Judicial development: human rights as ‘general principles’ of EU health law

The CJEU recognized human rights as ‘general principles’ of EU law in the 1960s.Footnote ²⁸ One of the most important sources of such general principles of EU law is the ECHR.Footnote ²⁹ Its position in EU law was recognized in the EU's founding Treaties in the early 1990s, and it is now found in Article 6 (3) TEU, which asserts that the ECHR's fundamental rights are general principles of EU law.

The ECHR is a traditional civil and political statement of human rights.Footnote ³⁰ It was drafted in the aftermath of the Second World War, and came into force in 1953. All the EU's Member States are signatories to the ECHR and thus individual citizens of all EU Member States may enforce their rights before the European Court of Human Rights.Footnote ³¹ A considerable number of actions brought before the European Court of Human Rights relate to health. For instance, Article 1 ECHR, which safeguards the right to life, has been used in claims concerning the status of the foetus and abortion,Footnote ³² resource allocationFootnote ³³ and the right to die.Footnote ³⁴ Article 5 ECHR, which safeguards the position of liberty and security of the person, has been used extensively in mental health claims.Footnote ³⁵ Article 8 ECHR, the right to privacy of home and family life, has been used in the context of health privacy and confidentiality of patient information, autonomy of treatment decisions, and reproductive rights.Footnote ³⁶ Article 12 ECHR, the right to marry and found a family, has featured in claims concerning reproductive rights.Footnote ³⁷

The various ECHR rights relevant to health contexts, as general principles of EU law, did not feature directly in a claim before the CJEU in a health context during this phase of the EU's human rights law development. The SPUC v. Grogan caseFootnote ³⁸ from the 1980s concerned abortion, but this was discussed in terms of free movement of services, and the CJEU was reluctant to engage with the human rights aspects of the litigation. Similarly, national courts applying EU law in circumstances concerning reproductive medical treatments, such as the UK's Court of Appeal in R. v. Human Fertilisation and Embryology Authority ex parte Blood,Footnote ³⁹ did not refer directly to ECHR rights to life, privacy or family life.

In its general jurisprudence, the CJEU has also recognized some other regional and international human rights instruments.Footnote ⁴⁰ Those which are of particular relevance in the health field include the Council of Europe's Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine,Footnote ⁴¹ 1997, a statement which, as its title suggests, is specifically targeted at biomedicine.Footnote ⁴² Article 1 of the Biomedicine Convention states that its purpose and object is safeguarding the dignity and identity of all human beings, and respecting their integrity and other fundamental rights and freedoms. The Convention refers to rights to consent,Footnote ⁴³ private life and the right to information,Footnote ⁴⁴ controls on genetics and prohibition on discrimination,Footnote ⁴⁵ researchFootnote ⁴⁶ and removal of organs and tissue from living donors for transplantation purposes.Footnote ⁴⁷ The Council of Europe has also produced additional protocols on cloning,Footnote ⁴⁸ transplantationFootnote ⁴⁹ and biomedical research.Footnote ⁵⁰

Again, the CJEU did not rely on these provisions in health litigation during this period of time. Netherlands v. European Parliament and Council (Biotechnology Directive),Footnote ⁵¹ concerning the validity of Directive 98/44/EC on the legal protection of biotechnological inventions,Footnote ⁵² was one possible opportunity in which to do so. However, the CJEU's judgment considered only ‘the fundamental right to human dignity and integrity’.Footnote ⁵³ The Advocate General referred to the ECHR, and to the Biomedicine Convention once,Footnote ⁵⁴ but did not rely significantly on this human rights instrument in his reasoning.

The Council of Europe's European Social Charter (ESC),Footnote ⁵⁵ Article 11, covers the ‘right to the protection of health’, obliging states to ‘take appropriate measures’ to ‘remove as far as possible the causes of ill-health’, ‘to provide advisory and educational facilities for the promotion of health and the encouragement of individual responsibility in matters of health’, and ‘to prevent as far as possible epidemic, endemic and other diseases as well as accidents’. The work of the European Committee of Social Rights, including under the complaints mechanism, has elaborated a ‘jurisprudence’ of social rights, in particular articulating the values (autonomy, dignity, equality and solidarity) which underpin the ESC. As Cullen has noted, the ways the Committee understands these values supports a generous interpretation of ESC rights, for instance, solidarity is seen as ‘a value supporting inclusion and protection against vulnerability’.Footnote ⁵⁶ Although, again, the ESC and the European Committee's work could form a resource for the CJEU, in practice connections between EU law and the ESC are notable in their absence during this period.Footnote ⁵⁷

Another important source of human rights as ‘general principles’ of EU law is the constitutional traditions of the Member States.Footnote ⁵⁸ The Member States protect ECHR rights, including those relied upon in health contexts, in their constitutions. The concept of human dignity from the German constitution has been particularly influential on the CJEU.Footnote ⁵⁹ Although the CJEU has stated that the concept of human dignity has an independent meaning in EU law,Footnote ⁶⁰ the ways in which national and EU human rights orders interlockFootnote ⁶¹ is underlined by Article 52 (4) EU CFR, which provides that rights from the common constitutional traditions of the Member States are to be interpreted ‘in harmony with those traditions’.Footnote ⁶² A majority (18/28) of Member States’ constitutions explicitly recognize a ‘right to health’.Footnote ⁶³

Although the Member States share health rights as human rights at the level of general legal or constitutional provisions, when it comes to the specifics of how these rights are understood and implemented, there are significant differences. Abortion, and the status of the human embryo, is the canonical example;Footnote ⁶⁴ but others include details on free and informed consent to medical treatment, or participation in clinical trials; details on the arrangements for donation of blood, organs and other human tissue; how human rights apply in the context of biotechnological and nanotechnological research; and on how privacy rights are reconciled with other interests in the context of the handling of health data. As we will see, EU law allows for reasonably significant variations in this regard.Footnote ⁶⁵

Treaty amendments: health rights in the EU Charter of Fundamental Rights

The formal place of human rights in the EU's legal order changed with the incorporation of the EU's Charter of Fundamental Rights and Freedoms 2000 (EU CFR) into the Treaties in December 2009.Footnote ⁶⁶ Assessments of the significance of the EU CFR vary. Certainly the promulgation of the instrument in 2000, as a measure of soft law, was a low-key affair. The CJEU did not cite the EU CFR until 2006, but continued its practice of referring to the ECHR.Footnote ⁶⁷ Since then, however, references to the EU CFR have increased, and, since the Treaty of Lisbon, its provisions now have the ‘same legal value’ as Treaty provisions.Footnote ⁶⁸

The EU CFR brings together a long list of human rights, drawing inspiration from international and regional human rights instruments, EU legislation and the jurisprudence of the CJEU. Its provisions are organized into six substantive ‘Chapters’, of which those on dignity, freedoms, equality, and solidarity are of most relevance to health rights. The EU CFR distinguishes between ‘rights’, ‘freedoms’ and ‘principles’, although does not explicitly identify which provisions fall in which category.Footnote ⁶⁹ While ‘rights’ and ‘freedoms’ are (potentially) individually enforceable, ‘principles’ are ‘judicially cognisable only in the interpretation of’ legislative and executive acts of the EU, and national acts which implement EU law.Footnote ⁷⁰

Since 2009, health rights (whether ‘rights’ or ‘principles’) have been expressed in the EU's ‘constitutional’ legal texts. However, as we have seen, this development may not be as significant in practice as it appears, given that most relevant rights had already been recognized as general principles of EU law, as noted above. In some ways, the EU CFR could be read as seeking to restrict, rather than encourage, the CJEU-led development of human rights in EU law. For instance, the Treaties explicitly state that the EU CFR ‘does not extend the field of application of Union law beyond the powers of the Union, or establish and new power or task for the Union, or modify powers or tasks as defined by the Treaties’.Footnote ⁷¹ The CJEU's case law establishes that human rights as general principles of EU law apply where Member States derogate from EU law; the Charter provides explicitly that it applies to the Member States ‘only when they are implementing Union law’.Footnote ⁷² However, the CJEU has stated more recently that the EU CFR applies ‘in all situations governed by EU law’.Footnote ⁷³

On the other hand, it is at least arguable that the incorporation of the EU CFR in the EU's Treaties has enhanced the role and significance of human rights in EU law.Footnote ⁷⁴ In the context of health rights, looking at the jurisprudence of the CJEU, for instance, we see an increased willingness to consider human rights implications in EU litigation. For instance, the EU CFR's ‘right to health care’Footnote ⁷⁵ was cited by the CJEU only once before 2009 (and that only in an AG Opinion),Footnote ⁷⁶ but has been cited five times since then.Footnote ⁷⁷

Furthermore, it is also at least arguable that, with the incorporation of the EU CFR into EU Treaty law, the possibilities for health claims being articulated as human rights claims in EU law have increased. Articulating a claim within a human rights frame may have implications for both legal reasoning and for legal outcomes, such as determining the standard of proof required to interfere with free movement rules. The CJEU has long recognized that the protection of human rights objectively justifies restrictions on free movement.Footnote ⁷⁸ For instance, what if a cross-border patient in a situation such as that in the Peerbooms case were in a life-threatening coma?Footnote ⁷⁹ Would the burden of proof on a Member State refusing to authorize cross-border treatment be greater in such a circumstance than if the right to life were not engaged? Equally, could a Member State more easily justify refusal to authorize cross-border treatment that could be interpreted as infringing the right to life, such as euthanasiaFootnote ⁸⁰ or abortion?Footnote ⁸¹ Only future litigation would determine the answers to these questions, but the power of human rights-based reasoning in European legal traditions suggests that it is at least conceivable that human rights reasoning could make a difference.

Moreover, some relevant rights were given increased prominence in the EU CFR. The best example is Article 1 EU CFR, on human dignity. Although this human right was recognized in pre-2009 litigation,Footnote ⁸² as well as legislation,Footnote ⁸³ its explicit articulation, and its place (the first provision of the EU CFR), suggest an increased importance. That said, the CJEU has delivered rulings referring to or explicitly relying upon Article 1 EU CFR only a few times, in cases involving asylum.Footnote ⁸⁴ However, particularly in combination with other provisions, such as the right to life,Footnote ⁸⁵ human dignity has significant potential in the EU's regulation of novel health technologies in particular.Footnote ⁸⁶

Institutional developments: the European Fundamental Rights Agency

The argument that health rights as human rights have become increasingly significant in EU law is lent strength by considering institutional developments beyond the role of the CJEU. In 2007, the EU established a Fundamental Rights Agency (FRA),Footnote ⁸⁷ replacing an earlier institution, with a narrower remit.Footnote ⁸⁸ The EU's FRA has an advisory role, gathering and disseminating information and good human rights practice to the EU institutions and the Member States and (through its Fundamental Rights Platform) promoting dialogue within civil society to raise human rights awareness.

The FRA works through a ‘Multiannual Framework’, which is agreed by the EU legislature. The first such Framework ran from 2007 to 2012.Footnote ⁸⁹ Its basic focus, at first glance, is on traditional ‘civil and political rights’, particularly in areas such as access to justice and exercise of democratic rights. Much of the FRA's early work, therefore, cannot be said to be increasing the ways in which EU law or policy treats health rights as human rights. However, several of the Framework's thematic priorities were relevant to health rights, in particular when combined with principles of non-discrimination. The relevant thematic priorities are tackling racism and xenophobia, discrimination based on a range of forbidden grounds, rights of the child and protection of children, asylum and respect for private life and personal data protection. A good illustrative example is its first Annual Report published after the EU CFR was incorporated into the Treaties.Footnote ⁹⁰ Health does not feature generally, but it is mentioned in the context of an examination of discrimination safeguards, particularly in terms of the social and economic position of members of the Roma community in the EUFootnote ⁹¹ and tensions between religious belief and health provision.Footnote ⁹²

The current Multiannual Framework runs from 2013 to 2017.Footnote ⁹³ Its thematic priorities are very similar to those of the previous Framework, although ‘Roma integration’ features as a specific priority in this Framework. In 2011, the FRA reported a serious data deficiency in terms of the human rights position of the Roma, including in terms of social and economic rights such as health.Footnote ⁹⁴ The FRA set about rectifying that information gap, commissioning research and making recommendations of good practice. Research from surveys, reviews of official information and qualitative data through participatory action research reveals that Roma are systematically worse off than other Europeans, in a range of areas including health and life expectancy.Footnote ⁹⁵ The headline figures of its key report are shocking: one out of three Roma respondents aged 35 to 54 report health problems limiting their daily activities; on average, about 20 per cent of Roma respondents are not covered by medical insurance or do not know if they are covered.Footnote ⁹⁶ Drawing on the work of the FRA, the European Commission called upon Member States to improve integration of Roma in four areas, one of which is health.Footnote ⁹⁷ A working group is developing indicators and measuring progress towards these goals.Footnote ⁹⁸

The FRA also uses a more legal approach in instances where its reports highlight deficiencies in implementing relevant EU law, or untapped potential legal avenues for enforcing human rights, often coupled with the principle of non-discrimination.Footnote ⁹⁹ Directive 2000/43 on race equality, for instance, applies to ‘social protection, including…healthcare’.Footnote ¹⁰⁰ A report on the Directive highlights the judicial, administrative and alternative dispute mechanisms available to enforce it.Footnote ¹⁰¹ The FRA has also worked on the health rights of people with disabilities.Footnote ¹⁰² In addition, a major FRA report in 2013 considered questions of ‘intersectionality’ in health inequalities.Footnote ¹⁰³ It found that unequal and unfair treatment in access to health and quality of health care persists across the EU, with particularly ill-served groups being those who experience discrimination on more than one ‘forbidden ground’ (for instance, a Muslim, older, woman with a disability). The report cites examples of discrimination at the intersection of sex, ethnicity and disability in violations of human rights provisions on informed consent to treatment, coupled with rights to human reproduction, such as sterilization of Roma women and women with disabilities.

The FRA has highlighted the limitations of the law and legal processes in remedying such human rights infringements in health contexts. Barriers include tolerance of or failure to recognize unlawful discrimination,Footnote ¹⁰⁴ difficulties in evidencing discrimination, and in choice of comparator, and lack of understanding of intersectionality by lawyers and judges alike. The consequence is that disputes are often pursued through non-human rights legal frameworks, such as medical negligence, or alternative dispute mechanisms such as Ombudsmen.Footnote ¹⁰⁵ So, on balance, although the FRA's work on the Roma communities of Europe is probably its most significant practical contribution to health and human rights,Footnote ¹⁰⁶ the mechanisms used here are not the traditional mechanisms of human rights law.Footnote ¹⁰⁷ Again, therefore, the conclusion is that the claim that health rights as human rights are increasingly significant in EU law may have some merit, but needs some nuance.

The validity and interpretation of EU legislation or administrative decisions and national implementing acts

Acts of the EU institutions which breach fundamental human rights are invalid. The CJEU has jurisdiction to hear judicial review claims on this (and other) ground(s),Footnote ¹¹⁰ brought by the ‘privileged’ applicants of the EU institutions and Member State governments, and by individuals in certain restricted circumstances.Footnote ¹¹¹ In principle, therefore, health rights could act as a constraint on the EU's law and policymaking powers. In practice, however, such constraining effects have been very limited.

As noted above, the CJEU mentioned human dignityFootnote ¹¹² in its judicial review of Directive 98/44/EC on the legal protection of biotechnological inventions.Footnote ¹¹³ But none of the EU's other legislation concerning development of new health technologies, or involving the use of human material in clinical research, has been challenged on grounds of breaching fundamental rights. The Advanced Therapy Medicinal Products Regulation,Footnote ¹¹⁴ for instance, establishes a special marketing authorization system for novel products based on genes, cells and tissues, at the boundaries between pharmaceuticals and medical devices, and using human material. Although the Regulation itself declares compliance with human rights instruments,Footnote ¹¹⁵ it is at least arguable that even developing these products at all, let alone authorizing their marketing, breaches fundamental human rights such as dignity or the right to life, as expressed through the idea that the human body is not a commodity. But no litigation was brought challenging the validity of the provisions of the Regulation. Nor has there been litigation challenging EU administrative acts, for instance, the decision to fund, or not to fund, certain types of research – even though such a decision might be claimed to breach human dignity, the right to life, or, conversely, freedom of scientific research.Footnote ¹¹⁶

On reflection, however, this is not such a surprise. The European Court of Human Rights is ambivalent about the application of the ‘right to life’ in the context of novel health technologies,Footnote ¹¹⁷ and there is every reason to expect similar caution from the CJEU. Perhaps this is in part because of the presence of competing rights (to life, to dignity) of those patients who might benefit from future therapies, and because a public interest justification applies in the context of developing novel health technologies. The EU CFR explicitly prohibits ‘the reproductive cloning of human beings’,Footnote ¹¹⁸ but is silent on the question of so-called ‘therapeutic cloning’,Footnote ¹¹⁹ perhaps implying that such uses of human material do not infringe human rights according to EU law.

Health rights as human rights have, however, played a stronger role in the interpretation of EU law. The CJEU was asked to interpret the Biotechnology Directive in the 2011 Brüstle case,Footnote ¹²⁰ in the context of German patents for ‘neural crest cells’ (a type of cell that can develop into many types of cells and tissues), derived from a blastocyst (the entity which has developed around five days after fertilization of an ovum), and the process of deriving these cells. These cells offer the promise of treatment of diseases such as Parkinson's disease. The national referring court asked whether the patent was excluded from patentability, in so far as it concerns cells obtained from embryonic stem cells. To answer that question, the CJEU was required to interpret Article 6 (2) (c) of the Biotechnology Directive, which provides that ‘uses of human embryos for industrial or commercial purposes’ shall be unpatentable. In essence, this involved an interpretation of the term ‘human embryo’, in this context.

The CJEU's judgment, and in particular the Opinion of its Advocate General, AG Bot, strongly articulate human rights as the rationale underpinning the decision. AG Bot goes so far as to say that the EU is ‘not only a market to be regulated’, but also ‘has values [in particular that of human dignity] to be expressed’.Footnote ¹²¹ The CJEU's interpretation of the Directive begins from ‘fundamental rights and the dignity of the person’,Footnote ¹²² and it is on this basis that the CJEU concludes that

Hence, according to the CJEU in Brüstle, ‘human embryo’ includes any fertilized human ovum; a non-fertilized human ovum into which a mature human cell nucleus has been transplanted (‘therapeutic cloning’); and a non-fertilized human ovum whose division and further development has been stimulated by parthenogenesis (a form of reproduction where embryos grow without fertilization, which has been achieved in human embryos since around 2004). The ruling means that these entities, and processes, are not patentable in the EU – although the CJEU left to the national court the final determination of whether the specific products and processes at issue in the Brüstle case fell within this definition.Footnote ¹²⁴ In this context, therefore, the human rights engaged meant that the concept of ‘human embryo’ was given a wide interpretation, hence excluding patentability of a range of possible novel health technologies on the basis of the imperative of protecting human dignity.

By contrast, however, in International Stem Cell,Footnote ¹²⁵ the wide definition of Brüstle was not embraced. International Stem Cell concerned the patentability of a ‘parthenote’ – an oocyte which can, once activated chemically and/or electrically, develop into a blastocyst (over about 5 days) but can never develop to term, because it lacks paternal DNA. Admittedly, the CJEU in International Stem Cell restates the Brüstle principle that ‘human embryo’ in Article 6 (2) (c) of the Directive must be interpreted broadly.Footnote ¹²⁶ But, following its Advocate General, the CJEU reasoned that ‘human embryo’ in that context ‘must…have the inherent capacity of developing into a human being’.Footnote ¹²⁷ In Brüstle, that was the case. Here, it is not, and hence the cases must be distinguished. The question of capability of the particular invention concerned to develop into a human being was left ultimately for the national court.

It has been claimed that the ruling in Brüstle will encourage certain types of research or certain types of industry behaviour. The International Stem Cell case certainly suggests that the patent concerned was for a process deliberately designed to avoid the creation of an entity that could, in theory, develop into a human being. The EU CFR's protection of ‘freedom of the arts and sciences’Footnote ¹²⁸ is unlikely to change future CJEU rulings on the subject, as it must be exercised consistently with Article 1 EU CFR on human dignity. It has been suggested that Brüstle is likely to encourage research using adult, rather than embryonic, stem cells. Greater investment in non-European companies developing these new technologies, and greater use of trade secrecy, are both expected,Footnote ¹²⁹ although little concrete evidence of widespread changes of behaviour has yet been reported.

The CJEU adopts a similar wide interpretation of provisions, where human rights are engaged, in the context of the EU's Data Protection Directive.Footnote ¹³⁰ In Lindqvist,Footnote ¹³¹ the CJEU was asked to interpret the term ‘personal data…concerning health’.Footnote ¹³² This category of data is given special treatment within the Directive. The rationale for the Directive is to enable the transmission of data between Member States. Hence, the general approach of the Directive is harmonize information privacy. Without such harmonization, Member States with higher levels of privacy protection could prevent data sharing across borders within the EU, and thus impede the creation of the internal market in data, and data-based services. So the main thrust of the Directive is to allow legitimate and lawful processing of data, including personal data. The Directive covers two types of personal data. Ordinary personal data may be legitimately processed only if the person concerned has unambiguously given consent.Footnote ¹³³ But for special categories of data the presumption is reversed. The processing of this type of data (which includes data concerning health),Footnote ¹³⁴ is prohibited under the Directive, unless one of a list of exceptions applies.Footnote ¹³⁵ A broad interpretation of ‘data concerning health’ thus extends the scope of the exceptional category within the Directive. This is the approach taken by the CJEU in Lindqvist. Although the underlying rationale of the Directive is market creation, the CJEU expresses its purposes as multiple, and states that a key purpose of the Directive is human rights protection. Hence, ‘in light of the purpose of the Directive’, the term ‘data concerning health’ must be interpreted widely – it includes ‘information concerning all aspects, both physical and mental, of the health of an individual’.Footnote ¹³⁶

A third illustration of the way in which the CJEU interprets health rights is found in cases which also demonstrate an important feature of human rights litigation – how to reconcile competing rights. In Deutches Weintor,Footnote ¹³⁷ the CJEU considered the interpretation of a Regulation on nutritional claims on food labelling.Footnote ¹³⁸ The Regulation provides that ‘beverages containing more than 1.2 per cent by volume of alcohol shall not bear health claims’.Footnote ¹³⁹ The CJEU held that the phrase ‘easily digestible’ constitutes such a claim. The CJEU then turned to the question of whether the prohibition of such a product description nonetheless breaches Articles 15 (1) and 16 EU CFR, on freedom to pursue an occupation and to conduct a business. It found that ‘the prohibition does not in any way affect the actual substance’ of those freedoms.Footnote ¹⁴⁰ In its reasoning, the CJEU balanced the freedom to conduct a business with Article 35 EU CFR, second sentence, which provides that ‘a high level of human health protection shall be ensured in the definition and implementation of all the Union's policies and activities.’Footnote ¹⁴¹ The CJEU's rationale in so doing was that health protection is among the principal aims of the Regulation.Footnote ¹⁴² Assessment of the validity of the Regulation must reconcile such competing fundamental rights, striking a ‘fair balance’ between them.Footnote ¹⁴³ The EU's legislature was entitled to prohibit such health claims, in order to ensure a high level of health protection for consumers.Footnote ¹⁴⁴ A similar balancing approach between freedom of thought, conscience and religion, and health rights, is found in the ECtHR's ruling in Pichon and Sajous v. France,Footnote ¹⁴⁵ upholding national policy requiring pharmacists to supply contraceptives, because of the need to protect health policy, as well as the rights and freedoms of others.

The effect of human rights law, as a tool for interpretation of these areas of EU health law, is to articulate a particular version of the EU's internal market. The underlying context and aims of the relevant legislation is to create and sustain the market for health products, data or services, or products that might have an effect on health. But this market is heavily regulated, and not only for reasons of patient safety. It is also regulated in order to protect an ethic of human dignity, expressed through human rights. Human rights claims must be balanced with market objectives, as well as with other human rights claims. The significance of human rights as health rights in this context is an underlying process of legitimization – the EU's claim to rule over human health is bolstered by its protection of human rights.Footnote ¹⁴⁶

However, the effects of human rights in this respect are limited. For instance, it is highly unlikely that the CJEU would interpret the Patients’ Rights Directive by reference to the right to life and the right to health care so as to find an individual entitlement to access life-saving treatment for a particular patient.Footnote ¹⁴⁷ Another example of the limitation of health rights as human rights in EU law is that the CJEU's case law has done little, if anything, to disrupt the Data Protection Directive's position over one of the major concerns of the health policy community: the use of ‘big data’ in health contexts, particularly clinical and epidemiological research and public health monitoring. This is an area where there are significant differences between national approaches, and moves to a greater use of electronic record keeping in health contexts mean that the traditional protections for human rights through health data management between patient and health care provider are under challenge.Footnote ¹⁴⁸ The consent provisions of the Directive have come under particular criticism from the research community. If taken literally, they would seem to impede research using health data collected from young children, or adults who are mentally incompetent to give consent. Moreover, much of the data held in banks of health information, such as cancer registries, could contravene the Directive, as it was information that had been transferred and used without explicit consent being given, and where none of the exceptions in the Directive appeared to apply.Footnote ¹⁴⁹ It may be that making such health data anonymous, as the Directive implies is to be effected wherever possible, is sufficient to protect privacy and data protection rights, although it is not clear how anonymization or ‘depersonalization’ is defined in the Directive.Footnote ¹⁵⁰

The CJEU is yet to rule on this question, but some national courts have done so, interpreting their implementing legislation. In the Source Informatics case,Footnote ¹⁵¹ the English Court of Appeal held that collection by a private company of data about the prescribing habits of general practitioners collected from pharmacists did not contravene the Directive. Indeed, the Court held that the fact that the data was anonymized protected the patients’ privacy, rather than undermining it.Footnote ¹⁵² In the context of that ruling, then, health rights as human rights have made little difference in terms of disrupting the legislative settlement, either through challenge to the validity of legislation, or its interpretation. We might therefore expect a similar approach by national courts to the interpretation of implementing legislation in a range of areas where human rights might be engaged. These include implementation of the Patients’ Rights Directive where the right to found a family might be impeded; of the Clinical Trial Directive, regarding consent of mentally incapacitated adults; or of freedom of expression where EU law places restrictions on advertising, for instance, of alcohol or tobacco.Footnote ¹⁵³

Health rights plus non-discrimination/equality

Where health rights have the potential to make the most difference to interpretation of EU legislation is where they are combined with the principles of non-discriminationFootnote ¹⁵⁴ or equality.Footnote ¹⁵⁵ These principles are a potent ‘bridge’ between the social and the civil rights components of the EU CFR.Footnote ¹⁵⁶ For instance, as Claire Kilpatrick suggests, were access to cross-border health care to be denied because of morbid obesity, Article 21 EU CFR on non-discrimination on grounds of disability would be engaged.Footnote ¹⁵⁷ Equally, as EU law plays an increasingly important role in health, as well as social, care, the rights of the elderly in the EU CFR apply.Footnote ¹⁵⁸

The link between social rights and enforceable entitlements is particularly important where some of the most vulnerable people in the EU are concerned: asylum seekers, unaccompanied migrant children, members of the Roma community, people with physical or mental disabilities, elderly people.Footnote ¹⁵⁹ While there is yet to be a decision of the CJEU involving the ‘right to health care’ in this regard, the Kamberaj case,Footnote ¹⁶⁰ concerning housing benefit, applies by analogy.

Servet Kamberaj, an Albanian national, was a lawful long-term resident in Italy. He was refused housing benefit, because the fund for ‘third country’ (non-EU) nationals ran out of resources. A separate fund covered housing benefit for EU nationals. Kamberaj claimed that this breached the ‘Long-term residents Directive’,Footnote ¹⁶¹ Article 11 of which provides that long-term residents are to be treated equally with nationals, as regards social assistance and social protection (as defined nationally). Member States may, however, limit equal treatment in social assistance and social protection to ‘core benefits’.Footnote ¹⁶² The CJEU was asked to interpret the Directive, in particular whether housing benefit was ‘social assistance or social protection’, and whether it was a ‘core benefit’.

Referring explicitly to Articles 12 and 34 EU CFR, the CJEU held that

Technically, the question of application of the Directive to housing benefit is a matter for the national court. But the CJEU gives a ‘very strong steer’Footnote ¹⁶⁴ to the national court, stressing the basic nature of housing benefit, as well as the ‘right to ensure a decent existence for all those who lack sufficient resources’.Footnote ¹⁶⁵

Although yet to be tested, the reasoning in Kamberaj should apply also to core health care benefits, especially as the Long-term Residents Directive itself refers to ‘assistance in case of illness, pregnancy’ in recital 13. By extension, and more significantly, it applies also in the context of EU asylum law. The qualification Directive 2011/95/EUFootnote ¹⁶⁶ requires Member States to grant access to health care to refugees or those with ‘subsidiary protection’, on the same basis as nationals.Footnote ¹⁶⁷ The reception conditions Directive 2013/33/EUFootnote ¹⁶⁸ provides that applicants for asylum must be given ‘an adequate standard of living for applicants, which guarantees their subsistence and protects their physical and mental health’, although this may be means tested.Footnote ¹⁶⁹ When implementing the Directive, Member States must take into account the needs of vulnerable applicants, including ‘persons with serious illnesses’, ‘persons with mental disorders’, disabled people, elderly people and pregnant women. And Directive 2008/115/EC on common standards and procedures for returning illegally staying third-country nationals (the returns Directive)Footnote ¹⁷⁰ gives safeguards pending return of third country nationals, including ‘emergency health care and essential treatment of illness’.Footnote ¹⁷¹ These provisions apply even to some of the categories of third country nationals which Member States may exclude from the Directive,Footnote ¹⁷² such as those who have been apprehended by the border authorities because of an irregular crossing of an external EU border, and who do not subsequently obtain an authorization to stay in that Member State.Footnote ¹⁷³

The potential for health rights as human rights to make a difference in this context is significant. The ECtHR has stressed that the particularly vulnerable position of asylum seekers requires special attention to their material needs, including health protection.Footnote ¹⁷⁴ The public health conditions in detention centres are a matter of concern for human rights groups.Footnote ¹⁷⁵ They highlight, in particular, the position of children,Footnote ¹⁷⁶ with significant breaches of their right to health, in contravention of the UN Convention on the Rights of the Child. The FRA has also identified uneven protection for the right to health care for irregular migrants in the EU, both ‘undetected’ and ‘non-removed’ people. In its view, ‘EU Member States should disconnect healthcare from immigration control policies’.Footnote ¹⁷⁷ As noted above, the FRA's work concerning inequalities and multiple discrimination in health careFootnote ¹⁷⁸ is based on Articles 21 and 35 EU CFR.Footnote ¹⁷⁹

Justifying restrictions on free movement

According to Article 51 (1) EU CFR, the provisions of the EU CFR apply to Member States ‘only when they are implementing EU law’. However, as noted above, the CJEU has held that human rights (as general principles of EU law) apply where Member States act ‘within the scope of application of EU law’.Footnote ¹⁸⁰ The case law on this topic is complex, and demonstrates the ways in which EU law, ECHR law and national constitutional law interact in non-hierarchical relationships.Footnote ¹⁸¹ Whether the EU CFR applies when Member States derogate from free movement rules (by justifying restrictions on freedom of movement within the internal market, on the basis of an objective public interest which is the protection of a human right) is not yet definitively settled by the CJEU.Footnote ¹⁸² For our purposes, however, the focus is on the implications of health rights as human rights in the context of internal market law. Two important questions arise. The first is the implication of interpreting an objective public interest (an exception to internal market law) as a human right. The second is the question of who gets to decide on the detailed contours of the interpretation of a particular human rights measure. Whether this is a matter for ECHR law, national constitutional law, or EU law, is essentially unresolved, although (put simplistically) from the point of view of the CJEU, it is the latter.Footnote ¹⁸³

The CJEU has been consistently criticized by the human rights community for placing human rights as technically subordinate to market freedoms in EU law (free movement is the rule; human rights protection is the exception).Footnote ¹⁸⁴ However, the practical implications are probably less significant than would appear. Although the ways in which litigation may be carried out, and the reasoning of national courts, may be affected, the outcomes of relevant rulings are rarely, if ever, affected by human rights reasoning. For instance, in cases involving human reproduction, although free movement of services was engaged, national constitutional protections of human rights were ultimately safeguarded.Footnote ¹⁸⁵ Human rights may provide analytical tools, but much more rarely will provide clear cut solutions.

The latter question (who gets to decide, and according to what standard) is potentially more significant. This question is illustrated by a case concerning human dignity, although not in a health context. It concerns the banning of laser ‘killing games’ by a German public authority. The provider of the games, Omega Spielhallen, challenged this decision as breaching EU law on free movement of services. In holding that the prohibition was justified on public policy grounds, and was a proportionate response, the CJEU referred to the concept of human dignity as corresponding with the level of protection of human dignity found in the German constitution.Footnote ¹⁸⁶ The CJEU therefore implied that, although it retained the authority to decide on a question of interpretation of EU law, the standard according to which it would decide is the national standard. This approach is also reflected in Article 52 (4) EU CFR, which provides that where fundamental rights in the EU CFR come from constitutional traditions common to the Member States, these rights ‘should be interpreted in harmony with those traditions’.Footnote ¹⁸⁷

If adopted more broadly, the approach of the CJEU in Omega would have significant consequences. Any restriction on free movement could be readily justified by reference to a national constitutional tradition, encapsulated in a human rights provision (and reflected in the EU CFR). Multiple examples in the health field spring to mind. As noted above, health rights can be derived from traditional civil and political rights, such as rights to life, to family life, and to privacy. However, the precise contours of entitlements, and general approaches to these human rights, differ considerably between the Member States, because of the potential fluidity of interpretation of human rights provisions. So, for example, the right to life, recognized universally, is subject to significant disparity in interpretation across EU Member States. Notable here is the scope for disagreement as to when life itself actually begins.Footnote ¹⁸⁸ Equally, the right to found a family is interpreted very differently in different national contexts. So is the right to health care. The implication would be that health rights as human rights in EU law would prevent the application of internal market law from disrupting national interpretations of health entitlements.Footnote ¹⁸⁹

However, there are reasons to suggest that Omega may be an exceptional case. The German Constitution is undoubtedly the source of inspiration for Article 1 EU CFR, and has been highly influential in the Opinions of several Advocates General, when developing the concept of human dignity as a ‘general principle’ of EU law, as well as when interpreting Article 1.Footnote ¹⁹⁰ By contrast, other provisions of the EU CFR, where a variety of different national understandings of the meaning of the human rights provision exist, may be interpreted by the CJEU by reference to an EU law, rather than national, standard. For instance, the CJEU has adopted an EU approach to interpretation of Article 35 EU CFR, in determining whether national laws regulating pharmacies are consistent with internal market law on freedom of establishment.Footnote ¹⁹¹

More nebulous or indirect effects

Finally, we consider some of the more indirect effects of health rights as human rights in EU law.

As we have seen in the above, human rights considerations have affected the terms of EU legislation in several areas relevant to human health. In particular, the non-commodification of the human body, as a specific expression of Articles 1 and 3 EU CFR features in a range of EU legislation on human blood, organs, tissues and cells. Similarly, Article 2 EU CFR has influenced EU administrative decisions concerning the funding of different types of health research. Shazia Choudry suggests that the right to marry and found a family may have effects on EU law and policy in health contexts, as the EU's competence in this field expands.Footnote ¹⁹²

However, although there may be agreement at the level of a general statement of a human right among the EU's Member States, there is often little agreement about its practical meaning in concrete circumstances. One of the most practical challenges arises where human rights conflict. One individual's human right may come in conflict with that of another individual. Or individual rights may come into conflict with rights of a broader group of persons. The ways in which these conflicts are managed differ significantly between EU Member States. The ECHR system manages these differences through the doctrine of margin of appreciation. And, in practice, EU law does little to change this. Now that EU law increasingly recognizes health rights as human rights, we might expect an increased reference to the rhetoric of rights, in both legislation and litigation, but no difference in terms of substantive outcomes of litigation, or the content of legislation.