By Kenneth E. Thorpe
May 12, 2023
https://www.realclearpolicy.com/articles/2023/05/12/trips_waiver_expansion__a_nightmare_for_patients_899213.html
Covid-19 case rates are dramatically down from their peak and still falling. Distribution networks have delivered treatments, tests, and vaccines to every country in the world. In short, humanity has achieved at least a qualified success against the pandemic.
Yet there is still a movement afoot to waive global intellectual property protections on Covid-19 therapeutics and diagnostic tools, a move that seems misguided at best. Such a policy would be devastating for patients -- in particular those with chronic diseases, who live in hope of new cures. The proposed waiver would also make it much harder to combat future health crises, including the rising threat of antimicrobial resistance.
Proponents argue that eviscerating patent rights will somehow hasten the pandemic's end. This wasn't a good idea even when it was first proposed back in 2020, when fear and uncertainty had decision-makers grasping at straws. But manufacturing the needed quantity of vaccines has never been the problem, instead it is the healthcare delivery systems that can get them to patients. IP waivers certainly aren’t going to fix that.
Today, the anti-patent argument is clearly a "solution" in search of a problem. There is no existing dilemma that will be fixed by gutting IP rights. In fact, doing so would do profound damage to the future of medical innovation. Yet it could still happen, depending on decisions the Biden administration and World Trade Organization make in the coming months.
Last summer, with the support of the White House, the WTO waived global IP protections for Covid-19 vaccines. Now it's considering expanding the waiver to include tests and treatments, and since the trade body makes decisions by consensus, it can only do if it gets U.S. support again.
The Biden administration has asked the U.S. International Trade Commission to further investigate the issue to inform its decision. But we don't need a new multi-month study to know the harm a new patent waiver would do.
Biopharmaceutical companies rely for their existence on secure intellectual property rights, including patents, which grant them the exclusive right to sell their products for a set period of time. These rights give companies a shot at recouping research-and-development expenses. Given that it costs, on average, more than two billion dollars to bring a new drug to market, patent protections are essential for keeping these companies solvent.
If the global arbiter of IP rights declares them invalid for all Covid-related products, it will set a terrible precedent for other medical research. Scientists, companies, and investors will understand that the same thing could happen to any drug at any time -- chilling research and innovation. This would be especially worrisome for the six in ten Americans with chronic diseases like Alzheimer's, heart disease, and cancer. Chronic diseases are the leading causes of death and disability in the United States, and patients need new treatments, especially those managing multiple chronic conditions at a time and increasingly reliant on medicines to do so.
We likewise need new solutions to antimicrobial resistance (AMR), which is quickly becoming our next global health crisis.
AMR occurs when bacteria, fungi, or other pathogens become "superbugs," adapted to withstand current medicines. It already causes about 35,000 deaths annually in the United States, and without new solutions, is expected to kill more than 10 million people a year worldwide by 2050. That's more than Covid-19 has killed in over three years. But companies will not develop new antimicrobials without secure IP rights.
The saddest irony of an expanded IP waiver would be that there's no actual reason to do it. Pharmaceutical companies have already signed more than 140 voluntary licensing and manufacturing agreements across 35 countries to increase global access to Covid-19 treatments, according to data analysis firm Airfinity. As a result, global supply greatly exceeds demand. As of last fall, governments and organizations had purchased 80 million courses of treatment but administered only 18 million.
If the WTO expands the patent waiver for Covid-19 vaccines, it will bring essential medical innovation to a halt. This will hurt patients everywhere and make it much harder to stop the next global health crisis. Given the global pandemic we have all just endured it seems impossible to imagine that anyone would want to undercut efforts to ensure we don’t face similar pandemic challenges ever again.
Kenneth E. Thorpe is chair of the Department of Health Policy and Management at the Rollins School of Public Health, Emory University. He is also chairman of the Partnership to Fight Chronic Disease.