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von Tigerstrom, Barbara --- "Globalisation, harmonisation and the regulation of therapeutic products: the Australian New Zealand Therapeutic Products Authority project in global context" [2007] CanterLawRw 11; (2007) 13 Canterbury Law Review 287

Globalisation, Harmonisation and the Regulation of Therapeutic Products: The Australia New Zealand Therapeutic Products Authority Project In Global Context

Barbara von Tigerstrom[*]

The many aspects of globalisation have profound implications for the regulation of therapeutic products. The growth in international travel and trade, increasing globalisation of the industry, and developments in information and communications technology all present significant challenges to national regulation of therapeutic products. At the same time, many of these factors create increased incentives and opportunities for harmonisation in this area. This paper considers the movement toward greater harmonisation at the international and regional levels. Within this broader context, it examines the proposal to establish a joint agency to regulate therapeutic products in Australia and New Zealand. By creating a single regulatory agency to set and enforce standards in both countries, this unique undertaking would have resulted in a greater degree of integration than presently exists in other regions or in other areas of the trans-Tasman relationship. It will be analysed as a manifestation of common drivers toward harmonisation at the global level as well as an example of how multiple objectives can present challenges for integration.

I. Introduction

Governments around the world devote considerable energy and resources to the regulation of therapeutic products such as medicines and medical devices,[1] in order to ensure that their use will be safe and beneficial. The importance attached to this area and the current approach to regulation can be traced back to notorious examples showing the harm that can be caused by these products, such as the 'thalidomide tragedy' in the 1960s in which the teratogenic effects of thalidomide were revealed by severe congenital disabilities in thousands of children born to women who had taken the drug during pregnancy. Effective regulation of therapeutic products requires a substantial investment of human and financial resources, and must attempt to balance multiple and sometimes competing interests on the part of government, consumers, and industry.

The development and marketing of therapeutic products raise a wide range of legal issues, from intellectual property rights to the protection of human research subjects in clinical trials. This article focuses on the regulatory regimes that attempt to ensure the safety, efficacy and quality of therapeutic products, and considers some of the implications of globalisation for these regimes. There is already a large body of literature discussing certain aspects of globalisation and pharmaceuticals, particularly the impact of economic globalisation and free trade agreements on access to medicines. Some of the questions raised by international clinical trials have been explored as well. However, there remain to be considered many important issues relating to the regulation of therapeutic products.

The various aspects of globalisation affect legal regimes entrusted with controlling the marketing of therapeutic products in several different ways. On many difficult or controversial aspects of drug regulation, such as clinical trials, the regulation of complementary and alternative medicines, and direct-to-consumer advertising of pharmaceuticals, globalisation plays a role and has exacerbated the challenges facing regulatory agencies. The increasing globalisation of the industry has resulted in mounting pressure to harmonise regulatory requirements and procedures. Harmonisation, and the more general phenomenon of regulatory convergence, may take a variety of forms, from informal cooperation to full integration of shared regulatory mechanisms. This article will examine a range of objectives and models of harmonisation in the area of therapeutic products regulation, focusing on a unique project in Australia and New Zealand to establish a joint therapeutic products authority. The Australia New Zealand Therapeutic Products Authority project will be analysed with a view to characterising the model of integration that it represents and describing the competing interests that have presented a barrier to the project's fulfilment, notwithstanding the fact that it is probably the best model to satisfy the relevant objectives. This example illustrates a model of regulatory convergence that may be of interest to other jurisdictions, as well as some of the challenges that can arise in harmonisation initiatives.

II. Globalisation and Therapeutic Products Regulation

Most jurisdictions regulate therapeutic products in order to ensure their safety, efficacy and quality. This typically involves regulation at three stages: pre-marketing evaluation, marketing approval, and post-marketing surveillance. In order for a product to be marketed in a particular jurisdiction, it must be approved in order to ensure that it is safe, effective for its intended use, and of sufficient quality. Often the particular manufacturers or distributors of the product will have to be approved or licensed as well, to provide some assurance of the quality of their product. They may also be required to adhere to 'good manufacturing practices' (GMP). The approval to market a product will require the submission of evidence of safety and efficacy. In order for this evidence to be sought through the conduct of clinical trials, the product will need to be administered to human subjects before it has been approved. Therefore, in the pre-marketing evaluation stage, limited use of the product for these purposes will be permitted, subject to approval by an ethics committee and/or the regulatory agency and in accordance with 'good clinical practice' (GCP). The distinction between the pre-approval and marketing stages may be blurred in some cases, where 'expanded access' is given to a product that is still under investigation. Finally, after a product has been approved and released onto the national market, the third stage involves post-marketing surveillance. This entails collecting reports of any adverse reactions and other monitoring of the product's quality, efficacy, and safety. This describes the typical approach to regulating medicines; other therapeutic products such as medical devices and biologics may be subject to some or all of the same requirements. Therapeutic products may also be affected by regimes determining which products will be available in a publicly funded health care system.

The levels of complexity and effectiveness of this regulation vary widely across different countries. Some have very well developed and well resourced regimes, while a significant proportion have very weak regulatory regimes or none whatsoever.[2] Regulatory agencies everywhere are being challenged as advancing technology generates a growing array of increasingly complex products to be evaluated. For each of these products, agencies must balance the need for adequate evaluation to minimise risk against pressure from both industry and consumers to approve new products quickly. Governments have a responsibility to ensure the safety, efficacy, and quality of therapeutic products as part of their obligations to protect the right to health,[3] which have been interpreted as encompassing the government's role in ensuring the availability, accessibility, acceptability, and quality of goods and services necessary for health such as drugs and equipment, and preventing the marketing of unsafe drugs.[4] However, as therapeutic products become more diverse and complex, it is increasingly difficult and costly for states to maintain the capacity to meet these obligations.

At the same time, globalisation is also creating pressures on existing regulatory mechanisms. Globalisation, which can be generally understood as 'the expanding scale, growing magnitude, speeding up and deepening impact of interregional flows and patterns of social interaction', has spatial, temporal, and cognitive dimensions.[5] Specific aspects include trade liberalisation and the increasing volume and speed of international trade, developments in information and communication technology that link distant parts of the world more quickly and easily than ever before, and increased mobility of persons in the form of international travel and migration. This complex phenomenon has significant implications for health and health policy,[6] and it affects the marketing and regulation of therapeutic products in a variety of ways. For example, the internet has challenged the ability of regulators to control the marketing and dispensing of pharmaceuticals to their populations, as internet-based advertising can circumvent bans on direct-to-consumer advertising of therapeutic products and internet pharmacies may undermine the carefully regulated system of prescribing and dispensing pharmaceuticals.[7] There is a growing problem with international trade in counterfeit and low quality drugs, which can present a serious threat to patients' health.[8] Finally, awareness and availability of non-Western and traditional medicines have increased through travel, migration, and cross-cultural interaction, raising questions about whether and how they should be integrated into national regulatory frameworks designed primarily to deal with conventional Western pharmaceutical products.

The structure of the pharmaceutical industry has changed significantly in the last few decades, with a trend toward fewer, larger companies dominating the global market.[9] A relatively small group of large research-based multinational pharmaceutical companies account for more than three quarters of global sales.[10] These companies are based in a few countries but carry out production, packaging and marketing throughout the world, showing a pattern of increasing internationalisation.[11] 'Pressures on companies to remain competitive ... have been the key drivers of industry globalization. ... Given the need for such substantial investment [in research and development], economies of scale are critical to ensure an adequate volume of sales. The result has been horizontal and vertical integration of the industry' on a global scale.[12] To date consumption has been predominantly concentrated in a small number of countries, but this is changing as the industry seeks out new markets, especially in Asia.[13] The industry is therefore characterised by geographical concentration of ownership and control juxtaposed against increasing globalisation of production and consumption.

As this brief summary reveals, globalisation presents several types of challenges in therapeutic product regulation. The strongest drive has been toward harmonisation as a result of the global integration of the pharmaceutical industry. However there are also questions to be addressed with respect to the substance of regulations and national policy choices. In addition, globalisation creates or exacerbates challenges in enforcing national regulations. Although the primary focus of this article is on the harmonisation process, all of these aspects are intertwined to some extent and may complicate harmonisation efforts.

III. Harmonisation of Therapeutic Products Regulation

Regulatory Convergence and Harmonisation

It is important at the outset to understand what is meant by 'harmonisation' and how it relates to other forms of regulatory cooperation and coordination. States may cooperate in a variety of ways, ranging from informal sharing of information to the creation of shared regulatory mechanisms. Harmonisation generally involves making the policies, standards or procedures of two jurisdictions the same or more similar.[14] Although regulatory convergence may evolve in an ad hoc or even unconscious manner, harmonisation is a deliberate effort to eliminate or reduce differences between jurisdictions. The target of harmonisation may be broad guiding principles, policy objectives, specific rules and procedures, or any combination of these.[15] Harmonisation efforts also vary in their scope and the degree of similarity that is sought within that scope (that is, the 'margin' of difference that will continue to be tolerated).[16] They may be linked to economic or political integration,[17] or pursued among otherwise unrelated jurisdictions.[18]

We could understand harmonisation in a broad sense to include any reduction of differences between jurisdictions, but for the sake of clarity, the term 'convergence' will be used here to refer to this phenomenon, while harmonisation is used more narrowly to mean the process of making laws, policies, and procedures more similar in substance. Harmonisation, understood in this more specific sense, is just one of a range of ways in which convergence can take place. Cooperation, for example in the form of information sharing and technical assistance, can help to align regulatory processes and outcomes among the cooperating jurisdictions (though cooperation may also have other objectives).[19] At the other end of the spectrum, integration involves two or more jurisdictions sharing a single decision-making mechanism.[20] This would also achieve the goal of eliminating differences, but goes significantly beyond harmonisation in doing so.[21] In the integration model, each jurisdiction gives up some of its autonomy by transferring the power to make decisions on certain matters to a common authority. Other mechanisms to achieve convergence include equivalence and mutual recognition. Equivalence involves two or more jurisdictions treating each other's standards as the same, even though they may in fact retain some differences.[22] Finally, in mutual recognition, two or more jurisdictions accept each other's decisions, or some other aspect of the regulatory process, for their own domestic purposes.[23] Such recognition may occur informally or by agreement,[24] and although mutual recognition agreements (in which recognition is reciprocal) are most common, one jurisdiction may decide to recognise the acts or decisions of another.[25] Generally, states entering into mutual recognition agreements are already compatible, having also engaged in a significant degree of cooperation and harmonisation of standards.[26]

When examining any harmonisation effort or other form of convergence, a key question to ask is why the elimination of difference is considered to be desirable. This underlying rationale will vary depending on the context and must be understood before we can evaluate the process:

Harmonization is not an end in itself. Rather, it is a means of achieving goals such as greater efficiency or fairness. Both the validity of the harmonization claim and the effectiveness of its implementation must be judged in terms of some asserted purpose, and it is the purpose that determines whether the form of harmonization adopted is suitable.[27]

One rational for regulatory harmonisation views it as a form of 'deep integration' to facilitate international trade.[28] The idea is that free trade requires more than just the removal of traditional trade barriers like tariffs or quantitative restrictions. Differences in national regulations may also act as trade barriers by making it more difficult and costly for producers from one country to market their goods in another. Therefore, the objective of regulatory harmonisation is reflected in many contemporary trade agreements, including the Uruguay Round agreements like the Agreement on

Technical Barriers to Trade and the Agreement on Sanitary and Phytosanitary Measures as well as many regional and bilateral trade agreements. Although differences between jurisdictions are necessary for the fundamental notion of comparative advantage which underlies trade liberalisation, contemporary thinking distinguishes between forms of diversity which are legitimate (such as differences in natural resources) and those which may not be (such as differences in environmental standards).

The motivations for harmonisation and other forms of convergence can be understood in a more sophisticated way if we distinguish between 'normative' and 'nonnormative' claims.[29] A normative claim for harmonisation implies that a common standard is sought because it is a 'better' standard than that currently used in one or more of the harmonising jurisdictions. A nonnormative claim, by contrast, is neutral in that it does not assume that any particular standard is more desirable; rather it asserts that sameness or similarity of the standard itself is crucial to achieving the objective — that is, it does not matter which standard is chosen, as long as the harmonising jurisdictions have the same standard. A normative claim may be based on philosophical grounds, such as particular notions of justice.[30] Alternatively, both normative and nonnormative claims may be grounded primarily in economic considerations.[31] A particular rule may be chosen as the common standard because it is more efficient from an economic point of view. Similarity in regulations among jurisdictions will also tend to be more efficient because it will reduce transaction costs for producers. The elimination of difference may also have an important political function as a way of promoting fairness, that is, as a way of preventing what is viewed as unfair competition rather than legitimate comparative advantage.[32]

In reality, the distinction between normative and nonnormative claims may not be entirely clear, and a harmonisation effort may have several concurrent objectives. For example, an argument that two trading partners should have the same environmental standards may involve a normative claim on philosophical grounds that environmental protection is an important goal that should be pursued by both states. This would justify one or both states adopting a higher level of protection. At the same time, making the standards the same in both jurisdictions should prevent a 'race to the bottom' and keep one state from gaining an 'unfair' competitive advantage by lowering its environmental standards in an effort to attract investment or reduce costs for its domestic producers.[33] This objective is attained to some extent by making the standards the same, regardless of the actual level of protection chosen, so this is a nonnormative element of the argument for harmonisation. As can be seen from this example, although the nonnormative claim relies on some objective being achieved by harmonisation in itself, rather than the choice of some particular standard, it is by no means devoid of normative considerations since it relies on notions of fairness and other values.

Although the reduction of regulatory diversity will generally tend to increase efficiency in any sector, the structure of the industry and the way in which specific products are regulated may affect the objectives of convergence in particular contexts. In the case of therapeutic products, there are some distinct motivations for harmonisation and convergence in addition to the general objectives that are usually cited in relation to trade liberalisation. The overriding motivation for harmonisation of pharmaceutical regulation is reduction of costs for the industry. Developing pharmaceutical products is a costly and time-consuming process, with a much larger proportion of costs being devoted to research and development (R&D) than most other industries.[34] An investment of more than US$350 million is estimated to be required for each new drug, and the majority of this cost 'is attributable to the extensive clinical testing of products required to win premarketing approval from the FDA and other national regulatory agencies.'[35] The time required to develop, test, and obtain approval for a new drug is approximately ten years on average.[36] Since the value of new pharmaceutical products is heavily dependent on patent protection which is available for a limited period, the length of time that it takes to begin marketing a new product will have a significant impact on its profitability. It has been estimated that for each additional day of delay prior to marketing approval, the manufacturer loses about $1 million in revenue.[37] Therefore, streamlining and speeding up the approvals process is a major objective of the pharmaceutical industry.[38] Harmonisation or mutual recognition arrangements provide access to new markets at a lower cost for companies that need not invest as much time and resources to obtain approvals in each jurisdiction. In addition, it is possible that harmonisation may help to reduce product liability exposure for the pharmaceutical industry.[39]

From the government's perspective, convergence in this area of regulation also has several potential advantages. Faster approvals generally benefit consumers as well as industry, so this objective will be shared by a government that is under pressure to improve access.[40] In addition, governments' capacity to regulate therapeutic products is increasingly under stress, as products become more complex. Therefore, convergence in its various forms may be seen as away to alleviate this pressure on regulatory capacity[41] It may be easier for governments to achieve adequate oversight at a reasonable cost if they cooperate with other jurisdictions. Harmonisation of standards may also help to avoid the risk of companies 'dumping' substandard or harmful product on jurisdictions with weak regulation,[42] and thereby enable governments to better protect the health of their populations. Finally, cooperation or integration will create a wider net for the reporting of adverse drug reactions in the post-marketing phase, which should further improve patient safety.

The various models of convergence will serve these diverse objectives to a greater or lesser degree.[43] For example, harmonisation of standards may be seen as primarily beneficial to industry, given that it reduces compliance costs. Mutual recognition and integration respond more directly to government concerns about regulatory capacity and costs by eliminating duplicative efforts. Each model, however, also carries with it some potential disadvantages. For example, harmonisation assumes that diversity in policies and procedures is negative, whereas in fact differences may serve other policy objectives which will be undermined by harmonisation. Both recognition (whether mutual or unilateral) and integration require the governments involved to give up a degree of autonomy in areas of regulation which may traditionally have been under strict national control. As a result, whether convergence is desirable and what form it should take will depend on a complex interaction of interests and values.

Regional and Global Initiatives

Harmonisation of therapeutic products regulation is a relatively recent development, but there are ongoing activities at both the global and regional levels, as well as numerous formal and informal bilateral arrangements. For example, a number of states have chosen to recognise approvals by the United States FDA, either de jure, through a formal agreement, or de facto.[44] Another type of mutual recognition agreement allows local inspectors to carry out inspections of pharmaceutical manufacturing facilities on behalf of foreign government agencies.[45] The Pharmaceutical Inspection Convention (PIC) and Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) (collectively known as PIC/S) aim to harmonise good manufacturing practice (GMP) and related inspections. The PIC is a treaty adopted in 1970 among 10 European countries, to which a number of other European countries and Australia later acceded. It provides for mutual recognition of inspections, harmonisation of GMP requirements, and uniform inspection systems.[46] The PIC Scheme was formed in 1995 and includes all of the PIC countries as well as 10 others.[47] It is established as an Association under Swiss law and aims to facilitate cooperation, exchange of information, training of inspectors, and development of harmonised GMP.[48]

At the global level, the WHO promotes collaboration and coordination through a variety of initiatives as part of its mandate to 'develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products'.[49] Under its Constitution, the WHO has the authority to adopt legally binding regulations regarding, inter alia, 'standards with respect to the safety, purity and potency of biological, pharmaceutical and similar products moving in international commerce' as well as advertising and labelling of such products,[50] but it has yet to use this power.[51] The biannual International Conference of Drug Regulatory Authorities provides a forum for discussion and adoption of recommendations for national regulators. Other key WHO contributions are the development of guidelines by the WHO Expert Committee on Specifications for Pharmaceutical Preparations, provision of a system of globally recognised unique names for pharmaceutical substances (International Nonproprietary Names), and publication of the International Pharmacopoeia,[52] containing specifications for pharmaceutical products.[53] The WHO Medicines Strategy includes as one of its four key objectives the assurance of quality and safety of medicines, to be achieved, inter alia, through development of global norms and guidelines, promotion of good practices in medicine regulation, and promotion of regulatory harmonisation 'as appropriate'.[54]

The three largest centres of the pharmaceutical industry — the US, Europe and Japan — have participated since 1990 in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH has six parties, consisting of the regulatory bodies and industry associations from each of the three participating areas; in addition, the WHO, the European Free Trade Area (represented by Swissmedic, the Swiss therapeutic products agency) and Canada are non-voting observers.[55] A subcommittee called the Global Cooperation Group provides information about ICH activities and guidelines to interested companies or government agencies.[56] The ICH membership represents 90 per cent of global pharmaceutical sales, though only 15 per cent of global population.[57] This leads to a complex dynamic between the ICH and non-ICH countries. Although the ICH was not designed to be a global standard-setting organisation, this has been an 'inevitable consequence' of its influence.[58]

The ICH holds biannual conferences and its ongoing activities are administered by a Steering Committee. Parties and observers can bring proposals for harmonisation to the Steering Committee, and if there is sufficient interest the matter will be examined by the Steering Committee and an expert working group, potentially resulting in adoption of a Guideline on the issue.[59] Most ICH guidelines relate to one of the three key areas of quality, safety or efficacy, while a few are multidisciplinary or cross-cutting topics (eg, medical terminology and standards for electronic data transmission).[60] The ICH guidelines aim to minimise R&D costs and delays by establishing common positions on such issues as the testing required for various types of products, how clinical trials should be carried out, and what information is required in applications. For example, ICH Guideline E5 on 'Ethnic Factors in the Acceptability of Foreign Clinical Data' aims to facilitate the acceptance of foreign clinical data in new drug applications,[61] thus eliminating the need for clinical trials to be duplicated in each jurisdiction where a drug is to be marketed. This not only reduces costs for industry, but also, since the conduct of clinical trials always carries some risk to participants, should help to protect national populations from unnecessary harm.[62] It appears that some guidelines have a normative as well as nonnormative dimension. For example, the guideline that harmonised long-term toxicity tests not only

establishes a common standard but replaces the previous standard, 'Lethal Dose 50' (administering increased doses until 50% of laboratory animals died) with a standard of repeated dose toxicity tests for a maximum of six months, which should significantly reduce the number of animal deaths as well as cutting costs.[63]

One of the most important and ambitious initiatives has been the development of a Common Technical Document (CTD), which standardises the format of new product applications. This multidisciplinary guideline was proposed in 1996 by industry and required a more extensive process for development than the usual expert working group structure, ultimately being completed in 2002.[64] Use of the CTD format has been mandatory in Europe and Japan since 2003, and is highly recommended for submissions to the FDA.[65] The ultimate goal is the creation of a single dossier that can be used for submission to any of the ICH member regulatory authorities, but further harmonisation of regulatory requirements must occur before this goal can be realised.[66]

A parallel process similar to the ICH exists for medical devices. The Global Harmonization Task Force is made up of regulatory and trade association representatives from the US, the EU, Japan, Australia and Canada, and produces guidance documents on regulation of medical devices.[67] It is a voluntary process aiming to 'promote international convergence in regulatory requirements and practices' while recognising the right of participating regulatory authorities 'to regulate according to their applicable sovereign regulations'.[68]

Convergence is also occurring at the regional level, to varying degrees. As one might expect, it is most advanced in Europe, where the current regime includes elements of both mutual recognition and integration. The first efforts toward convergence in Europe began in the mid-1960s, and in 1975 the Committee for Proprietary Medicinal Products (CPMP) was established to review drug applications and issue non-binding opinions on whether products should be approved.[69] A decentralised procedure was also established, in which a manufacturer that had obtained approval from one national agency could submit applications to other member states, which were supposed to take the initial approval into account and have any objection reviewed by the CPMP.[70] This first version of the decentralised procedure is widely considered to have been a failure, since objections were common and time limits for approvals often ignored.[71]

As part of the move toward a single European market, a new centralised procedure was created, in which the CPMP evaluated new product applications, with recommendations from member states. Although this procedure was limited in that it was intended to be used for biotech products and the CPMP's opinions were non-binding, 'this new procedure was intended as the first move towards genuine supra-national evaluation.'[72] In 1993, the new European Medicines Evaluation Agency (EMEA, now known as the European Medicines Agency) was created.[73] The EMEA was the first transnational regulatory agency with the power to issue marketing approvals for new therapeutic products.[74]

Two procedures for approval of new therapeutic products now coexist within the EU. The decentralised (mutual recognition) procedure, which is a revised version of the earlier arrangements, allows companies to apply for marketing authorisation in one EU member state and then submit an identical dossier to other member states. The first state will send its assessment report to the other states, which then have ninety days to decide whether to recognise the approval. Unlike under the former decentralised procedure, the other states must recognise an approval unless there is a risk to public health, and the EMEA will arbitrate in case of a disagreement.[75] The centralised procedure involves a single application to the EMEA, with a positive opinion of the EMEA having the effect of a market authorisation for the whole of the EU. The actual assessments are done by national agencies, assigned on a competitive basis by the EMEA. A scientific committee of the EMEA then produces an opinion which is adopted as a legally binding decision of the European Commission.[76] The centralised procedure is mandatory for biotechnology products and optional for other therapeutic products.[77] It has been estimated that use of the centralised procedure rather than separate applications to individual member states could save a large pharmaceutical company $5 million annually.[78] With these procedures, the EU has effectively created a single market for therapeutic products, although there is still limited scope for divergent national positions. Centralised authorisation does not affect 'the powers of Member States' authorities as regards setting the prices of medicinal products or their inclusion in the scope of national health system or social security schemes',[79] and member states are permitted 'exceptionally to prohibit the use in their territory of medicinal products for human use which infringe objectively defined concepts of public policy and public morality',[80] specifically contraceptives or abortifacients.[81]

Other regions show a variety of models and degrees of convergence. The Gulf Cooperation Council (GCC)[82] has developed a system of centralised drug registration that appears to be similar in many respects to the European regime.[83] The Gulf Central Committee for Drug Registrations is responsible for registration of companies and products, inspection of companies for good manufacturing practices, and approval of quality control laboratories. New product applications may be submitted centrally or nationally, and re-registration in national markets may or may not be required depending on the country.[84] The Pan American Network for Drug Regulatory Harmonization (PANDRH) promotes harmonisation in the Americas through dialogue, adoption of recommendations and technical cooperation. It encourages 'convergence of drug regulatory systems' in the region. Its membership is broader than ICH, including regulatory authorities, industry representatives, consumer groups, academics, professional associations, regional economic integration groups, global harmonisation initiatives, and other interested groups.[85] It holds conferences every two or three years, at which proposals for harmonised standards and guidelines may be adopted.[86] In Asia, a working group (Pharmaceutical Product Working Group) of the Association of South-East Asian Nations (ASEAN)[87] is working toward harmonisation of pharmaceutical regulation as part of the elimination of technical barriers to trade within the ASEAN Free Trade Area. It has used the ICH as a model, developing guidelines and a common technical document.[88] Harmonisation has also been discussed within the Life Sciences Innovation Forum of Asia-Pacific Economic Cooperation (APEC) but does not appear to have yet resulted in any formal arrangement. Finally, the Protocol on Health to the Treaty of the Southern African Development Community[89] provides that its States Parties will cooperate in the harmonisation of policies on health technology and equipment (article 27) and of procedures for quality assurance and registration of pharmaceuticals (article 29).[90] A set of guidelines on pharmaceutical medicines harmonisation were developed in an effort to improve quality, standardise regulatory requirements and eliminate duplication of efforts.[91]

IV. Australia New Zealand Therapeutic Products Authority Project

In late 2003, Australia and New Zealand signed a treaty providing for the creation of a joint agency to regulate therapeutic products,[92] which would essentially replace the existing Australian Therapeutic Goods Administration (TGA) and New Zealand Medicines and Medical Devices Safety Authority (Medsafe).[93] This ambitious and novel initiative, which had been many years in the making, took a significant step closer to realisation in the past year with the introduction of implementing legislation in New Zealand[94] and the release of draft legislation in Australia,[95] but then was suddenly put on hold when the New Zealand government announced on 16 July 2007 that it was not proceeding with the legislation.[96] The joint scheme contemplated under the Treaty would represent an unprecedented degree of regulatory integration between Australia and New Zealand, or indeed, it is believed, between any two countries in the world.[97]

Development of the Australia New Zealand Therapeutic Products Authority (ANZTPA)

Reflecting the broader global context described above, there were two main shared motivations for entering into the ANZTPA Treaty: removing barriers to trade and addressing limitations in regulatory capacity. Removal of trade barriers is a major objective, in keeping with the already close trading relationship between Australia and New Zealand.[98] Once the scheme came into force, it would join them as a single market for therapeutic products: products approved by the Authority would, in all but exceptional cases, be able to be marketed in either jurisdiction. This would substantially reduce costs for those marketing their products in both countries. The New Zealand government anticipated that this would help its therapeutic products industry to develop, since manufacturers would have access to a much larger market and potentially find it easier to expand into other international markets as well.[99]

The second major motivation for the initiative was a concern about regulatory capacity. This concern is more immediate for New Zealand, being the smaller jurisdiction and facing more intense pressures with respect to capacity, in particular the difficulty of maintaining sufficient local expertise.[100] It has been noted that 'due to the increasing difficulty and cost of attracting and retaining appropriately skilled staff, New Zealand will find it increasingly difficult to meet its regulatory objectives for pharmaceuticals to appropriate standards and within acceptable time frames'.[101] Australia could also be expected to derive some benefit in this respect, especially in the longer term:

While New Zealand faces a capacity problem now, Australia expects to fact a similar challenge to its regulatory capacity in the longer term. ... Neither Australia nor New Zealand alone has the capacity to operate a world-class regulatory scheme for therapeutic products on an ongoing basis; together, the 2 nations can pool resources and ensure that citizens of both countries gain the maximum protection in the area of therapeutic products safety.[102]

It was also expected that the joint agency would be better positioned to cooperate with other agencies and influence global standards.[103]

A third important objective, at least from New Zealand's perspective, was to address widely perceived weaknesses in New Zealand's 'outdated' legislative scheme governing therapeutic products.[104] Specifically, the regulation of medical devices and complementary and alternative medicines (CAM) is minimal under New Zealand's existing legislation. It was clear from the outset that bringing New Zealand's position more into line with other jurisdictions (primarily Australia but also other states such as the other members of the Global Harmonization Taskforce[105] ) was a distinct and important objective for the government, which would have been pursued even if the joint agency initiative did not proceed.[106] However, the fact that the reform effort has occurred as part of this project complicated the endeavour significantly, since this has been by far the most controversial aspect of the project within New Zealand, as will be discussed below.

The ANZTPA initiative developed in the context of already extensive trade liberalisation between Australia and New Zealand. The two countries have one of the most comprehensive trade liberalisation arrangements in the world, including free trade in goods and services under the Agreement on Closer Economic Relations (CER),[107] supplemented by a range of other agreements. The Trans Tasman Mutual Recognition Arrangement (TTMRA) allows goods that may legally be sold in Australia to be sold in New Zealand (and vice versa), effectively creating a single market for goods.[108] Therapeutic products were identified as a category of goods where 'significant differences in regulation existed' and thus were subject to a temporary special exemption while a cooperation programme was undertaken.[109] The possible options under the TTMRA included a permanent exemption for therapeutic products, a mutual recognition arrangement or 'harmonisation'.[110] The health ministers of both countries agreed in 1991 to pursue harmonisation of therapeutic products regulation, and in 2001 agreed to explore the feasibility of a joint agency.[111]

The Treaty thus negotiated was signed by both states on 10 December 2003. The Treaty envisages the establishment of a joint scheme for regulation, standard-setting, post-market monitoring, and enforcement, to be administered in both countries by a single joint agency (the Authority).[112] An approval granted by the Authority would normally have effect in both countries.[113] A Ministerial Council and a Board, both with representation from each country, would be responsible for oversight and governance of the Authority, respectively[114] The Authority would be established as a corporate body under Australian legislation, and given the rights, powers, and privileges required to administer the scheme in both countries by their respective implementing legislation.[115] The Ministerial Council would have the power to make 'Rules' (the equivalent of regulations) on a broad range of matters, and the Authority (through its Managing Director) could also make 'Orders' dealing with specific matters. Rules and Orders would have effect in each country through that country's implementing legislation.[116]

Following the conclusion of the Treaty, work progressed to establish the new agency, now referred to as the ‘Australia New Zealand Therapeutic Products Authority' (the ‘Authority' or ANZTPA), and develop its policies and procedures. Several rounds of consultation were undertaken, covering a wide range of topics. The Authority was to formally come into existence when both states passed implementing legislation and exchanged diplomatic notes, bringing the Treaty into force.[117] This was originally expected to occur as early as 2005, but was delayed several times by the drafting of legislation and other preparatory work, before being put on hold indefinitely in July 2007.[118]

The opposition to the ANZTPA in New Zealand that ultimately led to the suspension of the initiative existed even before the Treaty was signed. The New Zealand parliamentary Health Committee, in a report released on 9 December 2003 (one day before the Treaty was signed), had recommended against the joint agency model, preferring a mutual recognition approach.[119] A subsequent report in 2004 raised a series of concerns about the Treaty which the Health Committee believed needed to be addressed before the Treaty came into force.[120] When the Therapeutic Products and Medicines Bill was referred to the Government Administration Committee in 2007, the Committee was unable to reach agreement on the Bill and therefore could not recommend that it be passed.[121] Subsequent to this report and a substantial media and political campaign opposing the Bill, the government in New Zealand determined that it had insufficient support from parties in Parliament to ensure its passage and announced that it would not proceed.[122] Opposition to the scheme has centred on two main concerns: the impact on complementary and alternative medicine (CAM) products in New Zealand, and issues relating to sovereignty and accountability.

The most contentious aspect of the ANZTPA initiative has been its potential impact on the regulation of CAM products. As noted above, CAM products are currently subject to minimal regulation in New Zealand.[123] The existing approach to CAM products in New Zealand is best described as a 'permissive, laissez faire system' which in practice amounts to deregulation.[124] Most such products are classified as 'dietary supplements' and do not require pre-marketing approval or licensing; they are only subject to certain restrictions regarding claims and labelling.[125] Some products would be classified as medicines and subject to the usual requirements under the Medicines Act 1981 and its regulations, but 'many products that should be regulated as medicines ... are being sold as dietary supplements under the Food Act, without quality control or safety assessment'.[126] Lack of enforcement of both the Dietary Supplements Regulations and medicines legislation is a significant problem. This situation has been widely viewed as a weakness of New Zealand's regulatory regime, and the desire to change New Zealand's approach to regulating CAM products and medical devices was one of several motivations for entering into the joint agency arrangement. Regulatory reform in this area is a response to 'concerns that the New Zealand regulatory regime is inconsistent with that of other developed countries and inadequate in the management of health and safety risks from the use of medical devices and complementary healthcare products'.[127] However, not everyone agrees that stricter regulation would be beneficial. The different approaches to regulating CAM products reflect distinct views on the regulation of complementary medicine,[128] but the immediate practical concern is the impact of the proposed change on the New Zealand CAM products industry.[129] Although regulation of CAM products has a clear health and consumer protection rationale, some argue that consumer choice would suffer because additional regulatory requirements would impose costs on industry and therefore result in products becoming more expensive or even unavailable.[130] Some industry stakeholders also argued that they would be driven out of business by the new requirements.[131]

While these concerns may a valid basis, some arguments on this issue have seemed to misunderstand or exaggerate the likely impact of the ANZTPA scheme on CAM products. The approach to regulating therapeutic products that was to be adopted by the ANZTPA is a risk-based approach, under which the level of regulation is dependent on the risk presented by the type of product. Most CAM products would be classified as Class 1 or low-risk products, and therefore subject to minimal regulation, consisting of licensing based on submission of information and a declaration as to safety and quality.[132] While this does impose additional requirements compared to the status quo position in New Zealand, it is not a strict or onerous regime and is comparable to the approach taken to CAM products in other common law jurisdictions.[133] Thus some of the criticisms of the ANZTPA on this issue seem to have been exaggerated, and indeed the New Zealand Advertising Standards Authority found that an advertising campaign opposing the Therapeutic Products and Medicines Bill breached advertising standards by making absolute claims that did not distinguish fact from opinion, lacked an adequate level of proof, and were 'likely to play on fear'.[134] It is unfortunate, to say the least, that the decision to put the initiative on hold was partly the result of pressure based on misunderstanding and misinformation, rather than informed debate. It should also be noted that the concerns expressed by industry opponents did not represent the position of all CAM producers.[135]

Specific concerns were also raised with respect to the impact of the scheme, and in particular the new regime for CAM products, on Maori traditional medicines. The use of traditional medicines by Maori healers for individual patients (as opposed to commercialised or mass-produced versions of traditional remedies) was to be exempted from the regulatory requirements of the new regime.[136] Furthermore, intellectual property protection of therapeutic products was not intended to be within the ANZTPA's mandate, and the Treaty specified that it was not intended to affect other laws such as intellectual property laws.[137] Nevertheless, concerns remained that the ANZTPA could restrict Maori use of traditional medicines and that it might somehow affect Maori claims to intellectual property rights in traditional medicines.[138] These concerns led to the Maori Party refusing to support the Therapeutic Products and Medicines Bill.[139] The proposal to exempt Maori traditional medicines from the scheme did not satisfy these critics, because they sought a guarantee that the exemption would continue, and questioned whether they could trust the government to maintain it.[140]

The other main concern raised in opposition to the initiative has been the perceived loss of sovereignty and lack of accountability that could result from the joint agency model. This issue is not entirely separate from the question of CAM and traditional medicines regulation, since part of the objection to the regulatory regime for CAM seems to involve the prospect of adopting the Australian approach,[141] and Maori concerns about losing the traditional medicines exemption included a fear that a joint trans-Tasman agency 'will have a limited capacity to appreciate' Maori culture and values.[142]

From the outset it has been acknowledged that entering into a joint scheme would mean a 'reduced ability to regulate according to the specific conditions and preferences of New Zealand'.[143] Although approvals granted by the Authority would normally have effect in both countries,[144] there would be some limited room for differences under the contemplated scheme. Approvals could apply differently in Australia and New Zealand or apply in only one country where (a) one country has notified a 'departure' from common standards, (b) the Authority considers that different requirements are justified by differences in 'public health, safety, environmental or cultural circumstances', or (c) the Rules made by the Authority provide for differences.[145] Departures from common standards are permitted under Article 12, which allows either party to exclude or modify the application of the joint scheme to a specific therapeutic product or class of product. This may be done by domestic regulations, but only where 'it is necessary to do so having regard to exceptional public health, safety, third country trade, environmental or cultural factors'.[146] Departures must be kept under review and must not be more trade restrictive than necessary or result in less favourable treatment for imports from the other party.[147] The New Zealand Bill provides for regulations to be made in respect of products that are excluded under Article 12.[148] These provisions allow for a margin of difference within defined limits.

As to the control over the joint agency, the New Zealand government has always stressed that decisions made by the Ministerial Council will be by agreement of the Australian and New Zealand Health Ministers, ensuring 'an equal say'.[149] This can be compared to the joint food standards agency where New Zealand has one representative among Australian Commonwealth plus states and territories.[150] Questions have also been raised, however, about the mechanisms for accountability to and control by the New Zealand Parliament. In particular, the process relating to Rules and Orders under the new scheme has been scrutinised, since these instruments will be the means by which many crucial policy decisions and technical details of the scheme will be implemented.[151] Rules are essentially the equivalent of regulations, but the usual procedures for regulations do not necessarily apply to them.[152] The Government Administration Committee, in its review of the Therapeutic Products and Medicines Bill, suggested that Rules and Orders be subject to the scrutiny and complaints jurisdiction of the Regulations Review Committee.[153] It also would have recommended that all Rules and Orders be referred to the parliamentary Health Committee for consideration.[154] A submission by the New Zealand Law Society also suggested that Rules and Orders be published in the Gazette before they take effect.[155]

Following the decision in July 2007 to put the initiative on hold, the key question is how the Australian and New Zealand governments should proceed. They have stated that they will be taking stock of the work done so far and considering options for harmonisation.[156] As of the date of writing, it is not clear whether or how the joint agency initiative will proceed, or whether an alternative arrangement will be negotiated. In deciding how to move forward, it may be useful to consider, in light of the governments' objectives and the various models of convergence discussed above, how the joint agency model compares to possible alternatives.

The Joint Agency Model

The joint scheme contemplated under the Treaty and implementing legislation was to be the 'first example of a true trans-Tasman authority'.[157] It represents a step beyond the current scheme for food standards, for example, in which standards are set by a joint agency (Food Standards Australia New Zealand) but then these standards (the Australia New Zealand Food Standards Code) are incorporated into each country's legislation and enforced by its authorities.[158] For New Zealand, the proposed scheme would entail in essence that a foreign corporate entity be given the authority, by NewZealand legislation, to set and enforce standards within New Zealand. Although the Authority was designed to provide equal representation of both countries in key decisions,[159] this still presents some practical and political challenges. Furthermore, the transition to the joint agency would bring with it harmonisation of the two countries' approaches to regulating therapeutic products, which would entail some substantive changes to New Zealand's previous position.

In deciding to proceed with a joint agency model, the Australian and New Zealand governments had considered a number of other potential models, which resemble the range of options for convergence and harmonisation discussed above. In addition to the status quo, which was seen as unsustainable, at least from New Zealand's perspective, options included enhancing each of the domestic regimes separately or unilateral recognition by New Zealand.[160] Cooperation between separate regimes, mutual recognition, or some harmonisation of standards and procedures would also be possible alternatives to a joint agency.

As discussed above, any harmonisation initiative must be assessed in light of its objectives.[161] In this context, the key objectives have been identified as trade liberalisation, addressing capacity limitations, and the reform of New Zealand's regime governing CAM products and medical devices. However, the concerns that have been raised in response to the initiative point to a range of diverse objectives and interests, in addition to those identified by the governments. These are factors that will determine whether the outcome will be viewed as acceptable in each jurisdiction. For example, in any process of convergence, and increasingly as it moves toward the integration end of the spectrum, questions about sovereignty will be raised, since recognition, harmonisation, and integration all entail giving up a degree of control over key domestic policy decisions. The concern with protecting sovereignty is particularly intense for smaller jurisdictions like New Zealand.

The interests of industry and consumers also need to be scrutinised carefully, since they may not necessarily be uniform. We can expect, for example, that industry will benefit from harmonisation and integration because these will reduce compliance costs, which, as we have seen, are a significant burden in the therapeutic products sector. However, this is only true of producers that anticipate marketing their products in more than one jurisdiction. Small producers intending only to market in New Zealand will not benefit significantly from the initiative, and in fact may see themselves as disadvantaged to the extent that harmonisation raises the standards for compliance. Similarly, consumer protection is expected to be enhanced when therapeutic products regulation is harmonised 'upwards', but New Zealand consumers have been concerned about the loss of some products that may result from more stringent regulation. This diversity of interest has been particularly notable in the debate regarding CAM regulation under the ANZTPA.

Taking into account these multiple objectives and considering the various forms of convergence discussed above, we can better characterise the nature of the ANZTPA initiative and evaluate it against other possible models. The establishment of a joint agency with the power to issue approvals effective in both jurisdictions, creating a single market, is a form of regulatory integration. It necessarily entails harmonisation of both substantive rules and procedures, with a narrow margin of difference. The desire for harmonisation has both a normative and nonnormative component in this case. Liberalisation of trade between the two countries and reduction of costs for industry depend on harmonisation of standards and procedures. This is a nonnormative claim since for this objective, it does not much matter what standards and procedures are chosen, provided that they are the same. It will be most beneficial if they are also aligned with those of other trading partners, but again this is a nonnormative claim. However, from New Zealand's perspective, at least, regulatory harmonisation as it applies to medical devices and CAM products is also based on a normative claim. The New Zealand government has a distinct normative motivation (primarily consumer safety) for changing its regulatory approach to these products. Therefore adjusting its position to match Australia's is in this respect not just a matter of facilitating trade but a substantive policy choice.

This initiative has raised concerns about sovereignty, particularly since integration goes beyond harmonisation to establish shared governance structures. However, any form of regulatory convergence will entail some loss of sovereignty for participating governments. By agreeing to modify their standards, recognise others' regulatory decisions, or transfer decision-making power to a shared authority, governments give up the ability to make autonomous decisions on matters within the sphere of their sovereign jurisdiction. It must be appreciated that governments give up a significant degree of sovereignty under a mutual recognition or unilateral recognition ('abdication') model, which has been suggested as an alternative in this context.[162] In fact, recognition generally entails a greater sacrifice of sovereignty, since it requires a government to agree to recognise a decision (such as a product marketing approval) over which it may have had little or no control. By contrast, in the joint agency model, both Australia and New Zealand are represented and have a say in decisions of the Authority, and there are several mechanisms by which the Authority can be held accountable to both governments.

It has been acknowledged that shared standards could mean that 'standards do not fully reflect New Zealand's own circumstances and preferences';[163] the same could be true for Australia although the concern seems to be more intense for New Zealand given its smaller size and the fact that its therapeutic products regime has been specifically targeted for reform, meaning that it will experience more changes. The joint agency regime is designed to allow accommodation of differences in 'exceptional circumstances',[164] which may not satisfy its critics. However, any increase in the degree of latitude for accommodation of differences will compromise the other objectives of the regime. The desire to protect autonomy will always need to be weighed against efficiency and other objectives, since the ability to maintain divergent national positions tends to undermine the benefits of convergence. The margin for difference that is provided for in the ANZTPA Treaty accommodates sovereignty concerns, but almost inevitably undermines other objectives: any differences will detract from trade liberalisation and efficiency objectives, and unless each country intends to leave excluded products entirely unregulated (which seems unlikely), some domestic capacity will have to be retained to carry out this autonomous regulation.

From the perspective of industry, a preference for tighter harmonisation and integration is supported by a recent analysis of the European regime, which suggests that a weaker mutual recognition approach is not very effective. If applicants cannot rely on reciprocal approval, then the benefits of a mutual recognition regime to industry are marginal.[165] It has been suggested that 'without a meaningful central authority, divergent national interests will eventually thwart harmonization efforts'.[166] The greater scope there is for diversity within the regime, the less effective it will be in terms of reducing compliance costs and removing barriers to trade. A joint agency with unified approvals and enforcement, with very limited room for national deviation from joint decisions, is probably the ideal for industry — at least for larger producers that plan to market in both countries. An assessment of regulatory options carried out in 2002 concluded that the joint agency model would contribute most to trade liberalisation objectives.[167] Furthermore, although concerns have been raised about the impact on New Zealand producers of increased compliance costs with the new regime, it has been suggested that the cost to industry from increased regulation of CAM products and medical devices would be even greater if New Zealand established its own comparable regime for regulating these products.[168] The cost to government would obviously also be higher if it were to proceed with independent reform of its regulatory scheme.[169]

The regulatory capacity concern also seems to be better addressed by a single agency than by other models. As long as a national agency has to be maintained to set and/or apply standards,[170] local technical capacity will be required. Even under a mutual or unilateral recognition model, the local agency needs to be able to assess when departures from a foreign regulatory decision are justified. The 2002 regulatory assessment suggested that a joint agency would enjoy economies of scale and scope, allowing high quality regulation at lower cost.[171] These benefits could be increased by combining the joint agency with mutual recognition of other regulatory agencies: 'the improved international standing that a joint regulator is expected to enjoy would increase the potential to develop mutual recognition agreements with other regulators which would help to alleviate capacity concerns.'[172] It was thought that for New Zealand, especially, it would otherwise be difficult to get other regulators to cooperate with unilateral or mutual recognition as New Zealand had little to offer in return, and there would be a perception that New Zealand was simply 'free-riding' on others' regulatory regimes.[173]

Although many complex factors are at play, it seems reasonably clear from this analysis that the joint agency approach is likely to be the best option to satisfy the governments' identified objectives. Other options would not achieve those objectives as well, and would be subject to many of the same criticisms as the ANZTPA initiative. To some extent, those criticisms can be addressed in the implementation of the scheme, for example through enhanced accountability mechanisms to ensure effective control by the New Zealand government, and the use of provisions allowing for a margin of difference. However, gains in sovereignty and control will have trade-offs in decreased efficiency, and undermine some of the scheme's objectives, so a balance between these competing objectives needs to be struck. The controversy surrounding the regulation of CAM products is more difficult to deal with, because the harmonisation of CAM regulation is based on a distinct normative claim, relating to concerns about consumer health and safety. This means that proceeding with the establishment of the ANZTPA but excluding CAM products from its scope, which was discussed as a possible compromise solution,[174] will not satisfy key interests and objectives of the initiative. The central difficulty is that the normative claim itself is contested, because some do not accept that stricter regulation is necessary or desirable. Unfortunately, the debate about this regulatory objective, which would exist regardless of the model chosen,[175] has become intertwined with the fate of the joint agency as a model of convergence.

V. Conclusion

As the health and safety of the world's people, and the economic activities of its industries, are increasingly interconnected, the drive to harmonise regulatory regimes has emerged as a compelling objective. However, there are numerous means by which harmonisation or convergence can take place, and multiple objectives that they seek to satisfy. The existence of diverse objectives and interests can present challenges for harmonisation, as has been all too evident in the context of the ANZTPA initiative. Trade liberalisation, alleviating pressure on regulatory capacity, and reform of weak and outdated regulatory regimes are all common harmonisation objectives which are present in the initiative to establish a joint Australia-New Zealand therapeutic products regime. If implemented, the joint agency could serve as a model that would usefully inform initiatives in other jurisdictions, many of which will be suffering similar pressures on their capacity to regulate effectively in this complex field. In the trans-Tasman therapeutic products context, the joint agency model does seem to be the one that best satisfies the relevant objectives and interests. It would therefore be unfortunate if this unique and promising initiative were to be abandoned because of resistance to one aspect of the regime, especially when that resistance may not represent well-informed or widely-held concerns. However, the experience also points to concerns involving control over domestic policies and decision-making processes, which are likely to arise in any harmonisation initiative. The ongoing task, then, will be to determine the extent to which concerns can be addressed without compromising other objectives of the initiative, both in the design and implementation of a harmonisation model. Again, the ANZTPA model could be instructive as an example of balancing sovereignty and efficiency concerns in the context of harmonisation.

Barbara von Tigerstrom, BA, MA, LLB, PhD, is Assistant Professor at the University of Saskatchewan College of Law.

[*] An early version of this article was presented at a workshop on globalisation and health at the University of Sydney in November 2005. The author would like to thank Professors Don Rothwell and Belinda Bennett for the invitation to the workshop. Research assistance by Zoe Oxaal, Jodi Roach and Amanda Wickett (LLB students, University of Saskatchewan College of Law) is gratefully acknowledged.

[1] Therapeutic products are products that have, or are represented to have, a therapeutic purpose. Examples of therapeutic products include diagnosis or treatment of a disease or condition, influencing human physiological processes, and testing humans for susceptibility to disease. The primary categories of therapeutic products are pharmaceuticals or medicines, biologics or biological products (such as blood products, other tissues, vaccines, and gene and cell therapy products), and medical devices.

[2] The World Health Organization (WHO) estimates that one third of its members have no regulatory authority or a very limited capacity for regulation: WHO, Medicines Strategy 2004-2007: Countries at the Core (2004) 95.

[3] International Covenant on Economic, Social and Cultural Rights, opened for signature 16 December 1966, 993 UNTS 3, art 12 (entered into force 3 January 1976).

[4] Committee on Economic Social and Cultural Rights, General Comment 14: The Right to the Highest Attainable Standard of Health, UN Doc E/C.12/2000/4 (2000) [12], [34].

[5] David Held and Anthony McGrew, 'The Great Globalization Debate: An Introduction' in David Held and Anthony McGrew (eds), The Global Transformations Reader: An Introduction to the Globalization Debate (2nd ed, 2003) 1, 3-4.

[6] See, eg, Kelley Lee (ed), Health Impacts of Globalization: Towards Global Governance (2003); Derek Yach and Douglas Bettcher, 'The Globalization of Public Health, I: Threats and Opportunities' (1998) 88 American Journal of Public Health 735; David Woodward et al, 'Globalization and Health: A Framework for Analysis and Action' (2001) 79 Bulletin of the World Health Organization 875.

[7] See, eg, Nick Fox and Katie Ward, 'Global Consumption and the Challenge to Pharmaceutical Governance in the United Kingdom' (2005) 331 British Medical Journal 40.

[8] See, eg, WHO, 'Combating Counterfeit Drugs: A Concept Paper for Effective International Cooperation' (Background paper for the Combating Counterfeit Drugs: Building Effective International Collaboration Conference, Rome, 16-18 February 2006) <http://www.who. int/medicines/events/FINALBACKPAPER.pdf> at 9 October 2007; Todd A Rosenfeld, 'The Counterfeit Drug Invasion: How Drug Reimportation Unjustifiably Poses a Threat to the Health of the U.S. Public' (2004) University of Pennsylvania Journal of International Economic Law 1047.

[9] Kelley Lee, Globalization and Health: An Introduction (2003) 71-2; Robin J Harman, Development and Control of Medicines and Medical Devices (2004) 215.

[10] Bryan L Walser, 'Shared Technical Decisionmaking and the Disaggregation of Sovereignty: International Regulatory Policy, Expert Communities, and the Multinational Pharmaceutical Industry' (1998) 72 Tulane Law Review 1597, 1664.

[11] Lee, above n 9, 72.

[12] Ibid 73.

[13] Ibid 72-3.

[14] Compare David W Leebron, 'Lying Down with Procrustes: An Analysis of Harmonization Claims' in Jagdish Bhagwati and Robert E Hudec (eds), Fair Trade and Harmonization: Prerequisites for Free Trade? (1996) vol 1, 41, 43: 'Harmonization can be loosely defined as making the regulatory requirements or governmental policies of different jurisdictions identical, or at least more similar'. See also Trans Atlantic Consumer Dialogue (TACD), TACD Briefing Paper on Mutual Recognition Agreements (MRA's) (2001) 1 <> at 9 October 2007.

[15] Leebron, above n 14, 44-6.

[16] Ibid 47.

[17] Jagdish Bhagwati, 'The Demands to Reduce Domestic Diversity among Trading Nations' in Jagdish Bhagwati and Robert E Hudec (eds), Fair Trade and Harmonization: Prerequisites for Free Trade? (1996) vol 1, 9, 31, 34-5.

[18] Leebron above n 14, 48-9.

[19] This process of information sharing and consultation can also be referred to as 'cross-fertilization': Marney L Cheek, 'The Limits of Informal Regulatory Cooperation in International Affairs: A Review of the Global Intellectual Property Regime' (2001) 33 George Washington International Law Review 277, 279-80.

[20] This may also be referred to as 'consolidation': Walser, above n 10, 1661 ff.

[21] Leebron, above n 14, 43, 48-9.

[22] TACD, above n 14, 4.

[23] Ibid 5-6.

[24] Kalypso Nicolaidis and Gregory Shaffer, 'Transnational Mutual Recognition Regimes: Governance Without Global Government' (2005) 68 Law and Contemporary Problems 267, 273.

[25] Walser refers to this as 'abdication': Walser, above n 10, 1650-1.

[26] Cheek, above n 19, 280; Nicolaidis and Shaffer, above n 24, 268-9.

[27] Leebron, above n 14, 42 (footnotes omitted).

[28] Jagdish Bhagwati, 'Introduction' in Jagdish Bhagwati and Robert E Hudec (eds), Fair Trade and Harmonization: Prerequisites for Free Trade? (1996) vol 1, 1.

[29] Leebron above n 14, 501-51.

[30] Bhagwati above n 17. 9-18.

[31] Ibid 20-31.

[32] Ibid 31-2.

[33] Ibid 31-3.

[34] Walser, above n 10, 1647.

[35] Ibid. See also Arthur A Daemmrich, Pharmacopolitics: Drug Regulation in the United States and Germany (2004) 157. More than half of industry spending on R&D is for clinical trials.

[36] Walser above n 10, 1648.

[37] Ibid.

[38] WHO, 'Global Harmonization and the ICH' (2000) 14 WHO Drug Information 145; Patrice Trouiller, P Folb and K Weerasuriya, 'Legal and Regulatory Issues Affecting Drug Development for Neglected Diseases: Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use' (Médecins Sans Frontières Drugs for Neglected Diseases Working Group Expert Paper, September 2001) 133 <> at 9 October 2007.

[39] Thomas M Moore and Siobhan A Cullen, 'Impact of Global Pharmaceutical Regulations on U.S. Products Liability Exposure' (1999) 66 Defense Counsel Journal 101.

[40] See, eg, Walser, above n 10, 1651 regarding a mutual recognition agreement between Russia and the United States, which was hoped to provide better access to pharmaceutical products for Russian consumers.

[41] WHO, 'Norms, standards and guidance for pharmaceuticals' <> at 9 October 2007. See also below at nn 100-102 and accompanying text.

[42] See, eg, Christian Harlan Moen, 'Companies knowingly sold virus-tainted blood products abroad, class action claims' (August 2003) Trial72.

[43] On the various interests served by 'abdication', harmonisation and consolidation (i.e. integration), see Walser, above n 10, 1672-5.

[44] Ibid 1650-5. Walser describes a unilateral recognition (or 'abdication') agreement by which Russia would recognise FDA approval rather than requiring submission of the usual application dossier. He also notes that 'the FDA is widely viewed as a de facto local drug registration agency by a number of countries in Latin America and Eastern Europe': at 1652.

[45] Harman, above n 9, 191.

[46] PIC/S, 'Background to PIC’ <> at 9 October 2007.

[47] PIC/S, 'Accession Dates' <> at 9 October 2007. A number of further applications for membership are under consideration: PIC/S, 'PIC/S Committee Meeting, Geneva, Switzerland' (Press Release, 22 May 2007) <> at 9 October 2007.

[48] PIC/S, 'Pharmaceutical Inspection Co-operation Scheme', PIC/S 1/95 (Rev. 3), Geneva, 12 November 2003.

[49] Constitution of the World Health Organization, 22 July 1946, 14 UNTS 185, art 2(u).

[50] Ibid arts 21(d), (e).

[51] On the WHO's historical reluctance to use its law-making powers, see, eg, Obijiofor Aginam, Global Health Governance: International Law and Public Health in a Divided World (2005) 72-3 and the sources cited therein. The only regulations adopted under art 21 to date are the International Health Regulations regarding disease surveillance and control: International Health Regulations (1969) (3rd ed, 1983); World Health Assembly (WHA), International Health Regulations (2005), Revision of the International Health Regulations, WHA Res. 58.3, 23 May 2005.

[52] WHO, The International Pharmacopoeia (3rd ed, 2003).

[53] WHO, Medicines Strategy 2004-2007: Countries at the Core (2004) 84-91.

[54] Ibid 23.

[55] International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 'Structure of ICH' <> at 9 October 2007.

[56] ICH, 'ICH Global Cooperation Group' <> at 9 October 2007.

[57] WHO, The Impact of Implementation of ICH Guidelines in Non-ICH Countries: Report of a WHO Meeting, Geneva, 13-15 September 2001, WHO Doc. WHO/EDM/QSM/2002.3, Regulatory Support Series, No. 9 (2002) ('The Impact of Implementation’).

[58] VesnaKoblar, 'Impact of ICH on non-ICH countries' (Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA), Hong Kong, China, 24-27 June 2002) 49. See also The Impact of Implementation, above n 57, 16-17.

[59] ICH, 'The ICH Process for Harmonisation of Guidelines' <> at 9 October 2007. On the process for adopting guidelines, see also Urbani V. Venkataram, 'Common Technical Document — Quality: One Regulatory Participant's Perspective' in Ira R. Berry (ed), The Pharmaceutical Regulatory Process (2005) 547, 550-5.

[60] ICH, 'ICH Guidelines' <> at 9 October 2007.

[61] See Alberto Grignolo et al, 'Ways and Means to U.S. Registration of Foreign Drugs' in Ira R. Berry (ed), The Pharmaceutical Regulatory Process (2005) 517, 519-21.

[62] At the same time, facilitating the submission of foreign clinical data can create other problems, such as the temptation for manufacturers to conduct clinical trials in developing countries, where legal and ethical protections for human subjects are weaker.

[63] David Vogel, 'The Globalization of Pharmaceutical Regulation' (1998) 11 Governance: An International Journal of Policy and Administration 1, 11-12.

[64] Venkataram, above n 59, 558, 561.

[65] Justina A Molzon 'The International Conference on Harmonization Common Technical Document — Global Submission Format?' (2005) 60 Food and Drug Law Journal 447, 449.

[66] Venkataram, above n 59, 562.

[67] Global Harmonization Task Force (GHTF), 'General Information' <> at 9 October 2007.

[68] GHTF, GHTF Guiding Principles, 20 May 2005, GHTF/SC/N1R8:2OO5, <> at 9 October 2007.

[69] Vogel, above n 63, 3.

[70] Ibid 4.

[71] Ibid; Walser, above n 10, 1662.

[72] Vogel, above n 63, 5.

[73] Council Regulation 2309/93, [1993] OJ L 214; Council Directive 93/39/EEC, [1993] OJ L 214.

[74] Harman, above n 9, 179. Other countries had experimented with common registration procedures: see Vogel, above n 63, 9, describing initiatives by the Benelux countries and the members of the Nordic Council.

[75] Harman, above n 9, 184; Vogel, above n 63, 6-7.

[76] Harman, above n 9, 183.

[77] Council Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, [2004] OJ L 136, art 3 (‘Council Regulation (EC) No 726/2004').

[78] Vogel, above n 63, 7.

[79] Council Regulation (EC) No 726/2004, above n 77, art 1.

[80] Ibid clause 13.

[81] Council Directive (EC) 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use, [2001] OJL 311, art 4(4).

[82] Members of the GCC are Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates.

[83] Laila A Rahman, 'Centralized drug registration system in the Gulf region' (Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA), Hong Kong, China, 24-27 June 2002) 56, 56-7.

[84] Ibrahim A Alshowaier, 'GCC Presentation' (ICH Global Cooperation Group Meeting, 16 November 2004, Yokohama, Japan).

[85] Pan American Network for Drug Regulatory Harmonization (PANDRH), Pan American Network for Drug Regulatory Harmonization (Norms and Regulations), <> at 9 October 2007, 2-3.

[86] PANDRH, Pan American Network for Drug Regulatory Harmonization: An Overview, <> at 9 October 2007, 5.

[87] Members of ASEAN are Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.

[88] Mohd Zin Che Awang, 'Regional harmonization initiatives — the Association of South-East Asian Nations (ASEAN)' (Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA), Hong Kong, China, 24-27 June 2002) 53, 53-4; ASEAN, ACCSQ Pharmaceutical Product Working Group' <> at 9 October 2007.

[89] Treaty of the Southern African Development Community (as amended), 17 August 1992 (entered into force 30 September 1993) <> at 9 October 2007.

[90] Protocol on Health, 18 August 1999 (entered into force 14 August 2004) <> at 9 October 2007.

[91] Southern African Development Community (SADC), 'Press Briefing by Stephen Sianga, Supervisor of the Directorate of Social and Human Development and Special Programmes' (2004) <> at 9 October 2007.

[92] Agreement between the Government of Australia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products, [2003] ATNIF 22 (entered into force 10 December 2003); available at <> at 12 July 2007 (‘ANZTPA Treaty’).

[93] Annette King and Trish Worth, 'Australia and New Zealand Sign Treaty to Regulate Medicines and Therapeutic Products' (Joint Media Statement, 10 December 2003) < j.htm> at 10 October 2007.

[94] Therapeutic Products and Medicines Bill 2006 (Bill 103-1). The Bill was introduced on 5 December 2006 and received its first reading on 12 December 2006.

[95] Therapeutic Products Bill 2007 (Exposure Draft), Australia Department of Health and Ageing <$File/Exposure%20Therapeutic%20Products%20Bill.pdf> at 27 July 2007. See Brett Mason, 'New Therapeutic Products Exposure Bill Released' (Media Release BM03/07, 2 April 2007) <http://www.$File/bm003.pdf> at 10 October 2007.

[96] Annette King, 'Therapeutic Products and Medicines Bill on Hold' (16 July 2007) <> at 9 October 2007.

[97] King and Worth, above n 93; Health Committee, Forty-seventh Parliament, Inquiry into the Proposal to Establish a Trans-Tasman Agency to Regulate Therapeutic Products (2003) 41 ('Trans-Tasman Agency Report').

[98] Therapeutic Goods Administration and Medsafe, A Proposal for a Trans Tasman Agency to Regulate Therapeutic Products: Discussion Paper (2002) xix <> at 12 July 2007; Therapeutic Products and Medicines Bill, above n 94, 2-3 (Explanatory Note).

[99] Therapeutic Products and Medicines Bill, above n 94, 3 (Explanatory Note).

[100] Therapeutic Goods Administration and Medsafe, above n 98, xxi.

[101] New Zealand Institute of Economic Research (Inc), Assessment of Regulatory Options for Therapeutic Products: Report to the Trans-Tasman Working Group (2002) 10. See also Catherine Masters, 'The Politics of Selling Drugs', New Zealand Herald (Auckland), 21 July 2007 < & objectid=10452818> at 9 October 2007.

[102] Therapeutic Products and Medicines Bill, above n 94, 2 (Explanatory Note).

[103] Ibid 3 (Explanatory Note); New Zealand Institute of Economic Research (Inc), above n 101, 42.

[104] Therapeutic Products and Medicines Bill, above n 94, 2 (Explanatory Note).

[105] Ibid. On the Global Harmonization Taskforce, see above n 67 and accompanying text.

[106] See, eg, Therapeutic Goods Administration and Medsafe, above n 98, xxi.

[107] Australia New Zealand Closer Economic Relations Trade Agreement, [1983] ATS 2 (entered into force 28 March 1983); Protocol on Trade in Services to the Australia New Zealand Closer Economic Relations Trade Agreement, ATS 20 (entered into force 18 August 1988).

[108] Trans-Tasman Mutual Recognition Arrangement (TTMRA), opened for signature 14 June 1996 (entered into force 1 May 1998).

[109] Ibid Part IX Schedule 3, Annex 1.

[110] Ibid art 9.1.2, Annex 1.

[111] Government of Australia, Regulation Impact Statement: Agreement between the Government of Australia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products, [2004] ATNIA 6, 1.

[112] ANZTPA Treaty, above n 92, arts 3, 5. Note that the Treaty refers to the ‘Agency', while the New Zealand Bill and subsequent documents refer to the ‘Authority'.

[113] Ibid art 11(3). There is some limited scope for differences, as will be discussed below at nn 145-47 and accompanying text.

[114] Ibid arts 4, 6.

[115] Ibid arts 5(4)-(5).

[116] ANZTPA Treaty, above n 92, arts 9, 10.

[117] Ibid art 23.

[118] See, eg, Transtasman Therapeutic Products Agency Delayed', New Zealand Herald (Auckland), 12 December 2005, < & objectid=10359615> at 12 July 2007.

[119] Trans-Tasman Agency Report, above n 97, 48.

[120] Health Committee, International Treaty Examination of the Agreement between the Government of New Zealand and the Government of Australia for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products (2004) 9-10.

[121] Government Administration Committee, Therapeutic Products and Medicines Bill (103-1) (15 June 2007) 1.

[122] King, above n 96. The Bill was strongly opposed by the Green Party and Maori Party; the National Party also refused to support the legislation and attempts to secure sufficient support by means of a compromise backed by New Zealand First failed in mid-July 2007. See, eg, Audrey Young, 'Sugar coating for contentious medicines and therapeutic products bill' New Zealand Herald' 24 May 2007 < & objectid=10441470> at 9 October 2007; Paula Oliver, '"Lame duck" Government hits back over failed bill' New Zealand Herald 18 July 2007 < & objectid=10452161> at 9 October 2007.

[123] For discussion of New Zealand's current regime, see Barbara von Tigerstrom and Katherine Ellena, 'Regulation of Complementary and Alternative Medicine: A Trans-Tasman Perspective' (2005) 23:2 Law in Context 199, 217-19.

[124] Trans-Tasman Agency Report, above n 97, 41.

[125] Dietary Supplements Regulations 1985 (NZ).

[126] Medsafe, Submission to the Health Committee (2003).

[127] New Zealand Institute of Economic Research (Inc), above n 101, 10.

[128] For example, some argue that it is 'inappropriate to impose a pharmaceutical model of regulation and licensing' on CAM products: Government Administration Committee, above n 121, 3. See also the discussion in von Tigerstrom and Ellena, above n 123, 201-3.

[129] See, eg, Kevin Taylor, 'Outrage over health pills law', New Zealand Herald, 8 December 2003, < & objectid=3538181> at 9 October 2007; Trans-Tasman Agency Report, above n 97, 26ff. The CAM industry in New Zealand is substantial, with an annual retail turnover of over NZ$200 million and exports of about $100 million: Taylor.

[130] See, eg, Government Administration Committee, above n 121, 4; Taylor, above n 129; Sophie Hazelhurst, 'Committee fails to reach agreement on therapeutics bill' New Zealand Herald, 15 June 2007 < & objectid=10445946> at 9 October 2007.

[131] Ibid.

[132] Government Administration Committee, above n 121, 3-4; ANZTPA, 'The Proposed Joint Regulatory Scheme for Complementary Medicines' (Fact Sheet, January 2007) <> at 9 October 2007.

[133] See, eg, Natural Health Products Regulations, SOR/2003-196 (Canada).

[134] Paula Oliver, 'Watchdog Rules against Anti-Medicines-Bill Ads' New Zealand Herald (Auckland), 20 July 2007 < & objectid=10452685> at 9 October 2007.

[135] See, eg, Masters, above n 101.

[136] Government Administration Committee, above n 121, 4-5; ANZTPA, 'The Proposed Joint Regulatory Scheme for Complementary Medicines', above n 132; ANZTPA, 'How Would the New Authority and Proposed Joint Regulatory Scheme Affect Maori' (Fact Sheet, July 2007) <> at 9 October 2007.

[137] ANZTPA Treaty, above n 92, arts 3, 22.

[138] Maori Party, 'Therapeutic Products and Medicines' (Speech by Tariana Turia, Co-leader, Maori Party; Health Spokesperson, 12 December 2006) < & task=view & id=768 & Itemid=28> at 9 October 2007.

[139] Ibid.

[140] Ibid.

[141] See, eg, Masters, above n 101; Young, above n 122.

[142] Maori Party, above n 137.

[143] Ministry of Health (NZ), National Interest Analysis (March 2004), 4 <> at 10 October 2007 ('National Interest Analysis').

[144] ANZTPA Treaty, above n 92, art 11(3).

[145] Ibid art 11.

[146] Ibid art 12(2)(a).

[147] Ibid art 12(7).

[148] Therapeutic Products and Medicines Bill, above n 94, clause 269(1). It appears that this permissive provision allows some products to be left unregulated (if they are excluded from the scope of the ANZTPA and not made the subject of a New Zealand regulation), although it has been suggested that this should be clarified: see New Zealand Law Society, 'Submission on the Therapeutic Products and Medicines Bill' (7 February 2007) 10 <> at 10 October 2007.

[149] Annette King, 'Therapeutic Products and Medicines Bill tabled' (6 December 2006) <> at 9 October 2007.

[150] National Interest Analysis, above n 142, 7.

[151] See the lists of matters to be dealt with by Rules and Orders in ANZTPA Treaty, above n 92, arts 9, and 10, respectively.

[152] New Zealand Law Society, above n 148, 2-3.

[153] Government Administration Committee, above n 121, 5.

[154] Ibid 6. Because the Committee did not recommend passage of the Bill, it did not formally recommend any amendments.

[155] New Zealand Law Society, above n 148, 3.

[156] ANZTPA, 'Postponement of the ANZTPA Establishment Project' <> at 9 October 2007; Therapeutic Goods Administration (Australia), ‘Australia New Zealand Therapeutic Products Authority (ANZTPA) — Update' (18 July 2007) <> at 9 October 2007.

[157] Therapeutic Products and Medicines Bill, above n 94, 2 (Explanatory Note).

[158] On the difference between the two schemes, see Health Committee, Trans-Tasman agency report, above n 97 at 41.

[159] The Ministerial Council is comprised of the Australian and New Zealand Ministers responsible for health (ANZTPA Treaty, above n 92, art 4), and the Ministerial Council appoints the Board and Managing Director (ibid art 6) and makes rules (ibid art 9).

[160] Health Committee, International treaty examination, above n 120, Appendix D: National interest analysis, 26.

[161] See above n 27 and accompanying text.

[162] Health Committee, Trans-tasman agency report, above n 97, 3, 48.

[163] New Zealand Institute of Economic Research (Inc), above n 101, 42.

[164] ANZTPA Treaty, above n 92, art 12.

[165] J John Lee, 'What is Past is Prologue: The International Conference on Harmonization and Lessons Learned from European Drug Regulations Harmonization' (2005) 26 University of Pennsylvania Journal of International Economic Law 151, 172.

[166] Ibid 178.

[167] New Zealand Institute of Economic Research (Inc), above n 101, 42.

[168] Health Committee, International treaty examination, above n 120, Appendix D: National interest analysis, 28.

[169] Ibid.

[170] Currently, Medsafe and the TGA do both; in the case of food standards, the joint agency sets standards but the local agency still has to apply and assess compliance with them. While it is often said that the ANZTPA would 'replace' Medsafe and the TGA, it appears that these local agencies would continue to exist with more limited functions such as licensing of suppliers and pharmacies. See Therapeutic Products and Medicines Bill, above n 94, 8 (Explanatory Note).

[171] New Zealand Institute of Economic Research (Inc), above n 101, 14, 42.

[172] Ibid 14.

[173] Ibid 39.

[174] See, eg, Oliver, '"Lame duck" Government hits back over failed bill', above n 122.

[175] The Minister of Health has suggested that regardless of the joint agency initiative, 'the status quo of an unregulated market for medical devices and complementary medicines cannot remain': King, above n 96, quoting Health Minister Pete Hodgson.

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