Drugmakers Pause Trials in Russia While Still Sending Medicine

(Bloomberg) -- Top pharmaceutical companies in the U.S. and Europe said they’re halting recruitment for clinical trials in Russia, while continuing to send medicine and other health supplies to help those in need. 

Drugmakers including Pfizer Inc., Johnson & Johnson, Merck & Co., Roche Holding Ag and Bristol Myers Squib Co. are seeking to strike a balance between international opprobrium over Russia’s invasion of Ukraine and the needs of sick patients.

New York-based Pfizer said on Monday that it would no longer start new clinical trials in Russia and that it would donate all profits from its subsidiary in the country to Ukraine relief causes.

At the same time, the drugmaker said in a statement that it will continue to supply medicines to Russia, out of fear that vulnerable patients such as children and elderly people who rely on its therapies could be harmed by any halt. 

The company “concluded that a voluntary pause in the flow of our medicines to Russia would be in direct violation of our foundational principle of putting patients first,” according to the statement. Pfizer said it doesn’t own or operate any manufacturing sites in Russia and that it intends to cease planned investments with local suppliers.

There is increasing economic pressure on Russia, including sanctions from the U.S., European Union and other countries, over the war in Ukraine. Many multinational corporations have opted to suspend their operations in Russia as well, though Moscow has threated asset seizures and other potential reprisals. 

Medical Exemptions

However, the medical industry has largely been exempt from sanctions, and health-care companies are trying to meet the needs of patients while being sensitive to the international outcry over the war. The U.S. Treasury has authorized transactions related to the exportation of medicine, medical devices and other tools and services aiding with the prevention, diagnosis and treatment of Covid-19. Notably, this includes research or clinical studies relating to the disease. 

Pfizer said it would work with the U.S. Food and Drug Administration and other regulators to move current clinical trials to alternative locations outside of Russia. Patients already enrolled in studies will continue to receive medications, the company said. 

Shares of Pfizer were up 4.1% at 11:59 a.m. in New York on Monday. 

With the announcement, Pfizer joins pharmaceutical peers that have paused patient recruitment in Russia. 

Swiss drugmaker Roche, which has 71 trial sites in Russia, said it had paused new patient enrollment and site activation in the country. The company has set up a task force to assess the “impact of the situation on our clinical trials,” according to spokesperson Karsten Kleine.

“Our priority remains to ensure that all patients currently enrolled in clinical trials in Russia continue to get access to treatments,” Kleine said in an email, noting that Roche doesn’t have production sites in the country. 

J&J, Merck

U.S. drug and device giant J&J has paused trial enrollment in Russia, Belarus and Ukraine “based on the challenging local conditions,” J&J said in an emailed statement. 

J&J said it remains “committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.” 

Merck said that it has also paused clinical trial enrollment in Russia and Ukraine, and is continuing to support patients currently enrolled in trials. “We currently do not have research or production facilities in Russia and are operating in compliance with all international sanctions to ensure access to critical treatments,” the company said in an emailed statement. 

Meanwhile, Bristol Myers said it has temporarily suspended new patient recruitment and clinical trial activations in Russia, Belarus and Ukraine. 

“We condemn the invasion of Ukraine and ongoing violence,” Bristol Myers said in an emailed statement. “Our priority is ensuring the safety and wellbeing of our people and our patients, and we are doing what we can to minimize disruption to our business to continue delivering for patients who rely on our medicines.”  

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