Realizing Public Rights Through Government Patent Use.

A substantial portion of biomedical R&D is publicly funded. But resulting medicines are typically covered by patents held by private firms, and priced without regard to the public's investment. The Bayh-Dole Act provides a possible remedy, but its scope is limited.

[Scientific research in times of pandemics.] / La ricerca scientifica in tempi di pandemia.

When a pandemic occurs, scientific research moves fast in order to achieve readily results, such as effective therapies to fight the SARS-CoV-2 and vaccines. But this high-speed science, engaged by the emergency and characterized by the explosion of online publications in preprint form not subject to scrutiny by peer reviewers, carries some risks. And it represents a challenge to maintain research integrity and to comply with those globally recognized standard principles of fairness. Competition and the pressure to publish immediately - a way of encouraging rapid data sharing - can favor the dissemination of incomplete if not erroneous results obtained from partial studies, which feed false news, such as the benefits of a drug, and illusory hopes. It is commonly through press releases that "speed science" disseminates information to an audience that wants to be informed and reassured. Financial and political interests often mix with the urgency to find solutions. Covid-19 has highlighted in particular the risk of a politicization of science at the expense of transparency.

Framing access to medicines during COVID-19: A qualitative content analysis of Gilead's Remdesivir.

The COVID-19 pandemic calls into question the institutional structure underlying the pharmaceutical industry. While some have called for medical technologies to be global public goods and patent waivers on pharmaceuticals, much of the industry has pushed back against any attempts that might threaten their monopoly power to set prices. Public acceptance of the role of private companies to control life-saving drugs, as well as of the intellectual property system, informs campaigns guaranteeing universal access to medicines and corporate strategies to shape policy. This study consists of a qualitative content analysis of online comments about news reports of Gilead Science's pricing of remdesivir, a re-purposed drug that shows some positive efficacy against COVID-19 in clinical trials. Analysing elite and public framing about medicine pricing informs our understanding of the social construction of markets. The findings identify hegemonic and counter-hegemonic discourse about innovation, affordability, saving lives, health care savings and international comparisons that stimulate debate and potentially advocacy. As such, the discursive context delineates the possibilities for remediating the normative and material structure of a pharmaceutical system currently geared towards private profit instead of public health needs.

Developing an Ethics Framework for Allocating Remdesivir in the COVID-19 Pandemic.

On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow use of the antiviral drug remdesivir to treat patients with severe coronavirus disease-2019 (COVID-19). Remdesivir is an investigational drug studied in clinical trials for COVID-19 and is available to children and pregnant women through compassionate-use access but is not yet FDA approved. In early May, the US Department of Health and Human Services began to distribute remdesivir, donated by Gilead Sciences, Inc., to hospitals and state health departments for emergency use; multiple shipments have since been distributed. This process has raised questions of how remdesivir should be allocated. The Minnesota Department of Health has collaborated with the Minnesota COVID Ethics Collaborative and multiple clinical experts to issue an Ethical Framework for May 2020 Allocation of Remdesivir in the COVID-19 Pandemic. The framework builds on extensive ethical guidance developed for public health emergencies in Minnesota before the COVID-19 crisis. The Minnesota remdesivir allocation framework specifies an ethical approach to distributing the drug to facilities across the state and then among COVID-19 patients within each facility. This article describes the process of developing the framework and adjustments in the framework over time with emergence of new data, analyzes key issues addressed, and suggests next steps. Sharing this framework and the development process can encourage transparency and may be useful to other states formulating and refining their approach to remdesivir EUA allocation.