Medicine donations: a review of policies and practices.

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.

Disclosure, transparency, and accountability: a qualitative survey of public sector pharmaceutical committee conflict of interest policies in the World Health Organization South-East Asia Region.

BACKGROUND: Weak governance over public sector pharmaceutical policy and practice limits access to essential medicines, inflates pharmaceutical prices, and wastes scarce health system resources. Pharmaceutical systems are technically complex and involve extensive interactions between the private and public sectors. For members of public sector pharmaceutical committees, relationships with the private sector can result in conflicts of interest, which may introduce commercial biases into decision-making, potentially compromising public health objectives and health system sustainability. We conducted a descriptive, qualitative study of conflict of interest policies and practices in the public pharmaceutical sector in ten countries in the World Health Organization (WHO) South-East Asia Region (SEAR) (Bangladesh, Bhutan, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand, and Timor-Leste) between September 2020 and March 2021. RESULTS: We identified 45 policy and regulatory documents and triangulated documentary data with 21 expert interviews. Key informants articulated very different governance priorities and conflict of interest concerns depending on the features of their country's pharmaceutical industry, market size, and national economic objectives related to the domestic pharmaceutical industry. Public sector pharmaceutical policies and regulations consistently contained provisions for pharmaceutical committee members to disclose relevant interests, but contained little detail about what should be declared, when, and how often, nor whether disclosures are evaluated and by whom. Processes for preventing or managing conflicts of interest were less well developed than those for disclosure except for a few key procurement processes. Where processes for managing conflicts of interest were specified, the dominant strategy was to recuse committee members with a conflict of interest from relevant work. Policies rarely specified that committee members should divest or otherwise be free from conflicts of interest. CONCLUSIONS: Robust processes for conflict of interest prevention and management could ensure the integrity of decision-making and build public trust in pharmaceutical processes to achieve public health objectives. Upstream approaches including supportive legislative frameworks, the creation of oversight bodies, and strengthening regulatory institutions can also contribute to building cultures of transparency, accountability, and trust.

The risk of corruption in public pharmaceutical procurement: how anti-corruption, transparency and accountability measures may reduce this risk.

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.

Increasing transparency and accountability in national pharmaceutical systems.

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.

L'accès à des médicaments sûrs, efficaces et de bonne qualité peut être compromis par la mauvaise gouvernance du secteur pharmaceutique. Celui-ci est particulièrement exposé aux inefficacités et aux pertes dues à la corruption, du fait qu'il implique un ensemble complexe d'acteurs aux différentes responsabilités. Une grande transparence et l'obligation de rendre des comptes sont indispensables pour minimiser les possibilités de fraude et de fuite. Durant la dernière décennie, le programme de Bonne gouvernance dans le secteur pharmaceutique et l'initiative Medicines Transparency Alliance se sont attachés à améliorer la reddition de comptes dans le secteur pharmaceutique et à réduire la vulnérabilité de ce dernier face à la corruption, en augmentant la transparence et en encourageant la participation de nombreuses parties prenantes. L'expérience de ces deux programmes a révélé que les parties prenantes interprétaient la transparence et la reddition de comptes de différentes manières. En outre, la mise en œuvre des programmes et l'évaluation des progrès ont été compliquées par un manque de clarté quant aux informations que les gouvernements devaient communiquer et à la manière dont une plus grande transparence pouvait renforcer la reddition de comptes et l'accès aux médicaments. Cet article entend expliquer en quoi la transparence peut faciliter la reddition de comptes et améliorer l'accès aux médicaments. Nous avons identifié trois catégories d'informations nécessaires à la reddition de comptes: (i) normes et engagements; (ii) décisions et résultats; (iii) conséquences et mesures réactives. Des exemples sont présentés pour chaque catégorie. Un cadre théorique clair et des exemples pratiques d'informations nécessaires pour assurer la reddition de comptes peuvent aider les responsables politiques à déterminer les actions requises pour augmenter la transparence et la reddition de comptes dans leurs systèmes pharmaceutiques. Nous évoquons aussi les facteurs qui peuvent entraver ou faciliter l'utilisation des informations et engager la responsabilité des personnes chargées d'améliorer l'accès aux médicaments.

El acceso a medicamentos seguros, eficaces y de buena calidad puede verse comprometido por una mala gestión del sistema farmacéutico. Este sistema es particularmente vulnerable a las ineficiencias y a las pérdidas derivadas de la corrupción porque implica una compleja mezcla de distintos participantes con diversas responsabilidades. Un alto nivel de transparencia y responsabilidad es fundamental para minimizar las oportunidades de fraude y filtraciones. En la última década, el programa de Buena Gestión de los Medicamentos y la Alianza para la Transparencia de los Medicamentos se han centrado en mejorar la responsabilidad del sistema farmacéutico y en reducir su vulnerabilidad a la corrupción mediante el aumento de la transparencia y el fomento de la participación de una serie de partes interesadas. La experiencia con estos dos programas reveló que las partes interesadas interpretaban la transparencia y la responsabilidad de diversas maneras. Además, la implementación de los programas y las evaluaciones de progreso se complicaron debido a la falta de claridad sobre la información que deben divulgar los gobiernos y sobre cómo una mayor transparencia puede fortalecer la responsabilidad en el acceso a los medicamentos. Este artículo ofrece una explicación conceptual de cómo la transparencia puede facilitar la responsabilidad para un mejor acceso a los medicamentos. Se han identificado tres categorías de información como requisitos previos a la responsabilidad: (i) normas y compromisos; (ii) decisiones y resultados; y (iii) consecuencias y medidas de respuesta. Se ofrecen ejemplos de todas. La claridad de conceptos y los ejemplos prácticos de la información necesaria para garantizar la responsabilidad pueden ayudar a los responsables políticos a identificar las medidas necesarias para aumentar la transparencia y la responsabilidad en sus sistemas farmacéuticos. También se analizan los factores que dificultan o facilitan el uso de la información para responsabilizar a las personas responsables de mejorar el acceso a los medicamentos.

Promoting transparency, accountability, and access through a multi-stakeholder initiative: lessons from the medicines transparency alliance.

BACKGROUND: Barriers to expanding access to medicines include weak pharmaceutical sector governance, lack of transparency and accountability, inadequate attention to social services on the political agenda, and financing challenges. Multi-stakeholder initiatives such as the Medicines Transparency Alliance (MeTA) may help overcome these barriers. Between 2008 and 2015, MeTA engaged stakeholders in the pharmaceutical sectors of seven countries (Ghana, Jordan, Kyrgyzstan, Peru, Philippines, Uganda, and Zambia) to promote access goals through greater transparency. METHODS: We reviewed archival data to document MeTA activities and results related to transparency and accountability in the seven countries where it was implemented. We identified common themes and content areas, noting specific activities used to make information transparent and accessible, how data were used to inform discussions, and the purpose and timing of meetings and advocacy activities to help set priorities and influence governance decisions. The cross-case analysis looked for pathways which might link the MeTA strategies to results such as better policies or program improvements. RESULTS: Countries used evidence gathering, open meetings, and proactive information dissemination to increase transparency. MeTA fostered policy dialogue to bring together the many government, civil society and private company stakeholders concerned with access issues, and provided them with information to understand barriers to access at policy, organizational, and community levels. We found strong evidence that transparency was enhanced. Some evidence suggests that MeTA efforts contributed to new policies and civil society capacity strengthening although the impact on government accountability is not clear. CONCLUSION: MeTA appears to have achieved its goal of creating a multi-stakeholder shared policy space in which government, civil society, and private sector players can come together and have a voice in the national pharmaceutical policy making process. Assuming that transparency is in place to leverage accountability, the success of MeTA's efforts to promote accountability by the government as well as other stakeholders in the pharmaceutical sector will depend on how well efforts are sustained over time.