ABSTRACT
[...]CURES' BILL PROMOTES PANDEMIC PREPAREDNESS Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster (see https://bit.ly/2SKfA4S). Cures 2.0 continues and updates some of the main themes of the first Cures Act: support development of treatments for rare diseases, patient-focused drug development, diversity in clinical trials, expanded use of digital health systems, increased health literacy, and utilization of real-world data. A public education campaign, moreover, would aim to counter concerns about the safety of vaccines to promote widespread vaccination. Because these treatments are costly and unprofitable for biopharma companies to test and market, the legislation proposes additional financial support for both pre-market studies and post-market production and subsidized higher reimbursement rates for antibiotics that address critical needs.
ABSTRACT
By early 2020, COVID-19 has caused a global pandemic which led to an enormous number of challenges worldwide in various sectors. The Philippine government has implemented multiple quarantine guidelines and travel restrictions to ensure the people's health and safety. However, the International Labour Organization projected an initial economic and labor market disruption affecting 11 million workers, or about 25% of the Philippine workforce, due to the pandemic. Therefore, the government, thru the concerned agencies continues to encourage employers to implement alternative work plans such as a work-from-home (WFH) operation in compliance with the established regulations in line with existing laws and policies. In line with the telecommuting concept, various research has already been performed, however, some were regarded inconclusive and require further study. Hence, in this study, a Web application was developed along with an embedded fuzzy model to evaluate the telecommuting capability assessment of employees. The proposed web application with embedded fuzzy model is capable of providing capability assessment using the four main input variables which are also relatively characterized for possible telecommuting cost assessment. © 2022 IEEE.
ABSTRACT
[...]we've seen more companies diversifying their portfolios and investing in therapies for rare diseases so that advanced therapies, and in particular, gene therapies-which were deemed experimental and risky when I was involved with the European Medicines Agency's Committee for Advanced Therapies some 10-12 years ago-take centre stage," Schneider continues. The year's expectations were unsurprisingly centred around COVID-19 for Martin Lush, global vice president. "Many big pharma companies will continue down the path of externalising services for small molecules and/or known molecules maintenance, to keep their focus on novel molecules," she explains. [...]of this complexity, there can be much negotiation and, hence, delay in access to medicines, he explains.
ABSTRACT
The bio/pharma sector is an industry that has probably been most affected by the pandemic, not only is there an expectation for bio/pharma companies to step up and develop appropriate treatments quickly, resulting in regulatory flexibility and unprecedented collaborations, but there have also been concerns around supply chain security. Agencies have prioritized protocol consultations, shortened the timelines for clinical trial application review and approvals, and there is some focus on implementing fast-track and priority review processes for the evaluation of marketing authorization applications. Marton (Arriello): Authorities that have more experience in evaluation of data adapted quickly, while other authorities, such as those in the Commonwealth of Independent States area, stopped all activities for a period of time or adapted along the way. Gross (ProductLife): There is already some cooperation between the US and Europe, especially in the regulatory development process and in the evaluation process, so it's possible the current situation could reinforce those efforts and lead to some further joint assessments for clinical trial protocols and marketing authorization reviews.
ABSTRACT
This chapter looks at current and perspective legislative and regulatory scenario, identifying rules governing the use of Artificial Intelligence in the health sector at European Union level with a focus on the impact of AI on pharmacovigilance activities. After some preliminary considerations on definitory issues, attention will be paid to the challenges posed by AI to pharmaceutical industry in developing medicinal products and monitoring their quality, safety and efficacy. The European strategy addressing the use of AI in pursuing a better health policy will then be outlined, followed by some caveat concerning ethical implications and protection of personal data. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.
ABSTRACT
This chapter is a substitute for chapters that were not completed due to the COVID-19 pandemic. In lieu, this chapter on LGBT and cancer in the South-East Asia region provides an overview of recent changes in sexual and gender minorities' legal situation, various aspects of LGBT communities, and organizations. While cancer is recognized as a threat to the region, a literature review of LGBT health research shows that a wide range of different topics are explored, with infectious diseases being the main focus. The time appears right for an expansion of the scope of LGBT health research to more prominently address noncommunicable diseases, such as cancer. However, it might be possible that COVID-19 will further delay research on noncommunicable diseases among LGBT populations. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.
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This article highlights the relevance of the two important Indian labor legislations in relation to migrant workers. A few observed gaps in these legislations are discussed. The article addresses the research questions and objectives through an understanding of both the laws. ISMA and the Occupational Safety, Health and Working Conditions code (2020) (OSH). The identified gaps in these legislations could be a reason for their ineffectiveness at critical situations like the crisis caused by the Covid 19 lockdown. The study takes a timely review to bring some suggestions to enhance the applicability and effectiveness of the upcoming Occupational Safety, Health and Working Conditions Code 2020.
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This study discusses the development of the intellectual property (IP) marketplace model based on mobile location-aware computing. Referring to statistics released by the Directorate General of Intellectual Property, there has been a growth in the number of intellectual property rights (IPR) applications in recent years, even during the Covid-19 pandemic. On the other hand, after IPR protection, the commercialization of IPR is one of the pillars of the IP system. Nevertheless, research institutions such as LIPI/BRIN indicate that the potential for commercializing IPR is still low. Furthermore, the opportunity is that cellular networks have covered almost all parts of Indonesia, and there has been significant growth in smartphone users. The method utilized in this research is prototyping. This research results from an IP marketplace model based on mobile location-aware computing in Indonesia. Using the smartphone user's location, contextual IPR information from the user's location related to IPR will enter their smartphone. The experimental results indicate that the application can display a list of IPR information according to the smartphone user's location. Furthermore, the search feature can forage IPR listing information based on user queries. © 2022 IEEE.
ABSTRACT
The revised NIS-2 Directive has been assigned to the Committee on Industry, Research, and Energy (ITRE), within the European Parliament, and is intended to form one of the baselines for the European cybersecurity framework, as well as act as a central tool in advancing Europe's strategic autonomy and the Digital Europe Programme (3). The intention is that cyber resilience must be considered a priority at board and senior management level rather than be confined to the remit of technical teams. European Parliament Adopts New Draft Directive," Technology Law Dispatch, Reed Smith LLP, 20 Jan. 2022.
ABSTRACT
[...]on 25 Nov. 2020, the European Commission (EC) announced the new Pharmaceutical Strategy for Europe, which is likely to result in significant changes to the European Union (EU) regulatory framework and will have a substantial impact on both the marketing of medicinal products and the strategic business planning of pharmaceutical companies (2). (2021), the priority areas are as follows: * The performance and adequacy of the current legislation * Unmet medical needs-with a definition or set of principles for "unmet medical needs" under discussion * Incentives for innovation, including the area of unmet needs and a reflexion on regulatory data and market exclusivity * Antimicrobial resistance that includes measures to support innovation of antibiotic development * Future-proofing the regulatory framework for novel products * Improved patient access to, and affordability of, medicines in the EU * Competitiveness of the European markets to ensure affordable medicines, including considering measures to support patients' access to affordable medicines * Encouraging the repurposing of off patent medicines * Ensuring security of supply of medicinal products in the EU * Ensuring high-quality manufacture and distribution in the EU including consideration of the need to strengthen or adapt good manufacturing practice (GMP) to reflect new manufacturing methodologies * Environmental challenges (4). Availability, accessibility, and affordability of medicinal products The section on 'Prioritising unmet medical needs' in the strategy reflects the belief within EU Bianca Piachaud-Moustakis is lead writer at PharmaVision, Pharmavision.co.uk. institutions that "current incentive models neither provide an adequate solution for unmet medical needs nor appropriately incentivise investments in innovation" (2).
ABSTRACT
"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).
ABSTRACT
The UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country's competitiveness in pharma On 1 Jan. 2021, the United Kingdom formally left the European Union to become a third country and no longer a member of the Union's single market and customs union. The UK has, for example, decided to draw up its own version of the EU chemicals legislation-called REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)-which sets technical standards for chemical ingredients for medicines (1). Because the UK is a separate legal entity-a third country-the UK's excipient producers and their raw material suppliers have started to be concerned about procedures like customs declarations and rules of origin. [...]by 18 Feb. 2021 the UK had vaccinated 26% of its population versus 8% in Denmark-the leading EU country for vaccines availability-6% in Germany, and 5% in France (6). NICE needs to change Industry believes that the National Institute for Health and Care Excellence (NICE), the government's health technology assessment (HTA) body, is being too restrictive with its evaluation of digitalization products, which ultimately sets the price paid by the government for them (9).
ABSTRACT
The aim of the law is to ensure personal, material and organisational conditions for safe work without endangering human health, to prevent work accidents and occupational diseases by defining the rights and obligations of the state, employers and employees. Since 2003, the concept of occupational safety and health commissioning has been included in the law, which plays a prominent role in the commissioning of dangerous technology or work equipment in health care. [...]of the epidemic, not only the so-called back office area, but also in patient care, the concept of remote work appeared in the field of telemedicine, and some other areas, such as in the case of finding analysis. According to the legislation, the employer must register and Investigate all accidents at work. [...]of this, a wave of insourcing started and in several health institutions they started to employ their own doormen again, wh ich raises further problems.
ABSTRACT
The insolvency of travel agencies is dealt with in a special way by the EU legislator. European Union law introduces legal solutions for the benefit of consumers insofar as the relevant services are not performed by organizers as a consequence of its insolvency. The current 2015/2302 Directive provides much more comprehensive protection than 90/314/EWG Directive for travelers in the event of insolvency of a tour operator. However, in the past, in the practical functioning of travel agencies, it has repeatedly turned out that the Polish legislation has not been able to guarantee full protection provided for in EU law. This situation has changed. In Poland, since August 1, 2018 the system of security and financial guarantees in the event of insolvency of organizers and traders facilitating linked travel arrangements consists of two pillars. If Pillar I funds are exhausted, the costs of actions taken by the Marshal of the Province related to the repatriation of the customers of an insolvent tour operator will be covered from Pillar II, which is created from contributions to the Tourist Guarantee Fund. Due to the COVID pandemic, another form of security was introduced in Poland from January 1,2021 - Tourist Assistance Fund. The fund is designed to support tourism entrepreneurs in the event of extraordinary circumstances. The aim of the paper is to present the legal regulations in force in Poland in the field of financial security of tour operators in the event of their insolvency and to analyze whether these solutions sufficiently protect the interests of travelers. Conclusions included in the paper justify the statement that the extension of the security system by Pillar II make the full protection possible. The two-pillar solution should be sufficient in case of insolvency of a travel agency and that it fully implements the EU recommendations.
ABSTRACT
The "Report on the Condition of Education" is a congressionally mandated annual report from the National Center for Education Statistics (NCES). Using the most recent data available (at the time this report was written) from NCES and other sources, the report contains key indicators on the condition of education in the United States at all levels, from prekindergarten through postsecondary, as well as labor force outcomes and international comparisons. There are core indicators that are updated every year and spotlight indicators that provide in-depth analyses on topics of interest to education agencies, policymakers, researchers, and the public. At the broadest level, the Condition of Education Indicator System is organized into five sections: family characteristics;preprimary, elementary, and secondary education;postsecondary education;population characteristics and economic outcomes;and international comparisons. The Report on the "Condition of Education 2023" encompasses key findings from the Condition of Education Indicator System. The full contents of the Indicator System can be accessed online through the website or by downloading PDFs for the individual indicators. [For "The Condition of Education 2023": At a Glance, see ED628291. For the "Report on the Condition of Education 2022. NCES 2022-144," see ED619870.]
ABSTRACT
Air pollution is one of the major causes of health risks as it leads to widespread disease and death each year. Countries have invested heavily in fighting air pollution, arguably without convincing results. The outbreak of the highly infectious disease COVID-19 in December 2019 has been declared a pandemic and a worldwide health crisis by World Health Organization (WHO). Countries resorted to city lockdowns that sternly curtailed personal mobility and economic activities to control the spread of this deadly coronavirus disease. This paper examines the impact of Covid-19 city lockdowns on air quality. The researchers adopted a comprehensive interpretative document analysis for this study, which guided the careful but rigorous examination of air quality and coronavirus data. This method affirmed the authenticity of the information examined and interpreted in the US, Italy and China, the study areas. The study found that Covid-19 city lockdowns have contributed to a significant improvement in air quality within the first four months of the outbreak of Covid-19. National Aeronautics and Space Administration (NASA) had reported that NO2 concentrations in the study areas had reduced significantly using evidence from their Sentinel-5P instrument. Air quality in Covid-19 cities' lockdowns also improved because of the enforcement of other types of measures enacted to battle the virus. WHO still believes that the amount of NO2 concentration in the atmosphere is still high per their standards and regulations. Based on this, the researchers recommend that governments and other stakeholders put in much effort in terms of legislation to "win the war” against air pollution.
ABSTRACT
Responding to mistrust in the European agencies' risk assessments in politically salient cases, the European Union (EU) legislator, the European Food Safety Authority and the European Medicines Agency alike have accelerated their efforts to foster EU regulatory science transparency. These simultaneous endeavours have, however, taken place in a fragmented legislative and administrative context, with each agency operating under a different legal framework. By focusing on authorisation procedures, from registration of studies to authorisation of novel foods, pesticides and human medicines, this article examines the resulting regimes governing the disclosure of scientific data by EU agencies to identify common trends and sectoral specificities. Against the background of an overall shift towards enhanced transparency, we shed light on, first, the circulation of institutional arrangements and practices among agencies and, second, the new dimensions of transparency emerging from these developments. We also highlight the remaining sectoral differences and argue that they could have potentially large impacts on the amount and type of information disclosed and on the level of transparency perceived by stakeholders and citizens. We argue that more coherence across the sectoral transparency regimes is needed, in particular in light of the agencies' contested legitimacy and of their increasing cooperation on cross-cutting issues like antimicrobial resistance and medicine and pesticide residues in food.
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This set of tables introduces new data for national and state-level public elementary and secondary revenues and expenditures for fiscal year (FY) 2021. Specifically, these tables include the following school finance data: (1) revenue and expenditure totals;(2) revenues by source;(3) expenditures by function and object;(4) current expenditures;(5) revenues and current expenditures per pupil;(6) expenditures from Title I funds;and (7) revenues and expenditures from COVID-19 Federal Assistance Funds. The tables chosen for this report demonstrate the range of information available when using the National Public Education Financial Survey (NPEFS). [For "Revenues and Expenditures for Public Elementary and Secondary Education: FY 20. Finance Tables. NCES 2022-301," see ED619372.]
ABSTRACT
On 1 March 2021, the EC published its roadmap to revise the general pharmaceutical legislations building on lessons learnt from the COVID-19 pandemic to ensure that the future regulatory framework is fit-for-purpose and crisis-resistant (3). Since the EC published its strategy roadmap, it has conducted a series of consultations and has proposed a series of amendments to: o ensure access to affordable medicines o foster innovation, including in areas of unmet medical need o improve security of supply o adapt to new scientific and technological developments o reduce red tape (8). The Regulatory Scrutiny Board (RSB), an independent body within the EC that undertakes impact assessments and evaluation fitness checks, has reviewed the proposal and drafted a number of negative opinions. According to EFPIA, the overall goal of the new regulations should be to reinforce expertise-driven assessment and enable a more agile centralized authorization framework by facilitating member states and removing unnecessary, burdensome interfaces between committees and the EC (Figure 2).
ABSTRACT
Victoria is the first Australian jurisdiction to enact legislation establishing a regulatory framework specifically to guide government management of the COVID-19 pandemic and future pandemics. The Public Health and Wellbeing Amendment (Pandemic Management) Act 2021 (Vic) inserts Pt 8A into the Public Health and Wellbeing Act 2008 (Vic). The worthwhile stated objective of Pt 8A is to ensure that decision-making in response to an existing or emergent pandemic is "proactive and responsive", "informed by public health advice and other relevant information", and transparent and accountable. This column analyses sections of Pt 8A related to this aim, which grant decision-making powers, require various matters to inform this decision-making, and provide measures for oversight of decision-making. The column argues that Pt 8A constitutes a useful model on which Victoria and other jurisdictions could build and recommends further legislative amendments to help achieve its objective.