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Russia’s new drug problem Despite foreign companies continuing to supply drugs to Russian patients, the war is wreaking havoc on the country's pharmaceutical market

Source: Meduza
Viktor Korotayev, Kommersant

For years, Russian patients have been suffering from a medication shortage. After the country invaded Ukraine in February, the situation only got worse as drug prices rose. At first, this was due to a surge in demand, and drugs that initially disappeared began to return to the shelves. But despite the authorities’ attempts not to allow essential drugs to run out, problems remain. Their sources include a supply chain broken by sanctions, the departure of raw materials necessary for production from the market, and many Western companies’ refusal to conduct clinical trials in Russia. And the things still aren’t looking up: the future likely holds more supply chain disruptions, a drop in quality, rising prices, and a market closed to new drugs. Meduza explains what’s going on with Russia’s healthcare industry.

Condemning the war but taking pity on patients

In March, most major foreign pharmaceutical companies condemned Russia’s war in Ukraine and announced they were suspending both their clinical trials in Russia and their investments in the Russian market. At the same time, most companies assured consumers they would continue supplying essential medications; few companies left the market completely.

In March, the American pharmaceutical company Eli Lilly stopped supplying Cialis, an erectile dysfunction medication, to Russia. Soon after, AbbVie stopped supplying Botox. In April, the British company GSK stopped sending a number of popular vitamins and dietary supplements. According to media reports, the Japanese company Daiichi Sankyo has suspended sales of its medications Lixiana, Transamin, and Efient, though the latter, a blood clot prevention medication, is also registered in Russia under a different name.

Some foreign drug manufacturers did withdraw from the market entirely. That’s what the American company Bristol-Myers Squibb did, though in May it sold its business in Russia to a Swiss company, Swixx BioPharma, which will continue to operate there.

Say it with us: supply chain issues

Russia’s drug supply is facing issues beyond individual companies’ decisions to pull out of the market. In the spring, due to EU sanctions, Russia faced a near-total logistical blockade. Transport restrictions led to large-scale congestion at customs, which spelled long delays in the supply of imported drugs.

A batch of the cystic fibrosis drug Trikafta, for example, was supposed to arrive in Russia in April. Trikafta is one of the drugs purchased and provided to patients by Russia’s Circle of Kindness foundation. Trikafta isn’t registered in Russia, as it would be prohibitively expensive for individual patients to buy, but those who take it need it every day.

In April, the drug didn’t arrive as anticipated. According to the Circle of Kindness, logistical issues are to blame. For patients taking the medication as instructed, it was due to run out in late April or early May; Russia's customs office finally released the batch on May 31. In the interim, many patients were either not taking the drug or were taking it at a lower dose than prescribed. This can cause severe symptoms to return, such as frequent coughing, respiratory tract infections, trouble breathing, and others.

Patients who take Orkambi, another cystic fibrosis medicine, faced similar problems. The next shipment was expected in April, then in May, and the latest predictions have it arriving in June or July.

Putin's charity

A (very) close-knit circle Russia’s Circle of Kindness Foundation helps critically ill children by purchasing expensive drugs from providers with personal connections to top officials (including Putin himself)

Putin's charity

A (very) close-knit circle Russia’s Circle of Kindness Foundation helps critically ill children by purchasing expensive drugs from providers with personal connections to top officials (including Putin himself)

A broken supply chain isn’t the only reason behind the delays. Some drugs are already in Russia but are sitting in warehouses; due to reallocation of funds away from healthcare, they’re stuck there indefinitely. “There are a lot of chickenpox vaccines, for example,” said Antonina Oblasova, director of the nonprofit Collective Immunity. “There’s no reason to worry about them running out. But the fact that nobody’s buying it from suppliers is another issue.” According to Oblasova, producers are saying it’s still an open question whether hospitals will buy their product. But even if “the funds are reallocated for other purposes,” private vendors “should still have enough vaccine for a long time,” she said.

A decline in quality

Over time, the shortage might start to affect not just exports but also the medications produced in Russia (which account for just under half of Russia’s pharmaceutical market). Several suppliers of chemicals necessary for manufacturing medication have already left Russia, including BASF, IMCD, and others. In others cases, suppliers themselves haven’t pulled out, but shipments have stopped completely.

Most of the chemicals that have stopped reaching Russia are not active ingredients but auxiliary substances, which enhance quality but aren’t generally necessary for a drug to function. Still, according to regulatory expert Ravil Niyazov, it will be a challenge for Russian manufacturers to replace them quickly. “They’ll be forced to change their formulas,” he told Meduza. “In other words, [manufacturers will have to change] the makeup and the production technology that goes into several products.” This process will take between several months and a year for each product, Niyazov said, and success isn’t guaranteed. 

Changing the formula of non-injectable drugs will also require bioequivalence studies in humans, which can draw out the process significantly — not to mention the fact that these studies require chromatography columns, which are hard to come by in Russia right now.

Rising prices

There’s no question that drug prices have gone up at the consumer level. In March, the average price of drugs from Russia’s official list of vital and essential medicines had gone up five percent, while the average price of drugs not on the list had gone up 15 percent. In April and May, drug prices declined, though only by one percent.

The government has also raised the maximum selling price on drugs from the list, fearing shortages; if prices are too low and companies stop profiting from them, they’ll stop selling the drugs altogether.

A drug market frozen in time

Foreign drugs producers may have decided to keep supplying drugs to Russia for humanitarian reasons, but almost all of them have decided to stop conducting clinical trials there. As a result, the Russian drug market will almost certainly stop receiving new medications.

In order for a new drug to be registered in Russia, the results of “at least one clinical trial that was fully or partially conducted on the territory of the Eurasian Economic Union” must be included in its application,” said Ravil Niyazov. As long as this requirement remains, no new foreign drugs will reach patients, even if its suppliers are willing to supply it.

Western drug companies’ withdrawal from the Russian research space has already hit the market hard, Niyazov told Meduza. The industry is seeing “professional degradation, hemorrhaging personnel, the departure of foreign clinical research organizations, and a decrease in the quality of biological and chemical research in Russia,” he said. Many Russian clinical centers, according to Niyazov, will suffer financially as well, including hospitals in Moscow and St. Petersburg, almost all federal clinics, and rural hospitals.

Niyazov believes the reduction in the number of clinical studies done in Russia will have a ripple effect on medication development throughout the world. “Russia was an important region for conducting trials, and the loss of such a large region [...] may slow down the development of new drugs,” he told Meduza. “Russia has been a major supplier of patients; Phase III trials usually require large samplers, and Russia made a tangible contribution, though not a critical one.” In his view, the EU could serve as a replacement.

past pharma pains

Drug money In 2011, the Russian government launched a multibillion-dollar gambit to strengthen the country’s pharmaceutical industry. Ten years later, it’s led to a wave of arrests — and not much else.

past pharma pains

Drug money In 2011, the Russian government launched a multibillion-dollar gambit to strengthen the country’s pharmaceutical industry. Ten years later, it’s led to a wave of arrests — and not much else.

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