The World Trade Organisation’s Agreement (WTO) on Trade-Related Aspects of Intellectual Property Rights (TRIPS), negotiated in the 1986–1994 Uruguay Round, is the first binding agreement that extends intellectual property law into the multilateral trading system [7]. Signed by all members of the WTO, the agreement extends patent protections “in all fields of technology” and has been a source of contention between developed and developing countries. The Agreement was advocated by the United States in particular, and supported by other developed states. These countries were themselves lobbied by transnational industry networks, including the Pharmaceutical Research and Manufacturers of America (PhRMA) [8]. The requirements for implementing the agreement included extending intellectual property rights in the form of twenty year patent protection in all areas including pharmaceutical processes and products. At the signing of TRIPS, developed countries had one year to implement the requirements, with five years for developing countries and eleven years for least developed countries. However shortly after the agreement was made public, a number of civil society groups articulated concerns for the impact this agreement would have on access to medicines, in particular in the developing countries.

In response to TRIPS, a transnational civil society network emerged that coordinated with some developing countries to raise these concerns at the WTO. Such advocacy and networking led to the Doha Declaration on the TRIPS Agreement and Public Health adopted in 2001 [9], an amendment which reaffirmed flexibilities for states to protect public health, for example through the use of compulsory licensing and parallel importing. Article 4 of Doha states “The TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all” [9]. The amendment also extended transition time for TRIPS compliance for some developing countries to 2005, and for least developed countries to 2013, with the end date for introduction of pharmaceutical patents extended to January 2016. The Doha Declaration confirmed and clarified the flexibilities available to WTO member countries to implement TRIPS in a way consistent with public health, including their right to grant compulsory licenses for the manufacturing of drugs and to “determine the grounds upon which such licenses are granted”. Paragraph 6 of the Doha Declaration was amended in 2003 to enable countries with little to no manufacturing capability to import drugs manufactured elsewhere under compulsory licensing.

The Doha Declaration is commonly viewed as the breakthrough point for an “access to medicines” norm, defined as “shared expectations about appropriate behaviour held by a community of actors” [10]. Since 2004, 52 countries have made use of the flexibilities sanctioned at Doha to authorise generic imports of patented drugs for HIV/AIDS, or have negotiated a reduced price for these drugs [11]. Yet despite global commitments, it is apparent that “access to medicines” is an ambiguous policy objective, meaning different things to different actors. The limited impact of this agreement on the availability and accessibility of medicines for developing countries is well documented [12,13,14,15]. A United Nations Millennium Development Goal task force report in 2008 revealed that the price of medicine is still out of reach for many in developing countries, with some generics in the public and private sectors found to be priced on average 250 per cent and 610 per cent more than the estimated international reference price1 in countries surveyed [16]. As will be discussed below, states face a number of similar challenges in protecting public health, and these challenges represent broader issues at the core of the political economy of global health governance.

The Framework Convention on Tobacco Control (FCTC) is an international treaty developed under the auspices of the World Health Organisation in response to the globalisation of the tobacco epidemic which has spread to the developing world [17]. Increased empirical evidence of the adverse effects of tobacco use, along with sustained pressure from researchers and civil society groups, and leadership from elites, has resulted in the elevation of tobacco control to the forefront of the global health agenda. The FCTC was negotiated between 1999 and 2003 and as the first international treaty for public health is often described as a marked success. The negotiations were primarily undertaken by governments, but civil society organisations played a significant role in influencing policy decisions [18]. The FCTC entered into force in 2005, and as of February 2012, the treaty has been ratified by 174 countries covering 87.4 per cent of the world’s population [19]. Despite such an achievement, the negotiations of the treaty were not immune to the interests of tobacco companies and unwilling governments, as the treaty was “watered down” in its ability to address key concerns. For example, an explicit FCTC trade provision was removed [20], the language was weakened and terms made more flexible [21], and the final agreement allowed exceptions on total advertising bans for countries claiming constitutional impediments [22]. To meet the obligations under this international treaty, parties must implement a multitude of tobacco control provisions to reduce both the demand and supply of tobacco. Among many other provisions, this includes demand measures such as taxes on tobacco products, health warnings on cigarette packaging, bans on tobacco advertising, promotion and sponsorship, and supply measures including support for economically viable alternatives to growing tobacco. These provisions vary in the extent of their implementation. For example, guidelines and time-bound deadlines have been developed for the provisions for smoke-free environments, packaging and labelling, and bans on advertising, promotion and sponsorship. Time-bound commitments are yet to be developed for some other provisions.

That the FCTC has created some momentum for national governments to develop comprehensive tobacco control legislation was confirmed through our research of developments in several Pacific Island nations. In its 2010 global report on FCTC implementation the WHO stated that after five years of implementation, global progress is visible. It was self-reported by participating states that more than half of FCTC provisions had attracted high implementation rates [24]. It is also stated that implementation rates vary between different policy measures and the analysis of implementation of time-bound commitments suggests mixed results [24]. Despite its heralded success in the public health realm, developing countries in particular face significant challenges in the implementation of the FCTC. In relation to harnessing political will, some research suggests that there is a lack of civil society involvement [25,26], as well as competing concerns for resourcing such as the Millennium Development Goals, access to health care and poverty alleviation [27]. Furthermore, limited policy implementation capacity in many developing nations presents itself as a significant barrier [28]. A critical challenge is the limited funding available for both communicable and non-communicable diseases in low-income countries [29]. It should also be noted that global public investments in tobacco control are “extremely small compared with both corporate profits and government revenues from cigarette sales” [30]. Effective implementation and enforcement of the Convention in many developing countries requires that resources be transferred from other domestic public policy programs or become reliant upon overseas aid. In a similar critique to that of Calain in his study of the International Health Regulation requirements in developing countries, the FCTC, despite its successes, may too “have been conceived in neglect of fragile health systems” [31]. The challenges for implementing tobacco control are also indicative of common issues in the broader political and economic architecture of global health governance.

In light of funding constraints to provide medicines and to curtail tobacco use, we have seen private actors such as Bloomberg Philanthropies (for the FCTC) and the Bill and Melinda Gates Foundation (for both medicines and tobacco control) gain widespread acceptance as sources of funding. Similarly, public private partnerships such as the Global Fund and the GAVI Alliance have arisen as major fundraisers for the provision of essential medicines and vaccines. Yet developing countries face significant funding constraints to the extent that they rely on unsustainable private sources of funding to implement tobacco control and provide medicines to their citizens.

That this reliance is unsustainable is evident from the 2011 funding shortfalls at the Global Fund, a large donor for HIV/AIDS, Tuberculosis and Malaria treatment [32]. This funding shortfall has resulted in no scale-up of HIV treatment through the Fund until at least 2014. According to the NGO Medicines Sans Frontières (MSF), Kenya, Lesotho and South Africa “weren’t eligible to apply for funding from Round 11 because of lacking funding. In these countries, HIV treatment coverage (currently) lies at 52 per cent, 66 per cent and 49 per cent, respectively” [33]. Thus the real implications of the funding shortfalls of global partnerships are matters of life and death. Similarly, in the absence of sufficient WHO and government funding for tobacco control, non-state actors such as Bloomberg Philanthropies and the Bill and Melinda Gates Foundation have attempted to fill this void by providing support for tobacco control in low income countries. It is unsatisfactory for essential public health programs to depend on funding by a few private philanthropic organisations, particularly in an era in which global economic uncertainty looms large.

The FCTC has provisions to address both the supply and demand of tobacco. Yet evidence collected by one author from fieldwork in the Pacific islands reveals that the implementation of the FCTC addresses the demand side of intervention while neglecting to comprehensively address supply. The MPOWER policy package introduced to assist developing countries to implement the FCTC is sponsored by Bloomberg Philanthropies. The components of MPOWER include: “Monitor tobacco use and the policies to prevent it; Protect people from tobacco smoke; Offer people help to quit tobacco use; Warn about the dangers of tobacco; Enforce bans on tobacco advertising, promotion and sponsorship, and; Raise taxes on tobacco” [34]. This package gives no attention to the supply of tobacco. Despite good intentions, large-scale financial support for MPOWER by Bloomberg and the Bill and Melinda Gates Foundation [35] risks diverting attention and resources from the broader mandate of the FCTC to address the supply of tobacco.

Similarly, despite the flexibilities in TRIPS, confirmed in the Doha Declaration, philanthropy and global public private partnerships are now central to the procurement of essential medicines through drug donation programs and external aid for purchasing medicines. Developing countries are by no means making full and effective use of the flexibilities for protecting health. A recent survey of the use of compulsory licenses (CLs) since 1995 found that the use of CLs has diminished since 2006. Prior to that year, most CLs involved drugs for HIV/AIDS and occurred in upper-middle-income countries (UMICs), “few involved communicable disease and none occurred in least or low-income countries” [36].

Most public private partnerships for the provision of medicines do not address the structural issues at the core of medicines inaccessibility, including the cost and direction of research and development, and the inefficient patent system. This reflects similar critiques that prominent funding partnerships have “turned to a narrowly conceived understanding of health as a product of technical interventions divorced from economic, social and political contexts” [37].

It appears that these semi-corporate efforts lack a systemic and politically informed perspective. They cherish technological and behavioural interventions and investments over critical shifts in governance. As Birn argues, these programmes are devoid of long-term, sustainable, socio-political support mechanisms [37]. In the case of tobacco, restricting attention and resources to demand-side interventions could be related to the concept of “lifestyle drift” [38,39,40], where governments commit to addressing “wider social determinants of health, but end up instigating narrow lifestyle interventions” to affect individual behaviour [41]. This could also be said about dominant financial and partnership approaches to “access to medicines”, which pay too little attention to the social determinants that contribute towards illness. However, such critiques are beyond the scope of this article as our focus is on two global agreements and their implementation.

Globalisation has introduced new powerful actors into network constellations in health. The globalisation of tobacco use spans several centuries, although last century saw an expansion of this process where a handful of multinational tobacco corporations (and a Chinese state-owned monopoly) came to dominate the global market. Corporate mergers in pharmaceuticals have also led to dominance in this sector by a small number of large transnational companies. Such companies exert, or seek to exert a strong influence on international and domestic public policy. Despite the WHO excluding tobacco companies from involvement in the FCTC negotiation process the FCTC itself has not been free of undue influence by the industry in the negotiation of the treaty [20,21,22]. Indeed, vested interests contributed to a weakening of the terminology and focus of the FCTC. Firstly, the existence of state owned tobacco companies [42,43] present a vested interest that the WHO is unable to mitigate. This can be seen through “Japan’s success in arguing for optional language in the treaty”, where the Japanese government owns a substantial proportion of Japan Tobacco Inc. [21]. Gruning et al. [22] also explain that “Germany played a major role in the tobacco industry’s efforts to undermine the FCTC”. Germany’s position “served to protect the interests of the tobacco industry and mobilised other negotiating parties in the industry’s fight against a strong FCTC” [22]. It has also been suggested that “international factors, together with tobacco industry activities at the country level hampered development of international norms in trade and health in the FCTC” [20]. Collin also argues that the FCTC fails to adequately address trade, a major driver of the tobacco pandemic, where “health objectives have been subordinated to core principles of foreign and economic policy” [44].

In looking beyond the negotiation of the FCTC and the treaty text itself, the implementation of the FCTC is largely conducted at the national level. Despite a provision articulating that health policy should not be influenced by the tobacco industry, there are many examples of the industry seeking to influence or undermine national health policies in countries that have ratified the FCTC. Implementation of the FCTC requires a whole-of-government approach inclusive of areas of government outside of health such as finance, trade and customs. These different arms of government have different priorities and can be more vulnerable to lobbying and influence from the tobacco industry. After investigating the FCTC implementation in several Pacific Islands, one of the authors found that national governments are still approached by representatives of the industry seeking to influence decisions relating to tobacco control. In Australia, the Liberal party, one of two major political parties, still receives donations from the tobacco industry, and the industry has spent an estimated 20 million dollars (AUD) in advertising against the Australian Government’s plain packaging bill [45]. There would no doubt be many other examples of the tobacco industry seeking to influence decisions at the national level, despite the FCTC ratification and its provisions.

While Doha confirmed beyond doubt flexibilities under TRIPS available to protect health, developing countries continue to face corporate litigation by pharmaceutical companies, as well as pressures in bilateral and regional trade negotiations to extend intellectual property rights beyond the requirements of TRIPS. An example of corporate litigation is the case of Novartis in India, which after failing at the India Patent Office and in the High Court, has gone to the Supreme Court in an attempt to overturn Section 3(d) of India’s 2005 Patent Act. This section states that a “new use for a known substance” is not an invention and thus not patentable if it fails to demonstrate enhanced efficacy [46,47]. India has so far “rejected the Novartis patent application for the anti-cancer drug imatinib mesylate on the grounds that it lacked novelty, was obvious and un-patentable under Section 3(d)” [48]. The case was to be heard by the Supreme Court in July 2012 and its outcome could have global repercussions, undermining the role of India as the “pharmacy of the developing world”. India is the main supplier to the MSF and others international provides of essential medicines. Notably, “80 per cent of antiretrovirals (ARVs) procured by MSF are purchased in India, 89 per cent of the generic ARV’s approved by the US Food and Drug Administration for PEPFAR are from India, and 70 per cent of the ARV treatment purchased by UNICEF, the International Development Association, the Global Fund (GFATM) and the Clinton Foundation since July 2005 have come from Indian suppliers” [49].

An important development is that the Indian generic drug company Natco Pharma in March 2012 was successful in gaining India’s first compulsory license for the production and supply of the patented anti-cancer drug sorafenib, marketed by the German multinational Bayer as Nexavar. Bayer’s version of this drug costs Rs 280,000 (approximately $5,600) a month, an astronomical figure for almost all Indian households. Natco will sell the same drug at 3 per cent of this price, whilst paying a license fee and still making a profit [50]. The CL was issued essentially on the grounds that Bayer’s price is exorbitant. Bayer also does not manufacture the drug in India and imports in such small volumes that only a tiny fraction of potential patients could benefit. The Controller General of Patents concluded that the drug “was not bought by the public due to only one reason, that is, its price was not reasonably affordable to them” [50]. This decision in favour of Natco sets a very important precedent for possible CLs on other patented products sold at unaffordable prices.

India’s Patent Act, which affirms TRIPS flexibilities for public health, has set a precedent. In November 2011, the Working Group on Intellectual Property of the Brazilian Network for the Integrations of People (REPRIP), a network of civil society organisations, opposed the patent application by the US pharmaceutical company Abbott for the heat-stable versions of the drug lopinavir/ritonavir (LPV/r), which is a key HIV drug recommended by the World Health Organisation [47]. “The opposition is based on the fact that the applications lack novelty and an inventive step, being merely a combination of existing drugs, and known technologies for producing heat-stable formulations, respectively” [47]. If Novartis were to successfully overturn aspects of the Indian Patent Act, this could potentially set a precedent in which these lifesaving medicines would be out of reach for many in dire need. In Brazil’s case, a patent to Abbott would extend the monopoly of LPV/r to 2024, threatening expanded access to the drug. The battle between multinational pharmaceutical companies and some developing countries in their attempts to provide health resonates with Baum and Sanders critique of transnational corporations (TNCs) in the food industry [39]. In their critique of food and agricultural TNCs, the authors argue that the “combination of producer subsidies, global trade liberalization and strengthened property rights has given increasing power to the corporate food industry and undermined national food security in many countries” [39].

As noted, challenges facing developing countries in their protection of public health include bilateral and multi-lateral trade agreements that reflect the interests of Northern pharmaceutical companies. Such agreements are known as “TRIPS plus”, that is, intellectual property protection more extensive than required by TRIPS. Such provisions “extend patent terms in certain circumstances, establish a link between drug registration and patents, (and) grants exclusive rights with respect to test data” [15]. Leaked documents of a proposed India-EU Free Trade Agreement (FTA) reveal negotiations for greater intellectual property protection then required by TRIPS [51]. In response, the European Union has confirmed that patent extension and “data exclusivity” (the protection of data submitted for marketing approval) are on the table for negotiation, while at the same time stating commitment to “access to medicines” [52]. India has recently rejected data exclusivity, which extends the period of monopoly supply, delaying the market entry of cheaper generics, yet concerns still remain for the outcome of this FTA [53]. It is apparent that the rhetoric around “access to medicines” is an ambiguous aim meaning different things to the actors involved [54]. “Access to medicines” can accommodate a range of diverse competing interests, where discourses seek to protect, transform, or do away with the global intellectual property rights system.

Leaked texts of the Trans Pacific Partnership Agreement (TPPA) currently under negotiation also reveal extensive IP protections beyond TRIPS and “TRIPS plus” FTAs [55]. The TPPA is under negotiation between the US, Australia, New Zealand, Singapore, Brunei, Chile, Malaysia, Peru, and Vietnam. Draft texts have included rules on government procurement which can impact on government purchasing of medicines. The inclusion of an Investment State Dispute Settlement mechanism could enable corporations (including the multinationals in the tobacco industry) to sue governments seeking to implement policy measures to protect public health [56]. The negotiations are set to be finalised in 2012. The negotiation of these trade agreements highlight significant tensions between commercial interests and health globally, which can also take place at the national level, where for example, a Ministry of Trade can often have different priorities to that of the Ministry of Health.