Regulatory Impact and Compliance Cost Statement - Statement of the Nature and Magnitude of the Problem and the Need for Government Action

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Regulatory Impact and Compliance Cost Statement
Statement of the Nature and Magnitude of the Problem and the Need for Government Action

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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 the 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;
introduction and consideration by Select Committee of the Law Reform (Epidemic Preparedness) Amendment Bill (which would provide for Prime Minister Notices to manage wide social and economic disruptions caused by major pandemics such as could be caused by avian influenza. The Law Reform (Epidemic Preparedness) Amendment Bill will also amend the Health Act, among other statutes, to extend and clarify the Health Act’s special powers and quarantine provisions).

Proposals whose details have been developed significantly since 2001 are summarised in the following subsections:

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 the Health Act 1956 reads:

"health information, in relation to an identifiable individual, means -
information about the health of that individual, including that individual's medical history;
information about any disabilities that individual has, or has had;
information about services that are being provided, or have been provided, to that individual;
information provided by that individual in connection with the donation, by that individual, of any body part, or any bodily substance, of that individual.

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 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 regulation 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 the 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 (ie 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 this is decided in the future 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 which 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 what range of powers 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 the 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 the 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. But these decisions did not specify how to balance the interest of the 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 detail needed to guide the development of provisions for quarantine powers. Nor did it include 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 coordination 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). However, 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 Food Act 1981, Smoke Free Environments Act 1990 and 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 the Public Policy Objective(s)

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 (Maori 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 illness 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 the Desired Objective(s)

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 which 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 (i.e., the availability of accurate, comprehensive and timely information on communicable diseases and other conditions of public health significance);
- criteria for specified conditions (i.e., 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 diseases, 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 the 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, 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 issue, or disability for preventive or early intervention strategies;
- monitoring the effects of health service provision.
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 to 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/programme;
- no identifying information on the register/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/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 such vaccine-preventable illness 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 undergo detention or isolation.
rights, duties and offences both for people with communicable conditions and health practitioners responsible for their management.
a two-tier approach to decision-making and procedures:
- 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 a person, but not to physically require, to be examined or tested for a high-risk condition;
review and appeal safeguards (e.g. 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 to issue, 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, e.g. that treatment is critically important to protect the public health (this would not involve treatment being compulsorily administered but could involve the alternative of isolation/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 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 people concerned while achieving public health objectives;
criteria for conditions to which contact tracing may be applicable, including a significant risk to the 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/household members information that is relevant to the risks posed to them by another family/household member or partner (where infected persons do not themselves inform those contacts), taking into account:

the serious nature of the condition;
a 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:

clarifies that the primary role of health agencies in relation to border control relates to the protection of human health and, in particular, to monitoring and management of people as actual or possible sources of infection;
provides the Ministry of Health with an overview responsibility for border health protection while other agencies may have responsibility for delivery of services;
expands the scope for border health protection provisions from cholera, yellow fever and plague to conditions that present significant risk and/or are communicable, consistent with the International Heatlh Regulations 2005;
updates 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 travelers, if appropriate;
provides powers to require information and share information, ability to trace and inspect goods where there is good reason to believe they present a public health risk, and 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, construction, of goods, things or 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 the Net Benefit of the Proposal, Including the Total Regulatory Costs (Administrative, Compliance and Economic Costs) and Benefits (Including Non-Quantifiable Benefits) Of the 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 to $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 how the information can be used for the 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, 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 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 NZ 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 two recipients rather than one, 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 would be prepared.

Providers of private health and disability services (that is, those which are not funded by district health boards) would also be required to provide health and disability data on request to the Ministry of Health under the proposed amendment to s 2D. This may have a compliance cost (as noted below in the BCCS).

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 current Health Act. 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 disease 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 nine. A total of 606 submissions were received from 1190 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 current Health Act. 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 in 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 noncommunicable 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/Agencies Consultation

Comments have been sought on the proposals as they have been developed over the last five years from the following government agencies: Civil Defence & 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, 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 Prime Minister and Cabinet.
The following agencies commented on this paper: Corrections, Civil Defence & 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.
The Ministry of Education commented on earlier versions of the proposals relating to non-communicable diseases. These proposals have now been modified and are considerably more limited in their impact.
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.
Other agencies, in particular 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.
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.
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.
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.
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.
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 which 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 (e.g., 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 two recipients rather than one, 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 to the Bill or similar flexible instrument).

Although private hospitals are not funded for reporting to 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 providers of health and disability services (that is, those which 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.

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