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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

922981

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), whether they plan to (1) amend the Marketing Authorisation Holder fee waiver scheme in line with the Pharmaceutical Price Regulation Scheme (PPRS); and (2) exempt any companies with NHS sales below £5 million; and for what reasons the conditions for SecurMed’s fee waivers differ from those of the PPRS.
tabling member printed	Lord Hunt of Kings Heath
uin	HL8554
answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>SecurMed, the not-for-profit company, set up by stakeholders in the United Kingdom medicines supply chain, is responsible for setting the fee model and level of fees as the UK’s National Medicines Verification Organisation (NMVO). We understand that SecurMed do not want to amend the waiver scheme in line with the Pharmaceutical Price Regulation Scheme (PPRS) or exempt companies with National Health Service sales of below £5 million. As a not-for-profit company, if SecurMed’s income exceeds its needs, the excess will need to be returned to Marketing Authorisation Holders.</p><p>The PPRS is a voluntary agreement negotiated on NHS medicines selling prices and managed by the Department for the UK.</p><p>The fee waiver scheme is part of the implementation of the ‘safety features’ element of the Falsified Medicines Directive that is based on a European wide medicines supply chain stakeholder led model. The flat fee model they are using is based on a template (blue print) developed by stakeholders at a European level and published by the European Medicines Verification Organisation. The number of users and cost per connection is the main driver of the cost of the NMVO system. On that basis, the flat fee model was developed with a single fixed fee per marketing authorisation or connection.</p><p> </p> answering member printed Lord O'Shaughnessy question first answered 26/06/2018 12:20:10 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	2024 label Biography information for Lord Hunt of Kings Heath

922982

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), what assessment they have made of the impact the policy of requiring companies who are Marketing Authorisation Holders (MAHs) to pay identical set up and annual operational fees regardless of the size of those companies will have on (1) the competitiveness of smaller companies, and (2) barriers to market entry for prospective new MAHs; and whether they plan to ask the Competition and Markets Authority to carry out such an assessment.
tabling member printed	Lord Hunt of Kings Heath
uin	HL8555
answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>SecurMed, the not-for-profit company set up by stakeholders in the United Kingdom medicines supply chain, is responsible for setting the fee model and level of fees as the UK’s National Medicines Verification Organisation (NMVO). In their supervisory capacity, the Department and the Medicines and Healthcare products Regulatory Agency’s (MHRA) aim is to ensure that SecurMed is complying with the regulation in a fair and proportionate way and this includes consideration of their fee structure.</p><p>Our assessment is that the fee model and waiver that SecurMed is using is:</p><p>- Based on a template (blue print) developed by stakeholders at a European level and published by the European Medicines Verification Organisation (EMVO);</p><p>- In line with the model being used by other European Union countries; and</p><p>- Based on the number of users and cost per connection as the main drivers of the cost of the NMVO system, where larger organisations which are more likely to have multiple marketing authorisations pay more.</p><p>The annual fee waiver scheme for micro Marketing Authorisation Holders is designed to support start-ups and help ensure there is not a barrier to market entry. The fee model is part of the implementation of the ‘safety features’ element of the Falsified Medicines Directive, which is based on a European wide medicines supply chain stakeholder led model.</p><p>In a supervisory capacity, the Department and the MHRA’s scrutiny includes:</p><p>- EMVO’s blue print resulting from their assessment of different cost-allocation models;</p><p>- Aligning the UK’s approach with other EU NMVOs; and</p><p>- Seeking to ensure that the fee model is fit for purpose for the UK.</p><p> </p><p>We are not seeking changes to the fee model at this time and have no plans to carry out any additional assessment or request that the Competition and Markets Authority make an assessment.</p><p> </p> answering member printed Lord O'Shaughnessy question first answered 26/06/2018 12:09:33 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	2024 label Biography information for Lord Hunt of Kings Heath

922983

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 (HL8120), whether they will publish the information the European Commission has provided on how SecurMed’s fee model compares with other European Union National Medicines Verification Organisations.
tabling member printed	Lord Hunt of Kings Heath
uin	HL8556
answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>SecurMed’s fee model is based on a template (blue print) developed by stakeholders at a European level and published by the European Medicines Verification Organisation (EMVO). We know from discussions at the Commission led European Union Expert Group meetings that the flat fee model is being used by other National Medicines Verification Organisations (NMVOs) across Europe and therefore the United Kingdom is in line with other EU countries. It is for the EMVO and NMVOs to publish further information, rather than for the Department or the Medicines and Healthcare products Regulatory Agency in their supervisory role.</p> answering member printed Lord O'Shaughnessy question first answered 26/06/2018 12:14:17 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	2024 label Biography information for Lord Hunt of Kings Heath

922984

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 (HL8120), whether they will publish details of the changes to Marketing Authorisation Holder fee models they are calling for at a (1) national, and (2) European level to take account of the specific situation of small companies; and whether they are calling for fee waivers for a wider number of Marketing Authorisation Holders than in SecurMed’s new fee waiver scheme.
tabling member printed	Lord Hunt of Kings Heath
uin	HL8557
answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>In their supervisory capacity, the Department and the Medicines and Healthcare products Regulatory Agency’s aim is to ensure that SecurMed is complying with the regulation in a fair and proportionate way and this includes consideration of their fee structure. We are not seeking changes to SecurMed’s fee model at this time, including wider fee waivers. We have no current plans to publish details of our supervisory role, but to date this has included scrutiny over the European Medicines Verification Organisation’s blue print resulting from their assessment of different cost-allocation models; aligning the United Kingdom’s approach with other European Union National Medicines Verification Organisations; and seeking to ensure that the fee model is fit for purpose for the UK.</p> answering member printed Lord O'Shaughnessy question first answered 26/06/2018 12:10:15 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	2024 label Biography information for Lord Hunt of Kings Heath

910418

registered interest
date	23/05/2018
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	Carbon Monoxide: Poisoning
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government whether they will commission research into the impact of exposure to chronic levels of carbon monoxide through exposure to flueless gaseous appliances such as cookers, grills, hobs and gas fires on levels of dementia in the population.
tabling member printed	Lord Hunt of Kings Heath
uin	HL8176
answer	answer is ministerial correction date of answer 07/06/2018 answer text <p>The Department funds research on health and social care through the National Institute for Health Research (NIHR). The usual practice of NIHR is not to ring-fence funds for expenditure on particular topics such as dementia or the effects of exposure to indoor air pollutants such as carbon monoxide. Research proposals in all areas compete for the funding available. The NIHR welcomes funding applications for research into any aspect of human health. Applications are subject to peer review and judged in open competition, with awards made on the basis of the importance of the topic to patients and health and care services, value for money and scientific quality. In all disease areas, the amount of NIHR funding depends on the volume and quality of scientific activity.</p><p>The Department has asked the National Institute for Health and Care Excellence (NICE) to develop guidance on indoor air pollution in homes. NICE has worked with Public Health England to develop this scope. The focus will be on interventions related to the structure of, ventilation of, and materials used in, new/existing or retrofitted homes as well as on people’s knowledge, attitude and behaviour in relation to indoor air pollution. The guideline is to be published in September 2019.</p> answering member printed Lord O'Shaughnessy question first answered 07/06/2018 15:02:51 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

909624

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 about the need to ensure that the (1) set up, and (2) annual operational, fees paid by companies who are Marketing Authorisation Holders are proportional to the size of those companies.
tabling member printed	Lord Hunt of Kings Heath
uin	HL8119
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 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