Trade Bill

Baroness Thornton Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Monday 7th December 2020 Lords Chamber

Moved by

[Baroness Thornton]

11: After Clause 2, insert the following new Clause—
“International trade agreements: health, care or publicly funded data processing services and IT systems in connection with the provision of health and care
(1) Regulations under section 2(1) may make provision for the purpose of implementing an international trade agreement only if the conditions in subsections (2), (3) and (4) are met in relation to the application of that agreement in any part of the United Kingdom.(2) The condition in this subsection is that no provision of that international trade agreement in any way undermines or restricts the ability of an appropriate authority—(a) to provide a comprehensive publicly funded health service free at the point of delivery,(b) to protect the employment rights or terms and conditions of employment for public sector employees and those working in publicly funded health or care sectors,(c) to regulate and maintain the quality and safety of health or care services,(d) to regulate and maintain the quality and safety of medicines and medical devices,(e) to regulate and control the pricing and reimbursement systems for the purchase of medicines or medical devices,(f) to provide health data processing services and IT systems for commissioners, analysts and clinicians in relation to patient data, public health data and publicly provided social care data relating to UK citizens, or(g) to regulate and maintain the level of protection afforded in relation to patient data, public health data and publicly provided social care data relating to UK citizens.(3) The condition in this subsection is that the agreement—(a) explicitly excludes application of any provision within that agreement to publicly funded health or care services,(b) explicitly excludes provision for any Investor-State Dispute Settlement (ISDS) clause that provides, or is related to, the delivery of public services, health care, care or public health,(c) explicitly excludes provision for any ISDS clause regarding data access and processing in relation to patient and public health data for the purposes of research, planning and innovation,(d) explicitly excludes the use of any negative listing, standstill or ratchet clause that provides, or is related to, the delivery of public services, health care, care or public health,(e) contains explicit recognition that an appropriate authority (within the meaning of section 4) has the right to enact policies, legislation and regulation which protect and promote health, public health, social care and public safety in health or care services, and (f) prohibits the sale of patient data, public health data and publicly provided social care data, except where all proceeds are explicitly ring-fenced for reinvestment in the UK’s health and care system.(4) The condition in this subsection is that the agreement explicitly allows, in the case of any traded algorithm or data-driven technology which could be deployed as a medical device, for the methodology for processing sensitive data to be independently audited or scrutinised for potential harm by an appropriate regulatory body in the United Kingdom where it relates to trade in medical algorithms, technology or devices.(5) For the purposes of this section—“negative listing” means a listing only of exceptions, exclusions or limits to commitments made by parties to the agreement;“ratchet” in relation to any provision in an agreement means any provision whereby a party, if (after the agreement has been ratified) it has unilaterally removed a barrier in an area where it had made a commitment before the agreement was ratified, may not reintroduce that barrier; and“standstill” in relation to any provision in an agreement means any provision by which parties list barriers which are in force at the time that they sign the agreement and undertake not to introduce any new barriers.”Member’s explanatory statement
This new Clause would aim to protect the NHS, health, care or publicly funded data processing services and IT systems in connection with the provision of health and care in other parts of the UK from any form of control from outside the UK through trade agreements.

[Baroness Thornton (Lab) [V]]

My Lords, this proposed new clause aims to protect the NHS health, care or publicly funded data processing services and IT systems in connection with the provision of health and care in parts of the UK from any form of control from outside the UK through trade agreements. We know that Parliament does not yet have adequate powers to guide and scrutinise trade negotiations, and the current process provides no legal mechanism to directly influence or permanently block trade agreements—hence the amendments which we have discussed in Committee and earlier today. I thank the noble Lords, Lord Patel and Lord Fox, for adding their names to this amendment, and particularly the noble Lord, Lord Freyberg, for merging his important amendment about NHS data with the one about the NHS and public health. These are national assets which must not be put in jeopardy or squandered in whatever the future holds for UK trade with the world.

I will be very brief, because it is late—it is shocking that we are having to discuss something so important so late. We know that this Bill could mean that the UK enters into trade agreements that have a significant impact on public health and the domestic healthcare sector without Parliament having any meaningful role in their scrutiny. In this time of great uncertainty—do we have a deal or not?—the Trade Bill is currently the only legislative vehicle for Parliament’s oversight of trade negotiations. As a result, additional scrutiny mechanisms are vital to protect the NHS and public health as the UK begins to negotiate independent free trade agreements in earnest. These trade agreements could enhance health, if controls are put in place to ensure economic gain is not given priority over health, but they also have the potential to negatively impact upon health services. While the Government have repeatedly pledged that the NHS is not on the table in trade negotiations, we know that there have been detailed conversations between UK and US negotiators, revealing that health services have been discussed and that the US is probing the UK’s health insurance system and has made clear its desire for the UK to change its drug pricing mechanism.

I invite the Minister to accept this amendment so that the Government can proceed with their trade negotiations confident that Parliament has expressed its clear intention. I will not go through the detailed parts of this clause, because they are rather well drafted and completely clear in what they aim to do. There must be clear provisions on digital trade, where this affects health services. There must be clear exemptions for all health-related technology, as well as more transparency about digital provisions in trade deals. The noble Lords, Lord Freyberg and Lord Clement-Jones, will more than adequately explain those data issues, but we must remind ourselves that the NHS has longitudinal data the like of which exists in no other health system in the world. It is a huge asset from which the NHS and the British taxpayer should benefit. Does the Minister agree? I beg to move.

[Lord Freyberg (CB)]

My Lords, I am delighted to follow the noble Baroness, Lady Thornton, and congratulate her on her excellent and persuasive speech. I am pleased to contribute to consideration on Report of the Trade Bill and to speak to the new Amendment 11.

There is some question as to the status of new and enhanced digital trade provisions in replacement deals, such as the CEPA signed by the UK and Japan in September, and those promised next year in relation to the UK’s CETA with Canada, which are said to expand pre-existing agreements. These provisions have implications for health and care in the UK and warrant further discussion, despite the advice note issued by the Minister’s department on Friday—hence my decision to press the issues which I raised in Committee.

Amendment 11 would safeguard state control of policy-making and the use of publicly funded health and care data. This capability is of vital importance in the context of the pandemic, but it should be guaranteed in perpetuity, since it underpins the efficient and effective operation of publicly funded health and care services in the UK, as well as those data-driven health services managed at present by, for example, Public Health England and the Joint Biosecurity Centre. It also amounts to a significant national asset or resource with the potential to function as a dynamo in relation to research, innovation and continued growth of the UK’s life sciences, health and care tech sectors. The Trade Bill should recognise this and incorporate explicit provisions preventing the outsourcing of digital infrastructure that is critical to the nation’s health and wealth and, by implication, the loss of skilled personnel working in data analytics to support core health and care functions alongside research and development activity.

Agreement to Amendment 11 would also safeguard the state’s ability to regulate and maintain the level of protection afforded to health and care data relating to UK citizens. The Government seek to champion the free flow of data; this is writ large in the CEPA as well as in their recently issued advice notes on the subject. I am also mindful that the CEPA does not in itself change UK data protection laws. However, the Government should consider how the Trade Bill and enhanced provisions in rollover trade agreements could contribute to, or detract from, the public’s perception of their trustworthiness and accountability in relation to health and care data usage by third parties. After all, informed consent is the foundation on which UK GDPR is based.

The Government have stated that the CEPA deal

“removes unjustified barriers to data flows to ensure UK companies can access the Japanese market and provide digital services. It does this by limiting the ability for governments to put in place unjustified rules that prevent data from flowing and create barriers to trade.”

Does the Minister consider restrictions on the free flow of, for example, genomic and biometric data about citizens justifiable or not? Would he not, for example, consider it helpful to commit to data localisation or minimum cybersecurity standards to safeguard certain types of sensitive personal data? Having entered into the CEPA with Japan, are the Government now unable to insist on such rules? In putting my name to this amendment, I am concerned to ensure that the Government have not already tied the hands of policymakers and regulators, including the Information Commissioner.

Agreement to subsection (3)(c) in the proposed new clause inserted by Amendment 11 would prevent the introduction of any ISDS clause regarding data access and processing in relation to health data to a rollover or enhanced trade agreement. The Government continue to invest significant funds in research and development and are committed to leveraging private investment to propel the UK’s R&D effort. I feel sure—in fact, I will wager—that securing foreign direct investment in health and care data will be a feature of their trade negotiation strategy. However, in the interests of guaranteeing value for taxpayers’ money, the Government should not find themselves in a position where they are at risk of legal action from their trading partners or multinationals if, for example, they want to offer discounted access to health and care data assets for UK SMEs to stimulate homegrown economic development or invest to create employment opportunities in deprived communities in relation to the clean-up or curation of health and care data.

The Minister remarked in an earlier reply to me that ISDS provisions do not feature in the rollover trade agreements with which this Bill is primarily concerned. I also think I am right in saying that, rather than opting for ISDS in negotiating the CEPA, the Government agreed with Japan that the agreement would be subject to the World Trade Organization’s Dispute Settlement Body. That is not to say that other rollover agreements still to be finalised will not incorporate reference to ISDS, and nor do I profess a preference for reliance on the WTO’s dispute settlement body vis-à-vis claims that might arise in relation to government decisions on health and care data, since the UK will pose a less significant risk to those claimants who may be backed by big tech once separated from the European Union in earnest. I therefore stand by the amendment, which would prevent such claims arising in the first place.

Agreement to subsection (3)(f) of Amendment 11 reads across to a topic that I have spoken about on many occasions in this place: namely, the value of healthcare data. There is widespread recognition that the NHS uniquely controls nationwide longitudinal healthcare data, which has the potential to generate clinical, social and economic development as well as commercial value. The Government should take steps to protect and harness the value of that data and, in the context of the Trade Bill, ensure that the public can be satisfied that that value will be safeguarded and, where appropriate, ring-fenced and reinvested in the UK’s health and care system. The Government have stated that the UK-Japan deal includes agreement to encourage

“the release of anonymised government datasets where appropriate”

because public access to government datasets creates opportunities for innovative British businesses. Once again, the trade deal cuts both ways; I do not believe that the general public support a “great health data giveaway” of benefit to companies headquartered and paying taxes overseas.

Finally, conscious of time, I encourage the Minister to reflect upon my contribution to the discussion of the Medicines and Medical Devices Bill in Committee, and the helpful response of the noble Baroness, Lady Penn, which confirmed that the Government mean to undertake a review of pertinent regulations over the coming year, including the definition of a medical device and the regulation of algorithms and artificial intelligence in pertinent tools and innovations. I am concerned that the effect of provisions in some trade agreements could be to reduce access to the algorithms that underpin them.

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-19 pandemic and traded under both existing and new agreements that the Government might enter into with other countries. Yet, according to the Government’s advice note published on 4 November, the CEPA entered into by the UK and Japan will prevent the forced transfer of algorithms. The Trade Bill should contain up-to-date provisions to guarantee patient safety against this backdrop because it is unclear whether Article 8.3 of the CEPA—which provides a general exemption for measures deemed necessary to protect human health—would override provisions concerning the forced transfer of algorithms. Agreement to subsection (4) of Amendment 11 would have that effect.

I am passionate about harnessing the value of health and care data that is generated by, with and about UK citizens. The Government should, however, take note of those protections to which I have put my name in supporting Amendment 11; these are designed to maintain public confidence in our brave, new, data-driven world.

--- Later in debate ---

[Viscount Younger of Leckie (Con)]

My Lords, I will now address Amendment 11, tabled by the noble Lords, Lord Freyberg, Lord Patel and Lord Fox, alongside the noble Baroness, Lady Thornton. This amendment would place a range of restrictions on the regulations that we can make to implement continuity agreements. I will be relatively brief and will write to all noble Lords who asked questions to be sure that they are answered.

New subsection (2), proposed by this amendment, stipulates that regulations can be made only using Clause 2 of the Trade Bill if the agreement does not undermine the way in which the NHS is delivered, operated or regulated, but we believe that the conditions set out in subsection (2) are unnecessary. We have demonstrated time and again that we are not selling off the NHS, and this will not change.

I listened carefully to the remarks of the noble Lord, Lord Freyberg. In response, the Government are clear that health and care data should only ever be used or shared where it is used lawfully, treated with respect and is held securely, with the right safeguards in place.

The conditions set out in proposed new subsection (3) would defeat the purpose of having a Clause 2 power. It stipulates that no agreement can be implemented through Clause 2 regulations, unless it contains a range of explicit exclusions and inclusions in the text of the agreement. Importantly, this would effectively prohibit the implementation via Clause 2 of any continuity trade agreement that the Government have signed, which does not explicitly meet these requirements, even though this amendment did not exist at the time of their negotiation. Every single continuity agreement that we have negotiated over the past three years would be left null and void, without an implementing power. We would be forced to reopen negotiations with every single continuity partner, which would no doubt be used to extract costly concessions.

Rigorous protections for public services can be achieved in both positive and negative lists in services and investment schedules for FTAs. The sectoral commitments outlined in a schedule are only one part of a tapestry of protections for public services, which can also include scope exclusions and exceptions set out elsewhere in the FTA. The UK is party to agreements that use both positive and negative lists, and neither outcome has interfered with the Government’s right to regulate and ability to protect public services.

This amendment would also place a new requirement for exclusions on the sale of patient data—another condition that was not in place at the time of negotiation. There are already strict legal, privacy and security controls on how companies can use patient data, including principles set out by the National Data Guardian and the common law of confidentiality. We have clearly set out our principles governing data-sharing agreements entered into by NHS organisations, published in July 2019.

Finally, subsection (4) of this amendment stipulates that regulations can be made using Clause 2 of the Trade Bill only if they allow for the scrutiny of

“medical algorithms, technology or devices”

with respect to their

“methodology for processing sensitive data”.

I reassure your Lordships that before any medical device can be placed on the UK market it must be compliant with the Medical Devices Regulations 2002, which cannot be superseded by a trade negotiation without further legislation.

I now turn, quickly, to Amendment 43, proposed by the noble Baroness, Lady Sheehan, and the noble Lords, Lord Purvis of Tweed and Lord Alton of Liverpool. It would mean that the commencement power in Clause 32 could be used only to commence the substantive provisions of the Trade Bill if they do not restrict UK citizens’ access to medicines, if they do not curtail the Government’s power to use the safeguard provisions of the agreement on trade-related aspects of intellectual property rights, if they do not delay the market entry of lower-priced generic health technologies and if they do not lower the bar for patentability. Similar to Amendment 11, it also seeks to exclude health-related matters from the scope of ISDS provisions.

I also note that the voluntary scheme for branded medicines pricing and access—the so-called VPAS—which is the latest voluntary pricing scheme negotiated with industry, will continue to control the prices of branded medicines and their cost to the NHS. The VPAS runs in conjunction with the statutory pricing scheme, NHS England and NHS Improvement commercial arrangements, and the process for NICE appraisals. The 2019 VPAS will run until 2023 and, through a series of measures, supports patient access to innovative new medicines.

Furthermore, the UK remains committed to the Doha declaration on the TRIPS agreement and public health, which recognises the right to public health and the importance of intellectual property protection, while noting that the flexibilities contained in the IP system can be enacted to address public health needs. In addition to our commitment to our international obligations, we will also be bound by IP provisions designed to facilitate public health that are enshrined in domestic law. For example, the Patents Act 1977 provides for compulsory licensing in the unlikely circumstances that this is required. With that, I ask noble Lords not to press their amendments.

[Baroness Thornton (Lab) [V]]

My Lords, I thank noble Lords very much for the support that the amendment has received from across the House. I listened carefully to the Minister but was not at all convinced by what he had to say. It seemed to boil down to two things. The first was that nothing should change because you might have to change other agreements—which is clearly nonsense in this day of technology. Secondly, if the Minister really cared about the NHS and data protection, the Government should write their own amendments to the Bill, instead of having the rest of the House do it for them. On that basis, I wish to test the opinion of the House.

[The Deputy Speaker (Lord Bates) (Con)]

My Lords, I shall now put the Question. We have heard from a Member speaking remotely that they wish to divide the House in support of the amendment and I will take that into account. The Question is that Amendment 11 be agreed to.