European frameworks for patients’ rights

Patients’ rights are mainly determined at the national level and to some extent reflect differences in national contexts, especially where this concerns ethical questions, such as around the beginning and end of life. However, supra-national frameworks, such as the aforementioned UDHR and, within Europe, the European Convention on Human Rights (1950), play a role in influencing national legislation, as do more recent policy concerns, such as growing migration, increased mobility of patients and the need for cross-national cooperation in health care as well as the internationalization of medical research (Reference Roscam AbbingRoscam Abbing, 2004).

Within the European context, several developments have contributed significantly to promoting patients’ rights legislation in European countries (Reference Leenen, Gevers and PinetLeenen, Gevers & Pinet, 1993). These include the 1994 Amsterdam Declaration on the promotion of the rights of patients in Europe. It was a first attempt to formulate a consistent set of patients’ rights that should apply irrespective of the characteristics of a country’s health system or specific circumstances of patients. The Declaration sought to enhance awareness among citizens about their (active) role in health care, to strengthen collaboration and trust between patients and providers, and to support policy-makers in developing patient-centred policies (Table 13.1). This vision of strengthening citizens’ voice and choice in health care was later reasserted in the Ljubljana Charter on Reforming Health Care (1996).

This was followed, in 1997, by the European Convention on Human Rights and Biomedicine (Oviedo Convention) (Council of Europe, 1997). While primarily intended to protect human dignity against misuse of biological and medical advances, it also contains general patients’ rights (Table 13.1). These rights can be directly invoked in countries that have ratified this convention, provided they are unconditional and sufficiently precise (Reference Nys, Goffin and WismarNys & Goffin, 2011).

Within the EU, the issue of patients’ rights in the context of EU integration was pursued as early as 1984, when the European Parliament adopted a Resolution inviting the European Commission to submit a proposal for a “European Charter on the Rights of Patients”, taking into account the freedom of establishment for doctors and practitioners of paramedical professions. In 2002 the Active Citizenship Network, a group of European civic organizations, launched a European Charter of Patients’ Rights, which contains 14 specific patients’ rights and three additional active citizenship rights (Box 13.1). This initiative was inspired by the Charter of Fundamental Rights of the EU that was adopted in Nice in 2000. Mainly drawing on the right to health care (Article 35 of the Charter of Fundamental Rights of the EU), the focus was on access to high quality health care, which was seen to be of particular importance in the context of EU enlargement and increasing mobility in health care. Since 2007 an annual European Patients’ Rights Day has been organized to increase awareness about the importance of patients’ rights.

Another example of a voluntary arrangement developed by civil society is the European Cancer Patients’ Bill of Rights that was launched by the European Cancer Concord initiative in 2014. Motivated by the substantial differences in cancer incidence and mortality between countries in Europe, the charter provides three main rights: the right to accurate information and pro-active involvement, the right to timely and appropriate specialized care underpinned by research and innovation, and the right to be treated in health systems that ensure improved outcomes, patient rehabilitation, best quality of life and affordable health care (Reference LawlerLawler et al., 2014).

In 2011 the EU adopted and implemented the Directive on the application of patients’ rights in cross-border health care, which essentially focuses on social and consumer patients’ rights in the context of cross-border health care (Table 13.1).

Among the four frameworks reviewed here, only the Biomedicine Convention and the EU Directive are legally binding. Yet all four influenced the promotion and development of patients’ rights in Europe, as noted earlier. While there are slight differences in the formulation of these rights, with an emphasis on certain dimensions, there is relative consensus on the core elements of patients’ rights. Specific patients’ rights that are aimed at protecting specific patient groups (e.g. minors, those with disabilities or those with mental health problems) or people in specific circumstances (e.g. clinical trials, genetic testing) are omitted from the assessment presented in Table 13.1.

Self-determination and confidentiality

All EU Member States have developed (or are developing) a legal approach to defining and implementing the traditional rights to self-determination and confidentiality, including the right to informed consent, to participate in clinical decision-making, to data confidentiality and to accessing one’s medical record. These rights are often protected by multiple mechanisms.

Most countries have implemented strong mechanisms to protect the right to consent as it is fundamental to respecting a person’s autonomy (Reference Buelens, Herijgers and IllegemsBuelens, Herijgers & Illegems, 2016). There can be considerable variation in the way consent should be given (written, oral, implicit), although certain practices in place in some countries do not appear to be compatible with how informed consent is generally understood. For example, in Latvia, several hospitals require patients to sign a general consent form upon admission, which commits individuals to agree to any treatment recommended by the treating clinician. In practice this means that the consent given takes the form of a contractual obligation, that is, the patient can only be admitted to the hospital upon giving consent in advance. This further implies that the individual patient is being denied the right to be informed about alternative treatment options. This observation highlights the need for greater emphasis on self-determination in some European countries.

More generally, there is a growing perception that informed consent as a concept may be outdated in that it tends to overly rely on the notion of the patient as a passive recipient to whom certain information must be disclosed. Some commentators have argued for the development of a new ethical and legal standard that prioritizes patient autonomy in decision-making and which has been described as ‘informed request’ (Reference MoultonMoulton et al., 2013). The right to actively take part in decisions about treatment options has so far been formally recognized in a limited number of countries, such as Finland, Germany, the Netherlands, Norway and Sweden.

In most countries the right to privacy and confidentiality is perhaps even more strongly protected than the right to informed consent, with various civil, criminal and constitutional protections in place, including complaint and redress mechanisms and penalties for violation of confidentiality and data protection. However, there have been instances where privacy and confidentiality have been violated despite new legal safeguards. Examples include lack of privacy during physical examination or inadequate protection of individual patients’ health records. More systematic violations of confidentiality include the treatment of certain groups of people such as ethnic minorities, people with infectious disease or with substance abuse problems, and sex workers, with instances documented in a number of central and eastern European countries in particular that have been brought before the European Court of Human Rights (Reference TalbotTalbot, 2013). Whether such cases point to weaknesses in legislation or lack of legal protection remains difficult to assess with certainty, however. There remains a small number of countries that do not specifically guarantee the right to privacy or confidentiality; instead, this right tends to be covered by data protection legislation.

The right to access one’s own medical record is strongly provided for in most countries included in our review, although in some countries hospitals appear to restrict access in practice, through for example, charging administrative fees for people wishing to exercise this right. This right is crucially linked to the right to information while also serving as a means to monitor whether the right to privacy is being upheld.

Access and choice

The right to access medical care is intrinsically linked to the degree to which countries provide for universal coverage. It is for this reason that this right is generally addressed outside special patients’ rights laws. Yet as we have seen in the Introduction to this book, there remain gaps in health care coverage in a number of European countries, with evidence of an increase in the gaps following the global financial crisis of 2007–8 as indicated by rising levels of unmet medical need in some countries (Reference Reeves, McKee and StucklerReeves, McKee & Stuckler, 2015).

The right to receive safe and high-quality treatment in a timely manner is generally expressed as an obligation of the provider to adhere to a certain standard of care. The notions of ‘standard of care’ and ‘adherence’ are, however, not well defined in relevant legislation, ranging from ‘meeting certain patients’ expectation’ to ‘adhering to the current scientific medical knowledge’. Several countries have specified the right to receive treatment in a timely manner, with, for example, Denmark, Finland and Sweden defining maximum waiting times guarantees. Within the European Union, people are entitled to receive treatment in another EU Member State where that treatment cannot be guaranteed domestically within medically justifiable time limits (Reference Palm, Glinos and MossialosPalm & Glinos, 2010). This entitlement was reaffirmed in the aforementioned EU Directive on the application of patients’ rights in cross-border health care.

The ability to choose a health care provider is increasingly acknowledged as a patients’ right, although countries vary in the extent to which this right is realized. Provider choice can form an intrinsic value of the health system, or serve as a means to increase efficiency and improve quality and patient satisfaction (see Chapter 8). Under Directive 2011/24/EU, patient choice of provider is, within limits, extended to health care providers in another EU Member State irrespective of whether or not the provider in question is contracted by the publicly funded health system in that Member State. This can increase pressure on Member States to extend choice options and also allow reimbursement for non-contracted providers domestically. However, as shown in Chapter 8, provider choice can form an important source of inequity, especially for people living in rural and remote areas, and more importantly perhaps, for those who do not have the means to express choice and act upon it.

The right to a second opinion is less universally accepted, with only a small majority of countries having formally and unconditionally recognized this right. This implies that related costs will be covered under the publicly funded health system. In countries that do not permit free choice of provider, the right to a second opinion is often subject to strict rules and conditions, typically through strictly defined referral pathways requiring the explicit approval of the treating physician. Some countries only permit one referral per treatment or care process (Estonia, Norway, Slovenia, Spain) or a second opinion is limited to certain providers, usually public or contracted providers, or providers within the same provider organization (Slovenia), providers that are listed for a given pathology (some Italian regions), or as selected by the treating physician (Poland). In Estonia and Italy, a second opinion may also be obtained from a non-contracted provider or a provider outside the country, while elsewhere the right is restricted to certain (mostly life-threatening) conditions (Denmark, Italy, Spain, Sweden). In Denmark, the Health and Medicines Authority can establish a special second opinion panel for people with serious illness to assess the patient’s eligibility for experimental treatment at a private hospital in Denmark or elsewhere, with the treating physician responsible for the final decision. In Italy, patients with a (suspected) rare disease can be evaluated by experts from the National Network for Rare Diseases, and this may include seeking scientific advice from outside Italy. Overall, clinicians tend to have a high level of discretion in deciding whether the patient will be able to exercise their right to a second opinion. In Poland, the right to a second opinion is framed as a right of appeal to a medical opinion or decision, which is to be filed to a Medical Commission operated by the Patient Rights Ombudsman’s office. The Commission takes a decision on the basis of the medical records and any necessary examination. In 2013, 28 objections were filed but only two met the formal requirements and were forwarded to the Commission.

Information and redress

Informational rights are key to enable people to make informed decisions about their own care and to enforce other patients’ rights. Their enforcement requires procedural rights that ensure the provision of ex-ante information to enable people to exercise their rights and ex-post information that involves redress procedures in case of violation of these rights. One major challenge in the delivery of health care more generally, and the clinician–service user relationship specifically, remains the imbalance of knowledge, frequently referred to as information asymmetry (see also Chapter 4). It is against this background that enhancing access to information about health and health care is seen as a priority in many health systems in order to help people make informed decisions. Within the EU context, the aforementioned European Directive on the application of patients’ rights in cross-border health care emphasizes the need to improve information for cross-border patients, through, for example, establishing national contact points.

The right to information has three dimensions:

• The right to information about one’s health is instrumental to the right to consent and the right to participate in (clinical) decision-making more broadly. Countries vary in terms of the content of information that should be provided and its dissemination. Typically, information should address the effectiveness, benefits and risks of any proposed treatment as well as alternative options, and it should be provided in a way that is understandable and suited for different people’s needs, but this raises some practical and ethical issues (Reference EntwistleEntwistle et al., 1998). Importantly, the right to information also includes a right not to know, which needs to be respected where this is the individual’s expressed preference (Reference LaurieLaurie, 2014).

• The right to information about health care providers is instrumental for people to be able to exercise their right to provider choice. There are many challenges to realizing this in practice, such as the nature of the data and information that should be provided, approaches to data collection and validation, as well as their source and format (see also Chapter 7). Many countries have established an obligation for providers to publish information about various aspects, ranging from basic information about certification to practice to data about the quality of care provided, along with outcomes. A number of countries have invested in centralized web-portals to provide information about providers, but as discussed in Chapters 4 and 9, the evidence about the use and usefulness of this information by the public remains inconsistent.

• The right to information about rights and entitlements is instrumental to enforcing other patients’ rights. Providing accurate and transparent information about citizens’ rights and entitlements is part of good governance and is seen as a way to empower the public to access social services and demand the protection of their rights (Office of the United Nations High Commissioner for Human Rights, 2007). Governments have invested in improving access to information and reducing the administrative hurdles for people to claim and obtain the services to which they are entitled, including through central contact points, hotlines, web-portals, etc. The aforementioned EU Directive on cross-border health care specifies that the information provided should be easily accessible and made available by electronic means. It should include objective information about administrative procedures. While these provisions have been formulated in the context of cross-border care, people living in countries that have yet to establish public information systems may benefit, too.

Redress is the most critical aspect in the enforcement of patients’ rights. It covers the whole spectrum of instruments to settle disputes that may arise in the context of the patient–provider relationship. Disputes not only result from harm inflicted on the patient, but also from their rights being violated, expectations unmet or miscommunication. We have noted earlier that as effective sanctions are lacking in many settings, redress is often regulated under more traditional legislation covering breaches of duty of care and negligence (‘tort law’).

Professional liability regulations provide a strong incentive for providers to act cautiously and they also provide for fair compensation for patients who have suffered harm. Yet reliance on professional liability also has several flaws. Patients seeking compensation carry the burden of proof, including the need to provide evidence of damage incurred as well as evidence demonstrating negligence (fault) on the part of the provider and of the causal link between the provider’s action and incurred harm. Countries such as Sweden, Finland, Denmark, Norway, Iceland, France and Belgium have developed no-fault compensation schemes which grant financial compensation for medical injury without the need for the patient to establish evidence of negligence. While the modalities differ, no-fault out-of-court compensation systems are generally seen to be more fair and efficient, with some evidence pointing to reduced health care costs as a result of clinicians reducing the practice of defensive medicine (Reference VandersteegenVandersteegen et al., 2015). Relevant schemes may also benefit health systems more broadly by enhancing transparency around adverse events.

Redress based on medical malpractice is, however, not suited to address breaches of statutory rights which do not necessarily cause physical harm. Countries have thus developed alternative dispute resolution mechanisms that seek to prevent litigation through establishing complaint and mediation procedures. Several countries have introduced independent mediators, such as ombudsmen (Reference Mackenney and FallbergMackenney & Fallberg, 2004) or mediation councils, which act at provider level (e.g. Belgium, Finland), regional level (e.g. Norway, Slovenia), national level (e.g. Greece, Malta, Poland), or simultaneously at all levels (e.g. the UK). Outcomes range from out-of-court settlements, administrative or disciplinary sanctions, to explanations or apologies. The latter is typically done through providing a report to the complainant following an internal investigation by the health care provider or institution. If the outcome is not satisfactory, the patient can still decide to initiate a legal procedure. In order to address inequalities in the use of redress mechanisms, patients can be assisted or represented by patient advocates or patients’ organizations, who sometimes act as their legal representative in court (Belgium, Estonia, France, Hungary, Italy).

Complaints are most commonly triggered by concerns about the quality of care, in particular safety, including poor communication, staff attitudes and undignified service. Complaints data, where collected systematically, can help steer quality improvement initiatives, although the evidence of impact of such systems remains weak (Reference PedersenPedersen et al., 2013). Complaints procedures can also contribute to monitoring the implementation of patients’ rights. For example, Bulgaria, Greece, Hungary and Malta have introduced special patients’ rights committees inside or outside the health ministry, which are tasked with monitoring the situation and advising on any changes. At the international level, monitoring mechanisms for individual and social human rights also contribute to the implementation of patients’ rights. One example is the 1997 Biomedicine Convention described earlier, which can involve the European Court of Human Rights in giving advisory opinions on legal questions concerning the interpretation of the Convention, and the Court can also act directly if patients’ rights that fall within the remit of the European Convention on human rights are being violated.