Abstract The lack of affordable prescription medicines is a global problem. But even as various governments, nonprofit organizations and pharmaceutical companies attempt to address the issue, agreements lack transparency. The absence of key details — notably, pricing, in some instances — makes it difficult to determine whether the deals will sufficiently succeed in providing needed medicines.
This comment assesses the evidence from four papers on the development process for four breakthrough drugs or treatments. The comment notes that the papers show all the key breakthroughs in the development process were financed either through the National Institutes of Health or various foundations or charities, not drug companies looking to be compensated through patent monopolies. It argues that this evidence suggests patent monopolies are an unnecessary distortion that results in high drug prices and creates perverse incentives. Expanded public funding could replace patent monopolies, allowing new drugs to be sold at free market prices, ending the problem of high drug prices blocking access.
Hospital-based violence intervention programs (HVIPs) help survivors of violent injury to return to physical, psychological, financial, and social health by addressing a broad range of social determinants of health and reducing the risk of future injury. This work requires connections to a range of providers and services, which often requires the sharing of patient health information. While HIPAA gives providers more discretion to share information to address health-related social needs and care coordination than many providers realize, patients can and should be the ones deciding what health information is shared, with whom it is shared, and under what circumstances. Providers, patients, and programs like HVIPs would benefit from greater clarity on appropriate information-sharing practices. In this article, we consider the real and perceived barriers to information sharing to address social needs and we make recommendations for practice, research, and policy to improve how patient information is shared to address social needs, with relevance for a wide range of interventions.
Words can have inherently multiple meanings; therefore, semantics can directly impact policies and behaviours. In regulatory practice, semantics refers to the specific, actionable meaning behind terminology, and attention to semantics can help ensure that legal frameworks are interpreted accurately. Refining semantics is not a purely theoretical exercise, but a subtle yet powerful element that has the potential to make the regulatory system more efficient in setting priorities and more reliable in meeting societal expectations and needs. When their intended purpose does not align with their true meaning, labels widely used in pharmaceutical regulation such as "breakthrough," "orphans," or "unmet medical need" risks undermining the clarity and precision essential to a sound regulatory framework. In addition, differences in definitions, scopes, eligibility criteria, and incentives can obstruct the efficient convergence of efforts in drug development and access. As pharmaceutical investments and clinical research increasingly transcend borders, the adoption of consistent terminology and regulatory definitions becomes crucial. This alignment can enhance cooperation among investors, governments, regulators, researchers, health care practitioners, and patients.
Abstract This commentary offers a critique of the public health approach to hospital restraints proposed by Coyne and McDougall. While acknowledging the merits of their model, specifically its emphasis on protecting third parties, this commentary emphasizes that an ethical assessment of restraint is too complex to be situated on a single-axis continuum. Rather, a multidimensional approach is required that includes specific vulnerabilities of particular patients, the precise nature of the restraints being used, and the duration of their implementation.
