Preventing and Managing Conflict of Interest in Nutrition Policy: Lessons for Alcohol Control Comment on "Towards Preventing and Managing Conflict of Interest in Nutrition Policy? An Analysis of Submissions to a Consultation on a Draft WHO Tool"

Author(s):  
Katherine Severi

Ralston et al present an analysis of policy actor responses to a draft World Health Organization (WHO) tool to prevent and manage conflicts of interest (COI) in nutrition policy. While the Ralston et al study is focussed explicitly on food and nutrition, the issues and concepts addressed are relevant also to alcohol policy debates and present an important opportunity for shared learning across unhealthy commodity industries in order to protect and improve population health. This commentary addresses the importance of understanding how alcohol policy actors – especially decision-makers – perceive COI in relation to alcohol industry engagement in policy. A better understanding of such perceptions may help to inform the development of guidelines to identify, manage and protect against risks associated with COI in alcohol policy.

Author(s):  
Belinda Townsend ◽  
Mia Miller ◽  
Deborah Gleeson

Ralston et al highlight the ways that different actors in global nutrition governance conceptualise and frame the role of non-state actors in governance arrangements, including the potential for conflict of interest (COI) to undermine global health efforts. The authors argue that the World Health Organization (WHO) draft tool on managing COI in nutrition policy is an important innovation in global health, but that further research and refinement is needed for operationalising the management of COI with diverse actors in diverse contexts. In this commentary, reflecting on strategic framing and industry interference in policy-making, we argue for the urgent need for states and intergovernmental organisations to prevent alcohol industry interference in the development of national and global alcohol policy. We argue that policy incoherence remains a key barrier, where governments pursue health goals in the health sector while pursuing exports and market liberalisation of health harmful commodities in the trade sector.


Author(s):  
Katherine Cullerton ◽  
Jean Adams ◽  
Martin White

The issue of public health and policy communities engaging with food sector companies has long caused tension and debate. Ralston and colleagues’ article ‘Towards Preventing and Managing Conflict of Interest in Nutrition Policy? An Analysis of Submissions to a Consultation on a Draft WHO Tool’ further examines this issue. They found widespread food industry opposition, not just to the details of the World Health Organization (WHO) tool, but to the very idea of it. In this commentary we reflect on this finding and the arguments for and against interacting with the food industry during different stages of the policy process. While involving the food industry in certain aspects of the policy process without favouring their business goals may seem like an intractable problem, we believe there are opportunities for progress that do not compromise our values as public health professionals. We suggest three key steps to making progress.


Author(s):  
Ronald Labonté

With public health attention on the commercial determinants of health showing little sign of abatement, how to manage conflicts of interest (COI) in regulatory policy discussions with corporate actors responsible for these determinants is gaining critical traction. The contribution by Ralston et al explores how COI management has itself become a terrain of contestation in their analysis of submissions on a draft World Health Organization (WHO) tool to manage COI conflicts in development of nutrition policy. The authors identify two camps in conflict with one another: a corporate side emphasizing their individual good intents and contributions, and an non-governmental organization (NGO) side maintaining inherent structural conflicts that require careful proscribing. The study concludes that the draft tool does a reasonable job in ensuring COI are avoided and policy development sheltered from corporate self-interests, introducing novel improvements in global governance for health. At the same time, the tool appears to adhere to a belief that private economic (corporate) and public good (citizen) conflicts can indeed be managed. I question this assumption and posit that public health needs to be much bolder in its critique of the nature of power, influence, and self-interests that pervade and risk dominating our stakeholder models of global governance.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Atefeh Esfandiari ◽  
Vahid Yazdi-Feyzabadi ◽  
Leila Zarei ◽  
Arash Rashidian ◽  
Hedayat Salari

Abstract Background Policymaking in the pharmaceutical sector plays a pivotal role in achieving the health systems’ goals. Transparency in the pharmaceutical policy could increase confidence in decision-making processes. This study aims to assess transparency in the public pharmaceutical sector of Iran. Methods This qualitative study with a content analysis approach was conducted in 2017 using the World Health Organization tool to explore pharmaceutical transparency. The perceptions of the various stakeholders of the health system through semi-structured interviews with a maximum variation of stakeholders were obtained in eight functions, including registration, licensing, inspection, promotion, clinical trials, selection, procurement, and distribution of medicines. Results There are some problems in two main categories: (1) General problems, including lack of transparency, conflict of interest, centralization, and monopoly. (2) Ethical problems include illegal payments, gifts, bribes, conflicts of interest, hidden power, hoarding, relationship-oriented behavior, medicine trafficking, and counterfeit medicine. Suggested solutions include evidence-based decision-making, the use of transparent and accountable processes, standardization, needs assessment, declaring a conflict of interest, skilled human resources, and tracking prescription. Conclusion Despite the development of effective pharmaceutical policy in the health care system and government interventions for the control of the market, in some functions, reviewing the pharmaceutical policy is essential. Additionally, declaring a conflict of interest statement must be at the core of policy development to provide greater transparency.


Author(s):  
Marc A. Rodwin

This commentary situates the comments submitted in response to the World Health Organization (WHO) draft guidance on conflicts of interest in national nutrition programs in light of: (1) WHO policies to protect WHO integrity; (2) the Framework of Engagement with Non-State Actors (FENSA); (3) WHO’s attempt to seek funds due to cuts in member contributions; and (4) attempts—often by corporate entities—to redefine conflicts of interest to avoid oversight of conflicts of interest and increase corporate influence. The WHO guidance defines conflicts of interest in ways that deviate from standard legal usage which confuses its analysis and facilitates the creation of conflicted public-private partnerships. The guidance suggests that nations can allow engagement with non-state actors when the benefits are greater than risks without separate check due to conflicts of interest. Instead, the WHO should have recommended that nations seek alternative ways to achieve their goals when non-state actors have significant institutional conflicts of interest.


Author(s):  
Gary Jonas Fooks ◽  
Charlotte Godziewski

The World Health Organization’s (WHO’s) draft Decision-Making Process and Tool to assist governments in preventing and managing conflicts of interest in nutrition policy marks a step-change in WHO thinking on large corporations and nutrition policy. If followed closely it stands to revolutionise business-government relations in nutrition policy. Ralston and colleagues outline how the food and beverage industry have argued against the decision-making tool. This commentary expands on their study by setting industry framing within a broader analysis of corporate power and explores the challenges in managing industry influence in nutrition policy. The commentary examines how the food and beverage industry’s collaboration and partnership agenda seeks to shape how policy problems and solutions are interpreted and acted on and explores how this agenda and their efforts to define conflicts of interest effectively represent non-policy programmes. More generally, we point to the difficulties that member states will face in adopting the tool and highlight the importance of considering the central role of transnational food and beverage companies in contemporary economies to managing their influence in nutrition policy.


Author(s):  
A. Rob Moodie

Managing conflict of interest (CoI) among the interested stake-holders in nutrition policy is a vexed and controversial issue. This commentary builds on Ralston and colleagues’ highly informative analysis of the 44 submissions to the World Health Organization (WHO) draft tool on preventing and managing CoI in national nutrition programs. The commentary proposes that the commercial sector actors are, by definition, too conflicted to objectively respond to the draft tool. The responses of the commercial sectors are predictable, as they mimic their positions during the prior negotiation for the development of the Framework for Engagement of Non-State Actors (FENSA). Their overall approach, and specific responses, are typical of the now standard methods of the ultra-processed food and beverage industry’s ‘corporate playbook.’ In addition, Ralston et al’s analysis raises a number of other issues, such as: why these corporations are so keen to be included in the world of multi-stakeholder partnerships, why so few member states responded to the draft tool, and problems with the term ‘private sector.’ The commentary ends with a suggestion for WHO to seek broader involvement from the 160+ member states who have yet to participate in the consultations regarding the draft tool.


2020 ◽  
pp. 1-11
Author(s):  
Robin ROOM ◽  
Jenny CISNEROS ÖRNBERG

This article proposes and discusses the text of a Framework Convention on Alcohol Control, which would serve public health and welfare interests. The history of alcohol’s omission from current drug treaties is briefly discussed. The paper spells out what should be covered in the treaty, using text adapted primarily from the Framework Convention on Tobacco Control, but for the control of trade from the 1961 narcotic drugs treaty. While the draft provides for the treaty to be negotiated under the auspices of the World Health Organization, other auspices are possible. Excluding alcohol industry interests from the negotiation of the treaty is noted as an important precondition. The articles in the draft treaty and their purposes are briefly described, and the divergences from the tobacco treaty are described and justified. The text of the draft treaty is provided as Supplementary Material. Specification of concrete provisions in a draft convention points the way towards more effective global actions and agreements on alcohol control, whatever form they take.


Author(s):  
June YY Leung ◽  
Sally Casswell

Background The World Health Organization (WHO) has engaged in consultations with the alcohol industry in global alcohol policy development, including currently a draft action plan to strengthen implementation of the Global strategy to reduce the harmful use of alcohol. WHO’s Framework for Engagement with Non-State Actors (FENSA) is an organization-wide policy that aims to manage potential conflicts of interest in WHO’s interactions with private sector entities, non-governmental institutions, philanthropic foundations and academic institutions. Methods We analysed the alignment of WHO’s consultative processes with non-state actors on "the way forward" for alcohol policy and a global alcohol action plan with FENSA. We referred to publicly accessible WHO documents, including the Alcohol, Drugs and Addictive Behaviours Unit website, records of relevant meetings, and other documents relevant to FENSA. We documented submissions to two web-based consultations held in 2019 and 2020 by type of organization and links to the alcohol industry. Results WHO’s processes to conduct due diligence, risk assessment and risk management as required by FENSA appeared to be inadequate. Limited information was published on nonstate actors, primarily the alcohol industry, that participated in the consultations, including their potential conflicts of interest. No minutes were published for WHO’s virtual meeting with the alcohol industry, suggesting a lack of transparency. Organizations with known links to the tobacco industry participated in both web-based consultations, despite FENSA’s principle of non-engagement with tobacco industry actors. Conclusion WHO’s consultative processes have not been adequate to address conflicts of interest in relation to the alcohol industry, violating the principles of FENSA. Member states must ensure that WHO has the resources to implement and is held accountable for appropriate and consistent safeguards against industry interference in the development of global alcohol policy.


2018 ◽  
Vol 10 (12) ◽  
pp. 253-259 ◽  
Author(s):  
Marcos Renato de Assis ◽  
Valdair Pinto

Biological products or biopharmaceuticals are medicinal products derived from living systems and manufactured by modern biotechnological methods that differ widely from the traditional synthetic drugs. Monoclonal antibodies are the most rapidly growing type of biologic. They are much larger and more complex molecules with inherent diversity; therefore, different manufacturers cannot produce identical biological products, even with the same type of host expression system and equivalent technologies. Thus, legal follow-on biologics manufactured and marketed after patent expiration are usually referred to as biosimilars. Biosimilarity is based on a comparability exercise whereby unavoidable clinical differences are evaluated and must meet equivalence or non-inferiority criteria. Biosimilars need to comply with different regulatory requirements for market authorization in different sites. There are several other related issues that need to be defined by the national authorities, such as interchangeability, labeling and prescribing information. The Brazilian health surveillance agency follows the key principles established by the World Health Organization for the assessment of biosimilarity, although does not adopt the name ‘biosimilar’. However, the agency also made a compromise on a standalone application pathway that does not require the usual comparability exercise with the reference product, originating nonbiosimilar copies. Interchangeability and the use of nonproprietary names are not regulated, giving rise to pressures on physicians and conflicts of interest in the decision making on biosimilar use. The scope of this article is to present the Brazilian regulation on biosimilars, its strengths and weaknesses, and to discuss it in the face of regulations in the USA and Europe.


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