Sean Flynn at the American University Program on Information Justice and Intellectual Property has posted about the World Intellectual Property Organization’s action with regard to coronavirus and intellectual property, some of which is responsive to the open letter I blogged about last month. Flynn writes, “The new initiatives and statement respond to many of the issues raised in an earlier letter from a broad coalition to WIPO’s Director General asking for a clear stance on intellectual property and the COVID pandemic.”
U.S. Representative Bill Foster (Illinois 11th) is working on the issue of speeding up vaccine approval. Along with former HHS secretary and current member of Congress Rep. Donna Shalala (Florida 27th), Foster is spearheading a letter signed by dozens of members of Congress to HHS Secretary Azar and FDA Commissioner Hahn asking them to consider using human challenge trials to speed up a vaccine. The letter, which is worth reading in its entirety, is here: https://foster.house.gov/hhs-fda.
I believe it is too late to add signatures at this point, but consider calling your representatives to alert this to this effort and to ask them to support it.
On Friday, April 10, 2020, I presented at the First Mini-Conference on Coronavirus and Law—held over Zoom.
My talk was “Thinking About the Legal Dimension of the Pandemic,” and it leaned heavily on a forthcoming law review article I co-authored with Ted Bailey. I intended the talk as an introduction to the mini-conferences. In it, tried to make three points.
My first point was that the pandemic is not just a function of biology, it is also a function of law. How transmissible and fatal COVID-19 is depends on various legal inputs (mandated public health measures, regulatory approvals of treatments, etc.). My second point was that many professionals involved in this fight (clinicians, research scientists, etc.) seem to take the law as a given, something that can’t be changed. My third point follows from the first two—since the pandemic is in part a function of law, and since those on the frontlines in the healthcare field are not used to thinking that the law can be used, redirected, or changed, then there is the opportunity to make progress against the coronavirus pandemic by thinking of the law not as a fixed constraint but as a lever we can adjust. To sum it up: Changing the law can fight the pandemic.
In an opinion piece in The Hill, Penn State Dickinson law professor Martin Skladany argues that governors ought to be threatening to use their general police powers to compel manufacturers in their states to begin manufacturing personal protective equipment (PPE).
“In the absence of a quick and robust federal response,” Skladany writes, “governors need to seize an additional weapon in this fight. Even if they do not compel in-state manufacturers, just the threat of doing so could help them negotiate with companies or push the Trump administration to do more.”
The news is filled with examples of companies jumping in to help with the the fight against the pandemic by repurposing their assets and human resources. Among the many examples are a Chicago pizzeria using its oven to make face masks and a Brooklyn whiskey distillery making hand sanitzer. But to the extent businesses with relevant assets and expertise aren’t helping, Skladany’s plan is worth serious consideration.
Skladany acknowledges, of course, that states vary with regard to governors’ powers. And Skladany acknolwedges that any governors taking action along these lines would probably provoke lawsuits challenging the constitutionality of such moves. But he’s nuanced about this. The mere rattling of the saber may be sufficient to help push businesses in a state into doing more to help.
Indeed, this gets into an important thing that non-lawyers often don’t grasp about the law: Uncertainty in what the law allows doesn’t mean the law in this regard is bad or useless. To the contrary, uncertainty is often a powerful encouragement for opposing parties to meet in the middle. That often—although not always—creates good-for-society solutions where everyone gets at least part of what they want.
by Eric E. Johnson
It seems some users will not be able to see the opinion piece I wrote with Ted Bailey on the WaPo site because of the Washington Post’s paywall. Here is the full text:
Speed up the FDA’s vaccine-approval process
By Eric. E Johnson and Theodore C. Bailey
With the coronavirus pandemic, our challenge is to move faster than a very fast-moving problem. Changing the law could help.
The estimated 12-to-18-month timeframe for getting a vaccine to market is largely because of safety and efficacy testing required by the Food and Drug Administration. Legislation could shorten that timeframe without compromising the science — if the testing process tolerates more risk on volunteer study participants.
The FDA’s long-standing approval process places a premium on keeping human subjects safe. For most problems, this represents a prudent calibration of risks and benefits. For the coronavirus, however, the tradeoffs are different. The general public faces imminent danger from a virus capable of exponential growth.
Over the years, Congress has repeatedly, and rightly, stepped in with legislation to speed the process. Now, Congress should act to sharpen the curve of innovation against covid-19 by pushing the FDA to suspend its rules and practices and navigate according to the judgment of its experts.
Regular FDA approval processes begin human testing with a phase-one trial that must run its course with a small number of subjects — studying safety before enrolling subjects for larger phase-two and phase-three trials to assess a vaccine’s effectiveness. Yet clinical trial phases that are typically sequential could be combined or overlapped.
Collapsing trial phases without compromising scientific standards will require exposing more individuals to uncertain risk. Yet to do otherwise in a rapidly expanding pandemic leaves the global population exposed to a bureaucratically protracted period of pandemic risk without medical mitigation.
In the current crisis, it is ethically defensible to expedite clinical research with the cooperation of well-informed and consenting clinical subjects. There is no “safe” choice; it’s a risk-risk tradeoff — a question of more risk for research subjects or a longer wait for an approved vaccine.
We should respect the will of selfless individuals to knowingly take on the risks of investigational vaccines as an act of service for the sake of ending the pandemic.
Eric. E Johnson is an associate professor of law at University of Oklahoma College of Law. Theodore C. Bailey is chief of the Division of Infectious Disease at Greater Baltimore Medical Center.
Dr. Theodore Bailey of Greater Baltimore Medical Center and I argue in a Washington Post opinion piece published today that one way the law can help end the pandemic is by speeding up the vaccine approval process at the FDA.
I was very happy to sign an open civil society letter to the World Intellectual Property Organization regarding urgent issues involving intellectual property and the fight against the coronavirus pandemic. It is still open for signatures.
The letter asks WIPO for four things:
- Encourage countries that are members of WIPO to “take advantage of flexibilities … that permit uses of intellectual property-protected works for online education, for research and experimental uses, and for vital public interests, such as access to medicine and culture.”
- Call on “all right holders to remove licensing restrictions that inhibit remote education, research … and access to culture … both to help address the global pandemic, and in order to minimise the disruption caused by it.”
- Support Costa Rica’s request that the World Health Organization create rights pool of technology and data related to COVID-19, and also promoting measures such as compulsory license, antitrust enforcement, eliminate barriers to the making and selling of diagnostics and treatments.
- Support the rights of countries to take advantage of exceptions in intellectual property law, including trade secret law, “to facilitate greater access to manufacturing information, cell lines, confidential business information, data, software, product blueprints, manufacturing processes, and other subject matter needed to achieve universal and equitable access to COVID-19 medicines and medical technologies as soon as reasonably possible.”
I am rapidly throwing together an online, informal “mini-conference” on law and coronavirus. It will take place April 10 from 2:00 to 3:45 p.m. “at” OU Law via Zoom.
Rather than calling for “work-in-progress paper presentations,” I’m setting expectations much lower—something more like a “work-in-progress blog post presentation.” The idea is to issue-spot ways the law may help or hurt in the battle against COVID-19. Details are in the CFP: Call for Participants.
Participation is open to legal scholars, academics from other disciplines, and professionals with relevant perspectives (research scientists, public-health professionals, healthcare clinicians, etc.) who have ideas about how the law is either getting in the way or could be used to lend a hand in combatting the pandemic.
Confirmed participants so far include Stacey A. Tovino of UNLV William S. Boyd School of Law and Erika M. Douglas of Temple University Beasley School of Law.
Victoria Sutton, law professor at Texas Tech, is blogging about coronavirus on her Biominute Blog. Lots of great analysis there.
Particularly worth a look is her discussion of regulations requiring airlines to collect information about passengers for reporting to public health authorities to facilitate contact tracing. Her particular focus is on new U.S. regulations, found in 42 CFR 70 & 71, which allows the CDC to issue orders requiring airlines to provide such information.
Professor Sutton tells a surprising and wince-inducing story of meeting a passenger on a flight in mid March who found out he had previously been on a flight with a passenger who’d tested positive for COVID-19. The twist is that the passenger didn’t find this out by being contacted by public health authorities or the airlines. Instead, he found out about it on the news.