Asked by: Lord Kennedy of Southwark (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what protocols are in place to ration medical equipment if necessary during the COVID-19 pandemic.
Answered by Lord Bethell
As part of our concerted national efforts to respond to the coronavirus outbreak, the Department is working closely with industry, the National Health Service and others in the supply chain to help ensure patients can access the medicines and medical devices and equipment they need. Precautions are in place to reduce the likelihood of future shortages, including management of demand.
The Department shares regular information about impending supply issues and management plans with the NHS via networks in primary and secondary care and will liaise with relevant patient groups about issues affecting specific medicines, medical devices and equipment.
Asked by: Jim Shannon (Democratic Unionist Party - Strangford)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether her Department has made an assessment of the effect of the covid-19 pandemic on the supply chain for (a) urinary catheters and (b) other (i) urology products and (ii) medical devices.
Answered by Edward Argar - Minister of State (Ministry of Justice)
As part of our concerted national efforts to respond to the COVID-19 outbreak, the Department is working closely with industry, the National Health Service and others in the supply chain to help ensure patients can access the medicines and medical devices and equipment they need, and precautions are in place to reduce the likelihood of future shortages.
The Department shares regular information about impending supply issues and management plans with the NHS via networks in primary and secondary care and will liaise with relevant patient groups about issues affecting specific medicines, medical devices and equipment.
Asked by: Jim Shannon (Democratic Unionist Party - Strangford)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to help ensure that people with urinary incontinence have access to (a) urinary catheters and (b) other medical devices during the covid-19 outbreak.
Answered by Edward Argar - Minister of State (Ministry of Justice)
As part of our concerted national efforts to respond to the COVID-19 outbreak, the Department is working closely with industry, the National Health Service and others in the supply chain to help ensure patients can access the medicines and medical devices and equipment they need, and precautions are in place to reduce the likelihood of future shortages.
The Department shares regular information about impending supply issues and management plans with the NHS via networks in primary and secondary care and will liaise with relevant patient groups about issues affecting specific medicines, medical devices and equipment.
Asked by: Martyn Day (Scottish National Party - Linlithgow and East Falkirk)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when he plans to publish guidance for (a) medical professionals and (b) the public on access to medicines at the end of the transition period.
Answered by Edward Argar - Minister of State (Ministry of Justice)
The United Kingdom has now left the European Union and entered a transition period, which will run until 31 December 2020. EU regulations on medicines, vaccines and medical devices will continue to apply to the UK throughout the transition period, during which we will negotiate a new trade agreement with the EU.
Both the EU and the UK are committed to agreeing a future partnership by the end of 2020 and are working to achieve this. It is in the interests of both the UK and the EU to agree a future partnership that keeps goods flowing, services provided, and business carried out as usual.
The Department, NHS England and NHS Improvement will continue to keep medical professionals and the public updated with relevant communications on medicines as the need arises.
Asked by: Caroline Lucas (Green Party - Brighton, Pavilion)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure the maintenance of the relationship between the Medicines and Healthcare Products Regulatory Agency and the European Medicines Agency after the UK leaves the EU; and what assessment he has made of the effect on people with (a) cancer (b) other conditions of changes to that relationship.
Answered by Nadine Dorries
Our goal is to continue working closely with our European Union colleagues, as we do at present, to make sure patients have access to safe and effective medicines. As set out in the United Kingdom-EU Political Declaration, our priority is to seek a new relationship with the EU that includes close regulatory co-operation for medicines and medical devices. We have always been clear that we wish to explore with the EU the UK’s on-going participation with the European Medicines Agency (EMA) and wider regulatory network, as a part of the future relationship negotiations.
Whatever the outcome of the negotiations, we will set up a regulatory system that protects the best interests of patients and supports the UK life science industry to go from strength to strength. The Medicines and Healthcare products Regulatory Agency, with over 30 years’ experience licensing and monitoring the safety of new medicines, already licences the vast majority of medicines on the UK market.
The Government will ensure that patients are not disadvantaged by the future regulatory regime in order that UK patients are able to access the best and most innovative medicines and their safety is protected. The UK life sciences industry has much to offer in creating, developing, trialling and commercialising medicines that will benefit UK patients and strengthen the ability of the UK to compete internationally.
The Government has taken pragmatic steps to ensure that patients continue to access innovative treatments in the event that the UK leaves the EU without a deal. The Government’s stockpiling regime will minimise any supply disruption in the weeks after leaving without a deal. The Government has set out alternative licensing routes to incentivise companies to continue to apply for licences with a view to approval of a licence at the same time as the EU. This will ensure that patients, including those with the most critical conditions, are not put at a disadvantage with regard to accessing innovative treatment. Further to this, all centrally authorised products that are already approved by the EMA will be converted into UK-only licences after exit unless the licence holder chooses to opt out, ensuring continued supply of innovative treatment onto the UK market.
Asked by: John Howell (Conservative - Henley)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what measures are in place to support the import of insulin from Denmark (Nova Nordisk) and Germany (Sanofi) in the event of the UK leaving the EU (a) with and (b) without a deal.
Answered by Edward Argar - Minister of State (Ministry of Justice)
In the event that the UK leaves the EU with a negotiated deal, the Department’s assessment is that during the Implementation Period agreed with the EU, market access to medicines and medical devices won’t change for industry or the NHS.
We are working closely with partners across the health and care system and industry, to take all appropriate steps to prepare for leaving the European Union. Our robust plans and multi layered approach should help ensure the supply of medicines and medical products, including insulin, remains uninterrupted if we leave without a deal.
On 26 June, we wrote to suppliers of medicines to the United Kingdom from or via the EU or European Economic Area setting out our continuing multi-layered approach to support continuity of supply of medicines and medical products.
For commercial reasons, the Government will not be releasing details of contingency plans for individual medicines. We continue to work with individual suppliers directly to assure ourselves of their contingency plans. However, as an example of the preparations being taken by industry, insulin manufacturer Novo Nordisk recently publicly stated that they have 18 weeks' worth of supplies in the UK and had secured alternative ferry capacity to renew supplies.
Further details can be found at the following link:
Asked by: Wes Streeting (Labour - Ilford North)
Question to the Cabinet Office:
To ask the Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office, when he plans to provide a substantive answer to Question 286312, tabled on 3 September 2019 by the hon. Member for Ilford North.
Answered by Kevin Foster
Our highest priority is for patients to continue to have access to medicines and medical products.
DHSC has contacted 448 suppliers of medicines with an EU touchpoint in their supply chain and more than 1300 suppliers of medical devices and clinical consumables in order to understand their supply chains and their proposed contingency measures.
DHSC is implementing a multi-layered approach to minimise any supply disruption in a ‘no deal’ exit scenario. This includes supporting suppliers to secure alternative routes away from the short straits, stockpiling where practical, putting in place arrangements to deal with shortages in addition to normal shortage management routes, securing additional warehousing space, improving trader readiness and introducing regulatory flexibility.
Our plans should ensure the supply of medicines and medical products remains uninterrupted.
Asked by: Rosena Allin-Khan (Labour - Tooting)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the potential effect of the UK leaving the EU on the supply of drugs to the NHS.
Answered by Chris Skidmore
The United Kingdom will leave the European Union on 31 October, with or without a deal. The Government would prefer the UK to leave the EU with a deal and, in the event that the UK leaves the EU with a new deal, the Department’s assessment is that access to medicines and medical devices will not change for industry or the National Health Service.
While the Prime Minister is confident that he can strike a new arrangement with the EU, it is vital that we prepare for a ‘no deal’ outcome. Therefore, as a responsible Government, we continue to take steps to ensure the supply of medicines and medical products is uninterrupted in a ‘no deal’ scenario.
On 26 June, we wrote to suppliers of medicines to the UK from or via the EU or European Economic Area setting out our continuing multi-layered approach to ensure the continuity of supply of all medicines and medical products in a potential ‘no deal’ exit scenario on 31 October.
Further details can be found at the following link:
Ahead of 31 October, all necessary funding will be made available to support our ‘no deal’ preparations. On 1 August, Her Majesty’s Treasury announced an additional £434 million made available to help ensure continuity of supply of vital medicines and medical products, including through freight capacity, warehousing and stockpiling.
We are confident that the Department is doing everything appropriate to prepare for a possible ‘no deal’ EU exit on 31 October. We are working with our partners, including suppliers, freight companies and the health and social care system and our plans should ensure the supply of medicines and medical products remains uninterrupted.
Asked by: Lord Taylor of Warwick (Non-affiliated - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what steps they have taken to assess the impact on the NHS of leaving the European regulatory framework in the event of a no-deal Brexit.
Answered by Baroness Blackwood of North Oxford
The Government maintains that leaving the European Union with a deal is the best outcome. However, as a responsible Government, we continue to plan and prepare for all eventualities, including a potential ‘no deal’ exit.
The Government is committed to the safe and effective regulation of medicines and medical devices in the United Kingdom. We will continue to strengthen safety while ensuring National Health Service patients and the public have fast access to new, innovative medicines.
The Government is providing short-term regulatory flexibility, in order to ensure that the UK can still import medicines from the European Economic Area (EEA), when the UK leaves the EU. We have announced that, in the event of a ‘no deal’ scenario, the UK will recognise batch testing that takes place in the EU and EEA, thus ensuring regulatory continuity so that the NHS can maintain ease of access to medicines developed and manufactured in the EU.
In the event of a ‘no deal’ exit, the Government will continue to ensure that UK patients are able to access the best and most innovative treatments and that their safety is protected.
Asked by: Hugh Gaffney (Labour - Coatbridge, Chryston and Bellshill)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the availablity of (a) critical and (b) short shelf-life medicines in the event of the UK leaving the EU without a deal.
Answered by Stephen Hammond
The Government fully understands that maintaining access to all medicines and medical products, including critical medicines and short shelf-life products, is vitally important to millions of people in this country. Ensuring unhindered supply of these products remains the Government’s top priority.
As in preparation for 29 March and 12 April, our ‘no deal’ EU Exit contingency plans for 31 October will cover the NHS, social care and the independent sector and covers all medicines, medical devices and clinical consumables, supplies for clinical trials, vaccines and countermeasures, and organs and tissues for transplants.
The Department has continued to work closely with the Devolved Administrations, industry trade bodies and suppliers, the NHS and other key stakeholders. Prior to 29 March, the Department analysed the supply chains of 12,300 medicines, close to half a million product lines of medical devices and clinical consumables, vaccines used in national and local programmes, and essential non-clinical goods on which the health and care system relies. These analyses and assessments have been updated where necessary and will continue to be refined while a ‘no deal’ EU Exit remains a possibility. This work has informed our plans.
We are asking suppliers to analyse their supply chains and to make alternative plans if they anticipate disruption, including rerouting to alternative ports or using airfreight where necessary. Our contingency measures aim to support industry-led measures and, where required, act as a ‘last resort’ to be used only when a supplier’s alternative arrangements encounter difficulties, to ensure uninterrupted supply.
In the case of medicines that cannot be stockpiled because, for example, they have short shelf-lives, such as medical radioisotopes, we are working closely with suppliers to make alternative arrangements using airfreight.
Further details can be found at the following link:
While we never give guarantees, we are confident that, if everyone – including suppliers, freight companies, international partners and the health and care system – does what they need to do, the supply of medicines and medical products should be uninterrupted in the event of a no-deal EU Exit.