4.1 Introduction
Private law plays an important, if not always recognized, role in European health law. It governs relationships between patients, health care professionals, and medical institutions they rely on for their care. Private law creates lines of accountability between manufacturers of medical devices and the end user. However, the legal landscape, regulatory frameworks, and academic literature are primarily premised on notions of care being a public good that falls under public law.Footnote 1 Nevertheless, there are important distinctions between the United States (US) and Europe, which this chapter highlights. Grasping these distinctions requires taking a step back from the sharp end of the law to understand important structural differences between the health systems and the influence of private entities that exist but which might not be the obvious first port of call for research.
The sections that follow examine three aspects of private health in Europe. First, this chapter explores the structural distinction between the health systems in the US and Europe. Public health is the predominant form of care in Europe, but that headline ignores the complex reality of a shared structure between public and private entities and the diversity of how those arrangements manifest between different European countries. Second, the chapter examines the extent and role of private law as a mechanism for governing health care disputes in Europe. While tort law is a given for resolving disputes, this chapter queries the extent to which contract law is used, finding that empirical evidence is limited.
Third, there is an examination of the influence of health care lobbies and private interests and how they can permeate all levels of governmental decision-making concerning health care down to decisions about commissioning services on the ground. Public health has primacy in Europe, but that does not mean lobbyists do not constantly seek avenues to shape the policy and lawmaking environments to create new opportunities for funneling public funds toward their private services.
By highlighting these distinctions, this chapter provides a point of contrast to the US in other chapters of this volume, where private influences and private law are far more pervasive and a known part of the landscape. At the same time, the role of private influences and private law are less understood in Europe, and this chapter seeks to highlight their importance.
4.2 Europe Distinguished: The Structure of Health Services
There are four key distinctions between the US and Europe concerning the structure of health services that implicate the public and private distinction in health care.
First, the most pertinent distinction is that universal health care is a given in nearly every European country. In contrast, the US heavily relies on private health care to ensure that care is provided. In general, health care services in Europe are designated as public goods.Footnote 2 The form of public health coverage in Europe varies, but the underlying principles focusing on public universal health care are similar. For example, the United Kingdom (UK) has the National Health Service (NHS), Spain; the Sistema Nacional de Salud (SNS), and Italy; the Servizio Sanitario Nazionale (SSN), among others.Footnote 3 Of course, these are not absolutes. In the US, there are public hospitals, but these do not provide services for free, which precludes access to care for some. There are also elements of private care in Europe, but that does not preclude access to health.
Second, the role of government in providing health services and employing the health care workforce highlights another distinction. The UK is an extreme example because of its highly centralized nature, but it helps elucidate the government’s role compared to the US. In the UK, policy is determined by the Executive (specifically, the Treasury headed by the Chancellor of the Exchequer), which moves money downwards to the Department of Health and Social Care (DHSC) for capital projects such as investment in buildings and equipment, salaries, medicines, vaccinations, and other public health programs.Footnote 4 The remaining money is trickled down to NHS England (an executive non-departmental public body sponsored by the DHSC), which distributes that money further to various services and providers.Footnote 5
In this manner, the government controls the NHS and is, therefore, the main employer of the health workforce and main provider of health services, whereas the US Government is not primarily a provider of health care services.
Third, health insurance is another significant difference. In the US, Medicaid and Medicare are public programs limited to specific individuals (such as low-income individuals, retirees, and disabled individuals). However, the predominant basis for coverage is through expensive private health insurance. In Europe, coverage is mainly provided by the state and is governed by public law. In some cases, coverage is provided by mandatory health insurance, such as in Germany, and supplemental private insurance is common in other cases, such as Belgium, Holland, and Slovenia.Footnote 6 Public coverage generally ensures that most individuals pay no (or nominal fees) at the point of service.
Where private providers exist, the cost of their services is usually paid by the national health insurance system or regulated social insurance schemes that coordinate the purchasing of such services.Footnote 7 How this plays out depends on the country. For hospital care, four approaches are pertinent in Europe. In one group (Belgium, Netherlands, Germany, and Norway), private hospital bed numbers are similar to those in the public sector, and the difference in services between public and private hospitals is minimal, with consumers and social health insurance payers deeming both functionally equivalent.Footnote 8 In a second group (Austria, France, Italy, and Portugal), private entities have increasingly offered lower-risk outpatient services for profit, offering fewer beds than the public system.Footnote 9 In the third group (Czechia, Estonia, Finland, Hungary, Latvia, and Poland), private providers offer a narrower range of short-stay services in specialized areas.Footnote 10 In the final group (Iceland, Ireland, the UK, and Lithuania), private facilities are in the minority.Footnote 11 Areas where private care tends to dominate in Europe include dental care. In most countries, 80 to 100 percent of dentists are private practitioners.Footnote 12 Further, primary care tends to be provided in private settings,Footnote 13 and most pharmacies are privately owned and operated (although the state primarily pays for the medications).Footnote 14
Fourth, the final difference between the US and Europe is the legal framework and the types of disputes that arise. There are disputes concerning health insurance coverage in the US, which are rarer in Europe. Health care fraud and antitrust rules also feature more prominently in the US. Disputes in Europe center on administrative decisions, quality of care, and access to care.
These distinctions highlight that private entities and private care in Europe fall within a broader public care matrix. The next query is the extent to which private law plays a role in this matrix.
4.3 The Role of Private Law
While public law is of primary importance in Europe for regulating the relations between citizens and public authorities, private law can also regulate the medical field and ensure access to health.Footnote 15 One central area of law providing redress in Europe is tort law.Footnote 16 Similar underlying principles concerning duty, breach, and causation apply when compared to the US, but the application of those principles will likely differ between EU states. For contract law, contractual agreements can exist between medical institutions and doctors, between doctors and patients, and between insurance companies and hospitals.Footnote 17 It has been noted that the increased expansion and sophistication of regulations in Europe, such as consumer protections and anti-discrimination law in contractual relations, “amounts to an instrumentalisation of private law for political purposes.”Footnote 18 However, as a legislative matter, there is no “health care” law basis in legislation for managing relationships between doctors and patients (although they can be regulated “through different modes of market regulations”).Footnote 19
While European countries primarily deal with malpractice cases through tort or contract law,Footnote 20 the number of private contracts governing such relationships and any disputes arising from them is unclear. In the UK, at least from a patient perspective, there are no contracts between patients and the NHS, so breach of contract cannot be relied upon to sue health care institutions.Footnote 21 This is true not only for matters of care but also for the disclosure of confidential information. While the court may find an implied contract in such cases, it is thought to be unlikely.Footnote 22 A breach of contract claim may be more successful by the employer against their employee where the employee clinician divulges confidential patient information (thereby breaching the terms of the employment contract).Footnote 23 Linked to the legal pathway pursued is the concern about creating a compensation culture like in the US. A fear is that the slightest opportunity will be taken to make a “fast buck,” and the ability to sue for breach of contract could contribute to that culture.Footnote 24 However, it has been determined that this concern is a myth.Footnote 25 Overall, empirical evidence is needed to determine how prevalent contractual disputes between patients, doctors, and health care institutions are in other European countries.
Another area of note is private litigation concerning access to health for individuals in the EU on the grounds of free movement of persons.Footnote 26 With citizens moving across borders for work, demands arose for access to health in other member states.Footnote 27 The courts also addressed specific issues like abortion. In the early 1990s, the Court of Justice of the European Union (CJEU) determined that Irish citizens had the right to access abortion services in other member states, and they could not be prohibited from doing so.Footnote 28 A line of case law raised the issue of whether the EU operates as a free market for health, whereby citizens can travel from their country to another country to receive care and then be reimbursed by their home country. Those cases determined that citizens could travel and be reimbursed for their care (although the home state could impose restrictions on the extent of this).Footnote 29
Cohen has examined the intricacies of this paradigm, including the related case law, regulations, treaty provisions, and directives.Footnote 30 One major question has been whether patients are required to seek prior authorization from their home state for reimbursement of care in another EU member state. Case law has determined that prior authorization may constitute a restriction on the freedom to provide services, and that prior authorization requirements may not be justified for outpatient care.Footnote 31 Requirements for prior authorization may be justified where the patient has access to treatment without undue delay, otherwise the ability of the patient’s home country to “fund and organize its internal health care system” may become threatened.Footnote 32 If a patient is entitled to reimbursement, the level of reimbursement will depend on whether treaty or regulatory provisions apply. In some cases, where the level of reimbursement in their home country is lower than the cost of care they are seeking in another member state, the patient is entitled to be reimbursed for the additional costs they incur. In other cases, the patient will be required to make up the financial difference themselves.
Directive 2011/24Footnote 33 is also important in this area. It states that “decisions of refusal to grant prior authorisation, shall be restricted to what is necessary and proportionate to the objective to be achieved, and may not constitute a means of arbitrary discrimination or an unjustified obstacle to the free movement of patients.”Footnote 34 Matters falling under the “necessary and proportionate” criteria include the “financial balance of a social security system” and “planning requirements” for ensuring access to high-quality treatments.Footnote 35 A significant concern during the negotiations of the Directive involved the movement of expatriate pensioners. For example, Spain was concerned that expats living there would return home for medical care, which would be charged back to Spain. To combat this, several countries agreed that patients entitled to receive a pension from their country (even where they are no longer resident there) would pay for the treatment of those patients returning home for care, as opposed to the expat’s country of residence.Footnote 36 This would not apply to countries not on the list, or where the patient seeks treatment in a third country – in which case, the expat’s resident country would be required to pay.Footnote 37
Aside from medical tourism-type cases, there has also been a plethora of case law brought before the European Court of Human Rights (ECtHR) by individuals and groups concerning the right to “private or family life.”Footnote 38 The cases do not involve contract law issues but illustrate how individuals have brought a range of matters to the courts concerning their care.
These involve medically assisted procreation, surrogacy, abortion, prenatal testing, informed consent, and end-of-life situations. They also cover the health of detainees, health and immigration, health and the environment, health and the workplace, and the protection of medical data.Footnote 39
For example, in surrogacy cases, the courts have had to navigate a complex terrain between adhering to public law prohibitions on commercial surrogacy and permitting private contractual surrogacy arrangements. In the UK, the Surrogacy Arrangements Act 1985 was passed to discourage surrogacy following a case involving a British woman being employed as a surrogate mother for a Swedish couple via a US agency.Footnote 40 It is illegal to negotiate or arrange surrogacy on a commercial basis under the Act.Footnote 41 However, surrogacy is legally permitted when organized by an individual or non-commercial body, and there is no payment.Footnote 42 In one case in the UK Supreme Court in 2020, the court rejected an argument that surrogacy was contrary to public policy and noted that it was not unlawful to enter into commercial surrogacy abroad.Footnote 43 In most cases, the courts will promote the child’s welfare by determining what is in their best interests.
The particular arrangements and payments to the surrogate will not likely stand in the way of the courts giving a parental order because it will be in the child’s best interests. This was seen in one case where a British couple paid a Ukrainian surrogate 235 Euros per month and 25,000 Euros upon birth (which she used to pay the deposit on her flat). A parental order was still given, with the judge holding that:
The difficulty is that it is almost impossible to imagine a set of circumstances in which by the time the case comes to court, the welfare of any child (particularly a foreign child) would not be gravely compromised (at the very least) by a refusal to make an order.Footnote 44
Thus, despite the restrictions in public law, the reality is that commercial surrogacy exists, and the courts will likely only refuse a parental order in the clearest cases of fraud and bad faith because the best interests of the child will usually be served by granting the order.Footnote 45
Another area that intersects with private law is competition law. Increased competition may be seen as a solution to support the sustainability of public health care systems that are under strain. Yet, the applicability and scope of competition law is determined on a case-by-case basis, resulting in an inconsistent application of competition law to health care providers by the courts and the European Commission.Footnote 46 EU states do not favor introducing elements of competition law into the health care system because those systems are highly regulated, and it would increase the risk of conflicts between state interventions and EU law.Footnote 47 Exempting EU law from these realms could be an easier option in theory, but states cannot exempt health systems and the provision of care from competition law.Footnote 48 Consequently, there is limited scope for competition law to be adapted to enable more competition in health care in Europe.
Finally, it is worth noting developments concerning data. A survey by a European consumer organization finds that while Europeans are comfortable sharing their health data with doctors, they are not happy sharing that data with technology or insurance companies.Footnote 49 There is a particular reluctance to share health habits, genetic data, and sexual and reproductive data.Footnote 50 Some have called for protections for consumers to protect such data. The proposed European Health Data Space is a health-specific ecosystem designed to give individuals control over their health data while providing a consistent framework for using health data for research, innovation, policy, and regulatory activities.Footnote 51 There are already queries about how this space will intersect with contract law matters, such as whether data can be transmitted for research purposes based on contracts.Footnote 52
4.4 The Influence of Private Lobbies on Private Avenues of Care
The last area of examination pertains to lobbying. There has been a gradual creep of private health providers in Europe. The reason for this creep is multifaceted and complex, but much of it is enabled at the policy formulation level of government and even before that. The health care lobby is one of the most powerful in Europe.Footnote 53 Officially reported spending figures in the EU transparency register for pharmaceutical companies alone is 36 million Euros annually, but the figure is likely far higher owing to the voluntary nature of the EU’s transparency register.Footnote 54 Even from the reported figures, those companies far outspend civil society actors (at a rate of 15 to 1).Footnote 55 The aims of lobbyists are broad, but in general, they seek to influence the formulation of laws that are favorable to them, delay and eventually remove bills from the legislative agenda that may be harmful to their profits, and seek lucrative contracts for providing health services to the public health system. Despite these aims, the results of their efforts reveal a nuanced picture.
The UK provides an illustrative case study of how lobbyists operate in this space.Footnote 56 Various avenues exist for lobbyists and citizens to get involved in policy development.Footnote 57 The most obvious route is influencing decision-makers in Government (the Executive), Parliament, and political parties on health care bills, policies, or legislation.Footnote 58 For political parties, the aim is to influence their internal policies and their manifesto. While party members have some influence, the greatest power may lie with a few vested interests. Think tanks such as the Institute of Economic Affairs for the Conservatives and Demos for Labour have been quite influential in this manner.Footnote 59 In Parliament, Members of Parliament (MPs) will scrutinize Government bills, and extra scrutiny is undertaken for different aspects of NHS performance by parliamentary committees, including the Health and Social Care Committee, the Public Accounts Committee, and the Public Administration and Constitutional Affairs Committee. For example, in 2017, the Health Committee considered the potential impact of Brexit on health and social care in the UK.Footnote 60
For the Government, the DHSC is the ministerial department tasked with supporting and advising ministers, setting direction, and acting as “guardian” for the health and care framework.Footnote 61 It is chaired by the Secretary of State for Health and Social Care, whose responsibilities to Parliament are outlined under the National Health Service Act 2006. In practice, power is shared between ministers and civil servants, which will vary considerably depending on the personality and strength of the minister in charge.Footnote 62 The balance also depends on the quality of advice given by civil servants, the weight given to the departmental view on an issue, and the commitment of a minister to the relevant matter.Footnote 63 Numerous conflicts of interest have been detailed concerning relationships between decision-makers and the private health sector.
This can be seen with the Health and Social Care Act (HSCA) 2012, which was created to restructure the NHS and encourage more private-sector competition. One report argued that many people involved in policy formulation had personal interests in private health companies.Footnote 64 Individuals with links to private health companies and think tanks had previously held positions as health ministers, members of the Cabinet, or MPs who had voted for the Bill,Footnote 65 which led to accusations of large-scale conflicts of interest.Footnote 66 These concerns should be understood in the context of a historical revolving door problem of former ministers being employed by private health companies as advisers.Footnote 67
Another report revealed how McKinsey & Company (a management consulting firm that drew up many of the proposals for the Bill) had paid for the head of NHS regulator, Monitor, to attend an event with a banquet, five-star hotel, and first-class flights, which raised conflict of interest and undue influence concerns.Footnote 68 Finally, during the Bill stages, the Government “paused” the progression of the Bill to undertake a “listening exercise” after the proposals were subject to much criticism. During that period, the Government was accused of having private discussions with proponents of more privatization following a leaked document revealing that their purpose was to ensure that competition remained a core part of the Bill following the listening exercise.Footnote 69
Despite all these efforts, the ultimate results of these efforts by private lobbyists paint a nuanced picture. The King’s Fund (a health and social care charity) argued that the HSCA 2012 extended market-based principles and introduced more competition into the NHS, resulting in more contracts awarded to private providers.Footnote 70 However, the overall proportion of the budget spent on private providers did not increase. The King’s Fund also noted that the Health and Care Act 2022 removed the competition and market-based approaches introduced by the 2012 Act.Footnote 71 Other findings are far more critical. One study concluded that:
The privatisation of the NHS in England, through the outsourcing of services to for-profit companies, consistently increased in 2013–20. Private sector outsourcing corresponded with significantly increased rates of treatable mortality, potentially as a result of a decline in the quality of health-care services.Footnote 72
There was also criticism from the Deputy Chair of the British Medical Association (BMA), who argued that ministers were “throwing huge amounts of money at private firms rather than investing in rebuilding our health and care system.”Footnote 73 However, other findings argue that the ability of private firms to make profit in this paradigm is limited by a top-down squeeze on prices, and the state’s dominance of funding and provision.Footnote 74 Thus, while the result of private lobbying is contentious, the HSCA 2012 provides a useful case study for how private lobbyists can shape law and policy to encourage a shift toward greater marketization, creating more room for private entities to operate. Other European countries and the EU are not immune to the same influences.Footnote 75 Brussels is the world’s second capital for lobbyists, followed by Washington, DC.Footnote 76 Following COVID-19, commentators highlighted a “frenzy” of lobbying activity in the EU’s health policy space.Footnote 77 In the future, systematic research concerning the actual health policies influenced by private entities in the EU would help delineate the extent to which laws are being shaped to benefit those interests.
4.5 Conclusion
While public law is predominant as a matter of legal governance for health care matters, the reality is somewhat more complex in Europe. This chapter has explored the topic from three lenses to provide points of contrast with the US. First, by examining the structure of health care services, we can see how private care fits into the overarching system of health care services.
Second, while contract law mechanisms exist to resolve disputes, there is little empirical evidence to analyze their implications where they exist. As the data regulation ecosystem develops, more avenues for private law may arise. Finally, the influence of private lobbyists in Europe highlights how laws and policies can be shaped to create new avenues for those entities to provide services.
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