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Gavin's avatar

Nice article Brian!

> Companies may lack incentives to conduct human clinical trials for drug-free antivirals or repurposed drugs. Drug-free antivirals can enter the market without such trials, while repurposed drugs are often off-patent, which makes clinical trials a high-cost, low-reward proposition for sponsors. And without human clinical trials, we can’t be certain that broad-spectrum antivirals developed in these ways are truly effective. As a result, there remains significant value in navigating traditional regulatory paths for a new broad-spectrum antiviral.

Regarding this point - I agree that there will be low incentives for conducting clinical trials for drug-free antivirals or repurposed off-patent drugs, yet I wonder if something similar to an advance market commitment could be used here. In this case, instead of committing to purchase an approved drug, a public funder could instead commit to running a large clinical trial if a company commercialises an antiviral product that does not require regulatory approval and meets some initial criteria (e.g. a pre-specified efficiency in animals or a pilot-clinical trial). This 'advance research commitment' could incentivise innovation for broad-spectrum antivirals outside traditional regulatory pathways, the company benefits as a successful trial will provide the product with credibility and increase market demand, the public benefits as the antiviral can be sold at a lower price than if the company has to recover the cost of phase 3 clinical trial.

The of idea of public funders paying for clinical trials of pharmaceutical products is from the Chapters 9 and 10 of Against Intellectual Monopoly (free download at http://www.dklevine.com/general/intellectual/againstnew.html), where they argue that the public would benefit from reduced patent protection on drugs, and the monopoly pricing afforded by patent protection wouldn't actually be necessary if the Phase 2 and 3 clinical trials required for regulatory approval were publicly funded. The rational is that clinical trial result submitted to regulators are a public good, and should be paid for directly by the public rather than paid for by the pharmaceutical industry (and then recovered in high product prices).

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Nicholas Weininger's avatar

How does your approach compare to that of Kimer Med in New Zealand?

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