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 for Work and Pensions:
To ask the Secretary of State for Work and Pensions, how many people with epilepsy have been helped into employment through (a) the Work and Health Programme, (b) Personal Support Package and (c) Access to Work.
Answered by Justin Tomlinson - Minister of State (Department for Energy Security and Net Zero)
a) The information on the Work and Health Programme is not readily available and has not previously been published as official statistics. We are considering whether it is feasible to produce the statistics requested and, if so, will issue them in an official statistics release in accordance with the Code of Practice for Official Statistics.
b) The information on the Personal Support Programme is not readily available and has not previously been published as official statistics.
c) Access to Work support is available for disabled people who are in work or about to start work. Information on the number of people in receipt of a payment from Access to Work by primary medical condition is published and available at:
https://www.gov.uk/government/collections/access-to-work-statistics
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department for Work and Pensions:
To ask the Secretary of State for Work and Pensions, what steps she is taking to encourage SMEs to sign up to the Disability Confident scheme.
Answered by Justin Tomlinson - Minister of State (Department for Energy Security and Net Zero)
There are now over 11,000 employers signed up to Disability Confident, of whom over 7,800 are SMEs.
We are using a targeted business-to-business approach to encourage local employers, including SMEs, to sign up to the scheme. For example, we are supporting the development of regional networks, such as KPMG’s Midlands Ability Network and Manchester Ability Network. We are also working to ensure that Disability Confident reflects the diversity of the country’s population, by working with local groups like the Birmingham Asian Business Chamber of Commerce.
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department for Work and Pensions:
To ask the Secretary of State for Work and Pensions, what steps he is taking to ensure the effectiveness of the personal independence payment assessment process for individuals with (a) fluctuating conditions, and (b) neurological conditions that don’t consistently present with physical symptoms.
Answered by Justin Tomlinson - Minister of State (Department for Energy Security and Net Zero)
We want to enable disabled people to have the same opportunities and choices as non-disabled people. We have, therefore, designed Personal Independence Payment (PIP) to reflect a modern understanding of disability, treating all conditions fairly.
Key to the benefit is a more objective assessment, which allows us to accurately and consistently assess individuals’ needs.
The PIP assessment is designed to accurately reflect the impact of variations in an individual's level of impairment. The criteria consider an individual’s ability over a 12-month period, ensuring that fluctuations are taken into account. It remains a fundamental principle that the assessment should not just consider whether an individual can complete an activity, but the manner in which they can do it. In March 2013, the Government made changes in the Regulations to make clear that consideration must be given to whether individuals can complete the assessment activities “safely, to an acceptable standard, repeatedly and in a reasonable time period”.
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.