Updated 06/02/2021

Authors:

Liam Sunner, Maynooth and Tamara Hervey, Sheffield, in collaboration with Brian Fisher, Socialist Health Association

22 January 2021

The support of the ESRC’s Health Governance After Brexit grant ES/S00730X/1 is gratefully acknowledged.

With grateful thanks to Elitsa Garnizova, LSE.

Summary

• The NHS and other aspects of healthcare provision and planning are at risk from future trade deals, including one with the US.
• Some aspects of trade agreements may have direct or indirect effects on the NHSs of the UK, especially NHS England where the Health and Social Care Act 2012 requires some aspects of primary care, and hospital care, to be put out to tender, including to the private sector.
• It is important to be attentive to the details of (proposed) free trade agreements, to think through their direct and indirect implications for every aspect of the NHS.
• Broad brush statements, like ‘the NHS is not for sale’, are too imprecise to be useful, either in holding government to account, or in engaging about the specific content of (proposed) free trade agreements.
• The most important effects of leaving the EU on the UK’s negotiation of trade agreements and what this means for the NHS are the loss of sites of scrutiny, oversight and mechanisms of accountability.

Setting the scene

The United Kingdom has left the European Union and is embarking on a new era of setting its trade policy with the world.

More accurately, Great Britain has left the constraints of the EU’s single market trading rules (which continue to apply, in effect, in Northern Ireland).

While the UK’s membership of the EU was perceived by some to be detrimental to the NHS in England, that trade relationship was with an entity (the EU) the members of which organise their health systems on the basis of solidarity, involving taxation or social insurance structures, rather than the market, to ensure access to healthcare for their populations. Other countries, in particular the USA, with which the UK might enter trade agreements do not necessarily share those values or structures.

Free trade agreements (FTAs) seek to foster global trade and thus to promote economic growth. Although overall the link between economic growth and population health has been assumed to be a positive one, this general assumption must be treated with some caution. In particular, FTAs between more developed countries, especially where they have solidarity-based healthcare systems, potentially run the risk of having detrimental effects on health systems, and consequently on population health.

On 19 January 2021, the House of Commons (357 to 266) rejected a proposed amendment to the Trade Bill 2020-21. This amendment, added by the House of Lords, would have added a clause to the following effect:

“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.”

Such a clause would have significantly constrained governmental/executive action in entering into trade agreements where those trade agreements might have had various direct or indirect effects on the NHS.

The UK government’s position is that there was no need to protect the NHS in the Trade Bill. The Trade Minister Greg Hands stated that it was “offensive and absurd” to claim that the NHS is or would ever be “for sale”. But others in the debate expressed concern that the NHS might be “on the table” in trade agreements, and that ability to access medical treatment free at the point of delivery was in jeopardy. And according to some sources, US officials and businesses have repeatedly said that the NHS must be “on the table” in trade talks, with US pharmaceutical companies and healthcare businesses eyeing the UK health market as a source of profit.

The aim of this briefing is to bring some specificity and clarity into discussion of these claims.

US Trade Agreements

The Agreement between the United States of America, the United Mexican States and Canada 2020 (USMCA) provides a recent example of US trade policy and what the US might seek to achieve in future trade agreements. Although it is a product of the Trump Administration, and we expect the Biden Administration to take something of a different approach, the incoming Trade Representative of the US, Katherine Tai’s speech on 13 January 2021 notes that the US administration will be keen to enforce its existing trade deals, suggesting continuity in at least some respects. Tai also stresses protecting American interests, including through enforcement of trade agreements. The Bipartisan Congressional Trade Priorities and Accountability Act of 2015 passed by Congress sets out the terms for then-future trade agreements. As Congress has the power to set trade terms, this serves as a good guide as to the shape of future trade agreements.

Trade agreements do not, in general, have explicit provisions on national health systems. Rather, what is necessary when thinking about possible effects of a trade agreement on the NHSs in the UK is to look at each part (‘chapter’) of a trade agreement and think laterally about what aspects of a health system it might affect: the products that are used in the system (medicines, devices, equipment); the people who staff it; the new technologies that are developed for it; the data that is shared within it and so on. It is not enough, for instance, to secure a ‘carve out’ for all public services in a services chapter, when rules in a procurement chapter might include access for foreign products in ways that undermine the logics of a solidary-based health care system. Taking things further, we also need to consider the effects on the health system of how trade agreements might change population health, through food regulation, environmental standards, and labour rights.

That is why our most important recommendation concerns effective scrutiny, by expert stakeholders, of any future US-UK FTA, with a specific focus on effects on the UK’s national health systems.

For the purposes of this brief note, we focus ONLY on the NHS in England. Different rules apply to and in the NHS in Northern Ireland, Scotland, Wales, and these differences matter. NHS England alone has gone down the route of putting out to tender some of its services, which means that provision can be by privately owned entities, as opposed to bodies of the state. However, some aspects of NHS provision, broadly understood, are integrated across the whole of Great Britain, so some of what we have to say applies beyond England.

Aspects of a health system: model

The WHO ‘building blocks’ model of health systems gives a useful structure for considering the effects of trade agreements on health systems. To this we need to add population health matters. Combining the two, we reach the following model:

• health service delivery
• health workforce
• health systems financing
• information systems
• medical supplies
• leadership and governance
• communicable diseases
• non-communicable diseases
• public health capacity and governance

Of these, some areas of NHS England would be more directly potentially affected by a US-UK trade agreement (such as medical supplies), others more indirectly (such as non communicable diseases), and others (like health systems financing) not likely to be affected at all, except in the most tangential ways. We can organise the model along these lines thus:

Potential direct effects

Summary

Supplies of medicines, devices, equipment; development and implementation of new health technologies (novel medicines etc)

Free trade agreements (FTAs) bring in tariff-free trade in goods. Pharmaceuticals are zero rated anyway, so there would be no change there. But other products used in health systems could be affected, for example, medical equipment like personal protective equipment, or medical devices. Reducing tariffs could mean access to cheaper products, hence less cost for the NHS.

FTAs also seek to reduce regulatory barriers to trade (or ‘technical barriers to trade/TBT’ in trade speak). Every stage of regulation of (novel) health technologies, from ‘bench to bedside’, is a ‘barrier to trade’ in the sense of a FTA. Different regulatory requirements add cost, but they also protect patients from harm from unsafe or ineffective products.

However, FTAs typically also permit regulation that is not protectionist (overtly discriminatory on the basis of nationality) that protects interests like consumer safety or public health. In the context of medicinal products, and to a lesser extent other products used in the NHS, these technical standards are usually developed at international level. The recent EU-UK Trade and Cooperation Agreement, for instance, requires the EU and UK to use international standards where possible (Article TBT.5).

Reducing differences in barriers to trade such as clinical trials rules, by reducing duplication of processes and/or enhanced opportunities for research cooperation could result in lower costs and perhaps in novel products reaching the (smaller) UK market sooner than they otherwise would.

But the UK adopting, for instance, the authorisations for new medicines from the US FDA would mean a loss of UK regulatory control not only at market authorisation stage, but also when it comes to the question of which medicines are available within the NHS. There are concerns, for instance, that US approaches to (lack of) transparency of clinical trial data would lead to less effective scrutiny of novel products, and inefficiencies in terms of decisions within the NHS on value for money of new medicines, rather than simply their safety or efficacy.

Furthermore, there are concerns about the UK departing from EU regulatory standards, given existing trade patterns. An agreement to align with the US on such matters could amount to an agreement to diverge from the EU.

FTAs have chapters on government procurement of goods (and services) which require governments to open to tender contracts with the government for goods and services. Under the WTO’s Agreement on Government Procurement (GPA), governments are nonetheless required to take social policy objectives into account when they select between tenderers. This practice has been challenged as disguising protectionist agendas. While studies have shown negative effects on NHS services (negative impacts on patient care, poor value for money, employment and working conditions; variable effects on service quality and ‘productivity’ (if that is even a meaningful concept in terms of national health services) when opened up to private provision through competitive tendering, equivalent negative effects are not so obvious for products.

Taking the recent EU-UK Trade and Cooperation Agreement as an example, we may draw some lessons to indicate the power dynamic at play for a possible US-UK agreement. The EU-UK TCA goes much further than the GPA in terms of opening up opportunities for companies established in the EU/UK to provide goods or services for governments in the UK/EU. Within the EU-UK agreement, procurement is addressed under Title VI, and “The objective of this Title is to guarantee each Party’s suppliers access to increased opportunities to participate in public procurement procedures and to enhance the transparency of public procurement procedures” (Article PPROC.1). The rest of the procurement chapter deals in some detail with the process as a whole and the requirements for transparency/ensuring openness.

One key element to note in the EU-UK TCA’s provisions on the procurement process is that in instances where the lowest bidder is significantly lower than others, “it may also verify with the supplier whether the price takes into account the grant of subsidies” (Article PPROC.9). As such, provided such subsidies are declared within the procurement bidding process, their mere existence may not constitute a general ground for refusal. A term like this in a US-UK FTA would further contribute to the openness and transparency of the public procurement process.

The failed TTIP also included measures associated with a ‘GPA plus’ approach. Both the US and some actors on the EU side were keen to capitalise on benefits from openness of government procurement markets. The health sector was very much included. At the time, the UK government expressed a desire to secure access to global markets for the UK’s health sector industries. Opening up markets for cross-border procurement of health products (pharmaceuticals, medical devices, equipment) is an aspect of FTAs which could be beneficial to the UK: both to the UK’s health products sectors and, so long as quality standards are protected, to the NHS as purchaser.

It will be important to disaggregate goods from services in terms of procurement provisions in a possible UK-USA trade agreement, and to secure sufficient protection for health services (see further below).

FTAs may have provisions about protection of intellectual property rights. These have the potential to result in cost increases in products, especially pharmaceuticals. In a study on the TTIP, alignment between the EU and the US on IP was found to be associated with a potentially significant price increase in pharmaceuticals. Price increases may come about because of rules that increase the length of time of a patent. This is an area of free trade that the Trump administration was actively pursuing, characterising European health systems as ‘freeriders’ on the US system, because of their approach to intellectual property rights and pricing of pharmaceuticals.

The Doha Declaration on the TRIPS Agreement and public health 2001 gives significant leeway for parties to TRIPS to rely on flexibilities within the TRIPS Agreement where necessary to protect public health. TRIPS is a minimal agreement. Other FTAs have adopted an approach of securing more detailed protection for patent holders. It will be necessary to scrutinize intellectual property provisions of FTAs to ensure they do not have negative effects on pharmaceuticals pricing and pricing of other novel health technologies.

Information systems, data sharing, health data in biomedical research

FTAs can include provisions about data sharing. FTAs have allowed the transfer of data for the purpose of innovation but there has been very little to demand this data be shared, especially with such proprietary and personal data as health data. For example, the EU-UK TCA includes a general ‘right to regulate’ digital trade clause (Article DIGIT.3), for public interest reasons including public health protection, safety, privacy and data protection, which covers current and future regulation (Article DIGIT.4).

Further, FTAs may also have provisions about interoperability of information systems, but these are typically quite vague commitments. For example, the EU-UK TCA includes the general commitment to ensure cross-border data flows, as well as not creating restrictions through technical requirements (Article DIGIT.6).

So provisions in FTAs are unlikely to mandate in any way the sale of NHS data to entities outside of the UK. However, the data compatibility and data sharing rules may facilitate such a contract, if a future government decides to sell NHS data, in a similar way to, for instance, the Thatcher government selling telecommunications infrastructure or council housing stock in the 1980s. NHS data has apparently already been sold in this way, for research purposes. The recent valuing of NHS data at £10 bn has increased concern that FTA provisions would enhance the likelihood of sale to US companies.

Separate from the sale of the data per se is the question of data handling services, where US firms might rely on an FTA to access services contracts, if the FTA’s data protection provisions were combined with the government procurement rules for services (see below).

At present, virtually all IT systems within NHS England are privately provided (there is virtually no government-designed and provided IT infrastructure any more, with the one exception of the NHS App which gives access to GP records, which is in competition with private (better) provision). GP practices use private provisions for patient data handling. NHS hospital data handling is also conducted by private entities with which the CCGs contract. US firms are already operating in this market, and the approach adopted in England has led to an inefficient patchwork of provision with little interoperability or ease of data sharing, to the detriment of patients moving between different parts of the systems as a whole (eg GP to hospital to social care setting).

Health/clinical services and medical treatment

FTAs seek to secure access to markets for services in the relevant parties to the Agreement.

As with goods, FTAs typically also permit regulation that is not protectionist (overtly discriminatory on the basis of nationality) that protects interests like data privacy or public health. Unlike in EU law, however, the ‘organisation or financial balance of a national health system’ is not typically one of the grounds for permitted regulation, unless wording like ‘legitimate policy objectives, such as the protection of public health’ can be interpreted to include this. (For an example of a FTA which includes that wording as an exclusion from the provisions on trade in services see SERVIN.1.1 (2) of the EU-UK TCA.)

The essence of the concern about trade agreements’ effects on health and especially clinical services is the idea that healthcare is not (or should not be) organised on the basis of ordinary market principles. A trade agreement does not in general treat services in one sector any differently from any other sector.

FTAs typically however exclude entire sectors from the application of the service provisions. For example the EU-UK Trade and Cooperation Agreement excludes audio-visual services entirely from the Title on Services and Investment (Article SERVIN.1.1 (5)). This type of provision is called a ‘hard exclusion’ or ‘carve out’. Such approach has been described as ‘’20 years of protection that works” by the European Commission. However, the caveat of the political and economic power of the EU behind such protection must be taken into account. While the provision itself works as intended, its use at a similar scale may not be applicable between the US and the UK, because of the relative disparity of bargaining power between the US and the UK.

Another type of exclusion or exemption in a FTA can be found in reservations. A reservation is an aspect of domestic law or policy (either existing, or future) that does not comply with one or more of the main provisions of the FTA (such as market access, or national treatment), but for which it is agreed between the Parties to the FTA that the FTA will not apply.

To give some examples, in the EU-UK TCA, these are found in ANNEX SERVIN-1 (current measures) and ANNEX SERVIN-2 (future measures). These provisions could serve as a model for protecting European solidarity-based models of the healthcare system as opposed to US models. There are three pages of EU current measures reservations for medical, dental, midwives, nurses, physiotherapists and para-medical services, at Reservation No 3; EU reservations for research and development, at Reservation No 4; and five pages for health services and social services, at Reservation No 13.

The UK has an equivalent reservation to the EU’s for research and development. But the UK has no reservations for medical, dental, midwives, nurses, physiotherapists and para-medical services (only for veterinary surgery services), and no equivalent to the EU’s Reservation No 13, suggesting an openness to service providers from the EU to the UK’s health system. This makes sense, given the UK’s reliance on external service providers in the sector, especially in Northern Ireland.

For future measures, the EU and the UK both have a reservation (No 1) for ‘services considered as public utilities’, which explicitly includes health services. The EU reserves the right to maintain or adopt measures that mean those types of services may be subject to public monopolies, or to exclusive rights granted to private operators. This reservation significantly impedes market access and investment liberalization in the healthcare sector, especially where the State has organised its healthcare system through public monopolies.

In addition, for future measures, EU Member States have several reservations about health related professional services, and retail sales of pharmaceutical, medical and orthopaedic goods, and other services provided by pharmacists (Reservation No 3). So, for example, all EU Member States except Netherlands and Sweden require a local presence for supply of all health-related professional services, whether publicly or privately funded.  And the EU reserves the right to adopt future measures on supply of all other health services (for instance, ambulance services) which receive public funding or state support in any form (Reservation No 17). This looks like a useful model for a catch-all reservation clause for publicly-funded healthcare services.

The UK’s future reservations are similar: for instance, establishment in the UK under the NHS is subject to medical manpower planning, impeding market access and investment liberalization (Reservation No 3). Health-related professional services may only be provided by human beings physically present in the territory of the UK (Reservation No 3). The UK also reserves mail order retail services of pharmaceuticals, medical and orthopaedic goods to suppliers established in the UK (Reservation 3)

The question of access of US firms to NHS clinical services contracts is salient here.

It may be possible for the UK Government to prevent access for US firms seeking access to NHS clinical service contracts by excluding the NHS clinical service contracts  under Art. I:3 (b) GATS. This allows the UK to exclude services supplied in the exercise of governmental authority from the notion of “services” in the meaning of the agreement and therefore from the application of GATS. The term service “supplied in the exercise of governmental authority” is defined as “any service which is supplied neither on a commercial basis, nor in competition with one or more service suppliers” (Art. I:3 (c) GATS). Further to this, the vagueness relating to the distinction between “public utilities” and “publicly financed services” used in FTAs may also be a factor to be aware of when considering health/clinical services and medical treatment. This vagueness of precisely where NHS clinical services fall may help justify a ‘hard exclusion’ or ‘carve out’ by claiming it is a service supplied in the exercise of government authority, in this case the health aspects. This vagueness, can and has been, used by the EU to achieve favourable outcomes in the past.

If this is not the case and NHS clinical services fall outside the definition of a service supplied in the exercise of government authority, access to the NHS clinical service contracts may be open to US firms as part of the negotiations. However, it would be still possible to protect the NHS clinical services if they were to be explicitly removed per the negative list system (some issues with this system are discussed in the conclusion).

As noted above, the application of government procurement parts of a FTA to health/clinical services is concerning from the point of view of patient care, quality of service, value for money and employment conditions. Where an NHS such as the English NHS procures clinical or other health services on the open market, a FTA can have the effect of requiring the English NHS to open tendering processes to firms established in the other party to the FTA.

Further, some FTAs include ratchet clauses (which have the effect of limiting the circumstances in which a government can bring a sector back into a solely public realm, once a market is opened to private supply, without having to compensate private suppliers for existing/expected contracts.

This question has taken on particular salience during the COVID-19  pandemic. For example, in May 2020, the Spanish Government declared a state of emergency in response to the COVID-19 pandemic. In doing so, the Spanish Government temporarily assumed control over private hospitals in Spain to attempt to combat the pandemic. It would be reasonable to equate a similar situation, in particular the significantly high level of infection, as a grounds for the UK government to assume control over some aspects of the health sector without having to compensate private suppliers for existing/expected contracts. However, this would be dependent on several factors, such as the declaration of a state of emergency, the nature of the emergency, the duration of the emergency, and return to an open market once the emergency in question has been resolved.

Reservations clauses (as discussed above) can be used to prevent the application of ratchet clauses to aspects of trade barriers in aspects of sectors, such as the healthcare sector.

Health workforce

FTAs typically have few if any provisions on migrant labour. They may, for instance, include provisions setting up processes by which professional qualifications may be mutually recognised. This is the case in CETA, for example.

Some FTAs have clauses that seek to protect labour rights. These are usually relatively weak, and usually involve non-regression of existing labour protections.

Potential indirect effects

Summary

Non communicable diseases

• Food regulation
  • The USTR negotiating objectives include the reasonable expectation that sanitary and phytosanitary regulations will “build upon World Trade Organization rights and obligations . . . making clear that each Party can set for itself the level of protection it believes to be appropriate to protect food safety and plant and animal health in a manner consistent with its international obligations.”
  • So this is a question of interpretation of those WTO rights and obligations – where it is well-known (eg Turkey Tails) that some states have tried to use public health interests to impede trade, and this has been successfully challenged as being protectionist.
• Environmental regulation
  • Similar considerations apply for air and water quality and waste management regulation, all of which have clear effects on public health.
• Labour rights
  • See above.

Governance

As a member of the EU, the UK was part of a system whereby free trade agreements were negotiated by the EU (and sometimes also its Member States, depending on the content of the agreement). The rules-based process by which free trade agreements are negotiated in the EU involves a degree of transparency and oversight by elected representatives. Under Articles 207 and 218 TFEU, both the Council and the European Parliament are formally required to be involved in the negotiation and conclusion of trade agreements. In practice, the EU system also involves oversight by relevant stakeholders, through European Parliamentary relations, as well as through governmental channels in each Member State.

The UK has no equivalent rules-based approach to the negotiation of trade agreements.

International treaty making is an executive power in the UK’s constitutional practice. Parliament has no formal role in treaty-making. Neither do the governments or parliaments in the UK’s devolved jurisdictions.

Parliamentary oversight is formally required where a treaty requires a change in UK legislation or the grant of public money. Otherwise, Parliament can only use political pressure to seek to influence the government’s position. No formal transparency rules require the UK government to publish its negotiating position, or draft documents, although the government has done this as a matter of practice, often when the other negotiating party has published its texts.

The lack of formal parliamentary involvement in treaty-making differentiates the UK Parliament from most other national legislatures. Most written constitutions require parliamentary approval of treaties before ratification for at least some categories of treaty.

The constitutional arrangements for treaty-making in the UK significantly reduce the scope for oversight by knowledgeable stakeholders, as well as by the population as a whole.

Process

The phrase ‘the NHS is not on the table’ does not, by itself, equate to any real legal protection for the NHS.

Similar language was used by the UK Government during the Brexit discussions and subsequent transition periods, but was then mitigated as part of a compromised approach to finalise the negotiations. As such, such phrasing is more political rhetoric than an absolute protection of the NHS.

Further, the issue of how the US and the UK approach potential negotiations remains an active point of discussion. The US has previously sought the use of a negative listing system, whereby everything is ‘on the table’ unless exempted. This approach would require each service to be explicitly exempted. The US would then have to agree that the NHS is ‘not on the table’, service by service, prior to the formal negotiations. While such an approach may have some similarities to the reservations method as discussed above, in that items are removed from the negotiation, the reservation approach operates at the economic sector level while the negative listing system operates at the individual service level. Additionally, the Reservation system is removing aspects from sectors that were ‘on the table’.

Given the value of access to certain services within the NHS, agreeing to remove the entire NHS service by service may not be achievable between the UK and the US. Thus, arguments at the level of ‘selling off’ the NHS or ‘the NHS being on the table’ are unhelpfully imprecise, and too easy for a government to rebuff with an equally broad phrase.

What is needed is careful analysis of proposed legal texts, with a specific view to working out what their likely effect would be on aspects of the UK’s NHSs.