Vaporised nicotine products (VNPs) that are not approved as therapeutic goods are banned in some countries, including Australia, Singapore, and Thailand. We reviewed two non-profit regulatory options, private clubs and the Australian Therapeutic Goods Administration Special Access Scheme (SAS) that have been applied to other controlled substances (such as cannabis) as a potential model for regulating VNPs as an alternative to prohibition. The legal status of private cannabis clubs varies between the United States, Canada, Belgium, Spain, and Uruguay. Legal frameworks exist for cannabis clubs in some countries, but most operate in a legal grey area. Kava social clubs existed in the Northern Territory, Australia, until the federal government banned importation of kava. Access to medical cannabis in Australia is allowed as an unapproved therapeutic good via the SAS. In Australia, the SAS Category C appears to be the most feasible option to widen access to VNPs, but it may have limited acceptability to vapers and smokers. The private club model would require new legislation but could be potentially more acceptable if clubs were permitted to operate outside a medical framework. Consumer and regulator support for these models is currently unknown. Without similar restrictions applied to smoked tobacco products, these models may have only a limited impact on smoking prevalence. Further research could explore whether these models could be options for regulating smoked tobacco products.
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http://dx.doi.org/10.3390/ijerph15081744 | DOI Listing |
Int J Mol Sci
December 2024
State Key Laboratory of Tree Genetics and Breeding, Chinese Academy of Forestry, Beijing 100091, China.
Tannins are prevalent compounds found in plant fruits, contributing to the bitter taste often associated with these fruits and nuts, thereby influencing their overall taste quality. Numerous studies have been conducted to investigate the regulatory factors involved in tannin synthesis. Among these factors, transcription factors exhibit the most significant capacity to regulate tannin production as they can modulate the expression of several key enzyme genes within the tannin synthesis pathway.
View Article and Find Full Text PDFJ Clin Transl Sci
October 2024
Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Duke University Medical Center, Durham, NC, USA.
Efficient evidence generation to assess the clinical and economic impact of medical therapies is critical amid rising healthcare costs and aging populations. However, drug development and clinical trials remain far too expensive and inefficient for all stakeholders. On October 25-26, 2023, the Duke Clinical Research Institute brought together leaders from academia, industry, government agencies, patient advocacy, and nonprofit organizations to explore how different entities and influencers in drug development and healthcare can realign incentive structures to efficiently accelerate evidence generation that addresses the highest public health needs.
View Article and Find Full Text PDFPLOS Glob Public Health
December 2024
Yale Law School, Yale School of Medicine, Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, New Haven, Connecticut, United States of America.
Debates over the scope, terms, and governance of technology transfer-the sharing of essential technical information, know-how, and materials needed to manufacture a health product-are prominent and controversial in international health diplomacy. These debates have become focal points in recent contentious negotiations to amend the International Health Regulations (IHR) and draft a global Pandemic Agreement. While some countries advocate for automatic or compulsory mechanisms to facilitate access to health technologies, especially in times of crisis, others oppose legal frameworks that mandate non-voluntary participation by the pharmaceutical industry.
View Article and Find Full Text PDFbioRxiv
November 2024
Department of Genetics and Genomic Sciences, Department of Artificial Intelligence and Human Health, Center for Transformative Disease Modeling, Tisch Cancer Institute, Icahn Genomics Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
Protein abundance correlates only moderately with mRNA levels, and are modulated post-transcriptionally by a network of regulators including ribosomes, RNA-binding proteins (RBPs), and the proteasome. Here, we identified ster rotein abundance egulators (MaPRs) across ten cancer types by devising a new computational pipeline that jointly analyzed transcriptomes and proteomes from 1,305 tumor samples. We identified 232 to 1,394 MaPRs per cancer type, mediating up to 79% of post-transcriptional regulatory networks.
View Article and Find Full Text PDFJ Bioeth Inq
November 2024
Philosophy Department, Faculty of Arts, Centre for Agency, Values and Ethics, Macquarie University, North Ryde, NSW, 2109, Australia.
Objective: Approved medicines are not always sufficient to address the needs of patients so several legal pathways exist to enable access to unapproved medicines for treatment purposes. This article is the first to provide an in-depth analysis of this regulatory framework that governs access to unapproved medicines in Australia with a specific focus on affordability-motivated access.
Methods: Legislation, regulations, and guidelines were critically analysed to identify the de jure basis for importation and supply of unapproved medicines in Australia.
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