ABSTRACT
Under the background of major innovations and changes in international pharmaceutical technology, the continuous development of informatization and digitalization of drug R & D, technology, and the COVID-19 pandemic, the European Commission (EC) issued the pharmaceutical Strategy for Europe (PSE) at the end of 2020 in order to meet the unfinished clinical needs, stimulate industry innovation, enhance the adaptability of the regulatory system, and consolidate the international status of the EC drug regulatory system. PSE is regarded as the "cornerstone" of European health policy in the next five years, which has important guiding significance for the development and management of European pharmaceutical industry. This paper combs and analyzes the background, development strategic objectives and specific measures of PSE, and puts forward policy suggestions in combination with the actual work of China's epidemic prevention and control and industry development, pharmaceutical scientific supervision and encouraging innovation.Copyright © 2022 by the Author(s).
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Since the early 2000s, emerging markets have become the heart of global supply chains hosting a large volume of industrial productions. The second article looked into the barriers to attaining sustainability in supply chain of the Bangladeshi pharmaceutical sector and developed a hierarchical structure of those barriers using interpretive structural modeling and MICMAC analysis. The eleventh article explored a new way to assess suppliers' suitability by considering pseudo-resilience factors to achieve SSC in the post-COVID-19 era using an analytical hierarchy process and R. It also provided a case study of three smartphone processor suppliers (Jessin et al., 2023).
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Joint decision-making processes such as negotiations play a vital role in diverse societal contexts spanning from business and politics to sustainability-related negotiations. One of the most prominent examples of how negotiations play an important role in overcoming societal challenges was the COVID-19 vaccine supply negotiations. These negotiations have put the spotlight on an aspect of joint decision-making that always has been of great interest to both negotiation researchers and practitioners yet remains empirically understudied- the effect of uncertainty. In the present article, we develop a framework of uncertainty in negotiation using the COVID-19 vaccine supply negotiations between the European Union and pharmaceutical companies as an example. More specifically, we categorize different kinds of uncertainty based both on mathematical considerations (i.e., differentiation between risk, ambiguity, and uncertainty) as well as on more circumstantial factors. To do so, we adapted the nine kinds of uncertainty in environmental governance proposed by Dewulf and Biesbroek to the more general context of negotiations. We first differentiate between three natures of uncertainty (i.e., lack of knowledge, unpredictability, and interpretations) and three objects of uncertainty (i.e., issue- based, strategy- based, and context- based). Second, we illustrate the psychological barriers that negotiators face when handling uncertainty, before concluding with proposals for practitioners on how to manage different kinds of uncertainty. Overall, we aim at stimulating investigations of the effects of uncertainty in mixed- motive decision- making while simultaneously helping negotiation teachers and practitioners better cope with the additional demands created by specific kinds of uncertainty.
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Introduction: Cancer patients have a high risk of severe COVID-19 and complications from it. Although the COVID-19 pandemic has led to an increase in the conduction of clinical trials (CTs), there is a scarcity of data on CT participation among cancer patients. We aimed to describe the level of participation in a COVID-19 CT, willingness to participate, as well as trust in sources of information for CTs among persons with and without a previous cancer diagnosis in Puerto Rico. Method(s): Data collected from November 2021 to March 2022 from two cross-sectional studies were merged and used for analysis. Informed consent, telephone, face-to-face, and online interviews were conducted among participants >=18 years old living in Puerto Rico (n=987). Descriptive statistics and bivariate analysis (Fisher's exact text and chi-squared test) was done to describe the outcomes of interest, overall and by cancer status. Result(s): Mean age of participants was 41+/-15.5 years. Most participants were women (71.3%), with an educational level greater than high school (89.5%) and with an annual family income below $20,000 (75.1%). Overall, 4.4% of participants (n=43) reported history of cancer diagnosis. Only 1.8% of the population reported to have participated in a COVID-19 CT to receive either a treatment or vaccine;stratifying by cancer, none of the cancer patients had participated in a COVID-19 CT, and only 1.9% of non-cancer patients participated. While 37.0% of the participants indicated being very willing to sign up for a CT assessing COVID-19 treatment, willingness was higher in cancer patients (55.8%) than among participants without cancer (36.1%). Regarding trust in sources of information for CTs, the level of trust ("a great deal/a fair amount") was higher for their physicians (87.6%), researchers (87.0%), the National Institute of Health (86.7%), their local clinics (82.9%), and a university hospital (82.7%), while it was lower for a pharmaceutical company (64.0%), and for friend, relative, or community leader (37.6%);no differences were observed by cancer status. Conclusion(s): While participation in COVID-19 CTs was extremely low in the study population, the willingness to participate was higher among cancer patients. Education on CTs and their availability are necessary to increase participation in this understudied group. Such efforts will enhance the representation of Hispanic and vulnerable populations, such as cancer patients, on COVID-19 CTs, and thus proper generalizability of study findings in the future.
ABSTRACT
By Decision No. 81 of 19.06.2022, the Council of the Eurasian Economic Commission amended the Guideline on Good Pharmacovigilance Practices of the Eurasian Economic Union (EAEU GVP Guideline), the core regulatory document on pharmacovigilance requirements for the EAEU Member States. The amendment involved all critical pharmacovigilance processes, and its consequences are yet to be assessed. The aim of the study was to analyse the changes to the EAEU GVP Guideline effective since 06.12.2022. The author summarised information on the changes made to the EAEU GVP Guideline by Decision No. 81 of the Council of the Eurasian Economic Commission of 19.06.2022 "On Amendments to the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union". He described the differences between the old and the new versions of the EAEU GVP Guideline. Having critically reviewed the updated regulatory document, the author commented on its positive and negative aspects. The review created a starting point for further analysis of the changes to the EAEU GVP Guideline. At the time of writing, there were no other published works assessing the significance of most of the changes for the pharmaceutical industry and designated pharmacovigilance organisations in the EAEU Member States. The author assessed their significance through the prism of the recent years' events in Russia and the world, including the COVID-19 pandemic. In connection with the amended guideline coming into force in 2022, the author suggested a transitional standstill period for both the pharmaceutical industry and designated pharmacovigilance organisations. He offered further improvements for the guideline. The article may be of practical interest to pharmacovigilance specialists, heads of pharmaceutical organisations, and employees of regulatory authorities.Copyright © 2023 Eco-Vector LLC.
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3CL protease inhibitors has become the focus of the current research on anti-coronavirus drugs. The analysis of the patent information will help the research and innovation of such anti-coronavirus drugs. This paper analyzes the application trends of anti-coronavirus 3CL protease inhibitor-related patents, the distribution of regional status of patents, important applicants, patented technology themes, progress of key drug development and other factors. We also analyze the development of related patent technologies and aim to help domestic pharmaceutical enterprises carry out innovation and complete the strategic layout.Copyright © 2023 Chinese Journal of New Drugs Co. Ltd.. All rights reserved.
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This paper investigates the divergence between the objectives of the state in ensuring citizens' right to health and the profit-maximization objective of pharmaceutical corporations in relation to, access to, and supply of medicine. This divergence is pertinent given both the rising cost of medicines and unmet needs, particularly in developing countries. This paper analyses the correlation between pharmaceutical corporations' profit drive and the state's welfare obligation. There is a need to bridge the gap between business and human rights, which can be achieved by combining the concepts of "business ethical responsibility" and corporations' contributions to "common good" with the jurisprudence on the right to health. This is imperative in view of the impact of the business of pharmaceutical corporations on vulnerable populations, particularly in, but not limited to, developing countries.
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During the treatment of critically ill COVID-19 patients it has been revealed that the neutralizing monoclonal antibodies against 2019-nCoV have the advantages of high specificity, high purity, and can be prepared in a large scale, which are expected to be a effective preparation for clinical use. This article introduces the way of 2019-nCoV invasion into the host cells, the major variants of novel coronavirus, and the mechanism of action of anti-2019-nCoV monoclonal antibodies, as well as the progress of research and development of their preparation in major pharmaceutical companies, to provide reference for scientific research and clinical application.Copyright © Chinese Journal of Clinical Infectious Diseases.All rights reserved.
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During the tough times of SARS-CoV-2 (COVID-19), the pharmacy professionals played a significant role by providing their services at various working stations and levels including hospitals, private clinics, community pharmacies, nursing homes, pharmaceutical industries, CROs and various health care programmes. However, the services provided by pharmacists were seldom mentioned and the professionals were not recognized as first line health care professional. The media, authorities and even general public have failed to appreciate the efforts of the pharmacy professionals as a part of essential healthcare team during the disaster. This review is focussed upon the contributions of pharmacists in patient care, healthcare services, patient care and well-being of the public during the COVID-19 pandemic. The various important tasks and roles played by pharmacist are described in the literature which have highly contributed towards a safer and healthier world. We hope that after going through the review and after having the idea about the roles and responsibilities that the pharmacist has played during COVID-19 will change the perspective of the people and the efforts of pharma professionals will be appreciated and recognized.Copyright © The Authors.