THE CHALLENGE OF MEDICINAL CANNABIS TO THE POLITICAL LEGITIMACY OF THERAPEUTIC GOODS REGULATION IN AUSTRALIA.

• Date: 01 December 2019
• Author: Gleeson, Penny

I Introduction II The Regulation of Therapeutic Goods in Australia: A Brief Outline III The Regulatory Context and History of Medicinal Cannabis A The International Context B The Regulation of Cannabis in Australia before 2014 C Restricted Access to Medicinal Cannabis in Australia IV The Regulatory Reform Period of 2014-18 A The State of Victoria B The Commonwealth V The Different Voices of Medicinal Cannabis Regulatory Reform: 2014-18 A Medicinal Cannabis as an 'Object' of Regulation B The Dominant Voice C The Moderate Voice D The Radical Voice VI What Does Regulatory Reform of Medicinal Cannabis Tell Us about the Political Legitimacy of Therapeutic Goods Regulation in Australia? A What Is Political Legitimacy? B The 'Constant Dialogic' Approach to Political Legitimacy 1 Beetham's Framework of Political Legitimacy 2 The Dialogic Approach to Political Legitimacy 3 The 'Constant Dialogic' Approach to Political Legitimacy C The Challenge of the 'Moderate' and 'Radical' Voices to the Political Legitimacy of Therapeutic Goods Regulation D The Failure of Therapeutic Goods Regulation to Embrace the Constant Dialogic Approach to Political Legitimacy 1 The Absence of a Constant Dialogue with All Relevant Parties 2 The View that Expertise Trumps Discourse VII Steps towards a Constant Dialogic Approach to Political Legitimacy VIII Conclusion I INTRODUCTION

[T]he [Therapeutic Goods Administration] traditionally has dealt with clear-cut proposals which lead to drugs which can be commercialised ... It would not be a body that would be able to liaise with other state health departments and the like in the way that I believe is going to be essential to get effective control of medical cannabis. (1) On 31 August 2016, the Commonwealth Department of Health effectively determined that Australians could legally access cannabis for medicinal purposes. (2) The decision was made under the Australian regulatory scheme that applies to all pharmaceuticals and medical devices--collectively referred to as 'therapeutic goods'. (3) The decision followed a significant period of public controversy regarding the medicinal use of cannabis which engaged individual patients and their families, advocacy groups, state and Commonwealth governments, and the media. (4) While the drug itself was the subject of intense focus, the complex regulatory scheme pursuant to which the decision was made was less so. Yet, as the above quote illustrates, the controversy surrounding medicinal cannabis highlighted doubts about Australia's regulatory arrangements for therapeutic goods. This uncertainty contrasted starkly with the view that the Australian regulator, the Therapeutic Goods Administration ('TGA'), and the regime it administered, had 'an excellent reputation both internationally and domestically'. (5)

This article considers the reforms to the availability of medicinal cannabis between 2014 and 2018 in Australia and the resulting challenge to the political legitimacy of the regulation of therapeutic goods. (6) The reforms are one of a number of examples of 'difficult' or 'hard' cases that the therapeutic goods regulatory regime has dealt with, and continues to deal with. Others include drugs, like cannabis, that are commonly used recreationally or give rise to contentious ethical or social issues. (7) As this article illustrates, such 'difficult' case studies are commonly characterised by public controversy and conflict. Case studies like medicinal cannabis reform provide an insight into important aspects and deficiencies of the operation of the established regulatory regime in a way that other, more uniform examples may not. (8) The aim of this article is to analyse the case of medicinal cannabis reform in Australia to draw out these insights and their implications for the therapeutic goods regulatory regime.

Before outlining the contents of this article, it is useful to briefly describe the drug with which it is concerned. Cannabis is the generic name given to three species of plants. (9) It can be used for a variety of purposes--as a fibre (known as hemp), an oil for fuel, varnish, and soap, and, most relevantly, as a drug. (10) In biological terms, it is the nature and level of cannabinoids, the active components of the cannabis plant, which determine the medical impact of cannabis and its psychoactive affect. (11) Cannabis is commonly dried and smoked, but may also be administered as a resin, oil or as food. (12) Claims about the medicinal potential of the cannabis plant appear in texts on folk medicine from around the third to eighth centuries BCE. (13) This highlights the comparatively contemporary nature of the regulatory debates about the medicinal use of cannabis. The phrase 'medicinal cannabis' will be used in this article to refer to cannabis that is 'used for a medicinal objective' to achieve 'a curative or remedial effect', rather than for 'recreational' use. (14)

This article asks what the recent reforms around medicinal cannabis indicate about the political legitimacy of the regulation of therapeutic goods in Australia. It begins by providing an overview of the regulation of therapeutic goods. Part III summarises the restrictive historical regulation of medicinal cannabis in Britain, the United States, under international law and in Australia. This historical context is important in setting the scene for the unprecedented reform period from 2014 to 2018. Part IV describes these reforms in the State of Victoria and the Commonwealth and how they emerged. The reform period is more closely analysed in Part V--in particular, how the debate surrounding the changes to the regulation of medicinal cannabis was permeated by three sets of competing, and at times overlapping, 'voices'. Each of these voices expressed a different conception about what constituted 'medicinal cannabis' and, therefore, views about regulatory reform. Part VI of the article examines what the medicinal cannabis reform period tells us about the political legitimacy of therapeutic goods regulation in Australia. In doing so, it outlines an approach to analysing political legitimacy that emphasises constant dialogue between all parties to a power relationship to reach a shared set of normative values and beliefs. Applying this approach, the article examines how certain 'voices' of medicinal cannabis reform challenged the political legitimacy of Australia's therapeutic goods regulatory regime. The article concludes that the therapeutic goods regulatory regime should embrace a 'constant dialogic' approach to political legitimacy to better anticipate and respond to the challenges of its regulatory environment.

II THE REGULATION OF THERAPEUTIC GOODS IN AUSTRALIA: A BRIEF OUTLINE

The regulation of therapeutic goods plays a significant role in Australia's health system. Therapeutic goods are typically understood as constituting medicines (eg headache tablets), medical devices (eg bandages, gloves), or biologicals (eg tissue- or cell-based products). (15) In Australia, the regulation of therapeutic goods is overseen by the TGA, which is part of the Commonwealth government's Department of Health. (16) These regulatory arrangements are complemented by schemes for the subsidisation of medicines and medical services via the Pharmaceutical Benefits Scheme and the Medicare Benefits Scheme respectively. (17)

A complex mix of regulatory tools apply to the manufacture, import, export and supply of therapeutic goods, the most significant of which is the Therapeutic Goods Act 1989 (Cth) ('Therapeutic Goods Act'). For the purpose of this article I will collectively refer to these regulatory tools as the 'therapeutic goods regulatory framework, 'therapeutic goods regulatory regime', 'regulatory framework', or 'regulatory regime'. The Act establishes a cooperative Commonwealth-state regulatory scheme that reflects the respective constitutional powers of the two tiers of government. (18) The Act has two objectives. The first is to establish and maintain 'a national system of controls relating to the quality, safety, efficacy and timely availability' of therapeutic goods that are used in, or exported from, Australia. (19) The second object is to provide a 'framework' for a uniform national approach in relation to poisons. (20) In addition to the Act, a range of secondary legislation, guidelines, standards, and the decisions and practices of the executive branch of government also form part of the regulatory framework. (21) I will outline some of these in relation to medicinal cannabis below. The Act specifies that the key regulatory decision-makers are the relevant Minister and the Secretary of the Department of Health (or, typically, their delegates). (22) They are supported in relation to parts of their functions by certain advisory committees. (23)

The regulatory framework adopts a risk-benefit-based approach to determine whether a proposed therapeutic good should be made available to the public. (24) In simple terms, a higher degree of regulatory scrutiny is imposed on higher-risk goods. Before therapeutic goods can be made available, the Secretary of the Department of Health (or, typically, their delegate) must evaluate the proposed goods, 'having regard to ... whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established'. (25)

If a particular therapeutic good has been subject to, and passed, the applicable level of regulatory scrutiny, it is included on the Australian Register of Therapeutic Goods ('ARTG'). (26) The Act imposes criminal penalties for the import, export, manufacture or supply of therapeutic goods not approved for inclusion on the ARTG. (27) As will be explained, the Act provides that therapeutic goods may, however, be made available when they are not on the ARTG, 'in response to the needs of particular people or circumstances'. (28)

The second object of the Act--to facilitate the uniform...