scholarly journals Evaluation of Transparency to Improve Good Governance in Pharmaceutical Regulatory Sector of Iran

Author(s):  
Yasaman Herandi ◽  
Shekoufeh Nikfar ◽  
Hossein Bouzarjomehri ◽  
Akbar Abdollahiasl

Background: Improving good governance in the pharmaceutical sector is a valuable priority for improving access to essential medicines. Transparency as a means for good governance was the focus of this study. The objective was to evaluate different sectors of the pharmaceutical regulatory sector of Iran from the aspect of transparency. Awareness of the current situation may assist policymakers in making the right decisions. Methods: The aim of this methodology was to present only quantitative measurement but to gather qualitative information as well. The study was carried from November 2016 to July 2017. The questionnaires of the assessment instrument, which the World Health Organization (WHO) produced for measuring transparency in the public pharmaceutical sector, was used. The interviewees were among managers and staff at different levels of the Food and Drug Administration (IFDA) of Iran and its clients. Results: Medicines registration and distribution of medicines’ scores in the 10-point rating system means that they are minimally vulnerable to corruption. Besides, medicine promotion control and procurement of medical products got an acceptable score, which means that they are marginally vulnerable to corruption. On the other hand, qualitative findings and observation of the evidence presented by key informants proved the sufficient legal capacity for transparency in almost all sections. The controversial issue was the ‘conflict of interests,’ which was not anticipated in some cases. Conclusion: It is valuable to know if Iran’s medicine regulatory sector is transparent In order to improve good governance, transparency should be maximized in all sectors, and this is possible by implementing mechanized actions and online tools.

Author(s):  
M. Mercedes Galán-Ladero ◽  
M. Ángeles Galán-Ladero

There is currently a wide-ranging debate on whether it is ethical for pharmaceutical companies to profit and obtain large economic benefits by patenting and controlling the sale of essential medicines that can save thousands of lives, or, on the contrary, whether these medicines should be considered social products and offered at low prices so that anyone, in any country in the world, regardless of their purchasing power, can have access to them. This debate has intensified since health was considered a fundamental human right by the World Health Organization (WHO) and was expressly included in the Sustainable Development Goals (SDGs) adopted by the United Nations (specifically, in Goal 3: “Health and Well-Being”). Consequently, the overall objective of this chapter is to reflect on these questions: Should economic interests prevail over social ones in the case of essential life-saving medicines? Should the fundamental right to health prevail over the right granted by a patent? How far should corporate social responsibility (CSR) go in the pharmaceutical industry?


Author(s):  
Catherine Habashy ◽  
Sarah L. Comolli ◽  
Justin N. Baker

The concept of essential medicines (EM) was developed by the World Health Organization (WHO) to promote equitable access to safe, effective, and low-cost medicines. Access to EM is considered part of the right to health and is critical to the provision of palliative care. Access to EM is often disrupted in the setting of humanitarian crises, leading to further physical and psychological suffering. The recently published WHO document, Integrating Palliative Care and Symptom Relief into the Response to Humanitarian Emergencies and Crises, provides guidance on the prioritization and utilization of EM as part of an essential package of care. This chapter draws on the recommendations of the WHO as well as those of other expert committees and multilateral organizations. It provides an overview of commonly used medicines in palliative care and is applicable to the delivery of palliative care in humanitarian crises. It also provides general dosage guidelines.


2012 ◽  
Vol 40 (2) ◽  
pp. 220-233 ◽  
Author(s):  
Joo-Young Lee ◽  
Paul Hunt

The Constitution of the World Health Organization (WHO) affirms that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being.” The Universal Declaration of Human Rights lays the foundations for the international framework for the right to health. This human right is now codified in numerous national constitutions, as well as legally binding international human rights treaties, such as the International Covenant on Economic, Social and Cultural Rights.Although medical care and access to medicines are vital features of the right to health, almost two billion people lack access to essential medicines, leading to immense avoidable suffering. Improving access to essential medicines could save 10 million lives each year, four million of them in Africa and South-East Asia alone. Gross inequity is a shocking feature of the world pharmaceutical situation.


Author(s):  
Ali Azeez Al-Jumaili ◽  
Manal Mohammed Younus ◽  
Yasmine J.A. Kannan ◽  
Zinah E. Nooruldeen ◽  
Adi Al-Nuseirat

Background: Recent information on regulation of the pharmaceutical sector in Iraq is scarce. Aim: This report summarizes the regulations governing pharmaceutical products in Iraq, assesses the challenges faced and makes recommendations to tackle these issues. Methods: The Iraq pharmaceutical country profile 2020, prepared by the Iraqi Ministry of Health in collaboration with the World Health Organization (WHO) in 2020, was the main source of information. Results: Despite all the efforts by the Ministry of Health to provide adequate and safe medicines, the Iraqi pharmaceutical sector has several challenges, including inadequate budget allocated to the ministry, shortages in essential medicines, underutilization of electronic technologies in the management of regulation-related work, a large number of substandard and falsified medications in the private sector and a stagnant national pharmaceutical industry. Conclusion: The Ministry of Health needs more financial support from the federal government to fund its activities and technical support from international health organizations to provide training and resources.


2018 ◽  
Vol 28 (4) ◽  
pp. 1213-1217
Author(s):  
Jovana Džoljić ◽  
Ljiljana Đorđević

Food and Agricultural Organization as a “sweeteners” consider products used for sweetening derived from sugar crops, cereals, fruits or milk, or that are produced by insects. Sweeteners, as an additive, have important role for technological functions of food, especially in providing texture, bulk and color, and also as preservative agents. Regardless the numerous sweeteners, alternative sweeteners to sucrose are in main focus for implementation in food industry. Nowadays Food and Agricultural Organization and World Health Organization Food standards, Codex Alimentarius Commission (2018) accepted list of 27 food additives that have the functional class “sweetener”. Nowadays, alternative sweeteners and their application in food technology are in main focus of scientist. Stevia plant stands for one of the most important natural intense sweetener, since stevia glycosides are almost 400 times sweeter than sucrose. Extracts of stevia represents a powerful tool for reducing sugars in food and beverages, which can be acceptable substitutes to full sugar versions of this products. Regarding the data of Euromonitor international, new food products containing stevia grew 10% from 2016 to 2017. The biggest increment in stevia use was noticed in categories of snacks, juice drinks, dairy, carbonated soft drinks and confectionery. Barriocanal et al. (2008) highlighted that safety studies reported no negative side effects of stevia use. Can be expected that in recent future use of S. rebaudiana as sweetener would be extended to almost all the world’s countries, regarding all discovered beneficial health effects.


Author(s):  
Maithili Pramod Joshi ◽  
Ameya Chaudhari ◽  
Prashant S. Kharkar ◽  
Shreerang V. Joshi

: Historically, the use of Iodinated Contrast Media (ICM) for diagnostic purposes, particularly radiography and computed tomography (CT), is well-known. Many of the ICM are included in the World Health Organization (WHO)’s List of Essential Medicines. Depending on the chemotype and the presence of ionizable functional group(s), the ICM are categorized in the ionic/nonionic monomers/dimers. The lipophilicity, aqueous solubility, viscosity and osmolality are major characteristics dictating their use for one procedure versus the other. Over last several decades, substantial advancement occurred in the design and development of novel ICM, solely to reduce their propensity to cause adverse effects. Given the nature of their acute usage, some of the agents with appreciable toxicity are still used. Understanding their chemistry aspects is crucial to appreciate, acknowledge and justify the usage of these extremely important torch-bearers of diagnostic agent’s class. The present review article presents an in-depth overview of the synthetic methods, therapeutic indications, potential adverse effects along with the commercial and environmental aspects of ICM. The safety and tolerability of these agents is a field that has gained significant importance, which is given due importance in the discussion.


BMJ ◽  
2021 ◽  
pp. n526
Author(s):  
François Lamontagne ◽  
Thomas Agoritsas ◽  
Reed Siemieniuk ◽  
Bram Rochwerg ◽  
Jessica Bartoszko ◽  
...  

Abstract Clinical question What is the role of drugs in preventing covid-19? Why does this matter? There is widespread interest in whether drug interventions can be used for the prevention of covid-19, but there is uncertainty about which drugs, if any, are effective. The first version of this living guideline focuses on the evidence for hydroxychloroquine. Subsequent updates will cover other drugs being investigated for their role in the prevention of covid-19. Recommendation The guideline development panel made a strong recommendation against the use of hydroxychloroquine for individuals who do not have covid-19 (high certainty). How this guideline was created This living guideline is from the World Health Organization (WHO) and provides up to date covid-19 guidance to inform policy and practice worldwide. Magic Evidence Ecosystem Foundation (MAGIC) provided methodological support. A living systematic review with network analysis informed the recommendations. An international guideline development panel of content experts, clinicians, patients, an ethicist and methodologists produced recommendations following standards for trustworthy guideline development using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Understanding the new recommendation The linked systematic review and network meta-analysis (6 trials and 6059 participants) found that hydroxychloroquine had a small or no effect on mortality and admission to hospital (high certainty evidence). There was a small or no effect on laboratory confirmed SARS-CoV-2 infection (moderate certainty evidence) but probably increased adverse events leading to discontinuation (moderate certainty evidence). The panel judged that almost all people would not consider this drug worthwhile. In addition, the panel decided that contextual factors such as resources, feasibility, acceptability, and equity for countries and healthcare systems were unlikely to alter the recommendation. The panel considers that this drug is no longer a research priority and that resources should rather be oriented to evaluate other more promising drugs to prevent covid-19. Updates This is a living guideline. New recommendations will be published in this article and signposted by update notices to this guideline. Readers note This is the first version of the living guideline for drugs to prevent covid-19. It complements the WHO living guideline on drugs to treat covid-19. When citing this article, please consider adding the update number and date of access for clarity.


2021 ◽  
pp. 0272989X2110190
Author(s):  
Isabelle J. Rao ◽  
Jacqueline J. Vallon ◽  
Margaret L. Brandeau

Background The World Health Organization and US Centers for Disease Control and Prevention recommend that both infected and susceptible people wear face masks to protect against COVID-19. Methods We develop a dynamic disease model to assess the effectiveness of face masks in reducing the spread of COVID-19, during an initial outbreak and a later resurgence, as a function of mask effectiveness, coverage, intervention timing, and time horizon. We instantiate the model for the COVID-19 outbreak in New York, with sensitivity analyses on key natural history parameters. Results During the initial epidemic outbreak, with no social distancing, only 100% coverage of masks with high effectiveness can reduce the effective reproductive number [Formula: see text] below 1. During a resurgence, with lowered transmission rates due to social distancing measures, masks with medium effectiveness at 80% coverage can reduce [Formula: see text] below 1 but cannot do so if individuals relax social distancing efforts. Full mask coverage could significantly improve outcomes during a resurgence: with social distancing, masks with at least medium effectiveness could reduce [Formula: see text] below 1 and avert almost all infections, even with intervention fatigue. For coverage levels below 100%, prioritizing masks that reduce the risk of an infected individual from spreading the infection rather than the risk of a susceptible individual from getting infected yields the greatest benefit. Limitations Data regarding COVID-19 transmission are uncertain, and empirical evidence on mask effectiveness is limited. Our analyses assume homogeneous mixing, providing an upper bound on mask effectiveness. Conclusions Even moderately effective face masks can play a role in reducing the spread of COVID-19, particularly with full coverage, but should be combined with social distancing measures to reduce [Formula: see text] below 1. [Box: see text]


2020 ◽  
pp. 1-8
Author(s):  
Silvano Gallus ◽  
Elisa Borroni ◽  
Chiara Stival ◽  
Sharanpreet Kaur ◽  
Sofia Davoli ◽  
...  

Abstract Objective: Previous studies from European countries noted that food products promoted on TV for children did not comply with international guidelines, including the World Health Organization European Nutrient Profile Model (WHO-ENPM) and the EU Pledge Nutrition Criteria (EU-PNC, an initiative developed by leading food companies). We aim to provide new data from Italy. Design: Evaluation of Italian TV advertisements. Data on nutritional values for food product advertised were compared with nutritional standards issued by the WHO-ENPM and the EU-PNC. Setting: In total, 180 h of TV programmes from six Italian channels, 2016–2017. Participants: Eight hundred and ten consecutive advertisements during children’s programmes. Results: Out of 810 advertisements, 90 (11·1 %) referred to food products. Among these, 84·5 % of the foods promoted did not meet the WHO-ENPM and 55·6 % the EU-PNC guidelines. Advertisements promoting sweet and salty snacks (i.e. ≥ 70 % of all foods) v. other food products showed higher non-compliance with both the WHO-ENPM (OR: 73·8; 95 % CI: 4·09, 1330) and the EU-PNC (OR: 9·21; 95 % CI: 2·82, 30·1). Conclusions: In Italy, most food advertisements during children’s programmes are not compliant with European nutritional standards. Almost all the advertisements for snacks do not meet international guidelines. As the WHO-ENPM guidelines do not propose standards for all the food products, including meals, there is an urgent need to define independent and easy-to-read guidelines for food advertisements targeting children. As a first step towards the complete ban of food advertisements targeting children recommended by other researchers, these guidelines should be enforced by all the TV broadcasts.


2021 ◽  
Vol 104 (2) ◽  
pp. 003685042110198
Author(s):  
Helen Onyeaka ◽  
Christian K Anumudu ◽  
Zainab T Al-Sharify ◽  
Esther Egele-Godswill ◽  
Paul Mbaegbu

COVID-19, caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), was declared a pandemic by the World Health Organization (WHO) on the 11th of March 2020, leading to some form of lockdown across almost all countries of the world. The extent of the global pandemic due to COVID-19 has a significant impact on our lives that must be studied carefully to combat it. This study highlights the impacts of the COVID-19 pandemic lockdown on crucial aspects of daily life globally, including; Food security, Global economy, Education, Tourism, hospitality, sports and leisure, Gender Relation, Domestic Violence/Abuse, Mental Health and Environmental air pollution through a systematic search of the literature. The COVID-19 global lockdown was initiated to stem the spread of the virus and ‘flatten the curve’ of the pandemic. However, the impact of the lockdown has had far-reaching effects in different strata of life, including; changes in the accessibility and structure of education delivery to students, food insecurity as a result of unavailability and fluctuation in prices, the depression of the global economy, increase in mental health challenges, wellbeing and quality of life amongst others. This review article highlights the impacts of the COVID-19 pandemic lockdown across the globe. As the global lockdown is being lifted in a phased manner in various countries of the world, it is necessary to explore its impacts to understand its consequences comprehensively. This will guide future decisions that will be made in a possible future wave of the COVID-19 pandemic or other global disease outbreak.


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