Regulatory insights into nanomedicine and gene vaccine innovation: Safety assessment, challenges, and regulatory perspectives.

This analysis explores the principal regulatory concerns linked to nanomedicines and gene vaccines, including the complexities involved and the perspectives on how to navigate them. In the realm of nanomedicines, ensuring the safety of nanomaterials is paramount due to their unique characteristics and potential interactions with biological systems. Regulatory bodies are actively formulating guidelines and standards to assess the safety and risks associated with nanomedicine products, emphasizing the need for standardized characterization techniques to accurately gauge their safety and effectiveness. Regarding gene vaccines, regulatory frameworks must be tailored to address the distinct challenges posed by genetic interventions, necessitating special considerations in safety and efficacy evaluations, particularly concerning vector design, target specificity, and long-term patient monitoring. Ethical concerns such as patient autonomy, informed consent, and privacy also demand careful attention, alongside the intricate matter of intellectual property rights, which must be balanced against the imperative of ensuring widespread access to these life-saving treatments. Collaborative efforts among regulatory bodies, researchers, patent offices, and the private sector are essential to tackle these challenges effectively, with international cooperation being especially crucial given the global scope of nanomedicine and genetic vaccine development. Striking the right balance between safeguarding intellectual properties and promoting public health is vital for fostering innovation and ensuring equitable access to these ground-breaking technologies, underscoring the significance of addressing these regulatory hurdles to fully harness the potential benefits of nanomedicine and gene vaccines for enhancing healthcare outcomes on a global scale. STATEMENT OF SIGNIFICANCE: Several biomaterials are being proposed for the development of nanovaccines, from polymeric micelles, PLGA-/PEI-/PLL-nanoparticles, solid lipid nananoparticles, cationic lipoplexes, liposomes, hybrid materials, dendrimers, carbon nanotubes, hydrogels, to quantum dots. Lipid nanoparticles (LNPs) have gained tremendous attention since the US Food and Drug Administration (FDA) approval of Pfizer and Moderna's COVID-19 vaccines, raising public awareness to the regulatory challenges associated with nanomedicines and genetic vaccines. This review provides insights into the current perspectives and potential strategies for addressing these issues, including clinical trials. By navigating these regulatory landscapes effectively, we can unlock the full potential of nanomedicine and genetic vaccines using a range of promising biomaterials towards improving healthcare outcomes worldwide.

The impact of intellectual property rights protection on green innovation: A quasi-natural experiment based on the pilot policy of the Chinese intellectual property court.

In the context of high-quality economic development in China, it is important to promote green innovation development by protecting intellectual property rights (IPR). Taking the pilot policy of the intellectual property courts in Beijing, Shanghai, and Guangzhou for example in a quasi-natural experiment, this article examines the effect of IPR protection on the development of corporate green innovation and its mechanisms by using a difference-in-differences model and a mediating effect model based on Chinese enterprise data from 2011 to 2019. The study found that first, IPR protection promotes enterprise green technological innovation; second, IPR protection affects green innovation through enterprise financing constraints and R&D investment; that is, increasing enterprise R&D investment and alleviating enterprise financing constraints are two important channels through which IPR protection promotes enterprise green technological innovation.

Considerations for Clinician-Educators Developing Online Educational Content: A Narrative Review.

In modern medical education, clinician-educators are increasingly called upon to develop online education to complement or replace in-person instruction. Despite a growing need for online curricula, many medical professionals lack training and experience in digital content development, deployment, assessment, and maintenance. Previous studies offer guidance on some aspects of online education development but often overlook key components, such as accessibility, legal considerations, financial implications, and sustainability challenges. This review offers medical professionals a broad overview of these important issues. We discuss various pedagogical considerations, including aligning educational goals and objectives with the digital content, choosing the appropriate online interface, and employing strategies to mitigate cognitive load while maximizing accessibility to create an inclusive online learning environment. We offer practical tips for creating effective, high-quality, and enduring audio-visual content and reflect on initial content deployment, testing, assessment, and revision. We discuss the intricacies of obtaining continuing medical education credits when the target audience includes faculty members. We address several legal issues online educators must consider, such as copyright laws, intellectual property rights, and medical liability. The review concludes with a discussion of sustainability mechanisms and financial considerations to ensure the long-term success of the educational program. Our recommendations aim to equip medical professionals embarking on a digital education journey with practical tools to produce effective, inclusive, and sustainable online content while considering legal implications.

Intellectual Property Rights: Protection of Biotechnological Inventions in India.

The current Intellectual Property Rights (IPR) framework supports the commercialization of seed improvement, monoculture, and the patent protection of novel plant varieties, microorganisms, and genetically modified animals. As a consequence, our rich biogenetic diversity is irreversibly dissipating. However, we need to figure out how to create a methodology for elective choices that will achieve harmony between the official Intellectual Property (IP) structure and maintainable biodiversity components. The majority of the biotechnology sector's programmes in India are managed by the Department of Biotechnology. It is under the Ministry of Science and Technology. Its goals are to provide services in the fields of study, infrastructure, human resource development, biotechnology popularisation, industry promotion, and establishment of centres of excellence. Implementation of practise biosafety regulations for genetically modified organisms, recombinant DNA products, and programmes is based on biotechnology for the good of society. This creates an information network for India's bioinformatics mission in the local, national, and worldwide scientific community.

Development of Oral Bio-banks Past, Present and Future; Challenges and Opportunities.

Biobank involves collecting, processing, storing, and organizing biosamples, along with relevant personal and health information such as medical history, family records, genetics data, and lifestyle details, for medical research and clinical care. Oral biobanking is a recently evolved field alongside the rising of precision medicine due to recent research findings in oral oncology and other oral complaints, namely caries and periodontal disease. The common samples in oral biobanks are matured and primary teeth, dental pulp cells, oral biopsies, oral rinses, saliva, and swabs from the buccal region. Moreover, biobank should not conceive of as a static collection of samples and data but as a dynamic resource for developing novel techniques that meet current scientific demands through international networking. However, the major bottlenecks associated with oral biobanks are privacy, processing of samples, normalization of data, extended durability of interest markers of banked samples, and financial sustainability of biobanks. Thus in this correspondence, we argue that an alternative approach is urgently needed to protect the interests of many stakeholders.

Carbon emission reduction effects of renewable energy technological innovation in China: New insights into the intellectual property rights protection.

Renewable energy technological innovation (RETI) is of great significance in reducing carbon emissions. A deeper understanding of the impact of intellectual property rights (IPR) protection on the carbon reduction effect of RETI can provide policymakers with more specific information. Using the dataset from 30 provinces in China during 2007-2018, we provide a detailed analysis of the moderating role of IPR protection in RETI's impact on carbon emissions. The results suggest that RETI has a significant carbon reduction effect, but this effect is not substantial in hydropower technological innovation. Moreover, we find that IPR protection moderates the impact of RETI on carbon emissions; increased levels of IPR protection can enhance RETI's carbon mitigation effect. Specifically, this positive moderating effect is only evidenced in the high energy self-sufficiency ratio and eastern regions, and it diminishes as carbon emissions increase. However, we do not find any evidence that IPR protection moderates the impact of energy storage technological innovation on carbon emissions.

Can we move beyond vaccine apartheid? Examining the determinants of the COVID-19 vaccine gap.

While global health leaders call disparities in access to COVID-19 vaccines an 'apartheid,' this gap is not the first such disparity. The recurrence of these gaps in low and middle-income countries and especially in Africa, raises questions about their determinants and about the persistent failures of global health institutions to remediate them. We interrogate these determinants and questions by examining: (1) the distribution of COVID-19 vaccines; (2) primary determinants of vaccine access including availability and affordability; (3) factors affecting availability (hoarding, COVAX, and manufacturing capacity); and (4) factors affecting affordability (pricing, intellectual property rights (IPR), the TRIPS waiver and a potential pandemic treaty). We conclude that IPR constrained the affordability and availability of COVID-19 vaccines in ways inadequately addressed by COVAX and a waiver compromise thwarted by political, corporate, and philanthropic interests. While stronger limits to IPR in a pandemic treaty and a reformed International Health Regulations will not resolve structural inequities, they could meaningfully expand LMIC autonomy to protect public health. We urge equity-seeking Global South and North actors to fight for such IPR reforms as small and meaningful steps towards a more equitable global health order. Otherwise, criminally racist 'apartheids' will continue to be the norm when it comes to the distribution of essential health goods during global health emergencies.

COVID-19 and Global Distributive Justice: 'Health Diplomacy' of India and South Africa for the TRIPS waiver.

The second wave of the COVID-19 pandemic had left heart-wrenching impacts on all facets of life in general and the availability, accessibility, and affordability of medicines and vaccines in particular. Rather, the world has been divided into two groups regarding access to medicine and vaccines as haves and have-nots. The rich countries had pre-ordered the vaccines of COVID-19 along with the holding of the same. The pandemic situation was further worsened, given the Trade-Related Intellectual Property Rights (TRIPS) in practice and restrictions on sharing technology of vaccines, medicines, and life-saving equipment. In this context, India and South Africa have proposed the joint proposal and garnered support for waiving off TRIPS to ensure equity, accessibility, and affordability of vaccines and the same as public goods. In this review, we emphasize that global justice is one of the important elements of normative international theories, which focus on all the moral obligations from the world's rich to the world's poor. The paper also questions and argues that if the rich countries fail to go by the principles of global justice, can the Indian and South African (SA) patent diplomacy play a catalyst role in global justice? The review concludes with an emphasis on global solidarity, and the acceptance of joint India-South Africa's "patent diplomacy" for TRIPS waiver would result in mass production and fair distribution, making the COVID-19 medicines and technologies available to everyone regardless of their poor-rich status.

FEATURES OF EXERCISING THE RIGHTS OF PATIENTS TO MEDICAL TREATMENT IN WARTIME CONDITIONS.

OBJECTIVE: The aim: Study of Ukraine's international obligations in the field of access to medical treatment and analysis of Ukrainian legislation in respect of exercising the rights of patients to medical treatment in the conditions of Russia's war against Ukraine. PATIENTS AND METHODS: Materials and methods: The analysis of regulatory legal acts of Ukraine and international standards was carried out using the comparative method. CONCLUSION: Conclusions: The health care system of Ukraine has shown its effectiveness and focus on the protection of human rights and freedoms, as well as a vector for the harmonization of Ukrainian legislation with the EU in the field of health care.