The Legislative Approach and System Improvement of China's Compulsory Licensing for Drug Patents.

Compulsory licensing for drug patents is of great significance to ensure the accessibility of drugs. Although the development of China's compulsory licensing system for drug patents has been gradually improved, there are still problems. For example, the scope of the object is not realistic, the setting of the initiating subject is unreasonable, the reasons for issuance are not clear, the duration and scope of the license are not refined, and the provisions on the exploitation fee are missing. Consequently, in order to improve China's compulsory licensing system for drug patents, it is necessary to expand reasonably the scope of the object, remove the restrictions on the initiating subject, adjust the initiating rights of different subjects, determine the duration and scope of the license and the applicability of the hearing on a case-by-case basis, and determine a reasonable exploitation fee by taking into account the national income, patent cost, market share and other factors, in consideration of the flexibly international norms and the actual situation in China.

A Novel Health-Transportation Partnership Paves The Road For Young Driver Safety Through Virtual Assessment.

Motor vehicle crashes remain the leading cause of adolescent mortality and injury in the United States. For young drivers, crash risk peaks immediately after licensure and declines during the next two years, making the point of licensure an important safety intervention opportunity. Legislation in Ohio established a unique health-transportation partnership among the State of Ohio, Children's Hospital of Philadelphia, and Diagnostic Driving, Inc., to identify underprepared driver license applicants through a virtual driving assessment system. The system, a computer-based virtual driving test, exposes drivers to common serious crash scenarios to identify critical skill deficits and is delivered in testing centers immediately before the on-road examination. A pilot study of license applicants who completed it showed that the virtual driving assessment system accurately predicted which drivers would fail the on-road examination and provided automated feedback that informed drivers on their skill deficits. At this time, the partnership's work is informing policy changes around integrating the virtual driving assessment system into licensing and driver training with the aim of reducing crashes in the first months of independent driving. The system can be developed to identify deficits in safety-critical skills that lead to crashes in new drivers and to address challenges that the coronavirus disease 2019 pandemic has introduced to driver testing and training.

Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study.

BACKGROUND: The world is facing an unprecedented outbreak affecting all aspects of human lives which is caused by the COVID-19 pandemic. Due to the virus novelty, healthcare systems are challenged by a high rate of patients and the shortage of medical products. To address an increased need for essential medical products, national authorities, worldwide, made various legislative concessions. This has led to essential medical products being produced by automotive, textile and other companies from various industries and approved under the emergency use authorizations or legal concessions of national regulatory bodies. This paper presents a narrative commentary of the available documentation on emergency use authorizations and legal concessions for medical products during COVID-19 pandemic. METHODOLOGY: The basis for narrative commentary includes scientific articles published in Web of Science, Scopus, PubMed and Embase databases, official publications of international organizations: Food and Drug Agency (FDA), World Health Organisation (WHO), World Bank and United Nations (UN), and national regulatory agency reports in native languages (English, German, Bosnian, and Croatian) published from November 1, 2019 to May 1, 2020. This paper focuses on three types of essential medical products: mechanical ventilators, personal protective equipment (PPE) and diagnostic tests. Evidence-informed commentary of available data and potential identified risks of emergency use authorizations and legal concessions is presented. DISCUSSION: It is recognized that now more than ever, raising global awareness and knowledge about the importance of respecting the essential requirements is needed to guarantee the appropriate quality, performance and safety of medical products, especially during outbreak situation, such as the COVID-19 pandemic. Emergency use authorizations for production, import and approval of medical products should be strictly specified and clearly targeted from case to case and should not be general or universal for all medical products, because all of them are associated with different risk level. CONCLUSION: Presented considerations and experiences should be taken as a guide for all possible future outbreak situations to prevent improvised reactions of national regulatory bodies.

Accelerated Graduation and the Deployment of New Physicians During the COVID-19 Pandemic.

The COVID-19 pandemic has presented unprecedented challenges and opportunities for medical schools in the United States. In this Invited Commentary, the authors describe a unique collaboration between the University of Massachusetts Medical School (UMMS), the only public medical school in the state; the University of Massachusetts Memorial Medical Center (UMMMC); and the Commonwealth of Massachusetts. Through this partnership, UMMS was able to graduate fourth-year medical students 2 months early and deploy them to UMMMC to care for patients and alleviate workforce shortages during the COVID-19 surge, which peaked in Massachusetts in April 2020. The authors describe how they determined if students had fulfilled graduation requirements to graduate early, what commencement and the accompanying awards ceremony looked like this year as virtual events, the special emergency 90-day limited license these new graduates were given to practice at UMMMC during this time, and the impact these new physicians had in the hospital allowing residents and attendings to be redeployed to care for COVID-19 patients.

Accessibility of 'essential' alcohol in the time of COVID-19: Casting light on the blind spots of licensing?

Among the Australian and UK governments' responses to the COVID-19 pandemic has been the designation of outlets selling alcohol for off-premise consumption as 'essential' services, allowing them to remain open while pubs, hotels and restaurants have been forced to close. In a context of restrictions on movement outside the home in both countries, and where alcohol providers are trying to find new ways to reach their customers, this may lead to an intensification of the social and health harms associated with home drinking. By examining the current situation in both Australia and the UK, we argue that heightened risks from home drinking amid COVID-19 bring into sharp focus long-standing weaknesses within licensing systems in both countries: the regulation of off-premise outlets to minimise harms from drinking at home. We call for critical conversations on how licensing systems should be revised to take more responsibility for protecting people from the health and social harms associated with home drinking, both under COVID-19 and in the future.