The Coronavirus Is a Threat to the Global Drug Supply

Shoppers have rushed to stores in Toronto, Chicago, New York, and elsewhere, buying out all the face masks as coronavirus cases began emerging across the globe. As of Tuesday, the US had only five confirmed cases and Canada had just one, but some people don’t like to take any chances. They want protection.

The sell-out of protective gear that was likely made in China—to protect us from a virus coming from China—is a kind of metaphor for a much deeper supply issue posed by the outbreak. Every day, people rely on Chinese companies for life-saving products. The country is the world’s largest producer of active pharmaceutical ingredients, even if the finished medications get put together in the US or another country. Although it’s too soon to feel any repercussions, the coronavirus outbreak adds uncertainty to that supply.

“This outbreak just underscores what can happen in a worst-case scenario,” says Amesh Adalja, an infectious disease physician at the Johns Hopkins Center for Health Security, who has warned about the national security implications of a heavy dependence on China and other countries for vital medicine and medical supplies. “Any kind of supply shock or instability would render the drug supply vulnerable,” he says. “With this outbreak, it is concerning whether or not the stability of our supply chain will remain intact.”

Wuhan is not China’s largest site for pharmaceutical manufacturing, but the city, once known for its heavy industry and steel, has become a burgeoning center for bio-pharmaceutical research and development. Transportation in and out of the central Chinese city of 11 million, in Hubei Province, has been shut down—roads closed, planes grounded, trains halted. Sixteen cities in Hubei Province have similar travel bans. Shanghai has extended its Chinese New Year holiday, keeping businesses closed through February 3. Other countermeasures are likely as the outbreak evolves.

Drug manufacturers are required to notify the US Food and Drug Administration of supply disruptions. “At this time, manufacturers have not reported any impact and we will continue to be in communication with manufacturers,” the agency said in a statement. But because China ships raw materials to pharmaceutical plants around the world, which maintain some inventory of ingredients, it may take months for any shortages to affect supply, says Erin Fox, a pharmacist and expert on drug shortages at the University of Utah Health.

The biggest problem is that there is no publicly available information on what portion of which critical medicines originate in China, and specifically where those factories are located, she says. Pharmaceutical companies consider such information to be proprietary. “One of the big unknowns is how many products are sole-sourced—in which literally only one place in the world makes that raw material,” she says. “We don’t have good information on that at all.”

China has 15 percent of the world’s facilities that manufacture active pharmaceutical ingredients for 370 essential drugs, while the US has 21 percent of those facilities, according to the FDA. But the agency doesn’t know how much those facilities produce—if they produce anything at all.

That lack of information is unsettling. “What is the threat to our national health care if there is some kind of geopolitical issue or an outbreak like this or some kind of natural disaster? We really don’t know,” says Michael Ganio, director of pharmacy practice and quality at the American Society of Health-System Pharmacists.

Hurricane Maria in Puerto Rico provided a hint. A Baxter manufacturing plant that supplies half of US hospitals with small-volume saline bags was hit by the storm. The company had no redundancy in its manufacturing capacity, and hospitals around the country faced a critical shortage.

The coronavirus outbreak adds a sense of urgency as Ganio’s organization and other health advocates push for a Senate bill called the Mitigating Emergency Drug Shortages Act. It would require manufacturers to report supply disruptions of active pharmaceutical ingredients—not just finished medicines—and to create redundancies and contingency plans. It also would require federal agencies to conduct a risk assessment of national security threats posed by the lack of domestic manufacturing of critical drugs.

“All it takes is one plant to shut down to cause a global shortage. That’s because there’s such concentration of global production in China,” says Rosemary Gibson, author of China Rx and a strong advocate for rebuilding domestic capabilities.

“This is a warning to the United States and other countries,” she adds. “If you have a supply chain concentrated in a single country, no matter what country it is, that’s a risk of epic proportions.”

China also produces a significant portion of the world’s supply of protective gear, such as face masks and respirators. Chinese manufacturers have ramped up production. So has 3M, a manufacturer based in St. Paul, Minnesota. Last week it announced efforts to meet rising demand for respiratory face masks—by boosting output at two of its facilities in China.