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Human Experimentation, Legally
The Russian Ministry of Social Development and Rospotrebnadzor, the Russian consumer protection agency, have prepared legislation that includes several amendments to the law concerning the use of medications and that will more closely regulate clinical trials of new drugs. Russian officials assert that the new legislation, which will require additional administrative checks on the progress of clinical trials, will make them safer for the patients involved. Experts in the pharmaceuticals industry, however, maintain that the amendments include many superfluous bureaucratic barriers that will hinder the process of testing new drugs in Russia.
The new regulations are laid out in two different documents: one is comprised of amendments to the law concerning the use of medications, and one outlines Rospotrebnadzor's administrative regulations concerning the control of clinical drug trials in Russian medical facilities. Several of the legislation's fundamental proposals will significantly simplify treatment for patients in Russia. For example, one of the amendments will allow the import of unregistered medications into Russia if they can be shown to be necessary for the life-saving treatment of a specific patient (until now, this was forbidden by law, and in some cases doctors have even appealed directly to President Putin for special permission to bring an unregistered drug into the country to treat their patients).
According to data from Rospotrebnadzor, the market for clinical drug trials in Russia is worth $150 million, and trials are currently underway in 799 medical facilities in 80 of the country's 85 federal regions. In 2006, around 50,000 Russians participated in 324 clinical trials.
The new legislation repeals the previous obligatory accreditation procedure for medical facilities that are participating in clinical trials. In order to begin a trial of a new drug, medical facilities will now be required only to secure permission for the trial itself. This amendment will prevent cases in which medical researchers have been sued on the grounds that a given facility was technically not legally certified to carry out clinical trials.
Officials maintain that other aspects of the legislation will provide an additional level of protection for patients who participate in clinical trials of new drugs. Specifically, Rospotrebnadzor plans to carry out midterm checks at specific stages of all clinical trials being held in Russia, and negative results could lead to permission for a trial to continue being revoked. In conjunction with this, medical facilities will also bear legal responsibility for the clinical trials that they participate in and the medications that they prescribe. Rospotrebnadzor consultant Mikhail Getman explained to Kommersant that "there have been incidents in which a lack of a responsible party or a plaintiff has meant that courts have been unable to hear cases from people who have used certain medications."
The legislation also includes amendments that the authors consider essential for leveling the playing field in Russia for Russian and foreign pharmaceutical companies. Specifically, permission to carry out a clinical trial will be granted only if the medication being tested will be registered in Russia once the trial is over. "Russian medicine should benefit from the fact that Russian citizens are participating in these trials," explained Rospotrebnadzor head Nikolai Yurgel. New drugs must be registered under the name of a Russian legal entity, meaning that western pharmaceutical companies will have to transfer all of the corresponding legal rights to a Russian partner.
Many experts in the pharmaceuticals industry believe that, far from ensuring the safety of Russian patients, most of the officials' proposals will actually hamper the progress of clinical trials by introducing unwarranted bureaucratic obstacles for their organizers. For example, analysts from the Association of International Pharmaceutical Manufacturers warn that although international regulations already specify phases or stages for clinical trials, it is impossible to demand that these guidelines be followed precisely, either because no "typical progression" can be defined for many drugs or because there is simply no need to do so. In addition, Svetlana Zavidova, a former consultant at the association, maintains that the new rule that would allow officials to yank permission to continue a clinical trial based on a midterm inspection of the results up to a certain point is simply dangerous: "At certain stages, a trial could yield negative results, but that does not mean that the research should be scrapped. Existing legislation already allows patients to be withdrawn from a trial if it truly poses a threat to their health," she said.
The rule that new medications must be registered to a Russian legal entity has also attracted criticism from experts who point out that western pharmaceutical companies may simply not have registered Russian daughter companies or, even if they do have subsidiaries registered in Russia, that they may still refuse to transfer the right of ownership of new drugs to them. In any case, many experts express doubts that the rule will guarantee that new drugs that are tested in Russia will appear on the Russian market.
According to information obtained by Kommersant, the legislation, which will be introduced in the State Duma next week, is not expected to have an easy path to approval: many of the proposals included in the new regulations have already attracted the attention of the Ministry of Trade and Economic Development and the Duma's legal department.
Rospotrebnadzor head Nikolai Yurgel has announced that clinical trials involving children may soon be allowed in Russia. Between 2004 and 2007, Rospotrebnadzor has granted special permission for only 75 pediatric trials (4.4% of all clinical trials in Russia over that period), and doctors complain that the effect of possibly life-saving drugs on children is too often poorly understood because almost all clinical trials of new medications involve only adults. Legislation that would allow children to be involved in regular trials of medication is currently being prepared in the Federation Council.