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.