Debate over COVID-19 product IP flares up again

A two-day debate at the World Trade Organization (WTO) has reignited the argument over whether intellectual property protection for COVID-19 vaccines and treatments should be waived for low- and middle-income countries.

The main issue up for debate at the forum, which took place Oct. 12-13, was the request by developing countries for access to manufacturing technology that they say could help them better combat the pandemic. In October 2020, India and South Africa proposed a temporary waiver of Trade-Related Aspects of Intellectual Property Rights (TRIPS) rules on all COVID-19-related medical products. Over 100 member nations backed the proposal.

Members such as the European Union, Switzerland, and the UK pushed back. In May 2021, the US reversed its initial stance to voice lukewarm support for a partial waiver. In June this year, the WTO settled on a middle ground: a 5-year TRIPS waiver for COVID-19 vaccines. A decision on expanding the waiver to include diagnostics and treatments was postponed and set for December. The Oct. 12-13 debate would allow member nations to discuss the merits and drawbacks of the expansion.

The pharmaceutical industry, not surprisingly, opposes the waiver expansion. In a letter addressed to the White House, the industry group Biotechnology Innovation Organization argued that the waiver would stifle innovation by lowering the incentive for companies to develop novel therapies. This stance is echoed across the industry, which opposed the first TRIPS waiver.

“IP has never been a barrier,” says Komal Kalha, a trade expert at the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), another trade group. “You take that away, what you’re doing is you are fracturing a system that delivers in real time but also for the future.”

Kevin O’Connor, an IP lawyer with Neal, Gerber & Eisenberg, agrees that the waiver threatens future investment. “Companies might think twice about jumping in the next time such a health crisis arises, if that investment is going to be then turned around and essentially given away,” he says.

But Rochelle C. Dreyfuss, a professor at the New York University School of Law, counters that TRIPS waivers will probably not dent profits, especially during a pandemic. “If the entire globe needs something, there’s a very big market out there,” she says.

Companies aren’t the only ones who shouldered the initial investment, waiver proponents say. Governments and charitable agencies contributed to industry’s vaccine endeavors. Companies have an obligation to provide widespread access to vaccines because, to a certain extent, “the public also ‘owns’ vaccines and deserves to benefit too,” Nancy S. Jecker, a professor at the University of Washington School of Medicine, says in an email.

Waiver opponents argue that any failure to end the pandemic isn’t due to short supply of medical products. In the case of vaccines, the drug industry attributes the ongoing pandemic to vaccine hesitancy, pandemic fatigue, and export restrictions imposed by governments. In the first half of the year, millions of unused shots sat in manufacturing facilities in India due to a lack of demand, opponents note. The South Africa firm Aspen obtained a license to manufacture Johnson & Johnson’s COVID-19 vaccine in late 2021, but it has yet to receive orders.

When it comes to COVID-19 therapeutics, drug industry groups highlight an additional nuance: Many of them can potentially treat conditions other than the virus. An IP waiver expansion to these products will hurt their developers, many of which are small- or medium-sized biotech firms.

Industry lobbyists point to other TRIPS-sanctioned avenues such as voluntary and compulsory licensing schemes that allow foreign countries to manufacture patented products for their domestic market. Since the start of the pandemic, companies have formed over 380 partnerships to boost the manufacture of COVID-19 vaccines and over 140 for therapeutics, according to IFPMA. “Access is not the issue,” Kalha says.

Jecker says lower-income nations should not have to wait for help. “Requiring IP protections entrenches disparities between rich and poor countries,” she writes. The latter “should not be put in the position of beggars asking for charity.”