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Cloned Specimens

The Russian Ministry of Health and the Federal Customs Service (FTS) have signed a joint agreement laying out new regulations for the transport of human biological specimens out of Russia. The new agreement ends a two-week customs ban that health experts say threatened the health of 40,000 Russians. Kommersant

Two weeks after the ban was initially imposed, leaving a legislative vacuum on the issue, the Ministry of Health and the FTS have issued new regulations governing biological specimens being sent out of the country. In essence, the document repeals the ban on the transport out of the country of three basic categories of biological specimens: those being used in clinical studies of new drugs, as part of an international scientific exchange, and for laboratory analysis as part of the treatment of patients in Russia.

The ban on the export of biological specimens was imposed by the Federal Customs Service on May 28. For several days, the Russian authorities refused to divulge the reasons behind the decision, but FTS head Andrei Belyaninov soon revealed that the ban was occasioned by irregularities in the legislation governing the transport of biological materials, which gave rise to "a gigantic market for the export of organs and human tissues from Russia." Russian Health Minister Mikhail Zurabov also mentioned the threat of "bioterrorism": according to one version, tissue specimens from Russians were purported to be fodder for genetically-engineered biological weapons being developed by the West. It soon became clear, however, that those affected by the ban were not Western researchers but Russian patients.

Representatives of major Russian pharmaceutical companies, research institutes, and medical facilities calculated that the ban threatened the health of 40,000 Russians – those whose diagnosis or treatment involved analyses that can only be done in the West, as well as participants in clinical trials of new medicines. Blood samples destined to be used to select bone marrow donors were also held up at customs: bone marrow transplants have been being performed in Russia for five years, but the only banks that match Russian patients with donors are located abroad.

The FTS press service reported that the decree lifting the ban on the export of biological materials was circulated among the country's regional customs offices on Saturday. The courier service at TNT Express, one of two companies in Russia that deals extensively with the transport of biological specimens out of the country, confirmed the information: "We found out on Saturday that the customs posts had received letters concerning the new regulations for exporting biological materials," said TNT's coordinator for clinical studies, Maria Astanina. "Now the customs officials should pass these rules along to the couriers. So far we haven't received them." Ms. Astanina also said that, in conjunction with possible changes in the permission-granting process, the company is currently not accepting any new orders for the transport of such materials abroad.

Pharmaceutical companies expect to wait at least another week for the real removal of the ban. A representative of one such company told Kommersant that "some time will elapse while the decree is registered with the Ministry of Justice or until information is received indicating that the decree will go into force without registration."

Judging from the copy of the decree obtained by Kommersant, the authors of the new joint decision by the FTS and the Ministry of Health were content to largely duplicate the regulations that were in effect before the ban. As before, the Russian Federal Consumer Protection Agency (Rospotrebnadzor) alone has the authority to grant permission for biological specimens to be transported out of the country. Similarly, the new requirements for how specimens being used in clinical studies are to be prepared for shipping are taken from Rospotrebnadzor letters dated December 15, 2002 and June 15, 2004. If biological materials are being shipped as part of an international scientific exchange, the document refers to the "temporary regulations" set down by deputy health minister Vladimir Starodubov on September 12, 2006.

In essence, the regulations can be considered "new" only with regard to laboratory analyses "for patients' medical conditions." The document does not place any limits on what is considered such a condition, but further information from the Ministry of Health clarifies that the medical conditions in question are "oncological and cardiovascular diseases." Permission to export specimens that fall into this category involves a different document and is good for 30 days from registration with Rospotrebnadzor. In order to get permission, the clinic that is treating the patient must make an official request to Rospotrebnadzor and provide the agency with the decision of a commission of doctors concerning the necessity of transporting the specimen out of the country and the written consent of the patient or their authorized representative. The permit must also include the full name, including middle name, of the patient whose specimens are being sent.

The new decision was met with relief in pharmaceuticals market and the medical community. "Of course, the companies still have to appraise the damage that was done by the two-week ban, but the decision to allow tens of thousands of Russian patients to continue to participate in clinical studies and thus to receive progressive treatment can only be welcomed," said Association of Pharmaceuticals Manufacturers medical committee co-chair Pavel Tverdokhleb.

Experts in the field do not believe that the obligatory inclusion of the decision of a commission of doctors (or of a hospital bioethics committee) in the process will be an obstacle for the transport of biological materials out of the country. "Where saving the life of a patient was concerned, the decision of a committee of doctors has always been the basis for Rospotrebnadzor granting permission for medicines that are not registered in [Russia] to be used," explained Mr. Tverdokhleb.

The only unanimous reaction to the document among experts concerned the rule that the permit must be in the name of the patient. According to Svetlana Zavidova, a former legal advisor for the Association of Pharmaceutical Manufacturers, the rule violates patient confidentiality. Specifically, outside agencies – in this case, the customs offices where permits for the export of biological specimens are sent – will have access to patients' confidential medical histories. Experts point out that in most cases patients wish to conceal not only their names but also the nature of their illnesses. Until now a special code for analyses has been used to maintain patient confidentiality.

Pavel Tverdokhleb, however, believes that the requirement will negatively impact only large clinical trials: "Incidents in which specimens are sent to laboratories for analysis are sporadic, so the possibility that personal information will be misused is small," he said. Alexei Maschan, the deputy director of the Federal Center for Pediatric Hematology, agrees: "The specification of personal data will not, I hope, do anyone any harm. The most likely compliant will probably be that each shipment requires a separate permit – it is not possible to get a permit for a year." A source in the Ministry of Health told Kommersant that the new regulations were designed to impose "minimal restrictions": "Patient data is necessary to track whose blood and tissue is being sent abroad. This is a compromise of sorts – the restrictions could have been harsher," said a ministry spokesperson.

Experts are inclined to believe that the new regulations are being presented as a slight correction to the old rules because "the government simply needed to take action to correct the mistake that was made": "There is a feeling that the rules were dictated by the situation. The importance of the ban has to be explained somehow," said Ms. Zavidova.



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