A recent scandal over a Glaxo vaccine trial is prompting health officials to push for tougher rules, although local big pharma reps and docs say proposed legislation would put research at risk. The bill, which is expected to be submitted to the State Duma shortly, would give any clinic the right to carry out a trial as long as it secures permission first, says Maxim Lakomkin, a spokesman for the Federal Health and Social Development Inspection Service.

Currently, only specially accredited clinics can participate in trials. The Health and Social Development Ministry, which helped draft the bill, noted that the legislation would also for the first time allow any clinic to participate in trials, The Moscow Times reports. The proposed bill would also introduce midterm checks at specific stages of each trial, which could cause the permission to be revoked.

Volgograd prosecutors opened a criminal investigation into a clinic in February, accusing it, among other things, of not being on the list of accredited clinics. Parents had complained that the clinic was administering a chicken pox, measles and rubella vaccine made by Glaxo on their babies without telling them it was part of a clinical trial.

“The idea is to develop the practice of clinical trials in Russia, yet, protect its citizens,” Lakomkin says.

The proposed checks, however, would interfere with international research projects, argues Mikhail Lichinitser, deputy director of the Russian Cancer Research Center. “Our research has always been part of joint international projects into new drugs and subject only to international checks.”

Regis Lhomme, head of Pfizer’s Moscow office, says research is usually carried out concurrently in multiple countries, a practice that would be impossible to continue if each country had its own regulations. More importantly, he says Pfizer rarely has midterm checks in order to preserve the purity of trial results. Most research, he explains, is blinded so neither docs nor patients know whether they are using a real med or a placebo. “The checks would demand that the codes of the medicines be revealed. That would be very bad for the final result.”

However, Lichinitser says that midterm checks could help bring domestic trials on vaccines and medicines up to international standards.