Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021.

This paper aims to characterize the main actors in the Brazilian pharmaceutical industry — national companies, foreign companies and public laboratories — and analyze how they were affected and how they reacted to changes over the last 30 years in the institutional framework. The results show that national companies have been gaining prominence in the Brazilian pharmaceutical market with their internationalization movement and their strengthening of innovation strategies.

Six drug regulatory reviewers and 11 pharmaceutical industry scientists were interviewed to explore their perspectives on the obstacles and opportunities for greater implementation of the Three Rs (replacement, reduction, refinement) in drug research and development. Participants generally supported the current level of animal use in the pharmaceutical industry and viewed in vitro methods as supporting, but not replacing, the use of animals. Obstacles to greater use of the Three Rs cited by participants included the lack of non-animal alternatives; requirements for statistical validity; reluctance by industry and regulators to depart from established patterns of animal use; the priority of commercial objectives ahead of the Three Rs; and concern that less animal testing could jeopardise human safety. Opportunities identified for the Three Rs included the development of better animal models including genetically modified (GM) animals; pursuit of more basic knowledge, notably drug action on gene expression; re-use of animals; greater use of pilot studies; using sufficient numbers of animals per test to avoid repeating inconclusive studies; regular review of animal data in regulatory requirements; and following the regulatory option of combining segments of reproductive toxicology studies into one study. In some areas, greater implementation of the Three Rs seemed well aligned with industry priorities, for example, phenotypic characterisation of GM animals and validation of alternative methods. In other areas, wider use of the Three Rs may require building consensus on areas of disagreement including the usefulness of death as an endpoint; the suitability of re-using animals; and whether GM animals and the use of pilot studies contribute to reduction.

The research and development leading to the discovery and distribution of safe and effective COVID-19 vaccines demonstrated the indispensable nature of the pharmaceutical industry. While governments played an important role in financing these efforts by prepaying for dosages, it was private industry that delivered the scientific and technical miracles. At the same time, because of vaccine nationalism and hoarding, citizens of the global south have inadequate access to vaccines. This is a moral and human rights tragedy for which governments, not the pharmaceutical industry, are primarily responsible. This article argues that, as illustrated by humanitarian disaster of inadequate vaccine access in the global south, the failure of the UNGPs to adequately address the paramount role of government in human rights violations, even when there is shared responsibility with business, is a systemic failure that makes the United Nations an inappropriate forum for addressing business and human rights issues.

The Indian pharmaceutical industry has experienced rapid growth, becoming the world's largest provider of generic drugs, based on product and process innovation. The industry has undergone dynamic changes in recent decades, operating in a rapidly evolving environment affected by domestic and global policies; a key example of the latter is the TRIPS agreement. Taking an intellectual property perspective, we describe how changes in the innovation ecosystem have affected companies’ strategies related to international activity and accessing knowledge from both internal and external knowledge sources, during the transitional- and post-TRIPS periods (1995–2004 and 2005–2014, respectively). Combining intellectual property arguments with contextual aspects of the innovation ecosystem, we conjecture that, in the post-TRIPS period, externally-sourced knowledge will be more important than internally-sourced knowledge, for Indian pharmaceutical firms’ international business activity.

Cross-sectorial, dynamic, and innovative partnerships are essential to resolve the challenges of humankind in the 21st century. At the same time, trust in each other’s integrity and good will is a precondition for the solution of any complex problem, and certainly for the success of the United Nations Sustainable Development Agenda. Experience shows that a nation’s economic and social success is at its greatest if, and when, there is cooperation and even cocreation involving a fair division of labor and responsibility among the different societal stakeholders. This paper uses Ralf Dahrendorf’s seminal work on obligations, as well as the European Commission’s Science with and for Society unit’s definition of responsible research and innovation (RRI), to motivate industry responsibilities to make the world a healthier place.

Brazil has encouraged an ambitious set of policies towards the pharmaceutical industry, aiming to foster technological development while meeting health requirements. We characterise these efforts, labelled the ‘Complexo Industrial da Saúde’ (Health-Industry Complex, CIS), as an outcome of incremental policy change backed by the sustained efforts of public health professionals within the federal bureaucracy. As experts with a particular vision of the relationship between health, innovation and industry came to dominate key institutions, they increasingly shaped government responses to emerging challenges. Step by step, these professionals first made science and technology essential aspects of Brazil's health policy, and then merged the Ministry of Health's new focus on science, technology and health with industrial policy measures aimed at private firms. We contrast our depiction of these policy changes with a conventional view that relies on a partisan orientation of the executive.

Objectives: Optional scientific advice (SA) for the early benefit assessment of pharmaceuticals is offered by the German decision maker, the Federal Joint Committee (FJC). The aim of this study was to elicit manufacturers’ experiences with the SA procedures offered by the FJC to date.

Methods: A preliminary survey on a small sample size was conducted. Subsequently, a questionnaire comprising eight items, which was developed on the basis of that survey, was used. Data were analyzed using qualitative and quantitative approaches.

Results: The elicitation, including a sample of 25 percent of the completed advice, highlighted the following, regarding the process as well as to the content shortcomings of the SA procedures from an industrial perspective: inconsistencies, FJC's lack of expertise in conducting clinical trials, partially incomplete answers. and a low willingness of the FJC to engage in dialogue with industry were criticized. On the other hand, the majority of respondents expressed a positive attitude concerning unambiguousness, completeness, traceability, discussion atmosphere, and the protocol of the advice. Early SA, before pivotal trials start, showed a significantly higher completeness compared with late SA with respect to endpoints and study duration. Within 4 years the quality of FJC's propositions on some topics improved significantly.

Conclusions: Only a few statistically significant differences were detectable between early versus late SA. A positive trend in industry's perception of the SA can be observed over time. A more active involvement of additional stakeholders and the incorporation of procedural elements from other healthcare systems could improve the quality of the SA offered by the FJC.

By the turn of the twentieth century, the Dutch colony of the Netherlands Indies dominated the worldwide supply of antifebrifuge (to reduce fever) cinchona bark, the raw material for quinine, an antimalarial medicine. Over the next four decades, the high-quality and laboratory-conditioned cultivation of cinchona became the backbone of a Dutch transoceanic cinchona-quinine enterprise that dominated the international quinine markets. However, in the two decades after the Second World War, the Netherlands Indies’ cinchona bark dominance ended, and the Dutch transoceanic cinchona-quinine production and trade network collapsed. How can we explain this shift? In this study, we argue that this change was part of a process of globalization of cinchona bark production that created new sources and transoceanic production and distribution chains and hence new networks of control that were increasingly less associated with a specific nation than with multinational companies. Colonial networks of control were replaced by new industrial networks of control, and the colonial agro-industrial system was reconfigured into a global agro-industrial system. At the same time, this study also shows that the economic decolonization of Indonesia forced a process of deglobalization that resulted in a translocation of the cinchona-quinine trade networks. As such, this study shows a mix of globalization and deglobalization happening in tandem with Indonesian decolonization and agricultural globalization.

The historical development and economic impact of pharmaceuticals in the UK are nowadays reasonably well documented. That industry has become the most profitable and fast growing of the country's high-tech industries. Its member firms undertake more than one-fifth of the national research and development (R&D) activities, one half being carried out in Britain, and currently achieve a £2.4 billion favourable trade balance with the rest of the world.

This article analyses the role of the pharmaceutical and medical device industries (‘pharma’) in the construction of scientific and medical knowledge. Pharma's activities are part of the broader dispositif of institutions, enterprises, regulations and constituencies within which medical-scientific knowledge is generated, but pharma's contributions exhibit a specific character reflecting commercial pressures. As drug development proceeds, research and marketing activities coalesce around ‘product canons’ that integrate scientific truth-claims and commercial positioning, generating knowledge with implicit commercial functionality. From this platform, pharma stamps consensus-building ‘narratives’ into medical-scientific discourse, in which ‘problems’ arise and are ‘solved’ by drugs. Concurrently, pharma modulates the structure of discourse and the social networks through which discourse proceeds. Implicit within these activities is a meta-science whose goal is to understand and technologize the operation of science to an external end. This mode of knowledge production can be viewed as a normative transformation of Kuhnian normal science, characterized by the attachment (and at times subordination) of paradigmatic tenets to extrinsic goals; exaggerated control of belief, research and consensus formation; and a capacity for infringement of traditional norms of scientific truthfulness. An International Standard of Integrity in Science would strengthen pharma's contributions to medical and scientific knowledge.