Kerrigan: Biden’s IP waiver disaster for small businesses

The Biden administration is considering giving away ground-breaking American technologies to China, India, and other countries — yes, for free. This giveaway would ravage the small businesses that drive innovation in the United States, and crush the economy in the process.

The give-a-away would waive aspects of the World Trade Organization’s (WTO’s) Agreement on Trade Related Aspects of Intellectual Property Rights, or TRIPS Agreement, which sets global shared standards for intellectual property (IP) protection. Last year, with the Biden administration’s blessing, the WTO waived certain commitments in the TRIPS Agreement for COVID vaccines. Not a single shot can be attributed to that action. Now, the Biden administration may double down on failed policy, and potentially expand the waiver to COVID therapies and tests.

An expanded IP waiver would have disastrous consequences for the life sciences sector, and by extension small businesses. Nine out of 10 U.S. pharmaceutical companies have fewer than 500 employees. Three-quarters have fewer than 100 employees, and nearly half have less than 10. Even Cambridge’s Moderna was a relatively unknown startup only a decade ago.

Small firms account for an outsized share of biopharmaceutical innovation. And Massachusetts, in particular Boston and Cambridge, are major biotech hubs in the nation. Emerging companies are responsible for approximately 80% of drugs in the development pipeline. All told, small businesses generate about 14 times more patents than large firms and universities and employ roughly four in 10 scientists and engineers across the country.

They’re able to do so only because of the United States’ strong and reliable system of intellectual property protections, which gives entrepreneurs and investors an opportunity to earn a return on the time, energy and funds they’ve devoted to risky business ventures.

IP is particularly important in the pharmaceutical sector, where bringing just one drug to market routinely costs more than $2 billion and can take 10 years or more. Nearly 90% of experimental medicines that enter clinical trials are never approved by the FDA.

But significantly weakening IP protections, as a TRIPS waiver expansion would do, could send this carefully balanced system into a death spiral.

Knowing that governments can arbitrarily waive patents on revolutionary innovations, funders and entrepreneurs will hesitate to invest in risky R&D projects in the future. That would almost certainly leave us on our heels if and when the next pandemic hits.

An investment slowdown would also trigger a tsunami of consequences for workers in IP-intensive sectors, where small businesses make up roughly 96% of firms. Altogether, companies in IP-reliant industries employ nearly half of all U.S. workers and contribute more than two out of every five dollars of U.S. economic output.

Each new innovation in these industries generates jobs. Consider the development of COVID-19 vaccines and treatments, which has supported more than 400,000 U.S. jobs alone.

Expanding the TRIPS waiver would put future jobs like these in jeopardy by allowing foreign nations to manufacture cheap copies of products that would have otherwise been made in U.S. factories. It’s therefore no surprise that various labor unions — including the International Brotherhood of Electrical Workers and the United Association of Union Plumbers and Pipefitters — have spoken out against the proposal.

Sending American life sciences manufacturing jobs overseas would also play into the hands of our fiercest rivals. Biotech innovation and manufacturing is a central pillar of Beijing’s “Made in China 2025” strategy, which aims to boost Chinese competitiveness in a number of high-tech industries.

An expanded TRIPS waiver would assist China in its efforts to supplant the United States as the global biopharmaceutical powerhouse. And it would directly undermine the goals laid out in the Biden administration’s own executive order to advance domestic biotechnology and biomanufacturing.

Some might argue that these catastrophic consequences are simply the price we must pay to promote widespread access to COVID-19 treatments and tests throughout the world — a worthy goal, to be sure.

But there is zero evidence of an IP-induced shortage of COVID-19 diagnostics and therapeutics. Last fall, therapeutic manufacturing lines were sitting dormant and millions of courses destined for low- and middle-income countries had yet to be distributed. Pharmaceutical companies, meanwhile, had already entered into nearly 140 voluntary licensing and manufacturing agreements to increase access to COVID-19 treatments in 127 countries.

A TRIPS waiver expansion would hamstring America’s small businesses and entrepreneurs while assisting China in its efforts to bolster its own domestic biotech industry. For the sake of America’s small businesses along with health consumers who depend on the innovative prowess of small biotech risk-takers, the Biden administration must reject this misguided proposal.

Karen Kerrigan is President and CEO of the Small Business & Entrepreneurship Council.

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