General policy statement
The policy of this Bill is to update existing public health legislation in order to improve, promote, and protect public health and help attain optimal and equitable health outcomes for all population groups in New Zealand. The Bill will also enable New Zealand to comply with its obligations under the International Health Regulations 2005 (IHR 2005). The IHR 2005 came into force on 15 June 2007.
Background
The Bill will substantially replace the Health Act 1956, the Tuberculosis Act 1948, and associated regulations. The Health Act 1956 is New Zealand’s principal statute for public health, focusing primarily on environmental health and the control of communicable diseases. The Health Act 1956, the Tuberculosis Act 1948, and associated regulations have served New Zealand well, but their provisions are now outdated.
The process of reviewing the present legislative framework has been extensive, with several rounds of consultation based on 2 discussion documents. In 1998, Public health legislation review: A new public health legislative framework (Ministry of Health, 1998) was published. To further develop the detailed policy, a second round of consultation centred on the discussion document Public health legislation: promoting public health, preventing ill health and managing communicable diseases (Ministry of Health, 2002). This discussion document covered more detailed proposals for topics, including health information, screening, management of communicable diseases and non-communicable diseases, and border health protection.
Some changes have already been made to existing legislation through the Epidemic Preparedness Act 2006 and associated amendments to the Health Act 1956. These changes, primarily affecting emergency and quarantine provisions in the Health Act 1956, ensure an effective New Zealand response to the possibility of communicable disease-related emergencies such as that which could arise from pandemic influenza. The 2006 amendments are carried forward in this Bill.
How Bill will achieve its objectives
The Bill will achieve its objective of improving, promoting, and protecting public health by providing for—
an all-risks approach to the detection, assessment, and management of threats to public health, that is, an approach to allow the effective management of significant and emergent risks to public health that are not otherwise effectively managed:
controls on specified activities that pose risks to public health, for example, options for activity consents and public health risk management plans:
the continued responsibilities of territorial authorities for the management of public health issues in their districts:
obligations on specified persons to provide accurate, comprehensive, and timely information on conditions posing risks to public health, in particular notifiable conditions and notifiable contaminants:
measures concerning non-communicable conditions:
measures relating to persons posing serious risks to other people, including possibilities for directions and court orders that will set out an incremental range of restrictive powers, such as requiring a person to accept supervision, and more restrictive powers, such as detention:
measures relating to emergency management, in the main carried forward from the Health Amendment Act 2006 (enacted with the Epidemic Preparedness Act 2006):
responsibilities for border health protection.
The Bill will achieve its objective of ensuring that New Zealand complies with the International Health Regulations 2005 by—
updating provisions on border health protection (for example, by replacing the list of quarantinable diseases of yellow fever, cholera, and plague in the Health Act 1956 with a more extended list of conditions):
facilitating New Zealand’s response to international public health emergencies in accordance with the new IHR 2005 provisions, for example, by recognition of a national focal point.
The principles of risk management and proportionality underlie the Bill as a whole. Public health powers are to be exercised within a human rights framework.
Overview
The Bill will provide for a risk management approach to the detection, assessment, and management of significant or emerging risks to public health. This approach will operate locally, primarily through District Health Board public health providers and territorial authorities (TAs); and nationally, primarily through the roles of the Minister of Health (the Minister), the Director-General of Health (the Director-General), and the Director of Public Health.
Purposes and general duties
The Bill aims to improve, promote, and protect public health by contributing to achieving optimal and equitable health outcomes for Māori and other population groups.
Management of risks to public health
The Bill has provisions that enable the making of regulations to set various controls on a specified activity in order to prevent, reduce, or eliminate the risks to public health associated with the activity. These provisions have a wide potential application and cover activities relating to goods and services with the potential to pose risks to public health. The provisions require the making of regulations in order to apply to any particular activity. The making of regulations will involve the usual processes for public consultation and assessment of regulatory impacts prior to Cabinet decisions. Examples of potential regulated activities include the management of camping grounds and hairdressing (both presently subject to regulatory licensing requirements).
Controls that may be imposed by regulations could involve, depending on the nature and level of risk, some or all of the following:
a requirement to seek an activity consent (equivalent to a licensing regime):
compliance verification by an assessor:
a requirement for a public health risk management plan:
regulations to specify mandatory objectives, functional requirements, and performance measures.
Assessors will help monitor and verify compliance with relevant controls, including regulations and conditions specified for particular risk activities.
Territorial authorities
The Bill continues the Health Act 1956’s mandate for a significant role for TAs, principally in relation to environmental health (that is, public health matters related primarily to the physical environment). Territorial authorities will have duties and discretionary powers to improve, promote, and protect public health within their districts. As with the current Health Act 1956, the TA role will span nuisances, bylaws, sanitary works, and, subject to regulations, activity consents and assessor/verification functions. As under the Health Act 1956 at present, TAs will have a duty to employ or otherwise provide for the employment of 1 or more environmental health officers. Territorial authorities will also be required to inspect their districts for nuisances and to take steps to manage them. In addition, as now, TAs will be required to comply with any direction by the Minister of Health relating to provision for sanitary works.
Health and disability information
Reliable flows of accurate information are fundamental to health and disability policy and action. The Health Act 1956 currently has provisions to allow information about identified people to be exchanged between specified authorities. The Bill continues the provisions relating to routine information flows within the health and disability services sector, including information disclosure to support patient care and the funding of services throughout the health and disability sector.
The Bill includes some modifications and clarifications to current provisions, for example, the requirement to provide information will apply to all funders and providers of health and disability services, including private providers, instead of to public providers only (as at present). This will have the effect of ensuring the provision of health and disability information to the Ministry of Health for compiling statistics and advancing knowledge, education, and health research. For many service providers this proposal will formalise existing arrangements.
Notification
Notification involves a duty on specified people (such as medical practitioners) to provide information to specified authorities about people with health issues of public health concern. Notification allows investigation and possible control measures (in relation to particular individuals and their contacts), and also provides data for surveillance purposes. It generally relates to cases of important communicable diseases. The duty in current legislation to notify specified conditions will be retained, but in a more detailed and flexible form.
The Bill also includes a new duty to report an outbreak or cluster of cases of conditions, whether the condition is notifiable or not, or any other unexpected or unusual event of public health significance.
The Bill specifies persons or service providers responsible for making notifications, in particular, medical practitioners and laboratories. Contaminants, for example, from environmental testing, will also be notifiable to medical officers of health by laboratories and in some cases also by the person who orders the test.
The Bill includes a definition of condition to include diseases (whether communicable or not) and physical harm caused by chemical, radiation, or other exposure.
Specified persons and agencies will be required to notify conditions and contaminants, including pathogenic organisms. The Bill sets out criteria to guide decisions about which conditions and contaminants are to be specified as notifiable.
As in the Health Act 1956, there will be provision for schedules setting out the list of notifiable conditions, and supporting details will be able to be amended by Order in Council.
Non-communicable diseases
Public health legislation traditionally focuses on communicable diseases and environmental health. Although communicable disease and environmental health issues remain very significant, they are no longer the major causes of death and illness in New Zealand. The major causes of population ill-health today, and the major drivers of health care expenditure, are those broadly categorised as non-communicable diseases, such as cardiovascular disease, diabetes, cancers, mental illness, and addictions.
Reducing the impact of non-communicable diseases in the population requires intervention at a number of levels, as well as co-ordinated efforts across key sectors and settings that can support outcomes such as improved nutrition and physical activity. Legislation alone is not the answer, but, as experience with tobacco control has shown, appropriate legislative provisions can support effective public health action in a way that also reduces inequalities.
The Bill includes principles and provisions for the making of codes or guidelines to address non-communicable disease risk factors. The Director-General will be able to make non-binding codes and guidelines to promote public health, for example, in relation to—
exposure to, or access or use by, the public generally or specific groups in respect of products and services relevant to non-communicable disease risk factors:
matters relevant to the advertising, sponsorship, or marketing (direct or indirect) of products and services with an impact on non-communicable disease risk factors:
the performance, composition, contents, additives, design and construction of goods, things, or services or processes that impact on non-communicable disease risk factors.
The Bill requires the Minister of Health to report to the House of Representatives on options and proposals for addressing non-communicable disease issues within 3 years from enactment (with an option to extend this period).
Management of communicable conditions and restrictive powers
The Health Act 1956 and the Tuberculosis Act 1948 (along with associated regulations) have significant powers in relation to the control of people with communicable conditions such as legionnaires’ disease, AIDS, hepatitis, cholera, and tuberculosis. The Health Act 1956 provides for the detention of people with infectious diseases, by decision of the medical officer of health or health protection officer, with no time periods or appeal provisions specified other than that the person may be held until no longer infectious.
Provisions in the Bill cover rights, duties, offences, penalties, a range of restrictive powers, and procedures for decisions and urgent orders for people with significant communicable conditions. The provisions reflect the need to exercise management options that place as few restrictions as possible on the person concerned while, at the same time, meeting public health objectives.
The Bill sets out an incremental range of restrictive powers. Powers at the lesser end of the range (such as requiring a person to attend a particular health care programme or refrain from certain activities) will be able to be exercised by a medical officer of health. The lack of such intermediate powers has been identified as a weakness in the current legislation.
The more restrictive powers (for example, detention) could only be exercised following a court order. Where urgent action is required to take measures to protect public health, an interim order for detention for up to 72 hours could be issued by a medical officer of health with immediate effect.
The relevant provisions in the Bill support the exercise of the least restrictive alternative in relation to people with communicable conditions to the maximum extent compatible with achieving public health outcomes.
The Bill includes provision for review and appeal safeguards (including a 6-month time limit on public health orders, although renewable) and provision for variations to orders.
A medical officer of health may give a limited range of directions in respect of someone who is a contact of a person with a notifiable condition or a carrier (for example, a requirement to be tested, or to remain at home, or to be excluded from school).
Persons with a communicable condition will have a duty to minimise the risk of transmission.
Restrictive powers in situations other than communicable conditions
Section 126 of the Health Act 1956 allows for the committal of infirm or neglected persons who are living in insanitary conditions or without proper care or attention. While section 126 is rarely formally invoked, its existence as a last resort is useful in resolving difficult situations. In this Bill, a new version of section 126 provides for residence orders.
Contact tracing
Contact tracing is one way to investigate and manage communicable conditions. It involves identifying and seeking people who have been in contact with a person with a communicable disease in order to prevent further spread of the disease and to offer testing and treatment to people at risk. The present legislation has very few provisions to support contact tracing (which is mostly in secondary legislation), and these tend to be limited to contacts who have already been identified, rather than tracing further contacts.
The Bill authorises contact tracing and specifies criteria, relevant conditions, and procedures in the primary legislation rather than in regulations. In practice, most contact tracing will take place, as now, with the consent of the person with the original condition. The Bill, however, authorises contact tracing where the person concerned does not voluntarily inform others and any infringement of the person’s privacy is justified on public health grounds. Procedures for contact tracing will vary, depending on the availability of personally identifying details and urgency.
Where identifying information is not available to a medical officer of health, a health practitioner will be primarily responsible for undertaking contact tracing by requesting the person with the condition to communicate appropriately with contacts. If this is not successful, the medical officer of health will be able to initiate contact tracing.
People with relevant conditions will have a duty to provide, as far as practicable, information, including names, identifying details, and addresses of contacts, as well as other information relating to the circumstances and source of the relevant condition.
Disclosure of information to close contacts
Health practitioners, in limited circumstances, will be authorised but not required to disclose to partners and family or household members information on risks posed to them by a partner or family or household member with a communicable condition. Relevant criteria for the exercise of such discretion include the serious nature of the condition, a significant risk of infection through close contact, and the failure of the person with the condition to take steps to inform and protect a partner or family or household members.
Border health protection
The Health Act 1956 provisions relating to border health protection and quarantine are out of date given trends in international travel since 1956, new and emerging threats such as SARS and pandemic influenza, and changes in international law. The present Health Act 1956 enables implementation of New Zealand’s obligations under the International Health Regulations 1969 (IHR 1969). The IHR 1969 were revised by the World Health Organization (WHO), adopted by the World Health Assembly in May 2005 (IHR 2005), and came into force in June 2007.
The IHR 2005 have a wider scope than earlier international law in relation to risks to public health. The IHR 2005 also have more explicit obligations in relation to public health surveillance and response capacities, both at the border and within countries. They allow for potential controls on people departing as well as arriving (to prevent export of sources of risks to public health).
The Bill provides that the primary role of health agencies at the border relates to human health protection. It relates in particular to people and craft coming into, or leaving, New Zealand as possible sources of infection, as well as human environments and sanitary conditions associated with craft and around ports and airports.
The Bill has an expanded scope for border health protection consistent with the IHR 2005. The Health Act 1956 lists yellow fever, plague, cholera, and human-transmitted avian influenza as quarantinable diseases. The expanded scope of the IHR 2005 focuses on controlling the spread between countries of all conditions and events that may adversely affect the health of human populations. These include any diseases or other risks, such as emerging conditions like SARS and new forms of human influenza, but also harm caused by chemical and radionuclear sources.
The Bill follows the approach adopted in the IHR 2005 and allows the Ministry of Health to have a high-level, national-overview responsibility for border health protection, while recognising that other agencies may be responsible for delivering some services.
The Bill provides that all persons entering New Zealand may be required to provide information (for example, travel history) and submit to non-invasive screening measures. There are also provisions for screening and surveillance (for example, by reporting to a medical practitioner in their home town) or, as a last resort, isolation or quarantine in a suitable facility.
The Bill also specifies, in accordance with the IHR 2005, and as currently provided in the Health Act 1956, that craft crossing the border (ships and aircraft) must meet certain requirements to obtain health clearance (that is, pratique) and sanitation certification. Ports, airports, and conveyance operators must also ensure that they are free of such vectors as rats and mosquitoes and that the import and the export of organisms that pose risks to public health are minimised. There are also provisions relating to goods and organisms as possible sources of risk to human health.
Public health emergencies
The Bill largely reflects the legislation enacted in 2006 (the Epidemic Preparedness Act 2006 and Health Amendment Act 2006). The provisions of this Bill, however, apply to a broader range of public health emergencies, irrespective of cause (that is, communicable conditions as well as emergencies arising from biological, chemical, or radiological factors).
The Bill specifies powers for medical officers of health on the declaration of a public health emergency. These powers are similar to those in the present Health Act 1956 (special powers) but are more comprehensive. As now, the powers will be able to be enforced, for example, with the assistance of the police. These powers include an ability to limit movement, to close premises such as workplaces and schools (or to allow them to remain open only under specified conditions), and to require quarantine and isolation.
The emergency powers include an ability to detain people if preventive treatment, including vaccination, is declined. The justification for needing this power is the potential devastation for the whole community that could result from a full-scale new disease epidemic, or terrorist reintroduced smallpox, for example. The Bill does not authorise physical administration of treatment in the case of non-compliance. Non-compliance could result in detention for quarantine purposes.
Other provisions
The Bill includes provisions that encourage, but that do not require, health impact assessments for new proposals, for example, in relation to policy development and decision making by central and local government.
The existing Health Act 1956 provisions relating to the National Cervical Screening Programme are carried forward in this Bill.
The Bill includes specific powers (primarily relevant to children) in relation to screening and exclusion from schools in the case of disease outbreaks, and other regulation-making powers for immunisation, such as the authorisation of school-based immunisation recording. The Bill provides for a limited version of the Health Act 1956 provision on the examination of children to allow an authorised person to enter a pre-school or school in order to examine, test, or screen children, and to allow an authorised person to examine, test, or screen children where the parent consents; and, where there is no consent, for the authorised person to refer the child to an appropriately qualified health practitioner for further investigation and follow-up.
Regulatory impact and compliance cost statement
Statement of nature and magnitude of problem and need for government action
Background
In 2001, Cabinet agreed that a new Public Health Bill (the Bill) would provide for an outcome-focused, enabling, risk management framework to provide effective management of all significant and emergent risks to public health.
The 2001 decisions provided the broad framework, but further detail is required to inform the drafting of the Bill. A number of these details require consideration of how to balance the interests of public health with individual freedoms. Some issues related to non-communicable disease (NCD) risk factors (such as poor diet, or lack of exercise) were not considered explicitly in the 2001 decisions. Furthermore, a number of events since 2001 have informed the detailed proposals—
lessons from Severe Acute Respiratory Syndrome (SARS) and the emergence of other conditions:
a better understanding of the implications of developments in genetic screening:
decisions on the Biosecurity Strategy and responsibilities in border control:
finalisation of the International Health Regulations (IHRs) by the World Health Assembly (WHA) on 23 May 2005:
the introduction and consideration by select committee of the Law Reform (Epidemic Preparedness) Amendment Bill (which provided for Prime Ministerial notices to manage wide social and economic disruptions caused by major pandemics such as could be caused by avian influenza. The Epidemic Preparedness Act 2006 also amended the Health Act 1956, among other statutes, to extend and clarify the Act’s special powers and quarantine provisions).
Proposals, the details of which have been developed significantly since 2001, are summarised in the following sections:
health information and notifiable diseases:
prevention of ill health—registers, immunisation and screening:
management of people with communicable conditions and use of restrictive powers:
contact tracing:
border health protection:
non-communicable diseases.
Health information and notifiable diseases
In 2001, it was agreed to continue the present framework, which provides for disclosure of health information to a range of health providers and government agencies (in specified circumstances). The present definition of health information as set out in section 22B of the Health Act 1956 reads—
| | health information, in relation to an identifiable individual, means— (d) information provided by that individual in connection with the donation, by that individual, of any body part, or any bodily substance, of that individual:
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However, that definition is not the same as that in the Health Information Privacy Code, which includes ‘information about the individual which is collected before, or in the course of, and incidental to, providing health services to that individual’. The Health Act 1956 definition of health information is therefore somewhat more limited than that in the Health Information Privacy Code, and this could compromise the comprehensiveness and effectiveness of public health surveillance.
The 2001 Cabinet decisions included general provisions for the notification and surveillance of diseases. The decisions also envisaged that notification duties be extended beyond District Health Boards to encompass ‘medical practitioners, medical/diagnostic laboratories, and others’ (including community-based services). However, the decision did not specify criteria for when a disease should be notifiable, who should notify and their responsibilities, and how notification should occur. As a result, it is not transparent how the interests of the public, individuals, and potential notifiers would be balanced.
There is no provision for the notification of pathological organisms or contaminants that are not communicable diseases but may present public health risks. Lack of such provisions compromise the scope for prevention and early intervention.
It is anticipated that the list of notifiable diseases would be changed through an amendment to the Schedule or regulations by Order in Council. However, the policy and consultation processes that are generally required to make such an amendment might be too slow when highly infective viruses or new or unknown conditions emerge suddenly and need prompt management to avoid serious harm to public health.
Registers, register-based programmes, and screening
The 2001 Cabinet decisions provided for the establishment and maintenance of registers and register-based programmes for diseases, syndromes, conditions and other issues. The relationship of the provisions to the Official Information Act 1982 was also addressed. Generic provisions include national or sub-national registers, opt-on and opt-off registers, and privacy safeguards. The registers are to be created by regulations. However, the decisions do not specify the purpose and objectives to guide whether registers should be established and in what form. Clarity is important given the range of conditions for which registers could later be established, and the ensuing implications about privacy issues.
The 2001 Cabinet decisions did not address genetic screening. Specific attention should be paid to whether the scope of the Bill is to include genetic screening because it can be controversial, and because a current comprehensive screening programme (that is, the Guthrie test) may be considered to constitute a form of genetic screening. The Guthrie test consists of metabolic testing of newborn babies. There would be advantages in the Bill not excluding genetic screening in order to allow its potential application to the Guthrie test programme, if it is decided in the future that this is appropriate, and because other possible uses for genetic screening are evolving rapidly. Although confidentiality of individual information is addressed in the Privacy Act 1993 and the Health Information Privacy Code, the Guthrie test raises issues about the holding and use of medical samples that may warrant more specific regulatory detail than the Act and its Code are able to provide (as recommended by the Privacy Commissioner’s report on the Guthrie Test.) The growing range of possible uses of medical samples means that, increasingly, individual privacy rights may require additional protection and specific rules.
The Bill would continue the present powers of statutory officers in relation to vaccine-preventable illness (such as the ability to exclude children from school in outbreaks of such vaccine-preventable illness as measles). Regulations would be able to be made for immunisation-related functions.
Management of people with communicable conditions and use of restrictive powers
The 2001 Cabinet decisions included general approval that the Bill would include powers to manage significant and emergent risks to public health that were not otherwise managed effectively. The control of people with communicable diseases is an example. The Health Act 1956 provides for powers to detain people with infectious diseases without time limits or appeal provisions. The issue is the range of powers that would be appropriate (and under what circumstances) to ensure a person undergoes a test, is examined, or remains isolated from others, and what checks and balances should be available. This involves a balancing of the interests of public health with the rights of individuals.
In extreme emergency circumstances (such as the threat of a pandemic with serious health impacts), mandatory vaccination might be in the best interest of public health. But there is no framework to determine what such circumstances might be, what individual obligations or rights would be, and what enforcement powers would be available.
There is a related issue about what range of powers should be available when a person is found to be living in unsanitary conditions or without adequate care. The Health Act 1956 provides a power to remove persons from their homes but does not provide for less restrictive alternatives (such as a requirement to accept help with cleaning and meals), which may both be more appropriate in the circumstances and more consistent with human rights.
Contact tracing
The ability to trace and alert people who have been (or may be) in contact with a person with a communicable disease is an important tool for managing the public health risks of communicable disease. The 2001 decisions envisaged provisions for contact tracing. However, these decisions did not specify how to balance the interests of public health (including those of partners and family members) with the rights to privacy of the individuals involved.
Border health protection
The 2001 decisions consisted of a general approval that the Bill would enable the effective management of all significant and emergent risks to public health that were not otherwise effectively managed, including in relation to border control. The 2001 decisions did not include the detail needed to guide the development of provisions for quarantine powers. Nor did it include the detail on the legislative relationships between the health sector and other agencies with overlapping interests in border control (such as Customs and the Ministry of Agriculture and Forestry (MAF)). For example, control of cross-border movements of poultry with avian influenza is of interest both from a biosecurity and human health perspective. Nor were the 2001 decisions able to predict with detail the direction taken by the revised WHO IHRs (now finalised by the World Health Assembly in May 2005). Issues are—
how best to assign responsibilities for border health control in the Bill, given biosecurity, food, and customs legislations:
how best to provide for border health protection given modern patterns in international travel, when most people travel by air and symptoms are unlikely to be identified at the border:
how to implement the relevant international health obligations, in particular the revised International Health Regulations 2005. These include an expansion of conditions and of required information. They also require a greater capacity for emergency response and co-ordination at both international and national levels.
Non-communicable diseases
The 2001 decisions authorised some specific provisions of relevance to NCDs (such as registers and programmes for screening) but the decisions did not authorise any other specific provisions to address NCDs. However, NCDs (such as cancers and diabetes) are now the major causes of avoidable ill-health, disability, and premature deaths in New Zealand.
The District Health Boards, under the New Zealand Public Health and Disability Act 2000, have the objective to improve, promote, and protect the health of people and communities. To date, some risk factors for NCDs have been dealt with under specific legislation, such as the Food Act 1981, the Smoke-free Environments Act 1990, and the Sale of Liquor Act 1989. There are no provisions relevant to controls on products and services that impact on NCD risk factors for major causes of ill-health and disability.
Statement of public policy objectives
The public policy objective is to promote, protect, and improve the public health of New Zealanders and reduce inequalities in health, consistent with the New Zealand Health Strategy, the New Zealand Disability Strategy, and He Korowai Oranga (Māori Health Strategy). Specific policy objectives are—
that public health risks are detected and managed in a timely and effective manner:
that the costs of avoidable illness, disability, and premature deaths are minimized:
that the interests of public health are balanced with individual rights to freedom and privacy:
that there is a clarity of roles of health agencies and other government agencies:
that international health obligations are met.
Statement of feasible options (regulatory and/or non-regulatory) that may constitute viable means for achieving desired objectives
Status quo
The status quo is the set of decisions made in 2001 by Cabinet on matters to be included in the Public Health Bill. To avoid duplication, the key features of the status quo are set out in the problem section of this statement. Given the high-level nature of the 2001 decisions, events since 2001, and the 2002 consultation relevant to decisions on the balance between individual freedoms and the public good, it is considered that the status quo option would not meet the public policy objectives.
Preferred option—Public Health Bill 2007
Health information and notifiable diseases
It is proposed that—
the definition of health information include "information about the individual that is collected before or in the course of, and incidental to, the provision of any health service or disability service to that individual:
notification provisions would also apply to conditions, contaminants, or human pathogenic organisms that present or are precursors to significant health risks:
funeral directors be no longer required to notify conditions:
the Bill specify, among other things,—
the purpose of notification (that is, the availability of accurate, comprehensive, and timely information on communicable diseases and other conditions of public health significance):
criteria for specified conditions (that is, based on the level and nature of risk to the person or the public, the scope for prevention or management of the condition or risk factor, its value as an indicator of other risks (such as chemical or radiation exposure), or international obligations):
lists, in the form of schedules that could be amended by Order in Council, that set out notifiable conditions, and potentially additional persons or agencies (from those specified in the Bill) who may be required to notify:
possible categories of notifiable conditions, for example, by reference to type of disease or whether the condition is liable to contact tracing:
which persons, officials, and agencies are obliged to notify, including, in particular, medical practitioners and laboratories, to be further detailed if necessary in regulations from a list of potential notifiers in the Bill:
the agencies to which notifications must be made, in particular, a senior health officer or the Director-General of Health, with the potential for regulation-making powers to provide for additional agencies to which notification must be made, such as the World Health Organization:
provisions enabling medical practitioners to report to senior health officers outbreaks or clusters of cases (whether notifiable or non-notifiable) where the number of cases is unexpected and/or the public health impact could be serious:
fast track provisions to allow the Director-General to amend the scheduled list of notifiable conditions (by gazetting) for a period of up to six months if there are significant public health risks:
a duty of confidentiality on the notifier and any person or agency to which notifications are made, or to which information based on notifications is communicated:
that senior health officers may communicate information based on notifications to other agencies (including territorial authorities and government agencies, depending on the nature of the information), on a non-identifying basis unless the circumstances of the case require identifying information for public health action:
a requirement that health practitioners advise any person with a notifiable condition that information is to be sent to an appropriate agency, other than in exceptional circumstances.
Prevention of ill health: registers, immunisation, and screening
It is proposed that the Bill outline the requirements for registers and register-based programmes, such as their purpose, and the rules about the use of information and confidentiality, to be further detailed in regulations. Provisions relevant to registers and register-based programmes would not be operative without regulations to bring them into effect. The provisions would not exclude genetic screening.
Key features for registers and register-based programmes include—
the purpose or objectives for which registers and register-based programmes may be established, such as—
monitoring the health status and relevant risk factors of the relevant group of people, such as babies and young people, to allow the early identification of risk factors, health issues, or disability for preventive or early intervention strategies:
monitoring the effects of health service provision:
the protection of information, and access to information, for example, as relevant to the specific register or programme—
people enrolled on the register/programme to be informed about other persons who may have access to information on the register and the uses to which that information may be put:
provisions that information is not to be retained on the register if a person cancels enrolment, except to the extent that details are required to be kept to identify a person as not enrolled on the register or programme:
no identifying information on the register or programme to be disclosed, except with the consent of the person concerned or to specified persons such as those with functions relevant to evaluation, auditing, or quality control of the register or programme:
regulation-making powers to allow registers and register-based programmes to be established or recognised, following their own consultation and regulatory impact assessment processes.
In addition, this part of the Bill would limit the current law on examination of children to allow a health practitioner—
to enter a pre-school or school to examine, test, and screen children, where the parent consents or, in very limited circumstances, without consent where screening for a specified condition is likely to have benefits for the child or other children:
to allow a health practitioner to advise the school and parent that a child has a significant health condition and make arrangements for follow-up.
Further regulation-making powers would relate to immunisation (eg, to continue the present school-based recording of immunisation for as long as that is necessary) and screening. Such regulations would require specific consultation and regulatory impact assessment.
The present powers of statutory officers in relation to vaccine-preventable illness (such as the ability to exclude children from school in outbreaks of vaccine-preventable illnesses such as measles) would continue. Regulation-making powers relevant to immunisation and screening would be included.
Management of people with communicable conditions and use of restrictive powers
It is proposed that the provisions for the use of restrictive powers relevant to people with communicable conditions include a greater range of options. Key features of the proposal are—
restrictive powers to be proportionate to risk, including power to direct a person to—
accept supervision or participate in a programme:
refrain from specified activities under specified circumstances:
require a person to undergo medical examination or to accept treatment or undergo detention or isolation.
rights, duties, and offences both for people with communicable conditions and health practitioners responsible for their management:
a 2-tier approach to decision-making and procedures as follows:
a court to exercise the more restrictive powers (such as detention, compulsory testing examination, and required treatment), in accordance with stringent criteria (as well as the less restrictive powers for other conditions):
a senior public health officer to exercise the less restrictive powers (such as an order to refrain from certain activities in specified circumstances) for notifiable conditions, in accordance with criteria, as well as the power to direct, but not to physically require, a person to be examined or tested for a high-risk condition:
review and appeal safeguards (eg, public health orders would be time-limited, subject to appeal, etc):
criteria for the exercise of the restrictive powers, such as the seriousness of the condition and the extent to which other people are able to protect themselves from it, and criteria for decisions on public health orders:
provision for an urgent public health order to be issued by senior public health officers, subject to criteria, if it is not practicable in the circumstances to obtain a court order (to expire after 72 hours):
court orders for legally required treatment in very serious situations and with strict criteria, for example, that treatment is critically important to protect public health (this would not involve treatment being compulsorily administered but could involve the alternative of isolation or detention).
It is also proposed that the Bill would include provisions for compulsory (but not physically forced) vaccination in extreme emergencies, including—
the type of circumstances and the likely efficacy procedures for invoking powers:
the likely efficacy:
procedures for invoking powers:
consequences of not complying with emergency vaccination provisions.
It is also proposed that the Bill would include—
criteria for the use of restrictive powers in relation to persons who cannot care for themselves and where others cannot provide that care for them, and there is reason to believe that, as a result the person’s health will deteriorate or there is a health risk for others etc):
a range of powers, similar to those for people with communicable conditions, ranging from an obligation to accept supervision or community support to removal from home.
Contact tracing
It is proposed that the Bill would specify details on contact tracing, including—
the conditions which may be liable to contact tracing, that is, the list of notifiable conditions:
the principle that contact tracing should as far as possible respect the privacy and autonomy of the people concerned while achieving public health objectives:
criteria for conditions to which contact tracing may be applicable, including a significant risk to public health:
procedures for contact tracing for health practitioners and senior health officers.
The Bill would also allow for, but not require, health practitioners to disclose to partners and family or household members information that is relevant to the risks posed to them by another family or household member or partner (where infected persons do not themselves inform those contacts), taking into account—
the serious nature of the condition:
any significant risk of infection through close contact:
the failure of the person concerned to take steps to inform and protect others.
Border health protection
It is proposed that the Bill—
clarify that the primary role of health agencies in relation to border control relates to the protection of human health and, in particular, to the monitoring and management of people as actual or possible sources of infection:
provide the Ministry of Health with an overview responsibility for border health protection while other agencies may have responsibility for delivery of services:
expand the scope for border health protection provisions from cholera, yellow fever, and plague to conditions that present significant risk or are communicable or both, consistent with the International Heatlh Regulations 2005:
update provisions on quarantine and sanitary certification for people and craft:
ensure that airports and ports can be required to make provision for sanitary environments and appropriate facilities for assessing the health of travellers, if appropriate:
provide powers to require information and share information, the ability to trace and inspect goods where there is good reason to believe they present a public health risk, and provide some public health emergency provisions, reflecting the revised IHR.
Public health promotion and non-communicable diseases
It is proposed that the scope of the Bill be widened to include a focus on the management of NCD risk factors, and provide for relevant purposes, codes of practice or guidelines, provision to encourage but not require health impact assessment, and provide for a legislative report-back in accordance with which the Ministry would report to Parliament or a Select Committee on issues relevant to NCDs, including the possible use of regulation-making powers to address NCD risk factors.
The non-binding codes of practice or guidelines would include powers for the Director-General to make non-binding codes of practice or guidelines in promoting public health, and in particular in relation to—
exposure to, or access or use by, the public or specific groups to products and services that are relevant to NCD risk factors (such as soft-drink vending machines in schools):
matters relevant to advertising, sponsorship, or marketing of products and services with an impact on NCD risk factors, where such matters are not addressed by any other means:
the performance, composition, contents, additives, design, and construction of goods, things, services, or processes that impact on NCD risk factors:
the form and content of markings or warnings or information to accompany a good, thing, or service with an impact on NCD risk factors.
Where the preferred option (Public Health Bill 2007) overlaps with a specific provision of another statute, the other specific provision would be invoked in the first instance. In some cases of overlap, the other statute may be amended.
Statement of net benefit of proposal, including total regulatory costs (administrative, compliance, and economic costs) and benefits (including non-quantifiable benefits) of proposal, and other feasible options
The more detailed proposals fall within the scope of the 2001 Cabinet decisions and do not alter the overall assessment of costs and benefits as indicated in the RIS and cost benefit analysis carried out to inform Cabinet in 2001. Costs and benefits identified below provide further clarification of analyses undertaken in 2001 in addition to specific reference to new issues, in particular those relating to non-communicable diseases.
Government
Central government
An assessment of the financial implications for central government in relation to developing and administering the proposed Bill was included in the papers approved by Cabinet in 2001. At that stage, the estimated costs to the Ministry for developing the Bill and for 12 months prior to its enactment (including costs of policy development, drafting instructions and a methodology for developing subordinate legislation, and the proposed monitoring regime) was between $100,000 and $250,000 for the years 2002/03 to 2004/05 (personnel and operating costs).
However, taking into account the implications of the more developed proposals outlined in this paper, the total cost of policy development for the first year post-enactment may be $275,000 rather than $250,000. The cost of $275,000 will be met by reprioritising Vote Health resources.
It was also noted in 2001 that resource implications post-enactment would depend on factors such as decisions on the need for specific new or revised regulations. The estimate over a 5-year period for cost to the Ministry was in the order of $0.5–$1 million. This was intended to be met within baselines. In addition, costs associated with transitional arrangements were estimated as approximately $0.5 million. The Ministry considers these estimates remain valid. Transitional and implementation costs will include information for the health sector, the general public and particular stakeholders. Training needs should also be considered and manuals rewritten.
Public health arrangements will be more effective due to—
more complete and timely public health surveillance:
the ability to quickly invoke temporary notification requirements for new and emerging public health risks:
the increased recognition of NCD risk factors:
the clarification of the roles of the various border control agencies.
The net benefits of regulation-making powers (such as to establish registers) depend on the detail of specific proposals. A separate regulatory impact and business compliance cost statement would be prepared when detailed regulations are recommended.
Public health arrangements will be more transparent due to—
clear objectives and criteria for establishing registers and register-based programmes, and for how the information can be used for public health:
the use of courts for authorisation before certain restrictive powers can be used, and the criteria that should guide such decisions (while maintaining the flexibility of a senior public health officer in relation to the use of less restrictive powers or in emergencies).
Health information requirements will be consistent with other health information standards (Health Information Privacy Code).
The Bill would enable New Zealand to continue to meet the present WHO IHRs, as well as able to meet the revised IHRs in accordance with any government decision.
Costs for the Ministry of Health will relate to training and the development of guidelines and manuals etc, as well as consultation and other costs associated with regulation development.
There may be some workforce implications for enforcement agencies, in particular Customs and the Police, but any such potential will be identified and addressed in the drafting process together with those agencies.
Local government and district health boards
The Bill will provide for a more effective allocation of powers and duties at the central and local levels. This will ensure greater clarity and efficiency of responses to, and action on, public health issues (in particular through clarifying the roles of public health officers in relation to their employing agencies, usually district health boards and territorial authorities). Provision for operationalisation of district protocols at the local levels, in particular between district health boards and territorial authorities, will allow local agencies to work out arrangements in advance of how overlapping functions should be fulfilled in particular circumstances, and will facilitate planning for prevention and mitigation of public health emergencies. Implementation of the Bill will involve some time spent in staff training and development costs.
Industry
The codes and guidelines for non-communicable disease factors will be consulted on when developed. They will not be mandatory and any costs associated with their implementation will be one factor among others that the manufacturer or supplier would take into account in deciding whether, and the extent to which, compliance would be appropriate.
The cost of ship sanitary certification may be increased to a small extent as a result of the more extensive scope of inspection and hygiene checks that will be included in revised certification. At present ships in New Zealand ports pay $150 for "deratting certification". This does not cover the real costs of the present inspection. The new regime will go beyond inspection for rats, and should be adjusted upwards to recover to a greater extent some of the costs of certification. This regime will be global in its coverage and New Zealand requirements will be identical to those of other countries.
Some costs may be imposed in public health emergencies. Such facilities are, however, only expected to be required for use in times of emergency, (which by definition will occur extremely rarely). It is not possible to quantify the cost implications of the provisions in the Bill for this purpose, but it is noted that separate cost assessments have been made for the purpose of pandemic planning.
Providers of health and disability services
The proposal for notification of pathological organisms or contaminants may result in some additional compliance costs on medical laboratories in particular. Further detail is provided in the business compliance cost statement. However, any incremental costs will be minimal given that it will involve sending information that is already collated to 2 recipients rather than 1, and given that medical laboratories already have processes in place to share such health information. The impacts would be assessed when schedules to the Bill are prepared.
Providers of private health and disability services (that is, those not funded by DHBs) would also be required to provide health and disability data on request to the Ministry of Health under the proposed amendment to section 22D. This may have a compliance cost (as noted below in the business compliance cost statement).
Society
Wider society will benefit from a transparent balancing of the public’s expectations to be protected from avoidable communicable diseases, and individual rights to freedom and privacy, including—
the extent to which the movement of people with high-risk communicable conditions may be restricted when voluntary measures have not proved effective:
review and appeal safeguards on public health orders and other restrictive powers:
health practitioners’ discretion to disclose individual information in limited circumstances where the infectious individual is failing to take steps to inform and protect others:
a transparent and more reasonable application of powers to restrict an individual’s freedom (through clear criteria and principles, the use of court orders, and interventions that are commensurate with the risk to the public health):
the potential for a reduction in the costs of avoidable NCDs, such as cancers and diabetes, through greater awareness of NCD issues and their prevention promoted by provisions for codes and guidelines with respect to goods and services that impact on NCD risk factors.
It may be argued that more stringent expectations and procedures in relation to the management of people with communicable conditions may be perceived as costly in that decision-making will need to be more careful, with a comprehensive range of factors to be taken into account. This may have the result of a more lengthy decision-making process, when compared with the procedures envisaged in the Health Act 1956. These procedures, however, reflect current good clinical practice.
There are also confidentiality and privacy issues arising from provisions for notification, contact tracing, and disclosure of information by medical practitioners to close contacts and family members. These issues will be taken into account in drafting of the relevant provisions, and balanced with the benefits to other people and society in general which accrue from information to the health sector and enhancement of people’s ability to protect themselves from the risk of infection.
Statement of consultation undertaken
Stakeholder consultation
The proposals outlined in this paper have been the subject of a detailed public consultation process. In November 2002, the discussion paper Public Health Legislation: Promoting public health, preventing ill health and managing communicable diseases was released. As part of the consultation process, the Ministry held a series of meetings and workshops in Auckland, Wellington, and Christchurch in early 2003. Over 180 people attended these meetings, of which there were 9. A total of 606 submissions were received from 1 190 signatories. More than 300 “form”
letters from individuals and groups with concerns about immunisation were received. Other issues on which there was a broad range of opinion included the extent to which the legislation should include “last-resort”
powers (such as detention) to assist in managing serious communicable diseases, and the issue of whether and how the Bill could address NCD risk factors. Views on registers, screening, and contact tracing varied. The proposals developed following analysis of the submissions, and in order to address concerns to the greatest extent possible, are a middle course between extremes of positions.
In particular, the provisions that provide for managing serious communicable diseases require a greater range of procedural safeguards than in the Health Act 1956. Powers of detention would no longer be able to be exercised by a statutory officer but by a court (except in urgent cases and then only for a maximum of 72 hours). This, together with other safeguards, should help allay concerns about the appropriate use of ‘last-resort powers. Concerns about registers, screening, and immunisation are addressed by the fact that general provisions in the Bill will only be operative if and when regulations are made to invoke them. Such regulations will require their own consultative procedures, privacy impact assessments, and regulatory impact assessments. Issues relevant to contact tracing most relate to concerns about privacy and control of information. The proposals have been recast to emphasise to a significant extent the role of patients in communicating with their own contacts, except where this is not effective and the risks to public health are significant. The proposals relating to non-communicable diseases are relatively minor, but provide to some extent for future changes (and hence another opportunity to address concerns expressed by a range of sector groups in consultation on the 2002 discussion document) by the concept of a legislative report-back.) These concerns were diverse, ranging from the view that there was no need for legislation to address NCD risk factors, to the view that a very comprehensive framework to address NCD risk factors is required. The provision for codes is therefore a compromise between those who supported the need for binding regulation-making powers and those who did not consider the Bill as an appropriate way to progress such issues. The legislative report-back will allow for further opportunities to review these issues and the options then available.
In September 2004, the Ministry of Health undertook limited consultation with some port and airport representatives in relation to the revision of the World Health Organization International Health Regulations. A general overview of the implications of the revised International Health Regulations was provided, and stakeholders were encouraged to familarise themselves with the Regulations upon their completion (which occurred in May 2005).
Government departments and agencies consultation
1 Comments have been sought on the proposals as they have been developed over the last five years from the following government agencies: Civil Defence and Emergency Management, Conservation, Consumer Affairs, Corrections, Crown Law, Customs, Department of Building and Housing, Education, Environment, Health and Disability Commissioner, Human Rights Commission, Department of Internal Affairs, Justice, Labour, Ministry of Agriculture and Forestry, Ministry for Foreign Affairs and Trade, New Zealand Food Safety Authority, Office for Disability Issues, Pacific Island Affairs, Police, Social Development, State Services Commission, Te Puni Kokiri, Treasury, Youth Development, Women’s Affairs, the Civil Aviation Authority, Maritime New Zealand, Transport, Economic Development, Defence, and Ministry of Fisheries, Comments were also sought from Local Government New Zealand, as well as the Office of the Commissioner for Children, Human Rights Commission, Privacy Commissioner, the Health and Disability Commissioner, Parliamentary Counsel Office and the Department of the Prime Minister and Cabinet.
2 The following agencies commented on this paper: Corrections, Civil Defence and Emergency Management, Conservation, Customs, Department of Building and Housing, Environment, Internal Affairs, Justice, Labour, MAF, New Zealand Food Safety Authority, Pacific Island Affairs, Police, Treasury, Civil Aviation Authority, Maritime New Zealand, Transport, Economic Development, Local Government New Zealand, Human Rights Commission, and the Privacy Commissioner. Comments from the Health and Disability Commissioner received on a preliminary paper in August were incorporated in this paper.
4 Border agencies such as MAF, NZFSA, and Customs are interested in the interface between the proposals in this paper and their legislation. The proposals address interface and overlap issues and it is intended that officials from the various agencies will continue to work together to avoid or minimise overlaps as much as possible. NZFSA also note the need for clarity in the provisions relating to powers to act for public health in cases where other legislation is not being implemented and that consultation should occur with the relevant department responsible for that legislaton prior to its exercise. NZFSA also note the desirability for designation procedures for statutory officers with public health law functions to refer to comparable competencies.
5 Other agencies, in particular, the Ministry for the Environment, the Department of Building and Housing, and Transport, are also interested in overlap issues and have expressed strong interest in working on drafting with the Ministry of Health.
6 Other agencies identified issues that have resulted in amendments to the proposals or that will require ongoing discussions, for example Bill of Rights and privacy issues with the Ministry of Justice as well as agency responsibilities with SSC and others. The need to balance human rights of freedom and privacy in relation to the community good was stressed by such organisations as the Health and Disability Commissioner and the Privacy Commissioner. The Office of the Privacy Commissioner expressed support in general terms for the recognition of privacy concerns in the Bill, although it had a significant number of points on the draft outline.
7 The Human Rights Commission agreed with the emphasis on a human rights framework but queried the implementation of proportionality and privacy principles. The Commission also had some comments on specific proposals, for instance health impact assessments, disclosure of health information, and screening. The Commission agreed, however, that these proposals should go forward for Cabinet decision and then as appropriate consideration by Select Committee.
8 Customs confirmed their previous support for proposals for a modernised border health protection framework, but also note the need for agencies to work together to ensure the proposals are implemented in workable legislation. The Police did not raise issues except for concerns about whether the enforcement provisions in the Draft outline gave the Police sufficient authority to carry out their tasks effectively. These and other points (eg, on penalties) will be able to be worked through in drafting. Labour raised a point concerning the sharing of immigration status information which would require policy development.
9 Local Government New Zealand stressed the need in their comments for flexibility, further details, and effective and ongoing consultation with local government on further development of the proposals (particularly regulations) and their implications and implementation. These comments were supported by the Department of Internal Affairs.
10 A number of agencies, including NZFSA, Human Rights Commission, Customs, Labour, Justice, Transport, MAF, Police, the Department of Internal Affairs and, as noted above, the Office of the Privacy Commissioner, had specific comments on the draft outline that will be taken into account in development of further drafting instructions and in circulation of drafts of the Bill to those agencies and all agencies with an interest in the relevant areas. For example, the Office of Disability Issues noted antiquated language in the draft outline, and the Department of Internal Affairs expressed a particular interest in the roles of environmental health officers.
Business Compliance Cost Statement
The proposal for notification of pathological organisms or contaminants may result in some additional compliance costs on medical laboratories in particular. For example, they may need to put in place a check in their current processes to ensure the relevant authority (eg, a medical officer of health) is also alerted. However, any incremental costs will be minimal given that it will involve sending information that is already collated to 2 recipients rather than 1, and given that medical laboratories already have processes in place to share such health information. The assessment of the impacts would be the subject of its own regulatory impact and business compliance cost statement that must be prepared when detailed regulations are recommended. (The pathological organisms or contaminants that must be notified would be set out in a schedule of the Bill or similar flexible instrument).
Although private hospitals are not funded for reporting to the New Zealand Health Information Service, the required information will already be in existence and any additional costs would only be for the arrangements to convey the information to the Ministry.
Providers of private health and disability services (that is, those that are not funded by district health boards) would also be required to provide health information on request to the Ministry of Health. This may have a compliance cost, although the required information will already be in existence and any additional costs would only be for the arrangements to convey the information to the Ministry.
The associated costs will also be minimised by ensuring that affected parties are kept informed of their potential new obligations as the Bill passes through its parliamentary stages. This will enable such providers as laboratories to ensure that decisions they make on new information systems over the next few years will be consistent with new notification requirements.