Medicines and Medical Devices Bill

Lord Clement-Jones Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

[Baroness Wheeler (Lab)]

My Lords, I am pleased to move Amendment 23, in the name of my noble friend Lady Thornton, and to support Amendment 29, in the name of the noble Lord, Lord Clement-Jones.

Our amendment is a probing amendment, which has two aims. First, it provides us with the opportunity to hear from the Minister why the Government consider that the extensive delegated powers on the hub and spoke model for pharmacies are needed at this present time under the Bill, rather than ensuring that any such proposals are instead contained in future planned and well-thought-out primary legislation—properly consulted on and worked through—that amends existing legislation and regulations.

Secondly, we understand that there has been some discussion with key stakeholders in the pharmacy industry since the Government’s intentions were revealed in the nine short paragraphs on dispensing medicines in the impact assessment for the Bill—as we know, hub and spoke dispensing centres are not referred to on the face of the Bill. Today is an opportunity for the Minister to update us on the Government’s response to the concerns and issues raised by MPs in the Commons and by noble Lords during the Bill’s Second Reading, and in representations from leading industry organisations, including the National Pharmacy Association and the Pharmaceutical Services Negotiating Committee.

We need far greater clarity on what exactly is proposed, how the Government intend to take all this forward and how the very limited proposals that we have heard so far fit into the NHS long-term plan vision for the transformation of community pharmacy as an integral part of local primary care. How will pharmacists’ enhanced role in the future limit the number of people who will not have to see their GPs, in the way that the Government envisage?

Amendment 23 would amend Clause 2, on the “Manufacture, marketing and supply” of human medicines, and would delete the Secretary of State’s power to make provision for the distribution of human medicines by wholesale dealing, as is proposed for hub and spoke dispensing in the delegated powers proposed in the Bill. I have deep concern about the extensive range of delegated powers proposed under the Bill, and I support the decisive views of both the Delegated Powers Committee and the Constitution Committee on this matter, which have been made crystal clear by my noble friend Lady Thornton at all stages of the Bill. Major changes such as those envisaged for the community pharmacy sector through the extension of hub and spoke dispensing should be on the face of the Bill, with appropriate safeguards on their development, including a full public consultation.

The impact assessment tells us that

“dispensing needs to become more efficient to free up pharmacists’ time for other activities”

and that this will be achieved if all pharmacies have access to more efficient hub and spoke dispensing. We strongly support the aim of freeing up pharmacists’ time, better use of the skill mix in pharmacies, extending prescribing duties for pharmacists and a greater role in clinical service delivery. We also fully acknowledge the work, expertise and development of the hub and spoke models, including automated prescription assembly facilities—PAS facilities—operated by the large pharmacists, such as Lloyds Pharmacy, within their community retail pharmacy operations.

The impact assessment acknowledges the scale, substantial up-front and running costs and slow timetables of setting up and then operating hub and spokes efficiently and effectively, which are in reality way beyond local groups of pharmacies not part of nationwide businesses to fund and operate. In a moment of understated frankness, the IA admits:

“The costs and benefits remain uncertain, as do some details around the policy design, and the changes would be provided for by regulations made under the Bill.”


The Minister will know that the NPA has serious doubts about the suggested economic efficiency of the hub and spoke model, particularly in light of the impact assessment’s uncertainty. Under the five-year community pharmacy contractual framework agreement, the PSNC is tasked with the role of agreeing hub and spoke models which will allow the sector to benefit fairly. Can the Minister explain to the Committee how it is envisaged that hub and spoke models will be able to operate to ensure that the arrangements are fair to all pharmacies?

The NPA has stressed that, without a level playing field, competition and choice in the pharmaceutical wholesale market could be reduced by the pressure to set up or join hub and spoke arrangements. The resilience of the medicines supply system could be impacted, and medicine prices could rise as a result. As the NPA says, huge barriers will need to be overcome to make any model fair and appropriate for independents, including the risk of introducing new process errors, lack of clarity on the ownership of problems between the hub and spoke, longer lead-in times and impact on procurement margins—essentially, a reduction in system resilience and problems caused by restrictive distribution arrangements.

The impact assessment stresses that the proposed regulatory change is intended to be entirely permissive, with pharmacy businesses developing hub and spoke arrangements only where they deemed it would be

“beneficial for them to do so”.

Paragraph 255 sets out three types of hub and spoke arrangement that could be entered into, underlying the complexity of the range of models and reinforcing the need for greater consideration and thought to be given as to how further hub and spoke models could be introduced.

The Company Chemists’ Association, the trade body for large community pharmacy operations, which include Boots, Lloyds, Asda, Morrisons, Tesco and Superdrug, has expressed particular concern at hub and spoke models being introduced through secondary legislation and stressed the importance of extensive consultation with the industry—in fact, the consultation on the future of the industry began in 2016 but has yet to be concluded. When and how will consultation on this vital matter, which sees the most significant changes to pharmacy in decades, commence?

The Minister has rightly praised the contribution of independent pharmacies, particularly during the Covid pandemic. However, we know that, before Covid, more than half reported operating at a loss, a situation greatly exacerbated by Covid and extra costs, which led to their income decreasing while their role in the community became more important than ever, working long hours with often reduced staffing numbers, providing advice and support and supplying medicines. In rural areas, such pharmacies have always played a key role as often the only source of information and advice as well as of prescriptions and medical equipment. During Covid, in many areas they were and are the only primary healthcare professionals that patients can still see in person. What progress has been made in the discussions with the sector about additional funding on Covid costs? The £370 million provided in July was an advance payment to an already struggling industry rather than new money. Can the Minister place on record how much additional funding has been provided? My noble friend Lord Hunt will expand on this issue of funding community pharmacies and the wider pharmaceutical industry in relation to the price regulation scheme.

I want briefly to express support for Amendment 29 in the name of the noble Lord, Lord Clement-Jones, which would place a duty on the Secretary of State to consult the pharmaceutical, wholesale and pharmacy sectors and their regulators on an agreed framework for the safe transfer of patient data, prescription information and dispensed products between separate hubs and spokes. This and other provisions in the amendment would provide some vital safeguards if hub and spoke models are developed in future secondary legislation. We strongly support the noble Lord’s approach.

As I stressed earlier, the nine paragraphs of the impact assessment do not represent a strong or coherent case for moving forward at this time under the secondary legislation enabled by the Bill. Instead, they demonstrate the need for more thought, analysis and development of proposals for the future delivery and transformation of pharmacy services, with full involvement of and consultation with the industry, including on extending hub and spoke models. That would ensure a fair and level playing field and the survival of the independent local community pharmacies so valued by patients and their families and carers. I beg to move.

[Lord Clement-Jones (LD)]

My Lords, I want to speak to Amendment 29 in my name and those of the noble Lord, Lord Hunt, and my noble friend Lady Jolly. I thank the noble Baroness, Lady Wheeler, for her support and comprehensive exposition of the issues involved with regulation in respect of hub and spoke.

Like the noble Baroness’s amendment, mine is an attempt to flesh out concerns about the lack of detail in the regulation-making powers under Clause 2(1)(c) as regards authorising hub and spoke arrangements and the process by which new regulations will be agreed. For the record, I should say that “hub and spoke” describes how prescriptions are sent from a community pharmacy “spoke” to a central premise, or “hub”, for assembly, often using automated technology. The assembled medicines are then distributed back to the community pharmacy “spokes” for collection by patients. By removing elements of the existing workload in pharmacies, centralised automated assembly can give the pharmacist and their team more time to deliver healthcare services and advice and to support patients who have urgent and acute needs. This is not the same as an online-only pharmacy or a delivery system. It is not a means to enable home delivery of prescription items. There are significant costs of both setting up and running hub and spoke facilities, but it frees up capacity.

It is not blindingly clear on the face of it but, as a result of powers given under the Medicines and Medical Devices Bill, the Government intend to enable medicines assembly through hub and spoke models across legal entities, which is not allowed under current legislation. It is important that this technology is harnessed for the benefit of patients and the NHS within an agreed framework.

Over the past decade, many pharmacists have invested significantly in hub and spoke technology and use it to release capacity in their community pharmacy branches. It is hoped that, if wider use of the hub and spoke model can be permitted, this capacity can be used to enable community pharmacy teams to provide more clinical services to patients.

Noble Lords participating in Committee will be only too aware that community pharmacy is already helping the NHS in providing services and wants to deliver more. At a recent meeting with pharmacists I heard how, through freeing up capacity, hub and spoke arrangements support the delivery of essential and more advanced pharmacy services such as medicines use reviews, diabetes control, support during taking new medicines, minor ailments and vaccinations. NHS England, likewise, wants to open up the market to new technologies and enable greater efficiencies to be found in medicines supply, but the major pharmacy players believe that this can happen only if other barriers to automation are addressed through the community pharmacy contractual framework at the same time.

The noble Baroness, Lady Wheeler, mentioned the impact assessment and the need for much greater clarity on how the Government will deal with the barriers on the way to realising the efficiency benefits of hub and spoke. These barriers, over and above those mentioned by the noble Baroness, include, first, original pack dispensing. Very often, the quantities prescribed by doctors do not match the amount of medicines in the packs produced by the manufacturers. Pharmacy teams in England and Wales manually “snip” the plastic strips of pills to either add or take away from the manufactured quantity. Snipping is a time-consuming and expensive manual intervention that cannot be automated or delivered at scale.

A second barrier is the need for government support for infrastructure investment. Despite its potential, less than 10% of prescription items are currently dispensed using hub and spoke technology. The industry has already invested tens of millions of pounds in this technology. Government capital investment is needed for it to expand further.

A further barrier relates to fair community pharmacy funding, mentioned by the noble Baroness. The level of remuneration for pharmacy has been a challenge for some time. It needs to be addressed to help the sector to deliver the urgent care and services that the NHS badly needs, especially in the current Covid environment. This is even more important if pharmacy capacity is increased and there is a real prospect of enhancing pharmacy services to fill it.

The noble Baroness has explained the concerns over secondary legislation. I hope that the Minister will address some of these issues in her response and explain how she sees the extension of the hub and spoke dispensing model taking place and how consultation and agreement on a framework will take place.

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[The Deputy Chairman of Committees (Baroness Henig) (Lab)]

There are no requests to speak after the Minister, so I now call the noble Baroness, Lady Wheeler. Oh, apologies, I call the noble Lord, Lord Clement-Jones.

[Lord Clement-Jones (LD)]

I was very struck by the support for pharmacists and pharmacy services throughout this debate. It is not often we get a really good opportunity to talk about pharmacists’ potential. I chaired the London School of Pharmacy, which then merged into UCL. I used to see bright, bushy-tailed MPharms depart the School of Pharmacy, all expecting the bright future for pharmacy promised by plan after plan from Government after Government. To use their clinical skills in particular was the great goal.

Sadly, we are still not in the right place with community pharmacy. I was very struck by what the noble Lord, Lord Lansley, said: we have never achieved as much as we should. That is absolutely apposite in the case of pharmacy. We have all these highly skilled people, many of them very young, who are capable of taking on all kinds of clinical work in the community, with consultation and so on. We seem to ebb and flow in the services we think we can make available in pharmacy.

I am very grateful for what the Minister said about the need for proper consultation being a given and that there will be consultation to develop the policy and so on. She of course talked about the five-year plan, but many people are worried that the plan will run out and there will not be resources for hub and spoke to develop further. She talked about the fact the amendment would limit the time available but, as the noble Lord, Lord Hunt, pointed out, pharmacists have been talking about this since 2016. It is not as if we are imposing too harsh a timetable.

Underlying all this is the question: where is the plan to use that additional capacity? That is really what pharmacists are after. On the basis that automation is augmentative and will help community pharmacists free up capacity, they want to deliver more clinical services in particular. Where is the plan? That is what we all want: to use their expertise in and knowledge of the community, and the trust they have. We have talked about the access people have to the local pharmacy. I wish there was a better relationship between many general practitioners and the pharmacy profession. There is still that rather standoffish attitude to pharmacists. Be that as it may, this is a really important aspect that could deliver much greater capacity, but I do not feel that the Government have yet really picked up the ball and started running with it.

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[Lord O'Shaughnessy (Con) [V]]

My Lords, I speak in support of the intention of Amendment 27 in the names of the noble Lords, Lord Patel and Lord Hunt of Kings Heath. As noble Lords know, I made my views on the Brexit approach of working with other regulators clear on the first day in Committee and I do not intend to rehearse them—I am sure that noble Lords will be relieved—but I was struck by how this might work in practice. While listening to the noble Lord, Lord Patel, who gave an excellent exposition, I reflected on his story about CAR-T therapies and how that provides a good example of what we need to guard against as we move out of the EMA post Brexit.

In September 2017, I went on a visit to Pennsylvania and had the opportunity to go to Penn Medicine, which is where CAR-T was developed, in a lab sponsored by Novartis. I remember sitting down afterwards and being told about the amazing progress they had made, how this was rolling out to patients and indeed how they were thinking about the next iteration of this medicine, how useful it would be and how much demand there would be for it to be given to American dogs—that is right, dogs. I was sitting there at a time when UK patients did not have access to CAR-T therapies, but American dogs were about to get access. This in a way exemplifies a problem that we have today as part of the EMA but are likely to have tomorrow: our unwillingness to accept the decisions of other stringent regulators who make good decisions and whose processes we trust.

The idea of how we could work with other regulators as expressed in this amendment is incredibly important and could be carried out in two ways. The first is, as I said, in accepting decisions from other stringent regulators, including the FDA, the EMA, of course, and others. There has been resistance—there certainly was in my time as a Minister—about so-called rubber-stamping of other decisions and the implications for legal liability if things go wrong, but I am absolutely confident that these can be overcome. Our regulator should be prepared to accept the paperwork submitted to other regulators and the decisions of other stringent regulators where we have confidence in their processes. Ideally, as the noble Lord, Lord Hunt, said, this would be in the form of mutual recognition, but it is perfectly possible for us to do that unilaterally as well. That would go a long way to assuaging the concerns of industry.

The second way, and they are not mutually exclusive, is that the UK could lead the creation of a third global market to go alongside the FDA and EMA by working with independent regulators in Switzerland, Australia, Singapore, Canada and so on. As I say, these are approaches that we could follow in tandem as part of, I hope, a global move towards a single approach.

I am confident that we can follow these routes without causing any harm to patient safety while improving patient access. I am not convinced that they require legislation. I can understand why the noble Lord has tabled the amendment and I support its intention; I do not know that we need to change the law. What I would like to hear, and I hope other noble Lords would like the same, is a commitment from my noble friend the Minister that the Government intend to take this kind of approach. We look forward to speaking to the director of the MHRA on precisely this issue, as she has kindly agreed to meet us next week.

[Lord Clement-Jones (LD)]

My Lords, I am very glad that I put my name down to speak on this group of amendments. I had designed my contribution to be about the government amendments. Having heard the noble Lord, Lord Patel, I am reassured that I am not tilting at windmills. I hope that when the Minister winds up on this group she will be much more explicit about the purpose behind Amendments 48 and 109 and the limitations on their use. There are very thin explanatory statements accompanying the amendments. I heard the helpful paraphrase from the noble Lord, Lord Patel, but, regrettably, I did not receive the Minister’s letter although I have spoken on health data issues in the Trade Bill at some length. I share the noble Lord’s concerns.

I have a series of questions to put to the Minister in relation to those amendments. Can the Minister confirm that they do not, as such, permit the sharing of NHS patient data, whether related to medicines or medical devices and whether anonymised or not? The new UK-Japan trade agreement permits either party, in its Article 8.73, to share source codes and algorithms for regulatory purposes. This is directly relevant to modern medical devices. Is this why the Government are seeking the provision inserted by Amendment 109? In agreeing the trade deal, did the Government realise that they did not have a clear power to do so? How widely do the Government interpret these two amendments? What is their essential purpose and subject matter? I am raising this and the noble Lord, Lord Patel, raised it. What are the constraints as the Government see them?

Of course, there is an important patient safety issue in terms of the operation of medical devices. I entirely take the point raised by the Lord, Lord Patel, that there is no specificity in the article about that but does that mean that UK medical device manufacturers will, as a matter of routine, need to reveal their source codes and algorithms? Is this to be a standard provision in trade agreements, permitted by these provisions? What safeguards will there be against IP infringement and know-how theft in these circumstances?

I am sorry to throw these questions at the Minister in this fashion, but it comes as a result of me not having any brief from the Minister in the first place. We have all commented on the fact that the government amendments, tabled as they have been, need a fair bit of explanation. I hope the Minister can answer some of these questions and I look forward to her reply, but it may be that she prefers to write after Committee.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I understand that the noble Lord, Lord Lansley, has withdrawn so I call the next speaker on the list, the noble Baroness, Lady Jolly.

Medicines and Medical Devices Bill

Lord Clement-Jones Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord Clement-Jones (LD)]

My Lords, as we have heard loud and clear today, this Bill is fraught with many critical flaws that the Government must address. However, I will focus on the concerns that have been expressed by pharmacists about the wording of Clause 3, relating to the development of a successor UK system to prevent the supply of falsified medicines, which is symptomatic of the Government’s high-handed approach.

The clause refers to

“the use, retention and disclosure, for any purpose to do with human medicines”

of information collected by such a system, which considerably broadens the original data-collection provisions of the Falsified Medicines Directive. Yet the Explanatory Notes make no mention of this legislative creep and, indeed, the Health Minister, Jo Churchill, said in Committee in the Commons:

“The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices.”—[Official Report, Commons, 8/6/20; col. 7.]


In this context, data is sensitive, commercial currency. All parts of the medicines supply chain need access to broad patterns of medicines usage but, in the current scheme, access to pack information, which could highlight purchasing decisions and margins being made, is restricted to details such as the name, batch, expiry, serial number and active/inactive status, with some exceptions for investigating incidents and the national competent authority, MHRA, used for various purposes.

Because of the issue of the commercial sensitivity of data, Article 54a, regarding the protection of personal information or information of a commercially confidential nature generated by the use of the safety features, was inserted into the preamble of the Falsified Medicines Directive and the principle of “whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016, which followed the Falsified Medicines Directive.

The Department of Health and Social Care already has access to a very wide range of data on medicines sales and use in the UK under the Health Services Products (Provision and Disclosure of Information) Regulations. Ministers can request more detailed information if required. Given both this access and the known sensitivities around falsified medicines data, it is unclear why the department wants to extend the purposes for which data is collected under a future UK system and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme. Pharmacists have concerns not just that the department might accidentally release commercially sensitive data but that it might use such data to gain an unfair advantage, given its monopoly position as the main purchaser of medicines in the UK.

Of course, the details of a new scheme will need to be set out in regulation, but the regulation-making powers under Clause 1 are, as the Delegated Powers and Regulatory Reform Committee pointed out in very clear terms in its damning report—which many noble Lords have referred to—considerable, and they provide no guarantee at all that the use of falsified medicine data will follow the previously agreed pattern.

It is clearly important to ensure that primary legislation provides the necessary protection. I hope the Minister, on mature consideration, will agree to ensure that the Bill is amended to enshrine a duty of full consultation and agreement in the Bill over this data use as we go forward.

Covid-19: Test and Trace App

Lord Clement-Jones Excerpts

Monday 22nd June 2020 Lords Chamber

Asked by

[Lord Clement-Jones]

To ask Her Majesty’s Government, in the light of the announcement made on 18 June regarding the switch in technology for the NHSX Covid-19 Test and Trace app, what is their assessment of (1) the operational impact, (2) the financial impact, and what lessons have been learned.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, we remain optimistic that high-tech can help our fight against this horrible disease, but we have learned that consumers want a personal touch rather than a text exchange, that tools that assist outbreak management are our immediate priority and that the challenges of proximity detection have confounded many Governments around the world. That is why we are working with the best companies to build the best app that meets the needs of the British people.

[Lord Clement-Jones (LD) [V]]

My Lords, I hope that the Minister understands the anger at the Government’s and NHSX’s sheer incompetence and lack of humility in what was rightly called a fiasco by the Daily Mail last Friday, and that their go-it-alone approach and attempt to shift the blame on to tech companies simply will not wash. Is it not time that the Government just accepted that we cannot develop our own app and went straight to adopt the available interface, or API, behind the off-the-shelf, decentralised app now in widespread use? Such apps have been introduced in Germany, Italy, Switzerland and Denmark, where they appear to be working well, and are close to release in Holland, Ireland, Latvia and Estonia. They would help travellers avoid quarantine this summer, and many of us were urging this on the Government back in April?

[Lord Bethell]

I want to say a profound thanks to those at NHSX, NHS Digital and others who have worked so hard on the NHS app. They have made phenomenal progress and their hard work is hugely appreciated. I also want to say a profound thanks to those at Apple who are working with us to design an app that suits the British public. Both teams have faced enormous challenges and I look forward to their working together to overcome them.

Covid-19: Contact-tracing App

Lord Clement-Jones Excerpts

Wednesday 6th May 2020 Lords Chamber

Asked by

[Lord Clement-Jones]

To ask Her Majesty’s Government what action they are taking to (1) protect the privacy of users, and (2) provide oversight, of the National Health Service’s COVID-19 contact-tracing application and, in particular, whether the application will meet Apple’s privacy standard for Bluetooth.

The Question was considered in a Virtual Proceeding via video call.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, we have put privacy at the heart of the app and the way it works. It is designed so that you do not have to give up your personal details to use it. We have worked in partnership with both the National Cyber Security Centre and the Information Commissioner’s Office throughout. We continue to hold discussions with Apple and Google. The app uses only software development tools and mechanisms that are supported by Apple and Google.

[Lord Clement-Jones (LD)]

To be effective, achieve widespread adoption and ensure our safety, the new app needs to gain public trust. So, why have the Government developed a go-it-alone, centralised app which is not optimally privacy-preserving, not interoperable with the apps of other countries—not even Scotland, it seems —not fully compatible with the Apple and Google Bluetooth protocol, and has no mandatory oversight, time limit on its use or public data impact assessment?

[Lord Bethell]

My Lords, it is not a go-it-alone app; others are following our lead on this. It is interoperable, and we are working with other countries to make sure it is. Testing with the public has turned out to be extremely positive and we look forward to publishing the audit shortly.

Queen’s Speech

Lord Clement-Jones Excerpts

Thursday 9th January 2020 Lords Chamber

[Lord Clement-Jones (LD)]

My Lords, since we have just had the 12 days of Christmas, I want to use my five minutes to suggest 12 digital priorities for action by this new Government in the context of the Queen’s Speech—I will do so in shorthand, necessarily.

The first priority is action on online harms and internet safety. Will the Government bring forward a draft Bill for scrutiny, and designate Ofcom as the regulator to ensure the necessary work on codes of practice? Will they commit to bring back age verification for adult sites and widen it to cover social media platforms? Will they comply with the revised AVMS directive?

The second priority is to speed up the broadband rollout. What timescale is envisaged in the pledge to accelerate the rollout out of gigabit-capable broadband? Is it 100% by 2025, as promised by the Prime Minister in his leadership campaign?

The third priority is a moratorium on facial-recognition technology. The Home Office’s own Biometrics and Forensics Ethics Group has questioned the accuracy of live facial-recognition technology and noted its potential for biased decision-making. Will the Government agree to a moratorium as a vital first step before regulation?

The fourth priority is the control of algorithmic decision-making. The Government have published a guide to using artificial intelligence in the public sector. What plans do they have to monitor its use and ensure that there is compliance?

The fifth priority is data governance. There is increasing concern about access and security of personal data. Look at the current Travelex case: even sharing by the NHS gives rise to concern. We need to go well beyond the GDPR, with much more control over our personal information through personal data accounts, hubs of all things and data trusts. Will the Government continue to fund work on this by the Open Data Institute, the Alan Turing Institute and others?

The sixth priority is changes to corporate governance. AI can and should contribute positively to a purposeful form of capitalism which is not simply about the pursuit of profit. It is imperative that boards have the right skill sets in order to fulfil their oversight role and take accountability. Will the Government develop corporate governance for the Al age as part of their proposals on company audit and corporate reporting?

The seventh priority is a new approach to employment, skills and retraining. Whatever the scale of disruption by AI to the jobs market, retraining will be a lifelong necessity. What can the Minister tell us about the rollout of the national retraining scheme? How does it relate to the national skills fund? Have the Government considered the idea of personal learning accounts? How will the Government encourage greater diversity in the training and recruitment of AI specialists to minimise bias in training data and decision-making?

The eighth priority is the strengthening of data and digital competition, especially in digital advertising. When is the Government’s response to the Furman report going to emerge? With which regulator will the new digital markets unit sit?

The ninth priority is the adoption of international norms on ethics. What is the Government’s intention going forward with AI principles, such as those developed by the OECD and G20 last year and the potential of AI to help solve the UN’s sustainable development goals?

The 10th priority is the reform of digital taxation. The Government plan to introduce a digital services tax, ensuring that tech giants pay their fair share. Will this support and build on the OECD’s proposals? What are the Government’s intentions in that respect?

The 11th priority is ensuring better digital understanding and media literacy. Do the Government’s plans include teaching on how to use social media responsibly and provide advice and support for parents on how to help their children protect themselves online?

The final priority is a strong digital trade policy. Will the UK put the digital economy at the heart of its trade policy? Crucial areas such as data adequacy, tech skills from overseas, the EU digital services Act, data sovereignty and the US CLOUD Act will all need to be tackled in our trade policy. I hope that many, if not most, of these priorities will also be the Government’s priorities. If they are, they will get support from these Benches.

Queen’s Speech

Lord Clement-Jones Excerpts

Tuesday 22nd October 2019 Lords Chamber

[Lord Clement-Jones (LD)]

My Lords, yesterday my noble friend Lady Bonham-Carter covered a range of aspects of arts and creative industry policy, so I will focus on digital policy during today’s debate—but I hope my noble friend will have the benefit of a reply to her questions from the Minister at the end.

Digital technology and communication are now prevalent throughout our society and economy and are having a profound impact on all our lives, but it is clear that major differences with this Government of timing and priority for action are now emerging for many aspects of digital policy. This is the case above all on age verification. The Secretary of State has announced a huge delay in a policy which we debated in this House at length. I strongly agree with my noble friends and the noble Baroness, Lady Howe: this is a truly shocking and unfortunate decision. All the adult sites were preparing to install these robust mechanisms. What is the Government’s real aim? Is it to let these adult sites off the hook? Have they somehow decided that age verification is not workable? If that is not the case, when should we expect the introduction of this crucial policy? How will this impact on the anticipated age-appropriate design code when age verification is used as the default protection mechanism? How will the Government respond to the obligations of the revised Audiovisual Media Services Directive, which will enter into force in September 2020? The Government need to urgently reconsider this matter.

As regards online harms, it is widely agreed that tech companies should no longer be able to avoid responsibility for content on their sites. We agree that a statutory duty of care, properly framed, can protect the safety of the user and, at the same time, respect the right to free speech, allowing for a flexible but secure environment for users. The task of regulation in this area should fall to Ofcom. With its clout, experience of drawing up codes in sensitive areas affecting freedom of expression, understanding of how technology and content converge and experience of co-operating with other regulators, it is the most sensible choice. Given the complexity of the issues, and the need for clear definitions, we welcome the prospect of pre-legislative scrutiny of a draft Bill setting out the new regulatory provisions. Indeed, on these Benches, we suggested it. How do the Government intend that this is carried out? When can we expect the draft Bill, and will it designate Ofcom as the regulator so that it can start preparations?

Competition regulation for the digital industries needs to be substantially strengthened so that the importance of data as an asset is recognised and we prevent data monopolies that form barriers to innovation. We need to build on the recommendations in the Furman review, which recommended a new digital markets unit to ensure that we are abreast of these issues. When is the Government’s response to that report going to emerge? With which regulator will the new unit sit? Have the Government made a decision?

Online gaming and e-sports are becoming immensely popular hobbies for individuals of all ages, especially for our younger generation. They provide a positive outlet for creativity and a level of global communication the likes of which have not been possible for the generations before them. But we must also consider the negative consequences of new forms of online gambling for young people, such as loot boxing. What are Government doing in response to the loot box phenomenon? How are they responding to the Digital, Culture, Media and Sport Committee’s recent recommendation for a ban on these for children? Will they carry out a review of their impact?

In recent days, live facial recognition technology has been described as potentially Orwellian by the Metropolitan Police Commissioner, and deeply concerning by the Information Commissioner. The Home Office’s own Biometrics and Forensics Ethics Group has questioned the accuracy of live facial recognition technology and noted its potential for biased outputs and biased decision-making. The Science and Technology Select Committee recommended an immediate moratorium on its use,

“until concerns over the technology’s effectiveness and potential bias have been fully resolved”.

In this light, will the Government support my Private Member’s Bill, shortly to be introduced, enforcing a moratorium on this technology—pending a review—to assess the right form of regulation?

Even more prevalent than this technology is the use of algorithms in decision-making by public bodies. One in three councils is now using computer algorithms to make decisions about benefit claims, despite evidence emerging that some systems are unreliable. Are we not endangering public trust in artificial intelligence in a major way? When will this Government regulate this kind of decision-making by algorithm?

Fear and lack of trust in technology are very strongly related to the future of jobs and skills. AI in particular will have significant implications for the way in which society lives and works. The future.now initiative, recently launched by the Lord Mayor, Peter Estlin, recognises that there are some 17.3 million people in the UK without the necessary skills for work—but, despite this, the Government’s national retraining scheme is only at pilot stage. What can the Minister tell us about the rollout of the national retraining scheme?

In terms of the skills we should be nurturing, as a number of noble Lords have said, it is very clear that these should be not just tech skills, such as maths and coding, but social and creative skills. Are the Government taking on board the recommendations of the Durham commission, which so cogently set out the case for creative skills?

Above all, the black cloud of Brexit looms over the thriving tech and digital sector. What can the Government tell us about their preparations to seek data adequacy, which is so important for the tech and digital industries?

Healthcare (International Arrangements) Bill

Lord Clement-Jones Excerpts

Report stage (Hansard): House of Lords
Tuesday 12th March 2019 Lords Chamber

Moved by

[Lord Clement-Jones]

14: Clause 4, page 2, line 38, at end insert—
“( ) The processing of personal data in accordance with subsection (1) must comply with—(a) the seven Caldicott principles outlined in the Caldicott Committee’s Report on the Review of Patient-Identifiable Information and subsequent reports;(b) the Government’s Data Ethics Framework.”

[Lord Clement-Jones]

My Lords, I beg to move Amendment 14, and your Lordships will be pleased to hear that I will be brief.

During the passage of the Bill, considerable concerns have been raised by a number of noble Lords about the use and sharing of data within the NHS. It is a hotly contested subject, and one of the best briefings on it is from our Library, prior to a debate on 6 September initiated by the noble Lord, Lord Freyberg. It unpacks a number of the concerns and issues about data within the NHS, and I am sorry that I have been unable to be at Second Reading or in Committee to expand on some of those issues.

During our Select Committee inquiry into artificial intelligence, there were a number of witnesses who talked about the use of data in the NHS, and we drew a number of conclusions, namely that the data was not in good shape to be utilised for beneficial purposes such as research, diagnosis and screening. That is another issue, however; what concerns noble Lords is the question of sharing. Now that we have seen Amendment 1 pass, maybe we will deal only with countries where there is a level of data adequacy which gives us an assurance about the use of NHS data. As the King’s Fund said last year in its report, Using Data in the NHS:

“National policy has to keep a balance between responding to legitimate public concern about the security and confidentiality of data and enabling data to be shared and used by NHS organisations and third parties. It is also essential that NHS national bodies are transparent with the public about how patient data is used”.


It went on to suggest that the level of opt-outs for patients would be key to the quality and validity of future research, and that NHS England and NHS Digital should keep this under review. One of the issues in the NHS is that there are several organisations responsible for NHS data. It is not just NHS England, NHS Digital, the National Information Board and Public Health England. The Caldicott Guardian—the national guardian for health and care—has a responsibility as well. It is quite a disparate, rather balkanised issue.

I was reassured on reading what the noble Baroness, Lady Manzoor, had to say when she responded, as the Minister, to this set of amendments in Committee:

“Under the Bill, personal data can be processed only in accordance with UK data protection law, namely the Data Protection Act 2018 and the general data protection regulation, which will form part of UK domestic law under the EU withdrawal Act 2018 from exit day”.


I am not going to go into all the questions about data adequacy and so on. I take what she said as quite reassuring, but it was less so when she later responded to what was then Amendment 23—this amendment is identical. She said:

“I assure the Committee that the Government are committed to the safe, lawful and responsible processing of people’s data”.


However, she then said:

“As the noble Baroness, Lady Jolly, and my noble friend Lord O’Shaughnessy noted, the Caldicott principles and the Government’s Data Ethics Framework are admirable standards to apply to the handling of patient data. Both of these non-legislative frameworks are in line with the Data Protection Act and the GDPR, which are enshrined in the Bill”.—[Official Report, 19/2/19; cols. 2261-63.]


That is not unequivocal in terms of those standards applying. As the Minister knows, we discussed this between Committee and Report. I had hoped to receive correspondence from her, but sadly I have not done so. She may need to repeat whatever text of the letter she may be able to find in her outbox. I hope she can give the House reassurance that the national data ethics framework and the Caldicott principles will apply to any sharing of data. The data ethics framework is a cross-government standard, of course, but the Caldicott principles are specific to the NHS. It is important to make sure they apply both domestically and internationally.

[Lord O'Shaughnessy]

My Lords, I am grateful to the noble Lord, Lord Clement-Jones, for giving the House the opportunity to talk about this issue again. He has been deeply involved in this topic and, as he said, I spoke on it in Committee. Compliance with this country’s very robust data protection rules is critical in general and particularly important in healthcare. This was discussed in the debate instigated by the noble Lord, Lord Freyberg; it has been a topic of conversation in this House, both in and out of the Chamber, on many occasions.

The noble Lord talked about the number of bodies that have some responsibility: he called it balkanised. It is important that we do not create a balkanisation in the law, even if a small one is in operation. One set of law should take precedence over all data protection, security and connected issues. That is, and should be, the Data Protection Act 2018. This means that there are operational guidelines, frameworks, principles and so on about how these ought to operate within individual contexts. That is precisely where the Caldicott principles come in. They take a general piece of legislation and translate what good practice in interpreting it ought to mean in a health setting. In that sense, it is important to say that we should not put those principles in a legislative setting. They are interpretive of the core, primary legislation and may need to change over time. They may need to adapt; there may be an eighth principle as we get into interesting questions about the value of data and so on.

It is important to recognise that the Caldicott principles bring to life what the Data Protection Act ought to mean in health settings. It would be a mistake to create competing law. Of course the Government agree with the noble Lord about the importance of giving force to the principles. That is one reason why we supported the Private Member’s Bill brought into this House by my noble friend Lady Chisholm to put the national data guardian on a statutory basis. I hope that that gives him the strength of reassurance about the way that the framework is constructed, which is not to create an opportunity to do funny stuff at the edges, but rather to make sure that there is primacy of one set of legislation.

[Lord Clement-Jones]

My Lords, the noble Lord used the expression, “giving force”. If those principles are given force, it means that the Government treat themselves and put on the record that they are bound by those principles. That is what giving force would mean in those circumstances, because these are novel circumstances set out in the Bill. That kind of reassurance is needed with the data ethics framework.

[Lord Patel (CB)]

My Lords, I had amendments that the Minister responded to at the Dispatch Box and I accepted her explanation at the time. Now I take the point that the noble Lord, Lord Clement-Jones, is trying to raise, that those principles that she enunciated about data protection included the Caldicott principles. As that reassurance was given at the Dispatch Box, I think it will cover the issue.

[Baroness Manzoor (Con)]

My Lords, I thank the noble Lord, Lord Clement-Jones, and the noble Baronesses, Lady Jolly and Lady Thornton, for tabling Amendment 14 and raising the issue of the lawful and responsible processing of data. I start with an apology to the noble Lord, Lord Clement-Jones. My noble friend Lady Blackwood did write to the noble Lord, and I am sorry that he has not yet received the letter. We will endeavour to send him another copy as soon as possible.

As my noble friend Lord O’Shaughnessy said—and I reassure the noble Lord, Lord Patel, that—data sharing is a necessary and crucial aspect of maintaining effective complex reciprocal healthcare arrangements, and the Government are committed to the safe, lawful processing of people’s personal data. There are, as the noble Lord said, safeguards in place in respect of processing personal data for the purposes set out under the Bill, for which the Bill makes express provision. The Bill makes it absolutely clear that it does not authorise the processing of data that contravenes UK data protection legislation.

Data processing will be permitted only for the limited purposes set out in the Bill. Personal data will be processed in accordance with UK data protection law—as the noble Baroness, Lady Thornton, observed—namely, the Data Protection Act 2018 and the general data protection regulation, which will form part of UK domestic law under the European Union (Withdrawal) Act 2018 from exit day.

I assure the noble Lords, Lord Patel and Lord Clement- Jones, and the noble Baroness, Lady Thornton, that the Caldicott principles are an important part of the governance of confidential patient information in the NHS and a guiding mechanism for organisations in how they should handle confidential patient information on a practical level. The NHS is expected to adhere to these principles.

Since 1999, NHS bodies have been mandated to appoint a Caldicott Guardian. These principles are therefore ingrained in the current operation of the NHS and confidential patient data handled by the NHS for purposes in relation to reciprocal healthcare will be subject to these principles. The principles are consistent with the requirements of the GDPR and a breach of the Caldicott principles would most likely amount to a breach of the GDPR and the Data Protection Act 2018. The principles are not intended for statute but are of real practical and operational importance when confidential patient information is processed. This will be the case when confidential patient information needed for reciprocal healthcare arrangements is processed.

It is also worth noting that reciprocal healthcare arrangements will not normally involve the processing of confidential patient information, except in particular circumstances, such as facilitating planned treatment. However, where this information is processed through reciprocal healthcare arrangements under the NHS, it must comply with UK data protection legislation. NHS organisations, as they do now, will be required to adhere to the Caldicott principles. The data ethics framework that the noble Lord, Lord Clement-Jones, mentioned sets out collective standards and ethical frameworks for how data should be used across the whole public sector, as well as the standards for transparency and accountability when building or buying new data technology. Where the framework refers to personal data, it consistently cross-refers to the principles in the GDPR, which is the relevant legislation that policymakers must consider when processing personal data.

Personal data processed for the purposes of reciprocal healthcare arrangements would therefore also take into account the data ethics framework. In addition, from 1 April 2019, the National Data Guardian will be put on a statutory footing and will therefore be able to issue formal guidance and informal advice to organisations and individuals about the processing of health and adult social care data in England. This will provide patients statutory independent oversight of the use of health data, with health bodies being required by law to have regard to the guidance issued by the National Data Guardian. This is another way in which NHS organisations in England which are processing data in respect of reciprocal healthcare will be monitored and personal data can be further protected as necessary.

It is important to note that express reference to these principles in the Bill would not provide any additional protections for personal data or confidential patient information, as the standard of protections required is the same as the existing data protection legislation already provided for in the Bill. I am grateful to the noble Baroness, Lady Thornton, and others for their support in observing this. Furthermore, as I have said, these principles already apply to NHS organisations and will continue to do so in respect of reciprocal healthcare. As a result, it would be inappropriate to put these in the Bill and I am therefore unable to accept the amendment. However, the Government have listened carefully to concerns surrounding the list of persons who can lawfully process data as a part of implementing new reciprocal healthcare arrangements under the Bill and have tabled an amendment on this issue.

Currently, the list of authorised persons under the Bill includes the Secretary of State, Scottish Ministers, Welsh Ministers and a Northern Ireland department, NHS bodies and providers of healthcare. Of course, over time, public bodies change, are reformed and refashioned, and functions are transferred between them in consequence. Clause 4(6)(e) gives the Secretary of State the ability to respond to such changes so that systems can operate efficiently and data can follow in an appropriate and lawful way to enable such operation. We propose, however, subjecting any regulations that add to the list of persons authorised to process data for the purposes of the Bill to the draft affirmative procedure. This would allow Parliament the opportunity to scrutinise authorised persons handling personal data while ensuring that the Government have the ability to guarantee that future agreements are administered in the most efficient way possible.

The Government are firmly committed to the safe, lawful processing of personal data, and to ensuring that patients have enforceable protections under data protection legislation. I hope, given my assurances that any data processing under the Bill would comply with the Caldicott principles and the data ethics framework as appropriate, that the noble Lord will feel able to withdraw the amendment.

The noble Baroness, Lady Thornton, kindly mentioned the factsheet. Of course, if it is useful, we would be very happy to put this in the Library. Officials do a tremendous job and I am very grateful to them. I hope, with the assurance I have given noble Lords, and the fact we are providing greater scrutiny, that the noble Lord feels able to withdraw the amendment.

[Lord Clement-Jones]

My Lords, that was exactly the kind of robust response from the Minister that I was hoping for. It is very rare that I listen to a government response and nod all the way through, so I thank her for that very careful response, both on the Caldicott principles and the framework for data ethics, and for going into the accountabilities, and the affirmative procedure guarantee at the end—that was a bouquet. It is not that we on these and other Benches do not understand the value of NHS data and the real importance of that balance. This is not designed as a negative approach to the use of NHS data; it has huge potential benefits, but we have to make sure that it is kept within that ethical framework. The Minister has demonstrated that that kind of culture is ingrained—or is certainly expected to be ingrained—in the NHS and that Caldicott Guardians, post 1 April, will be very much on the case. In those circumstances, with pleasure, I beg leave to withdraw my amendment.

Amendment 14 withdrawn.

Queen’s Speech

Lord Clement-Jones Excerpts

Thursday 29th June 2017 Lords Chamber

[Lord Clement-Jones (LD)]

My Lords, I am afraid that there is precious little to welcome in the Queen’s Speech for our arts and culture and our creative industries. The Creative Industries Federation, in its Brexit report published last autumn, reinforced by its recent report, Our Red Lines on Brexit, rightly stated:

“Talent and skills are fundamental to the UK’s creative success. It is vital we continue to cultivate our own talent as well as to attract the best and brightest from around the world.”


The UK is a creative hub. The freedom of movement of people to work and travel across Europe without the need for visas has both facilitated and fuelled an exchange of culture, creativity and expertise, as well as generating commercial and artistic opportunities. Our immigration system must continue to enable easy access to critical skills and talent from both EU and non-EU countries. Freedom of movement for the sector is essential, as my noble friend Lady Bonham-Carter has emphasised. Brexit must also not be allowed to interfere with an IP regime that has worked well for our creative industries. To date, the UK has worked closely with the EU and its member states to reduce copyright infringement and the proliferation of counterfeit goods. The current standards of IP protection need to be maintained with continuing co-operation on enforcement of IP generated in the UK.

We need to maintain our influence within the EU to ensure the continuation of territorial licensing of rights. We want to see initiatives such as Follow the Money being pursued at both UK and EU level. We want the UK to have an influential role in the development of the EU digital single market, including the new copyright directive. TV channels, too, must be able to continue to operate in the EU on the basis of origin in the UK, and UK content to qualify as EU, otherwise our status as a creative hub is at risk. The creative industries should also be at the heart of the Government’s education, employment and industrial strategies. My noble friend Lady Bonham-Carter has dealt comprehensively with the need for focus on arts education, creative training and skills development, not least in terms of flexibility in the apprenticeship levy.

In our UK industrial strategy, we must support small and start-up creative businesses. Creative enterprise zones should be established to grow and regenerate cultural output across the UK and measures taken to counter the threat posed by gentrification and property development to vital artistic and artisan communities such as the Old Gas Works in Fulham. Grassroots music venues are also under threat. We need to address the barriers to finance faced by small creative businesses. I commend our manifesto proposal for a new allowance to help those starting up a new business with their living costs in the crucial first weeks and reforming entrepreneur’s relief to enable investors to retain more of their money on exit, provided that it is reinvested in new projects.

There are many other important issues being faced by our creative industries and artists. My noble friend Lady Bonham-Carter made clear our views on the issue of Channel 4 as well as on the establishment of a BBC licence fee commission. We still have unfinished business from the Digital Economy Act. I welcome the incorporation of the general data protection regulation into UK law and in principle the proposal for a digital charter, along with the prospect of an online safety strategy. But will the Bill and the charter be guided by the report published today by the Royal Society and the British Academy proposing a stewardship body for data governance?

We also need to respond to the threat of illicit IPTV streaming. What can the Minister say about progress on the call for evidence? Do the Government really understand the need for urgent action in this area? On these Benches, we are extremely conscious of the power of platforms and aggregators on the internet. YouTube’s failure to pay properly for its right to stream music is a continuing cause for concern. Rights holders should not have to send literally hundreds of millions of notices to search engines to remove links to infringing content. We need to ensure that any code of conduct on search and copyright between search engines and the creative industries is underpinned by statutory powers of enforcement. FOBT stakes, mentioned by the noble Baroness, Lady Sherlock, is another matter for action. So much needs to be done in all these cases, but I can see very little that the Government have indicated they wish to do.

I add a few closing words on higher education. I declare an interest as the incoming chair of Queen Mary University of London. The jury is still out on the recent Bill, now an Act, the new regulatory structures which have been created and the TEF ratings, about which I share the reservations expressed earlier by my noble friend Lady Garden. However, I strongly welcome Sir Michael Barber as the incoming chair of the Office for Students. He said in his recent speech to Universities UK:

“We need to transform expectations of what is possible and see universities become ever more powerful engines of opportunity”.


We are facing many challenges in the higher education sector, not least as a result of Brexit, but that is exactly the ambition our universities should be adopting.

Pharmacies: Funding

Lord Clement-Jones Excerpts

Wednesday 2nd March 2016 Lords Chamber

[Lord Mawhinney (Con)]

My Lords—

[Lord Clement-Jones (LD)]

My Lords—

[Noble Lords]

This side!

--- Later in debate ---

[Lord Prior of Brampton]

The noble Baroness makes a very important point. There are many delayed discharges from hospital because people are waiting for their medications and many hospitals do not have the automation within their in-house pharmacies to meet the demand to which she refers. The big driving force going through healthcare and community pharmacy today is one of integration, which means that community pharmacies must in future work more closely with their local hospitals and GPs.

[Lord Clement-Jones]

My Lords, we all have heard what the Minister has to say, but is not the Government’s policy totally inconsistent in that community pharmacists are being encouraged to do more but, as these drastic cuts are being put into effect, they can only do less?

[Lord Prior of Brampton]

I think the noble Lord has misunderstood what I said. Interestingly, 40% of all community pharmacies are in clusters of more than three within 10 minutes’ walk. There has been a proliferation in the numbers of community pharmacies at a time when we want a deeper integration of community pharmacy with primary care in particular.

Autism

Lord Clement-Jones Excerpts

Monday 17th June 2013 Lords Chamber

[Earl Howe]

My Lords, we will certainly consider the idea of an innovation fund during the course of the review. We have allocated some central funding already to support the implementation of the autism strategy, for example in commissioning a range of training products from expert bodies to support local areas and professionals. I hope the noble Lord will agree that the strategy and the statutory guidance that goes with it mark a great step forward for adults with autism in England. We now need to take an honest look at how it is all working and come up with further ideas and actions as necessary.

[Lord Clement-Jones]

My Lords, I declare an interest as president of Ambitious about Autism. Can my noble friend confirm that the Government’s review of the adult autism strategy will pay close attention to the kind of day support services, such as the NAS’s Horizons service, which the recent Deloitte report, Ending the Other Care Crisis, has demonstrated not only leads to increased quality of life and reduced dependency but has clear economic benefits?

[Earl Howe]

My noble friend draws attention to a very important strand of support for people with autism. Many people with this condition can benefit from small amounts of advocacy, help and support often through less formal support networks and not necessarily through the local authority. We will certainly be looking at that area.