Asked by: Lord Balfe (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what steps they have taken to ensure that medical professionals received guidance on how (1) to differentiate between, and (2) to treat, patients with varying severity levels of COVID-19 infections.
Answered by Lord Bethell
During the COVID-19 pandemic, NHS England and NHS Improvement have published a comprehensive range of online only guides for use by clinical staff and National Health Service managers to support the management of patients.
Clinical guide for the management of emergency department patients during the coronavirus pandemic, published on 17 March, sets out the categories of acute patients to consider for obligatory inpatient emergency admissions, as well as a flowchart for emergency department attendances and key steps in optimising the acute care pathways for all patient groups.
Reference guide for emergency medicine, published on 22 April, includes an algorithm agreed with the British Society of Thoracic Imaging that focuses on disease severity and differentiation from other diseases.
Guidance for the role and use of non-invasive respiratory support in adult patients with COVID19 (confirmed or suspected), published on 6 April, should be used to guide clinicians on the appropriate use of continuous positive airway pressure, non-invasive ventilation, and high flow nasal oxygen in patients with confirmed or suspected COVID-19. It is designed to provide a useful aid to use alongside clinical judgement and can be adjusted to suit individual clinical environments.
Asked by: Lord Balfe (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what estimate they have made of the number of potential additional deaths during any reasonable worst case scenario of a peak in COVID-19 infections during the winter period resulting from continued disruption of routine treatment for non-COVID-19 patients.
Answered by Lord Bethell
The Government has undertaken no specific assessment. The Scientific Advisory Group for Emergencies reviewed a paper on direct and indirect impacts of COVID-19 on excess deaths and morbidity in July, which provides a scenario-based estimate for additional deaths that may result from the changes necessary to routine care during the first six months of the pandemic. A copy of the paper is attached.
Asked by: Lord Balfe (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government, further to their letter sent to GPs and Clinical Commissioning Groups on 14 September about the importance of providing face to face appointments, what steps they are taking to ensure that such appointments are made available at GP surgeries.
Answered by Lord Bethell
Following NHS England and NHS Improvement’s letter to general practitioner practices and clinical commissioning groups of the 31 August 2020, it has been working with the seven NHS England and NHS Improvement regions to investigate and resolve reports of poor face to face provision, patient complaints and poor practice communications on accessing services.
NHS England and NHS Improvement regions are also reviewing local readiness for winter plans that include access to general practice services and provision of face to face appointments, so that any local risks are identified early and addressed.
NHS England and NHS Improvement continue national and regional campaigns to urge the public to come forward with any health concerns and to reassure them that the National Health Service is open.
Asked by: Lord Balfe (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of (1) the statement made by the Deputy Chief Medical Officer on 11 October that "we are at a tipping points similar to where we were in March", and (2) the efficacy of the measures they have taken since then to address the COVID-19 pandemic.
Answered by Lord Bethell
The Government welcomes the honest and impartial view of senior medical and scientific advisers. Throughout this crisis, they, and the Scientific Advisory Group for Emergencies, have provided robust scientific evidence and advice to guide decisions regarding the measures taken to address the COVID-19 pandemic. The Government has also undertaken significant wider analysis and evaluation to inform decisions. This analysis includes consideration of economic impacts, the level of compliance with measures, amount of enforcement needed and impacts felt by local authorities.
The measures taken have been effective at slowing the virus while balancing the need to protect the economy. Ahead of what will be a challenging winter, the Government will continue to take swift action to combat the spread of the virus.
Asked by: Lord Balfe (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what plans they have to review their powers to deal with pharmaceutical companies that make significant increases to the cost of their drugs.
Answered by Lord Bethell
Prices of branded medicines are controlled through the 2019 Voluntary Scheme for Branded Medicines Pricing and Access and equivalent statutory scheme. There are no controls on prices of generic medicines. Instead, we rely on competition to drive prices down which has led to some of the lowest prices in Europe. In some instances, where there is no competition, some very large price increases have been observed. The Competition and Markets Authority has a number of live investigations into excessive prices of generic medicines.
The Department also has powers in the National Health Service Act 2006 to control the prices of NHS medicines. Those powers were updated in 2017 in respect of generic medicines and data provision. The Department has been considering proposals for ways to address high prices of generic medicines, on which it expects to consult.
Asked by: Lord Balfe (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what steps they are taking to give the same, or higher priority, to deaths resulting from cancer as those related to COVID-19.
Answered by Lord Bethell
Cancer is a priority for this Government and survival rates are at a record high. Over the past decade, rates of survival from cancer have increased year-on-year.
In October 2018 the Government announced a package of measures that will be rolled out across the country with the aim of seeing three quarters of all cancers detected at an early stage by 2028 (currently just over half). This is part of the NHS Long Term Plan, which also included commitments on radiotherapy, personalised care interventions and screening, among others.
During the COVID-19 crisis, urgent and essential cancer treatments continued. Some cancer diagnostics and treatments were rescheduled to protect vulnerable patients from having to attend hospitals. These were all clinical decisions made with the patient and the recovery and restoration of cancer services to pre-pandemic levels is well underway.
Asked by: Lord Balfe (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government how they intend to cooperate with the European Medicines Agency's Pharmacovigilance Risk Assessment Committee from 1 January 2021; whether this cooperation will include (1) participating in the Committee's reviews, and (2) accepting the Committee's findings; and if so, what level of participation in the decision making process they foresee.
Answered by Lord Bethell
The United Kingdom published its approach to the Future Relationship with the European Union in February 2020. The approach set outs the UK’s commitments to facilitating trade in medicinal products and supporting high levels of patient safety.
After the transition period, we will ensure patients in the UK are not disadvantaged and continue to be able to access the best and most innovative medicines that are safe. We want patients to be reassured that their safety will be protected through the strongest regulatory framework.
From January 2021, the safety issues that are considered by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), and the outcomes of the PRAC discussions, which are made publicly available, will be closely monitored and, where appropriate, we will take into account the decisions of the PRAC with regards to safety measures that are implemented for the UK.
Asked by: Lord Balfe (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee's recommendation to revoke the marketing authorisation of ulipristal acetate as a treatment for uterine fibroids; and whether they intend to implement the same revocation in the UK.
Answered by Lord Bethell
Medicines containing ulipristal acetate for the treatment of uterine fibroids were recalled from the United Kingdom market in March 2020 and no woman should have been treated with these medicines since then.
The Medicines and Healthcare products Regulatory Agency (MHRA) has assessed the data underpinning the European Union Pharmacovigilance Risk Assessment Committee's (PRAC) recommendation to revoke the marketing authorisations for ulipristal acetate 5mg for uterine fibroids. Independent advice was sought from the Commission on Human Medicines Expert Advisory Group on Medicines for Women’s Health in May 2020 and UK comments on the EU assessment reports were fed into the EU review.
The EU review for ulipristal acetate 5mg is ongoing pending a final opinion expected in October 2020 from the European Medicines Agency’s Committee for Medicinal Products for Human Use on the PRAC’s recommendation, and a decision from the European Commission within three months of the Committee for Medicinal Products Opinion. The MHRA intends to act in accordance with the outcome of the EU review.
Asked by: Lord Balfe (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of the impact of their relationship with the European Medicines Authority on the time taken to find a new manufacturer for the drug Camcolit; and what plans they have, if any, to change that relationship.
Answered by Lord Bethell
No such assessment and no plans have been made. Camcolit (lithium carbonate) is not being discontinued and so work to find a new manufacturer has not been undertaken.
Asked by: Lord Balfe (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of reports that, following its acquisition by a Swiss private equity firm, Essential Pharma has increased the price of one of its branded lithium carbonate tablets from £3.22 to £87.00 a packet, and withdrawn its other brand of lithium carbonate tablet; what estimate they have made of the time it would take to obtain a marketing authorisation for a replacement; and what plans they have to speed up that process.
Answered by Lord Bethell
Camcolit 250 tablets - branded lithium 250 milligram (mg) tablets - were discontinued in 2015. The generic list price of lithium carbonate 250 mg tablets manufactured by Essential Pharma has been £87 since 2016. While there are no controls on prices of generic medicines, we rely on competition to drive prices down which has led to some of the lowest prices in Europe. Where we have seen some very large price increases, the Department has brought the issue to the attention of the Competition and Markets Authority (CMA). The CMA is considering the case of lithium pricing.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for licensing of medicines. Its evaluation of a submitted application which meets the necessary standards of quality, safety and efficacy through to determination, would normally be within the statutory time frame of 210 days following receipt of a valid application. This excludes clock-stop periods when time is taken by the applicant to provide further information or generate the necessary data and update their dossier in response to questions raised during the assessment of the application. The MHRA has expedited processes to ensure that marketing authorisation applications are evaluated as rapidly as possible if necessary, to meet a public health need.