Duma passes bill to modernise Russian pharma sector
Legislation addresses supply chain security, quality issues and affordability
The Russian parliament, the Duma, has passed a bill that aims to stimulate the development of the domestic pharmaceutical industry, protect the market from counterfeit medicines and guarantee affordable prices for consumers.
The legislation should come into effect following a third reading in September 2010 and is part of the government’s wider modernisation agenda. It followed criticism of the industry by President Medvedev in August 2009, and the subsequent announcement by Trade Minister Khristenko of a modernisation plan for the a pharmaceutical industry.
According to Russia Today, the bill will standardise and stabilise medicine prices, and the government is to set a maximum price on 500 drugs, including those to treat tuberculosis and diabetes, to make them more affordable. ‘The pharmaceutical market is not like any other, said Diana Mikhailova, head of the Health Ministry Department for development of the pharmaceutical market. ‘It has to do with the health of our citizens. That’s why the government must be involved and regulate prices.’
Initially it was proposed that every pack of medicine should display the recommended price by the producer, but this measure was scrapped, taking into account that Russia’s size means transport costs can vary immensely. 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.
Preliminary pre-production quality checks have been scrapped, and while some experts have expressed concern that quality will be affected, the Ministry of Health argues that this will ensure that products are more easily accessible in the Russian marketplace.
Mikhailova 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’.
In a recent interview with the health supplement of Vzglyad newspaper, she said that by 1 January 2014 Russian pharmaceutical companies must meet European quality standards. However, she added that the state would assist in this transition to Good Manufacturing Practice (GMP) to ensure medicines remain available to consumers during this period.
As imports currently account for around 75% of Russia’s burgeoning pharmaceutical market, it is hoped this will support the development of a competitive domestic medicine manufacturing industry.
‘The main aim of the law is that we have quality medicine made by domestic producers,’ Mikhailova said. ‘We have to make sure that all those drugs currently produced by companies that have no chance of switching to European standards will still be produced by other companies in the future.’