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A sensible decision—the defining criteria still apply

BackgroundSince the WHO Framework Convention on Tobacco Control’s (FCTC) entry into force, the tobacco industry has initiated litigation challenging tobacco control measures implemented by governments around the world, or supported others to initiate such litigation on its behalf. In defending their tobacco control measures against such litigation, governments have invoked their obligations and rights under the WHO FCTC. We assess the extent to which the WHO FCTC has provided legal weight to governments’ defences against legal challenge.MethodsWe reviewed 96 court decisions concerning legal challenges to tobacco control measures, determining whether or not they cited the WHO FCTC and their outcomes. We then reviewed the cases where the WHO FCTC was cited, analysing how the WHO FCTC contributed to the resolution of the case.ResultsThe WHO FCTC was cited in 45 decisions. Decisions both citing and not citing the WHO FCTC were largely decided in favour of governments, with 80% of WHO-FCTC-citing and 67% of non-WHO-FCTC-citing cases upholding the measure in its entirety and on every ground of challenge. In cases where it was cited, the WHO FCTC contributed to the resolution of the case in favour of governments by providing a legal basis for measures, demonstrating the measure’s public health purpose, demonstrating the evidence in favour of a measure, demonstrating international consensus, demonstrating that a measure promotes or protects health-related human rights and demonstrating whether or not a measure is reasonable, proportionate or justifiable.ConclusionsThe way the WHO FCTC has been cited in court decisions suggests that it has made a substantial contribution to courts’ reasoning in tobacco control legal challenges and has strengthened governments’ arguments in defending litigation.

Access to medicines and vaccines to prevent and treat non-communicable diseases (NCDs) is unacceptably low worldwide. In the 2011 UN political declaration on the prevention and control of NCDs, heads of government made several commitments related to access to essential medicines, technologies, and vaccines for such diseases. 30 years of experience with policies for essential medicines and 10 years of scaling up of HIV treatment have provided the knowledge needed to address barriers to long-term effective treatment and prevention of NCDs. More medicines can be acquired within existing budgets with efficient selection, procurement, and use of generic medicines. Furthermore, low-income and middle-income countries need to increase mobilisation of domestic resources to cater for the many patients with NCDs who do not have access to treatment. Existing initiatives for HIV treatment offer useful lessons that can enhance access to pharmaceutical management of NCDs and improve adherence to long-term treatment of chronic illness; policy makers should also address unacceptable inequities in access to controlled opioid analgesics. In addition to off-patent medicines, governments can promote access to new and future on-patent medicinal products through coherent and equitable health and trade policies, particularly those for intellectual property. Frequent conflicts of interest need to be identified and managed, and indicators and targets for access to NCD medicines should be used to monitor progress. Only with these approaches can a difference be made to the lives of hundreds of millions of current and future patients with NCDs.

As the governing body of the WHO Framework Convention on Tobacco Control (FCTC), the Conference of the Parties (COP) is mandated to ‘keep under regular review the implementation of the Convention and take the decisions necessary to promote its effective implementation’. The COP has a range of critical roles to play spanning the setting of normative standards, the building and dissemination of knowledge, the monitoring of implementation, the facilitation of international cooperation and the mobilisation of resources to support implementation. The COP has met four times to date. It has made significant achievements in the setting of normative standards, with the adoption of a number of high-standard implementation guidelines and a declaration recording the commitment of Parties to prioritise the implementation of health measures in the context of concerns about the effect of international trade and investment obligations. Less progress has been made in other areas, including a general lack of support for the conduct of needs assessments by developing countries—though needs assessments have been designated as a prerequisite to the mobilisation of funding support—and a reluctance to consider the adoption of a robust system of implementation review. Much remains to be done to build the FCTC's implementation support structure. Other looming challenges include maintaining the voice and influence of developing countries against priorities being overly dictated by wealthier Parties and in the face of recent cutbacks to travel support pushed by the European Union, and managing the likely resource demands and other risks of the proposed illicit trade protocol.

In November 2011, Australia became the first country in the world to legislate for “plain packaging” of tobacco products. As of December 1, 2012, the packaging of tobacco products sold in Australia must be a standard, drab dark brown color; and the printing of tobacco company logos, brand imagery, colors, or promotional text on that packaging and on individual tobacco products is prohibited. While the Australian scheme is described as “plain packaging,” tobacco packaging is required to be far from “plain” in the ordinary sense of the word. The scheme requires large health warnings composed of graphics, warning statements and explanatory messages, and information messages. Plain packaging of tobacco products—which has also been called “generic packaging” or “standardized packaging”—is not a new idea. It was proposed as far back as June 1986, when the Canadian Medical Association agreed to a motion in favor of its adoption.

The impressive policy outcomes of COP-3-primarily strong guidelines on implementation of articles 5.3 (protection of public health policies with respect to tobacco control from the commercial and other vested interests of the tobacco industry), 11 (packaging and labelling of tobacco products) and 13 (tobacco advertising, promotion and sponsorship)-will doubtless be detailed elsewhere.

This article examines two spheres of global governance in which the World Health Organization (WHO) has sought to exercise international leadership — combating “counterfeit” medicines and illicit trade in tobacco products. Medicines and tobacco products lie at polar opposite ends of the health spectrum, and are regulated for vastly different reasons and through different tools and approaches. Nevertheless, attempts to govern counterfeit trade in each of these products raise a host of somewhat similar challenges, involving normative and operational conflicts that cut across the crowded intersection of health protection and promotion, intellectual property protection, and activity to combat transnational organized crime. As negotiations of an illicit trade protocol to the WHO Framework Convention on Tobacco Control enter their final stages, lessons learned from counterfeit medicines governance need to be applied to ensure that the most appropriate governance arrangements are adopted.

There is much debate about the future of tobacco regulation. Some have argued that to achieve maximum possible reduction in the harm tobacco causes, new regulatory models that involve fundamental institutional change must be adopted. The tobacco industry will continue to undermine tobacco control, and, so it is argued, we must change the way in which it operates if we are to be able to make the necessary progress. Such proposals may have an immediate appeal, especially for those frustrated that progress in tobacco control is not as rapid as they would hope—with all the avoidable loss of life and livelihoods that that entails—but they need to be carefully analysed and assessed, and much thought must be applied before spending time and resources advocating for them. One such proposal, advanced by Borland, involves the establishment of a monopsonistic statutory purchasing agency and wholesale distributor of tobacco products. Borland argues the relative benefits of such a model as compared to a more “conventional” model. On close examination, the benefits of the Borland proposal, as compared to the conventional model, appear overstated, and the Borland proposal introduces significant regulatory problems. There is still much that can be achieved in tobacco regulation through more conventional approaches, and within the “existing system”. We should be wary of allowing the understandable allure of new or radical approaches to distract us from this reality.

An Economist special report 7 divides CSR into three layers: corporate philanthropy (giving to good causes of one sort or another); risk management (generosity after some reputation-damaging event such as a lawsuit for smuggling or causing harm to consumers) and value creation (the strategic use of good behaviour to build competitive advantage). Niall Fitzerald, former chief executive officer (CEO) of Unilever, leaves no doubt about this: \"Corporate social responsibility is a hard-edged business decision\".