Medicines and Medical Devices Bill

Lord Freyberg Excerpts

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

I just say to the Minister that the NHS has form in giving away data to American companies without enough care being taken over the conditions under which the data can be used, and certainly without adequate resource compensation. This makes it all the more important to ensure that we beef up the safeguards. The amendments from my noble friend Lady Thornton and those from the noble Lords, Lord Clement-Jones and Lord Patel, all deserve support for seeking to do that.

[Lord Freyberg (CB)]

My Lords, I was privileged to speak at some length about the provisions of this Bill in Grand Committee, and I thank those who supported the amendments in my name, which concerned the role of cutting-edge, data-driven medical devices. The Minister has since reassured me of his intention to further explore their implications in the course of a consultation exercise about their definition and regulation over the coming year. Like the noble Lord, Lord Patel, I want to put on record my gratitude for the way that he has facilitated these discussions.

The amendments that I rise to support today seek to protect patient information, including what is properly “special category data” in the Data Protection Act 2018, which is crucial in the development of new pharmaceutical products and medical devices.

Of course, it goes without saying that efforts to facilitate the flow of data in the context of the ongoing health emergency are vitally important. These are extraordinary circumstances in which we find ourselves. Today, however, we must take steps with an eye to the long term; steps that will introduce legal provisions to prevent a situation that might give rise to undue concern or restrict scrutiny of matters pertaining to patient safety in the future, both at home and overseas.

I am certain that the Minister is well aware of public sentiment concerning privacy and data protection, which are, of course, not limited to the healthcare domain. Maintaining the trustworthiness of organisations that function as stewards of the nation’s healthcare data is paramount, and a carefully considered approach to patient safety is needed to preserve that trustworthiness, as the Government move to improve upon and forge new international arrangements.

The Minister’s amendments make it mandatory for consent to be provided where patient information is being shared with territories outside the United Kingdom. The noble Baroness, Lady Thornton, has tabled clarifying amendments to ensure that the purpose for which patient information is being shared is limited to patient safety and its scrutiny. For these reasons, I support Amendments 18, 36 and 57, to which I have added my name.

[Lord Lansley (Con) [V]]

My Lords, I am very glad to follow the noble Lord, Lord Freyberg, who has made some very cogent points, both in that speech and when we discussed these clauses in Grand Committee.

I want to make two points. The first is about the structure of Amendment 18. I am not entirely sure that I understand why pharmacovigilance has been singled out in the amendment as a reason why disclosure should be made, as distinct from, for example, public health co-operation or the pursuit of research. Indeed, the Minister referred to the sharing of information in relation to international clinical trials as a very good example. If one were to legislate in this form, it would be inevitable that the reference to pharmacovigilance would be regarded as having additional weight, and the absence of reference to other purposes for which information would be shared would be regarded as less important. I am not sure that that would be at all helpful to have in statute.

My other point is in relation to Clause 7(5). Government Amendment 22 refers to and introduces a provision that assists in understanding the relationship between this legislation and other enactments concerning the disclosure of information. Clause 7(5) states:

“Nothing in this section authorises a disclosure of information which … contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section)”.


Noble Lords may recall the Trade Bill and, in particular, the debate we had on the Trade (Disclosure of Information) Act just before Christmas and new year. We passed legislation the purpose of which was, among other things, to ensure that we clarified the relationship between that enactment and others that authorise disclosures of information or, in some circumstances, prohibit such disclosures. The particular basis for the structure of that Bill was to clarify a situation where there is a statutory gateway and other enactments that put constraints on the disclosure of information.

In subsection (5) it is clear that if someone is considering a disclosure that might contravene the data protection legislation, that legislation must be considered alongside the powers in this legislation. That enables them to satisfy the test in the Christian Institute and others v The Lord Advocate 2016 Supreme Court decision, as referred to in my noble friend Lord Grimstone’s letter to us about the Trade Bill. In the Trade Bill, though, as is the case in this Bill, we have reference both to the data protection legislation and to the Investigatory Powers Act. In the Trade Bill, amendments were introduced on Report to ensure that the saving reference—that is, when determining whether a disclosure would contravene the legislation, it takes into account the powers in this section—was applied to both the data protection legislation and the Investigatory Powers Act. However, in this legislation—Clause 7(5)(b) —the saving reference is applied to the data protection legislation but not to the Investigatory Powers Act.

My question, which I am sorry I have not had an opportunity to give the Minister notice of, as I have started working through these issues only very recently, is this. Having dealt with this matter on the Trade Bill, I would have thought that both these subsections should have the saving reference that allows the question of the contravention of those Acts to be considered, including reference to the powers in this Bill. I wonder if he would agree.

Medicines and Medical Devices Bill

Lord Freyberg Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

Moved by

[Lord Freyberg]

83: Clause 12, page 7, line 28, at end insert—
“(3) Within 12 months of this section coming into force, the Secretary of State must initiate a comprehensive technical review of the definition of “medical device” under the Medical Devices Regulations 2002 with a view to addressing the inclusion of artificial intelligence software and algorithms including methodologies for the interpretation of data and associated technical architecture in medical devices.”Member’s explanatory statement
This amendment seeks to improve how the Bill addresses new technologies which have significant potential for harm, aligning with and improving on the EU and US equivalents.

[Lord Freyberg (CB)]

My Lords, I thank the Minister for the opportunity to speak today about medical devices that make use of data-processing methodologies, algorithms, artificial intelligence and other technical architecture. In moving Amendment 83, I shall speak also to Amendments 112 and 113.

I am a long-standing advocate of the use of patient data to provide better healthcare. Noble Lords can therefore rest assured that I by no means seek to introduce obstacles to the vital research and innovation that I know the Government wish to encourage and facilitate to improve the nation’s health. However, I seek to guarantee patient safety in our increasingly data-driven health service and to ensure that the UK is well placed to become a rule-maker and world leader post Brexit.

Others in this place have spoken eloquently about the need to prioritise consideration of patient safety in the Bill. In particular, I was moved by the expert and passionate speech made by the noble Baroness, Lady Cumberlege, at Second Reading. I hope and anticipate that the noble Baroness, Lady Bennett of Manor Castle, will remind us of the social and environmental consequences we should pay heed to in encouraging innovation in medicines and medical device development, which, I believe, should result in closer consideration of the implications of the growth in digital healthcare for the climate as the Government prepare to host COP 26. However, it was the noble Lord, Lord Patel, who helpfully reminded us of the importance of precision in the definitions and wording we agree in this place, and it is my intention here to do the same.

In speaking to Amendments 112 and 113, I am recommending specific protections in the form of an up-to-date definition of a medical device, because the Bill currently relies on a definition from the Medical Devices Regulations 2002, which were updated to include the term “software” in 2007 and therefore do not safeguard individuals from the potentially harmful effects of the full range of contemporary medical devices. The effect of my amendment would be to update the definition of a “medical device” and bring it in line with regulatory provisions in the EU and the US. The use of technology has advanced significantly since 2007 and I can see no good reason why the UK should be a laggard at this time.

In moving Amendment 83, I recognise that we are always, in some senses, on the cusp of new developments or breakthroughs in science and technology that have the potential to transform healthcare services as well as outcomes for individuals. I can therefore understand the Government’s desire for flexibility in presenting this Bill as they have done. However, I am certain that the Minister will agree that we find ourselves on the cusp where growth in the use of artificial intelligence in healthcare is concerned, not least because the Department of Health and Social Care has invested more than £250 million in establishing an AI lab this year and is preparing to publish the first national health and care data strategy this autumn, which is expected to state that the Government will prioritise the

“safe, effective and ethical use of data-driven technologies, such as artificial intelligence, to deliver fairer health outcomes”.

As such, I very much hope that the Government will, at the very least, support Amendment 83, the effect of which would be to require the Secretary of State to initiate a comprehensive technical review of the definition of a “medical device” under the Medical Devices Regulations 2002 within 12 months of this Bill coming into force, with a view to addressing the inclusion of artificial intelligence, software and algorithms, including methodologies for the interpretation of data and associated technical architecture, in the legal definition of a “medical device”.

--- Later in debate ---

[Baroness Penn (Con)]

My Lords, the consultation will look at the specific issue of medical device regulation that takes place through secondary legislation. However, the noble Baroness is right in that this is not the only aspect of this issue that we are looking at and working on. There is work across government on a number of areas where this technology comes up, and we have established a number of bodies to help us in our work, such as the Centre for Data Ethics and Innovation. So, although the specific issue about the definition of a medical device and medical device regulations will take place under this Bill—subject to public consultation —there is a broader landscape that we will also address across the board and across government.

[Lord Freyberg (CB)]

My Lords, I first thank the Minister for her attentiveness during my very long and quite tortuous speech, and for the very detailed responses I have had, back and forth, from the Minister’s officials, which have been exceptionally helpful. They have been doing that over many days and many weeks. I also thank the other noble Lords who supported my amendment: the noble Baronesses, Lady Jolly and Lady Bennett, and the noble Lord, Lord Clement-Jones. It was hugely welcome and I thank them for the contributions that they made.

I was fascinated by the fact that the Minister thought that it was both dynamic and static. That is not what I had understood from the letters, but I would like to look at that again. I will obviously follow her remarks in Hansard quite closely. Perhaps I could have further dialogue with her or the noble Lord, Lord Bethell, about that, because I am not entirely sure that that is how I have interpreted it—so I would like to come back on that, if I may.

Like the noble Baroness, Lady Thornton, I recall what the noble Baroness, Lady Cumberlege, said about the ongoing situation that faces those affected by sodium valproate and mesh. We do not want to be in a situation in years to come of not having something that adequately protects the public, and I worry that we are not getting to the root of this. So, while I am happy that the Minister has offered this review in 12 months’ time, I would like more information about that. In the meantime, I beg leave to withdraw my amendment.

Amendment 83 withdrawn.

Medicines and Medical Devices Bill

Lord Freyberg Excerpts

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

[Lord Freyberg (CB)]

My Lords, I have spoken at length about the value of harnessing healthcare data in the UK, and the Bill reads across to that topic. The Bill is needed to regulate medicines and the estimated 500,000 medical devices licensed for manufacture world- wide as we transition from membership of the European Union. However, it is heavily reliant on definitions set out in the Medical Devices Regulations 2002, and the use of technology has advanced significantly since then.

Simply stated, the Bill would benefit from up-to-date definitions of medical devices, or what are commonly referred to as decision support tools, that more readily reflect recently developed and near-future technologies. Many are deployed by professionals in clinical settings, while others are designed for use by members of the public. The Bill should guarantee patient safety and the efficacy of tools, including, for example, algorithm-based smartphone apps that help people assess the extent to which they may be at risk of skin cancer. A recent study found that the regulatory process for awarding the CE kitemarking to algorithm-based apps does not currently provide the public with adequate protection.

The onus is currently on the professional or individual to make appropriate use of such devices, rather than on the developers and regulators to take clearly defined steps to guarantee patient safety. Ideally, the Bill should offer at least the same level of protection afforded to patients in the EU and the US, where legal provisions make use of contemporary definitions associated with data-driven devices.

Medical devices are being developed in novel ways, and the regulation of software that makes use of algorithms to process vast quantities of data raises different issues to the regulation of software that has traditionally controlled, for example, pacemakers. These newer products are also developed, realised and updated in a very different way. By their very nature, many change, or learn over time, as they are informed by, or amass, new data. Without the means to monitor such updates, it is impossible to assess how many patients might be adversely affected by them at any point in time.

The Government have made plain their ambition to invest in science and innovation while boosting digital trade post Brexit, and the Bill is in part designed with that in mind. However, Ministers must negotiate new trade agreements with countries that subscribe to an increasingly protectionist approach to intellectual property. I am concerned that the effect of some provisions in agreements could be to reduce access to and understanding of the algorithms which underpin data-driven medical devices, in particular where developed countries seek restrictions on forced disclosure of digital technology, treating source code and algorithms as trade secrets.

I will therefore ask the Minister three questions about the Bill. First, do the Government intend to make provision for decision-support tools and the use of algorithms in medical devices now or in the future, and, if so, when? Secondly, does the Minister perceive merit in building on pertinent provisions introduced to safeguard systems of the European Union or under development in the US, and, if not, why? Finally, if there is an opportunity to learn from other countries, can the Minister highlight which nations the UK is looking towards and outline what he thinks he can usefully learn from them?

Queen’s Speech

Lord Freyberg Excerpts

Thursday 9th January 2020 Lords Chamber

[Lord Freyberg (CB)]

My Lords, I wish to restrict my remarks on the gracious Speech to health. With a new year and a new Government, I thought it an appropriate moment briefly to discuss trust and transparency in the context of the NHS, given how prominently it featured during the election campaign.

The election campaign involved numerous pledges from opposition parties about data protection and ethics and, in particular, measures intended explicitly to provide the public with confidence about the extent to which health data controlled by the NHS would feature in trade negotiations post Brexit or be subject to new provisions designed to “reign in” the perceived excesses of big pharma and tech. The Conservative Party, now the Government, took a different tack and pledged significant—although, as yet, unspecified—investment in R&D and the fourth industrial revolution.

Against this backdrop, the campaign saw significant press coverage of “health data deals” entered into by the Government, as well as talk of meetings attended by senior officials and representatives of global businesses to explore how best to “exploit” the value of UK health data, valued at an estimated £10 billion by Ernst & Young in recent months. I encourage colleagues to take a look at the online reactions to this coverage from privacy advocates, tech experts and front-line professionals working in health, as well as from the general public. For me, it highlighted a number of important issues.

First, we have a way to go before we can be assured that people are adequately informed of their rights and the measures that we have put in place to date to protect them. Secondly, we have a way to go before we can be assured that we can count on the trust that is, when all else is said and done, the real asset to which I am referring today. Thirdly, we have even further to go before we can be assured whether and how people want health data deployed, in conjunction with third parties, to stimulate the research and innovation that I know we would all wish to encourage. Here, it seems that transparency is fundamental to our cause. I therefore ask the Minister, in response to the gracious Speech, how the Government plan to build and maintain public trust over the months ahead and whether he will commit today to promoting radical transparency with that in mind.

I look forward to further detail of the Government’s medicines and medical devices Bill over the coming months, which I am sure, like me, colleagues will take a keen interest in debating. I note also that, as I speak, the Government are busy recruiting personnel to staff the national centre of expertise, to be hosted by NHSX, which will offer legal and commercial advice to NHS organisations in recognition of the data deals they are expected to enter into with third parties over the coming period—something that I have long encouraged. However, how will the national centre of expertise, with its remit to develop a national policy framework, take steps to ensure that whatever results is fit for purpose in a fast-evolving and inherently global marketplace, driving significant investment flows into data-driven health research and innovation?

In particular, I am keen to understand what the Minister makes of recent developments pertaining to health data in China and India, and data localisation restrictions on sensitive personal and biometric data. Replying on behalf of DCMS on 7 January to my Question for Written Answer, the noble Baroness, Lady Barran, stated:

“The Government considers that in the UK, data localisation should be limited to cases that are specific and well-justified”.


Perhaps the Minister might expand on this Answer and set out in more detail what the Government mean by this and what areas might fall into this category. I would also welcome his assessment of measures in California’s new data protection law which afford individuals the right to restrict “sale” of data about them by organisations that they nevertheless consent to process it.

Finally, I ask the Minister to reassure noble Lords that the Government have no plans to lower the bar either in the course of taking back control of the UK’s data protection laws, or in negotiating future trade deals post Brexit.

NHS: Healthcare Data

Lord Freyberg Excerpts

Thursday 6th September 2018 Lords Chamber

Moved by

[Lord Freyberg]

To move that this House takes note of NHS and healthcare data and how that data could be used to improve the health of the nation.

[Lord Freyberg (CB)]

My Lords, I am grateful for the opportunity to lead this morning’s debate about the value of healthcare data and how it might be harnessed to transform outcomes for the health and wealth of the United Kingdom for generations to come. I very much look forward to the maiden speech of the noble Lord, Lord Bethell, and wish him every success for this and future contributions that he will no doubt make in this House.

Healthcare is a very personal subject and noble Lords may recall that I have spoken before in this House on the issue. My sister contracted mesothelioma and received poor care from the NHS, when she could not access existing health innovations in time to treat her, as there was no data even on the basics, such as where she could get the radical and uncommon thoracic surgery that she needed in a timely manner. Later, there was no data to allow her rapid path to a clinical trial that might save her life. This is the role of data for care navigation. In the four years since her death, I have come to realise that routine healthcare data has two other crucial roles to play: first, in generating life-saving breakthroughs through real-world research, for which the UK rightly has a global reputation; and, secondly, in providing the real-time care quality assurance that will allow the NHS to make sure that all patients have good quality care. Depending on your choice of expert, the prize in care quality analytics in routine data in cancer alone is tens of thousands to hundreds of thousands of lives a year.

Given that prize and my personal experience, I approach this debate as a patient advocate, not as a politician. In doing so, I have relied on the assistance of many individuals and organisations for advice. I would, however, like to single out one organisation and charity, Future Care Capital, and, in particular, Annemarie Naylor and Joel Charles, for their support and wise counsel as I have tried to get to grips with this complex area. It is my hope that noble Lords will make the most of this opportunity to begin building a consensus view on the national approach to high-value healthcare data which will permeate through here and the other place over the weeks and months ahead.

The value of data in improving healthcare and health is not new. It was the use of data by UK scientists Doll, Hill and Peto that showed the link between tobacco and lung cancer that has driven dramatic life-saving changes in policy, behaviour and life expectancy worldwide. One hundred years before Doll, Florence Nightingale used data to revolutionise the cleanliness of military hospitals, and Dr John Snow used data to identify the source of a deadly cholera outbreak in Soho. Now we have another unique UK opportunity for global leadership. The healthcare data we have amassed over the course of the first 70 years of our NHS can, if ethically and widely used, radically transform the treatments and technologies we will deploy to improve the health of our increasingly ageing nation. At the same time I want to ensure that as a nation, we pioneer reinvesting the social and economic value of this data in full, such that it benefits everyone in the UK, both their personal health and economically.

Across the country, fragmented NHS bodies are separately exploring ways in which to harness the value of the healthcare data they control, while addressing the technical, legal, ethical and cultural barriers to delivering potential benefits, working with researchers as well as industry players from the UK and overseas. Cutting-edge examples of which I am aware include the work of Moorfields Eye Hospital with Google DeepMind—whose artificial intelligence can now use NHS data to recommend how patients should be referred for over 50 sight-threatening eye diseases as accurately as world-leading doctors—and Sensyne Health’s collaboration with the University of Oxford and Oxford University Hospitals Foundation Trust to pioneer a remote management service for patients with heart failure. Given that our principal aim here must be to improve patient outcomes, I am certain that noble Lords welcome such data-driven innovations. I am, however, concerned that there is currently no clearly agreed or stated strategy which sets out how the NHS intends to approach and benefit from providing third-party access to the valuable healthcare data assets the NHS stewards on our behalf, while maintaining the highest ethical standards in respect of safeguarding individuals’ rights to have their personal data protected.

A strategy is required because the Government should have a clearly stated objective in this area, backed up with the ways and means by which to achieve it. It is not credible to devolve this to a fragmented, wild west community of individuals, semi-independent public sector institutions, US technology companies or, at worst, the global market. It is needed because the Government are doing too little to incentivise healthcare data quality “by design” through the exercise of relevant policy and funding levers, impacting its immediate value to the NHS to improve everyday treatment and care quality as well as its value for the purposes of research and innovation. It is needed because government has been slow to take steps to improve or join up data collection across healthcare organisations through an emphasis on standards, open interfaces and interoperability—and it is needed because we are falling behind. Although we are starting to invest in healthcare data access and curation to stimulate third-party access and innovation, our investment is relatively modest when compared with other countries. For example, Israel will invest 1 billion shekels—approximately £231 million—in a project to make data about the health of its population of only 8 million people available to researchers as well as private companies. That is twice the level of recent announcements by Her Majesty’s Government for our 65 million people.

Crucially, in the absence of coherent objectives for national data capture, the Government are neglecting to act at a national level to prevent what might be termed healthcare data “leakage” from an NHS whose primary focus must be on the non-commercial, day-to-day care of the nation. This leakage is already occurring through “barter deals” between individual trusts and commercial entities—for example, in the case of the Royal Free Hospital and Google’s DeepMind—and I expect it could worsen rapidly in new trade deals to be entered into post Brexit with non-EU countries, in particular the USA. This, to my mind, is giving away the family’s digital silver.

Value capture should not be viewed as a simplistic cash transaction to the highest bidder. As the noble Lord, Lord Mitchell, eloquently laid out in previous debates, this would favour US technology companies and provide only a transient return to UK plc. Value capture can, and should, be more sophisticated than that. It can include widespread, cross-NHS rights to use new technologies derived from the use of data, discounted drugs, inward investment and health sciences job creation. It must also address the tension that exists between local and national bodies so that revenues can be amassed and reinvested at the most appropriate level. However, if Government continue to have no stated objectives, it is no surprise that value potential is lost in the commotion and that cash-strapped trusts are lured into one-sided deals.

There is merit in encouraging experimentation at the local level—I have already mentioned some high-profile examples—but in doing so there are also attendant risks. Those innovators engaging in health data usage and value capture may become over-influenced by the needs of an industry partner. They may become wary of linking up their data with that of other institutions for financial reasons, at precisely the time when joining up data would add national value.

Will trusts that are “data and expertise poor” be left having to compensate other “data and expertise rich” trusts in future for the intellectual property they help to develop, potentially exacerbating the postcode lottery in access to innovative treatments and, with that, health inequalities? In other words, do we want healthcare data to create value for the NHS and society as a whole, or for only elite hospitals? Moreover, if healthcare data-sharing agreements do not conform to any nationally agreed standards, is that not liable to impact the financial value generated in different places and, with that, erode public trust and support for related initiatives in other locations? Practically, on clinical trial access, when is it appropriate to use data to inform a patient that there is a trial in another trust that might help them, and how should that research contact take place?

As I have said, we are not altogether asleep at the wheel. The Government have supported the important work of the UK Biobank, Genomics England and health catapults. They have established Health Data Research UK and have recently confirmed their intention to invest in digital innovation hubs to harness high-value healthcare data in a bid to tackle some of Britain’s biggest health challenges. They are also establishing a new Centre for Data Ethics and Innovation and, only yesterday, announced their initial technology partnership code of conduct for data-driven health and care technology. These developments are to be welcomed but, to my mind, they fall short of the coherent approach that is needed if we are to make the most of the data revolution that is patently under way around the world. I would like to understand whether the Government have considered the chaotic implications that are liable to flow from this policy vacuum.

To my mind, the Government, with the help of balanced solutions developed across this House and the other place, should define their objectives for securing the social and economic value that healthcare data has the potential to generate. They should put trust in patients’ demands to have their data used to full effect and regard it as unethical if it is not. They should engage patient representative groups, clinicians and the wider public sector, as well as the general public, to establish the priorities for using healthcare data and reinvesting its value. They should put in place measures to ensure data quality “by design” and fund data clean-up and curation to hasten delivery of those priorities. They should develop a framework for healthcare data-sharing agreements involving NHS bodies to ensure that they conform to nationally agreed standards. They should also provide trusts with access to a dedicated commercial team in order to optimise the financial value to be derived from the healthcare data-sharing agreements they enter into with third parties.

Only then will Great Britain once again pioneer the use of healthcare data, lead rather than follow and capture the maximum value from the data assets offered by patients and citizens alike, while respecting each and every citizen’s right in law to opt in or out of such use. Only then will we be able to realise the prize that data promises, which is better care today through care quality management and better care tomorrow through innovation.

In recent months, I have spoken to noble Lords across this House about the issues that I have outlined today, and I am grateful to both the Government and Opposition Benches for their engagement, as well as their thought-provoking input. Ultimately, I believe that a consensus in this House and the other place is needed if we are to build and maintain public trust in sharing healthcare data to deliver social and economic value for everyone in the UK. I look forward to the contributions of noble Lords from across the House this morning.

--- Later in debate ---

[Lord Freyberg]

My Lords, I thank all noble Lords who have spoken today. It has been quite an excellent debate and I have learned much from it. I echo other noble Lords in congratulating the noble Lord, Lord Bethell, on his excellent maiden speech. He emphasised serious points about the fears that individuals have about their data and how it is used—which I share—but also its benefits. I thank him for his fascinating contribution. I also thank the Minister for the way he has engaged with and embraced this subject. I know he shares a passion for shaping this area to derive maximum public benefit in a socially acceptable way. However, while I recognise that his code of conduct is welcome, in reality it is fine words with no delivery teeth. Without a competent central resource to support the trusts in commercial negotiations on data, they will be steam-rollered. I therefore look forward to engaging with him to prevent that.

As I listened to noble Lords, several themes emerged. If I were to highlight one it would be that making this data resource do what we hope it will do will be hard won. The records are fragmented and incomplete, considerable investment is required to make the data useful, the skills to do this well are scarce and the politics of medical data are challenging. My noble friend’s analogy of North Sea oil in the 1980s seems apt. I therefore call on all sides of this House to engage in this debate and create consensus on the core principles for such a policy.

Motion agreed.

NHS: Cancer Treatments

Lord Freyberg Excerpts

Thursday 25th January 2018 Lords Chamber

[Lord Freyberg (CB)]

My Lords, less common and rare cancers account for more than half of all cancers, but each is a small individual market and so under-researched. Be they brain or, in my sister’s case, mesothelioma, they suffer a chronic lack of innovation. I therefore commend the noble Baroness, Lady Jowell, for her bravery and the moving way in which she has brought these important issues to the House.

This country has a globally unique research asset that could make a difference. It is the cradle-to-grave records inside the NHS. We are uniquely placed to supply the insights on what works and what does not. This large-scale, real-world information could revolutionise care and research, especially health economic evaluation.

Yet researchers cannot get access. Let me explain, with some examples. The Brain Tumour Charity has been trying to unlock this data for their patients, 97% of whom want their data to be used for research. They have written informed consent, yet they have been met with official obstruction at every turn. NHS Digital wants £100,000 a year. Public Health England wants £378 an hour, and for information that would be more than a year out of date.

The same challenges affect those developing cures. In a recent survey, more than 80% of UK biotech companies said that NHS data and patients are a unique asset for the UK life sciences sector. However, almost all said that access to these insights was near impossible given current processes and policy, and that they were forced abroad.

We want to see the NHS improve patients’ lives through innovation. We are all aware that there is no infinite money tree from which to pay for such innovation and, as a result, we need timely and accurate evaluation based on real-world insights from within the NHS on what works and what does not. It is important to stress that decision-makers and researchers generally do not need access to patient-level data; they need access to privacy-conserving statistical insights such as, “Is treatment A or B more effective?”. Statistical technologies exist to do this routinely, and at very low cost, yet they are almost unknown in the NHS, which employs armies of human analysts instead.

We must get the policy and investment on real-world research right if we are to make effective use of these assets. It does not require primary legislation, but it does require joined-up thinking across health, business and research, and careful management of various internal vested interests. The creation of Health Data Research UK provides a unique opportunity to drive such alignment. Therefore, I ask the Minister to commit to using the life science sector deal to make this happen. Can he confirm the routine measurement of care outcomes in the NHS as his top priority, and clarify who will be in charge of co-ordinating and funding delivery for this critical cross-cutting agenda?

It has been a huge privilege to partake in the debate of the noble Baroness, Lady Jowell.

Queen’s Speech

Lord Freyberg Excerpts

Thursday 29th June 2017 Lords Chamber

[Lord Freyberg (CB)]

My Lords, I wish to restrict my remarks on the gracious Speech to health. I welcome the new patient protection Bill and the focus on mental health, but in both the Government are not going far enough in driving a quality agenda into the NHS, and do not seem to understand that care quality and the UK’s attractiveness as a destination to industry for clinical research post Brexit go hand in hand.

Moreover, most of the changes needed to drive quality in the NHS can be achieved without legislation, as they are about how we measure quality and encourage a culture of accountability. Accurate, disease-specific care quality data, sometimes called care outcome data, are the missing link that can drive both these agendas. Given that the life science strategy is in the Minister’s portfolio, and Sir John Bell’s committee has had extensive discussion of what it will take to make the UK attractive to pharma, I would like to draw his attention to the connection.

Care quality data are information on how a particular episode of care turned out for the patient. These outcomes have to be defined and measured in standardised ways, or all manner of games get played by clinicians and hospitals to time and choose the measurement to favour themselves. The not-for-profit International Consortium for Health Outcomes Measurement—ICHOM—has done much to define these standards through international consensus building. It now has standard sets that cover about half of disease by burden. The outcomes are rich in patient-reported outcomes that can now be collected cheaply using smartphone technology. Seven European countries, including Wales, have now committed to using those standards. That allows international comparison, which can only accelerate best practice development. However, England has not made as much progress as we should have in defining quality. What clinical audits we do have are slow to report and miss the high-frequency and important complications that cannot be measured in the electronic health record.

A good example of this is the recent maternity audit, Each Baby Counts, under Professor Lesley Regan, looking at stillbirth and major brain injury in 2015. This affected 1,136 babies that year. What is shocking is that about one-half of those deaths and brain injuries are believed by experts to be preventable. The UK is at the bottom of international league tables for maternity deaths, and has been since the Second World War. I applaud the effort that went into the audit as a first step in lifting the UK from 33rd of 35 countries on severe harm to babies. It is great, too, to see the first audit with 100% coverage of trusts, but we are going too slowly.

What can be done about this? Each Baby Counts made a number of recommendations, but I want to bring to the Minister’s attention the most important, following on from the remarks of the noble Baroness, Lady Cumberlege: the need to change team behaviours to create the right culture of safety. An audit that reports back many months after an event is unlikely to do much good, given the turnover in NHS staff. They can legitimately say, “It wasn’t us”.

Changing culture is hard, but we can learn from other industries with strong safety cultures—in particular, the airline industry, as the noble Lord, Lord Ribeiro, mentioned. Through experience, they have worked out that safety cultures that only look at the severe-impact, low-frequency events, such as a plane crash—or, in the NHS, stillbirth—fail to change the culture. The events are too rare; they can be written off too easily as “chance” by practitioners. So plane safety experts innovated to look at high-frequency risks, such as near misses, and creating a culture of learning through appropriate team-based discussion of those incidents in close to real time. Reducing near misses works—it has led to fewer plane crashes. That is what we need in the NHS, and is missing from the patient safety Bill.

We need to add these higher-frequency, smaller harms to the metrics. Almost always they are, or could be, patient-reportable outcomes. From their red book, most mothers know how blue their baby was. Mothers also know whether they got good care, and are highly engaged. We do not need costly NHS internal data entry to measure this; we can just ask mothers to give us their outcomes via their smartphone. Those data need to be used in weekly or monthly team discussions to improve care, as part of normal team management meetings. There are enough births that it is meaningful to track these higher-frequency statistics at that frequency, unlike stillbirths and brain injury. Those near real-time discussions and continuous small improvements are what changes the culture, not an audit on a major event that reads out 18 months after the event.

If we really want to half the stillbirth and major brain injury rate—or in any other area of care—we need to change the culture, and manage these near misses. To be clear, this is an “and”, not an “or”; we should still audit in depth the severe, low-frequency events such as stillbirth, just as in air safety we investigate crashes in depth. But we need to add the more common harms. To that end, would officials from the Minister’s department meet representatives of the International Consortium for Health Outcomes Measurement to be briefed on work in the UK and elsewhere and to identify areas such as maternity services, mental health and cancer, where that work can make a difference? That difference is critical. Those same disease-specific, patient-reported outcomes are the dynamite of health economics.

If, as the life sciences strategy suggests, we want the UK post Brexit to be the destination of choice for life sciences research, we need to invest in NHS data, especially care outcomes linked to episode-of-care data. Why? First, because the data that pharma are after come in flavours—some rare, some valuable and some ubiquitous. Any care system with an electronic record can supply activity data; almost none can provide reliable care outcomes beyond death and hospital admissions. Scarcity drives value.

Secondly, to pharma, payers like NICE are now as important as, or more important than, decision-makers as regulators in getting a drug to patient. Large-scale outcome data is gold dust for health technology assessment and performance-based pricing. For example, if the NHS is uncertain that, in the real world, a new $100,000-per-patient wonder drug works as well as its makers say, the NHS can demand, “We’ll pay according to real-world performance”, and measure it.

Finally, it takes 15 to 20 years or so to get a drug from bench to market. Less well known is that it then takes another 15 years to get peak clinical uptake, as care systems are so resistant to change, even for effective innovation supported by a strong sales force. Appropriate real-world outcome data will allow truly innovative drugs—

[Noble Lords]

Order.

Mesothelioma

Lord Freyberg Excerpts

Thursday 27th October 2016 Grand Committee

[Lord Freyberg (CB)]

My Lords, I thank the noble Lord, Lord Wills, for securing this debate and giving us an opportunity to discuss this subject once again.

I shall focus my remarks today on how we might improve mesothelioma surgery in the NHS. It is a subject that rarely gets discussed, but one that deserves much more attention than it gets at present. I was delighted that the noble Baroness, Lady Couttie, was able today to highlight some of the options available.

When my sister Annabel was diagnosed with mesothelioma a couple of years ago, one of the treatments available to her was radical surgery. This meant removing her pleura, the lining surrounding each of her lungs. Finding a surgeon with the right experience was not a straightforward process and relied entirely upon a Rolodex network of surgeons that her oncologist had built up over many years, often scattered around the country. Eventually, she found someone to evaluate her, but it took a long time to arrange and the procedure proposed was very risky, which was due in part to the fact that her tumour had grown so rapidly since her original diagnosis. On top of that, the surgeon, although very experienced, had not performed the procedure very often and lacked the familiarity of approach that specialisation usually provides. Given its radical nature and the need for complete tumour removal, should not surgical resection be concentrated at one centre of excellence, where patients can receive immediate attention, new techniques can be researched and surgeons can benefit from training and others’ experience? I am sure that patients will be willing to travel as far as needed to be in the hands of super-specialists.

Given the highly specialised procedure of removing pleura, what research is currently being carried out on resection methods? How does the NHS plan to optimise its approach to such surgery? Does it, for example, appear in the National Institutes of Health research plan? If not, why not? Again, there is huge scope for improvement here.

With regard to new drugs, what research is currently taking place on the impact of preoperative non-steroidal anti-inflammatory agents, given their success in other forms of cancer surgery? This should be another research priority for the NIHR, especially given the chronic inflammation component of mesothelioma. The synergies are such that we ought to be applying the benefits of such cancer research wherever possible. This is a cheap intervention, given that the drugs are generic.

All these issues point to the need for a specialist surgical registry and surgical outcome transparency in mesothelioma. Even transparency on the basics of annual volume and 30-day mortality by surgeon, centre and surgical approach would allow the supervising oncologists to find experienced surgeons in a timely manner. It will also allow for continuous surgical method improvement and best-practice dissemination. This holds true not only in mesothelioma but in less common and rare cancers requiring radical high-risk surgery. These cancer surgical registries should be a priority for the NIHR and NHS England. We need clarity about which body is responsible for their funding, given that they span both quality control and research. I hope that the Minister will encourage the bodies responsible to outline how they plan to drive and develop surgical registries and associated research in these cancers.

Access to Medical Treatments (Innovation) Bill

Lord Freyberg Excerpts

Friday 26th February 2016 Lords Chamber

[Lord Freyberg (CB)]

My Lords, I, too, am delighted to support the Bill. I speak today, as many noble Lords do, as one touched by the tragedy of cancer. As some noble Lords may know, my sister died two years of mesothelioma. Recent data from the Office for National Statistics show that 43% of cancers are less common cancers such as mesothelioma. While each is small, collectively they account for well over half of cancer deaths. There is insufficient commercial incentive globally for the current innovation processes to bring new hope to sufferers of these terrible diseases. We can see this in the rate of improvement in annual mortality ratios, which are the number of deaths linked to a cancer divided by the number of incident cancers. In the top five cancers, mortality ratios have improved 12% since 1999, from 49% to 37%. In the less common cancers the improvement was only 4%, and today’s mortality ratio is a shocking 56%, 19% worse than the 37% found in common cancers. That is three times less innovation in less common cancer.

So where have the modern precision drugs been launched? They have been launched for common cancer, of course. What is that? It is economics. At $75,000 per patient, cancer clinical trials are immensely expensive. It can cost billions to bring a drug to market. Where are rational economic agents going to place their research bets? They will do so in the big markets of common cancer, not the small, such as mesothelioma.

What is so unfortunate is that less common cancer has the same underlying genetic causes as common cancer. Modern precision drugs developed for common cancer often, but not always, work in these rarer diseases, but the costs of trials and the challenge of finding patients in rare disease mean that little development happens. That does not matter much in the US, the largest market in the world. There, a physician can prescribe off-label. There is no rationing watchdog like NICE breathing down his or her neck. US insurers will generally pay for the drug, with very limited data, such as a small case series in that cancer. As a result, the largest market in the world has extensive off-label use and does not require costly trials in rarer cancers. By implication, most of the economic incentive for formal label expansion vanishes. Pharma can get revenue without much R&D cost. Sadly, the research potential of this off-label use is not captured in the US, as its balkanised healthcare system does not capture the outcome data needed to close the loop and to discover what works for whom.

It is in this global context that we must evaluate this Bill. In particular, concerns about the Bill overriding UK due regulatory process ignore these economic realities. This is not the 19th century; there is no sea of pink on the maps. The regulatory and reimbursement process that matters globally for the pharma industry is the US, not the UK. We are a paltry 3% of the global market; it is 40%. Also, the US has a system that allows promiscuous off-label use. We must deal with the consequences of those global incentives and not be distracted by due process, as the noble Lord, Lord Ryder, stated.

Let us explore this global context further. As the noble Lord, Lord Saatchi, mentioned, US Vice-President Joe Biden is leading Obama’s $1 billion moonshot on cancer, after his son died of a rare brain cancer. A key part of that initiative looks set to be a database similar to that proposed by this Bill, implemented in willing but small US integrated care systems such as the Veterans Association. These databases have a name: stratified outcome registries. They are large-scale, real-world clinical databases, but upgraded for the 21st century with molecular diagnostic information, treatment outcomes and electronic consents. They capture not only what works for whom but, as importantly, what does not work. They close the learning loop.

I have consulted the supporters of the Bill and will be looking to see that it is appropriately amended—or not, depending on how we come to it in the time limit—to this effect in Committee. That is in line with the recent input from the Association of the British Pharmaceutical Industry on the importance of capturing both the good and the bad in such a database.

I also commend to the House the work that is being done by a small and innovative US not-for-profit, Cancer Commons, in helping to design such registries. In the US, it pioneers the application of these registries for optimising the use of existing drugs in common cancer and extending their use into less common cancer. It points out that such databases have a number of other benefits. They can discover which patients will not respond to costly treatment, saving those patients side-effects for no gain and saving the system money.

As an example, my sister had a molecular test that showed that cisplatin would not work for her cancer and would be more toxic for her than for most. As it is the NHS’s standard cancer treatment for the disease, she was given it. The toxicity occurred as predicted. She suffered horrendously and became ineligible for trial. The NHS faced significant costs in managing those unnecessary side-effects and complications. My sister might have lived a few months longer but for the side-effects.

Another benefit is that these databases have enough molecular information for scientists to hypothesise why a drug worked or did not work and so pump-prime basic research. Where we cannot explain the response, we can feed those exceptional patients to Genomics England, which will make that superb basic research engine more efficient. Finally, over time, the database would generate the information to derisk formal trials in less common disease. That will make such trials more economically attractive to industry and so change drug availability globally.

What may not be known to the House is that the UK is well placed to lead globally on developing these databases. In particular, we have a secret weapon in the National Cancer Intelligence Network registry in England. This covers 280,000 new cancer patients a year and today captures classical presentation, treatment and outcome data and small amounts of molecular data. The best US outcomes registry today covers fewer than 30,000 patients a year.

That volume of patients with clinical data gives us huge power globally. It is the largest in the world by a factor of 10, housed in the country that led the human genome initiative and with an enviable clinical research tradition. We should aim to use it to recraft the NHS to be the workshop for the world in precision oncology. This would win back a significant share of pharma’s global R&D spend, create a huge number of high-value precision medicine research jobs, and have a positive impact on investment flows into the UK. In particular, if we deployed low-cost generic panel-based cancer molecular diagnostics proactively into the NHS and ahead of approved drugs, pharma would supply late-stage research drugs in less common cancer. It would do this because the clinical data generated would both encourage off-label use in the US and give it future expansion options.

The evidence for this can be seen in France, where the Institut National du Cancer has been driving a national molecular pathology programme for over a decade. It is the preferred European partner for large pharma like Pfizer for late-stage clinical trials in precision oncology. That investment also created equality of access to modern molecular diagnostic technologies and prevented a testing postcode lottery. Today in the UK, we have an appalling postcode lottery in molecular testing, as recently highlighted by the Independent Cancer Taskforce and the NHS Atlas of Variation in Healthcare. We need the political will to change how we fund molecular diagnostics in the NHS to alter this. France drove the adoption of such tests by top-slicing the hospital care activity budgets to create a dedicated pool of money for a national testing programme and taking on entrenched vested interests to drive reform. We need to be similarly brave and creative if we are to achieve this here but it will save money and lives.

If we upgraded NCIN to being a stratified registry through the investment in a national molecular pathology service, I am confident that quickly some, but not all, UK patients would also live longer as a result of the increased access to innovative drugs. Over time we will also close some, but not all, of the yawning gap in mortality burden in the less common cancers, and we would have an intelligence system that could manage the risks of real-world innovation.

If such a system had existed when my sister had been ill, it might have helped her. Half of us will get cancer—it might well help you. In short, we can do well as a nation by doing good for the world. We can make the UK the preferred destination for the US drug companies for their clinical development, but only if we reshape the NHS to be a cradle for the sorts of innovation supported by the Bill, not a barrier. Let us use the global drug development system and its perverse incentives to our national advantage. Let us support the Bill and its database of innovation and work together on the many important details that may need ironing out in Committee.

Health: Cancer

Lord Freyberg Excerpts

Wednesday 20th January 2016 Lords Chamber

[Lord Freyberg (CB)]

My Lords, I begin my speech with a startling fact: rare cancers accounted for 43% of cases in 2010, but 59% of cancer deaths. Let me repeat that: these less common cancers affect roughly four in 10 of new patients, but make up six in 10 of deaths. If we want to improve survival overall we have to improve our performance in these cancers, and our performance in caring for them is poor relative to international peers. Broadly speaking, in every case there is a 5% to 15% gap in the UK’s one year performance. In stark numbers, we kill one patient more for every 10 we treat. This cannot go on.

So what can we do to improve care in these cancers? First, we should publish risk-adjusted hospital survival by cancer so that patients have informed choice. These do not need to be put into the NHS dashboard if that will delay things. Patient advocacy groups can pick up the data and take them to their constituents.

Secondly, we should measure other important care quality outcomes, such as incontinence in prostate cancer. To give noble Lords a sense of the power of measurement, Germany recently introduced metrics in incontinence and impotence after prostatectomy. On average, about 50% of German patients are left incontinent, except in Hamburg, where the Martini-Klinik has been tracking its outcomes to drive internal performance improvements. Its rates are 6.5%—in other words, a national average of one in two men in diapers for the rest of their lives, versus one in 20.

Thirdly, we should streamline diagnosis and better connect primary and secondary care. The Government should be commended for putting one-year survival rates and emergency presentation data into the CCG dashboards, and these will drive local behaviours in this area.

Fourthly, we should centralise more services, especially specialist surgery. As an example, my sister’s cancer was in the chest cavity. Getting access for such thoracic surgery is highly complex and risky. General surgeons doing these sorts of procedures get worse outcomes than those who do them more often. It is like playing the piano; the more you practise, the better you get, yet we run shy of the necessary service reconfigurations to achieve this; and, without the data on hospital performance, one can see why. Patients can judge only convenience.

Fifthly, we should introduce national molecular testing for those cancers where there is no service incumbency, such as cancers of the upper digestive system or of the female reproductive system. We should use that patient volume to catalyse precision medicine trials in these diseases. They share the same genetic mutations as common cancer, and so, if pharma can recruit to trial, they will prove whether their drugs for common cancers work for these less common ones.

Sixthly, we must continue to collect rich clinical data on all patients with cancer out of routine care. This is essential in the emerging era of personalised molecular medicine. England has at the moment the largest and best cancer registration data collection service anywhere in the world. It is this rich clinical data linked to the molecular and genomic analysis that will allow us to understand both rare and common types of cancer. However, if we allow large numbers of individuals to opt out of the registries, then our hopes for improving care quality and finding treatments and cures for rare cancers will be lost for ever.

While some of these measures will cost money, some are cost-free. Public Health England, in the form of the National Cancer Intelligence Network, has hospital survival data, but we just do not publish them on. The Government have made a commitment to open data. This is an area where data can save lives. We must unlock Public Health England’s vaults and give the information to patients and doctors.