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There is sufficient evidence to prove that the improved health status of a nation’s citizens results in economic growth and development via improved functionality and productivity of labor. It is also commonly accepted that healthcare expenditure significantly influences health status through, for instance, improving life expectancy at birth and reducing morbidity, death, and infant mortality rates. Within healthcare, medicines account for a considerable share of health-related expenditure in both developed and developing countries. Therefore, it seems reasonable to assume that improved access to medicines is likely to contribute not only to the well-being of families and individuals but also to the economic growth and development in all societies. It has been widely advocated that pharmaceutical multinational enterprises (MNEs) can play an important role to address this problem, as they develop and supply a significant proportion of the drugs imported by low- and middle-income countries. This chapter is dedicated to a systematic review of literature in order to identify the strategies implemented by pharmaceutical MNEs to improve access to medicines in the low- and middle-income countries. A total of 76 research articles have been identified, and we have found that the main strategies of pharmaceutical MNEs are related to improving health outcomes through R&D, establishing partnerships for product development, pricing strategies to improve access to medicines, technology transfer, licensing agreements, and nonmarket efforts to improve access to medicines, among other strategies to overcome barriers imposed by intellectual property rights. We have also found that pharmaceutical MNEs’ strategies take place within a complex system and often involve interactions with a wide range of actors, such as international organizations, governments, private not-for-profit sector, universities and research institutes, and generic manufacturers. However, there is still a need for major progress in the field of access to medicines, and pharmaceutical MNEs should be more active in this field in order to avoid potential negative consequences, such as loss of legitimacy and compulsory licensing of their patented medicines.

In this study, the authors aimed to explore consumer perspectives on accelerated access to medicines. The authors were particularly interested in how they balance competing considerations of safety, efficacy, equity and access; whether and how their views change when there are different levels of uncertainty surrounding the safety and efficacy of new medicines; and the procedures that they think should be used to make decisions about accelerated access to new medicines.

This was an exploratory qualitative study. Thirteen semi-structured interviews with patient advocates and two focus groups with patients were conducted and analysed thematically. Interviews and focus groups were audio recorded and transcribed verbatim. Data were analysed through inductive thematic analysis.

Participants outlined a range of justifications for accelerated access, including addressing unmet medical needs and encouraging further research and development. However, they were also cognisant of the potential risks and viewed ongoing data collection, disinvestment and market withdrawal as ways to address these. They also emphasised the importance of transparent decisions being made by people with relevant expertise, based on a thorough consideration of scientific evidence and stakeholder perspectives.

This is the first study to comprehensively explore Australian consumers' views of accelerated access to medicines. The results suggest that consumers want timely access to new medicines, but not at the expense of safety, efficacy, equity and sustainability. While accelerated access programs are likely to be welcomed by consumers, they must be fully informed of their conditions and limitations, and robust post-market data surveillance must be implemented and enforced to protect the interests of both individual patients and the broader community.

Pharmacy sales of over‐the‐counter medicines in the UK represent an economically significant and important mechanism by which customers self‐medicate. Sales are supervised in pharmacies, but this paper seeks to question whether patients' electronic health records (EHRs) – due to be introduced nationally – could be used, ethically, by pharmacists to ensure safe medicines sales.

Using theoretical arguments, three areas of ethical concern are identified and explored in relation to pharmacists' access to EHRs‐consequentialsim, analogies and confidentiality/privacy.

Consequentialist arguments include positive benefits to customer's welfare and control of medicine of abuse, but negative economic healthcare burdens and consequences due to potentially increased or paradoxically, decreased presentation of patients to doctors. Socially accepted analogous practices – credit checks, existing pharmacy access to information and hospital treatment – are then argued to be ethically relevant and supportive of access. Privacy and confidentiality are then considered as reasons not to allow EHR access. A contrasting view is that pharmacy access to EHRs is another form of surveillance and hence the question of pharmacists' assess to EHRs may be answered negatively by empirical research that locates pharmacy customers as expert users and identifies confidentiality and privacy concerns about information technology in healthcare more generally.

This paper offers a unique and valuable contribution to the debate about healthcare professionals' role‐based access to patients' medical records and offers a reflection on the ethical concerns surrounding patient information and the rival concerns of patient qua customer autonomy and safety.

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.

Using the pharmaceutical sector as a microcosm of the health sector, we highlight the most prevalent structural and policy issues that make this sector susceptible to corruption and ways in which these vulnerabilities can be addressed. We conducted a literature review of publications from 2004 to 2015 that included books, peer-reviewed literature, as well as gray literature such as working papers, reports published by international organizations and donor agencies, and newspaper articles discussing this topic. We found that vulnerabilities to corruption in the pharmaceutical sector occur due to a lack of good governance, accountability, transparency, and proper oversight in each of the decision points of the pharmaceutical supply chain. What works best to limit corruption is context specific and linked to the complexity of the sector. At a global level, tackling corruption involves hard and soft international laws and the creation of international standards and guidelines for national governments and the pharmaceutical industry. At a national level, including civil society in decision-making and monitoring is also often cited as a positive mechanism against corruption. Anticorruption measures tend to be specific to the particular “site” of the pharmaceutical system and include improving institutional checks and balances like stronger and better implemented regulations and better oversight and protection for “whistle blowers,” financial incentives to refrain from engaging in corrupt behavior, and increasing the use of technology in processes to minimize human discretion. This chapter was adapted from a discussion piece published by Transparency International UK entitled Corruption in the Pharmaceutical Sector: Diagnosing the Challenges.

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.

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.

Public health policy often excludes access to essential medicines. Drawing on an in-depth case study examining access to essential medicines in the context of the HIV/AIDS pandemic in South Africa, and more briefly, making reference to the U.S. diabetes epidemic, we highlight the relationship between the need for essential medicines in world populations, and the role of groups external to government in promoting access to essential medicines in public health policy. We consider how, in the context of health stratification, the activities of patient advocacy groups, and “third way” social policies of the pharmaceutical industry generate “social capital,” creating enhanced access to essential medicines for a few, and promoting the ideal of the right to access for all. The implications for the development of public health policy inclusive of essential medicines are discussed.

The subsidization of artemisinin combination therapy (ACT) at supranational level to avoid undermining the private distribution system in sub‐Saharan Africa and elsewhere, as advocated by Committee on the Economics of Antimalarial Drugs board on Global Health, requires the appraisal of the economic behaviour of relevant private agents in these regions, in order to assess their potential influence on access to ACT. The purpose of this paper is to analyze the economic behaviour of informal medicine retailers and how this effects access to ACT, using data generated from a primary survey in southeast Nigeria.

A field survey was carried out which included health providers and households. A market price survey was undertaken to generate primary data, using closed and semi‐open questionnaires, and there were focus group discussions in two south‐eastern states in Nigeria. A standard two‐stage method was used for the design of the survey.

The study demonstrates that the economic behaviour of informal medicine affects market prices of ACT, facilitates information diffusion, improves availability and acceptability dimensions of access to ACT. However, their clinical practices are weak and require policy interventions.

This paper brings to the fore the influence of economic behaviour of retail agents in the medical market, which needs to be taken into account when considering alternative distributional channels for ACT, if the WHO goal of universal access in malaria‐endemic regions is to be achieved.

A Novartis social business in India completely separated the activities of its social and business units—the former engaging in raising the health awareness of villagers and encouraging them to visit free health camps, while the latter developed affordable medicine delivered directly to village pharmacies. Connections between these units were made through open and fluid market-type mechanisms, and by appealing to the needs and interests of villagers with incentives. This synchronized business model was developed partly because Novartis believed in villagers' self-initiated behavior for health improvements, which made it not interfere into marginalized institutions, and more significantly because it used its internalized control and coordination systems with clear goals of social contribution in operating the business unit. Consequently, Novartis achieved economies of scale, business sustainability, and social contribution.