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1149879

registered interest
date	16/10/2019
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 policy is on compassionate use programmes that allow the use of an unauthorised medicine.
tabling member constituency	Scunthorpe
tabling member printed	Nic Dakin
uin	1014
answer	answer is ministerial correction date of answer 25/10/2019 answer text <p>In the United Kingdom, there are currently arrangements in place for unlicensed medicines to be provided that are either manufactured in the UK or imported into the UK under a notification scheme. The national provisions are set out in the Human Medicines Regulations 2012 (Statutory Instrument 2012/1916). Sponsor companies may set up compassionate use programmes under the direction of a prescribing physician for specific patients.</p><p>Where an unmet need has been identified, the Early Access to Medicines Scheme run by the Medicines and Healthcare products Regulatory Agency also provides opportunity for supply of medicines awaiting a licence. These are to be prescribed under the responsibility of the treating physician, supported by a published scientific opinion that has been considered by the Commission on Human Medicines.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 25/10/2019 13:03:48 answering member 1481 label Biography information for Ms Nadine Dorries
tabling member	4056 label Biography information for Nic Dakin

1149902

registered interest
date	16/10/2019
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 recent steps he has taken to ensure the adequacy of the provision of essential medicines in the event that the UK leaves the EU on 31 October 20109.
tabling member constituency	Strangford
tabling member printed	Jim Shannon
uin	1028
answer	answer is ministerial correction date of answer 24/10/2019 answer text <p>The Department is doing everything appropriate to prepare for leaving the European Union. We want to reassure patients that our plans should ensure the uninterrupted supply of medicines and medical products, once we have left the EU.</p><p>The Department, as part of our EU exit preparations, is implementing a multi-layered approach to mitigate potential disruption to supply, which consists of stockpiling where possible, securing freight capacity, changing or clarifying regulatory requirements, procuring additional warehousing, working closely with industry to improve trader readiness and putting in place the National Supply Disruption Response to manage potential shortages. Further details can be found at the following link:</p><p><a href="https://www.gov.uk/government/news/medicines-and-medical-products-supply-government-updates-no-deal-brexit-plans" target="_blank">https://www.gov.uk/government/news/medicines-and-medical-products-supply-government-updates-no-deal-brexit-plans</a></p><p> </p><p> </p><p> </p> answering member constituency Charnwood answering member printed Edward Argar question first answered 24/10/2019 14:19:18 answering member 4362 label Biography information for Edward Argar
tabling member	4131 label Biography information for Jim Shannon

1150169

registered interest
date	16/10/2019
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 ensure that global pharmaceutical companies are required to prioritise patient access to drugs ahead of profit.
tabling member constituency	South Holland and The Deepings
tabling member printed	Sir John Hayes
uin	877
answer	answer is ministerial correction date of answer 25/10/2019 answer text <p>The Government is committed to ensuring that patients have access to medicines at prices that are fair and affordable to the National Health Service.</p><p>In the National Institute for Health and Care Excellence, we have a system for making independent, authoritative, evidence-based decisions that means that taxpayers can be assured that the price we pay for new medicines reflects the value they bring. Where companies are willing to set prices for their products that reflect the benefits they bring to patients, it is a system that has helped to ensure access to effective new treatments for many thousands of NHS patients.</p><p>We are committed to accelerating patient access to innovative, life changing treatments, as well as supporting the United Kingdom’s position as a global leader in life sciences. The Early Access to Medicines Scheme gives people with life threatening or seriously debilitating conditions from across the UK early access to new medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. Prior to market authorisation, companies provide their products for free to the NHS.</p><p>In addition, we have strengthened the Accelerated Access Collaborative (AAC) to serve as the umbrella body for UK health innovation. The AAC brings together senior leaders from across Government, industry and the health and care system, to work together in a more joined up way, act as the front-door for innovator support and accelerate patient access to the best new treatments and technologies.</p><p> </p><p> </p><p> </p> answering member constituency Bury St Edmunds answering member printed Jo Churchill question first answered 25/10/2019 12:51:26 answering member 4380 label Biography information for Jo Churchill
tabling member	350 label Biography information for Sir John Hayes

1148861

registered interest
date	14/10/2019
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 Explanatory Memorandum to The Human Medicines (Amendment) Regulations 2019, 7.12, whether in the event of a Serious Shortage Protocol being issued for immunosuppressant medicines patients would always be referred back to the prescriber for any decision on their treatment before any therapeutic or generic alternative is supplied.
tabling member constituency	High Peak
tabling member printed	Ruth George
uin	326
answer	answer is ministerial correction date of answer 22/10/2019 answer text <p>While Serious Shortage Protocols (SSP) in England have the scope to cover all medicines and appliances that are on a National Health Service prescription in primary care, including immunosuppressant medicines, it is clear that an SSP for therapeutic or generic equivalents will not necessarily be suitable for all medicines and patients. For example, where medicines need to be prescribed by brand for clinical reasons, which may be the case for certain immunosuppressant medicines. In these cases, patients would always be referred back to the prescriber for any decision about their treatment before any alternative is supplied.</p><p>Any protocol would however only be introduced if clinicians with expertise in the relevant area think it is appropriate. So, if an SSP for an immunosuppressant medicine was under consideration, this would be agreed with, for example, transplant specialists or other relevant clinicians. Pharmacists will have to use their professional judgment as to whether supplying against the protocol rather than the prescription is appropriate or the patient should be referred to their prescriber.</p><p> </p><p> </p> answering member constituency Bury St Edmunds answering member printed Jo Churchill question first answered 22/10/2019 11:21:30 answering member 4380 label Biography information for Jo Churchill
tabling member	4662 label Biography information for Ruth George