Asked by: Viscount Waverley (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether they check the Personal Protection Equipment (PPE) that is supplied to local resilience forums for quality prior to dispatch; and what (1) standards, and (2) safety, checks they have in place for centrally distributed PPE.
Answered by Lord Bethell
Personal protective equipment (PPE) provided must be fit for purpose, meeting the necessary safety standards to ensure it provides the required level of protection. Our requirements and specification are clearly articulated and published in technical specifications.
Certification of PPE is supplied by the manufacturer having had it independently tested. Assurance is checked by the regulators, the Health and Safety Executive and the Medicines and Healthcare products Regulatory Agency. Evidence of certification is requested for products as part of the due diligence process. Contracts that involve the manufacture of PPE have the appropriate clauses to ensure that testing and certification is undertaken before the goods are accepted.
Our priority is to protect health and social care staff, including making sure they have the equipment they need to do their job safely.
Asked by: Viscount Waverley (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government, further to the answer by Lord Bethell on 14 September (HL Deb, col 1007) that they "are looking at making up to half of our personal protective equipment (PPE) requirements in the UK", why they do not plan to manufacture more than half of PPE in the UK; and what plans they have to increase the amount of PPE requirements manufactured in the UK to more than half.
Answered by Lord Bethell
The Government has been working to build a resilient, diversified supply chain of personal protective equipment (PPE). We have therefore massively expanded both our supply of PPE from overseas and our domestic manufacturing capability. This has helped to build resilience for our supply of PPE into the future.
The proportion of United Kingdom-based PPE manufacturing is rising all the time and we are increasingly confident of achieving more than 50% for most lines this year.
The Government is hugely grateful to all the UK-based manufacturers that came forward during a time of unprecedented global supply chain demand. This has ensured we build and maintain a domestic base for the future.
Asked by: Viscount Waverley (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of the sustainability of the NICE appraisal process for rare disease medicines that do not meet the highly specialised technology criteria.
Answered by Lord O'Shaughnessy
With the aim of improving the lives of all those affected by a rare disease, the United Kingdom Government published The UK Strategy for Rare Diseases in 2013, a high-level framework containing 51 commitments which sets out a seven-year strategic vision from 2013-2020. A copy of the Strategy is attached. The Government is committed to implementing the Strategy’s commitments and has, in January 2018, published two implementation plans setting out its actions for England. Copies of the Department’s The UK Strategy for Rare Diseases: Rare Diseases implementation plan for England and NHS England’s Implementation Plan for the UK Strategy for Rare Diseases are attached.
The Government has not made any assessment of differences in access to medicines for the treatment of rare diseases or on the available number of treatments between England, the devolved administrations and economically similar countries in Europe.
With regard to the Government’s assessment of the sustainability of the National Institute for Health and Care Excellence’s (NICE) appraisal process for rare disease medicines that do not meet the highly specialised technology criteria, patients with rare diseases in England benefit from the same NHS Constitution right to clinically and cost-effective medicines as patients with more common conditions. NICE has recommended a number of medicines for the treatment of rare diseases through its technology appraisal and highly specialised technology evaluation programmes which are now routinely available to National Health Service patients in line with NICE’s recommendations.
Asked by: Viscount Waverley (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of how many treatments for rare diseases are available in Scotland that are unavailable in England.
Answered by Lord O'Shaughnessy
With the aim of improving the lives of all those affected by a rare disease, the United Kingdom Government published The UK Strategy for Rare Diseases in 2013, a high-level framework containing 51 commitments which sets out a seven-year strategic vision from 2013-2020. A copy of the Strategy is attached. The Government is committed to implementing the Strategy’s commitments and has, in January 2018, published two implementation plans setting out its actions for England. Copies of the Department’s The UK Strategy for Rare Diseases: Rare Diseases implementation plan for England and NHS England’s Implementation Plan for the UK Strategy for Rare Diseases are attached.
The Government has not made any assessment of differences in access to medicines for the treatment of rare diseases or on the available number of treatments between England, the devolved administrations and economically similar countries in Europe.
With regard to the Government’s assessment of the sustainability of the National Institute for Health and Care Excellence’s (NICE) appraisal process for rare disease medicines that do not meet the highly specialised technology criteria, patients with rare diseases in England benefit from the same NHS Constitution right to clinically and cost-effective medicines as patients with more common conditions. NICE has recommended a number of medicines for the treatment of rare diseases through its technology appraisal and highly specialised technology evaluation programmes which are now routinely available to National Health Service patients in line with NICE’s recommendations.
Asked by: Viscount Waverley (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what steps they are taking to reduce any disparity in access to rare disease medicines in England compared with economically similar countries in Europe.
Answered by Lord O'Shaughnessy
With the aim of improving the lives of all those affected by a rare disease, the United Kingdom Government published The UK Strategy for Rare Diseases in 2013, a high-level framework containing 51 commitments which sets out a seven-year strategic vision from 2013-2020. A copy of the Strategy is attached. The Government is committed to implementing the Strategy’s commitments and has, in January 2018, published two implementation plans setting out its actions for England. Copies of the Department’s The UK Strategy for Rare Diseases: Rare Diseases implementation plan for England and NHS England’s Implementation Plan for the UK Strategy for Rare Diseases are attached.
The Government has not made any assessment of differences in access to medicines for the treatment of rare diseases or on the available number of treatments between England, the devolved administrations and economically similar countries in Europe.
With regard to the Government’s assessment of the sustainability of the National Institute for Health and Care Excellence’s (NICE) appraisal process for rare disease medicines that do not meet the highly specialised technology criteria, patients with rare diseases in England benefit from the same NHS Constitution right to clinically and cost-effective medicines as patients with more common conditions. NICE has recommended a number of medicines for the treatment of rare diseases through its technology appraisal and highly specialised technology evaluation programmes which are now routinely available to National Health Service patients in line with NICE’s recommendations.
Asked by: Viscount Waverley (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what steps they are taking to reduce any disparity in access to rare disease medicines between England, Wales, Scotland and Northern Ireland.
Answered by Lord O'Shaughnessy
With the aim of improving the lives of all those affected by a rare disease, the United Kingdom Government published The UK Strategy for Rare Diseases in 2013, a high-level framework containing 51 commitments which sets out a seven-year strategic vision from 2013-2020. A copy of the Strategy is attached. The Government is committed to implementing the Strategy’s commitments and has, in January 2018, published two implementation plans setting out its actions for England. Copies of the Department’s The UK Strategy for Rare Diseases: Rare Diseases implementation plan for England and NHS England’s Implementation Plan for the UK Strategy for Rare Diseases are attached.
The Government has not made any assessment of differences in access to medicines for the treatment of rare diseases or on the available number of treatments between England, the devolved administrations and economically similar countries in Europe.
With regard to the Government’s assessment of the sustainability of the National Institute for Health and Care Excellence’s (NICE) appraisal process for rare disease medicines that do not meet the highly specialised technology criteria, patients with rare diseases in England benefit from the same NHS Constitution right to clinically and cost-effective medicines as patients with more common conditions. NICE has recommended a number of medicines for the treatment of rare diseases through its technology appraisal and highly specialised technology evaluation programmes which are now routinely available to National Health Service patients in line with NICE’s recommendations.
Asked by: Viscount Waverley (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what steps they are taking to ensure access to rare disease medicines is not delayed after Brexit.
Answered by Lord O'Shaughnessy
The Government is committed to the safe and effective regulation of medicines in the United Kingdom; ensuring patients and the public have fast access to new, innovative medicines, including medicines for rare diseases.
The future regulatory system for medicines is subject to negotiation. The White Paper proposal sets out a proposed UK-European Union free trade area for goods, to ensure continued frictionless access at the border to each other’s markets, underpinned by an upfront commitment to a common rulebook on goods and a Facilitated Customs Arrangement to avoid customs checks and controls at our borders. A copy of the White Paper The Future Relationship Between the United Kingdom and the European Union is attached.
Furthermore, UK and EU negotiating teams have already agreed a time-limited implementation period, that will maintain access to each other’s markets on current terms - providing certainty for businesses across the EU and UK and time to prepare for the future.
On 22 August the Government also set out its plans for medicines regulation in the unlikely event of no deal, through a technical notice. In the unlikely event of a no-deal scenario, the Medicines and Healthcare products and Regulatory Agency would be a stand-alone medicines regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level.
The Government also launched a consultation on medicines regulation for the event of no deal; this closes on 1 November 2018.
Whatever the exit scenario, we will continue to ensure that UK patients are able to access the best and most innovative medicines and medical devices and that their safety is protected.
Asked by: Viscount Waverley (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what guidance is provided by NHS Trusts about making the drug Spinraza available through the NHS to patients with spinal muscular atrophy (SMA).
Answered by Lord O'Shaughnessy
The National Institute for Health and Care Excellence (NICE) is currently developing technology appraisal guidance for the National Health Service on the use of nusinersen (Spinraza) for the treatment of spinal muscular atrophy (SMA).
NHS England has published an Interim Policy Statement Urgent Clinical Commissioning Policy Statement: Nusinersen for genetically confirmed Spinal Muscular Atrophy (SMA) type 1 for eligible patients under the Expanded Access Programme (EAP) determining the circumstances in which patients will be supported to access nusinersen through the EAP scheme sponsored by Biogen, the manufacturer of nusinersen. A copy is attached. The policy statement enables patients with type 1 SMA to access nusinersen in advance of NICE’s guidance.
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: Viscount Waverley (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of making financial resources available to patients with spinal muscular atrophy (SMA) to obtain medication not approved by NICE.
Answered by Lord O'Shaughnessy
The National Institute for Health and Care Excellence (NICE) is currently developing technology appraisal guidance for the National Health Service on the use of nusinersen (Spinraza) for the treatment of spinal muscular atrophy (SMA).
NHS England has published an Interim Policy Statement Urgent Clinical Commissioning Policy Statement: Nusinersen for genetically confirmed Spinal Muscular Atrophy (SMA) type 1 for eligible patients under the Expanded Access Programme (EAP) determining the circumstances in which patients will be supported to access nusinersen through the EAP scheme sponsored by Biogen, the manufacturer of nusinersen. A copy is attached. The policy statement enables patients with type 1 SMA to access nusinersen in advance of NICE’s guidance.
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: Viscount Waverley (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what guidance is provided to NHS Trusts about the use of medication not approved by NICE to treat spinal muscular atrophy (SMA).
Answered by Lord O'Shaughnessy
The National Institute for Health and Care Excellence (NICE) is currently developing technology appraisal guidance for the National Health Service on the use of nusinersen (Spinraza) for the treatment of spinal muscular atrophy (SMA).
NHS England has published an Interim Policy Statement Urgent Clinical Commissioning Policy Statement: Nusinersen for genetically confirmed Spinal Muscular Atrophy (SMA) type 1 for eligible patients under the Expanded Access Programme (EAP) determining the circumstances in which patients will be supported to access nusinersen through the EAP scheme sponsored by Biogen, the manufacturer of nusinersen. A copy is attached. The policy statement enables patients with type 1 SMA to access nusinersen in advance of NICE’s guidance.
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.