The Federal Customs Service issued an order to ban the export of biological materials from Russia.
Photo: Grigoriy Sobchenko
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40,000 Patients to Suffer due to Ban on Biomaterials Export
// Biological samples got stuck at the customs
Russia’s Ministry of Healthcare and Social Development gave official comments on Wednesday concerning the ban on exporting human biological samples from Russia. The ministry said the ban concerns only the export of large lots of bio-samples “unrelated to medical treatment of patients”. However, companies that transport biomaterials state that since May 28th, the entire flow of biomaterials, including the bio-samples of patients of Russian clinics, sent abroad for confirming the diagnosis and for testing sensitivity to medical drugs, has been suspended.
Ministry of Healthcare and Social Development was the only ministry to give on Wednesday the official comments on the situation around the ban on exporting biomaterials (blood, samples of tissues, etc) from Russia. Deputy Minister Vladimir Starodubov said that only the shipping of “large lots of bio-samples unrelated to medical treatment of patients” has been blocked. “People will not suffer of it,” the deputy minister assured.
However, transporting companies, medical centers that send biomaterials to the West, pharmaceutical companies interested in clinical research of new medical drugs, did not share the ministry’s optimism. Supervisor of medical clinical research of TNT Express courier mail company Maria Astanina said they managed to ship the last lot of bio-samples on Monday. Yet, on Monday evening the shipment was stopped (the Federal Customs Service’s order arrived at 6:30 p.m.). Consequently, over the half of the day’s mail (some 60 boxes with bio-samples) missed the flight. The samples belonged to at least 10 medical centers of Moscow that specialize in cardiosurgery and psychiatry.
The next day, the company informed its customers about the ban, but clinics failed to react on time to the decision of the FTS. So, 70 percent of boxes remained in the office of TNT Express. Meanwhile, 80 percent of the bio-samples cannot be kept in storage. For instance, blood samples can survive the delay in shipping only if they are frozen. The company assured that the ban did not concern specific categories of bio-samples. Their shipping depended only on whether they managed to get on the plane before the order.
Mikhail Maschan, head of the blood cancer department at the Russian Clinical Hospital for Children, also questioned the ministry’s comments on Wednesday. The doctor said the only legally adjusted opportunity for sending bio-samples to the West exists for import and export of biomaterials within the framework of international cooperation, that is, for scientific and clinical research by pharmaceutical companies. Meanwhile, many Russian clinics send to the West the bio-samples directly for treating their patients, masking it as ‘international exchange’. “It happens when clinics cannot, due to the insufficient qualification or equipment, make precise diagnosis to a patient,” said Maschan. “Or when the bio-sample is needed for complicated surgeries, like bone marrow transplantation. A patient’s blood samples are sent to Germany to find a donor. Germany has a database of donors which Russia does not have so far. A patient’s blood gets to a Western laboratory for comparing it to a donor’s blood samples.”
The doctor added that up to 100 similar surgeries are performed in Russia annually. Thus, the ban means the same number of patients will not have transplantation now: “In a week, we are to send the blood of one of our patients. So we are making guesses now whether they’ll catch us at the customs.”
Liudmila Zubarskaya, deputy director of the Bone Marrow Transplantation Clinic at the St. Petersburg State Medical University, apprehends difficulties as well: “The order might mean the ban on our activities. We are afraid that very soon we’ll face a problem with one of our female patients, for whom it is necessary to send biomaterial to London.” The doctor believes that Russia is isolated from the world: “In the U.S., any samples can be shipped from any post-office. All over the world, there is exchange going on, there are laboratories that unify the parameters so that there are no divergences.”
Experts of the pharmaceutical market remind that clinical research is a part of medical treatment. “If patients’ bio-samples do not arrive on time to a research center, it is impossible to find out the body’s reaction to this or that medical drug. That is, keeping a patient on therapy is unsafe,” explained Alexei Brevnov, international relations manager at Glaxo Smith Kline company. Experts estimated the ban on bio-samples’ export has already affected nearly 40,000 patients.
The Healthcare Ministry did not explain on Wednesday how the issues with specific patients will be solved, since the order of the Federal Customs Service does not divide bio-samples into categories. The authorities do not name the ban’s terms either.
Yulia Taratuta
All the Article in Russian as of May 31, 2007
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