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Written Question
Immunosuppression
Tuesday 15th February 2022

Asked by: Baroness Brinton (Liberal Democrat - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty's Government how many people in the UK are immunocompromised or immunosuppressed and classified as (1) severely clinically extremely vulnerable, and (2) clinically extremely vulnerable excluding those who are severely clinically extremely vulnerable.

Answered by Lord Kamall - Parliamentary Under-Secretary (Department of Health and Social Care)

The success of the COVID-19 vaccination programme has meant that shielding and identifying people as clinically extremely vulnerable (CEV) are no longer necessary. This is because the majority of those previously considered to be CEV will benefit from the COVID-19 vaccine. However, there remains a smaller number of people who, in spite of vaccination, are at higher risk of serious illness from COVID-19. This is due to a weakened immune system or specific other medical condition, which means they require enhanced protections such as those offered by antivirals and therapeutics, additional vaccinations and potentially other non-clinical interventions.

Within this smaller group, approximately 1.3 million people have been identified as potentially eligible for Antivirals, and Neutralising Monoclonal Antibodies, as non-hospitalised treatments, and approximately 0.5 million people in England have been identified as severely immunosuppressed and therefore eligible for a third primary COVID-19 vaccine dose.


Written Question
Alcoholic Drinks: Misuse
Thursday 20th August 2020

Asked by: Baroness Brinton (Liberal Democrat - 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 alcohol-related ambulance service callouts in each of the last four years in England.

Answered by Lord Bethell

The information requested is not centrally collected.


Written Question
Coronavirus: Screening
Wednesday 3rd June 2020

Asked by: Baroness Brinton (Liberal Democrat - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty's Government whether they have placed a bulk order for the Roche Elecsys Anti-SARS-CoV-2 antibody tests; and if so, (1) how many tests were ordered and at what cost, and (2) the quantities expected to arrive in the UK by (a) the end of May (b) mid June and (c) the end of June.

Answered by Lord Bethell

We have signed contracts to supply over 10 million tests from Roche and Abbott in the coming months. We have agreed these contracts with two suppliers whose assays have been evaluated by Public Health England and continue to engage with other companies to establish further agreements to meet our testing strategy. These contracts will secure a significant volume to meet the United Kingdom’s testing plans. Further details are commercially sensitive.


Written Question
Coronavirus: Screening
Wednesday 3rd June 2020

Asked by: Baroness Brinton (Liberal Democrat - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty's Government when they first became aware of the Roche Elecsys Anti-SARS-CoV-2 antibody test; what discussions they held with the European Medicines Agency and stakeholders in Germany about their trials and approval processes; and why they decided to run their own separate trials and approval process.

Answered by Lord Bethell

Public Health England (PHE) were asked to review all major suppliers of assays for National Health Service use, including the Roche Elecsys Anti-SARS-CoV-2 antibody test, in order to limit the amount of on-site evaluation each facility has to perform.

PHE is familiar with the processes involved in European Medicine Agency registration. No discussions have been held with stakeholders in Germany about their trial and approvals processes.


Written Question
Biomedicines
Wednesday 6th January 2016

Asked by: Baroness Brinton (Liberal Democrat - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty’s Government what provisions have been put in place by NHS England to ensure that patients who are being prescribed biosimilar medicines are informed about the medicines and have given their consent.

Answered by Lord Prior of Brampton

NHS England is undertaking a programme of work to engage, inform and support commissioners, clinicians, pharmacists, patients and others in their consideration of the optimal use of biosimilar medicines. In September 2015 they published a What is a Biosimilar Medicine? guide, which provides an update for clinical and non-clinical stakeholders about the developing role of biosimilar medicines in the NHS in England and to support the safe, effective and consistent use of all biological medicines, including biosimilar medicines, to the benefit of patients. A copy is attached and is also available at:


https://www.england.nhs.uk/wp-content/uploads/2015/09/biosimilar-guide.pdf


NHS England has also convened a National Biosimilar Medicines Group, chaired by the Chief Pharmaceutical Officer, whose role includes improving education and understanding of both the theory and practical considerations related to biosimilar medicines.


Guidance to prescribers requires them to explain to patients the likely benefits, risks and burdens, including serious and common side effects of treatments they are proposing. The What is a Biosimilar Medicine? guide makes it clear that patients’ needs preferences and values are an essential part of evidence based medicine. Local collaborations involving both patients and clinicians have been successful in introducing biosimilars.


Written Question
Biomedicines
Wednesday 6th January 2016

Asked by: Baroness Brinton (Liberal Democrat - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty’s Government what work has been undertaken by NHS England to ensure that prescribers and commissioners have the right information to introduce biosimilar medicines in a safe and sustainable way.

Answered by Lord Prior of Brampton

NHS England is undertaking a programme of work to engage, inform and support commissioners, clinicians, pharmacists, patients and others in their consideration of the optimal use of biosimilar medicines. In September 2015 they published a What is a Biosimilar Medicine? guide, which provides an update for clinical and non-clinical stakeholders about the developing role of biosimilar medicines in the NHS in England and to support the safe, effective and consistent use of all biological medicines, including biosimilar medicines, to the benefit of patients. A copy is attached and is also available at:


https://www.england.nhs.uk/wp-content/uploads/2015/09/biosimilar-guide.pdf


NHS England has also convened a National Biosimilar Medicines Group, chaired by the Chief Pharmaceutical Officer, whose role includes improving education and understanding of both the theory and practical considerations related to biosimilar medicines.


Guidance to prescribers requires them to explain to patients the likely benefits, risks and burdens, including serious and common side effects of treatments they are proposing. The What is a Biosimilar Medicine? guide makes it clear that patients’ needs preferences and values are an essential part of evidence based medicine. Local collaborations involving both patients and clinicians have been successful in introducing biosimilars.


Written Question
Drugs: Safety
Wednesday 6th January 2016

Asked by: Baroness Brinton (Liberal Democrat - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty’s Government which organisation has responsibility for ensuring compliance with EU legislation on pharmacovigilance.

Answered by Lord Prior of Brampton

The Medicines and Healthcare products Regulatory Agency has the responsibility for ensuring compliance with European Union legislation on pharmacovigilance.


Written Question
Biomedicines
Tuesday 5th January 2016

Asked by: Baroness Brinton (Liberal Democrat - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty’s Government which organisation has responsibility for ensuring implementation and compliance with the Medicines and Healthcare products Regulatory Agency guidance, which states that biologic medicines should be prescribed by brand name and tracked by batch number.

Answered by Lord Prior of Brampton

In 2008, the Medicines and Healthcare products Regulatory Agency (MHRA) issued best practice guidance on the prescribing of biological products. This advised:


“All biosimilar products are prescription only medicines (POM). When prescribing biological products, it is good practice to use the brand name. This will ensure that automatic substitution of a biosimilar product does not occur when the medicine is dispensed by the pharmacist. Products (biosimilar and reference) that have the same international non-proprietary name (INN) are not to be presumed identical for the reasons given above.”


The MHRA does not have responsibility for monitoring the compliance of healthcare professionals with its prescribing guidance. The responsibility for prescribing rests with the practitioner who has clinical responsibility for their patient's care and we would expect practitioners to take any relevant guidance into account when making their prescribing decisions. Practitioner professional bodies also have a role in setting out best practice to their members.