My Lords, I thank the noble Lord, Lord Grimstone, for the opportunity to speak today about trade agreements involving healthcare data and technology and, in moving Amendment 71, I shall speak also to Amendment 72 in this group.
Noble Lords will be aware that I am a long-standing advocate for the use of patient data to provide better healthcare, and some will know that my motivation is personal to the extent that the treatment of my sister, before she passed away, very sadly, was impacted by the poor flow of healthcare information. Therefore, noble Lords can rest assured that in tabling these two amendments I do not seek to restrict the free flow of data or to introduce obstacles to vital research and innovation. I do, however, wish to guarantee patient safety in our increasingly data-driven health service and, allied to that, continued government control of publicly funded healthcare data as we move beyond the transition period post Brexit to forge new trading relationships.
8.30 pm
The noble Lords, Lord Bassam, Lord Patel and Lord Fox, drew attention to the need to protect data controlled by the NHS in the context of trade agreements in their contributions to this Committee. The noble Baroness, Lady Thornton, also sought protections for
“publicly funded health and care services.”
Here, however, I am recommending that specific protections be included in the Bill. These are required first and foremost because the circumstances we find ourselves in at present are such that none can doubt the need to prioritise the safety of the public, as new treatments and technologies are developed in the face of the Covid pandemic and will be traded under both existing and new agreements that Her Majesty’s Government might enter into with other countries. They are also required because publicly funded health data processing services and IT systems for which NHS England and NHS Improvement, or NHS Digital, have overarching responsibility may or may not be regarded as “health and care services” in the context of trade agreements.
The effect of Amendment 71 would be to introduce a new clause to the Trade Bill to ensure that any source code or algorithm underpinning traded medical devices, which might recommend or inform treatment and care, is not beyond scrutiny by an appropriate body—thereby enshrining in law the Government’s commitment to patient safety. It reflects concerns that inclusion of provisions akin to those outlined in Article 19.16 of the United States-Mexico-Canada agreement might be requested of the UK Government in future, if that has not already been the case in its negotiations with the Japanese Government over recent weeks—as has been reported by the media—and others who might assist the UK in acceding to the CPTPP. Here, I take the point made by the noble Lord, Lord Lansley, last week in Grand Committee that the Bill amounts to continuation legislation, but the lack of transparency regarding trade negotiations and access to the detailed text of existing trade deals, to which the UK is a party, is such that noble Lords cannot be assured of the position that the Government have and will otherwise agree.
Many nations are increasingly adopting a more protectionist stance to technology, treating source code as a trade secret. At times, this approach is extended to algorithms. In the case of medical device technology, this is a serious concern that has the potential to put patient safety at risk where such code cannot readily be scrutinised. During the Second Reading of the Medicines and Medical Devices Bill, the Minister for Innovation, the noble Lord, Lord Bethell, assured us that patient safety is his top priority in introducing legislation designed to protect the public while stimulating healthcare innovation. I urge noble Lords to adopt an equally rigorous approach in establishing a framework for our future trading relations. There must be no trade-off between patient safety and the desire to see the UK become among the best places in the world to develop, test and deploy an array of next-generation medical devices.
The effect of Amendment 72 would be to introduce a further clause to the Bill. Subsection (2) would protect publicly funded data processing services and IT systems for which NHS England and NHS Improvement, or NHS Digital, have overarching responsibility from any form of control outside the UK.
Subsection (3) would ensure that Her Majesty’s Government retain control of access to healthcare data for the purposes of research, planning and innovation,
consistent with its own policy framework and associated regulations. This would include the national data opt-out, which exists to safeguard patient privacy, and its Code of Conduct for Data-Driven Health and Care Technology, particularly principle 10, which governs the derivation of fair benefits for the NHS in respect of the research and commercial usage of publicly funded healthcare data.
The amendments that I have tabled offer specific protections that pertain to the scrutiny of data-driven medical device technology in the interests of patient safety and control over publicly funded healthcare data processing services and IT systems. The Government have recently published their National Data Strategy, which champions the use of data to
“transform our public services and dramatically improve health outcomes nationally.”
For this strategy to be a success, it is crucial that the Government take back and retain control of their ability to make policies, regulate and provide medicines, medical devices and data processing services that safeguard and enhance the health of the nation. I beg to move.