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Background: The global pharmaceutical industry has a long history of prioritizing profits over public health through widespread practices such as price gouging, deceptive marketing, and fraud. A prominent example of this issue is the mislabeling and mass-marketing of OxyContin by Purdue Pharmaceuticals (Purdue) that catalyzed the opioid crises in and beyond the United States., Methods: Guided by Actor-Network Theory, this case study employs Visual Network Analysis to map the actors-networks involved in responding to the harms caused by Purdue. Data was generated from peer-reviewed and grey literature published between 2007 and 2022 (n = 40) and imported into Gephi visualization software where centrality metrics were applied., Results: A total of 39 actors and 99 relationships were visualized based on the relational thinking that actors who are heavily interconnected with others are rendered important. Centrality measures identified the socio-technical centrality of Purdue in influencing the response to the harms it caused. Purdue exerted influence through various avenues, most prominently through the creation and cooptation of pain advocacy groups, their close ties with United States elected officials, and through embedding pro-opioid messaging in international guidance documents. In doing so, Purdue was able to extend the reach and impact of their opioid promotion, while simultaneously limiting the capacity of regulatory bodies to pursue accountability and implement policies to mitigate opioid-related harms., Conclusion: This study advances understandings of the complex interplay between transnational pharmaceutical companies, global health systems, regulatory bodies, and public health. In doing so, we underscore the need for stronger regulation and increased transparency surrounding the interactions between pharma, patient groups, governments, and international organizations to better address and prevent future harms., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests Andrea Bowra reports financial support was provided by Government of Canada Social Sciences and Humanities Research Council. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Pharmaceutical sector corruption undermines patient access to medicines by diverting public funds for private gain and exacerbating health inequities . This paper presents an analysis of UN Convention Against Corruption (UNCAC) compliance in seven countries and examines how full UNCAC adoption may reduce corruption risks within four key pharmaceutical decision-making points: product approval, formulary selection, procurement, and dispensing. Countries were selected based on their participation in the Medicines Transparency Alliance and the WHO Good Governance for Medicines Programme. Each country's domestic anti-corruption laws and policies were catalogued and analysed to evaluate their implementation of select UNCAC Articles relevant to the pharmaceutical sector. Countries displayed high compliance with UNCAC provisions on procurement and the recognition of most public sector corruption offences. However, several countries do not penalise private sector bribery or provide statutory protection to whistleblowers or witnesses in corruption proceedings, suggesting that private sector pharmaceutical dispensing may be a decision-making point particularly vulnerable to corruption. Fully implementing the UNCAC is a meaningful first step that countries can take reduce pharmaceutical sector corruption. However, without broader commitment to cultures of transparency and institutional integrity, corruption legislation alone is likely insufficient to ensure long-term, sustainable pharmaceutical sector good governance.

Access to safe, effective, good-quality medicines can be compromised by poor pharmaceutical system governance. This system is particularly vulnerable to inefficiencies and to losses from corruption, because it involves a complex mix of actors with diverse responsibilities. A high level of transparency and accountability is critical for minimizing opportunities for fraud and leakage. In the past decade, the Good Governance for Medicines programme and the Medicines Transparency Alliance focused on improving accountability in the pharmaceutical system and on reducing its vulnerability to corruption by increasing transparency and encouraging participation by a range of stakeholders. Experience with these two programmes revealed that stakeholders interpreted transparency and accountability in a range of different ways. Moreover, programme implementation and progress assessments were complicated by a lack of clarity about what information should be disclosed by governments and about how greater transparency can strengthen accountability for access to medicines. This article provides a conceptual understanding of how transparency can facilitate accountability for better access to medicines. We identified three categories of information as prerequisites for accountability: (i) standards and commitments; (ii) decisions and results; and (iii) consequences and responsive actions. Examples are provided for each. Conceptual clarity and practical examples of the information needed to ensure accountability can help policy-makers identify the actions required to increase transparency and accountability in their pharmaceutical systems. We also discuss factors that can hinder or facilitate the use of information to hold to account those responsible for improving access to medicines.

Corruption in healthcare generally and specifically in the pharmaceutical arena has recently been highlighted in reports by Transparency International. This article focuses on four areas of corruption: legislative/regulatory, financial, ideological/ethical, and communications. The problems identified and the solutions considered focus on structural considerations affecting how pharmaceuticals are discovered, developed, distributed, and ultimately used in clinical settings. These include recourse to user fees in the regulatory sphere, application of intellectual property rights to medical contexts (patents and access to research data), commercial sponsorship of ghost writing and guest authors, linkage/delinkage of the funding of research and overall health objectives to/from drug pricing and sales, transparency of payments to healthcare professionals and institutions, and credible regulatory sanctions. In general, financial and other incentives for all actors in the system should be structured to align with desired social outcomes - and to minimise conflicts of interest among researchers and clinicians.

Background: Access to medicines and the development of a strong national pharmaceutical industry are two longstanding pillars of health policy in Brazil. This is reflected in a clear emphasis by Brazil's Federal Government on improving access to medicine in national health plans and industrial policies aimed at promoting domestic pharmaceutical development. This research proposes that such policies may act as incentives for companies to pursue a strategic Corporate Social Responsibility (CSR) agenda. CSR that supports Governmental priorities could help companies to benefit significantly from the Governmental industrial policy. We sought to determine whether CSR activities of Brazilian pharmaceutical firms are currently aligned with the Federal Government's health prioritization. To do so we examined key Brazilian health related policies since 2004, including the specific priorities of Brazil's 2012-2015 Health Plan, and compared these with CSR initiatives that are reported on the websites of select pharmaceutical firms in Brazil., Results: Brazil's national health plans and industrial policies demonstrated that the Federal Government has followed diverse approaches for improving access to medicines, including strengthening health care infrastructure, increasing transparency, and supporting product development partnerships. Case studies of six pharmaceutical firms, representing both public and private companies of varying size, support the perspective that CSR is a priority for firms. However, while many programs target issues such as health infrastructure, health care training, and drug donation, more programs focus on areas other than health and do not seem to be connected to Governmental prioritization., Conclusion: This research suggests that there are loose connections between Governmental priorities and pharmaceutical firm CSR. However, there remains a significant opportunity for greater alignment, which could improve access to medicines in the country and foster a stronger relationship between the Government and industry.

Background: Glivec (imatinib mesylate), produced by the pharmaceutical company Novartis, is prescribed in the case of chronic myeloid leukemia, one of the most common blood cancers in eastern countries. After more than a decade of legal battles surrounding its patentability, the Supreme Court of India gave its final decision on April 1st of 2013, rejecting the appeal of the Swiss giant drug manufacturer. In 2006, the Indian Patent Office first refused Glivec's patent under Section 3(d) of the Indian Patent Act arguing that it was only a modified version of an existing drug, Imatinib, and therefore that the drug was not innovative. Novartis replied filing legal challenges against the Indian government but the final verdict in April of 2013 ends the battle. Indeed, the Supreme Court stated that even if the bioavailability of the drug was improved, it did not demonstrate enhanced efficacy and that Glivec was not patentable., Methods: The research primarily focused on journal, newspaper and magazine articles relevant to the time frame of the lawsuit (from 1994 to 2013) as well as news searches through Google, Factiva, ProQuest, PubMed, and YouTube where press articles from court verdicts were obtained by using the following keywords: "India", "Novartis", "Glivec", "Patent", "Novartis Case", and "Supreme Court of India". The data sources were interpreted and analyzed according to the authors' own prior knowledge and understanding of the exigencies of the TRIPS Agreement., Results: This case illuminates how India is interpreting international law to fit domestic public health needs., Conclusions: The Novartis case arguably sets an important precedent for the global pharmaceutical industry and ideally will help improve access to lifesaving medicines in the developing world by demanding that patient health needs supersede commercial interests. The Supreme Court of India's decision may affect the interpretation of the article of the TRIPS Agreement, which states members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.

Background: The reform of pharmaceutical policy can often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR), a legislative amendment that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only two orders of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda have been exported. Future use of the regime appears unlikely. This research aimed to examine the politics of CAMR., Methods: Parliamentary Committee hearing transcripts from CAMR's legislative development (2004) and legislative review (2007) were analysed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analysed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR., Results: In 2004, policy debates in Canada were dominated by two themes: intellectual property rights and the TRIPS Agreement. The right to medicines as a basic human right and CAMR's potential impact on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007, which can be partly accounted for by experience in implementing the legislation and hence a greater representation of the interests of potential beneficiary country governments., Conclusions: The Canadian Government designed CAMR as a last resort measure. Increased input from the developing country beneficiaries and shifting to institutions where the right to health gets prioritized may lead to policies that better achieves affordable drug access.

Within the array of measures for improving medicines access for the world's neediest populations, governments of many countries have turned to compulsory licensing, a statutory mechanism to enable third parties to manufacture a product or process still under patent. In this paper, we focus on a historic case example from Canada and the present example of Thailand's use of domestic compulsory licenses as a policy tool for ensuring public access to affordable medicines. The overarching objective is to draw out policy and legislative insights that may be of value for countries with pharmaceutical manufacturing capacity and which are considering better access to patented medicines for their populations under the current global intellectual property regime. From these cases, it is apparent that although compulsory licensing is not a novel remedy, even in a post-Trade Related Aspects of Intellectual Property Rights environment, it remains a powerful policy tool in improving access to medicines in a variety of domestic settings.

Drug companies aggressively market their products to increase sales and economic rewards. Different countries have different regulatory regimes for controlling promotion. In the United States control rests directly with the Food and Drug Administration whereas Canada relies on a mixture of voluntary self-regulation and an autonomous agency. Each method has significant weaknesses. We examine these weaknesses by analyzing the promotion of OxyContin (the time release version of the opioid oxycodone) by Purdue in Canada and the United States. We then look at the association between promotion and the misuse and abuse of OxyContin in both countries. Finally, we advance specific recommendations for regulating promotion for drugs that may have a high abuse potential.

This paper examines how current legislative and regulatory models do not adequately govern the pharmaceutical industry towards ethical scientific conduct. In the context of a highly profit-driven industry, governments need to ensure ethical and legal standards are not only in place for companies but that they are enforceable. We demonstrate with examples from both industrialized and developing countries how without sufficient controls, there is a risk that corporate behaviour will transgress ethical boundaries. We submit that there is a critical need for urgent drug regulatory reform. There must be robust regulatory structures in place which enforce corporate governance mechanisms to ensure that pharmaceutical companies maintain ethical standards in drug research and development and the marketing of pharmaceuticals. What is also needed is for the pharmaceutical industry to adopt authentic "corporate social responsibility" policies as current policies and practices are insufficient.