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A major driver for innovation within the bio/pharma sector has been the COVID-19 pandemic, which propelled advances such as the approval of messenger RNA (mRNA) vaccines at record-breaking speeds and led to many companies pivoting to deal with the urgent requirements for capacity and supply chain flexibility needed to overcome pandemic challenges. "Before deciding on a location, we conducted extensive market research, and it quickly became clear, just by the sheer proximity of so many biopharmaceutical companies, associations, and research centres, that the event had to be in Geneva. Organized as four half-days, they will each address a theme related to the four main areas of the supply chain present in the exhibition area: pharmaceutical packaging (primary and secondary), medical devices, pharmaceutical sub-contracting, and pharmaceutical equipment. The dream scenario, the real measure of success, is when a product comes to market that happened as a result of a meeting or discussion that took place at our event.
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The regulation also sets out obligations on marketing authorization holders (MAHs) and medical devices manufacturers, authorized representatives, importers, distributors, and notified bodies duties to: * Provide information that will assist with the monitoring by the MSSG/MDSSG of shortages of medicinal products and devices contained in the critical medicines list and updating this when necessary * Provide a justification for any failure to provide the requested information by the established deadlines * Immediately provide any evidence of an actual or potential shortage of medicinal products or devices * Provide information to EMA by 2 Sep. 2022 that will enable the establishment of a Single Point of Contact (SPOC) network, and the industry Single Point of Contact (iSPOC) network, with mandates to updating this when necessary (7). Enhanced advisory role In addition to the measures designed to address medicinal and medical device shortages, an Emergency Task Force (ETF) will also be established within EMA to provide scientific advice and review evidence on medicines that have the potential to address public health emergencies, offer scientific support to facilitate clinical trials, and support existing EMA committees with their authorization and safety monitoring of medicines (8). According to the document published by EMA on Crisis Preparedness and Management, the key benefits for EMA of having these responsibilities include: * Accelerated evaluation and access to safe and effective medicines which could treat or prevent a disease causing, or likely to cause, a public health emergency * Improved quality of data and the effective use of resources through increased support at EU level towards the conducting of clinical trials in preparation for, and during a public health emergency * Improved coordination and harmonization at EU level in preparation for and during a public health emergency (7).
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Current FDA programs to accelerate access In order to accelerate the product approval process, four regulatory programs currently exist to reduce development and review times for products that address unmet medical needs for the treatment of serious or life-threatening conditions. In May 2014, FDA issued a Final Guidance for Industry entitled, "Expedited Programs for Serious Conditions-Drugs and Biologics" which addresses fast track designation, breakthrough therapy designation, priority review designation and accelerated approval.3 In addition to this guidance document, under section 564 of the FD&C Act, 21 U.S.C. 360bbb3, in a situation where the Secretary of Health and Human Services (HHS) issues a declaration of emergency or threat justifying authorization of emergency use for a product caused by chemical, biological, radiological or nuclear (CBRN) agents, as well as an infectious disease, the Commissioner of the FDA may authorize an EUA of an unapproved product or an unapproved use of an approved product. In January 2017, the "Emergency Use Authorization of Medical Products and Related Authorities" guidance was finalized.4 Fast Track designation Section 112 of the Food and Drug Administration Modernization Act of 1997 (FDAMA), entitled "Expediting Study and Approval of Fast Track Drugs," mandates the facilitation of the development and processes to expedite review of therapeutics intended to treat serious or life-threatening conditions presenting with unmet medical needs. [...]a two-tiered system of review times, Standard Review and Priority Review was created.
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"Though Europe's response has demonstrated strengths," the strategy document reports, "existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines, or the availability of manufacturing capacities to adapt and support the production of medicines" (2). [...]a lot of the strategy's proposals stem from the European Green Deal, published in late 2019 (4), from which has emanated last year's EU industrial strategy (5). [...]setting up critical medicines production capacity in the EU would have to be compliant with the Union's competition rules and those of the World Trade Organization, the commission warned (2).
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Conversely, in Italy DTx are classed as medical devices and must pass International Organization for Standardization (ISO) standards to ensure they are compliant with safety requirements. The new EU MDR should help to simplify the exchange of data on medical devices and improve data collection and post-market surveillance to reinforce end-user confidence in DTx solutions. In Germany, Ireland, and the Netherlands, DTx manufacturers have directly targeted self-insured employer health plans, whereas in France, Belgium, and the United Kingdom, a B2P reimbursement model has proven successful.
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The EMA pandemic Task Force (COVID-ETF) helps EU member states and the European Commission (EC) to take quick and coordinated regulatory action on COVID-19 treatments and vaccines. Delayed submissions As a result of pressure on the work time of regulators from COVID-19 matters, pharmaceutical companies are thought to be holding back the application for marketing authorizations of their products or approval of variations of marketing authorizations. Regulators are not only worried about having to grapple with a rush of delayed submissions but also the extra burden of implementing new EU legislation in areas like veterinary medicine, medical devices, and personal data protection. A joint HMA/EMA Big Data Task Force recommended in December 2019 that the regulatory network set up a platform for access and analysis of healthcare data from across the EU (5).
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PurposeThe COVID-19 pandemic has had a significant and worldwide influence on healthcare delivery, and it has significantly increased the pace at which digital technology is being used. Blockchain, one of these developing digital technologies, is distinguished by a number of properties. This study focuses on a blockchain-enabled healthcare supply chain. The purpose of this work is to investigate how blockchain technology (BCT) benefits the performance of healthcare supply chain management (HSCM).Design/methodology/approachThe present study is based on the empirical research. Blockchain Technology (BCT), Healthcare Sustainable Supply Chain Practices (HSSCP), Healthcare Supply Chain Performance (HSCP) and Stakeholders' Involvement (SI) practices are identified from the literature review and hypotheses are framed to check their interrelationship. For testing of hypothesis, a questionnaire was developed. Data collection was done by healthcare professionals via Google docs. The IBM SPSS version 22.0 was used to analyze the data and IBM SPSS AMOS 22.0 software was used for the development of structural modal. The data was collected through the Google form from the stakeholders of healthcare sector and analyzed through Structural Equation Modelling.FindingsThis research is focused on adoption of BCT enabled Healthcare Sustainable Supply Chain to improve HSCP. From the result, it had been found that BCT is positively effecting the stakeholder's involvement (SI) and HSSCP practices. Cumulatively, they positively impact the performance of HSCP. From this study, it is found that adoption of BCT enabled Healthcare Sustainable Supply Chain succours to combat COVID-19 situation.Originality/valueThis study attempts to show the potential benefits of the adoption of BCT enabled HSSCP to improve HSCP.
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Israel's aid initiatives have historically been facilitated through the Agency for International Development Cooperation (MASHAV). However, the COVID-19 pandemic impacted MASHAVs ability to provide assistance due to budget cuts and government instability. As such, Israel's COVID-19 diplomacy initiative took on greater importance in maintaining its presence and reputation internationally. This article analyzes Israel's approach to COVID-19 diplomacy, which involved providing medical teams, PPE, and surplus vaccines to approximately 20 countries, and examines the political and strategic calculations behind Israel's decision to extend assistance to specific countries. The article argues that Israel's COVID-19 diplomacy initiative was more limited in scope and geography compared to other countries with similar economic development levels, and aid efforts were concentrated in regions where Israel has sought to increase its involvement in recent years, particularly sub-Saharan Africa and Central Europe. Finally, the article assesses the impact of Israel's COVID-19 diplomacy initiative on its diplomatic relations with recipient countries and the broader international community.
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Pursuant to a directive of Congress, the Federal Trade Commission (FTC) issued a report in May of 2021 examining consumer protection and antitrust issues relating to repair restrictions with a focus on the prevailing practices of mobile phone and auto manufacturers.12 In its report, the FTC identified eight primary methods by which OEMs restrict independent repair and repair by consumers: * Product designs that complicate or prevent repair;* Unavailability of parts and repair information;* Designs that make independent repairs less safe;* Policies or statements that steer consumers to manufacturer repair networks;* Application of patent rights and enforcement of trademarks;* Disparagement of non-OEM parts and independent repair;* Software locks and firmware updates;and * End User License Agreements.13 Software locks, often called digital rights management (DRM) tools or technological protection measures (TPMs), are access controls through which OEMs have throttled independent repairs on a wide range of software-enabled products.14 End-user license agreements (EULAs) are "contracts that users must agree to before using a product or service," which are also known as "click-wrap," "shrink-wrap," or "terms of service" agreements, constituting another major way OEMs restrict repairs.15 In the style of adhesion contracts-inundating consumers with virtually every digital service and software-enabled product they utilize-EULAs often impose post-sale usage, repair, and modification restrictions, granting corporations "unprecedented access to monitor, manage, and restrict how consumers use their products, even going so far as to revoke ownership. B.The Right-to-Repair Movement Today Leading the charge for the right-to-repair movement today is the Repair Association, comprised of notable consumer-rights groups and industry organizations such as the U.S. Public Interest Research Group (PIRG),19 the Electronic Frontier Foundation,20 and iFixit,21 along with a variety of other members whose interests align with advancing the right to repair.22 The right-to-repair movement consists of two main, interdependent branches.23 The first is focused on amending the Digital Millennium Copyright Act (DMCA),24 an important facet of the federal intellectual property law regime.25 The second branch of the movement is focused on pushing bills through legislatures, mainly at the state level. The Act Protecting Motor Vehicle Owners and Small Businesses in Repairing Motor Vehicles.28 Although limited to automobile repairs, this landmark state law mapped the core provisions of template legislation advanced by the Repair Association for enshrining the right to repair broadly across industries.29 Pursuant to these provisions, the Massachusetts law gave car owners and independent repair shops access to the same manuals, diagnostic software, and diagnostic repair tools provided to licensed dealerships by their respective automobile manufacturers.30 Specifically, the law required motor vehicle manufacturers to "make available for purchase by owners . . . and by independent repair facilities the same diagnostic and repair information" and "all diagnostic repair tools" provided to dealers by OEMs on "fair and reasonable terms. In 2014, the Alliance of Automobile Manufacturers, the Association of Global Automakers, and two automobile aftermarket industry groups came together to sign a "Memorandum of Understanding" by which the automobile industry nationwide effectively agreed to voluntarily abide by substantively the same provisions of the Massachusetts right-to-repair law.32 Unsurprisingly, the law generated considerable momentum for the right-to-repair movement over the following years, which saw a greatly amplified nationwide effort by advocates pushing for legislation "that would recognize the right to repair consumer electronics-not only smartphones, laptops, and televisions, but also household appliances, wearable technology, farm equipment, and medical devices, to offer just a few examples.
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During the initial spread of the Covid pandemic in India, I was posted in a Corona hospital and faced problems of arrangement and supply of corona essentials to the hospital so that precious human lives can be saved. Based on my experience I have suggested a concept of reimagining of supply chain of essentials in the country during any such crisis in future. My concept is at very naive stage at this point of time but may be developed further.
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[...]management behavior plays a crucial role in developing CSR strategies. [...]with the development of new theoretical constructs and new models, it is necessary to better understand the dynamics and critical factors of the relationship between CSR and company performance as well as the context in which they operate (Lin et al., 2019;Surroca et al., 2010). In developed countries, CSR has become an important element for firms, as CSR strategies enhance their competitiveness and corporate reputation (e.g. Becker-Olsen et al., 2006;Aguilera et al., 2007). [...]of particular interest – in terms of context influences – are also countries considered as fastest-developing, such as BRICS, CIVETS, Next Eleven, and MINT, in which different cultural and social aspects can influence CSR strategies in different ways compared to developed countries (e.g. Aguinis and Glavas, 2019;Sardana et al., 2020). [...]this special issue aimed to attract rigorous research studies from scholars all over the world, contributing to enrich theoretical and practical knowledge about CSR, helping scholars – as well as executives of small and medium-sized enterprises (SMEs), emerging market SMEs, multinationals enterprise (MNEs) and emerging market MNEs (EM-MNEs) – to navigate through, overcome and learn from the COVID-19 global crisis.
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It’s time to reflect back. The global pandemic resulting from the COVID-19 is regarded as one of the greatest health crisis in WHO records. Many countries came to a halt as a result of the pandemic: businesses, employees, and markets have been dealing with a variety of difficulties ranging from spread of the disease to various social-human-economic impacts. In India, the crisis started in March 2020 and the consumers were confined to homes like the rest of the world. The individuals became skeptical of all their purchase decisions whether related to essentials like grocery items or high priced lifestyle products. There was indeed a paradigm shift in consumer psychology although the same may not last post covid era. However, the pandemic phase did influence the consumers’ mindset although for a brief stint. This phase gave a valuable insight about how purchase making decisions changes because of the changes in the macro-environment. The purpose of this research is to document and assess how these external shifts in the marketplace impacted consumer behavior overall. The pandemic era may have also created different consumption traits and opportunities for new business patterns that fit in better with changes. An in-depth study was conducted to determine the changes in customers buying perceptions for shopping various products. It also assessed whether the consumer preferred a different shopping environment in terms of inclination towards online shopping;and whether their perception of going back to shopping malls for their purchases have altered a bit.
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A pharmacy is a health care institution engaged in the activity of providing health care for the supply of medicines, where it provides the medicine and the professional information related to its use directly to patients. A pharmacy can only obtain medicine from an organization that has a pharmaceutical wholesale license. In Hungary, there are 7 large pharmaceutical wholesalers serving the needs of pharmacies, however, each pharmacy is connected to a maximum of 2-3 wholesalers and in addition there is usually only one that delivers twice a day and in case of any order limit. This is done on the basis of an individual agreement or contract between pharmacies and wholesalers.
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Objetivo: O artigo buscou analisar os impactos e reflexos da pandemia de COVID-19 na gestão dos resíduos plásticos. Referencial teórico: A preocupação com a COVID-19 resultou em diversas medidas protetivas, como a determinação do uso de EPIs e restrições de circulação nos centros urbanos. Essas mudanças também impactaram padrões de geração e gestão de resíduos sólidos, especialmente de resíduos plásticos, cujos reflexos negativos nos aspectos socioambientais podem emergir, dado seu descarte inadequado. Método: Foi realizada uma revisão sistemática de literatura, nas bases de dados Scopus, Sage e Web of Science, com utilização do Methodi Ordinatio. Ao total, 22 estudos foram selecionados, compondo o portfólio de pesquisa. Resultados e conclusão: Os resultados demonstraram uma maior concentração de estudos que relacionam os resíduos plásticos nas regiões costeiras, especialmente provenientes de EPIs, e a poluição por microplásticos. Além disso, há uma preocupação com a geração de resíduos de embalagens pela alteração nos padrões de consumo, com o aumento da procura por serviços de e-commerce e delivery. Além de uma preocupação ambiental, destaca-se um problema de ordem social à longo prazo, devido à quebra de padrões de comportamentos sustentáveis na utilização de plástico descartável. Implicações da pesquisa: Soluções são propostas no sentido de utilização de plásticos biodegradáveis, reutilização de EPIs e novas tecnologias de tratamento de resíduos, além da mudança no comportamento social. Originalidade/valor: De um modo geral, o estudo fornece insights e promove reflexões sobre os desafios enfrentados no gerenciamento de resíduos plásticos durante a pandemia de COVID-19.Alternate :Purpose: The article aims to analyze the impacts and reflections of the COVID-19 pandemic on plastic waste management. Theoretical Framework: The concern with COVID-19 resulted in several protective measures, such as the use of PPE and movement restrictions in urban centers. These changes also affected patterns of generation and management of solid waste, especially plastic waste, whose negative effects on socio-environmental aspects may emerge due to its inadequate disposal. Method: We conducted a systematic literature review in the databases Scopus, Sage and Web of Science, employing the Methodi Ordinatio. The review selected 22 studies to compose the research portfolio. Results and conclusion: The results showed a higher concentration of studies on plastic waste in coastal regions, especially from PPE and microplastic pollution. Moreover, there is a concern with the generation of packaging waste by shifting consumption patterns with the increased demand for e-commerce and delivery services. Besides an environmental concern, a long-term social problem stands out regarding the breaking of sustainable behavior patterns in using disposable plastic. Research implications: We propose solutions involving the use of biodegradable plastics, reuse of PPE, and new waste treatment technologies, besides changes in social behavior. Originality/Value: Overall, the study provides insights and promotes reflections on the challenges faced in managing plastic waste during the COVID-19 pandemic.
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Covid-19 pandemic affected millions of people across the globe. Healthcare professionals need various kind of medical product like drugs, vaccines, other biologicals, and diagnostic equipment to combat pandemics. Fake vendors introduced falsified medical products in national and international markets during pandemic. These counterfeit products are life threatening due to inferiority in quality and available in noncompliance of label claim. Europol confiscated 34,000 counterfeit surgical masks in just one coordinated assignment of fake goods. The data for the unauthorized medical product sell is higher than expectation during this Covid-19 pandemic. World Health Organization reported that up to $200 billion worth of counterfeit pharmaceutical products are sold globally every year. It is a challenge to track and trace counterfeit medical products because these products must pass through many complicated distribution channels which allows opportunity for counterfeit drugs to enter in supply chain. In current supply chain methods, central authorities control transacted data among parties. Multiple intermediates needed to enable activities and creating trust. In this scenario, there is chance of manipulation in data fabrication. Block chain protects supply chain and maintain a shared source of data information. Trust enabled by cryptographic algorithms and immutability of data preserved in Block chain. In this paper, a Theoretical Block chain Architecture Model (t-BAM) proposed using hyper ledger Fabric as a Block chain platform and Byzantine Fault Tolerance (BFT) Algorithm for mutual consensus in supply chain of medical products during COVID-19 pandemic. This model validated for immutability, Mutual consensus, Transparency and Accountability, Privacy and Security, Temperature and Humidity control parameters.
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Considering the current COVID 19 pandemic, but not limited to this exceptional situation, contractors can experience different types of setbacks that may result in the impossibility to complete the works they have undertaken by a contract, either in due time, or at all. Positive law institutions, regulated in both common and continental law systems may help adjusting these conditions, taking into account particular situations that constructors might encounter. Thus, generally determined institutions, such as force majeure, hardship, imprevision, frustration or even the impossibility might lawfully intervene in such contracts, depending on the circumstances of each case, and also taking into account the positive law under which the contract is drafted. By this study, we aim to analyze the impact of the above-mentioned institutions on construction agreements, that in general imply a longer execution term and thus, must usually be drafted taking into account these clauses. The study mainly concentrates on the Romanian regulations in force, but also takes into account the international dimension, as we are also looking at common law institutions that are generally recognized by international practice.
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The California Prison Industry Authority (CALPIA), a semiautonomous prison labor agency under the California Department of Corrections and Rehabilitation, runs two optical laboratories operated by people incarcerated at Valley State Prison and California State Prison, Solano,1 and these laboratories supply ophthalmic lenses to eligible Medicaid recipients, such as this young patient. Documents we obtained through a public records request revealed that our state's public health agency, the California Department of Health Care Services (DHCS), agreed to pay CALPIA up to $37.9 million for the 2021/22 fiscal year for optical services alone. CALPIA wages in prison-based optical shops range between $0.35 and $1.00 per hour,6 up to 55% of which can be deducted by law for restitution and administrative costs, resulting in an effective pay rate as low as $0.16 per hour.7 Courts have routinely rejected legal challenges to these meager wages by concluding that, because the Thirteen Amendment permits the involuntary servitude of incarcerated people, the federal minimum wage law does not apply to prison labor.8 The result is a strange supply chain that is not always transparent or top of mind: medical devices produced by poorly paid imprisoned people are provided to the poorest members of free society, such as the infant who needed sight-saving glasses. Others have called for public health officials, researchers, and physicians to address the sprawling reach of the prison industrial complex.14 Medical providers could use their position of authority to advocate better pay and conditions for incarcerated workers who produce the very devices that providers prescribe.
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[...]it has a positive effect. Because the buyers and sellers do not need to meet face-to-face and are carried out in the open Internet network environment, various business activities of e-commerce have incredibly played its advantages. The impact of the COVID-19 pandemic is reflected in the daily increase in cases and deaths. [...]this paper attempts to solve the problems of what is the overall impact of Covid-19 on Chinese e-commerce companies in 2020. According to Nakhete and Jain (2020), 205 countries and their economies and politics have been infected with the virus. According to the survey, 52% of consumers avoid shopping in physical stores, and 36% of them do not go to the physical stores before they are vaccinated with the COVID-19 vaccine, which means that the short run of the fundamental business is declining.
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The term 'Health-Care-Providers' (HCPs) include a host of stakeholders. Some of them comprise of doctors, nurses, hospitals, nursing homes, diagnostic-services, pharmacists, other paramedical staff, chemists and druggists besides others. This paper delves into HCPs in Pharmaceutical Industry ranging from pharmaceutical industry ranging from pharma-companies, field sales representatives (or Medical Representatives as they are commonly called), production-personnel, doctors: both General Practitioners and Specialists in various domains and tries to examine how working practices have undergone changed, if at all any, during the pandemic in general and predictions for the new normal for them post-pandemic in particular. While pharmaceutical companies during COVID-19 stressed on innovative strategies, digital solutions, strict good manufacturing practices of products including medicines and vaccines complying to norms of sterile facilities and resorted to norms like avoiding contamination through wearing of masks, maintaining social distancing, using sanitizers, a cross-section of doctors during COVID period, started online consultations, advocating telemedicine. It is quite likely that even in post-pandemic era, such practices will continue constituting the new normal's futuristic practices.
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The Covid-19 pandemic has profoundly impacted all areas of our private and public lives, including how we travel and how our goods reach their final destinations. The Covid-19 pandemic is affecting our mobility and transportation functions in unprecedented ways. It serves as a reminder of the importance of the movement of people and goods to our economy and society, but also of the industry's structural weaknesses. The supply chain has been strongly impacted by the devastating effects caused by the spread of the Covid-19 pandemic on the global economy. The degree of impact of these effects has reached companies' supply chains, particularly in terms of transport activity. For this, We carried out a study on the impact of transport activity on the supply chain of 196 Moroccan companies during the spread of the Covid-19 Virus. Thanks to the Chi-square test and the non-parametric Kruskal-Walis test, we found that the supply chain was significantly impacted by the disruption of this activity, particularly in terms of supply, purchase, and transport of goods ( p < 0.01) and a weak effect on production (p < 0.1). We found that the level of the chain disturbance is related to the nature of the transport. The upstream of the supply chain was impacted by the disruption of the transport of information while the downstream of the supply chain was influenced by the transport of goods.