1. The Pharmaceutical Industry and Global Health: Emerging Models of Pharmaceutical Development and Production

Pharmaceutical companies have contributed significantly to global health, supplying over 1,200 new medicines in the last sixty years, many of which have played an important part in improving the health of people around the world. Producers of generic medicines have similarly played a crucial role in improving global health by making many drugs much more affordable. That is especially true in response to the HIV/AIDS pandemic in low- and middle-income countries, where generic drugs represent more than 80% of donor-funded anti-retroviral therapies (ARVs). Yet the pharmaceutical industry is also undergoing profound structural transformations. Despite advances in biotechnology heralding the promise of revolutionising human health, analysts in fact report declining innovative productivity and that an investment focus on non-communicable diseases (as well as predominantly large markets) are limiting the industry’s contribution to global health. Pharmaceutical development and production are further affected by a range of additional pressures – such as growing safety concerns, challenges to the international intellectual property rights regime, and by the rapid rise of new competitors from emerging markets. Global health policy will be profoundly shaped by, as well as actively shape, many of these fundamental transformations in the pharmaceutical industry. So what are the new models of innovation that are emerging within the industry? How can industry collaborate with public and not-for-profit organisations in the development of new therapies for global health? How will these industry changes impact upon the future of global health and visa versa?

2. The Ethics of Evidence: Challenges Related to Treatment in Low-Income Countries

Widening access to treatment has brought with it a range of new dilemmas. Treatment effectiveness in one population may differ from that in another, for reasons related to genetics, politics or cultural understandings of disease. These differences are rarely explored prior to the roll-out of new programs. Drivers of global treatment initiatives may use distribution as their key metric, while on the ground, clinical and social outcomes are neglected. Treatment for conditions rarely found in high-income countries may have developed ad hoc and not have benefitted from rigorous testing. Imposing a requirement for trials in these situations may benefit patients, but equally it may act as yet one more barrier to accessing treatment. Finally, given the need for a trial in a low-income setting, many issues arise concerning contextualisation of trial ethics to the specific setting. This panel will debate a range of issues concerning the gathering and use of evidence around treatment in low-income countries, exploring to what extent treatments used in one context ought to be tested before use in another; the ethical issues related to generating evidence from pragmatic trials, and the consequences of not conducting such trials; ‘standard care’ and control groups; global concepts of ‘Good Clinical Practice’; and contextualising ethics of clinical trials.

3. Designing Pharmaceutical Markets: Pharmaceuticalisation, Regulation and Global Health

The influence of medicines on many aspects of everyday life is increasing around the world. This trend towards increased global pharmaceutical consumption has been widely noted by experts and the public alike – especially in relation to controversial advances of drug therapies into existing and novel medical conditions such as attention deficit hyperactivity disorder (ADHD). Yet over the past decade global health policy has emerged as another crucial driver behind increased use of pharmaceutical products by making many medicines much more widely available internationally. The social forces behind this global trend towards ‘pharmaceuticalisation’ remain predominantly Western in origin, and diffused by multinational companies with strong clinical connections, significant experience of international regulation, and marketing presence – though this dynamic may be challenged with growing production in ‘Rising Powers’ countries. The multidimensional generation and diffusion of this pharmaceutical ‘power’ is also deeply unequal, challenging us to identify its different effects across different societies and cultures, in disease applications, local health economies and more broadly. At the same time, the transnational nature of pharmaceutical production and marketing is also creating new challenges for regulators, prompting major regulatory bodies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to seek to extend their reach. Thus the FDA is now claiming a global role in standard setting, whilst the EMA is expanding its remit to include important biomedical innovations such as cell therapy. This panel discusses the drivers, limits and consequences of ‘pharmaceuticalisation’ in the context of global health. What institutional and cultural forms does it take, how is it promoted or resisted in low- and middle-income countries, and how do different regulatory regimes shape pharmaceutical markets and consumers?  Finally, what interventions might stimulate this pharmaceutical imperative to tackle global health needs and inequalities more effectively?

4. The Price of Life: Intellectual Property, Patents and Standards in Global Health

The growth of the pharmaceutical industry has gone hand in hand with the expansion of legal systems for the protection of intellectual property (IP) rights. Whilst the granting of such IP rights is still largely a matter of national legislation, the World Trade Organization (WTO) agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) established internationally binding minimum standards for all WTO member states. In addition, a fast growing web of bilateral and regional free-trade and investment treaties is further strengthening the protection of IP rights at the international level, notably in the fields of data exclusivity (the protection of trial data) and the linkage of patent and registration procedures. From the outset, the creation of this international intellectual property regime has proved controversial in the context of global health, and continues to do so, because it is widely perceived as restricting access to medicines in low-income countries. Even after the move towards increased use of generic ARVs, Indian pharmaceutical companies (which contribute more than 80% of ARVs bought through international development aid) are unable to produce generic versions of newer drugs for second- and third-line treatment HIV/AIDS treatment regimes. On the other hand, several – mostly low- and middle-income countries – have invoked flexibility provisions in TRIPS when they implemented the agreement into national law, including by issuing compulsory licenses, using more narrowly defined patentability criteria, and allowing for pre-grant opposition. Against the background of a number of ongoing controversies around intellectual property, this panel asks: Which strategies have governments used to increase access to low-cost generic medicines and what challenges they have encountered? What impact does the increasing emphasis on data exclusivity have on access to medicines – given that TRIPS provides for flexibilities only with regard to patent protection? How do product development partnerships for neglected disease drugs deal with the tightening web of international IP standards? And how has the growing investment of originator companies into generics businesses and into the pharmaceutical markets of emerging economies affected their IP strategies?

5. Medical Countermeasures: Pharmaceuticals, Antimicrobial Resistance and Global Health Security

The areas of health protection and global health security have emerged as crucial sectors attracting substantial public investment for the development and acquisition of innovative medicines. One driver for this is the growing concern about the possibility of a bioterrorist attack – fears fuelled not only by the attacks of 11 September 2011 and 7 July 2005, but also by the anthrax letters posted to prominent addresses in the United States in the autumn of 2001. A parallel driver is the need to prepare populations against the threat of naturally occurring pandemics (SARS, H5N1, H1N1) that threaten lives and prosperity. Here we have seen considerable public investment in the creation and stockpiling of antiviral medications (like Tamiflu and Relenza) as well as (pre)-pandemic vaccines. As in other areas of global health, unequal international access to these new medicines has proved diplomatically divisive, prompting protracted disputes about the difficulties that low-income countries face in accessing such medicines, even where – as in the case of pandemic flu – they freely share the virus samples needed by the international community to produce these new vaccines. More recently, several medical countermeasures have also attracted other – but no less contentious – controversies. In the case of antivirals, for example, there is an on-going struggle for widening public access to the clinical trial data about the efficacy and safety of Tamiflu – especially given the substantial investments that went into creating large stockpiles. Pandemic vaccines have similarly attracted attention because of the emergence of rare – but significantly elevated – health risks. All the while existing medicines widely used for health protection, especially antibiotics, are becoming less effective – as recently highlighted by the World Health Organization in relation to anti-microbial resistance. Against that background, this panel discusses: What new medicines are being developed in the context health security? What forms of collaboration between government and industry are required to successfully develop new medicines? How can international inequalities over access to these new medicines be addressed?

6. Pharmaceutical Selves: Drugs, Research Subjects and Patients in Global Health

Patients and research subjects are central to pharmaceuticals. This is certainly the case in relation to drug making in regulated markets, as regulators will not permit drugs to enter the market before clinical trials are successfully conducted on human subjects. This use of these subjects is a highly disputed area characterised by media reports denouncing the exploitation of human ‘guinea pigs’, ethical guidelines claiming to protect vulnerable populations and severely ill patients demanding to be given drugs that have yet to be approved. But the centrality of patients is also evident in relation to drug taking. They are the target of pharmaceutical companies’ direct-to-consumer advertising and bottom-of-the-pyramid sale strategies. So too, they are the beneficiaries of the right to health and access to medicines campaigns conducted by NGOs. And they are the members of the patient groups and internet-based communities that discuss and exchange about particular diseases and drugs. Drawing upon notions such as ‘biosociality’, ‘therapeutic citizenship’ and ‘pharmaceutical selves’ this panel will examine the complex linkages between patients, research subjects and pharmaceuticals. What are the different figures of the patient and research subjects that are imagined in relation to pharmaceuticals in global health? Who contributes to their making and how? And in what ways do patients and research subjects participate, resist and reshape the making and taking of drugs?