Russian pharmaceutical industry overhauled by new law

On March 17, the Duma passed a bill that will make medicines more affordable and spur development of the Russian pharmaceutical industry, officials claim.

“The main aim is that we have quality medicine made by domestic producers,” Diana Mikhailova, director of the Health Ministry's department for the development of the pharmaceutics market, told Russia Today.

Deputy Duma Speaker Oleg Morozov said the bill has three overarching goals - to protect the market from counterfeit pharmaceuticals, stimulate the development of the Russian pharmaceutical industry and enable the population to buy pharmaceuticals at affordable prices.

It will also streamline drug development by scrapping preliminary pre-production quality checks, which are currently required in addition to post-production checks. While experts have expressed concern that this move may affect the quality of drugs produced, the Ministry of Health has said that it will mean producers can get drugs out on the market more easily.

Furthermore, Russian pharmaceutical companies will be required to meet European quality standards by January 1, 2014. In an interview with the health supplement of Vzglyad newspaper, Health Ministry Official Mikhailova said that the state will assist manufacturers in this transition to Good Manufacturing Practice (GMP) to ensure medicines remain available to consumers.

She also sought to allay fears that under the new rules the introduction of foreign drugs on the Russian market would be delayed by five to seven years due to requirements for clinical testing, describing this as “nothing more than speculation”.

The bill passed in its second reading and Olga Borzova, who heads the Duma Committee on Health, remarked that while the Russian pharmaceutical industry disagreed with the initial composition of the law, it approved of the revised version.

Speaking in the Duma, Health Minister Tatiana Golikova said that regional authorities would be obliged to inform the population about the prices for pharmaceuticals and publish a price list available at each pharmacy.

Key points:

Medicine prices will be standardized and stabilized
Government to set a max. price on 500 ‘vital’ drugs
Pharmaceutical companies must register by April 1
European production standards must be met
New medicine must be registered within 210 days 
Registration of new medicine tariffs more than halved