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The World Health Organization estimated that in 1999 roughly one-third of the world's population lacked access to essential medicines that would have saved or improved their lives. Our analysis focuses on how pharmaceutical product patents restrict access to essential medicines in developing countries. It is well established that pharmaceutical product patents provide little incentive for pharmaceutical companies to develop new medicines designed to treat diseases prevalent in developing countries or to market in developing countries those patented medicines developed to treat diseases prevalent in developed countries. Economists have developed theoretical models showing that these incentives could be changed if (1) developing countries provided intellectual property protection for new pharmaceutical innovations and (2) an international regulatory framework were established to facilitate pharmaceutical companies setting lower prices in developing countries and higher prices in developed countries for patented medicines. We develop an index of property rights in pharmaceutical innovations covering 129 countries from 1960 to 2005. It shows that in 1960 only a handful of countries provided significant protection for pharmaceutical innovations, but by 2005 over 95 percent of countries in our sample provided significant statutory protections. However, an international framework to allow pharmaceutical companies to price discriminate has not been put in place. We conclude that international price discrimination mechanisms, compulsory patent licenses, and regional patent buyouts are not viable mechanisms for providing access to essential medicines to patients in developing countries. Global patent buyouts are more likely to achieve this goal, as they are not founded on an impractical separation of pharmaceutical markets in developing and developed countries and they provide critical incentives to develop new essential medicines.

This chapter discusses the genealogy and development of the ‘access abyss in palliative care and pain relief’ affecting 80 per cent of the world’s people. It argues that the larger context is an epistemic abyss constituted by incomplete information about the need for controlled medicines for pain relief, and that decades of drug policy based on supply control have prevented development of the necessary knowledge base in many countries. Transnational civil society organisations are working to map and bridge this abyss through education, advocacy and action. Deeper (original) systemic and tensions in the original multilateral drug control narrative produced the current epistemic/clinical abysses and now provide space for more participatory civil society involvement. Where the earlier narrative focussed on a fear-based drive to discipline and punish non-medical use of controlled substances, the evolving (and still contested) ‘world drug problem’ narrative foregrounds person centred, human rights based, public health approaches to drug policy that explicitly support improved access to internationally controlled essential medicines. Recommended policies can only be operationalised through a concerted ‘all hands on deck’ effort guided by the international law principle of ‘mutual and shared responsibility’ for improving access within the context of the 2030 Agenda for Sustainable Development. This calls for enhanced communication, concerted advocacy, collaboration and pluralist praxis to fill the often gaping abyss between ‘black letter law’ — what is actually written in the drug control conventions — and how member states learn to interpret and operationalise it.

This study aims to determine the factors and dynamic systems behaviour of essential medicine stockout in public health-care supply chains. The authors examine the constraints and effects of mental models on medicine stockout to develop a dynamic theory of medicine availability towards saving patients’ lives.

This study uses a mixed-method approach. Starting with a survey method, followed by in-depth interviews with stakeholders within five health-care supply chains to determine the dynamic feedback leading to stockout and conclude by developing a network mental model for medicines availability.

The authors identified five constraints and developed five case mental models. The authors develop a dynamic theory of medicine availability across cases and identify feedback loops and variables leading to medicine availability.

The need to include mental models of stakeholders like manufacturers and distributors of medicines to understand the system completely. Group surveys are prone to power dynamics and bias from group thinking. This survey’s quantitative output could minimize the bias.

This study uniquely uses a mixed-method of survey method and in-depth interviews of experts to assess the essential medicine stockout in Nigeria. To improve medicine availability, the authors develop a dynamic network mental model to understand the system structure, feedback and behaviour driving stockouts. This research will benefit public policymakers and hospital managers in designing policies that reduce medicine stockout.

Increased outsourcing and importation of drugs from different parts of the world to the Latin America and the Caribbean (LAC) region result in the proliferation of substandard and fake medicines, posing a threat to public health. The presence of substandard and fake medications in LAC regions is a source of public health concern and causes an economic burden to the governments in these regions. Whereas testing and detecting medication quality can easily be achieved in developed countries, the situation is different in developing countries such as LAC. This paper aims to examine the public health challenges faced by LAC regarding substandard, fake and counterfeit medicines and how the region can tackle these challenges.

Databases such as Scopus, PubMed, ScienceDirect, Embase, HINARI, EBSCOhost, Google Scholar, unpublished data, conference abstracts and papers from World Health Organization, Pan-American Health Organization and electronic newspapers were searched concerning medicine quality and in LAC.

Drug treatment improves the quality of life while decreasing morbidity and mortality among diseased populations. Absence of or inadequate testing laboratories, old and ineffective legislature, lack of enforcement or willpower and lack of effective surveillance are challenges in LAC for the proliferation of substandard and falsified medicines (SFMs).

The most significant limitation of this study was the need for the reviewers to have used articles written in other languages besides English. The LAC region has a large population in non-English-speaking countries, and many articles are written using local languages. Hence, excluding those articles is a limitation worthy of note in this review. The articles accessed needed to provide adequate information on SFM markets and illegal pharmacies or hospitals but did not. Future reviews may focus on providing illegal substandard and falsified medicines markets in the region and how they can be minimized or eliminated.

This review highlights the challenges faced by LAC countries regarding substandard, fake and counterfeit medicines. The sources, prevalence and consequences of substandard and falsified drugs were identified to suggest the measures needed to curb the infiltration of low-quality medicines in LAC.

This paper aims to reflect on different issues and perspectives on returns on investments made by MNEs towards social development. Need for an inclusive society drives accountable and effective cooperation between different actors in a market. Although multinational enterprises (MNEs) that operate in developing markets invest in social development, their managers find it very challenging to incorporate social development agenda into their business practices. Therefore, academics should develop business models which can guide thoughts and actions of managers of MNEs towards social development while allowing them to hold on to the business objectives and targets.

A review of current literature with available anecdotes about business practices helped the author to form a viewpoint and make recommendations.

The objective of the eighth millennium development goal is to promote global partnership between MNEs and domestic firms with or without intervention of a subsidiary. Addressing the particular needs of developing countries, such as capability enhancement or poverty reduction by managers of MNEs in a global setting, becomes a very complex issue. Investments by MNEs in developing countries towards these objectives are driven by different factors such as operational transparency, technological efficiency, investment types, innovation capability, branding strategy, quality assurance, public–private partnership, market-based pricing, reciprocity, distribution for penetration, etc., apart from linkages they create for developing resource-based competencies required for survival in a competitive market.

Empirical investigation of the viewpoint presented here will be required to convert recommendations into models applicable by managers of MNEs.

This study will help to enable managers of MNEs to perform need-based socially responsible actions.

This study will facilitate participation of MNEs in social development through their contributions towards poverty reduction and capability enhancement.

This paper pushes managers and academic scholars to think about the strategies required to incorporate social agenda into business models of MNEs benefiting from developing markets.

Through the example of a “regulatory ranking” – an index produced with the aim to regulate the pharmaceutical market by pushing companies in the direction of providing greater access to medicine in developing countries – this chapter focuses on indexing and ranking as infrastructural processes which inscribe global problem spaces as unfolding actionable territories for market intervention. It foregrounds the “Indexal thinking” which structures and informs regulatory rankings – their aspiration to align the interests of different stakeholders and to entice competition among the ranked companies. The authors detail the infrastructural work through which such ambitions are enacted, detailing processes of infrastructural layering/collage and patchwork through which analysts naturalize/denaturalize various contested categories in the ranking’s territory. They reflect on the consequences of such attempts at reconfiguring global topologies for the problems these governance initiatives seek to address.

Intentions of managers of pharmaceutical multinational enterprises (MNEs) to adopt business strategies, which will aid global health and wellbeing, are in some ways linked with their understanding of the returns that their company will receive from these investments. However, the MNE’s managers are unaware of business strategies that will allow them to link their business activities with the corporate objectives of contributing to Sustainable Development Goals (SDGs). Pharmaceutical companies are moving toward monopolistic practices by acquiring local companies for manufacturing purposes or by engaging local companies in contract manufacturing and directing the focus of these companies away from innovation and toward profit making. At the same time, pharmaceutical MNEs are promoting global health and wellbeing as their SDGs. This study uses knowledge from existing sources and expert insights to explain the returns that MNEs can get from their investments related to global health and wellbeing. One of the important recommendations from the ethical point of view is engaging local firms in the innovation process; from the marketing perspective, this study recommends the use of a corporate brand and not a product brand for offering generic medicines. The operations perspective explains how MNEs can incorporate the social agenda into their mainstream business strategies. Limitations of the study are discussed, and avenues for future research are explained.

Substandard medicines contribute to poor public health and affect development, especially in the developing world. However knowledge of how manufacturers, distributors and providers understand the concept of drug quality and what strategies they adopt to ensure drug quality is limited, particularly in the developing world. The purpose of this paper is to explore pharmaceutical manufacturers', distributors' and providers' perceptions of drug quality in South Africa and how they ensure the quality of drugs during the distribution process.

The approach taken was qualitative data collection through key informant interviews using a semi‐structured interview guide. Transcripts were analysed thematically in Johannesburg, Pretoria and Durban, South Africa. Participants were recruited purposefully from a South African pharmaceutical manufacturer, SA subsidiaries of international manufacturers, national distribution companies, national wholesaler, public and private sector pharmacists, and a dispensing doctor. In total, ten interviews were conducted.

Participants described drug quality in terms of the product and the processes involved in manufacturing and handling the product. Participants identified purchasing registered medicines from licensed suppliers, use of standard operating procedures, and audits between manufacturer and distributor and/or provider as key strategies employed to protect medicine quality. Effective communication amongst all stakeholders, especially in terms of providing feedback regarding complaints about medicine quality, appears as a potential area of concern, which would benefit from further research.

The paper hightlights that ensuring medicine quality should be a shared responsibility amongst all involved in the distribution process to prevent medicines moving from one distribution system (public) into another (private).