to manage and mitigate medication shortages and may be used in the exceptional and rare situation when other measures have been exhausted or are likely to be ineffective.
As the explanatory memorandum of the amending Statutory Instrument acknowledges, Protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients. For example, those types of protocols would not be suitable for treatments for epilepsy or treatments requiring biological products where the medicines that are prescribed need to be prescribed by brand for clinical reasons. In these cases, patients would always be referred back to the prescriber for any decision about their treatment before any therapeutic or generic alternative is supplied.
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps the Government is taking to maintain levels of funding for epilepsy (a) research and (b) treatment after the UK leaves the EU.
Answered by Caroline Dinenage
The Government funds research on health and social care through the National Institute for Health Research (NIHR). The NIHR welcomes funding applications for research into any aspect of human health and the healthcare system, including epilepsy. It is not usual practice to ring-fence funds for particular topics. After the United Kingdom leaves the European Union, the NIHR will continue to welcome applications for funding, which will be 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.
There have been 10 studies directly funded by the NIHR relating to epilepsy in the last five financial years, from 2013/14 to 2017/18, with total spend of £9.4 million. Additionally, over the same period, there has been support through the NIHR Clinical Research Networks for 180 studies, with total expenditure of £16.7 million, as well as support for 95 studies through other NIHR infrastructure. There are a further four NIHR-funded studies starting in 2019 related to epilepsy.
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what plans he has to (a) monitor and (b) mitigate the risks to patient safety that could result from a Serious Shortage Protocol and planning for the UK leaving the EU without a deal; and if he will make a statement.
Answered by Steve Brine
Serious shortage protocols can help patients get timely access to medicines. In order to monitor and mitigate the risks to patient safety that could result from a serious shortage protocol, any protocol would only be introduced if clinicians with expertise in the relevant area think it is appropriate. Pharmacists still have to use their professional discretion as to whether supplying against the protocol rather than the prescription is appropriate, or whether the patient needs to be referred back to their prescriber.
The operation of the serious shortage protocol legislation will be reviewed one year after the first protocol has been issued.
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, for what reason there is no national service specification for ceroid lipofuscinosis type 2 (CLN2).
Answered by Steve Brine
The NHS England service specifications for Metabolic disorders (children) and Metabolic disorders (adults) both include ceroid lipofuscinosis type 2 (CLN2). These can be found on the NHS England website at the following links:
https://www.england.nhs.uk/wp-content/uploads/2013/06/e06-metab-disorders-child.pdf
https://www.england.nhs.uk/wp-content/uploads/2013/06/e06-metab-disorders-adult.pdf
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to make cerliponase alfa available to eligible children in advance of an agreement being signed between NHS and the manufacturer of the drug.
Answered by Steve Brine
The National Institute for Health and Care Excellence (NICE) is currently evaluating cerliponase alfa for use in the treatment of neuronal ceroid lipofuscinosis type 2, through its highly specialised technologies programme. NICE published draft guidance on cerliponase alfa in February 2018 that does not recommend use of the drug as there is considerable uncertainty about the long-term effects of the drug.
NHS England is in discussions with Biomarin, the manufacturer of cerliponase alfa, to seek to agree a managed access agreement (MAA) that may address the uncertainty and enable NICE to recommend the drug as value for money. Cerliponase alfa is not therefore currently routinely funded on the National Health Service, but NHS England and the company are working jointly to agree a MAA.
In the absence of final guidance from NICE, clinicians can apply to NHS England for funding in exceptional cases through the individual funding request process.
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department has plans to review NICE’s criteria for reviewing new medicines so that it ensures appropriate access to treatments by people with rare diseases.
Answered by Steve Brine
The Department has no plans to review the National Institute for Health and Care Excellence’s (NICE) criteria for assessing medicines. NICE is an independent body and is responsible for the methods and processes it uses in the development of its guidance. NICE’s methods and processes for the assessment of drugs have been carefully developed over time through extensive engagement with stakeholders and are internationally respected. NICE continues to keep its procedures under periodic review to ensure that they remain fit for purpose.
All topics, including drugs for rare diseases, are considered through a rigorous topic selection process before formal referral to NICE to ensure that NICE guidance is appropriate and will add value. NICE assesses most significant new drugs through its technology appraisal programme and has been able to recommend a number of drugs licenced for the treatment of rare diseases for routine use on the National Health Service.
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to improve the (a) standard and (b) capacity of NHS crisis and inpatient services.
Answered by Jackie Doyle-Price
The Five Year Forward View for Mental Health set out an ambitious plan to improve mental health services up to 2020/21 and includes commitments to invest in mental health crisis and acute care. This includes:
- more than £400 million for crisis resolution and home treatment teams (CRHTTs) to ensure that people across the country are able to access a 24/7 community based crisis response and intensive home treatment as a safe and effective alternative to hospital admission;
- £249 million for liaison mental health services in every acute hospital, ensuring that at least 50% of acute hospitals have dedicated on-site 24 hours/seven days provision; and
- £30 million to provide more places of safety for people who may experience a mental health crisis and to eliminate the use of police cells as place of safety.
NHS England is also leading a programme to introduce standards for acute care services over the next five years, including elimination of inappropriate out of area placements for people requiring acute inpatient admission.
NHS England is consulting until 30 September on the development of the long-term plan for the NHS over the next ten years, which includes mental health as a clinical priority. Further information is available at the following link:
https://www.engage.england.nhs.uk/consultation/developing-the-long-term-plan-for-the-nhs/
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to improve access to child and adolescent mental health services for schools and families.
Answered by Jackie Doyle-Price
We are making an additional £1.4 billion available over the course of 2015/16-2020/21. This money will transform services and increase access to specialist mental health services for an additional 70,000 children and young people a year by 2020/21.
Specifically on improving access to mental health support for schools: with the Department for Education, we are setting up new Mental Health Support Teams, as announced in our joint Green Paper. These teams will deliver mental health interventions for those with mild to moderate needs in or close to schools and colleges (and refer those with more severe needs on to specialist services). The Green Paper also announced the piloting of a four week waiting time to improve access to National Health Service mental health services, which we will roll out in a number of trailblazer areas alongside the support teams. The Department for Education is also setting up new training to incentivise schools and colleges to train a Designated Senior Lead for Mental Health to promote a whole-school approach to mental health and work closely with the new Support Teams.
We will also ensure that at least one teacher in every primary and secondary school will receive mental health awareness training to enable school staff to spot common signs of mental health issues, and to help children and young people receive appropriate support.
We have also introduced two waiting time standards for children and young people. The first aims for 95% of children (up to 19 years old) with eating disorders to receive treatment within a week for urgent cases and four weeks for routine cases. The second is that 50% of patients of all ages experiencing a first episode of psychosis receive treatment within two weeks of referral. We are currently exceeding or on track to meet these waiting time standards.