NHS: Babylon’s GP at Hand App
Debate between Lord Bethell and Baroness Thornton
Baroness Thornton (Lab)
My Lords, I beg leave to ask the Question standing in my name on the Order Paper. In doing so, I declare my interests as set out in the register.
Lord Bethell (Con)
NHS England and partners commissioned an evaluation report of Babylon GP at hand. This was published in May 2019 and concluded that, overall, users are satisfied with the service, in particular its convenience. The GP at hand work- force demonstrated high satisfaction with the service, particularly with the flexible work arrangements. However, satisfaction was lower for waiting times for face-to-face appointments. Practice funding is being revised to improve fairness following the emergence of digital- first providers.
Baroness Thornton
I am not sure how many noble Lords realise what GP at hand is. It is a virtual GP app that uses artificial intelligence to identify health problems and has a partnership with the NHS in London and Birmingham, where patients can sign up for the digital-first GP at hand service and receive video consultations. I am absolutely in favour of the use of new technology in primary healthcare—this is not a Luddite Question—but clinical commissioning groups in London have, on the instructions of NHS England, had to reserve large sums of money, of up to £1 million, in their 2019-20 budgets for the next year to meet the costs of Babylon GP at hand. They have not commissioned this work; it is not included in the safeguarding or quality oversight of them; and it is paid for without basic information about how many or which patients are leaving local GP lists or the impact that this might have. Does the Minister think that this is a satisfactory situation, in terms of the control and accountability of local budgets? Would the money, which I understand stands in London at about a £21 million deficit, not be better spent providing technology and IT infrastructure for the use of our GPs in their surgeries?
Lord Bethell
The noble Baroness raises an important question. The Government are aware of the issues faced by out-of-area commissioning, and particularly of the concerns of Hammersmith and Fulham Council. We are looking at its concerns about its budget provisioning. We do not recognise all the numbers, but we are trying to understand them better. I reassure her, however, that we are putting in measures to ameliorate the situation. We are looking at ways to disaggregate a patient list if there are large numbers of digital-first patients; we are making more timely adjustments to CCG budgets, moving to quarterly rather than annual assessments; and we are looking at how to apply technology to under-doctored areas.
Brexit: Medicines and Medical Devices
Debate between Lord Bethell and Baroness Thornton
Baroness Thornton
To ask Her Majesty’s Government what steps they are taking to safeguard the supply of medicines and medical devices in the event of a no-deal Brexit.
Lord Bethell (Con)
My Lords, the Department for Health and Social Care is doing everything possible to prepare for an exit from the European Union, whatever the circumstances. We have worked with trade bodies, product suppliers and the health and care system throughout the UK and have made great progress towards ensuring continuity of supply to the whole of the UK and its Crown dependencies. I reassure patients that our plans to ensure the uninterrupted supply of medicines and medical products when we leave the EU are as solid as possible.
Baroness Thornton (Lab)
I thank the Minister for his Answer. This Question was prompted by the National Audit Office report published last week, which justified considerable concern among NHS workers and patients about the availability of basic medicines if the UK crashes out of the European Union.
I wish to raise two specific concerns with the Minister. It seems likely that the availability of the flu vaccine will be affected by a no-deal exit. Andrew Goddard, the president of the Royal College of Physicians, said:
“I can’t … say, ‘Don’t worry, no deal will be fine, no one is going to come to any harm, no one is going to run out of medicines.’ What we can see is we’re likely to not have enough flu vaccine … and that is likely to have an impact on the NHS”.
So will the Minister inform the House whether the department has a plan to deal with this eventuality and, if so, what it is? Secondly, what is the plan for the availability of medicines and treatments that cannot be stockpiled, such as isotopes, which are vital for cancer treatment and which by definition have a short shelf life?
Brexit: Advertising of Duty-Free Shopping
Debate between Lord Bethell and Baroness Thornton
Baroness Thornton
To ask Her Majesty’s Government what assessment they have made of the compatibility of their recent campaign advertising the return of duty-free shopping after Brexit with (1) domestic law and (2) international charters governing the advertising of tobacco products.
Lord Bethell (Con)
My Lords, the recent announcement provides clarity for consumers on the application of duty-free in the event of a no-deal Brexit. It allows businesses and port and airport operators time to prepare. This is a temporary policy only that complies with international laws by broadly treating all individuals in a similar way while aiming to ensure that individuals can continue to cross the border without undue disruption or delay. The Government commit to consulting on a longer-term approach.
Baroness Thornton (Lab)
I thank the noble Lord, Lord Bethell, and welcome him to his brief—whether it will be a permanent or a temporary occupation of it. I suspect that we will be seeing quite a lot of each other this afternoon. The Chancellor said:
“As we prepare to leave the EU, I’m pleased to be able to back British travellers. We want people to enjoy their hard-earned holidays and this decision will help holidaymakers’ cash go a little bit further”.
Fine. I reassure noble Lords that this is not about alcohol but about tobacco. Accompanying this, information was posted on the Government Brexit website and shown on main television channels containing information about purchasing duty-free tobacco without duty. The law in the UK is quite clear:
“A person who in the course of business publishes a tobacco advertisement, or causes one to be published, in the UK is guilty of an offence”.
So my question to the Minister, which he has not answered, is whether the Government have strayed outside our tobacco regulations and law. Another question I need to ask is whether this is a sign that the Government intend to use Brexit as a way of undermining or relaxing the UK’s legal and regulatory position on tobacco regulation.
Lord Bethell
Perhaps I may remind the House that we are talking about a tweet from Her Majesty’s Treasury’s on its Twitter feed: it was not a paid-for promotion in any way. The advertising authority reviewed the tweet and confirmed:
“It was posted in non-paid for space, (i.e. their own Twitter account) and features no direct encouragement for consumers to buy or do anything, so it falls outside our rules”.
This Government are fully committed to our health policy on tobacco and to bringing down tobacco smoking and consumption in this country. However, a no-deal Brexit creates ambiguity both for shop owners in airports and ports and for consumers, so this was a perfectly reasonable move to bring clarity to a confusing area of policy.
Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Debate between Lord Bethell and Baroness Thornton
Lord Bethell (Con)
My Lords, I am confident that all noble Lords have a shared intention to protect and improve the safety of patients using medicines, while enabling their access to the most innovative treatments. As my noble friend Lady Manzoor stated previously:
“Our regulator, the Medicines and Healthcare products Regulatory Agency, MHRA, has over 30 years’ experience as a leading regulator in the EU. This expertise and experience is globally recognised and respected; we want to ensure that this continues, to the benefit of UK patients. It is with this at the forefront of our minds that the UK’s plans for the regulation of medicines … in a no-deal scenario have been developed”.
As my noble friend set out on 7 March 2019, it is important to reiterate our aim to retain a recognised regulatory system, which ensures that,
“patients in the UK and the EU continue to have timely access to safe and effective medicines”.—[Official Report, 7/3/19; col. 758.]
The system for regulating medicines is currently set out in EU legislation, and we have made legislation to ensure that our national regulatory system continues to function without any detriment to our ability to protect the public health in the event of the UK leaving the EU without a deal. We will then be considered a third country by the EU and, in this scenario, the UK regulator will take on the functions currently carried out by the EU. Additional changes are now being made through the SI in areas the Department of Health and Social Care has identified would benefit from further clarification. This is being done in response to comments from stakeholders, including industry and the life sciences sectors, and from internal review.
The changes proposed do not in any way represent changes in any underlying policy; rather, they are technical in nature, correcting minor drafting errors and omissions, and seek to ensure only that the original policy intention is delivered in legislation. The amendments proposed by this SI continue to be based on the department’s priority to ensure timely availability of safe, effective medicines and medical devices, while minimising disruption to patients and businesses, and to ensure that the regulator can continue to protect public health.
Noble Lords will note that the original regulations were developed through close consultation and co-operation with stakeholders, and that the department has published an impact assessment. After a period of informal consultation in August last year, the MHRA published an initial proposal for the UK’s medicines regulation framework and followed this up through a four-week public consultation in October. The feedback from that consultation—which received about 170 responses—led to revised proposals, which were published in January, and informed the development of the system that will come into place in the event of no deal. Noble Lords will have seen the published impact assessment, which was developed by experts at the MHRA and influenced by responses to the consultation. Noble Lords will want to be reassured that none of the proposed amendments change this impact assessment.
I will now give some specific detail of the arrangements set out in this SI. The majority of the changes being made are technical in nature and have arisen as we have reviewed the legislation and identified areas requiring changes to the legal text to ensure that it gives effect to the published policy. There are no new policy changes introduced in this SI.
This SI makes the following amendments for medicines specifically. First, it makes clear the requirements for a responsible person for import and RPI and for a wholesaler’s licence to hospitals importing human medicines directly from a country on an approved list for their own use. Secondly, it clarifies that UK generic applications can rely on data supplied in relation to medicinal products whose EU marketing authorisations were cancelled pre-exit on grounds other than safety, quality and efficacy. Thirdly, it gives additional detail in relation to the process by which companies may make representations to the Commission on Human Medicines about decisions on rare disease medicines and paediatric matters. Fourthly, it provides for a temporary exemption, subject to a specified condition, from the obligation to maintain a UK pharmacovigilance system master file for companies whose UK authorisations are included in an EU file. This also includes the condition that information required by the licensing authority be provided by the marketing authorisation holders on request. Fifthly, it clarifies that the temporary exemption as to the geographical location of an appropriately qualified person for pharmacovigilance applies to all marketing authorisations and herbal registrations that a company holds, whether granted before or after exit day. This is provided that they are covered by a single pharmacovigilance system in respect of which there is the same qualified person. Lastly, it adds the Republic of Korea to the approved list of countries with equivalent regulatory standards for the manufacturing of active substances on exit day. This is to reflect the updates to the EU list since the no deal SI was made.
For medical devices, there are some changes resulting from amendments made by the EU to the underlying medical devices regulations since the no-deal SI was made via the recently published corrigendum. The changes range from grammatical and reference corrections to a change concerning what is included in the transitional arrangements. Two further changes are inserted to ensure that products mainly used for cosmetic purposes are required to comply with common specifications and to require the information registered with the MHRA about medical devices to be updated by the manufacturer.
In conclusion, in the event of no deal these regulations will put in place technical changes that will ensure that the UK’s medicines regulations legislation continues to function effectively after exit day. These provisions will minimise any impact on patients and businesses and will ensure the timely availability of safe, effective medicines in the UK market.
Baroness Thornton (Lab)
I thank the Minister and welcome him to the world of EU health statutory instruments and their amendments—whether it is just for today or for a longer period. I also thank him for his explanation. I really hope that the Government have managed to get it right this time—I am not quite sure whether I have visited this twice or three times in the last year or so.
This statutory instrument comes into force immediately before exit day to correct the defects and omissions in the Human Medicines (Amendment) Regulations 2019 and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. They come into force on exit day and, as the Minister described, amend our various regulations to ensure that they are fit for purpose in the case of the UK crashing out of the European Union without a deal.
As noble Lords know, EU law provides that the EU medicines regulatory system—of which the UK is currently a part—ensures, for example, the recognition of prescriptions across the EU and EEA, provides for the monitoring of the safety of medicines and incentivises the development of medicines to treat rare diseases and children. EU law also provides for an EU regulatory system for medical devices and in vitro diagnostic devices. This provides a conformity and safety before these things can be placed on the European Union market—so they are very important.
I have a few questions. First, it is said:
“The new Medical Devices Regulations … and in-vitro Diagnostics Regulations … have been applied directly in UK law since May 2017 and will be fully implemented in the EU from May 2020 and May 2022 respectively”.
So my question is: what is happening to them in the meantime? If we leave the European Union in six weeks’ time, will these things still be implemented or not? I just want to know whether my reading of that—from the Explanatory Notes in this case—is right.