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1125380

registered interest
date	08/05/2019
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	NHS: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to the Health Service Products (Provision and Disclosure of Information) Regulations 2018, how many times his Department has sought information relating to bespoke medicines from small producers with an annual NHS turnover of less than £5 million; and whether he plans to make an assessment on the potential merits of requiring all small producers to automatically supply quarterly information on those medicines.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	252063
answer	answer is ministerial correction date of answer 13/05/2019 answer text <p>The Health Service Products (Provision and Disclosure of Information) Regulations 2018 (the Regulations) prescribe when manufacturers, importers and wholesalers of special medicinal products are required to provide information. Since the Regulations entered into force, quarterly information has been received in November 2018 and February 2019 and information is again due at the end of May 2019. The requirement to provide quarterly sales, purchase and volume information about special medicinal products already applies to all manufacturers, importers and wholesalers regardless of their size. Therefore, there is no need for an assessment on the potential merits of requiring all small producers to automatically supply quarterly information.</p> answering member constituency South Ribble answering member printed Seema Kennedy grouped question UIN 252064 question first answered 13/05/2019 15:40:15 answering member 4455 label Biography information for Seema Kennedy
tabling member	4249 label Biography information for Anne Marie Morris

1125381

registered interest
date	08/05/2019
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	NHS: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to the Health Service Products (Provision and Disclosure of Information) Regulations 2018, what criteria his Department uses to decide on which small producers to seek information from.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	252064
answer	answer is ministerial correction date of answer 13/05/2019 answer text <p>The Health Service Products (Provision and Disclosure of Information) Regulations 2018 (the Regulations) prescribe when manufacturers, importers and wholesalers of special medicinal products are required to provide information. Since the Regulations entered into force, quarterly information has been received in November 2018 and February 2019 and information is again due at the end of May 2019. The requirement to provide quarterly sales, purchase and volume information about special medicinal products already applies to all manufacturers, importers and wholesalers regardless of their size. Therefore, there is no need for an assessment on the potential merits of requiring all small producers to automatically supply quarterly information.</p> answering member constituency South Ribble answering member printed Seema Kennedy grouped question UIN 252063 question first answered 13/05/2019 15:40:15 answering member 4455 label Biography information for Seema Kennedy
tabling member	4249 label Biography information for Anne Marie Morris

1125382

registered interest
date	08/05/2019
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	NHS: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to the Health Service Products (Provision and Disclosure of Information) Regulations 2018, what steps he is taking to ensure that (a) wholesalers and (b) importers are providing his Department with information on medicines.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	252065
answer	answer is ministerial correction date of answer 13/05/2019 answer text <p>The Department is undertaking an exercise to ensure that all companies that are required to provide quarterly information under the Health Service Products (Provision and Disclosure of Information) Regulations 2018 (the Regulations) are doing so. Where they are not, the Department will consider taking the appropriate action provided for in the Regulations.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 13/05/2019 15:39:14 answering member 4455 label Biography information for Seema Kennedy
tabling member	4249 label Biography information for Anne Marie Morris

1125383

registered interest
date	08/05/2019
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	NHS: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, when he plans to use the powers set out in the Health Service Products (Provision and Disclosure of Information) Regulations 2018 to seek information on the special health service medicine selected yy medical professional bodies.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	252066
answer	answer is ministerial correction date of answer 13/05/2019 answer text <p>The Department selects medicines to be included in the quarterly collection of information on special medicinal products based on the level of prescribing. If medical professional bodies have selected special medicinal products that they believe should be included with a reimbursement price in Part VIIIB of the Drug Tariff then the Department will consider including those products in the quarterly collection, but only if those products are prescribed in primary care. If products are not prescribed in primary care then there is no sales, purchase and volume information for special medicinal products supplied to primary care that can be provided by suppliers in the quarterly information collection.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 13/05/2019 16:08:08 answering member 4455 label Biography information for Seema Kennedy
tabling member	4249 label Biography information for Anne Marie Morris

1124979

registered interest
date	07/05/2019
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	NHS: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps his Department is taking to improve the administration of medicines in NHS trusts.
tabling member constituency	St Austell and Newquay
tabling member printed	Steve Double
uin	251361
answer	answer is ministerial correction date of answer 15/05/2019 answer text <p>Work has commenced on a variety of projects to help improve the administration of medicines in National Health Service trusts.</p><p>Following the announcement of £75 million of funding for ePrescribing and Medicines Administration (ePrescribing or ePMA) systems, work has commenced to accelerate the uptake and implementation across the NHS. Funding was provided to 13 trusts in 2018/19 all of whom have now commenced work. Applications for the second wave of funding have been received – a total of 48 bids are currently being reviewed for 2019/20 funding. A further round of funding is also planned for 2020/21.</p><p>Additionally, the Global Digital Exemplar programme is providing funding to support the roll-out of new, integrated technologies including ePrescribing and closed loop medicines administration and will share their learning as they make progress.</p><p>The sites that have led the way with closed loop medicines administration have provided valuable learning for what is a relatively new approach to support this process in England. Early work is demonstrating a positive impact on medication related administration error.</p> answering member constituency Gosport answering member printed Caroline Dinenage grouped question UIN 251362 question first answered 15/05/2019 15:49:08 answering member 4008 label Biography information for Dame Caroline Dinenage
tabling member	4452 label Biography information for Steve Double

1123441

registered interest
date	26/04/2019
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	NHS: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 12 April 2019 to Question 242165 on NHS: drugs, whether the drug distribution issues have been resolved.
tabling member constituency	Ellesmere Port and Neston
tabling member printed	Justin Madders
uin	248045
answer	answer is ministerial correction date of answer 01/05/2019 answer text <p>The Department is aware that the supplier of Sabril tablets has experienced a delay in delivery and as a result the short term local distribution issues are now expected to be resolved in mid-May 2019.</p><p>The supplier has confirmed that there are no current supply issues affecting Sabril granules and supplies are available.</p><p>We understand the importance of this medicine and we continue to monitor the situation and work with the supplier to resolve the situation as quickly as possible.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 01/05/2019 15:20:37 answering member 4455 label Biography information for Seema Kennedy
tabling member	4418 label Biography information for Justin Madders

1121842

registered interest
date	18/04/2019
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	NHS: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure adequate supplies of treatments for (a) epilepsy and (b) bipolar disorder in all scenarios surrounding the UK's exit from the EU.
tabling member constituency	Eastbourne
tabling member printed	Stephen Lloyd
uin	245751
answer	answer is ministerial correction date of answer 30/04/2019 answer text <p>The Department fully understands that maintaining access to treatments for epilepsy and bipolar disorder is vitally important to many people in this country.</p><p>The Government remains committed to leaving the European Union with a deal. We have now reached agreement with the EU on an extension to the Article 50 period until 31 October at the latest, with the option to leave earlier as soon as a Withdrawal Agreement has been ratified.</p><p>Under the terms of the Withdrawal Agreement, there will be an implementation period running till the end of 2020, during which there will be no changes to the current trading arrangements with the EU. Therefore, if the Withdrawal Agreement is ratified, the supply of medicines will continue on the same basis it does now during this period.</p><p>Leaving without a deal remains the legal default at the end of the extension period if no Withdrawal Agreement is agreed. Therefore, as a responsible Government, we will continue to prepare to minimise any disruption to the supply of medicines and medical products in a potential ‘no deal’ scenario. We are considering what impact this longer extension may have on our EU exit preparations, and are working closely with our stakeholders to review our position.</p><p>While we never give guarantees, we are confident that if everyone does what they need to do, the supply of medicines and medical products including treatments for epilepsy and bipolar disorder should be uninterrupted in the event we leave the EU without a deal.</p><p>The Department has a long-established pharmacist-led team and dedicated processes to deal with medicine shortages, whatever the cause. This team works closely with the Medicines and Healthcare products Regulatory Agency, the pharmaceutical industry, NHS England and others in the supply chain to help prevent shortages and to ensure that the risks to patients are minimised when they do arise.</p> answering member constituency Wimbledon answering member printed Stephen Hammond question first answered 30/04/2019 16:17:46 answering member 1585 label Biography information for Stephen Hammond
tabling member	3968 label Biography information for Stephen Lloyd

1121519

registered interest
date	11/04/2019
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	NHS: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what his Department’s (a) anticipated growth rate, (b) allowed growth rate and (c) anticipated rebate payment percentages will be for the current (i) Voluntary Scheme for Branded Medicines Pricing and Access and (ii) statutory scheme to control costs of branded health service medicines in each year of the operation of both schemes.
tabling member constituency	Cambridge
tabling member printed	Daniel Zeichner
uin	244134
answer	answer is ministerial correction date of answer 24/04/2019 answer text <p>The following table shows the initial growth forecast for the Voluntary Scheme for Branded Medicines Pricing and Access and Statutory Scheme to control costs of branded health service medicines in each year of the operation of both schemes.</p><table><tbody><tr><td><p>Voluntary Scheme</p></td><td><p>2019</p></td><td><p>2020</p></td><td><p>2021</p></td><td><p>2022</p></td><td><p>2023</p></td></tr><tr><td><p>Initial forecast growth rate of Voluntary Scheme Measured Sales</p></td><td><p>5.91%</p></td><td><p>7.16%</p></td><td><p>8.90%</p></td><td><p>9.53%</p></td><td><p>9.12%</p></td></tr><tr><td><p>Voluntary Scheme Allowed Growth Rate</p></td><td><p>2.0%</p></td><td><p>2.0%</p></td><td><p>2.0%</p></td><td><p>2.0%</p></td><td><p>2.0%</p></td></tr><tr><td><p>Initial payment percentage for Voluntary Scheme members</p></td><td><p>9.6%</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Estimated 2020 future payment percentage for Voluntary Scheme members</p></td><td><p> </p></td><td><p>14.2%</p></td><td><p> </p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Statutory Scheme</p></td><td><p>2019</p></td><td><p>2020</p></td><td><p>2021</p></td><td><p>2022</p></td><td><p>2023</p></td></tr><tr><td><p>Initial forecast growth rate of Statutory Scheme Measured Sales</p></td><td><p>5.8%</p></td><td><p>7.0%</p></td><td><p>8.7%</p></td><td><p> </p></td><td><p> </p></td></tr><tr><td><p>Statutory Scheme payment %</p></td><td><p>9.9%</p></td><td><p>14.7%</p></td><td><p>20.5%</p></td><td><p> </p></td><td><p> </p></td></tr></tbody></table><p> </p><p> </p><p>Statutory Scheme allowed growth rate:</p><p>“The payment percentages are calculated to limit the growth rate of branded health service medicines sales consistent with the average annual growth rate agreed in the 2014 voluntary scheme, which was an average of 1.1% per annum growth.”</p><p>These figures are published in the following publications:</p><p>Page 13 of the 2019 Voluntary Scheme Annex 3 which is available at the following link:</p><p><a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/761835/voluntary-scheme-for-branded-medicines-pricing-and-access-annexes.pdf" target="_blank">https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/761835/voluntary-scheme-for-branded-medicines-pricing-and-access-annexes.pdf</a></p><p>Page 8 of the Statutory Scheme Impact Assessment which is available at the following link:</p><p><a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/761064/impact-assessment-2018-statutory-scheme-branded-medicines-pricing.pdf" target="_blank">https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/761064/impact-assessment-2018-statutory-scheme-branded-medicines-pricing.pdf</a></p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 24/04/2019 12:50:51 answering member 4455 label Biography information for Seema Kennedy
tabling member	4382 label Biography information for Daniel Zeichner

1111070

registered interest
date	10/04/2019
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	NHS: Drugs
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 report from the Pharmaceutical Services Negotiating Committee about the impact of Brexit on a shortage of medicine supplies at UK pharmacies.
tabling member printed	Lord Taylor of Warwick
uin	HL15199
answer	answer is ministerial correction date of answer 26/04/2019 answer text <p>There is no evidence to suggest the small number of current supply issues we are managing are related to European Union exit, or increasing because of it. We have well established processes to manage and mitigate supply issues from whatever cause, including manufacturing or distribution problems.</p><p>Leaving the EU with a deal remains the Government’s priority. Under the terms of the Withdrawal Agreement, there will be an implementation period running until the end of 2020, during which there will be no changes to the current trading arrangements with the EU. Therefore, if the Withdrawal Agreement is ratified, the supply of medicines will continue on the same basis it does now during this period.</p><p>Leaving without a deal remains the legal default at the end of the extension period if no withdrawal agreement is agreed. We are considering the impact of the EU exit date being extended until 31 October 2019 on our EU exit preparations and are working closely with our stakeholders to review our position.</p><p>We are confident that if everyone does what they need to do, the supply of medicines should be uninterrupted in the event that the United Kingdom exits the EU without a deal.</p><p><strong> </strong></p> answering member printed Baroness Blackwood of North Oxford question first answered 26/04/2019 10:54:42 answering member 4019 label Biography information for Baroness Blackwood of North Oxford
tabling member	1796 label Biography information for Lord Taylor of Warwick

1110202

registered interest
date	08/04/2019
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	NHS: Drugs
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what assessment he has made of the adequacy of the availability of the (a) sabril, (b) enoxaparin and (c) fosamax in the NHS.
tabling member constituency	Ellesmere Port and Neston
tabling member printed	Justin Madders
uin	242165
answer	answer is ministerial correction date of answer 12/04/2019 answer text <p>The Department fully understand that maintaining access to Sabril, enoxaparin and Fosamax is vitally important to many people in this country.</p><p> </p><p>With regards to Sabril, we are aware there have been short term local distribution issues. However, this is expected to be resolved by mid-April with no further issues anticipated.</p><p> </p><p>We are not aware of any issues currently affecting the supply of enoxaparin and Fosamax, and supplies are available.</p><p> </p><p>We continue to work closely with medicine suppliers and partners in the health system to help prevent shortages and to ensure that the risks to patients are minimised when supply issues do arise.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 12/04/2019 14:16:16 answering member 4455 label Biography information for Seema Kennedy
tabling member	4418 label Biography information for Justin Madders