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Background: The goal of the public procurement of pharmaceuticals is to purchase sufficient quantities of high-quality pharmaceuticals at cost-effective prices for a given population. This goal can be undercut if corruption infiltrates the procurement process. Good procurement practices can help mitigate the risks of corruption and support equitable access to affordable and high-quality medicines. Objectives: This paper aims to 1) examine manifestations of corruption in the pharmaceutical procurement process and key factors behind them, and 2) identify how to design and implement effective anti-corruption, transparency and accountability mechanisms within this process. Methods: This paper was informed by a narrative literature review from 1996 to the present. The search focused on publications that addressed the issue of pharmaceutical procurement and governance and corruption issues. Our search included peer-reviewed literature, books, grey literature such as working papers, reports published by international organizations and donor agencies, and some media articles. Some documents used in this paper were already known to the authors. Results: Procurement is highly vulnerable to corruption particularly in the health sector. What is more, corruption in the procurement process does not appear to be limited to any one level of government or type of health system. The better integration of accountability, transparency and anti-corruption mechanisms in the procurement process is needed to reduce the risk of corruption. Conclusions: Lessons learned suggest that anti-corruption, transparency and accountability mechanisms in the pharmaceutical procurement process, such as open contracting and integrity pacts are helpful towards reducing the risk of corruption. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background Corruption in the health sector can hurt health outcomes. Improving good governance can in turn help prevent health-related corruption. We understand good governance as having the following characteristics: it is consensus-oriented, accountable, transparent, responsive, equitable and inclusive, effective and efficient, follows the rule of law, is participatory and should in theory be less vulnerable to corruption. By focusing on the pharmaceutical system, we explore some of the key lessons learned from existing initiatives in good governance. As the development community begins to identify post-2015 Millennium Development Goals targets, it is essential to evaluate programs in good governance in order to build on these results and establish sustainable strategies. This discussion on the pharmaceutical system illuminates why. Discussion Considering pharmaceutical governance initiatives such as those launched by the World Bank, World Health Organization, and the Global Fund, we argue that country ownership of good governance initiatives is essential but also any initiative must include the participation of impartial stakeholders. Understanding the political context of any initiative is also vital so that potential obstacles are identified and the design of any initiative is flexible enough to make adjustments in programming as needed. Finally, the inherent challenge which all initiatives face is adequately measuring outcomes from any effort. However in fairness, determining the precise relationship between good governance and health outcomes is rarely straightforward. Summary Challenges identified in pharmaceutical governance initiatives manifest in different forms depending on the nature and structure of the initiative, but their regular occurrence and impact on population-based health demonstrates growing importance of addressing pharmaceutical governance as a key component of the post-2015 Millennium Development Goals. Specifically, these challenges need be acknowledged and responded to with global cooperation and innovation to establish localized and evidence-based metrics for good governance to promote global pharmaceutical safety. [ABSTRACT FROM AUTHOR]

Background Glivec (imatinib mesylate), produced by the pharmaceutical company Novartis, is prescribed in 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 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. [ABSTRACT FROM AUTHOR]

Pharmacovigilance in low and lower middle-income countries has not been commensurate with increasing access to medicines, despite growing recognition that it is important to health outcomes. Pharmacovigilance is impeded where healthcare systems are overburdened and under-resourced. In countries such as India, the population is increasingly exposed to potential adverse drug reactions. Pharmaceutical industry corporate governance, that advances pharmacovigilance in under-resourced countries, would support postmarket drug safety. An analytic framework is used to guide this comparative analysis of pharmacovigilance governance within global pharmaceutical corporations (GPCs) and their Indian subsidiaries. Findings reveal that pharmacovigilance is not fully integrated into corporate governance of the GPCs studied. GPCs exhibiting the least integration have more outstanding drug safety issues. Policy incentives would advance integration of corporate governance and pharmacovigilance. [ABSTRACT FROM AUTHOR]

This research assesses informal markets that dominate pharmaceutical systems in severely disrupted countries and identifies areas for further investigation. Findings are based on recent academic papers, policy and grey literature, and field studies in Somalia, Afghanistan, the Democratic Republic of Congo and Haiti. The public sector in the studied countries is characterized in part by weak Ministries of Health and low donor coordination. Informal markets, where medicines are regularly sold in market stalls and unregulated pharmacies, often accompanied by unqualified medical advice, have proliferated. Counterfeit and sub-standard medicines trade networks have also developed. To help increase medicine availability for citizens, informal markets should be integrated into existing access to medicines initiatives. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The article examines several domestic legislative amendments created by the World Trade Organization (WTO) to elaborate several aspects that both facilitate and hinder utilization of the General Council Decision. The WTO Decision allows compulsory licensing of patented medicines for the aim of exporting the generic versions to countries with less or no pharmaceutical manufacturing capacity. It focuses on the attempt of Rwanda to import under Canada's implementation of the 2003 WTO Decision.