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  1. Article: State capture through indemnification demands? Effects on equity in the global distribution of COVID-19 vaccines.

    Gorodensky, Ariel / Kohler, Jillian C

    Journal of pharmaceutical policy and practice

    2022  Volume 15, Issue 1, Page(s) 50

    Abstract: Background: State capture by the pharmaceutical industry is a form of corruption whereby pharmaceutical companies shift laws or policies about their products away from the best interest of the public and toward their private benefit. State capture often ...

    Abstract Background: State capture by the pharmaceutical industry is a form of corruption whereby pharmaceutical companies shift laws or policies about their products away from the best interest of the public and toward their private benefit. State capture often limits equitable access to pharmaceutical products by inflating drug prices and increasing barriers to entry into the pharmaceutical industry. During the COVID-19 pandemic, the high demand and low supply of COVID-19 vaccines has put governments that manage vaccine procurement at risk of capture by COVID-19 vaccine manufacturers, both through bilateral deals and the COVID-19 Vaccine Global Access (COVAX) Facility; this threatens equity in the global distribution of these products. The purpose of this study is to determine whether COVID-19 vaccine manufacturers have been engaging in state capture and, if so, to examine the implications of state capture on equitable access to COVID-19 vaccines.
    Methods: A targeted rapid literature search was conducted on state capture by the pharmaceutical industry. Results were limited to journal articles, books, and grey literature published between 2000 and 2021 in or translated to English. A literature search was also conducted for information about state capture during the COVID-19 pandemic. Results were limited to media articles published between March 2020 and July 2021 in or translated to English. All articles were qualitatively analyzed using thematic analysis.
    Results: COVID-19 vaccine manufacturers have demanded financial indemnification from national governments who procure their vaccines. While most high-income countries are legislatively capable of indemnifying vaccine manufacturers, many low- and middle-income countries (LMICs) are not. A number of LMICs have thus changed their legislations to permit for manufacturers' indemnification demands. Amending legislation in this way is state capture and has led to delays in LMICs and vaccine manufacturers signing procurement contracts. This has critically stalled access to vaccines in LMICs and created disparities in access to vaccines between high-income countries and LMICs.
    Conclusions: COVID-19 vaccine manufacturers' indemnification demands constitute state capture in many LMICs though not in high-income countries; this has enhanced global COVID-19 vaccine inequities. Results underscore the need to find alternatives to financial indemnification that do not hinder critical efforts to end the pandemic.
    Language English
    Publishing date 2022-08-19
    Publishing country England
    Document type Journal Article
    ZDB-ID 2734772-2
    ISSN 2052-3211
    ISSN 2052-3211
    DOI 10.1186/s40545-022-00442-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Why the COVID-19 pandemic should be a call for action to advance equitable access to medicines.

    Kohler, Jillian C / Mackey, Tim K

    BMC medicine

    2020  Volume 18, Issue 1, Page(s) 193

    MeSH term(s) Betacoronavirus ; COVID-19 ; Coronavirus Infections ; Global Health ; Health Services Accessibility ; Humans ; Pandemics ; Pneumonia, Viral ; SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-06-25
    Publishing country England
    Document type Letter
    ISSN 1741-7015
    ISSN (online) 1741-7015
    DOI 10.1186/s12916-020-01661-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Shared health governance, mutual collective accountability, and transparency in COVAX: A qualitative study triangulating data from document sampling and key informant interviews.

    Gorodensky, Ariel / Grundy, Quinn / Persaud, Navindra / Kohler, Jillian C

    Journal of global health

    2023  Volume 13, Page(s) 4165

    Abstract: Background: To facilitate global COVID-19 vaccine equity, the World Health Organization, the Coalition for Epidemic Preparedness Innovations, the Global Alliance for Vaccines and Immunizations, and the United Nations Children's Fund supported the COVID- ... ...

    Abstract Background: To facilitate global COVID-19 vaccine equity, the World Health Organization, the Coalition for Epidemic Preparedness Innovations, the Global Alliance for Vaccines and Immunizations, and the United Nations Children's Fund supported the COVID-19 Vaccine Global Access (COVAX) partnership. COVAX's goals may have best been pursued through shared health governance - a theory of global health governance based on six premises, in which global health actors collaborate to achieve a shared goal. Shared health governance employs a framework for accountability termed "mutual collective accountability", in which actors hold each other accountable for achieving their goal, thus relying on transparency with one another.
    Methods: We conducted a multi-method qualitative study triangulating document analysis and key informant interviews to address the question: To what extent did COVAX employ shared health governance, mutual collective accountability, and transparency? We thus aimed to explore the governance structures and accountability and transparency mechanisms in COVAX and determine whether these constituted shared health governance and mutual collective accountability.
    Results: We identified 117 documents and interviewed 20 key informants. Our findings suggest that COVAX's co-convening organisations were governed by their individual formal governance mechanisms, while each was formally accountable to its own leadership team, resulting in challenges when activities and decisions involved collaboration between organisations. Furthermore, COVAX's governance lacked transparency, as there was little public information about their decision-making processes and operations, including information about the algorithm with which they make vaccine allocation decision, possibly contributing to its inability to achieve its goals.
    Conclusions: The COVAX partnership only achieved four of the six premises of shared health governance. Since actors involved in COVAX did not hold one another accountable for their role in the partnership, it did not employ mutual collective accountability, while also lacking in transparency. Although these results do not entirely explain COVAX's shortcomings, they contribute to evidence about the roles of good governance, transparency, and accountability in large global health initiatives and underscore failures of the current global governance system.
    MeSH term(s) Child ; Humans ; COVID-19 Vaccines ; World Health Organization ; Global Health ; United Nations ; Social Responsibility
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2023-12-08
    Publishing country Scotland
    Document type Journal Article
    ZDB-ID 2741629-X
    ISSN 2047-2986 ; 2047-2986
    ISSN (online) 2047-2986
    ISSN 2047-2986
    DOI 10.7189/jogh.13.04165
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Book ; Online: Why the COVID-19 pandemic should be a call for action to advance equitable access to medicines

    Kohler, Jillian C / Mackey, Tim K

    2020  

    Keywords covid19
    Language English
    Publishing date 2020-06-25
    Publishing country ca
    Document type Book ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Medicine donations: a review of policies and practices.

    Permaul Flores, Hannah / Kohler, Jillian C / Dimancesco, Deirdre / Wong, Anna / Lexchin, Joel

    Globalization and health

    2023  Volume 19, Issue 1, Page(s) 67

    Abstract: Background: To help promote the effective delivery of drug donations, the World Health Organization (WHO) developed the Guidelines for Medicine Donations. The need for revisions is timely given the large-scale influx of medicine donations since the ... ...

    Abstract Background: To help promote the effective delivery of drug donations, the World Health Organization (WHO) developed the Guidelines for Medicine Donations. The need for revisions is timely given the large-scale influx of medicine donations since the start of the COVID-19 pandemic. This study analyses current policies of donors and recipients that are commensurate with the recommendations in the Guidelines and examines current practices, challenges, and revision suggestions.
    Results: A search for medicine donation policies of donors and recipients was conducted in May/June 2022 and repeated in January 2023. Potential donor countries were identified from the high-income countries on the United Nation's (UN) List of G20 Countries. Potential pharmaceutical company donors were selected from those with 2021 revenue of $30 billion or greater. Potential non-government organization donors came from the WHO list of non-governmental organizations (NGOs) and two other sources. Potential recipient countries were those on the UN List of Least Developed Countries. These four lists were supplemented with actual donors and recipients identified from the literature. All policies retrieved were screened to identify which of the 12 recommendations from the WHO Guidelines were incorporated. We identified 38 policies from 1 donor country, 6 brand-name multinational pharmaceutical companies, 6 NGOs and 25 recipient countries. Most policies incorporated all 12 recommendations. Twenty-five of the 38 policies were developed in 2010 or later. The majority of actual donors and recipients did not have policies that were publicly available. A rapid literature review for publications from 2010 onwards identified challenges in implementing the WHO Guidelines and suggested for revisions. Challenges included: (1) information management; (2) medication presentation; (3) influence from the pharmaceutical industry; (4) donation sustainability; and (5) the belief that donations are inherently good.
    Conclusions: Our findings suggest that both donors and recipients could further align their policies with the existing Guidelines and both groups should be consulted on any revisions to ensure that their experiences are reflected and their needs are addressed. While the current WHO Guidelines for Medicine Donations are a solid base for medical humanitarian efforts, evidence points to the need for an update to meet current challenges.
    MeSH term(s) Humans ; COVID-19/epidemiology ; Pandemics ; Developing Countries ; Drug Industry ; Policy
    Language English
    Publishing date 2023-09-01
    Publishing country England
    Document type Review ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2185774-X
    ISSN 1744-8603 ; 1744-8603
    ISSN (online) 1744-8603
    ISSN 1744-8603
    DOI 10.1186/s12992-023-00964-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: A systematic review of digital technology and innovation and its potential to address anti-corruption, transparency, and accountability in the pharmaceutical supply chain.

    Saeed, Gul / Kohler, Jillian C / Cuomo, Raphael E / Mackey, Tim K

    Expert opinion on drug safety

    2022  Volume 21, Issue 8, Page(s) 1061–1088

    Abstract: Introduction: The urgent need to acquire medical supplies amidst the COVID-19 pandemic has led to bypassing of controls that govern the global pharmaceutical supply chain, increasing the risk of corruption. Hence, promoting anti-corruption, transparency, ...

    Abstract Introduction: The urgent need to acquire medical supplies amidst the COVID-19 pandemic has led to bypassing of controls that govern the global pharmaceutical supply chain, increasing the risk of corruption. Hence, promoting anti-corruption, transparency, and accountability (ACTA) in supply chain and procurement has never been more important. The adoption of digital tools, if designed and implemented appropriately, can reduce the risks of corruption.
    Areas covered: Following PRISMA guidelines, we conducted an interdisciplinary systematic review of health/medicine, humanities/social sciences, engineering, and computer science literature, with the aims of identifying technologies used for pharmaceutical supply chain and procurement optimization and reviewing whether they address ACTA mechanisms to strengthen pharmaceutical governance. Our review identified four distinct categories of digital solutions: e-procurement and open contracting; track-and-trace technology; anti-counterfeiting technology; and blockchain technology.
    Expert opinion: Findings demonstrate an increase in research of technologies to improve pharmaceutical supply chain and procurement functions; however, most technologies are not being leveraged to directly address ACTA or global health outcomes. Some blockchain and RFID technologies incorporated ACTA mechanisms and mentioned specific policy/governance frameworks, but more purposeful linkage is needed. Findings point to the need for targeted policy development and governance to activate these innovative technologies to improve global health .
    MeSH term(s) COVID-19 ; Digital Technology ; Humans ; Pandemics ; Pharmaceutical Preparations ; Social Responsibility
    Chemical Substances Pharmaceutical Preparations
    Language English
    Publishing date 2022-06-28
    Publishing country England
    Document type Systematic Review
    ZDB-ID 2088728-0
    ISSN 1744-764X ; 1474-0338
    ISSN (online) 1744-764X
    ISSN 1474-0338
    DOI 10.1080/14740338.2022.2091543
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Why the COVID-19 pandemic should be a call for action to advance equitable access to medicines

    Kohler, Jillian C. / Mackey, Tim K.

    BMC Medicine

    2020  Volume 18, Issue 1

    Keywords General Medicine ; covid19
    Language English
    Publisher Springer Science and Business Media LLC
    Publishing country us
    Document type Article ; Online
    ISSN 1741-7015
    DOI 10.1186/s12916-020-01661-3
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article ; Online: Why the COVID-19 pandemic should be a call for action to advance equitable access to medicines

    Jillian C. Kohler / Tim K. Mackey

    BMC Medicine, Vol 18, Iss 1, Pp 1-

    2020  Volume 3

    Keywords Health policy ; COVID-19 ; Access to medicines ; Pharmaceutical policy ; Pandemic response ; Medicine ; R ; covid19
    Language English
    Publishing date 2020-06-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article ; Online: Intellectual property and access to medicines: mapping public attitudes toward pharmaceuticals during the United States-Mexico-Canada Agreement (USMCA) negotiation process.

    Wong, Anna S Y / Cole, Clarke B / Kohler, Jillian C

    Globalization and health

    2021  Volume 17, Issue 1, Page(s) 92

    Abstract: Background: Transparency and accountability are essential components at all stages of the trade negotiation process. This study evaluates the extent to which these principles were upheld in the United States' public consultation process during the ... ...

    Abstract Background: Transparency and accountability are essential components at all stages of the trade negotiation process. This study evaluates the extent to which these principles were upheld in the United States' public consultation process during the negotiation of the United States-Mexico-Canada Agreement (USMCA), with respect to public comments about the pharmaceutical sector and access to medicines.
    Results: The public consultation process occurred before the start of official negotiations and was overseen by the Office of the United States Trade Representative (USTR). It included both written comments and oral testimony about US trade negotiation objectives. Of the written comments that specifically discussed issues relating to pharmaceuticals, the majority were submitted by private individuals, members of the pharmaceutical industry, and civil society organizations. Nearly all comments submitted by non-industry groups indicated that access to medicines was a priority issue in the renegotiated agreement, with specific reference to price affordability. By contrast, more than 50% of submissions received from members or affiliates of the pharmaceutical industry advocated for strengthened pharmaceutical intellectual property rights, greater regulatory data protections, or both. This study reveals mixed outcomes with respect to the level of transparency achieved in the US trade negotiation process. Though input from the public at-large was actively solicited, the extent to which these comments were considered in the content of the final agreement is unclear. A preliminary comparison of the analyzed comments with the USTR's final negotiating objectives and the final text of the USMCA shows that several provisions that were advanced exclusively by the pharmaceutical industry and ultimately adopted in the final agreement were opposed by the majority of non-industry stakeholders.
    Conclusions: Negotiators could increase public transparency when choosing to advance one competing trade objective over another by actively providing the public with clear rationales for their negotiation positions, as well as details on how public comments are taken into account to form these rationales. Without greater clarity on these aspects, the public consultation process risks appearing to serve as a cursory government mechanism, lacking in accountability and undermining public trust in both the trade negotiation process and its outcomes.
    MeSH term(s) Attitude ; Commerce ; Drug Industry ; Health Services Accessibility ; Humans ; Intellectual Property ; International Cooperation ; Mexico ; Negotiating ; Pharmaceutical Preparations ; United States
    Chemical Substances Pharmaceutical Preparations
    Language English
    Publishing date 2021-08-20
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2185774-X
    ISSN 1744-8603 ; 1744-8603
    ISSN (online) 1744-8603
    ISSN 1744-8603
    DOI 10.1186/s12992-021-00740-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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