I OVERVIEW

The New Zealand healthcare system has undergone significant changes over recent decades. The market, insurance and regulatory reforms have resulted in a healthcare system that is truly unique internationally.

Perhaps the most unique aspect of the system is the no-fault compensation scheme for personal injury caused by accident – overseen and run by the Accident Compensation Corporation (ACC). In exchange for no-fault national insurance cover, the right to sue for compensatory damages for personal injury – including injury caused in the provision of health services – has been removed. In the absence of clinical negligence litigation, a number of other regulatory processes have emerged.

The public system is overseen by the Ministry of Health – with the funding and provision of services largely devolved to 20 District Health Boards (DHBs) responsible for the services in their districts. The publicly funded system is supplemented by a well-established private health sector – funded by private health insurers, state funders (DHBs and ACC) and private paying patients.

In May 2018, Health Minister Dr David Clark announced a major review designed to future-proof New Zealand's health and disability sector. An interim report is due in July 2019, with the final report due in early 2020.

II THE HEALTHCARE ECONOMY

i General

New Zealand's healthcare system is fundamentally a centrally funded, tax-based system, with the large majority of healthcare being publicly funded (i.e., free or subsidised).2 Publicly funded services are available to all 'eligible persons' (which includes New Zealand citizens, certain types of permanent residents and people on work permits3) and include hospital care, primary care, maternity services, community mental health services and a range of other health and disability services. Under the previous centre-right National government, the amount New Zealand is spending on its public health system dropped to around 6 per cent of GDP. In its first budget, the new Labour-led coalition government has increased health spending by NZ$2.2 billion.

New Zealand also has a well-established network of private health providers ranging from major surgical hospitals to private cancer-treatment facilities, small one-person providers and aged care facilities. In most geographical areas, patients have a choice of accessing publicly funded or privately funded services (or a mixture of both). Healthcare services provided by private providers are paid for in a number of ways, including by health insurers, the patients themselves and, in some cases, by public funders.

ii The role of health insurance

Central to New Zealand's healthcare economy is the state-run ACC, which provides comprehensive, 'no-fault' personal injury insurance cover for people who are injured in New Zealand. The ACC is the sole and compulsory provider of accident insurance cover in New Zealand and is funded mainly by mandatory levies.

Private health insurance is not mandated under New Zealand legislation. Currently, around 35 per cent of adults and 28 per cent of children have private health insurance.4

iii Funding and payment for specific services

The New Zealand Public Health and Disability Act 2000 (the NZPHD Act) provides the legislative framework for the public funding and provision of healthcare services. Under the NZPHD Act, most public funding is devolved to 20 DHBs, which are publicly owned statutory organisations responsible for providing or funding healthcare services in their geographical areas. Each DHB operates at least one public hospital and funds the majority of public healthcare services within its district.

Apart from services provided by DHBs, some 'nationally important' services are funded directly by the Ministry of Health (for example, some screening programmes, mental health services, elective services and primary maternity services).

The range of publicly funded services that are fully or partially funded is fairly comprehensive. The government subsidises primary healthcare services (discussed below) and dental care for children up to 18 years. Inpatient and outpatient public hospital care is provided free of charge, with prioritisation used to manage demand for elective services.5 In some cases, alternative health therapies are eligible for government subsidies (for example, the ACC may subsidise the costs of acupuncture provided to treat personal injuries). Means-tested subsidies are available for elderly people in long-term residential care facilities. The government also subsidises pharmaceuticals included in the New Zealand Pharmaceutical Schedule.6 Pharmaceutical Schedule items are free for inpatients and provided at a capped price when prescribed and purchased in the community (although items prescribed for children under six years old are free).

Services that are not subsidised include optometry, orthodontics and most adult dental care.

III PRIMARY / FAMILY MEDICINE, HOSPITALS AND SOCIAL CARE

Since the release of New Zealand's Primary Healthcare Strategy in 2001, essential primary healthcare services have been coordinated through not-for-profit bodies called primary health organisations (PHOs).7 PHOs receive capitated funding from DHBs, and work with general practices and other contracted providers to provide comprehensive primary healthcare services for their enrolled populations. Although patients are not required to enrol with a PHO, and providers are not required to affiliate with a PHO, there is a strong incentive to do so in order to access government funding, particularly since the 2018 budget, where the Labour-led coalition government introduced initiatives to extend eligibility and access to subsidised services.8

Another key player is the 'third sector', which refers to the non-profit, non-governmental organisations that offer primary healthcare, community-based health services and disability support services (many of which are fully or partially publicly funded).

In terms of patient care pathways, unwell people will usually seek advice from community pharmacists or contact their GP in the first instance. In emergencies or after hours, people may visit an emergency department at their local public hospital (where services are generally free) or an after-hours clinic (where services attract a fee).

Generally, referrals from GPs are required in order for a patient to be seen by a specialist working in a publicly funded hospital or, alternatively, patients can choose to see a specialist working privately and pay for the appointment themselves (or through insurance). The patient may then be re-referred to the public system or continue to be treated privately by the specialist. Although this system is largely governed by a contractual rather than legislative framework, New Zealand's Code of Health and Disability Services Consumer's Rights9 and human rights legislation10 have been interpreted to support rights to fair and efficient systems for handling patient referrals (particularly by DHBs), appropriate coordination of care between primary and secondary or tertiary providers, and to information about the availability of, and waiting times for, publicly funded healthcare.

To ensure continuity of care between primary, secondary and tertiary healthcare providers, New Zealand's data protection laws do not restrict the appropriate sharing or disclosure of patient information (although they generally require providers to inform patients of such sharing or disclosures and to take reasonable security safeguards to protect health information from loss and unauthorised access, use, modification or disclosure).11 This is not expected to change with the new Privacy Bill, introduced to Parliament in March 2018.

New Zealand does not currently have a single, unified approach to electronic health records for patients. Instead, a range of patient management systems and electronic health records programmes and information technology systems are used by healthcare providers and within DHBs, and many still maintain hard copy records alongside electronic patient records. One of the central aims of the Ministry of Health in recent years has been to improve access to patients' health information and to support the coordinated development of IT capabilities across the health sector, and an indicative business case for the use of a single electronic health record for all patients in New Zealand is expected to be completed by the Ministry in 2017.12

IV THE LICENSING OF HEALTHCARE PROVIDERS AND PROFESSIONALS

i Overview

The safety and quality of health services in New Zealand, including who may offer such services, is regulated by various sector-specific statutes and regulations, notably the Health and Disability Services (Safety) Act 2001 (HDSS Act); the Health Practitioners Competence Assurance Act 2003 (HPCA Act); and the Health and Disability Commissioner Act 1994 (HDC Act).

ii Regulators

The Ministry of Health plays a central role in administering, implementing and enforcing legislation and regulations relevant to the healthcare sector, including administering public health legislation, overseeing the performance of DHBs, certifying some types of healthcare providers and regulating the licensing of pharmacies.

Individual health professionals are largely regulated by 16 statutorily independent 'responsible authorities' (RAs) appointed under the HPCA Act. The powers and functions of RAs include prescribing the qualifications necessary for scopes of practice for each regulated profession, maintaining a register of practitioners, conducting competence reviews and quality assurance activities in relation to registered practitioners, and (through independent committees) investigating complaints about conduct.

Other key regulators include the Health and Disability Commissioner, a statutory ombudsman appointed under the HDC Act to assess and investigate complaints about healthcare services; and the Privacy Commissioner, appointed under the Privacy Act 1993 to investigate complaints about breaches of privacy (including in relation to health information).

The responsibility for professional discipline sits with the Health Practitioners Disciplinary Tribunal. The Tribunal hears charges of professional misconduct and other disciplinary matters and has the power to suspend or cancel a health practitioner's registration.

iii Institutional healthcare providers

Some, but not all, healthcare providers are covered by specific licensing or approval regimes.

Under the HDSS Act, providers of hospital care, rest home care, residential disability care and fertility services must be certified by the Ministry of Health.13 In order to gain (and retain) certification, these providers must meet relevant service standards and are audited for compliance.14 If the provider does not meet the requisite standards, their certification may be cancelled or a cessation or closure order issued.15

Pharmacies are required to be licensed under the Medicines Act 1981 and there are restrictions on who can hold a licence to own and operate a pharmacy – although this may soon change.16 A licensing regime also governs providers that use ionising radiation for medical purposes.17

All healthcare providers are regulated by the HDC Act and associated regulations – most notably the Code of Health and Disability Services Consumers' Rights (Code of Rights). Under the Code of Rights, healthcare providers have a legal duty to provide services that are safe and of an appropriate standard, and that duty means that providers are required to ensure that all people, including medical specialists, who undertake work at the healthcare provider's premises are qualified, safe and competent to do so. This is achieved, in a large part, through internal credentialing processes that are designed to ensure medical specialists are safe to perform their clinical responsibilities within a designated service environment.

iv Healthcare professionals

New Zealand regulates most healthcare professionals by way of a certification regime under the HPCA Act. In effect, any healthcare professional who wishes to provide services using one of a specified list of titles must be registered under the HPCA Act with the relevant RA. Those titles include 'medical practitioner', 'nurse', 'midwife', 'dentist' and 'pharmacist'. However, registration under the HPCA Act is not a prerequisite to providing healthcare services in New Zealand, as individuals who are not certified can offer services in competition with certified professionals, provided they use a different title.18 With the exception of a few 'restricted' clinical interventions, there are no overarching prohibitions on non-registered health professionals providing healthcare services in New Zealand;19 although even non-registered health professionals will need to comply with the HDC Act and the Code of Rights.

Once registered, healthcare professionals must work within a prescribed scope of practice when performing a healthcare service that is part of their profession20 and obtain and maintain an annual practising certificate while doing so.21 RAs also have significant powers under the HPCA Act to take action to assure the competence and safe practice of registered health practitioners. There are established appeal and review processes for practitioners to challenge decisions of the RAs.

V NEGLIGENCE LIABILITY

i Overview

A key aspect of the New Zealand healthcare system is its compulsory accident compensation scheme (the ACC Scheme). The ACC Scheme was established in 1974 as a result of a Royal Commission of Inquiry into compensation for personal injury22 and provides compensation for personal injuries (including those suffered while receiving treatment) on a 'no fault' basis. However, in exchange for the benefits of the ACC Scheme, people have significantly limited rights to sue for compensatory damages arising out of any personal injury, and for that reason, New Zealand has little medical negligence litigation.23 We note, however, that claims for exemplary damages and other remedies may still be available, and we return to this point below.

Notwithstanding the prohibition on claims for compensation in relation to personal injuries, there are a number of avenues that recipients of healthcare services can pursue in order to hold healthcare providers and professionals to account. Complaints may be made to the Health and Disability Commissioner, who has responsibility for promoting and protecting patients' rights as set out in the Code of Rights. In serious cases, the Commissioner can investigate a complaint to determine whether or not a provider has breached the Code of Rights. Although a breach finding by the Commissioner is not directly 'actionable' in the general courts, it can have significant implications for individual healthcare professionals and providers. For example, it could lead to disciplinary proceedings against the registered health practitioners involved or open the door to proceedings against an individual practitioner or provider organisation in the Human Rights Review Tribunal (HRRT).24 The latter is a statutory tribunal that has the power to award damages to patients in respect of a breach of the Code of Rights (such as punitive damages in respect of any action that was in 'flagrant' disregard of a patient's rights, or damages for injury to feelings and loss of dignity, regardless of whether there was a personal injury). In practice, however, HRRT proceedings in relation to breaches of the Code of Rights are rare and awards are typically modest (usually between NZ$5,000 and NZ$15,000).25

ii Notable cases

As noted above, medical negligence litigation is rare in New Zealand. The relevant jurisprudence has tended to focus on the ambit of coverage under the ACC Scheme and the circumstances in which a common law action for damages is statute-barred. Notable cases include a decision allowing cover under the ACC Scheme for pregnancy arising from a failed sterilisation;26 a decision holding that the delivery of a stillborn baby was a personal injury to the mother;27 and a decision holding that cover is available to a mother in relation to a child born with spina bifida (following a failure to detect that condition during an ultrasound scan).28

Several important cases have also considered the availability of other forms of remedies in circumstances where the ACC statutory bar does or is likely to apply. The decision in Couch v. Attorney General (No. 2)29 confirmed that exemplary damages are available in respect of conduct that has caused a personal injury, but set a very high threshold for such awards; that is, only where it can be established that the defendant either intended to cause harm or was 'subjectively reckless'.30 To date, exemplary damages have only been awarded against healthcare professionals in cases of intentional sexual misconduct; and none have been awarded against healthcare professionals or providers since the judgment in Couch.31

Another case that has been influential is the decision in Baigent's case,32 which confirmed that public law damages are available where financial compensation is necessary to vindicate the state's breach of an individual's rights under the New Zealand Bill of Rights Act 1990. Since that decision, public law damages have been successfully sought against government entities in a number of cases involving personal injury,33 but unsuccessfully in a claim relating to risperidone treatment provided by a DHB.34

VI OWNERSHIP OF HEALTHCARE BUSINESSES

In New Zealand, business ownership structures include limited liability companies, partnerships, limited partnerships, trusts, joint ventures and sole traders. With the exception of pharmacy businesses (which we return to below), New Zealand law does not impose any limitations or requirements on the ownership of healthcare businesses over and above what would apply to any other kind of business.

There are a number of generic pieces of legislation that regulate business in New Zealand and may be particularly relevant to non-domestic organisations considering establishing a business, or investing in an existing business, in New Zealand. These pieces of legislation include the Overseas Investment Act 2005 (which sets out restrictions on overseas persons establishing or acquiring a New Zealand business including requirements of the individuals in control of the overseas person); the Commerce Act 1986 (which is New Zealand's competition legislation, and among other things, prohibits contracts, arrangements, understandings and the purchase of shares or assets that have the purpose, effect or likely effect of substantially lessening competition in a market); and the Companies Act 1993 (which imposes various requirements on companies incorporated outside of New Zealand and operating in New Zealand and requires that each New Zealand registered company has at least one New Zealand resident director or one Australian resident director who is also a director of an Australian company, and a New Zealand registered office or address for service).35

The Medicines Act 1981 establishes a licensing regime for pharmacies and imposes significant restrictions on the ownership of pharmacy businesses.36 For example, natural persons may only be granted a licence to operate a pharmacy or own a majority interest in a pharmacy if they are registered pharmacists;37 a company may only be granted a licence to operate a pharmacy if its majority shareholding capital is owned by one or more registered pharmacists and those pharmacists must have effective control of the company;38 and prescribers39 are generally not permitted to hold interests40 in pharmacies. In addition, companies may not operate more than five pharmacies, and individual pharmacists may not operate or hold a majority interest in more than five pharmacies.41 Finally, pharmacy licences will only be granted where the applicant is a 'fit and proper' natural person or a body corporate of 'good repute',42 and has not been disqualified.43 New Zealand does not place any restrictions on the distribution of pharmacies;44 although pharmacy licences are granted in respect of a particular site.45 Importantly, a new therapeutic products regime has been proposed to replace the Medicines Act 1981; and is expected to remove pharmacy ownership restrictions and replace them with appropriate licensing requirements.

VII COMMISSIONING AND PROCUREMENT

In New Zealand, the large majority of healthcare is publicly funded, and most public funding is devolved to 20 DHBs via Crown funding agreements with the Ministry of Health. Each DHB is responsible for providing healthcare services in its district and is free to do so in the way that it sees fit (including continuing to provide existing services and introducing new services), provided that it meets its obligations under its Crown funding agreement and the NZPHD Act. The Ministry of Health also introduces new services from time to time and either directly funds the rolling out of these services itself or requires and funds the DHBs to roll them out on a district-by-district basis.

DHBs procure a wide range of goods and services including healthcare-related goods and services (such as hospital supplies and diagnostic testing services) and general goods and services (such as office equipment and courier services). The basis on which these goods and services are procured varies depending on whether other DHBs or public sector agencies also need the relevant goods and services. Public sector agencies (which include DHBs) are required to purchase from a range of supply agreements that have been established to cover the entire public sector.46 In addition, various third-party agencies have been established to procure goods and services on behalf of DHBs (either on a national or regional basis). Currently, the most significant of these agencies is New Zealand Health Partnerships Limited. Other than that, DHBs procure goods and services on a local (i.e., district) basis or regionally in concert with other geographically proximate DHBs. The Ministry of Health predominantly procures goods and services on a national basis.

Public sector agencies in New Zealand are required to conduct procurement activity in accordance with the Government Rules of Sourcing (the Rules)47 along with a range of generic business and public sector statutes.48 The Rules predominantly focus on the sourcing process, rather than imposing mandatory pre-qualification or other requirements on potential providers. We note, however, that the Rules expressly require agencies to treat suppliers from other countries no less favourably than New Zealand suppliers49 and prohibit discrimination on the grounds of the country that the goods, services or works come from or the degree of foreign ownership or foreign business affiliations of the supplier.50

The key Rule is that agencies must undertake any procurement of goods or services or refurbishment works with a total estimated value of NZ$100,000 or more using a publicly advertised, competitive process.51 There are various exceptions to this requirement, however, including where the procurement is of 'health services provided by government for the public good'.52 Accordingly, a good proportion of the procurement of healthcare services by DHBs may not be undertaken using a publicly advertised, competitive process.

In the recent case of Attorney-General v. Problem Gambling Foundation of New Zealand,53 the Court of Appeal held that judicial review of commercial contracting decisions by public sector agencies will only be available if the agency failed to follow a statutory requirement, where there was fraud, corruption, or bad faith on the part of the agency or where the procurement has some extra public law feature.

VIII MARKETING AND PROMOTION OF SERVICES

The generic law that regulates advertising and promotion in New Zealand is set out in the Fair Trading Act 1986 (FTA) and the Consumer Guarantees Act 1993 (CGA). The FTA prohibits false, misleading or deceptive advertising54 and penalties for breach can be in the order of NZ$200,000 in respect of an individual, and NZ$600,000 in respect of a body corporate.55 The CGA imposes a guarantee that services are provided with reasonable care and skill, that they are reasonably fit for the particular purpose, and that they are of such a nature and quality that it can reasonably be expected to achieve the (expressly desired) result.56 There are also guarantees to provide services, where not otherwise agreed, for a reasonable price and within a reasonable time.57 A party can bring civil proceedings for damages for breach of guarantees in the CGA.

The Medicines Act 1981 also sets out specific legal requirements relating to medical advertisements. Notably, it prohibits the publication of advertisements to the public that claim, indicate or suggest that a medicine, medical device or treatment (1) will prevent, alleviate or cure any of a list of diseases and physiological conditions (which include cancer, diabetes and infertility);58 or (2) is a panacea or infallible. It also prohibits endorsements by doctors, nurses and pharmacists.59

In addition, the Therapeutic and Health Advertising Code (Health Advertising Code) covers all words and visual depictions in all advertising for health services, methods of treatment, medicines and medical devices. It includes the key principles that advertisements should observe a high standard of social responsibility as consumers often rely on medical-related products and services for their health and well-being, and they should not mislead, deceive or confuse consumers, abuse their trust, exploit their lack of knowledge, or, without justifiable reason, play on fear. The Health Advertising Code also requires that any scientific information in an advertisement should be presented in an accurate manner, and that scientific terminology should be appropriate, clearly communicated and able to be readily understood by the audience to whom it is directed. In addition, advertisements should not claim or imply endorsement by any government agency, professional body or independent agency unless there is prior consent, the endorsement is current and verifiable, and the agency or the body is named. If a complaint that an advertisement breaches the Health Advertising Code is upheld, then the advertiser is required to withdraw the advertisement immediately.

The Code of Rights may also come into play with regard to medical advertising – for example, the right to freedom from coercion and exploitation, the right to effective communication and the right to be fully informed.

In terms of professional regulation, many of the responsible authorities that regulate different types of health professionals have either stand-alone codes for advertising practice that apply to their profession or incorporate standards relating to advertising in their general code of ethics.60 One notable characteristic of some of these codes and standards is the detailed provisions concerning when different professional titles can be used. Failure to comply with these codes and standards may result in the health professional being referred to a professional conduct committee or the Health and Disability Commissioner, which may lead to a charge being laid before the Health Practitioners Disciplinary Tribunal.

IX FUTURE OUTLOOK AND NEW OPPORTUNITIES

Like many other countries, New Zealand's healthcare sector continues to be shaped by increasing demand and associated health spending; growing prevalence of non-communicable and chronic diseases; the development of new, more costly technologies and pharmaceuticals; and a more educated and consumerist population.61 In addition, the global recession and the costs of rebuilding Christchurch following two major earthquakes in 2010 and 2011 continue to have an impact on the New Zealand economy, with flow-on effects to health, including social impacts such as unemployment and overcrowded housing, and budgetary constraints on all government spending.62 In view of the need to provide healthcare services in a way that meets current public demand and expectations, health organisations are under more pressure than ever to make smarter use of existing resources, people, facilities and funding to drive better, cheaper and more efficient care.

On 29 May 2018, Dr David Clark, Health Minister in the new Labour-led government announced a wide-ranging review of the health system, aimed at future-proofing the sector. An interim report is due by the end of July 2019, with the final report to follow by 31 January 2020.

With these challenges in mind, a key trend that will continue to influence the delivery of healthcare services in the years to come is the development and use of 'telehealth' and other technology-enabled health services. The introduction of patient portals; increasing use of digital health apps and smartphones as diagnostic tools; proposals to use online videoconferencing and related communication technologies to provide online consultations, prescriptions and other telehealth services; and the proposed development of a 'single' electronic health record are just some examples of the ways in which technology is increasingly being used to help reduce the overall cost of healthcare delivery and increase accessibility in New Zealand. Of course, a shift towards digitalisation also means that patient privacy and cybersecurity issues will be top of the minds of providers and consumers of health services, particularly with recurring incidences of health professionals inappropriately accessing patient health records and increased cybersecurity risks in the form of malware, viruses and 'ransomware' threats. Potential opportunities and risks associated with rapidly emerging technologies forms part of the core considerations set out in the draft terms of reference for the current review of the New Zealand health and disability sector announced in May 2018.

New technologies and treatments, together with increasing demand for health services, have also been drivers for adaptation and diversification across New Zealand's health workforce. To this end, a number of key regulatory and legislative changes are currently in the process of being introduced to support innovative and efficient practices, and to maximise the use of health practitioners' skills. These changes include registered nurse prescribing and the commencement of a number of provisions that enable a range of health practitioners to undertake certain statutory functions that are currently only able to be carried out by doctors (such as issuing sickness certificates and taking blood samples to test blood alcohol levels of drivers).63

Elsewhere in the legislative arena, new regimes for medicines and natural health products have been proposed. In relation to therapeutic products, drafting of the Therapeutic Products Bill is well under way, although the 2017 election and resulting change of government has had an impact on the time lines for the consultation phase. As well as replacing and modernising the current regulatory arrangements for medicines and pharmacy businesses under the Medicines Act 1981, this new regime will provide for the regulation of all therapeutic products, including medical devices and cell and tissue therapies (which are currently not fully regulated in New Zealand). A separate regime for natural health products is also set to be implemented in the near future, with the Natural Health and Supplementary Products Bill currently awaiting its third (and final) reading in Parliament. The Bill is designed to address a range of problems with the current piecemeal regulatory regime for natural health products, including inadequate controls on safety and quality, inadequate information about risks and benefits, and enforcement difficulties.64

The new Labour-led government's 2018 budget has seen a funding boost for health, which has been met with approval by both the public and private health sectors. Money allocated to reduce surgical waiting lists in particular is likely to have a flow effect for the private sector.

Finally, health policy continues to be vigorously debated in Parliament. Issues such as medical cannabis and a number of public health initiatives relating to childhood obesity, smoke-free policy, a sugar tax and plain packaging for tobacco are all likely to be key areas of interest, in addition to the ever-present concerns of health spending and inequalities in access to care. The contentious issue of assisted dying and euthanasia also remains topical, after ACT Leader David Seymour's End of Life Choice Bill was drawn from the ballot for debate in Parliament.65

X CONCLUSIONS

The New Zealand healthcare system is largely stable. While there has been a change of government, there is unlikely to be wholesale changes over the coming year.

On the legislative front, a proposed new therapeutic products regime (with fewer restrictions relating to pharmacy ownership), and reforms of public health legislation, are two matters that will be closely watched.

There will be continued focus on innovation – and trying to do things differently so that limited public health resources can keep up with demand. Any health sector organisation – public or private – that can come up with new and innovative ways of providing healthcare services will be well received.


Footnotes

1 Jonathan Coates is a partner, Aisling Weir is special counsel and Andrea Lane is a solicitor at Claro.

2 Ron Paterson 'Regulation of Health Care' in Peter Skegg & Ron Paterson (eds) Health Law In New Zealand (Thomson Reuters, Wellington, 2015) at [1.2.1(1)].

3 See Ministry of Health's Health and Disability Services Eligibility Direction 2011, which describes the groups of people who are eligible for publicly funded health and disability services in New Zealand.

4 Ministry of Health 'Private Health Insurance Coverage 2011–15: New Zealand Health Survey' (17 October 2016) www.health.govt.nz/publication/private-health-insurance-coverage-2011-15-new-zealand-health-survey (last accessed 8 June 2018).

5 Paterson, see footnote 2, at [1.2.1(2)].

6 See the NZPHD Act, Section 48(a).

7 Currently there are 32 PHOs in New Zealand, which vary widely in size and structure. The Ministry of Health's website reports on quarterly progress towards achieving agreed primary care health targets for each PHO.

8 As above, the New Zealand government provides subsidies to lower the cost of general practice visits for people enrolled in a PHO. Patients can only be enrolled in one PHO at a time, and the practice in which the patient is enrolled will receive funding for that patient. Because PHO subsidies do not usually cover the full cost of delivering care, general practitioners (who operate private businesses) often charge a patient co-payment. Higher fees are charged for casual patients (which are patients who visit the practice who are not enrolled).

9 The Code of Health and Disability Services Consumers' Rights is a legally binding set of regulations issued under the Health and Disability Commissioner Act 1994. It grants a number of rights to all consumers of health and disability services in New Zealand, and places corresponding obligations on providers of those services.

10 For example, the Human Rights Act 1993 prohibits discrimination in the provision of health services on the basis of a prohibited ground (such as age or disability).

11 This legislation is predominantly comprised of the Privacy Act 1993, the Health Information Privacy Code 1994 and parts of the Health Act 1956.

12 A number of other initiatives to use technology to deliver better health outcomes for New Zealanders are included in the Ministry of Health's 'Digital Health 2020' strategy, which sets out the key strategic digital investments that are expected to occur across the health and disability sector in New Zealand in the next three to five years.

13 A provider who provides these services while not certified commits an offence under the HDSS Act, and may be liable for a fine of up to NZ$50,000. See HDSS Act, Sections 9 and 54. In relation to fertility services, Section 80 of the Human Assisted Reproductive Technology Act 2004 deems fertility services to be 'specified health and disability services' for the purposes of the HDSS Act.

14 See the Health and Disability Services (Safety) Standards Notice 2008 and the Health and Disability Services (Safety) Standards Notice 2010.

15 HDSS Act 2001, Sections 48 and 49.

16 A new therapeutic products regime has been proposed to replace the Medicines Act 1981, and is expected to remove pharmacy ownership restrictions and replace them with appropriate licensing requirements. As at June 2018, drafting of the Therapeutic Products Bill continued to progress, although the 2017 election and resulting change of government has had an impact on the time lines for the consultation phase.

17 Users of radiation sources must either hold a licence under the Radiation Safety Act 2016; be authorised in regulations; be authorised in a source licence; or act under the supervision or instructions of someone who is authorised. They must also satisfy a number of requirements set out in the Radiation Protection Regulations 2016 and Codes of Practice issued by the Director for Radiation Safety.

18 See HPCA Act, Section 7.

19 These clinical interventions are deemed to be 'restricted activities' under Section 9 of the HPCA Act, and include surgical and operative procedures, orthodontic procedures and ophthalmic procedures. These interventions can only be undertaken by health practitioners with a relevant scope of practice.

20 See HPCA Act, Section 8.

21 Ibid.

22 New Zealand Royal Commission of Inquiry into Compensation for Personal Injury in New Zealand: Report of the Royal Commission of Inquiry (Government Printer, Wellington, 1967).

23 See Accident Compensation Act 2001, Section 317. This prohibition applies even where a person chooses not to lodge a claim or is not entitled to compensation.

24 For a discussion of the HRRT jurisdiction, see T Baker 'Human Rights Review Tribunal: The role of the tribunal in upholding the rights of consumers of health and disability services in New Zealand' (2009) 16 JLM 85.

25 See HDC Act, Sections 55 and 57, and the schedule of damages awarded by the HRRT published online at www.justice.govt.nz/tribunals/human-rights/damages-and-costs-awarded/.

26 Allenby v. H [2012] NZSC 33.

27 Harrild v. Director of Proceedings [2003] 3 NZLR 289 (CA).

28 Cumberland v. Accident Compensation Corporation [2011] NZAR 389.

29 [2010] NZSC 27, [2010] 3 NZLR 149.

30 That is, the defendant 'consciously appreciated the risk the impugned conduct posed to the plaintiff's safety and went ahead deliberately and outrageously to run that risk, causing harm to the plaintiff': Couch v. Attorney General as cited in White v. Attorney General [2010] NZCA 139 at [214].

31 See L v. Robinson [2000] 3 NZLR 499, where exemplary damages of NZ$10,000 were awarded against a psychiatrist who engaged in a sexual relationship with a vulnerable and former patient; R v. Eade DC Auckland NP3604/97, 12 May 2000, where NZ$27,500 in exemplary damages was awarded for breach of fiduciary duty as a result of a primal therapist's sexual relationship with a vulnerable client with a history of sexual abuse; and G v. G (1996) 15 FRNZ 22 (HC), where an award of NZ$85,000 in exemplary damages was made against a doctor, although this involved private rather than professional conduct (spousal abuse and violence).

32 Simpson v. Attorney General [Baigent's case] [1994] 3 NZLR 667.

33 For examples of awards of public law compensation in personal injury cases, see Greenwood v. Attorney-General [2006] DCR 586 (DC); and Falwasser v. Attorney-General [2010] NZAR 445 (HC).

34 PF v. Capital and Coast District Health Board [2013] NZHC 1792.

35 Other relevant law includes the Financial Reporting Act 2013, Tax Act 2007, Limited Partnerships Act 2008, Partnership Act 1908 and Privacy Act 1993.

36 See Medicines Act 1981, Sections 5A-B, 42A-C and 55A-G in particular, and the Medicines Regulations 1984.

37 Medicines Act 1981, Section 55E (the exception to this is hospital pharmacies).

38 Medicines Act 1981, Section 55D (the exception to this is hospital pharmacies).

39 Prescriber is a defined term under the Medicines Act 1981.

40 'Interest' is broadly defined and includes a beneficial interest in a shareholding of a holding company, being the lessor to the pharmacy and being a party to a commercial agreement involving key money or profit sharing. See Medicines Act 1981, Sections 5A and 42C.

41 See Medicines Act 1981, Section 55F.

42 See Medicines Act 1981, Section 51(1)(b).

43 See Medicines Act 1981, Sections 51(1)(c) and 83.

44 Regulation of Pharmacy Ownership: Review Paper and Position Statement, Pharmaceutical Society of New Zealand Incorporated, March 2017; The state and the market: the impact of pharmacy licensing on the geographical distribution of pharmacies, Norris P, Health Place, December 1997 1;3(4):259:-69.

45 Medicines Regulations 1984, reg 45A.

48 Statutes include the Commerce Act 1986, Sale of Goods Act 1908, Sale of Goods (UN Convention) Act 1994 and Public Records Act 2005.

49 Rule 4(1).

50 Rule 4(3).

51 Rule 7. The requirement to use a publicly advertised, competitive process also applies to procurements relating to new construction works with a total estimated value of NZ$10 million or more (see Rule 8).

52 See Rule 13 and the definition section.

53 Attorney-General v. Problem Gambling Foundation of New Zealand [2016] NZCA 609.

54 Fair Trading Act ۱۹۸۶, Section ۹.

55 Fair Trading Act, Section 40.

56 Consumer Guarantees Act 1993, Section 28 and 29.

57 Consumer Guarantees Act 1993, Section 30 and 31.

58 Note that the Medicines Act does state that it will be a good defence in a prosecution based on a breach of this prohibition if the defendant proves that the matter claimed, indicated or suggested in the advertisement is true.

59 Medicines Act 1981, Section 58.

60 See, for example, Statement on Advertising (Medical Council of New Zealand, November 2016); Code of Practice on Advertising (Dental Council of New Zealand, March 2011, available at www.dcnz.org.nz/assets/Uploads/Consultations/2012/Advertising-COP.pdf); and Aotearoa New Zealand Physiotherapy Code of Ethics and Professional Conduct (Physiotherapy Board of New Zealand, October 2011, at Section 10.4).

61 Ministry of Health New Zealand Health Strategy: Future direction (New Zealand Government, April 2016) at page 9.

62 New Zealand Health System Review (Health Systems in Transition, Vol. 4 No. 2 2014) at Chapter 8.

63 The provisions bring the legislation that resulted from the Health Practitioners (Replacement of Statutory References to Medical Practitioners) Bill into force. This was an omnibus Bill which amending eight statutes. The first seven amendments commenced in January 2018. The final amendment will commence in November 2018.

64 The full regulatory scheme will be phased in over three years after the legislation comes into force.

65 While previous Bills on assisted dying have been defeated at first reading (or withdrawn from the ballot out of concern the issue would become a political football during election year), cross-party backing and widespread public support in favour of a law change suggest that rigorous debate will continue in this area.