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 statementThis 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.
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.
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
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.
My Lords, Amendment 43 in my name provides for safeguards to trade agreements to ensure affordable access to medicines for all. I thank my noble friend Lord Purvis of Tweed and the noble Lord, Lord Alton, for adding their names. I express my support for Amendment 11 in the names of the noble Baroness, Lady Thornton, the noble Lords, Lord Freyberg and Lord Patel, and my noble friend Lord Fox. It dovetails nicely with my Amendment 43 in seeking to protect the NHS and connected services from control through free trade agreements; Amendment 43 seeks to affirm fair access to affordable medicines for international agreements to which the UK is already a party.
The monopoly system created by the pharmaceutical business model is entrenched globally through the WTO’s 1995 TRIPS agreement—the Agreement on Trade-Related Aspects of International Property Rights. Included within it are provisions to safeguard public health. However, concerns about affordable medicines in developing countries, particularly access to antiretroviral drugs in the face of the HIV/AIDS epidemic, led to the Doha declaration in 2001. These identified options open for Governments to address public health needs, which are known as flexibilities. The importance of such flexibilities was highlighted by their inclusion in the UN’s sustainable development goals.
However, despite these safeguards, the misuse and abuse of these monopoly rights continue and are taking precedence over human rights in all countries of the world, not just developing ones. The NHS’s spiralling drugs bill led even the Health Secretary, Matt Hancock, to protest that pharmaceutical companies are “ripping off taxpayers”. I have no objection to profit-making by companies, but I object vehemently to people suffering and dying needlessly under the NHS because of quite obscene profit-taking by pharmaceutical companies, as happened with Vertex’s cystic fibrosis drug Orkambi. In South Africa, private health companies are charging $39,000—an obscene amount—for Trastuzumab, a WHO essential drug to treat breast cancer. This is a human rights issue.
If accepted by the Government, my amendment would be a powerful statement and signal to the world our intent to uphold our principles and values when trading abroad, very much in keeping with modern trade agreements that nudge us towards a more progressive trading environment. This issue becomes even more urgent with the emergence of vaccines for Covid-19. Only one vaccine, from Pfizer-BioNTech, has been granted regulatory approval at the moment. It has to be kept at -70 degrees centigrade and presents huge logistical challenges. We have ordered enough for about 20 million people but it is already clear that we must wait in line. Supplies in the numbers that we need are not forthcoming quickly enough. The Oxford-AstraZeneca vaccine, once regulated, will help us here in the UK enormously but only if we can ramp up its manufacture as planned. However, we are dependent on international supply chains for getting all the necessary materials in the right place at the right time, and this will be no easy task with Brexit, deal or no deal.
I say all this because it is patently in our interests—and the world’s—to support the proposal by South Africa and India to waive unhelpful parts of the TRIPS agreement so that know-how, data and materials can be readily shared and the world can collaborate in getting the right vaccine to the right people as quickly as possible. The science community collaborated to develop vaccines in superhuman time. The billions of pounds of public money helped, of course, but it is now the turn of politicians to do likewise and remove political barriers to rolling out vaccines. The South African and Indian waiver proposal has been welcomed by the WHO. Next year, the UK will host the G7, and health will be top of the agenda. If we do not support the waiver, what will our position be on ramping up the supply of vaccines? Past experience has shown that it will be foolhardy to rely on the goodwill of pharmaceutical companies. Will the Minister make the case for supporting the waiver proposal at the WTO TRIPS council meeting coming up later this week, on Thursday
I will not be putting my amendment to a vote. However, its main points will be brought back when this House debates the Medicines and Medical Devices Bill on Report.
My Lords, it is a great pleasure to follow the noble Baroness, Lady Sheehan. I support her Amendment 43 and share her concerns about big pharma, although I would go further and suggest that the profit motive should have no place in healthcare. Chiefly, I will offer three brief paragraphs in support of the cross-party Amendment 11, so ably introduced by the noble Baroness, Lady Thornton.
Looking at the excellent UNISON briefing on this amendment, I was taken back, as was the noble Lord, Lord Freyberg, to the Committee debate on the Medicines and Medical Devices Bill, in which we were discussing the place of artificial intelligence and big data in care and, of course, the dreaded algorithms. Clearly, this will be a fast-growing area of care, needing careful monitoring and democratic oversight, which is what this amendment seeks to achieve. What is decided by Parliament must not be undermined or overturned by free trade agreements. As the medicines Bill debate highlighted, these are big issues and there are huge issues around discrimination and potential misuse—accidental or otherwise—of the data, the algorithms and the whole approach.
I wish briefly to point noble Lords to the case of Henrietta Lacks in the US, including the treatment of her cells, the treatment of her data and the destruction of her privacy. It is an experience that surely should be studied as we face the loss of the protection of GDPR, as there remains uncertainty about the plans for WTO e-commerce rules and as there is grave concern about the way in which the UK-Japan agreement undermines UK domestic digital and AI regulation in healthcare services.
My Lords, I rise to speak to the health data aspects of Amendment 11, which has been mentioned and was so well introduced by the noble Baroness, Lady Thornton, and the noble Lord, Lord Freyberg. I would add to the point of the noble Baroness, Lady Thornton: I join her in deploring the fact that we are debating this group of amendments, which are so important in this area, impacting on the NHS, at this late hour.
NHS data is a precious commodity, especially given the many transactions between technology, telecoms and pharma companies concerned with NHS data. In a recent report, EY estimated that the value of NHS data could be around £10 billion a year in the benefit delivered. The Department of Health and Social Care is preparing to publish its national health and care data strategy in the new year, in which it is expected to prioritise the
“safe, effective and ethical use of data-driven technologies, such as artificial intelligence, to deliver fairer health outcomes.”
Health professionals have strongly argued that free trade deals risk compromising the safe storage and processing of NHS data.
Through this amendment, the objective is to ensure that the NHS—not US big tech companies and drug giants—reaps the benefit of all this data. This is especially important given what the Ada Lovelace Institute called in its report—The Data Will See You Now—the “datafication” of health, which, it says, has profound consequences for who can access data about health, on how we practically and legally define health data and on our relationship with our own well-being and the healthcare system. Health information can now be inferred from non-health data, and data about health can be used for purposes beyond healthcare. So harnessing the value of healthcare data must be allied with ensuring that adequate protections are put in place in trade agreements if that value is not to be given or traded away.
There is also the need for data adequacy to ensure that personal data transfers to third countries outside the EU are protected in line with the principles of the GDPR. Watering down the UK’s data protection legislation will only reduce the chances of receiving an adequacy decision. There is also a concern that the proposed National Data Strategy will lead to the weakening of data protection legislation, just as it becomes ever more necessary for securing citizens’ rights. There should, however, be no conflict between good data governance, economic growth and better government through the effective use of data.
“Commitments to uphold world-leading standards of protection for individuals’ personal data, in line with the UK’s Data Protection Act 2018, when data is being transferred across borders. This ensures that both consumer and business data can flow across borders in a safe and secure manner.”
The Department for International Trade, as mentioned by the noble Lord, Lord Freyberg, issued a document headed “UK-JP CEPA—a good deal for data protection”. However, the agreement has Article 8.3, which appears to provide a general exception for data flows, where this is
“necessary to protect public security or public morals or to maintain public order” or
“to protect human, animal or plant life or health”.
The question has been raised of whether this will override data protections and what its impact will be on access to source codes and algorithms. There is also the question of the combined effect of Article 8.84, on the free flow of data, which provides that:
“A Party shall not prohibit or restrict the cross-border transfer of information by electronic means, including personal information, when this activity is for the conduct of the business of a covered person.”
Article 8.80, on personal information protection, says:
“Recognising that the Parties may take different legal approaches to protecting personal information, each Party should encourage the development of mechanisms to promote compatibility between these different regimes.”
It is all very well making reassuring noises, but what public legal analysis of the language in the relevant articles—and how advocacy will be permitted despite this—are the Government going to provide? Why, for instance, are these articles included, which the EU for its part will not sign up to? Unless the Government do this, there will be zero trust in future trade deals, especially regarding the US.
To date, there have been shortcomings in the sharing of data between various parts of the health service, care sector and Civil Service. The development of the Covid-19 app and the way the Government have procured contracts with the private sector for data management have not improved public trust in their approach to data use. There is also the danger that the UK will fall behind Europe and the rest of the world unless it takes back control of its data and begins to invest in its own cloud capabilities. Specifically, we need to ensure genuine sovereignty of NHS data and that it is monetised in a safe way, focused on benefiting the NHS and our citizens.
With a new national data strategy in the offing, the Government can maximise the opportunities afforded by the collection of data and position the UK as a leader in data capability and protection. As Future Care Capital says in its briefing on the Bill:
“Any proceeds from data collaborations that the Government agrees to, integral to any ‘replacement’ or ‘new’ trade deals, should be ring-fenced for reinvestment in the health and care system, pursuant with FCC’s long-standing call to establish a Sovereign Health Fund.”
This is an extremely attractive concept. Retaining control over our publicly generated data, particularly health data, for planning, research and innovation is vital if the UK is to maintain its position as a leading life science economy and innovator. That is why, as part of the new trade legislation being put in place, clear safeguards are needed to ensure that in trade deals, our publicly held data is safe from exploitation, except as determined by our own Government’s democratically taken decisions.
My Lords, I refer to my entry in the register. This is a particularly important group of amendments, on health and the protection of data. I thank the noble Baronesses, Lady Thornton and Lady Sheehan, and the noble Lord, Lord Freyberg, for introducing them.
I will limit my remarks to the specific issue of data, which will be relevant to the recently reached super-agreement with Japan. It was discussed as recently as last week, when my noble friend Lord Grimstone spoke about the importance—I agree with him—of a greater exchange of data flows, particularly from that agreement. However, as the noble Lord, Lord Freyberg, said, it is extremely important, as set out in Amendment 11, to protect this data. I will give one example. The Government have been heavily dependent on vaccine trials for the three vaccines that are coming out. Would people readily submit to such trials and completing confidential surveys if there was any doubt that the data they submit would be treated confidentially?
If my noble friend Lord Younger of Leckie is not minded to support this amendment, will the Government table their own amendment to ensure the greater protection of data processing services?
My Lords, I speak strongly in support of Amendment 11, in the name of the noble Baroness, Lady Thornton. The hour is late, and we spent a long time discussing the matter in Committee. The noble Baroness, Lady Thornton, and others have dealt with the subject in detail and eloquently. Hence, I will be brief, as the last speaker before the Front-Bench speakers.
No matter what the Government say about the NHS not being on the table for any trade negotiations with the USA, it is naive to think that that will be so. Members of the US Congress and big pharma have made it clear that they expect the NHS to be part of any negotiation of a United States trade deal. In fact, the chair of the Senate finance committee—a committee that will have a final say in any trade deal that will be made—said that it is clear that all goods and services are part of the negotiation and, furthermore, that the NHS would benefit from competition from US companies. US big pharma has always complained that the UK, with its regulatory and medicines pricing regime, does not pay full price for medicines. It has even suggested that, as a result, US patients end up paying a higher price.
The US data and tech firms see an opportunity in our NHS patients’ records to develop patient management platforms and an opportunity to conduct clinical trials on cohorts of stratified patient and much more. I can quote an example: the company Palantir that has been involved in data mining and in security and intelligence. It was given a contract for the price of £1, at the beginning of the pandemic in March, to develop a platform for Covid-19 data. The contract was to be re-examined three months later. It was extended briefly and now I gather that, without any public debate, it has been granted a contract for five more years. Why would a data mining company be interested in having data related to health and health management? The answer is quite obvious: data is gold. In the absence of any government policy in relation to security and governance of health and patient data, it is an open goal for tech companies.
As I mentioned in Committee, several US firms are already involved in managing services worth billions of pounds. The prize for running services and exploiting patient and service-based data will be worth tens of billions of pounds. In market-driven self-service, the losers will be the patients and taxpayers.
Recently, it was reported that there was a meeting, organised by the Office for Life Sciences, between NHS England and big pharma and big tech with the intention to digitise and use the data of tens of millions of patients. Such an exercise would cost billions of pounds, which might be funded by the tech firms, but there was discussion about who would hold the IP. The risk we run, not only concerning data but also about how the services are managed in the NHS, is that they will be given to overseas companies, particularly American companies, that will benefit and profit from it. The NHS will be the loser, and therefore I strongly support this amendment.
My Lords, this has been necessarily a short debate, but it has been an incredibly high quality debate. We have heard, from all the speakers, a high level of understanding of the issue and the dangers that Amendment 11 is seeking to address. I speak as one of those who signed Amendment 11. I support Amendment 43 and congratulate my noble friend Lady Sheehan on her eloquent presentation, but I am going to focus on Amendment 11 because it is a really important issue. We heard a lot about data from people who know a lot about data.
Sitting above this is the fact that the Government have no published cross-border data transfer policy. Without that, it seems as though each trade deal will be a series of negotiations without a framework. The noble Lord, Lord Freyberg, and my noble friend Lord Clement-Jones set out the benefits of having constraints and frameworks for this. It is clear from the Japan trade deal that the Government have indicated a level of flexibility around data. Once that has been delivered for one trade deal, it becomes a necessity for the next—and a bit more and a bit more. Even if that is not what will happen, I am sure the Minister understands that this fuels the fires of people’s suspicion and concern about the way in which data is being treated in this country.
From his position of great knowledge, the noble Lord, Lord Patel, set out some specific examples—not of a trade deal but of trade in this country—where data is already being parlayed. One things that has not been said is that, for patients to consent to their data being used, they have to believe that there will be a benefit. They do not want that benefit to flow across these borders through trade; they want it to accrue to the NHS. That is why Amendment 11 is important, and why I hope that it goes to a vote shortly and gets the support of Members from these Benches and beyond.
The noble Baroness, Lady Thornton, spoke very clearly in moving this amendment. Like me, she recognises the benefits of trade, but only when health takes the central place in our trade policy. That is what Amendment 11 seeks to achieve.
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.
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.