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1109438

	registered interest
	date	03/04/2019
	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 has taken to ensure that the serious shortage protocols safeguard individuals who suffer from a condition, such as epilepsy, in which any change in medication could pose a serious risk to their health.
	tabling member constituency	Ross, Skye and Lochaber
	tabling member printed	Ian Blackford
	uin	240571
	answer	answer is ministerial correction date of answer 08/04/2019 answer text <p>A serious shortage protocol is an additional tool to manage and mitigate medication shortages and may be used in the exceptional and rare situation when other measures have been exhausted or are likely to be ineffective. Any protocol would only be introduced if clinicians with expertise in the relevant area think it is appropriate. Pharmacists still have to use their professional discretion as to whether supplying against the protocol rather than the prescription is appropriate, or whether the patient needs to be referred back to their prescriber.</p><p> </p><p>As the explanatory memorandum of the amending Statutory Instrument acknowledges, protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients. For example, those types of protocols would not be suitable for treatments for epilepsy or treatments requiring biological products where the medicines that are prescribed need to be prescribed by brand for clinical reasons. In these cases, patients would always be referred back to the prescriber for any decision about their treatment before any therapeutic or generic alternative is supplied.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 08/04/2019 15:24:32 answering member 4455 label Biography information for Seema Kennedy
	tabling member	4390 label Biography information for Ian Blackford

1110235

	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 discussions he has had with community (a) pharmacies and (b) pharmacy organisations in Scotland on the implementation of the Human Medicines (Amendment) Regulations 2019 (S.I., 2019, No. 62).
	tabling member constituency	Central Ayrshire
	tabling member printed	Dr Philippa Whitford
	uin	242153
	answer	answer is ministerial correction date of answer 11/04/2019 answer text <p>Community Pharmacy Scotland is a member of the joint Departmental and Medicines and Healthcare products Regulatory Agency Falsified Medicines Directive Implementation Advisory Board. In relation to implementation of the serious shortage protocol provisions the Department has had discussions with Community Pharmacy Scotland, representing community pharmacy owners in Scotland, in the Pharmaceutical Services Negotiating Committee Brexit Forum.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 11/04/2019 16:59:00 answering member 4455 label Biography information for Seema Kennedy
	tabling member	4385 label Biography information for Dr Philippa Whitford

1110241

	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 discussions he has had with the Scottish Government’s Chief Pharmaceutical Officer on the implementation of legislative changes in the Human Medicines (Amendment) Regulations 2019 (S.I., 2019, No. 62).
	tabling member constituency	Central Ayrshire
	tabling member printed	Dr Philippa Whitford
	uin	242154
	answer	answer is ministerial correction date of answer 11/04/2019 answer text <p>The Department has engaged fully with officials of the Scottish Government, including its Chief Pharmaceutical Officer, on the implementation of legislative changes in the Human Medicines (Amendment) Regulations 2019 (S.I. 2019, No. 62) in relation to the Falsified Medicines Directive and the Serious Shortage Protocol.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 11/04/2019 16:57:37 answering member 4455 label Biography information for Seema Kennedy
	tabling member	4385 label Biography information for Dr Philippa Whitford

1109773

	registered interest
	date	04/04/2019
	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 supply of drugs for (a) epilepsy, (b) bipolar disorder and (c) neuropathic pain; and if he will make a statement.
	tabling member constituency	Leicester South
	tabling member printed	Jonathan Ashworth
	uin	241039
	answer	answer is ministerial correction date of answer 12/04/2019 answer text <p>Medicines supply problems can occur for a number of reasons due to manufacturing difficulties, regulatory problems and problems with the supply of raw materials, or from issues which are related to the distribution of the product. The manufacture of medicines is complex and highly regulated, and materials and processes must meet rigorous safety and quality standards, so difficulties can arise for various reasons.</p><p> </p><p>The Department understand that maintaining access to anti-epileptic drugs, drugs for bipolar disorder and those used in the management of neuropathic pain is vitally important to many people in this country. We are aware of some issues with medicines used in epilepsy, bipolar disorder and neuropathic pain over the past few months. During this time, we sought specialist advice to allow a clinical management plan to be developed. Expert clinicians provided input on the clinical management plan to ensure affected patients can be managed appropriately during the supply issue. We communicated any information about the supply issue and clinical management plan to the National Health Service including patient groups.</p><p> </p><p>We continue to work closely with industry 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 11:30:45 answering member 4455 label Biography information for Seema Kennedy
	tabling member	4244 label Biography information for Jonathan Ashworth

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

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

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

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