Pharmaceutical Companies vs. the State: Who is Responsible for Post-Trial Provision of Drugs in Brazil?

2012 ◽  
Vol 40 (2) ◽  
pp. 188-196 ◽  
Author(s):  
Daniel Wei L. Wang ◽  
Octavio Luiz Motta Ferraz

This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for pharmaceutical products in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs.

2019 ◽  
Vol 8 (3) ◽  
pp. 3080-3087

The Indian pharmaceutical industry is very wide and in volume it has been ranked 3rd in the world. It is contributing to 10% of the total pharmaceutical production. In terms of value the pharmaceutical industry is 14th largest in the world. As far as market is concerned it is 1.5% of the total pharmaceutical market. India is a good source of good quality and cheap medicines with strong retail base. It is also a hub for clinical trials, biotechnology, contract research, and clinical data management services. There has been tremendous competition among all pharmaceutical companies. In this competitive situation, media has emerged as a strong tool to promote pharmaceutical drug to end customers. This research paper contributes to the different aspects of pharmaceutical drug promotion in media in India.


1983 ◽  
Vol 21 (20) ◽  
pp. 77-79

Many large pharmaceutical companies operate subsidiaries or divisions with separate names and identities. Some of these subsidiaries have been specially created while others are survivors, in name, of take-overs or mergers. This has led to an increase in the number of trading companies promoting pharmaceutical products and to the practice of transferring established products from the parent companies to their subsidiaries. The results of the proliferation and re-organisation of companies will affect prescribers.


2006 ◽  
Vol 32 (2-3) ◽  
pp. 351-364 ◽  
Author(s):  
Robert Gatter

The world relies largely on private firms for the development of new medicine, and the system is efficient. Driven by the incentive to profit from sales of new pharmaceuticals, drug companies risk millions of dollars and years of work to shepherd basic scientific discoveries through laboratory and human testing in the hope of developing a marketable drug. For example, it is estimated that in 2002 alone, pharmaceutical companies invested $45 billion the development of new medicine worldwide.While the profit incentive generates such enormous private investment in human drug development, it also encourages firms to pose inappropriate risks to the safety of human subjects when speeding a new drug to the market. The risks posed by financial conflicts of interest associated with human subjects research on new pharmaceutical products are notable examples, both in the U.S. and internationally.


2017 ◽  
Vol 8 (1) ◽  
pp. 42-49 ◽  
Author(s):  
Nina Bucalo ◽  
Borut Jereb

Abstract The pharmaceutical industry is one of the most competitive businesses in the world. Supply chain in this industry has been directed towards the production of large batches to avoid lack of supplies, and the achievement of regulatory requirements, at the cost of high level of inventory, higher costs and inventory write-off due to expiration or other reasons. In recent years this industry is facing major changes and challenges such as intense globalization processes, increased competition and innovations in technologies, which has broadened and deepened risks in supply chain. The paper reports the results of the study of the risk in distribution processes of Slovenian pharmaceutical companies, which was conducted among five companies and aims to draw attention to risks that arise in supply chain, to emphasize the importance of their management and to present a model for an effective assessment of risk in companies, developed at the Faculty of Logistics.


2008 ◽  
Vol 14 (1) ◽  
pp. 10-16 ◽  
Author(s):  
A. James

Recent controversy over the use of serotonin reuptake inhibitors in children and adolescents has focused attention on the role of the pharmaceutical industry in the treatment of young people. Failure of pharmaceutical companies to fully disclose negative outcome trials has led to new guidelines for publication of all trial results. Scrutiny is on the conduct of trials and the relationship of the pharmaceutical industry with prescribing doctors and post-trial surveillance of new drugs. It is argued that drug treatments in child psychiatry are a powerful therapeutic tool but vigilance is needed to ensure that data on the efficacy and safety of drugs are freely available.


2021 ◽  

The first report of Coronavirus Disease 2019 (COVID-19) was presented in Wuhan, Hubei province, China, in December 2019 (1). COVID-19 is an infectious virus with a high level of spread. According to its fast pandemic condition in the world, it has been announced as an emergency of public health by the World Health Organization (WHO) related to its fast pandemic condition (1-3). Movements of population, communication among humans, and environmental factors cause the transfer of this virus. The most prevalent clinical symptoms include fever, cough, headache, muscle cramps, and fatigue (4). Different industries in different countries have faced many problems and even there were many days off in the world after the COVID-19 pandemic. The pharmaceutical industry, among all industries, has a unique and exclusive sensitivity according to the necessity in the production of pharmaceutical products. The pharmaceutical industry has been important since the past years as a complementary part of the primary process in the treatment of the patients that shows the significance of development in this industry. In the COVID-19 pandemic situation, pharmaceutical companies try to respond to the challenges in the supply chain, change the business process, and protect the health of the staff. If the epidemic of COVID-19 continues for a medium/long time, this will affect active supplies, necessary materials, and medication export/import. Moreover, it causes adverse effects on research and development (R&D) activities, production, and developmental projects related to improving the industry. Although the effect of global expansion has not been apparent yet, pharmaceutical companies should respond, improve, and develop. Therefore, during the COVID-19 pandemic situation, pharmaceutical companies should continue their activities and even develop it while facing many challenges. Moreover, it will help them detect the challenges and approaches of development in safety and health in pharmaceutical companies during the COVID-19 pandemic situation. Challenges of pharmaceutical companies in the COVID-19 pandemic situation include: 1) Hiding or lack of reports in COVID-19 affection; 2) Lack of appropriate monitoring of distribution vehicles in the prevention of infection; 3) Continual contacts with documents and internal permissions of products leading to the lack of supervision of health principles; 4) Production in closed and limited space; 5) Continual production line and necessity of team working; 6) Commotion of the personnel with public transportation and lack of knowledge in family health; 7) The physical presence of staff in administrative positions (R&D, marketing, IT, and planning); 8) Serving food in the restaurant of the company (breakfast, lunch, dinner, and snack); 9) Closing of air conditioning system in departments; 10) Lack of correct extrusion of produced wastes; 11) Lack of the attention of personnel on their health; and 12) The entrance of infected products and raw materials to the COVID-19. Solutions in safety and health improvement of pharmaceutical company in facing COVID-19 pandemic include: 1) Disinfection of the external surface of the vehicles which contain materials and raw materials barrels at the entrance; 2) Use of electronic forms for documentation, product permissions, other production processes, quality control, and Health and Safety Executive ; 3) Use of distancing between the personnel with separator and fresh air injection into the rooms with building management system equipment; 4) Supply of mask and shield for all staff in sufficient number, and control of the use, extirpation, and protection of documents; 5) Use of masks with cartridge and N95 pad in administrative departments in exposure to chemical materials and changing them according to standard; 6) Assignment of the dedicated vehicles to the staff communication and their disinfection; 7) The necessity of using masks by the staff during transportation; 8) Provision of the opportunity for administrative staff to work from long distance; 9) Installation of the bags and buckets for sanitary wastes (mask, gloves, and tissue); 10) Disinfection of air conditioning system based on WHO rules; 11) Disinfection of all spaces and surfaces per hour or after use; 12) Installation of automatic disinfection equipment at the entrance of all buildings and busy places; 13) Introduction of COVID-19 as a job sickness to fast identification and self-declaration of the staff and elimination of transferring chain; 14) Assignment of subvention to treatment and leave of absence with salary for COVID-19 patients; 15) Psychological consultation and call contact with COVID-19 patients; 16) Online monitoring of the personnel and their families with an online questionnaire; 17) Transfer and management of waste by mechanizing systems and trained executive team with personal protection equipment; 18) Arrangement of all internal and external meetings online; 19) Presentation of all training courses in online classes (sky-room webinar); 20) Risk assessment in facing COVID-19 patients based on age, background illness, facing jobs, and a team of colleagues; 21) Non-public quarantine of the staff according to the importance of medicine production; 22) Specialization in COVID-19 tests for a suspicious person; 23) Distribution of self-protect equipment and disinfectants among the staff’s families; 24) Quarantine of suffering, suspicious people or those who were in contact with suffering patients; 25) Quarantine of the products in the warehouse to eliminate the transporting chain of the infected products. Conclusion The pharmaceutical stability of industry and permanent presence is an inseparable part of treatment teams in the world. Therefore, the necessity of continual observation of environmental health in pharmaceutical companies and the staff health could develop the efficiency, health protection of the personnel, and consumers in the COVID-19 pandemic situation. Controlling the challenges, as the next step, helps the presence of pharmaceutical companies in the current condition. Therefore, international, national, and local organizations should emphasize the revision of health and safety standards in the workplace. In addition, the self-declaration of industries and physical observation is necessary to conduct the suggested solutions for the personnel health as a staff in the health area.


2020 ◽  
Author(s):  
Divyansh Sehgal

As humans are spreading throughout the world, infectious diseases have been a constant companion such as Bubonic Plague (200 Million deaths), 17th Century Great Plague (3 Million deaths), Plague of Justinian (30-50 Million deaths), etc . Coronavirus Disease (COVID-19) which was published on 11th January 2020 showing the intensity of Global research and development activity to develop a drug/vaccine against the disease. COVID-19 is an infectious disease caused by a newly discovered coronavirus. Human to human transmission has created a pandemic situation across the world. Pharmaceutical companies play a crucial role in this scenario to provide Drugs/Vaccines/Therapies to treat and tackle the novel coronavirus disease of 2019. This paper consists of the Drugs and Vaccines which are developed, or in the process of development , their current stage of development (clinical trials) with their patent review.


2016 ◽  
Vol 19 (1) ◽  
pp. 53-57 ◽  
Author(s):  
Jesmin Sultana

The present study is focused towards the analysis of different barriers and prospects of pharmaceutical industries in Bangladesh. Pharmaceutical industry is one of the most promising sectors in Bangladesh. After the promulgation of local industry friendly Drug (Control) Ordinance in 1982 the scenario of pharmaceutical industries changed considerably. Now, after fulfilling the local demand Bangladesh is exporting pharmaceutical products to over 100 countries of the world. There are still lots of space for Bangladesh to flourish in this sector. So initiatives from the stakeholders are required to ensure the remarkable growth of pharmaceutical industries in Bangladesh. In this study, the scopes of advancement and the factors that can hinder the growth of pharmaceutical business are discussed thoroughly.Bangladesh Pharmaceutical Journal 19(1): 53-57, 2016


2021 ◽  
Vol 9 (1) ◽  
pp. 48-61
Author(s):  
Devender Kumar ◽  
Shivali Rahi ◽  
Arpana Rana

The national regulatory authorities, such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Central Drugs Standard Control Organization and the Australian Therapeutic Goods Administration (TGA), approve every drug that is prescribed for patients around the world. The process of approval undertaken by pharmaceutical companies for drug candidates consists of a series of phases to ensure the product is safe and effective at treating the disease. In this paper, we will compare the clinical trial regulations of India with respect to Australia, Europe, Japan & USA in order to determine the safety and efficacy of pharmaceutical products like drugs, biologics and medical devices in different geographical regions and to confirm the clinical trials studies follow strict scientific standards.


2021 ◽  
Vol 65 (11) ◽  
pp. 49-59
Author(s):  
S. Balashova ◽  
N. Volgina

The pharmaceutical industry is one of the key sectors of the world modern economy, both in terms of its innovativeness and in terms of its contribution to GDP. Many countries and companies strive to achieve pharmaceutical leadership in the global market, by which we mean the volume of foreign sales (we distinguish between country and corporate pharmaceutical leadership). The aim of this article is to identify a number of factors that (to one degree or another) determine the leadership of countries in the global pharmaceutical industry or in the global pharmaceutical market. We hypothesize that the volume of national pharmaceutical exports depends on domestic R&D expenditures carried out by national companies, as well as on the volume of national pharmaceutical imports, that is, on the degree or depth of participation of pharmaceutical companies in the internationally fragmented pharmaceutical chain. Based on the conducted econometric analysis, the authors come to the conclusion that both R&D expenditures and participation in fragmented production have a significant impact on the volume of national pharmaceutical exports. At the same time, in the latter case, the effect of the continuous growth of imports of previous periods for the growth of exports of subsequent periods gets special significance. In the case of R&D expenditures, a special role is played by the cumulative effect of these costs, rather than individual, albeit large investments in pharmaceuticals. When modelling the volumes of pharmaceutical exports, the countries “outpacing” the market were identified, that is, countries with the rates of national pharmaceutical exports exceeding the world ones. Among them were both countries where the headquarters of Big Pharma are located, and countries where there are no major pharmaceutical companies leading. This conclusion means that countries that do not have the headquarters of Big Pharma companies on their territory, which include, in particular, Russia, Kazakhstan and Belarus, also have certain potential windows of opportunity to take a leading position in the global pharmaceutical market. Acknowledgements. The article was prepared with the support of the RFFI as part of the research project “Comparative analysis of the benefits and risks of embedding national companies in global value chains: on the example of the Russian pharmaceutical industry. Belarus and Kazakhstan” (no. 20-014-00011/20).


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