New Amendments to Russian Pharmaceutical Market

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Feb. 14 – New amendments arranged by the Federal Antimonopoly Service (FAS) may release overseas pharmaceuticals backed by suitable foreign trials from re-examination in Russia.

The FAS also suggests calling off a five-year validity of drug registration certificates, Head of the Department for Control over Social Sphere and Trade of FAS Timofey Nizhegorodtsev said at the sidelines of the conference “Pharmaceutical Business in Russia: Times of Change.” FAS amendments were following the watch dog’s inspection of the drug registration procedure of the Ministry of Health Care and Social Development.

Nizhegorodtsev said some of the amendments have already been brought into line with the ministry.

Currently – in line with the federal law “on the circulation of medicines” that came into effect in September 2010 – all overseas medicines must undergo local trials before they can be sold in Russia, regardless of whether they have already undergone trials or have been approved elsewhere.

Originally, the law was intended to streamline the bureaucratic system for testing and registering new drugs in Russia. In reality it has hampered clinical trials and limited the number of drug approvals since the law came into force, according to a report from the Association of Clinical Trials Organizations (ACTO) in Moscow, which represents companies conducting clinical trials in Russia.

A recent ACTO report describes one European company’s struggles to register a drug for preventing preterm delivery, a condition that affects about 5 percent of pregnancies. The medicine is already approved for this use in many western countries. The cost of running a Russian trial was estimated to be US$1.3 million. Furthermore, clinical trials on pregnant women are rare in Russia, so there are few accredited facilities that can screen participants.

“No one can say — including, probably the regulatory agency — what kind of trials specifically should be run,” says Dmitry Margolin, co-chairman of ACTO’s regulatory committee. “No one can give the guarantee that if you do these trials then the data will allow you to register the medicine.”

Margolin says he is aware of “several tens” of instances in which manufacturers have planned to seek registration for a medicine, but had been deterred by the requirement for fresh trials.

“If the situation continues, large numbers of new products will not be registered and will not reach Russian pharmacies,” Margolin said.

Meanwhile, foreign companies play a key role in the Russian pharmaceutical market. Some 207 items, or 36.5 percent of medicines produced by foreign companies, are among drugs included in the government-approved list of vital and essential medicines for 2012, while only 93 domestically produced items (16.4 percent) made the list.

Russia has been one of the fastest growing emerging pharmaceutical markets in the world in recent years, where domestic pharmaceutical manufacturers largely focus on low-cost drugs, while foreign players dominate the expensive drugs segment.

Russia Pharma Report, recently published by Focus Reports, forecasts that the Russian pharmaceutical market grew 15 percent to 21 percent in value terms in 2011, while the total market value was US$14.86 billion in 2010, with a growth rate of 11.3 percent over 2009 in value terms.

According to Pharmaexpert, about 75 percent of drugs were imported in Russia in 2010. Statistics for 2011 are not available yet.

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