Russia

Russia enacted legislation in 2010 concerning the creation of decentralised ethical committees, while maintaining a central committee at the level of the Health Minister. In spite of these changes, the situation is far from optimal. On one side is an “official” committee having the power to forbid a trial, but which is overloaded; and on the other “local” committees which – when they exist – can study the portfolios but have no powers of decision. Conflicts of interest are also frequent. In one hospital in Moscow, for example, the doctor responsible for a clinical trial is also the president of the ethical committee responsible for evaluating it. When questioned about this situation, he did not see a problem.

Doctors in Russia do not hesitate to recruit patients on the internet, sometimes referring to “observation programmes” rather than drug testing, with the consequent risks for those participating. As they benefit from trials from a financial point of view – the remuneration can represent several times their basic salary – some doctors shamelessly multiply these activities.

The vulnerable situation in which most patients find themselves is also a dangerous factor. In the case of significant side-effects, the participants prefer to store the drugs away rather than consuming them, for fear of being excluded from the trial. This behaviour skews the results of clinical trials.

Novartis accused by patients

In the context of our investigation, we were able to question people having participated in a study by Novartis on Gilenya (medication for multiple sclerosis). The interviewees denounced several ethical violations: signature of consent forms after the beginning of treatment; absence of compensation for side-effects; and interruption of treatment at the end of the trial. Also, while the consent form provided an insurance policy in case of problems, such compensation seems inexistent in Russia. Between 2007 and 2009, none of the 70,000 patients had received compensation.

Due to a lack of resources, the inspectors from the Russian medicines agency are completely powerless. The situation is made worse because the legislation does not allow them to impose sanctions on investigating doctors or clinical trials sites that do not respect the law. As with the ethical committees, the inspectors are not authorised to meet the patients. When questioned, an inspector even denounced cases of “phantom research” with no patient or assigned doctor. These accusations were confirmed by the person responsible for a CRO (Contract Research Organisation), sub-contracting companies commissioned by pharmas to perform clinical trials.