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Is it really necessary to add something like the Health Impact Fund to the existing global patent system? We can divide this question into two parts. First, is there something seriously wrong with the status quo and, if so, what exactly is it? Second, how do we best go about solving the problem; that is, how does the design of the reform proposal address the flaws in the status quo? Jorn Sonderholm, in his critique of the Health Impact Fund, or HIF, raises both of these issues. These criticisms afford us the opportunity to reaffirm our commitment to ameliorating glaring problems with the current system for incentivizing R&D for essential medicines, and to clarify why we believe the HIF is exactly what the world needs. [ABSTRACT FROM PUBLISHER]

The Health Impact Fund has been proposed as an optional, comprehensive advance market commitment system offering financial payments or ‘prizes’ to patentees of new drugs, which are sold globally at an administered low price. The Fund is designed to offer payments based on the therapeutic impact of the drugs or vaccines, so that innovators will have efficient incentives to develop drugs that maximize health gains. Consumers would have improved access to such drugs because of low prices. [ABSTRACT FROM PUBLISHER]

One reason expressed in surveys of people reporting coronavirus disease 2019 (COVID-19) vaccine hesitancy is how rapidly these vaccines have reached the market. To estimate the length of time the COVID-19 vaccine spent in research and development as compared to other novel vaccines, we apply previously established methods for estimating medical product development times, using the key associated patent filings cited by the manufacturer as the marker of when commercial development activity began. Applying these methods to a cohort of recently approved innovative vaccines and comparing them to the first-approved COVID-19 vaccine (BioNTech/Pfizer), we found key patent filings for the technology in this COVID-19 vaccine occurred 10.0 years prior to regulatory authorization. By this metric, the development timelines for innovative vaccines have been shortening since the 1980s, and the COVID-19 vaccine comfortably fits within this pattern. Vaccine development timelines have now even drawn to parity with many of the most commonly used drugs. [ABSTRACT FROM AUTHOR]

Background Management of suspected Clostridioides difficile infection (CDI) in the hospital setting typically results in patient isolation, laboratory testing, infection control, and presumptive treatment. We investigated whether implementation of rapid near-patient testing (NPT) reduced patient isolation time, hospital length of stay (LOS), antibiotic usage, and cost. Methods A 2-period pragmatic cluster randomized crossover trial was conducted. Thirty-nine wards were randomized into 2 study arms. The primary outcome measure was effect of NPT on patient isolation time using a mixed-effects generalized linear regression model. Secondary outcomes examined were hospital LOS and antibiotic therapy based on a negative binomial regression model. Natural experiment (NE), intention-to-treat (ITT), and per-protocol (PP) analyses were conducted. Results During the entire study period, a total of 656 patients received NPT for CDI and 1667 received standard-of-care testing. For the primary outcome, a significant decrease of patient isolation time with NPT was observed (NE, 9.4 hours [ P <.01]; ITT, 2.3 hours [ P <.05]; PP, 6.7 hours [ P <.1]). A significant reduction in hospital LOS was observed with NPT for short stay (NE, 47.4% [ P <.01]; ITT, 18.4% [ P <.01]; PP, 34.2% [ P <.01]). Each additional hour delay for a negative result increased metronidazole use (24 defined daily doses per 1000 patients; P <.05) and non-CDI-treating antibiotics by 70.13 mg (P <.01). NPT was found to save 25.48 US dollars per patient when including test cost to the laboratory and patient isolation in the hospital. Conclusions This pragmatic cluster randomized crossover trial demonstrated that implementation of CDI NPT can contribute to significant reductions in isolation time, hospital LOS, antibiotic usage, and healthcare cost. Clinical Trials Registration. NCT03857464. [ABSTRACT FROM AUTHOR]