Is the U.S.-China agreement on fentanyl a 'game changer'?

President Donald Trump meets with China's President Xi Jinping during their bilateral meeting at the G20 Summit, Saturday, Dec. 1, 2018 in Buenos Aires, Argentina. (AP Photo/Pablo Martinez Monsivais)

President Donald Trump is touting an agreement with Chinese President Xi Jinping as a potential "game changer" that could help prevent the most deadly form of opioid, fentanyl, from being exported to the United States.

During a lengthy meeting on the sidelines of the G20 summit in Argentina, President Xi reportedly committed to designate fentanyl and its chemical variants as controlled substances.

"One of the very exciting things to come out of my meeting with President Xi of China is his promise to me to criminalize the sale of deadly Fentanyl coming into the United States," Trump tweeted Wednesday morning. "This could be a game changer on what is ... considered to be the worst and most dangerous, addictive and deadly substance of them all."

China is the main supplier of illicit fentanyl to the United States where its use and availability have been steadily increasing every year. The drug is 50 times more potent than heroin and has been the cause of nearly 30,000 drug overdose deaths last year, more than half the total opioid overdose deaths, according to data from the Centers for Disease Control.

Trump continued, "If China cracks down on this 'horror drug,' using the Death Penalty for distributors and pushers, the results will be incredible!"

In a statement released after the Trump-Xi meeting, the White House described Xi's pledge as a commitment "to designate Fentanyl as a Controlled Substance, meaning that people selling Fentanyl to the United States will be subject to China’s maximum penalty under the law."

Drug trafficking, smuggling and the illicit manufacture of drugs are offenses punishable by death in China. Drug users are also subject to strict penalties, including compulsory rehabilitation and prison. Earlier this year, Trump recommended the death penalty for drug traffickers convicted in the United States.

China's understanding of the agreement was different from the White House readout and suggested a more sweeping effort to designate the entire class of fentanyl-related substances. In an official statement, China's Foreign Ministry said that "China has decided to list all the fentanyl-like substances as controlled substances and start working to adjust related regulations."

The difference is significant. Fentanyl has been a designated controlled substance for decades in China and under international conventions. However, drug manufacturers have been able to skirt these designations by chemically altering these drugs, creating virtually unlimited variants of equally deadly fentanyl analogs.

U.S. officials have been pressing the Chinese for months to schedule the drug as a class to match a U.S. regulation that took effect in Feb. 2017. The regulation implemented emergency controls making it illegal to illicitly distribute any fentanyl-related substance for two years.

The State Department Bureau of International Narcotics and Law Enforcement Affairs (INL) lauded China's decision to reciprocate.

"President Xi’s commitment to schedule all fentanyl-related substances as a class is a major milestone, with the potential to greatly advance U.S.-China cooperation to stem the flow of deadly synthetic opioids into our nation," Assistant Secretary Kirsten Madison said in a statement to The Washington Post. "We welcome this move and look forward to seeing the Chinese government implement and enforce these controls as soon as possible."

There is broad consensus in the United States among officials and experts that Chinese cooperation is critical for managing the U.S. opioid epidemic.

"Nothing will reduce the number of deaths, given what we see in the mix today, as much as stopping Chinese fentanyl," said John Walters, Hudson Institute director of political studies and former White House drug czar.

What is less clear is if China will follow through on the commitment made over the weekend. That will depend on whether China is willing or able to regulate its illicit fentanyl production.

Chinese officials publicly acknowledge their responsibility to control fentanyl as well as 25 fentanyl analogs and two chemical precursors used in the production of the drug. Despite that commitment under international drug control laws, the Drug Enforcement Agency continues to document an increase in the amount of fentanyl entering the United States sourced from China.

In it's most recent National Drug Threat Assessment, the DEA reported that 66 percent of all the synthetic opioids the agency seized and analyzed were fentanyl. The remaining portions were analogs and non-fentanyl synthetics, which DEA also said represent a growing threat.

Internationally, China is the point of origin for roughly 68 percent of global fentanyl movements, according to the Defense Intelligence Agency.

"At the end of the day, regulations only matter if you can enforce them," said Bryce Pardo, a policy researcher at the Rand Corporation. Pardo is skeptical that the new Chinese regulation will have much of an effect on the supply of fentanyl to the United States. "They still need to regulate the laws they have on the books," he said.

China is the world's largest exporter of pharmaceutical ingredients and has roughly 5,000 pharmaceutical firms. The country is also one of the world's largest chemical producers and exporters. The State Department estimates China has as many as 400,000 chemical manufacturers and distributors, some operating illegally.

To regulate those firms, China has a patchwork of agencies with competing responsibilities, incentives and limited resources, Pardo explained in a report to the U.S. Congress. Typically regulators will only inspect a small number of firms for quality and compliance. At the same time, the central government agencies that design the regulations are not responsible for enforcing them. Provincial authorities are tasked with oversight, creating opportunities for corruption and regulatory capture.

In its most recent annual report, the China Food and Drug Administration inspected only 15 firms that made controlled substances of precursors for controlled substances. Of those firms, three failed the inspections.

"A 20 percent failure rate on an already small number of firms they're inspecting, that indicates red flags," Pardo said. It also suggests China needs technical support monitoring their pharmaceutical and chemical sectors. "They have to get their own regulatory house in order," he added.

The State Department and other agencies have been working with their Chinese counterparts to provide technical assistance to regulators, according to testimony earlier this year from INL Assistant Secretary Madison. U.S. diplomats have looked for opportunities to deepen counternarcotic cooperation with China, Madison said, even amid tensions over trade and other issues that have created "very strong headwinds" in the bilateral relationship.

The DEA, Justice Department and Department of Homeland Security have been working to expand law enforcement cooperation with Beijing, resulting in Chinese authorities taking down illicit drug smuggling networks and laboratories. In 2017, the Trump administration announced the first-ever indictments and sanctions against Chinese fentanyl manufacturers. That included levying sanctions under the Drug Kingpin Act on a Hong Kong-registered chemical company.

The United States and China have agreed to drug control measures in the past to combat the supply of fentanyl with no clear impact on alleviating the U.S. opioid epidemic. At the 2016 G-20 Summit, the Obama administration reported it had an agreement with China to enact "enhanced measures" to target U.S.-bound shipments of fentanyl and other substances controlled in the United States. They also agreed to improve law and information sharing on controlled substances.

The challenge for the Trump administration will be keeping the pressure on China, Walters said, noting the Trump-Xi agreement will be relatively easy to verify. "If the deaths from fentanyl go down, they're doing something. If the deaths from fentanyl don't go down and continue to go up, we'll know the Chinese are liars and failing," he said.

It is not clear how the agreement will take shape. China's Foreign Ministry spokesperson Geng Shuang said in a Tuesday press conference that "the relevant work is yet to be started."

China has defended its commitment to international drug control conventions and has argued the United States bears responsibility for the opioid epidemic because of its high demand.

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