“It is time for the Biden administration to rescind this misguided intellectual property waiver once and for all. “
Many countries are urging the United States to dismantle the cornerstone of its economic success. The Biden administration may give them exactly what they want.
The goal of this proposal is to ensure that people living in developing countries have access to the same life-saving medicines available in wealthier countries. It's an admirable goal, but unfortunately the proposal would have exactly the opposite effect, by destroying the US biotechnology industry and depriving future generations of revolutionary treatments.
Here's some background. With US support, the World Trade Organization in 2022 waived global intellectual property protection for Covid-19 vaccines – a measure originally proposed by India and South Africa. The WTO has since discussed expanding the exemption to include coronavirus treatments and diagnostics, but no final decision has been made.
It is time for the Biden administration to rescind this misguided intellectual property waiver once and for all. While some U.S. policymakers portray it as a humanitarian measure that would expand access to COVID-19 testing and treatments in poor countries, there is no need for such an effort today. The “emergency” phase of the pandemic has ended. The White House, the Centers for Disease Control and Prevention, and the World Health Organization have said so.
In fact, the waiver is a Trojan horse that would jeopardize the competitiveness of U.S. manufacturing and research, even as China and other competitors work overtime to outpace us in the life sciences. This would work directly against the Biden administration's efforts to boost biotech innovation in the United States.
“Even if the coronavirus emergency does not end, widespread intellectual property waivers will remain a solution in search of a problem. “
Even if the coronavirus emergency does not end, widespread intellectual property waivers will remain a solution in search of a problem. Several companies have already signed licensing agreements to ensure access to oral antivirals in more than 100 low- and middle-income countries.
The same dynamic was present when the World Trade Organization approved an exemption for vaccines last year. In fact, India, South Africa and other countries that pushed for the measure had a surplus of doses when the waiver was approved. In September 2022, India's largest vaccine manufacturer disposed of 100 million expired doses. Around the same time, Aspen Pharmacare's plant in South Africa halted production of a vaccine it licensed from Johnson & Johnson due to low demand.
Simply put, intellectual property protection was not preventing countries from distributing vaccines. Regulatory issues and persistent vaccine hesitancy were the real culprits.
Likewise, as a recent report from the US International Trade Commission confirms, global intellectual property rights are not responsible for the decline in uptake of tests and treatments in the developing world.
Although this would not solve any real problem, waiving intellectual property protections would have dire consequences for America's world-class biotechnology industry. This waiver would force US companies to hand over not only the chemical compositions used in Covid-19 treatments, but also the technical details of the manufacturing processes needed to create these advanced drugs. Essentially, it would allow developing countries to help themselves obtain billions of dollars worth of American trade secrets – for free.
Patents and other intellectual property rights enable life sciences companies to participate in the risky process of drug development. Without this protection, copycats can take advantage of the years of work and billions of dollars needed to invent just one new drug. Arbitrarily ignoring intellectual property rights – as the WTO proposal would do – deprives life sciences companies of the opportunity to earn a return on their investments and reduces their incentive to innovate in the first place. As a result, we will miss out on countless future treatments.
By stifling investment in the life sciences sector, the exemption would harm ordinary Americans by threatening hundreds of thousands of biotechnology manufacturing and R&D jobs.
“America may lead the world in developing new treatments today, but expanding exemptions may change that.“
An expanded waiver of intellectual property would also have major implications for competition between the United States and China. China is already ahead of the United States in 37 out of 44 advanced technologies. Leaders in Beijing have made no secret of their desire to make China a global biopharmaceutical superpower, and biotechnology has been singled out as a crucial growth industry in the so-called “Made in China 2025” national strategy. America may lead the world in developing new treatments today, but expanding exemptions may change that.
Fortunately, no country benefited from the original vaccine exemption. But there is no guarantee that the same will be true for the waiver of tests and treatments, which, if used, would represent an unprecedented transfer of proprietary American biotechnology abroad.
A strong global intellectual property system has enabled the development and distribution of advanced Covid products that have saved millions of lives. The proposed waiver would fail to achieve its purported humanitarian goal of expanding access to treatment, because intellectual property protection is not actually an obstacle. Instead, a waiver would only undermine our ability to confront future public health threats and weaken America's economic competitiveness. It is imperative that the White House abandon this disastrous proposal.
James Pauley is the former Deputy Director-General of the United Nations World Intellectual Property Organization and a member of the Center for Understanding Intellectual Property.
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