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931632

	registered interest
	date	26/06/2018
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Liothyronine
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government what action they propose to ensure that the Brighton and Sussex University Hospitals NHS Trust withdraws its policy of no longer making Liothyronine (T3) available to NHS patients, contrary to advice issued by NHS England which sets out the circumstances under which Liothyronine (T3) can be prescribed to new patients and continued for existing patients.
	tabling member printed	Lord Hunt of Kings Heath
	uin	HL8980
	answer	answer is ministerial correction date of answer 10/07/2018 answer text <p>The national guidelines advise clinical commissioning groups (CCGs) that local decisions should be made regarding arrangements for the on-going prescribing of liothyronine, taking into account the local needs of the population. While CCGs are expected to have regard to national guidance, they are entitled to develop their own local approaches to its implementation. During a debate on 20 June on the Branded Health Service Medicines (Costs) Regulations, I committed to pursuing further with NHS England ways in which they can clarify the guidelines on the prescribing of liothyronine to CCGs, including looking at whether greater clarity on the criteria for appropriate patient usage is merited.</p><p>The prescribing of Liothyronine (T3) was considered by the Sussex and East Surrey Sustainability and Transformation Partnership (STP) clinical board, which covers Brighton and Sussex University Hospitals, and High Weald, Lewes and Havens CCG, following engagement with primary care clinicians and endocrinologists. Based on the evidence presented, the decision not to routinely prescribe Liothyronine (T3) was supported across the STP region. It was, however, recognised that there would be some exceptions to this and that the use of the individual funding request triage process would be an appropriate mechanism to consider these.</p><p><strong> </strong></p> answering member printed Lord O'Shaughnessy grouped question UIN HL8981 HL8982 HL8983 question first answered 10/07/2018 15:41:18 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	2024 label Biography information for Lord Hunt of Kings Heath

931634

	registered interest
	date	26/06/2018
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Liothyronine
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government what assessment they have made of the Brighton and Sussex University Hospitals NHS Trust mistakenly stating that the only option for patients wishing to continue Liothyronine (T3) therapy is through the private sector, contrary to advice issued by NHS England which sets out the circumstances under which Liothyronine (T3) can be prescribed to new patients and continued for existing patients.
	tabling member printed	Lord Hunt of Kings Heath
	uin	HL8982
	answer	answer is ministerial correction date of answer 10/07/2018 answer text <p>The national guidelines advise clinical commissioning groups (CCGs) that local decisions should be made regarding arrangements for the on-going prescribing of liothyronine, taking into account the local needs of the population. While CCGs are expected to have regard to national guidance, they are entitled to develop their own local approaches to its implementation. During a debate on 20 June on the Branded Health Service Medicines (Costs) Regulations, I committed to pursuing further with NHS England ways in which they can clarify the guidelines on the prescribing of liothyronine to CCGs, including looking at whether greater clarity on the criteria for appropriate patient usage is merited.</p><p>The prescribing of Liothyronine (T3) was considered by the Sussex and East Surrey Sustainability and Transformation Partnership (STP) clinical board, which covers Brighton and Sussex University Hospitals, and High Weald, Lewes and Havens CCG, following engagement with primary care clinicians and endocrinologists. Based on the evidence presented, the decision not to routinely prescribe Liothyronine (T3) was supported across the STP region. It was, however, recognised that there would be some exceptions to this and that the use of the individual funding request triage process would be an appropriate mechanism to consider these.</p><p><strong> </strong></p> answering member printed Lord O'Shaughnessy grouped question UIN HL8980 HL8981 HL8983 question first answered 10/07/2018 15:41:18 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	2024 label Biography information for Lord Hunt of Kings Heath

930914

	registered interest
	date	25/06/2018
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Drugs: Misuse
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government what assessment they have made of the extent to which the commissioning guidance for the NHS and local government on how to respond to the needs of people who are addicted to prescription and over the counter medicines, published by Public Health England in June 2013, has been implemented.
	tabling member printed	Lord Hunt of Kings Heath
	uin	HL8914
	answer	answer is ministerial correction date of answer 09/07/2018 answer text <p>No assessment has been made of the extent to which the commissioning guidance has been implemented. Responding to the needs of people who are addicted to prescription and over the counter medicines is the responsibility of local authorities and the National Health Service in each area. Local authority and clinical commissioning group commissioners should work together to ensure that there are appropriate services and interventions available to meet the needs of their local populations.</p><p>Public Health England supports local commissioners to better understand and address local need, by publishing guidance and supplying information about people in touch with specialist substance misuse services who are being treated for addiction to medicines.</p><p>People who have developed problems with prescription and over the counter medicines should seek help from their general practitioner (GP) in the first instance. Specialist advice for GPs and support for patients with complex and severe problems is available from substance misuse services in each local authority across the country.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL8915 question first answered 09/07/2018 14:18:52 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	2024 label Biography information for Lord Hunt of Kings Heath

930915

	registered interest
	date	25/06/2018
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Drugs: Misuse
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government what assessment they have made of the extent to which support is available in every area for people with a dependency on prescription or over the counter medicines as set out in the guidance published by Public Health England in June 2013.
	tabling member printed	Lord Hunt of Kings Heath
	uin	HL8915
	answer	answer is ministerial correction date of answer 09/07/2018 answer text <p>No assessment has been made of the extent to which the commissioning guidance has been implemented. Responding to the needs of people who are addicted to prescription and over the counter medicines is the responsibility of local authorities and the National Health Service in each area. Local authority and clinical commissioning group commissioners should work together to ensure that there are appropriate services and interventions available to meet the needs of their local populations.</p><p>Public Health England supports local commissioners to better understand and address local need, by publishing guidance and supplying information about people in touch with specialist substance misuse services who are being treated for addiction to medicines.</p><p>People who have developed problems with prescription and over the counter medicines should seek help from their general practitioner (GP) in the first instance. Specialist advice for GPs and support for patients with complex and severe problems is available from substance misuse services in each local authority across the country.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL8914 question first answered 09/07/2018 14:18:52 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	2024 label Biography information for Lord Hunt of Kings Heath

930912

	registered interest
	date	25/06/2018
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Prescription Drugs: Misuse
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government whether they will ensure the timely publication of the agenda, papers and minutes of the Public Health England Expert Group on Prescribed Drug Dependence.
	tabling member printed	Lord Hunt of Kings Heath
	uin	HL8912
	answer	answer is ministerial correction date of answer 09/07/2018 answer text <p>Public Health England (PHE) has been commissioned to undertake a public health evidence review of available data and published evidence on the problems associated with dependence, and the short term discontinuation or longer term withdrawal symptoms, associated with prescribed medicines.</p><p> </p><p>PHE is aware of the importance and relevance of the experience of patients in understanding the issues. The review will include a call for papers which specifically identifies published accounts of the patients’ experiences, and this material will be specifically and deliberately focused on in the review. This process is distinct from a public inquiry, which would include individual testimony.</p><p> </p><p>PHE is committed to publishing the agenda, papers and minutes of meetings of the expert reference group and the first set of these documents will be available during July 2018.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL8913 question first answered 09/07/2018 14:17:45 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	2024 label Biography information for Lord Hunt of Kings Heath

930913

	registered interest
	date	25/06/2018
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Prescription Drugs: Misuse
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government whether the Public Health England Expert Group on Prescribed Drug Dependence will accept as evidence the individual testimonies of patients.
	tabling member printed	Lord Hunt of Kings Heath
	uin	HL8913
	answer	answer is ministerial correction date of answer 09/07/2018 answer text <p>Public Health England (PHE) has been commissioned to undertake a public health evidence review of available data and published evidence on the problems associated with dependence, and the short term discontinuation or longer term withdrawal symptoms, associated with prescribed medicines.</p><p> </p><p>PHE is aware of the importance and relevance of the experience of patients in understanding the issues. The review will include a call for papers which specifically identifies published accounts of the patients’ experiences, and this material will be specifically and deliberately focused on in the review. This process is distinct from a public inquiry, which would include individual testimony.</p><p> </p><p>PHE is committed to publishing the agenda, papers and minutes of meetings of the expert reference group and the first set of these documents will be available during July 2018.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL8912 question first answered 09/07/2018 14:17:45 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	2024 label Biography information for Lord Hunt of Kings Heath

922979

	registered interest
	date	12/06/2018
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Drugs: Marketing
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 5 June (HL8118), (1) how many Marketing Authorisation Holders (MAHs) there were, and (2) what proportion of MAHs were micro MAHs, in the most recent fiscal year for which data is available.
	tabling member printed	Lord Hunt of Kings Heath
	uin	HL8552
	answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) has 800 Marketing Authorisation Holders (MAHs) registered on their system.</p><p>For medicine licensing purposes we do not hold information on MAHs in relation to the size of their business. The MHRA does have a payment easement scheme for small companies who voluntarily apply and can demonstrate they meet at least two of the following criteria:</p><p>- annual turnover must be not more than £6.5 million;</p><p>- the balance sheet total must be not more than £3.26 million; and</p><p>- the average number of employees must be not more than 50.</p><p> </p><p>The MHRA has 17 MAHs who are currently registered on the MHRA’s payment easement scheme</p><p>We do hold information on companies making sales of branded medicines which had sales of less than £5 million to the National Health Service. However, this does not distinguish between companies which are the MAHs, and those which are not. Currently, there are 93 companies which, through membership of the 2014 Pharmaceutical Price Regulation Scheme (PPRS), are assessed as having NHS sales (as defined by the scheme) of less than £5 million. Of those companies which are not members of the 2014 PPRS and therefore fall under the statutory pharmaceutical pricing scheme, 85 are currently assessed as having NHS sales of branded medicines (as defined by the scheme) of less than £5 million. We do not hold this data for manufacturers of generic medicines.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL8553 question first answered 26/06/2018 12:11:20 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	2024 label Biography information for Lord Hunt of Kings Heath

922980

	registered interest
	date	12/06/2018
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Drugs: Marketing
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 5 June (HL8118), (1) how many, and (2) what percentage of, Marketing Authorisation Holders had NHS sales below £5 million in the most recent fiscal year for which data is available.
	tabling member printed	Lord Hunt of Kings Heath
	uin	HL8553
	answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) has 800 Marketing Authorisation Holders (MAHs) registered on their system.</p><p>For medicine licensing purposes we do not hold information on MAHs in relation to the size of their business. The MHRA does have a payment easement scheme for small companies who voluntarily apply and can demonstrate they meet at least two of the following criteria:</p><p>- annual turnover must be not more than £6.5 million;</p><p>- the balance sheet total must be not more than £3.26 million; and</p><p>- the average number of employees must be not more than 50.</p><p> </p><p>The MHRA has 17 MAHs who are currently registered on the MHRA’s payment easement scheme</p><p>We do hold information on companies making sales of branded medicines which had sales of less than £5 million to the National Health Service. However, this does not distinguish between companies which are the MAHs, and those which are not. Currently, there are 93 companies which, through membership of the 2014 Pharmaceutical Price Regulation Scheme (PPRS), are assessed as having NHS sales (as defined by the scheme) of less than £5 million. Of those companies which are not members of the 2014 PPRS and therefore fall under the statutory pharmaceutical pricing scheme, 85 are currently assessed as having NHS sales of branded medicines (as defined by the scheme) of less than £5 million. We do not hold this data for manufacturers of generic medicines.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL8552 question first answered 26/06/2018 12:11:20 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	2024 label Biography information for Lord Hunt of Kings Heath

909623

	registered interest
	date	22/05/2018
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Drugs: Marketing
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government what discussions they have had with the UK Medicines Verification Organisation about its policy of requiring companies who are Marketing Authorisation Holders to pay identical (1) set up, and (2) annual operational, fees regardless of the size of those companies; and what assessment they have made of the impact of that policy on the competitiveness of smaller companies.
	tabling member printed	Lord Hunt of Kings Heath
	uin	HL8118
	answer	answer is ministerial correction date of answer 05/06/2018 answer text <p>SecurMed, the United Kingdom’s National Medicines Verification Organisation, is responsible for the fee model and level of fees. In their supervisory capacity, the Department and the Medicines and Healthcare products Regulatory Agency have been involved in discussions with SecurMed to challenge and seek to influence the pricing model to ensure that the UK’s fee structure is fair and proportionate.</p><p>The European Commission has confirmed that the fee model being used by SecurMed is in line with the majority of other National Medicines Verification Organisations across the European Union.</p><p>However, in light of feedback on the potential impact of the proposed level of fees for smaller companies, SecurMed has announced an annual fee waiver scheme for the Marketing Authorisation Holders (MAH) Set up Fee and Annual MAH Operational Fee applicable to those MAH or Parallel Distributor legal entities who can demonstrate that they are a micro MAH in the relevant year.</p><p>There continues to be on-going efforts at a national and European level to ensure that fee models take into account the specific situation of small companies.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL8119 HL8120 HL8121 question first answered 05/06/2018 16:09:16 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	2024 label Biography information for Lord Hunt of Kings Heath

909625

	registered interest
	date	22/05/2018
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Drugs: Marketing
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government whether they intend to hold discussions with the UK Medicines Verification Organisation on the need to benchmark the (1) set up, and (2) annual operational, fees paid by companies who are Marketing Authorisation Holders with National Medicines Verification Organisations in other comparable European countries such as France and Germany.
	tabling member printed	Lord Hunt of Kings Heath
	uin	HL8120
	answer	answer is ministerial correction date of answer 05/06/2018 answer text <p>SecurMed, the United Kingdom’s National Medicines Verification Organisation, is responsible for the fee model and level of fees. In their supervisory capacity, the Department and the Medicines and Healthcare products Regulatory Agency have been involved in discussions with SecurMed to challenge and seek to influence the pricing model to ensure that the UK’s fee structure is fair and proportionate.</p><p>The European Commission has confirmed that the fee model being used by SecurMed is in line with the majority of other National Medicines Verification Organisations across the European Union.</p><p>However, in light of feedback on the potential impact of the proposed level of fees for smaller companies, SecurMed has announced an annual fee waiver scheme for the Marketing Authorisation Holders (MAH) Set up Fee and Annual MAH Operational Fee applicable to those MAH or Parallel Distributor legal entities who can demonstrate that they are a micro MAH in the relevant year.</p><p>There continues to be on-going efforts at a national and European level to ensure that fee models take into account the specific situation of small companies.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL8118 HL8119 HL8121 question first answered 05/06/2018 16:09:16 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	2024 label Biography information for Lord Hunt of Kings Heath