COVID-Related Changes Have Implications for Public Acceptance of Innovation

In Europe, deep concerns have been raised about the arrangements granting immunity from liability for the half-dozen manufacturers that have forged supply deals with the European Union for vaccines they have in development, and the still-confidential aspects of these deals leave many unresolved questions for the coming months and years. [...]a wider range of trained personnel will be authorized to administer COVID-19 or flu vaccines, with a view of ensuring that vaccines and treatments for specific types of public health threat, such as a COVID-19 vaccine, can be promoted as part of national vaccination or treatment campaigns. "The existing Human Medicines Regulations contain a provision (regulation 174) that enables the temporary authorization of the supply of an unlicensed medicine (including vaccines) in response to a public health emergency," it says.

Mesenchymal Stem/Stromal Cells: BIOLOGICAL THREAT AGENT RICIN INTOXICATION OF THE LUNGS IS EFFECTIVELY TREATED BY MESENCURE, A PROFESSIONALIZED ALLOGENEIC MESENCHYMAL CELL THERAPY, PREFERABLY VIA THE SUBCUTANEOUS ROUTE

Background & Aim: Ricin is one of the most lethal toxins, particularly if inhaled, and is considered a biological threat agent due to its wide availability and ease of production. Pulmonary ricin intoxication manifests in ARDS, cytokine storm, immune infiltration, and severe edema. Passive immunization is the preferred measure against pulmonary ricinosis, but only if administered shortly after exposure. Despite their potential to remedy pulmonary injury and inflammation, mesenchymal cell (MSC) therapies were never investigated in ricinosis. Here, we report the potential for treating pulmonary ricinosis with MesenCure, a professionalized allogeneic MSC therapy shown to reduce the mortality of patients suffering from severe pulmonary manifestations of COVID by 68%. Methods, Results & Conclusion(s): Preliminary studies demonstrated positive MesenCure effects in a sub-lethal pulmonary ricinosis model in CD1 mice. This model is regarded as highly translational due to the broad heterogeneity of these outbred mice. Positive effects included a reduction in excess protein content of the bronchoalveolar lavage fluid (BALF) by 45% when MesenCure was injected intravenously (IV) at 125k cells/animal, 48h post-exposure (PE) and evaluated one day later (p<0.05, Fig. 1A). Moreover, we found up to 52% reduction in the excess BALF leukocytes, when MesenCure was injected IV, 24h PE using the same dose (p<0.05, Fig. 1B) or 6h PE using a double dose (p<0.01, Fig. 1C), and evaluated two days PE. Optimizing the dose and administration route further improved the therapeutic outcome of MesenCure applied 6h PE as assessed by weight loss. As shown in Fig. 1D-E, IV injection of 250k-500k MesenCure cells/animal slightly protected the intoxicated animals against weight loss (p for treatment x time interaction <0.01 or <0.05 for 250k and 500k cells/animal, respectively). Interestingly, one million cells IV resulted in a lesser effect (not shown), however when injected subcutaneously (SC), 1M cells were very effective (p<0.001, Fig. 1F), seemingly even more effective than 2M cells/animal SC (Fig. 1G). Surprisingly, 2M thawed cells/animal injected SC protected the animals against weight loss almost completely (p<0.0001, Fig. H). In conclusion, we provide evidence for the potential of SC MSCs, specifically MesenCure, for treating pulmonary ricinosis and possibly other forms of ARDS. In agreement with Giri and Galipeau (2020), we provide further evidence for the dependency of MSC outcomes on their specific state and administration route. [Figure presented]Copyright © 2023 International Society for Cell & Gene Therapy

Equitable Access

The COVID-19 epidemic has once again highlighted the challenges to achieve equitable access to critical antimicrobials and vaccines. The problem is particularly acute for antimicrobials. Despite recent investments improving the pipeline for new treatments, most new treatments are not available to populations most in need, especially in low- and middle-income countries. Once a drug is approved a range of factors may hinder access, from lack incentives to register and commercialize products due to unattractive market potential to unfunded national action plans that can help improve the uptake and appropriate use of new tools to combat antibiotic resistance. Previous studies have shown that the majority of the 18 new antibacterials approved and launched between 2010-2020 were accessible in only 3 out of 14 high-income countries (Sweden, UK, and US). In low- and middle-income countries, the problem is even worse, with only 10 of the 25 new antibiotics that entered the market between 1999 and 2014 registered in more than ten countries. While lack of equitable access to life-saving medicines, diagnostics, and vaccines is not a new problem for infectious diseases, emerging opportunities and innovative approaches can help improve access globally. This talk will review promising recent developments in governance and collaborations, policies, economic models and initiatives that may help correct deadly inequities. For example, the objectives of the Access to COVID-19 Tools Accelerator may serve as model that convenes diverse actors to mount a coordinated access response which may be applied to access to other antimicrobials and vaccines. In addition, novel licensing agreements for access and stewardship to cefiderocol, an antimicrobial that is on the WHO Essential Medicines List can help serve as a pathfinder to accelerate equitable access to novel antimicrobials. The talk will also surface critiques of ongoing initiatives and raise questions for further study and discussion.Copyright © 2023

Safety surveillance of covid-19 vaccines using large-linked database

In the global drive to vaccinate against SARS-CoV-2, millions of people have received at least one dose of a COVID- 19 vaccine. Vaccination safety is the key to the success of immunisation programs and in combating vaccine hesitancy among the public. Post-licensure safety monitoring of COVID-19 vaccines is essential to detect rare or severe vaccine-associated adverse events in the population and provide ongoing data of safety issues. Passive surveillance is the primary method most widely used to collect adverse events following immunisation (AEFI) via voluntary reporting. Monitoring through active surveillance is strongly encouraged to improve vaccine safety monitoring and provide more robust data. The SAFECOVAC project was initiated to evaluate risk of serious adverse events following COVID-19 vaccination. It leverages on the availability of nationwide COVID- 19 vaccine registry, hospital admission database, and other data sources to create a large-linked database. Uniquely for Malaysia, diverse vaccine portfolio was used and we are able to compare the risk estimate for the three major vaccine types of different platform i.e., mRNA-based vaccine (BNT162b2), inactivated vaccine (CoronaVac), and adenovirus vector-based vaccine (ChAdOx1). Current data shows that safety of COVID-19 vaccine is assured and findings are fairly consistent with data from other countries.

Moral licensing, identity and eco-leadership: Can public managers' support for a green recovery be undermined?

IMPACTLocal public managers are increasingly involved in policy co-design, especially in the aftermath of the Covid 19 pandemic. Municipal top management will benefit from this article because it shows how public managers' policy priorities are shaped by their own and their leaders' goals for the local administration. The authors provide a model clarifying the role of managers' environmental self-identity and municipal eco-leadership in policy decisions that involve a trade-off between economic growth and protecting the environment/climate. Previous research has not shown whether ‘economy versus environment' messages can influence public managers' policy priorities. This article is important because it provides evidence, while there is still time to use it in policy-making, to support efforts to combat issues like climate change.Alternate :The authors investigate the effects of compensatory (i.e. ‘economy versus environment') messages on public managers' attitudes towards ‘business-as-usual' plans, as opposed to green recovery plans, in the aftermath of the Covid 19 pandemic. They created a model which was tested on 90 Basque public sector managers. Exposing managers to compensatory messages increased support for green recovery plans due to an unintended moral licensing reduction effect. In addition, the authors show why it is important to acknowledge the link between public management and behavioural sciences.

Compulsory licensing: an effective tool for securing access to Covid-19 vaccines for developing states?

A significant issue in combatting the Covid-19 pandemic is the need to enhance developing states' access to Covid-19 vaccines. The present paper considers the request for a temporary waiver of intellectual property rights in relation to Covid-19 technologies and treatments submitted to the World Trade Organization and analyses a key argument against the proposed waiver: that the compulsory licensing provisions set out in the TRIPS Agreement are sufficiently flexible to help states get access to vaccines. The compulsory licensing flexibilities set out in TRIPS, including the amendment to TRIPS in Article 31bis, are evaluated, to explore whether compulsory licensing could be an effective tool in helping developing states to access Covid-19 vaccines. Key issues are explored from a human rights perspective to examine whether a rights-based approach to the compulsory licensing provisions could offer further insights as to how the provisions could be more workable, to enhance access to medicines and vaccines for developing states.

IP Waivers in a Pandemic: Great in Theory, Wrong in Practice

[...]granting sweeping IP waivers can ultimately impede incentivization in a time where such innovation is needed most. "25 And, as a result, innovation would slow, and consumers would suffer. [...]it is no wonder why governments can-and often do- effectively promote innovation through IPRs.26 A. IP and International Law As advancements in transportation made it possible to export and import goods outside one's own country, the need for a multilateral IP treaty became necessary to protect IPRs across borders. [...]on March 20, 1883, the Paris Convention for the Protection of Industrial Property was formed.27 While it has been revised many times since its formation, the treaty's objective has remained unchanged: to harmonize how each nation treated other nations when seeking protection for their industrial property.28 Only five years after the Paris Convention, the Berne Convention for the Protection of Literary and Artistic Works was formed.29 Like the Paris Convention, the Berne Convention focuses on international harmonization, but goes a step further by providing minimum standards for copyright law.30 However, because the Paris and Berne Conventions are both non-self-executing treaties,31 they only have legal effects within a member state if, and when, countries implemented them through their own laws.32 As a result, adoption of the two treaties was slow, and their effects less profound. "38 Unlike the prior Berne and Paris treaties, TRIPS is unique because WTO membership is a "package deal," meaning that members cannot just selectively choose which agreements to implement and which to ignore.39 B. TRIPS and the Pharmaceutical Industry Tensions have long existed between IPRs in the biopharmaceutical industry and public health concerns in LMICs.40 Before TRIPS, some countries, such as India and Brazil, did not permit patents on medicine;rather, they only permitted drug companies to patent the processes used to create them.41 This meant generic alternatives could enter the market right away, keeping prices affordable for consumers.42 After TRIPS was formed, WTO member states were required to provide IPRs to innovators for product patents43 with a minimum term length of 20 years.44 This was necessary because it allowed biopharmaceutical companies to recover many of the R&D costs they would otherwise lose to generic companies.45 And, as technology has advanced, R&D costs have only skyrocketed.46 Between 2009 and 2018, the estimated median R&D cost per individual drug was $985 million.47 However, giving the pharmaceutical industry blanket monopolies for every patented drug would exacerbate the lack of access in LMICs, as name brand drugs-without generic alternatives-can be priced at monopolistic price points.48 Thus, in an attempt to find the right balance between promoting R&D into new drugs and furthering access to existing drugs, the TRIPS agreement includes two exceptions outlined in Articles 30 and 31.

Telepsychiatry

The use of communication technologies to provide psychiatric services is broadly termed telepsychiatry. While telehealth is not new and has been in existence for over 50 years, the COVID-19 pandemic accelerated the use of this modality and demonstrated its advantages in healthcare delivery. Although on the surface telepsychiatry may simply appear to be the practice of psychiatry through videoconference, like any innovation it presents nuanced regulatory, liability, and practice considerations. Familiarity with relevant rules regarding licensure, prescribing, credentialing, malpractice coverage, and privacy and security is important prior to getting involved with providing virtual services. Clinical issues such as informed consent, establishing a physician-patient relationship, documentation, and standard of care must also be considered. In this chapter, we will review these key issues through the lens of enhancing clinical practices and reducing the risk of medical malpractice and licensure violation when providing these services. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

COVID-19, vaccines and international knowledge governance on trial

The production, distribution and availability of vaccines to combat the COVID-19 pandemic are all impacted by the international rules of knowledge governance. These rules include patents, trade secrets and health and efficacy regulatory approval processes. This article discusses how these intellectual property related mechanisms all interfered with vaccine availability. It analyses the international rules, related exceptions (including compulsory licensing and national security) and the possible waiver of the relevant rules found in the World Trade Organization TRIPS Agreement. Throughout the first two years of the pandemic, vaccines were not available widely enough. Although most of the developed world had enough vaccine doses by late 2021, that was not the position in much of the developing world, where the problem became the distribution of vaccines. Distribution may have always been difficult, but the failures in timely local supply exacerbated the problem of vaccine inequality between the developed and developing world. The inequality had several likely causes including intellectual property rules. The problem was not neces-sarily the existence of patents (or other rules) but the insufficiency of checks and balances that are necessary to address global public health needs. This resulted in private interests, whose primary goal is not public health, wielding too much power. The article concludes that collectively the effect of the international rules enacted in domestic laws supports a regime that was not fit for purpose to address the COVID-19 pandemic and is not fit to address future pandemics. © 2022 The Author.

Innovative Business Models in the Context of Organizational Culture Transformation in the COVID-19 Pandemic

The purpose of this article was to establish the interrelations and mutual influence of organizational culture transformation, national culture, and innovative business models' formation under the COVID-19 pandemic. To achieve the study goal, a multi-stage comprehensive exploratory study based on primary information obtained by expert interviewing was implemented. The developed methodological approach was tested on the example of small and medium-sized enterprises in Russia and China. As a result of the conducted testing, the previously formulated hypotheses were fully proved. H1: the negative shock of the pandemic and the ensuing quarantine restrictions caused critical changes in the business environment, cancelling the relevance of previously effective business models. H2: the new business environment required enterprises to significantly transform their organizational culture. H3: under the conditions of shock changes in the business environment and forced transformation of organizational culture the main condition for the sustainable development of enterprises is innovative business models. Н4: implementation of innovative business models depends on both the business environment and the influence of national culture. The main obstacles to the implementation of innovative business models in small and medium-sized enterprises were also identified. The developed methodological approach can be used in the real sector of the economy by state organizations and non-state funds in the development of programs to assist small and medium-sized businesses in the COVID-19 pandemic. In addition, the study results may be of interest to academic researchers, suggesting empirically determined stable relationships (hypotheses H1, H2, H3, H4) between the transformation of organizational culture, national culture, and innovative business models' formation to ensure sustainable development of enterprises under the COVID-19 pandemic and opening new promising directions for further research.

Building a One Country One Licensure Framework: Applications for the future of Canadian Space Physicians

Space medicine provides care in the most extreme environment known to humankind. The global space economy is forecast to be a $1 trillion industry by 2040. Its increased utilization will require additional legal healthcare support frameworks. We reviewed the current Canadian medicolegal framework for the capability to adapt to this new demand. Currently, Canadian physicians are required to hold a license in each province they practice. As space medicine encompasses multiple medical specialties and its practice is beyond Canadian provincial jurisdictions, we identified medicolegal gaps in the Canadian ability to provide space healthcare. Geographical licensing restrictions have caused detriment to healthcare provision in remote communities, military medicine, and telemedicine, exacerbated by COVID-19. By examining similarities and solutions from these terrestrial situations, bi-directional translational licensing solutions may be found. Recommendations for an improved Canadian licensing framework targeting provision of space medicine may lead to improving healthcare access and universality for Canadians nationwide. Author

Medical Interns' Perceptions and Attitudes During the COVID-19 Pandemic: A Qualitative Study

Objective: This study was designed to explore the potential association between the severity of the impact of the coronavirus disease-2019 (COVID-19) pandemic on perceptions and attitudes among medical interns. Material(s) and Method(s): The study was carried out as qualitative key informant semi-structured interviews, and were enrolled from September-October 2020 using a convenience sampling was used to recruit nine medical interns at King Faisal University College of Medicine, Saudi Arabia. Data were analyzed qualitatively using framework analysis. Semi-structured interviews were performed in Mi-crosoft Teams (online) for an average of 21 minutes, and the English language was utilized. A thematic analysis was done to identify the main concerns of the interns about education loss. Result(s): Nine participants (4 male medical interns and 5 female interns) were interviewed. The interview time averaged 18.4 minutes (range 17-21 minutes) and the mean age of the sample was 24 (standard deviation 0.707) years. Interns were more likely to be anxious, panic-ridden, horrified, depressed, stressful and disorganised due to the influence of the COVID-19 pandemic. In addition, the COVID-19 pandemic has had an impact on interns' organization of hospital rotation schedules. Furthermore, there is disagree-ment on the impact of the COVID-19 epidemic on preparation for the Medical Licensing Exams. Conclusion(s): It should be ensured that the pandemic does not affect any more interns on medical rotations, by rais-ing awareness through a bundle of educational courses.Copyright © 2023 by Turkiye Klinikleri.

BREXIT AND OUTLOOK FOR A U.S.-UK FREE TRADE AGREEMENT *

Brexit introduced new exporting and importing licensing requirements, border checks, and regulatory compliance requirements, raising costs and the potential for bottlenecks at borders. For financial services, which account for 7% of UK GDP and one million jobs, the deal does not address UK financial services firms' access to the EU, which previously was through a "passporting" right that allowed banks to use their UK bases to access EU markets without establishing legally separate subsidiaries;the parties aim to establish a framework for cooperation by March 2021. U.S. and other exporters will need to manage separate customs regimes and relationships for the UK and EU. Since the transition period, the UK has engaged in negotiations to replicate existing EU trade deals with non-EU countries (e.g., Switzerland, Iceland, Norway, South Korea, and Turkey), and pursued new deals with countries with which the EU has not concluded trade deals (e.g., Australia, India, and the United States). [...]UK farmers and some in civil society voice concerns about the implications of U.S. demands for greater access to the UK market, and potential changes to UK food safety regulations.

Compulsory licensing of patents.

Compulsory licensing (CL) is a mechanism made by the government to provide balance between the monopoly right holders and the third person with public interest by ensuring the ease availability of the patented products at reasonable rate. This paper discusses the background criteria for getting CL in India as per the Indian Patent Act, 1970 starting from the concepts outlined in the Trade-Related Aspects of Intellectual Property Rights agreement. We reviewed the case studies for the accepted and rejected CL in India. We also discuss important CL cases that were permitted internationally, including the present COVID pandemic CL. Finally, we provide our analytical perspectives regarding the pros and cons of CL.

Meeting report: 6th Global Forum on Tuberculosis Vaccines, 22–25 February 2022, Toulouse, France

Safe, effective, and accessible vaccines are urgently needed to end tuberculosis (TB) by 2030. The 6th Global Forum on TB Vaccines, convened virtually 22–25 February 2022, was hosted by Toulouse, France, under the high patronage of President Emmanuel Macron, and the patronages of Minister for Solidarity and Health, Olivier Véran, and Minister for Higher Education, Research and Innovation, Frédérique Vidal. The theme for the meeting, "New horizons for TB vaccines”, reflected the changing landscape in which TB vaccine research and development (R&D) is being conducted: TB vaccines advancing into late-stage clinical trials and toward licensure, innovative research toward diversifying the TB vaccine pipeline and developing the next generation of candidates, increasing political, civil society, and community support for TB vaccines, and the ongoing COVID-19 pandemic. In this report, we summarize key themes and findings from the meeting, highlighting progress and gaps in the TB vaccine field.

How to advise women on the safe use of medicines while breastfeeding

Medicines use plays an important role in women's decisions to start or continue breastfeeding. Some may stop breastfeeding or the medicine to avoid combining the two, as they feel very strongly about tainting their milk when breastfeeding[10]. Women deserve to be involved in discussions on compatibility, using evidence-based resources presented in a manner in which they can understand. There is a presumption by some healthcare professionals, mothers, families and wider society that formula has benefits over breast milk with a trace of medication in, or that adverse events are likely and serious if this breast milk is consumed. In addition, there is a reticence from healthcare professionals to use professional judgement and go outside the licence application for medicines. This leaves the mother with a dilemma: to interrupt or stop breastfeeding to take the medication, or to delay medication - with chronic diseases, the latter is rarely an acceptable option. In January 2021, the MHRA launched the Safer Medicines Consortium, owing to the "need for reliable and consistent information about medicines used before or during pregnancy and breastfeeding for women and the healthcare professionals who advise them". The vision of the consortium is that "all women will have access to accurate and accessible information to make informed decisions with their healthcare professional about taking medicines before or during pregnancy or breastfeeding"[44]. As experts in medicines, pharmacists should share evidence-based information with the mother and support her in making a decision that is right for her and her baby, as outlined above. Copyright © 2021 Pharmaceutical Press. All rights reserved.

The coverage of medical injuries in company trial informed consent forms.

Best practice consent forms in company clinical trials detail the financial coverage for medical treatment of injuries. In trials undertaken for licensing purposes these arrangements can raise concerns. We detail three cases in which elements of the consent forms appear misleading and designed to elicit a consent to participation that might not be forthcoming if volunteers for these clinical trials were aware that what is outlined in principle is not likely to happen in practice. Beyond clinical trial participants, these consent forms have wider implications. Medical coverage of injuries sustained in a clinical trial is a nexus where business, scientific and ethical considerations meet. It is not clear that anyone to date has grappled with the issues posed. This paper uses three clinical trials to illustrate the problems to be addressed.

Framings of risk and responsibility in newsprint media coverage of alcohol licensing regulations during the COVID-19 pandemic in England.

INTRODUCTION: Licensing is recognised as a World Health Organization (WHO) 'best buy' for reducing alcohol harms. In response to the 2020 COVID-19 outbreak, many countries-imposed restrictions on outlets selling alcohol to reduce virus transmission. In England, while shops selling alcohol were deemed 'essential', multiple restrictions were imposed on licenced outlets such as pubs and bars. Media reporting of licensing restrictions during the pandemic might have shaped public discourses of alcohol risks and responsibilities. METHODS: This study aimed to understand how alcohol licensing changes in England were framed in newsprint media. Two hundred and fifty-three relevant articles from UK newsprint publications were identified through the Nexis database, published within six time points between March and December 2020 reflecting key changes to licencing in England. Thematic analysis, drawing on framing theory, was conducted to identify 'problems' framed in the reporting of these changes. RESULTS: Four dominant framings were identified: (i) licensed premises as 'risky' spaces; (ii) problematic drinking practices; (iii) problematic policy responses; and (iv) 'victimisation' of licensed premises. The presence of these framings shifted across the reporting period, but consistently, social disorder was constructed as a key risk relating to licensing changes over health harms from alcohol consumption. DISCUSSION AND CONCLUSIONS: The analysis shows newsprint media reproduced narratives of 'inevitable' drinking culture and social disorder, but also emphasised expectations for evidence-based policy-making, in the context of licensing during the pandemic. Discourses of dissatisfaction with licensing decisions suggests potential for public health advocacy to push for licensing change to reduce alcohol health harms, in England and internationally.