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?