Intellectual property (IP) is absolutely central to our entire world. Dean Baker’s arguments are central to the debate around IP. Even if you don’t agree with Baker’s arguments, you should definitely know about them.
In my piece called “Listen, Progressives!”, I wrote:
How many progressives put IP at the center of the inequality solar-system? The Sanders campaign never touched this. The Warren campaign never touched this. Brace yourself, because your eyes will pop when you see how much money is at stake.
It’s absolutely true that IP should be at the center of the inequality solar-system. But IP is also crucial in many other respects. Take antibiotics. Our current IP-system cannot finance new antibiotics:
It’s official: Bacteria are outsmarting us. Bacterial strains that are impervious to even the most powerful antibiotics, nicknamed “superbugs,” are increasingly common and frighteningly lethal. Physicians are often left with their hands tied, forced to see patients die from infections that could have easily been treated 10 years ago. In this eye-opening book, McCarthy (The Real Doctor Will See You Shortly: A Physician’s First Year, 2015, etc.)—an assistant professor of medicine at Weill Cornell and a staff physician at NewYork-Presbyterian Hospital, where he is a member of the ethics committee—breaks down the complex interplay among biomedical researchers, the pharmaceutical industry, the Food and Drug Administration, and clinicians. Unsurprisingly, the most important consideration in this complicated equation is money. Conducting clinical trials to test the efficacy and safety of new antibiotics is expensive, and even when they are approved, the medications may not be hugely profitable for the manufacturer. “A study from the London School of Economics,” writes the author, “estimated that, at discovery, the net present value of a new antibiotic was minus $50 million.” McCarthy, however, is not deterred, and he agreed to lead a cutting-edge clinical trial involving a brand-new, synthetic antibiotic known as dalba. He pulls no punches as he details the tension between institutional bureaucracy and patient care, often becoming emotional as he describes his patients and their stories. He makes it clear that despite the importance of protocol, there is no time to waste. The author’s storytelling is at once urgent and empathetic, a compelling combination that leaves readers feeling informed and optimistic.
There is literally negative financial incentive for the development of antibiotics. This is a disastrous situation. See the abstract from this paper titled “Reinventing the antimicrobial pipeline in response to the global crisis of antimicrobial-resistant infections”:
The pipeline for new antibiotics is dry. Despite the creation of public/private initiatives like Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (Carb-X) and the Antimicrobial Resistance (AMR) Centre, the current focus on ‘push-pull’ incentives for the pharmaceutical industry still relies on economic return. We propose a joint, internationally-funded antimicrobial development institute that would fund permanent staff to take on roles previously assigned to pharmaceutical companies. This institute would receive ring-fenced, long-term, core funding from participating countries as well as charities, with the aim to focus on transforming the largely dormant antimicrobial pipeline. Resulting drugs would be sold globally and according to a principle of shared burdens. Our proposed model for antimicrobial development aims to maximise society’s investment, through open science, investment in people, and the sharing of intellectual property.
From Dean Baker’s peer-review of the paper:
This article proposes to establish an international center for antimicrobial research and development. The center would develop and then sell drugs according to a principle of “shared burden.” There is a need for such a center, since the private pharmaceutical industry has largely abandoned research in this area since it sees little prospect for profit.…
Anyhow, this is a worthwhile proposal which should advance the debate on the best way to finance the development of prescription drugs.
Our IP system has left us vulnerable in the war against bacteria. After we deal with Covid, we need to focus on the superbug crisis. The bacteria never sleep.
Regarding Covid, Baker just did an absolutely fascinating debate (click here to listen to it) with Thomas Cueni. You should listen to the debate if you can. Baker made an urgent argument:
The COVID-19 vaccines should be free for everyone for several reasons.
In humanitarian terms, we’re looking at a situation where much of the world still has no access to vaccines, and it will be 2023 or 2024 until the world is fully vaccinated. While China and Russia are filling much of the gap with their vaccines, we should be doing our part and trying to get the world vaccinated as quickly as possible in order to prevent hundreds of millions of people from getting the disease and perhaps tens of millions from dying of it. That’s a very big deal.
There is also a direct self-interest to make vaccines free. We know this virus mutates, as all viruses mutate. We could well end up in a situation where we get a vaccine-resistant strain, perhaps one that’s deadlier than the ones that are already circulating, and then we have to go back to the drawing board. Maybe we could develop a new vaccine, but do we really want to shut down entire countries and have everyone vaccinated again? That would be catastrophic.
And contrary to what the pharmaceutical industry will tell you, governments actually helped fund the development of these vaccines. They picked up much of the tab for clinical testing, research and regulatory approvals to get the vaccines to market as quickly as possible.
The United States government gave a US$2-billion ($2.5-billion) advance purchase agreement to Pfizer, which took less than 10 months to get the vaccine developed and approved. It also had comparable agreements with other countries. As for the Moderna vaccine, Americans and Europeans basically picked up the entire tab: US$450 million was given for the basic research and early clinical testing, and another US$450 million was awarded for the Phase 3 trials.
In these cases, there was very little financial risk for the pharmaceutical companies. They have already been paid. They do not need to further profit from this. Why do they need patent protection if governments paid them to make these vaccines? We must try to make them as widely available as possible, as quickly as possible, so that we can successfully stop the spread of the pandemic.
The 30 million doses currently being given to 35 developing countries will hardly make a dent in a total population of several billion people. We need to solve this problem as quickly as possible, and the failure to have more tech transfer and the insistence on maintaining patent monopolies are obstacles to doing so. Anyone who can produce the vaccines should be able to do it, and pharmaceutical companies should share the technology associated with making them, as well.
Our intellectual property structure is problematic and we need to change it. There is lots of evidence that publicly funded research, particularly open source research, could be very effective and likely to leave us much better prepared for the next pandemic.
See also:
“Is the Distribution of Vaccines the Biggest Trump Screw Up Yet?”
“More on Open-Source Versus Patent Monopoly Financing of Drug Development”
Baker responded with shock to something that Thomas Cueni said during the debate. Cueni said this:
We just co-convened a workshop with Chatham House in London where we brought together more than 100 suppliers, vaccine-manufacturers—from developing and developed countries—exactly looking at where are the bottlenecks, what are the issues.
Amazingly…everybody there agreed the issues are scarcity of—example—glass vials, scarcity of syringes, scarcity of raw materials, bottlenecks in single-use bioreactors, giant plastic-bags.
Baker was shocked at what Cueni said. Baker responded:
I’m just fascinated to hear Thomas talk about how they had a meeting in March to discuss what are the shortfalls in vials and syringes. March. March. March of 2021. Not March of 2020. What were these people doing over the last year? It is a little mind-boggling. I’d be reluctant to accuse them of that level of incompetence, but he seems to think that’s the case. I don’t doubt those are the shortfalls, but why was this not planned a year ago? This speaks to the importance of open-sourcing technology, open-sourcing these developments so that hopefully you’d be sitting down and people could be figuring out where are the shortfalls. But when you have everyone trying to secret away what they’re doing, then you wait a year later and you suddenly realize we don’t have enough syringes. Kind of mind-boggling.
Baker wrote this:
Note that this is March of 2021 that he was talking about, not March of 2020. If we accept Mr. Cueni’s assertion at face value, we must believe that Bill Gates, and the highly credentialed public health experts at his foundation, COVAX, the WHO and elsewhere, didn’t realize that we would need billions of syringes and huge volumes of other ancillary items to administer the billions of vaccines that would be needed. Alternatively, we would have to believe that even with a year of preparation, and billions of dollars at their disposal, they were not able to arrange the manufacture of these mundane items.
If either of these happens to be true, then “moron” would certainly be the right description. Of course, there is another possibility. Mr. Cueni may be trying to deflect attention from the fact that his organization is trying to block efforts to override the government-granted patent monopolies held by the members of his organization.
The event evidently took place. Cueni was referring to this event:
9 March 2021: Chatham House, in collaboration with COVAX, IFPMA, DVCMN, and BIO, convened a Global COVID-19 Vaccine Supply Chain & Manufacturing Summit on 8th and 9th March. The unprecedented scaling up of vaccine manufacturing, from zero to billions of doses in record time, has led to shortages that are impacting the entire vaccine supply chain. Open dialogue among manufacturers, suppliers, international organizations and governments is urgently needed to address these shortages so that they do not interrupt vaccine manufacturing. The meeting aimed to kick start the dialogue to identify, understand, and discuss potential solutions for these supply chain challenges. Held under the Chatham House Rule, the meeting provided the opportunity for frank, open and problem-solving discussions while respecting anti-trust rules.
Here is the event’s “Discussion Document”.
In a post on 11 March 2021 (the event was on 8th March and 9th March), Cueni wrote this about the bottlenecks:
We should not be surprised that this scale up of biological processes has its difficulties and there will be bumps along the road. Not least, because when scaling up exponentially the number of doses, it put a huge strain on the productive and yields produced by the new manufacturing lines put in place for these new vaccines. More than doubling of worldwide annual vaccine production puts a huge strain on the hundreds of raw materials and components such as lipid nanoparticles for the mRNA vaccines, the adjuvants to boost the vaccines, the giant plastic bags for single use bioreactors, glass vials, or the single use filters. These strains on the whole manufacturing supply chain can be further challenged by scarcity of expert technicians, by scarcity of materials, compounded by the interdependencies of materials needed for other biologicals, vaccines or cancer drugs.
Journalists should investigate why bottlenecks were not prepared for. If indeed they weren’t prepared for.
No matter what turns out to be the situation regarding these bottlenecks, it’s clear that the corporate sector—so far, at least—has zero remotely serious responses to Baker’s urgent arguments.
We’ve got bacteria. We’ve got viruses. We’ve got problems. Baker’s arguments need a major spotlight before it’s too late.