Strategizing for Strength in EU PharmaN

"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).

Recovery from International Trade Crisis

Since the beginning of COVID-19, the trade crisis has raised many important questions about whether globalization and international trade are dead. It further raised questions whether the persistent trade deficit is an obstacle to recovery and the persistent trade imbalance nullifies or impairs the benefits of international trade. International trade is a privilege given by sovereign countries. Any trade which deprives people's right to livelihood is against the norms of human rights. Should such types of international trade be discouraged by multilateral trade agreements? This article examines what improvements are required within multilateral trade agreements. This article has been divided into five subchapters: (I) Introduction, (II) Impact of COVID-19 on international trade and its legal implications, (III) The new deal to recovery and subject of international trade, (IV) Trade imbalance as an obstacle to recovery, (V) Impact of COVID-19 on globalization, and (VI) Conclusion. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2023.

Close the deal: Mechanisms for the payment of the purchase price in share purchase and sale agreements

The past events that have shaped our world, such as the COVID-19 Pandemic and the different political outcomes, entailed a scenario of major economic uncertainty in the global market that remains, particularly, in our country. Admittedly, mergers and acquisitions of companies (M&A) in Peru have also been heavily affected. However, it is the market agents' duty to find new strategies to mitigate the economic uncertainty by generating incentives through legal and financial security to the foreign and national investors. Consequently, in this article, the authors have identified the pricing mechanism, employed in Shares Purchase Agreements, as a key element in the recovery and boosting of M&A deals in the Peruvian market driven by uncertainty. Thus, the authors present the pricing mechanisms that have been traditionally used in Shares Purchase Agreements but also introduce the new trends in global pricing mechanisms that have come to stay and fit. © 2022, Pontificia Universidad Catolica del Peru. All rights reserved.

Recent Development of Climate Change Mitigation in the Aviation Sector: For Better Incentive Design Between Developed and Developing Countries

During the past several years, the circumstances surrounding aviation sector have changed considerably from the environmental aspects. International aviation sector is included in neither Kyoto Protocol (1997) nor Paris Agreement (2015), although domestic aviation is covered by both. In fact, the international aviation is left to the deliberation at ICAO, a UN specialized agency. In 2016, ICAO has set the first ever global market-based measure for an entire sector, the Carbon Offsetting and Reduction Scheme for International Aviation (CORSIA) in order to achieve the global sector target of 2% annual fuel efficiency improvement and carbon-neutral growth from 2020 onward. Market-based mechanism is also written in Paris Agreement (Article 6) but member states continued to negotiate its details and they are not yet agreed upon as of August 2020. It might be said that the general perception of air travel has been significantly diversified from traditional safety and efficiency only, to include more and more environment and sustainability just as we can see in the terminology of "Fly Shame.” This could be because there have been steadily growing concerns about environmentally negative aspects of aviation congestion at many air travel hubs, social and community levels of adverse effects of over-tourism, and occurrence of more and more severe natural disasters from powerful typhoons or huge wildfires, which many suspect could be caused by climate change stemming from emission of GHGs including from autos or aircrafts. Then came the COVID-19, which could fundamentally change the way of traveling, working, and even communicating in the direction of touchless, remote, or virtual relationships. Its imminent effects are overwhelming worldwide, but the medium-or longer-term effects are yet to be seen. We have now common global target and the basket of measures to achieve it in international aviation sector at ICAO. In the domestic aviation sector, which is now covered in Paris Agreement, parties also agreed on the common global target and started constructing details of the measures to achieve the target, such as market-based mechanism. The effective financial and technical aids, for example, from developed countries to the developing ones, are ever more important to incentivize and execute the necessary efforts of both sides to actually meet the global target. We are going to shed lights on the incentive design problem between developing countries and developed ones with the framework of the game theoretic analysis under asymmetric information structure focusing on the so-called double moral hazard situation of the two sides. The main results show that it is extremely difficult for both sides to achieve common optimal incentive rules about aid payments under the information asymmetry. The measures to drastically mitigate the cost of efforts, to fundamentally reduce risk averse, and to equalize damage effects of temperature anomaly between the two sides through scientific researches and long-term education on the matter are the key for such optimal incentive design. © Springer Nature Switzerland AG 2022. All rights are reserved.

STRUCTURAL AGREEMENT: THE CASE OF INDIGENOUS HEALTH CARE IN THE STATE OF MATO GROSSO DO SUL OVER THE PANDEMIC

The purpose of this paper is to study the structural agreement called the "term of technical cooperation” signed in august 2020 by the Prosecution Office, by the State Health Department, by the Special Department of Indigenous Health, by the Municipal Health Department of Aquidauana, Miranda and Sidrolândia, by the Western Military Command and by the Federal University of Mato Grosso do Sul. The case study is justified because the "term of technical cooperation” was characterized as a structural agreement, built through consensual and negotiated solutions to remedy the crisis health involving fundamental social rights. By means of the deductive method, a dogmatic and critical research is carried out. The research also carried out the analysis of content and documental data collected from samples. As a result of the case study, it is concluded that the scope of the functions of justice institutions in Brazil should reflect the culture, objectives and values that promote dialogue, participation and the purposes of the structural process, so that they can fulfill their functions in an adequate, timely, efficient and effective way in the implementation of jurisdiction in the course of the structural process, which has as an essential dimension of protection of fundamental social rights. © 2023, Universidade do Estado do Rio de Janeiro. All rights reserved.

Fit for purpose? The patents regime, the Fourth Industrial Revolution, and sustainable development

This article uses data from several publicly available databases to show that the distribution of intellectual property for frontier technologies, including those useful for sustainable development, is very highly skewed in favor of a handful of developed countries. The intellectual property rights (IPR) regime as it exists does not optimize the global flow of technology and know-how for the attainment of the sustainable development goals and is in need of updating. Some features of the Fourth Industrial Revolution imply that the current system of patents is even more in need of reform than before. COVID-19 vaccines and therapies and the vast inequality in access to these has highlighted the costs of inaction. We recommend several policy changes for the international IPR regime. Broadly, these fall into three categories: allowing greater flexibility for developing countries, reassessing the appropriateness of patents for technologies that may be considered public goods, and closing loopholes that allow for unreasonable intellectual property protections.

Feasibility Using Telehealth for Planning Use of Extracorporeal Shockwave Therapy in a Sports Medicine Clinic.

(1) Background: The purpose of this study is to describe whether telehealth compared with in-person visits, led to a similar agreement of primary diagnosis reached at the time of procedure using extracorporeal shockwave therapy. (2) Methods: This retrospective study consisted of chart reviews of all new patients evaluated in a sports medicine clinic prior to performing extracorporeal shockwave therapy from April 2020 to March 2021. The primary outcome of the study was describing agreement in primary diagnosis at the time of evaluation (telehealth and in-person) and during the procedure using extracorporeal shockwave therapy. Logistic regression was utilized to identify patient characteristics that may predict agreement of diagnosis using telehealth. (3) Results: The chart review identified 166 patients (45 telehealth and 121 in-person) evaluated for extracorporeal shockwave therapy. Agreement of diagnosis was similar for patients evaluated using telehealth compared to in-person visits (84% vs. 92%, Χ2 = 1.90, p = 0.168). Agreement on diagnosis was more likely in patients who started shockwave within the 1 week of initial visit (OR = 8.27, 95% CI = 1.69-45.29), patients over age 60 (OR = 0.94, 95% CI = 0.90-0.99), and in patients without a history of osteoarthritis (OR = 14.00, 95% CI = 1.88-113.46). (4) Conclusions: Telehealth resulted in a similar agreement to in-person visits to identify a primary diagnosis for planning extracorporeal shockwave therapy. Telehealth may be a reasonable alternative to in-person visits for procedural planning of extracorporeal shockwave therapy.

Socio-emotional, cognitive, affective disorders and substance use in a sample of students in first- and second-grade high school in Italy: A comparison among students', parents', and teachers' perceptions

The closure of schools, social hubs, and extracurricular activities due to lockdown measures imposed to curb the spread of SARS-CoV-2, has increased the risk factors for students' mental health. This cross-sectional study, conducted from March 2020 to March 2021, aimed to estimate socio-emotional, cognitive, and affective disorders and substance use in a sample of first- and second-grade high school students in Northern Italy. This study compared data from 284 Italian students' self-perceptions along with the perceptions of their parents and teachers through a web-based survey. The differences in the perceptions of the three groups (students, parents, and teachers) were analyzed using an analysis of variance test, applying a Bonferroni correction. The chi(2) test was used to assess the comparison between students, parents, and teachers in the substance use questions. The results showed statistically significant differences among the three groups. The most important outcomes were sociality, scholastic performance, extracurricular activity, emotional symptoms, affective disorders (depression and anxiety), and substance use. These findings could be interesting for the promotion of mental health and prevention of psychopathological risks in students.

A Secure and Efficient Scheme for Mutual Authentication for Integrity of Exchanged Data in IoMT

The emergence of pandemic diseases like Covid-19 in recent years has made it more important for Internet of Medical Things (IoMT) environments to build contact between patients and doctors in order to control their health state. Patients will be able to send their healthcare data to the cloud server of the medical service provider in remote medical environments through sensors connected to their smart devices, such as watches or smartphones. However, patients' worries surrounding their data privacy protection are still present. In order to ensure the security and privacy of patients' healthcare data in remote medical environments, a number of different schemes have been proposed by researchers. However, these schemes have not been able to take all security requirements into account. Consequently, in this study, we have proposed a secure and effective protocol to safeguard the privacy of patients' medical data when it is sent to the server. This protocol entails two components: mutual authentication of the patient and the server of the medical service provider, as well as the integrity of the exchanged data. Also, our scheme satisfies security requirements and is resistant to well-known attacks. Following this, we used the Scyther tool to formally analyze our proposed scheme. The results showed that the scheme is secure, and in the section on performance analysis, we demonstrated that the proposed scheme performs better than comparable schemes. © 2023 IEEE.

Privacy-Preserving Fast Three-Factor Authentication and Key Agreement for IoT-Based E-Health Systems

Electronic healthcare (e-health) systems have received renewed interest, particularly in the current COVID-19 pandemic (e.g., lockdowns and changes in hospital policies due to the pandemic). However, ensuring security of both data-at-rest and data-in-transit remains challenging to achieve, particularly since data is collected and sent from less insecure devices (e.g., patients' wearable or home devices). While there have been a number of authentication schemes, such as those based on three-factor authentication, to provide authentication and privacy protection, a number of limitations associated with these schemes remain (e.g., (in)security or computationally expensive). In this study, we present a privacy-preserving three-factor authenticated key agreement scheme that is sufficiently lightweight for resource-constrained e-health systems. The proposed scheme enables both mutual authentication and session key negotiation in addition to privacy protection, with minimal computational cost. The security of the proposed scheme is demonstrated in the Real-or-Random model. Experiments using Raspberry Pi show that the proposed scheme achieves reduced computational cost (of up to 89.9% in comparison to three other related schemes).

Cost-effectiveness and economic investment to eliminate chronic hepatitis C in Mexico.

In July 2020, the Mexican Government initiated the National Program for Elimination of Hepatitis C (HCV) under a procurement agreement, securing universal, free access to HCV screening, diagnosis and treatment for 2020-2022. This analysis quantifies the clinical and economic burden of HCV (MXN) under a continuation (or end) to the agreement. A modelling and Delphi approach was used to evaluate the disease burden (2020-2030) and economic impact (2020-2035) of the Historical Base compared to Elimination, assuming the agreement continues (Elimination-Agreement to 2035) or terminates (Elimination-Agreement to 2022). We estimated cumulative costs and the per-patient treatment expenditure needed to achieve net-zero cost (the difference in cumulative costs between the scenario and the base). Elimination is defined as a 90% reduction in new infections, 90% diagnosis coverage, 80% treatment coverage and 65% reduction in mortality by 2030. A viraemic prevalence of 0.55% (0.50-0.60) was estimated on 1st January 2021, corresponding to 745,000 (95% CI 677,000-812,000) viraemic infections in Mexico. The Elimination-Agreement to 2035 would achieve net-zero cost by 2023 and accrue 31.2 billion in cumulative costs. Cumulative costs under the Elimination-Agreement to 2022 are estimated at 74.2 billion. Under Elimination-Agreement to 2022, the per-patient treatment price must decrease to 11,000 to achieve net-zero cost by 2035. The Mexican Government could extend the agreement through 2035 or reduce the cost of HCV treatment to 11,000 to achieve HCV elimination at net-zero cost.

Use of daily home spirometry to predict clinical outcomes in persons with cystic fibrosis

Background: Use of home spirometry to monitor lung function has been increasing in popularity in persons with cystic fibrosis (PwCF) since the start of the COVID-19 pandemic. Although clinic spirometry is interpreted from validated standards, expected test-to-test variation of home spirometry and how variation during baseline health may relate to clinical changes are unknown. The aim of this study was to determine variation in baseline lung function during daily home spirometry and identify associations with clinical outcomes. Method(s): Subjectswere selected based on available spirometry data from a cohort of PwCF enrolled in a long-term airway microbiome study. Subjects were provided with a PiKo-6 hand-held spirometer (nSpire Health, Inc., Longmont, CO) and asked to perform spirometry maneuvers three times per. Validity of home spirometry (percentage predicted forced expiratory volume in 11 second (FEV1pp)) was compared with that clinic spirometry using Bland-Altman plots. Spirometry acceptability across multiple maneuvers in the same day was assessed using the American Thoracic Society (ATS) guidelines, with grade A or B (two or more maneuvers within 150 mL) considered acceptable. Variation in FEV1pp was assessed by calculating a mean FEV1pp and coefficient of variation (CoV). The association between CoV and pulmonary exacerbations (PEx) was tested using Cox proportional hazards regression models. Result(s): Thirteen subjects (62% female) with a mean age of 28.7 +/- 8.3 and mean FEV1pp of 59.9 +/- 8.2%were included. Median study durationwas 377 days (range, 33-730 days). Subjects used the home spirometer on average 51.2% of the study days (range 15-97%). On average, 58.9% of subjects (range 12-100%) used the home spirometer at least twice aweek, and 76.8% (range 65-100%) at least once aweek. To focus on periods of baseline health, days associated with PEx (spirometry performed 2 weeks before and during times of antibiotic therapy) were excluded. A median of 204 days (range 11-728 days) of baseline spirometry readings was available for further analysis. Comparing validity of home spirometry with that of clinic spirometry, Bland-Altman plots demonstrated overall good agreement with a slight bias (+0.042 L) toward higher readings for clinic FEV1pp (95% limits of agreement, -0.11-0.19 L). Spirometry quality was graded as acceptable on most study days (mean 90.6 +/- 4.6%) in which two or more maneuvers were recorded. Intra-individual variation in baseline FEV1pp was high, with a mean variation of 17.6 +/- 5.9% day to day and 15.2 +/- 6.2% week to week. Neither rates of acceptable spirometry grades nor CoV was associated with lung disease severity. Of the 13 subjects, 10 experienced one or more PEx, for a total of 32 PEx during the study. CoV was not associated with time to first PEx (hazard ratio [HR], 0.78;95% confidence interval [CI], 0.51-1.21;p = 0.24) or time to subsequent PEx (HR, 0.91;95% CI, 0.73-1.12;p = 0.28) during the study. Conclusion(s): Although home spirometry has generally good validity and acceptability, variation in lung function during baseline health is present and often exceeds expected variation in clinic spirometry per ATS standards. Variability may represent normal physiological variation or be related to the home spirometer itself or other factors but did not portend upcoming PEx. Recognition of variation during baseline health provides important context for interpretation of home spirometry.Copyright © 2022, European Cystic Fibrosis Society. All rights reserved

Comparison between in-person and remote assessment of four field tests for people with chronic lung diseases

Introduction: COVID-19 pandemic has driven an abrupt shift from centre-based pulmonary rehabilitation to home-based or telerehabilitation models in order to safely deliver this important treatment. However, functional capacity assessment is still carried out with in-person supervision. Aim(s): To compare remote and in-person assessment of four field tests for patients with chronic lung diseases. Method(s): People with chronic respiratory diseases underwent timed up and go test (TUG), 5-repetitions sit-to-stand test (5-repStS), 1-minute STS (1-minStS), and modified incremental step test (MIST). Tests were carried out at participants' home with in-person or remote (Skype or WhatsApp) assessment, in random order. During the remote assessment, the physiotherapist was at the pulmonary rehabilitation centre. The order of the tests was also randomized and was the same for in-person and remote supervision. Each test was performed twice and the test with best performance was used for comparison between remote and in-person supervision. A kit containing a finger pulse oximeter, tape measure, and a step was provided. Pair t -test expressed as mean difference (95% CI), intraclass correlation coefficient (ICC 2:1), and Bland-Altman method were used for analysis. Result(s): Forty-four participants (23 COPD, 18 bronchiectasis, three cystic fibrosis, FEV 1 47 +/- 19%, 56 +/- 15 years old) were assessed. There was no difference between in-person and remote supervision for all tests (TUG 0.04(-0.2-0.2) s, 5-repStS: 0.3(-0.1-0.7) s, 1-minStS: -0.9 (-1.9-0.1) repetitions, and MIST: -3.1 (-9.9-3.7) steps). High reproducibility was observed by ICC (95% CI) (TUG: 0.94 (0.89-0.97), 5-repStS: 0.96 (0.92-0.98), 1-minStS: 0.87 (0.77-0.93), and MIST: 0.94 (0.88-0.96). Limits of agreement were narrow for TUG (-0.8-1.7), 5-repStS (-2.3-2.9), and 1-minStS (-7.4-5.5), but wide for MIST (-46-40). Conclusion(s): Remote assessment provides similar results to in-person assessment for four field tests commonly used in people with chronic lung diseases.

Validity and test-retest reliability of field tests carried out by teleassessment of children and adolescents with cystic fibrosis

Background: The COVID-19 pandemic led to the rapid adoption of alternative evaluation methods for measuring functional capacity in people with cystic fibrosis, who are at high risk for severe COVID-19 outcomes. Teleassessment may be an alternative to conducting in-person field tests in this population. Objectives : To investigate the validity, reliability, and safety of field tests conducted by teleassessment in children and adolescents with cystic fibrosis. Method(s): Participants underwent three functional tests: 3-min step test (3-min ST), 1-min sit-to-stand test (1-min StS), and a timed up-and-go (TUG) test performed in their homes with in-person and remote assessment, in random order. During the remote assessment, the physiotherapist was at the pulmonary rehabilitation center. The order of the tests was randomized and the same in both assessments. For validity, main outcomes were compared between in-person and remote supervision by Wilcoxon test for 3-min ST and TUG, expressed as median (IQR), and pair t -test for 1-min StS, expressed as mean (SD). For test-retest reliability (test 1 vs. test 2) of the remote tests, intraclass correlation coefficient (ICC 2,1) and Bland-Altman analysis were used. Result(s): Thirty-two participants (15 boys, 11 +/- 3 years, FEV 1 73 +/- 17% of predicted) were included. No significant difference was observed between in-person and remote supervision (3-min ST: 88 [83.5-90] vs. 88 [82.5-90] steps;1-min StS: 33(7) vs. 32(8) repetitions;TUG: 6.5 [5.6-8.0] vs. 6.6 [5.7-7.9] s). Test-retest of remote supervision demonstrated very good to excellent reliability for all field tests (ICC (95%CI) 3-min ST: 0.88 [0.65-0.95], 1-min StS: 0.86 [0.67-0.94], and TUG: 0.76 [0.41-0.89]). Mean difference (lower-upper limits of agreement) were 3-min-ST: -3.6 (-13.9-6.7) steps, 1-min StS: -1.9 (-8.6-4.7) repetitions, and TUG: 0.8 (-1.4-2.9) s. No adverse events were reported. Conclusion(s): In children and adolescent with cystic fibrosis, 3-min ST, 1-min StS, and TUG are valid, reliable and safe when carried out by teleassessment.

Web-based pediatric visual acuity testing at home

Introduction: Pediatric eye care access, particularly in rural areas, has been an ongoing concern. The COVID-19 pandemic has led to a growing appreciation and acceptance of a role for telemedicine in pediatric eye care. However, many at-home visual acuity (VA) charts and apps have poor test design or inaccurate optotype sizes, and may passively provide misinformation for clinical decision making.1-3 We evaluated the new M&S EyeSimplify At-Home Visual Acuity Tests, which include web-based versions of the ATS-HOTV and E-ETDRS tests commonly used in clinical trials. Method(s): Children with and without VA deficits were enrolled. In-office VA was tested with the M&S Smart System ATS-HOTV (ages 3-6;N = 34;68 eyes) or E-ETDRS (ages 7-12;N = 31;62 eyes) protocol. The child was registered on the EyeSimplify web-based portal and the parent was emailed a link to the at-home VA test. The portal notified us when at-home testing was completed and provided us on-line access to VA results. Equivalence of the two test settings was evaluated by mean difference and 95% limits of agreement (LOA) using Bland-Altmann analysis. Result(s): The mean difference between in-office and at-home was small for both ATS-HOTV (0.01 + 0.08 logMAR) and E-ETDRS 0.04 + 0.08 logMAR;95% LOA = -0.15 to 0.17 and -0.11 to 0.19, respectively, comparable to test-retest agreement in an office setting. Conclusion/Relevance: The M&S EyeSimplify At-Home Visual Acuity Tests provided VA equivalent to in-office testing. If the burden of travel is significant, at-home testing may provide the information needed to continue care via telemedicine consultation when it might otherwise be discontinued or delayed.Copyright © 2022

Coal Is a Priority for Energy Security, until It Is Not: Coal Phase-Out in the EU and Its Persistence in the Face of the Energy Crisis

In the wake of the COVID-19 pandemic and the Russian invasion of Ukraine, many countries see coal as the easiest solution to their energy sector challenges, despite the consequences for climate goals. Several countries of the European Union started to re-evaluate their coal policies vis-à-vis the current energy crisis and, although such a change is expected to be short-term in nature, it nevertheless has negative consequences for the Union's 2050 climate goal. However, most of the EU countries did not revise their phase-out goals. This paper examines Slovakia as a country that embarked on a coal phase-out trajectory only a few years before the pandemic broke out and stayed firmly on this path despite benefits stemming from the continued use of domestic coal. Domestic coal used to be considered a safeguard of energy security in Slovakia, especially after the 2009 gas crisis. However, a decision was made in 2018 to phase out coal by 2023, and this has not changed despite increased focus on domestic energy sources as energy security guarantors during the current energy crisis. This paper explains the decision in favour of a coal phase-out and its support vis-à-vis the energy crisis using the concept of ‘financial Europeanisation', which stresses the importance of EU funds for the development of the domestic policies of EU member states. While the expected funds serve as a catalyst for the coal phase-out needed to reach climate goals, short-term advantages of revising a coal phase-out were outweighed by long-term benefits provided by EU funds.

An Evaluation of ASEAN Renewable Energy Path to Carbon Neutrality

Maintaining our standard of living and keeping the economy running smoothly is heavily reliant on a consistent supply of energy. Renewable energy systems create abundant energy by utilizing resources such as the sun, wind, earth, and plants. The demand for renewable energy is increasing, despite power scarcity, pollution, and climate change posing challenges to long-term development in the Association of Southeast Asian Nations (ASEAN), which has seen significant social and economic growth in recent years. To achieve its 23% renewable energy (RE) target, ASEAN can develop solar photovoltaic (PV) electricity. Members of the ASEAN have established regulations and incentives to encourage individuals and businesses to use renewable energy in the future. This paper explores Southeast Asian countries' comprehensive fossil-free energy options, the region's renewable energy potential, current capacity, goals, and energy needs. Through the ASEAN Plan of Action for Energy Cooperation (APAEC) 2016–2025 and the ASEAN Declaration on Renewable Energy, ASEAN is committed to reducing its greenhouse gas emissions and promoting sustainable development aligning with the Paris Agreement's aim to limit global warming to well below 2 degrees Celsius above pre-industrial levels. Results show that decarbonizing the region's energy system is possible, but current policies and actions must be altered to reach that target level. Further research is necessary to optimize the ASEAN region's renewable resource technical potential and commercial viability with available technology.

Patent suspension on the COVID-19 vaccine in Indonesian patent law perspective

Vaccination patent is associated with exclusive rights that restrict the production, use, and sale of inventions by third parties for a specific period. This factor contributes to the high cost of vaccines, making it challenging to access vaccines in many underdeveloped nations such as Indonesia. The urgency for faster vaccine distribution during the COVID-19 pandemic further highlights this issue. However, the patent provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement) may exacerbate the unequal distribution of vaccines worldwide. This study analyzes the implementation of the flexibility feature of the TRIPs Agreement, and Doha Declaration contained in Law Number 13 of 2016 respecting Patent to achieve a pandemic-free era. It is also necessary to examine the Indonesian patent rules and regulations, the TRIPs Agreement, the Doha Declaration, and other legal documents to examine these issues. The results showed that the patent rules and regulations have adopted flexibility under the TRIPs Agreement and the Doha Declaration. However, the effect on the country's sluggish pharmaceutical supply chain has not been improved. A patent suspension system on a global scale is required to hasten the transition to a pandemic-free period since the feature of flexibility cannot handle the slow pace of vaccine procurement. The patent suspension system can be implemented through international agreements, such as the Patent Suspension Proposal filed by South Africa and India in October 2020. The suspension is crucial to accelerate the equitable distribution of vaccines and reduce their price. © 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Evaluating the Impact of Executive Orders Lifting Restrictions on Advanced Practice Registered Nurses During the COVID-19 Pandemic.

Background: In the early stages of the COVID-19 pandemic, strains on the healthcare system forced many U.S. states to revisit long-standing statutory limitations on the care coordinated by advanced practice registered nurses (APRNs). This was done by issuing waivers via executive, legislative, or board of nursing orders. Purpose: To identify the impact of temporary practice waivers on APRNs' direct patient care during the COVID-19 pandemic. Methods: This cross-sectional study utilized a two-phased approach. First, a confidential online survey was conducted of APRNs practicing across 27 U.S. states. Second, comprehensive APRN discipline data from 2019 to 2021 were retrieved from the National Council of State Boards of Nursing's Nursys database and reviewed. Univariable and multivariable binary logistic regression models were used to determine the significance of observed trends. Results: A total of 16,699 APRNs responded to the survey for a response rate of 14.2%. APRNs practicing in private outpatient clinics, in rural areas, and in health provider shortage areas were more likely to report a positive effect of the practice waiver (all p < .05). Providers noted that the waivers allowed them more time with their current patients and expanded the geographic boundaries of their direct patient care to take on new patients. Furthermore, despite the changing profile of APRN care during the early stages of the pandemic, including a pronounced increase in telehealth usage, the current review found no evidence of an uptick in discipline cases brought against APRNs in 2021. Conclusion: Full practice authority for APRNs benefits patients by promoting expanded access to care and increasing the resiliency of our healthcare system without compromising patient safety. It is time for states and organizations that employ APRNs to recognize that permanently removing barriers to APRN practice is essential to the health of our nation.

Global uncertainty in the diagnosis of neurological complications of SARS-CoV-2 infection by both neurologists and non-neurologists: An international inter-observer variability study.

INTRODUCTION: Uniform case definitions are required to ensure harmonised reporting of neurological syndromes associated with SARS-CoV-2. Moreover, it is unclear how clinicians perceive the relative importance of SARS-CoV-2 in neurological syndromes, which risks under- or over-reporting. METHODS: We invited clinicians through global networks, including the World Federation of Neurology, to assess ten anonymised vignettes of SARS-CoV-2 neurological syndromes. Using standardised case definitions, clinicians assigned a diagnosis and ranked association with SARS-CoV-2. We compared diagnostic accuracy and assigned association ranks between different settings and specialties and calculated inter-rater agreement for case definitions as "poor" (κ ≤ 0.4), "moderate" or "good" (κ > 0.6). RESULTS: 1265 diagnoses were assigned by 146 participants from 45 countries on six continents. The highest correct proportion were cerebral venous sinus thrombosis (CVST, 95.8%), Guillain-Barré syndrome (GBS, 92.4%) and headache (91.6%) and the lowest encephalitis (72.8%), psychosis (53.8%) and encephalopathy (43.2%). Diagnostic accuracy was similar between neurologists and non-neurologists (median score 8 vs. 7/10, p = 0.1). Good inter-rater agreement was observed for five diagnoses: cranial neuropathy, headache, myelitis, CVST, and GBS and poor agreement for encephalopathy. In 13% of vignettes, clinicians incorrectly assigned lowest association ranks, regardless of setting and specialty. CONCLUSION: The case definitions can help with reporting of neurological complications of SARS-CoV-2, also in settings with few neurologists. However, encephalopathy, encephalitis, and psychosis were often misdiagnosed, and clinicians underestimated the association with SARS-CoV-2. Future work should refine the case definitions and provide training if global reporting of neurological syndromes associated with SARS-CoV-2 is to be robust.