developments in Australia’s regulation of prescription drug marketing and promotion. We show that the pharmaceutical industry has proved less capable of shaping the regulation of promotion than other areas of pharmaceutical policy. Public health advocates have effectively highlighted the negative impact of promotion on quality use of medicines. While consumers have long been assumed to be in need of protection from drug promotion, it is now accepted that marketing to medical professionals should also be more closely controlled. Government has responded by tightening such regulation but has stopped short of ending industry self-regulation.The authors comment that
Concern that the promotion of therapeutic goods too often involves ‘quackery’ and ‘extravagant or otherwise objectionable’ claims has been a feature of Australia’s regulatory control of medicines since Federation in 1901 (McEwen 2007). Such apprehensions intensified as medicines came to play an increasingly important role in most Australians’ pursuit of health. The focus has been mainly, but not exclusively, on prescription drugs that often provide effective treatments but are also the most hazardous. Regulating prescription drug promotion is intended to prevent extravagant and objectionable claims by suppliers and minimise inappropriate, risky and expensive consumer demand.
Pharmaceutical policies reflect the enduring tensions between government objectives of supporting economic activity, on the one hand, and ensuring that the public has access to safe, effective and affordable drugs, on the other (Grund 1996; Abraham 2008; Fox & Ward 2008a). Much is at stake in this policy domain—citizen health and safety, the public purse, and the profit interest of powerful corporations. The imperative for governments is to strike an acceptable balance between the competing interests and commitments of stakeholders—regulators, drug manufacturers, medical and pharmacy professionals, and consumers. The emphasis of Australia’s regulation of drug promotion has been on public safety and efficacy, closely followed by containing the cost of drug use that promotion is intended to stimulate. These goals, however, are meant to be achieved without imposing undue restrictions and costs on manufacturers (Toogoolawa Consulting 2002).
The most salient feature of Australia’s regulation of prescription drug promotion is the ban on Direct-to-Consumer Advertising (DTCA). The Therapeutic Goods Act (1989) prohibits DTCA of prescription drugs although manufacturers are able to indirectly promote their products to the public in other ways (described below). The rationale for prohibiting DTCA is that consumers’ lack adequate knowledge of medicines and may be negatively influenced by promotion. Advertising and other forms of drug promotion directly to doctors (also described below) are permitted on the assumption that a doctor’s expertise largely precludes any negative influence. In other words, the information asymmetry between drug manufacturers and doctors is less stark than that between suppliers and general consumers. Controlling non- DTCA promotion has largely involved manufacturers self-regulating through a Code of Conduct framed within the relevant legislation. This is a co-regulatory governance arrangement, premised on partnership between government and business, but ultimately self-regulation is undertaken in the shadow of government. The industry can expect the imposition of more intrusive and direct government controls should self-regulation be deemed inadequate (Bartle & Vass 2005).
For successive Australian governments, the balance between ensuring safety and minimising burdensome regulation has been struck through prohibition of DTCA in conjunction with the co-regulation of drug promotion to doctors, an arrangement (ostensibly) accepted by drug manufacturers. This is considered to provide adequate safeguards against inappropriate practices, making more direct regulation or legislation of promotion unnecessary (Medicines Australia 2010). This arrangement, however, has become less acceptable to critics of drug promotion. Many within Australia’s public health community consider self-regulation inadequate; a strong case has been made for it to be strengthened if not abandoned and replaced by independent oversight (Vitry, Lexchin & Mansfield 2007; Mintzes 2010).
Drug promotion is one area of pharmaceutical policy where interests other than manufacturers and government—notably public health advocates and health consumer groups—have sought and achieved greater input. In this paper we show that owing to a sustained effort by such advocates, drug promotion is almost invariably constructed as a problem for quality use of medicines (safe, timely and affordable use) in current policy discourse. Significantly, while consumers have long been assumed to be vulnerable to drug promotion, it is increasingly accepted that doctors too are vulnerable and should not be exposed to unconstrained industry marketing. This has resulted in unprecedented scrutiny of drug promotion. But notwithstanding the relative success of public health advocates in constructing the policy issue as one of consumer safety, drug promotion in Australia remains largely self-regulated by the industry.
The regulation and governance of pharmaceuticals emerges from the ‘nexus of power relations existing between the stakeholders in a social and political context’ (Fox, Ward & O’Rourke 2006). In an era of ‘regulatory capitalism’ Australian governments seek to minimise direct regulation (Braithwaite 2005). Indeed, a senior federal Cabinet member is titled the Minister for Finance and Deregulation. This does not necessarily translate into less regulation but is typically reflected in the devolvement of regulation to those stakeholders that are to be regulated, such as businesses and professions. Self-regulation may then be ‘meta-regulated’—a term for the regulation of self-regulation (or co-regulation). Self-regulation is a central element in contemporary governments’ attempts to establish governance of economic and social activities. Rather direct oversight and control, such governance works through interactive processes of networks and partnerships that develop capacities of jointly pursuing common goals (Stoker 1998). For proponents, this approach to governance achieves an ‘effective but light touch regulation’ where government is seen as ‘steering’ rather than ‘rowing’ towards public policy objectives (Bartle & Vass 2005). Steering rather than rowing is expected to reduce the ‘regulatory burden’ and avoid the ‘regulatory fallibility’ that can generate unintended negative consequences and ultimately undermine policy objectives (Banks 2003).
Governance involves co-ordination by state agencies of conflictual interest groups through ‘set piece’ policy events such as commissions and public consultations and ‘behind the scenes’ negotiations between government officials and stakeholders (Fox & Ward 2008). Co-ordinating a plurality of policy actors relies less on command and coercions and more on sustaining a broad ‘field of consent’ regarding the appropriate goals and rules of the particular activity (Fox, Ward & O’Rourke 2006). Gaining and sustaining consent means that differences among stakeholders need to be accommodated and balanced, which requires an ongoing, dynamic process of brokering and compromise (Fox & Ward 2008). Governance is thus fluid and consent partial and contingent. Its configuration evolves in response to (cultural, political, economic and technological) changes in the wider environment and to changes in the relative power of stakeholders. An important element of the power of stakeholders is the force and currency of their ideas.
A critical issue in policy contests is the capacity of stakeholders to frame the relevant issues in the terms of its own ideas (Sell & Prakash 2004). Ideas—theories, conceptual models, beliefs and values—define policy problems and provide legitimate programs for policy action (Yee 1996; Campbell 1998). Ideas range from abstract ontological and normative principles to specific theoretical propositions (Surel 2000) and can operate at a level of taken-for-granted general assumptions or as explicit imperatives and justifications for policy action (Campbell 2002). In the Australian context, the normative idea of equity underpinning pharmaceutical subsidy programs is an example of the former; the idea of ‘moral hazard’ underpinning prescription cost sharing is an example of the latter (Doran & Robertson 2009). The influence of an idea within a policy community at a given time will depend on the power of individuals and groups proposing particular policy perspectives. Influence will also depend on an idea’s normative and cognitive appeal to policy makers—an appeal intimately connected to prevailing intellectual and public sentiments. In the following, we focus on two ideas central to drug promotion regulation in Australia; minimising ‘regulatory burden’ and ensuring ‘quality use of medicines’ (QUM). We also highlight how a third idea—the susceptibility of doctors to drug promotion—has been used to shift the balance between the two.