Public-private partnerships in fostering outer space innovations.

As public and private institutions recognize the role of space exploration as a catalyst for economic growth, various areas of innovation are expected to emerge as drivers of the space economy. These include space transportation, in-space manufacturing, bioproduction, in-space agriculture, nuclear launch, and propulsion systems, as well as satellite services and their maintenance. However, the current nature of space as an open-access resource and global commons presents a systemic risk for exuberant competition for space goods and services, which may result in a "tragedy of the commons" dilemma. In the race among countries to capture the value of space exploration, NASA, American research universities, and private companies can avoid any coordination failures by collaborating in a public-private research and development partnership (PPRDP) structure. We present such a structure founded upon the principles of polycentric autonomous governance, which incorporate a decentralized autonomous organization framework and specialized research clusters. By advancing an alignment of incentives among the specified participatory members, PPRDPs can play a pivotal role in stimulating open-source research by creating positive knowledge spillover effects and agglomeration externalities as well as embracing the nonlinear decomposition paradigm that may blur the distinction between basic and applied research.

Intellectual property licensing of therapeutics during the COVID-19 crisis: lessons learnt for pandemic preparedness and response.

During the COVID-19 pandemic, intellectual property licensing through bilateral agreements and the Medicines Patent Pool were used to facilitate access to new COVID-19 therapeutics in low- and middle-income countries (LMICs). The lessons learnt from the application of the model to COVID-19 could be relevant for preparedness and response to future pandemics and other health emergencies.The speed at which affordable versions of a new product are available in LMICs is key to the realization of the potential global impact of the product. When initiated early in the research and development life cycle, licensing could facilitate rapid development of generic versions of innovative products in LMICs during a pandemic. The pre-selection of qualified manufacturers, for instance building on the existing network of generic manufacturers engaged during the COVID-19 pandemic, the sharing of know-how and the quick provision of critical inputs such as reference listed drugs (RLDs) could also result in significant time saved. It is important to find a good balance between speed and quality. Necessary quality assurance terms need to be included in licensing agreements, and the potentials of the new World Health Organization Listed Authority mechanism could be explored to promote expedited regulatory reviews and timely access to safe and quality-assured products.The number, capacity, and geographical distribution of licensed companies and the transparency of licensing agreements have implications for the sufficiency of supply, affordability, and supply security. To foster competition and support supply security, licenses should be non-exclusive. There is also a need to put modalities in place to de-risk the development of critical pandemic therapeutics, particularly where generic product development is initiated before the innovator product is proven to be effective and approved. IP licensing and technology transfer can be effective tools to improve the diversification of manufacturing and need to be explored for regional manufacturing for accelerated access at scale in in LMICs and supply security in future pandemics.

The potential impact of the Comprehensive and Progressive Agreement for Prans-Pacific Partnership on Thailand's hepatitis C treatment program.

BACKGROUND: Thailand has expressed interest in joining the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), a twelve-country plurilateral trade agreement whose original incarnation included the United States of America (USA). When the USA withdrew from this agreement, key intellectual property clauses relevant to pharmaceuticals were suspended. These could be reinstated should the CPTPP Parties decide to do so. METHODS: This study uses two scenarios to cost the impact the CPTPP would have had on Thailand's 2020 hepatitis C treatment regime if Thailand joined the CPTPP and suspended clauses were reinstated. RESULTS: Joining the CPTPP could have increased the cost more than tenfold if suspended CPTPP clauses were reinstated and Thailand was not willing or able to issue compulsory licenses. Based on the 2020 budget, the price for this possible scenario could have reduced hepatitis C treatment coverage by 90%. CONCLUSIONS: Acceding to trade agreements such as the CPTPP that require increasing intellectual property protection, could compromise Thailand's hepatitis C program and other national treatment programs reliant on affordable generic medicines. The CPTPP could also prevent Thailand from relying on its own pharmaceutical capabilities to manufacture medicines needed to sustain its treatment programs.

The Legal Framework for Public-Private Partnerships in Drug R&D.

Public-private partnerships in drug R&D have great potential for driving innovation. They can bridge between excellent fundamental research and development and commercialization of innovative medicines to address unmet needs for the therapy of severe diseases in the interest of public health and human welfare. Therefore, public-private partnerships in drug R&D are promoted and publicly funded by governments and the European Commission. Nonetheless, they need to comply with legal requirements, particularly stemming from State aid law and competition law. Those requirements do not only protect a fair competition, but rather also further open information exchange as well as fair sharing of risks and fair participation in gains and results with the goal of having a successful collaboration and increasing the chance of successful commercialization of pharmaceutical innovations.

Ethical Considerations and Fundamental Principles of Large Language Models in Medical Education: Viewpoint.

This viewpoint article first explores the ethical challenges associated with the future application of large language models (LLMs) in the context of medical education. These challenges include not only ethical concerns related to the development of LLMs, such as artificial intelligence (AI) hallucinations, information bias, privacy and data risks, and deficiencies in terms of transparency and interpretability but also issues concerning the application of LLMs, including deficiencies in emotional intelligence, educational inequities, problems with academic integrity, and questions of responsibility and copyright ownership. This paper then analyzes existing AI-related legal and ethical frameworks and highlights their limitations with regard to the application of LLMs in the context of medical education. To ensure that LLMs are integrated in a responsible and safe manner, the authors recommend the development of a unified ethical framework that is specifically tailored for LLMs in this field. This framework should be based on 8 fundamental principles: quality control and supervision mechanisms; privacy and data protection; transparency and interpretability; fairness and equal treatment; academic integrity and moral norms; accountability and traceability; protection and respect for intellectual property; and the promotion of educational research and innovation. The authors further discuss specific measures that can be taken to implement these principles, thereby laying a solid foundation for the development of a comprehensive and actionable ethical framework. Such a unified ethical framework based on these 8 fundamental principles can provide clear guidance and support for the application of LLMs in the context of medical education. This approach can help establish a balance between technological advancement and ethical safeguards, thereby ensuring that medical education can progress without compromising the principles of fairness, justice, or patient safety and establishing a more equitable, safer, and more efficient environment for medical education.

Hardware-Efficient Configurable Ring-Oscillator-Based Physical Unclonable Function/True Random Number Generator Module for Secure Key Management.

The use of physical unclonable functions (PUFs) linked to the manufacturing process of the electronic devices supporting applications that exchange critical data over the Internet has made these elements essential to guarantee the authenticity of said devices, as well as the confidentiality and integrity of the information they process or transmit. This paper describes the development of a configurable PUF/TRNG module based on ring oscillators (ROs) that takes full advantage of the structure of modern programmable devices offered by Xilinx 7 Series families. The proposed architecture improves the hardware efficiency with two main objectives. On the one hand, we perform an exhaustive statistical characterization of the results derived from the exploitation of RO configurability. On the other hand, we undertake the development of a new version of the module that requires a smaller amount of resources while considerably increasing the number of output bits compared to other proposals previously reported in the literature. The design as a highly parameterized intellectual property (IP) module connectable through a standard interface to a soft- or hard-core general-purpose processor greatly facilitates its integration into embedded solutions while accelerating the validation and characterization of this element on the same electronic device that implements it. The studies carried out reveal adequate values of reliability, uniqueness, and unpredictability when the module acts as a PUF, as well as acceptable levels of randomness and entropy when it acts as a true random number generator (TRNG). They also illustrate the ability to obfuscate and recover identifiers or cryptographic keys of up to 4096 bits using an implementation of the PUF/TRNG module that requires only an array of 4×4 configurable logic blocks (CLBs) to accommodate the RO bank.

Economic evaluations of eHealth interventions targeting mental health problems in the workplace: a systematic review.

BACKGROUND: Work-related mental health problems impose significant economic and personal burdens. eHealth interventions may offer low-cost, practical solutions, but guidance on their cost-effectiveness in workplace mental health is limited. OBJECTIVE: The objective of this study was to systematically review economic evaluations of workplace eHealth interventions for mental health, offering insights into methodologies and cost-effectiveness outcomes. METHODS: Adhering to PRISMA guidelines, searches were conducted in Embase, MEDLINE, Web of Science, Google Scholar, Cochrane library, PsycInfo and EconLit databases in May 2022, selecting peer-reviewed papers that performed economic evaluations on workplace eHealth interventions for adult mental health. Quality was assessed using the Drummond checklist. RESULTS: From 3213 references, eight met the inclusion criteria. These studies varied in economic perspective, types of economic analysis type, primary outcome measures, intervention focus (e.g. stress, alcohol, insomnia & return-to-work) and direct non-medical costs. Five eHealth interventions were found to be cost-effective and/or have a positive return on investment, with seven studies rated as high quality according to the Drummond checklist. CONCLUSIONS: The study outcomes unveiled the potential cost-effectiveness of eHealth interventions targeting mental health issues, particularly these focusing on workplace stress. However, generalization is challenging due to variations in the methodologies across studies.

Corporate income tax, IP boxes and the location of R&D.

We discuss corporate tax effects on multinationals' R&D. Theoretically, we find that a host country's tax increase may boost local R&D expenditure: while R&D becomes deductible at a higher rate, this higher rate may not apply to all R&D returns. First, as R&D creates a public good within the MNE, some R&D returns are taxed at other countries' tax rates. Second, some of the R&D returns are taxed at a lower IP regime tax rate. The positive tax rate effect is empirically supported by country-by-country R&D data of U.S.-owned subsidiaries for countries that have an IP regime.