scholarly journals Transparency in public pharmaceutical sector: the key informants’ perceptions from a developing country

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):  
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):  
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.


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.


2020 ◽  
Vol 11 (SPL1) ◽  
pp. 1054-1057
Author(s):  
Bindu Swetha Pasuluri ◽  
Anuradha S G ◽  
Manga J ◽  
Deepak Karanam

An unanticipated outburst of pneumonia of inexperienced in Wuhan, , China stated in December 2019. World health organization has recognized pathogen and termed it COVID-19. COVID-19 turned out to be a severe urgency in the entire world. The influence of this viral syndrome is now an intensifying concern. Covid-19 has changed our mutual calculus of ambiguity. It is more world-wide in possibility, more deeply , and much more difficult than any catastrophe that countries and organizations have ever faced. The next normal requires challenging ambiguity head-on and building it into decision-making. It is examined that every entity involved in running supply chains would require through major as employee, product, facility protocols, and transport would have to be in place. It is an urgent need of structuring to apply the lessons well-read for our supply chain setup. With higher managers now being aware of the intrinsic hazards in their supply chain, key and suggestions-recommendations will help to guide leader to commit to a newly planned, more consistent supply chain setup. Besides, the employees’ mental health is also a great concern.


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.


2007 ◽  
Vol 22 (5) ◽  
pp. 414-417 ◽  
Author(s):  
Shivani Parmar ◽  
Ano Lobb ◽  
Susan Purdin ◽  
Sharon McDonnell

AbstractThe effectiveness of humanitarian response efforts has long been hampered by a lack of coordination among responding organizations. The need for increased coordination and collaboration, as well as the need to better understand experiences with coordination, were recognized by participants of a multilateral Working Group convened to examine the challenges of coordination in humanitarian health responses. This preliminary study is an interim report of an ongoing survey designed by the Working Group to describe the experiences of coordination and collaboration in greater detail, including factors that promote or discourage coordination and lessons learned, and to determine whether there is support for a new consortium dedicated to coordination. To date, 30 key informants have participated in 25-minute structured interviews that were recorded and analyzed for major themes. Participants represented 21 different agencies and organizations: nine non-governmental organizations, eight academic institutions, two donor organizations, the US Centers for Disease Control and Prevention, and the World Health Organization.Common themes that emerged included the role of donors in promoting coordination, the need to build an evidence base, the frequent occurrence of field-level coordination, and the need to build new partnerships. Currently, there is no consensus that a new consortium would be helpful.Addressing the underlying structural and professional factors that currently discourage coordination may be a more effective method for enhancing coordination during humanitarian responses.


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.


2021 ◽  
Author(s):  
Angela Kwartemaa Acheampong ◽  
Lillian Akorfa Ohene ◽  
Isabella Naana Akyaa Asante ◽  
Josephine Kyei ◽  
Gladys Dzansi ◽  
...  

Abstract Background: The World Health Organization has admonished member countries to strive towards achieving universal health coverage (UHC) through actionable health policies and strategies. Nurses and midwives have instrumental roles in achieving UHC via health policy development and implementation. However, there is a paucity of empirical data on nurses and midwives’ participation in policy development in Ghana. The current study explored nurses and midwives’ participation in policy development, reviews and reforms in Ghana.Methods: A qualitative descriptive exploratory design was adopted for this study. One-on-one individual interviews were conducted after 30 participants were purposefully selected. Data was audiotaped with permission, transcribed and analyzed inductively using the content analysis procedures. Results: Two main themes emerged from the data: participation in policy development and perspectives on policy reviews and reforms. The findings showed that during health policy development and reviews, nurses in Ghana were overlooked and unacknowledged. Policy reforms regarding bridging the pre-service preparation gap, staff development and motivation mechanisms and influence on admission into nursing schools were raisedConclusion: The authors concluded that nurses and midwives are crucial members of the healthcare systems and their inputs in policy development and reviews would improve health delivery in Ghana.


Sign in / Sign up

Export Citation Format

Share Document