Tuesday, April 7, 2020

Never Let A Crisis Go To Waste

On March 13th, an Elsevier press release entitled Elsevier gives full access to its content on its COVID-19 Information Center for PubMed Central and other public health databases to accelerate fight against coronavirus announced:
From today, Elsevier, a global leader in research publishing and information analytics specializing in science and health, is making all its research and data content on its COVID-19 Information Center available to PubMed Central, the archive of biomedical and lifescience at the US. National Institutes of Health’s National Library of Medicine, and other publicly funded repositories globally, such as the WHO COVID database, for as long as needed while the public health emergency is ongoing. This additional access allows researchers to use artificial intelligence to keep up with the rapidly growing body of literature and identify trends as countries around the world address this global health crisis.
Elsevier and the other oligopoly academic publishers have reacted similarly in earlier virus outbreaks. Prof. John Willinsky pounced on this admission that these companies normal restrictive access policies based on copyright ownership slow the progress of science, and thus violate the US Constitution's intellectual property clause:
That Congress shall have Power...To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.
Below the fold I provide some details of his proposal.

Willinsky posted Copyright Reform for Post-Covid Open Access to the LibLicense forum:
A summary of the case for an open access reform of the United States Copyright Act:
  1. A consensus has recently formed among scholarly publishing’s principal stakeholders (including the big publishers) that open access to published research does more than closed subscriptions for the progress of science.
  2. This consensus means that the current use of copyright to restrict access to research places the law in violation of the Constitution, which holds that such laws are “to promote the progress of science,” rather than impede it.
  3. In lieu of copyright reform, the National Institutes of Health and other parties have created legal and extra-legal workarounds that compromise open access (with embargoes, final drafts, illegal copies), slow its spread, and allow costs to soar, with copyright contributing to open access’ market failure to date.
  4. Yet, copyright offers a promising strategy in “compulsory licensing,” which could require, in the case of scholarly publishing, immediate open access to published research and fair compensation to its publishers from its principal institutional users and funders.
  5. Such reform would be daunting, if Congress had not amended copyright nearly 60 times in the digital era (but not for science), with many of its reforms now operating internationally, which is the goal for open access copyright reform.
He linked to a draft of six chapters of a book entitled Copyright’s Constitutional Violation: When the Law Fails to “Promote the Progress of Science” (While Promoting Practically Everything Else):
  • Chapter 1 A Realistic Proposal
  • Chapter 2 The Open Access Consensus, 1989-2019
  • Chapter 3 The Market Failure of Open Access
  • Chapter 4 The Constitution’s Intellectual Property Clause
  • Chapter 5 Compulsory Licensing for Research Works
  • Chapter 6 The Global Public Good of Universal Open Access
While I've only read the first, and some of the fifth chapters, the book looks very interesting. Willinsky details the way copyright impedes "the Progress of Science and useful Arts" and the interminable series of failures to either change or work around the law to fix this problem, and then writes:
Yet the alternative I have in mind to initiating this legislative reform on behalf of science may seem no less brazen. It entails suing the United States government for violating the Constitution’s intellectual property clause. After all, Congress is empowered to pass laws that will, in matters of copyright, “promote the progress of science.” It has yet to pass a law that will facilitate what is now agreed upon as best for such progress.
He argues that the time is ripe:
Three conditions today make this proposal for legislative reform viable and timely. The first is a consensus among the principal stakeholders in scholarly publishing, including big and small publishers, that what is best for science is for it to be freely circulated in the digital era. The second is the state of market breakdown in scholarly publishing, reflected in the contorted legal workarounds for open access created by the United States government and others, amid publishers’ copyright-based monopoly pricing, all of which impedes what is agreed upon as best for science. The third is Congress’ internet updating of the well-established copyright alternative of compulsory licensing, with its Music Modernization Act of 2018, which might well be applied to scientific publications in ways that overcome the principal roadblocks to reaching universal open access.
Willinsky might be right. It isn't just that the current pandemic makes "Progress of Science and useful Arts" literally a matter of life and death, but also vital to recovery from what seems likely to be a major depression. There is an emerging consensus that falling research productivity is a serious economic problem. I wrote about this in 2018's Falling Research Productivity, commenting on Are Ideas Getting Harder to Find? by Nicholas Bloom et al. and last year's Falling Research Productivity Revisited, commenting on The Economist's column entitled How to get more innovation bang for the research buck.

It isn't just the malfunctioning copyright system that the current pandemic has exposed, but also the malfunctioning patent system. Ed Silverman's Under intense criticism, Gilead forsakes monopoly status for its experimental Covid-19 drug reports that patent-based price gouging of drugs to treat COVID-19 has become toxic:
In an unexpected move, Gilead Sciences has asked the Food and Drug Administration to rescind orphan drug designation for an experimental medicine being tested to combat Covid-19. The request comes after intense criticism that it unfairly pursued a lucrative monopoly for remdesivir.

The designation, which offers a drug maker seven years of marketing exclusivity, drew immediate condemnation from consumer advocates because orphan status is reserved for medicines targeting rare diseases that afflict 200,000 or fewer people.
The orphan designation would have allowed Gilead to block lower-cost generic version of a vital drug for years, assuming the FDA ultimately approves the medicine, known as remdesivir, for treating the novel coronavirus. Several clinical trials are under way to test the medicine and some results are due shortly, although hopes are already high remdesivir will prove effective. Orphan status also provides tax credits.

For this reason, the Trump administration, whose coronavirus task force includes former Gilead executive Joseph Grogan, was criticized for considering Covid-19 to be a rare disease. The company was also pilloried for seeking the designation. And in its statement, Gilead acknowledged seeking orphan status in early March, suggesting the company was well aware that Covid-19 would not be contained.
Note that Gilead still has patent protection on remdesivir, the orphan drug status would merely have enhanced and extended their ability to gouge COVID-19 patients. But the outcry shows the public's understanding that, at least during a pandemic, exclusivity on life-saving drugs isn't acceptable.

Never let a crisis go to waste is commonly attributed to Rahm Emanuel but is apparently due to M. F. Weiner.

No comments: