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?

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

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.