FAS will adjust the production of drugs for reasons of national security

Security and coercion

The Federal Antimonopoly service (FAS) has proposed to deprive pharmaceutical companies exclusive rights to manufacture and sell patented drugs if they are for economic or political reasons, refused to supply these drugs to Russia. The relevant amendments to the Civil code and the law “On protection of competition”, the Agency published on the website disclosure of legal information on Friday, November 28.

Emergency measures in respect of pharmaceutical companies will be applied in the event if their conduct threatens “national security,” life and health of citizens, follows from the document. In a press-service FAS have explained that under such a threat implies a waiver of its supply of socially important medicines in the country. Only in this case will be used the mechanism of compulsory licensing and transfer of rights to sell and drug manufacturing to third parties without consent of the owner.

The company, which supplies patented socially important medicines, has not left the Russian market, but the FAS want to work in advance, said service head Igor Artemyev. “When there is a situation that foreign pharmaceutical manufacturer refuses to supply medicinal products to the territory of Russia, to take some decisions will be too late. We want to protect our citizens from this situation,” — said Igor Artemyev.

However, in the summary report to the bill as international experience FAS cites the examples of Malaysia and Zambia who used the mechanism of compulsory licensing for national security, and to reduce prices of patented anti-HIV drugs.

Malaysia and Zambia

In 2003 in Malaysia after unsuccessful negotiations to reduce the price for medicines against HIV, the government issued a compulsory license for the drugs didanosine and zidovudine Indian company Cipla. As a result, the cost of treating HIV/AIDS in the country fell by 80%.

The government of Zambia issued a compulsory license in 2004 for a drug against HIV — lamivudine+stavudine+nevirapine. Statistics to reduce spending in this country, the FAS failed.

In addition to Malaysia and Zambia compulsory licensing in the different times used in Canada, India, Brazil and some other countries. The purpose of the introduction of a mechanism has always been the same — the decrease of prices of socially significant medicinal drugs.

The wording of “national security” as prescribed by the FAS, too vague, said Executive Director of the Association “Pharmaceutical innovation” Vadim Kukava. If the document is adopted in its current form, the government will be able to issue a compulsory license for almost any reason. For example, if it is not satisfied with the price of the drug or the volume of its deliveries to the market, says Kukava.

Savings in Russia

If Russia is to focus on Malaysia and Zambia, as proposed by the FAS, under compulsory licensing can get expensive drugs against HIV and hepatitis C. It can be “Kaletra”, “Isentress”, “Daklinza” and “Savoldi,” said the head of monitoring ITPCru Alexei Mikhailov.

“Kaletra”, produced by Abbott, is 6.6 thousand RUB over the package. Each year, the drug costs the state approximately RUB 5.2 billion, emphasizes Mikhailov. “Isentress” produced by the firm MSD at a price of 34.8 thousand RUB over the package. Its purchases amount to about 2 billion rubles per year. For these drugs takes more than one third of the total budget for the purchase of drugs against HIV.

Need them, so these medications need to significantly reduce prices, says Mikhailov. The price reduction required for the drug “Daklinza” developed by Bristol-Myers Squibb, and “Savalgi”, produced by Gilead, says Mikhailov. According to ITPCru, “Daklinza” costs about 120 thousand rubles. per pack, and “Cavaldi” — 190 thousand rubles, Estimate the volume of procurement of drugs impossible, because they appeared on the market recently.

In Russia there are companies ready to produce the analogues of expensive patented drugs. On localization “Cavaldi” claims the company “pharmasyntez”. Its President Vikram Singh Punia said that the firm will be able to produce the drug at a price of 50-70 thousand rubles. for packaging.

Expensive cancer drugs, protected by patents, are ready to produce and in the Russian company BIOCAD, said CEO Dmitry Morozov. According to him, BIOCAD will be able to provide lower prices by 30-70%.

The statements of the Russian manufacturers are unfounded, as the volume of drugs they produce for the domestic market will be too small to provide a significant reduction in prices, says head of corporate Affairs Department Sanofi Yuri Mochalin. In addition, the fast-track procedure to market can lead to problems of quality control of the manufactured drug.

In April 2016 the government has opposed the compulsory licensing mechanism of drugs. All the relevant agencies considered that the introduction of compulsory licensing is inappropriate. But in September, the White house returned to the discussion of the initiative, wrote “Kommersant”. The Ministry of health and the Ministry did not respond to a request .

Negotiations with manufacturers

In addition to compulsory licensing, there is another way to reduce the price of socially important patented medicines. It’s the government’s negotiations with producers.

Conducts such negotiations, a government Commission consisting of representatives of the Ministry of health, Ministry of industry and trade and FAS, reported in early October 2016. The government plans to lower prices of essential medicines for the treatment of cancer, HIV, multiple sclerosis, hemophilia, etc.

In parallel, the FAS conducted a comparative analysis of prices in several countries for expensive medicines, necessary for the treatment of cancer and rare hereditary diseases. The office compiled a list of 48 items, which cost in Russia is overstated. On 21 November 2016 prices were reduced by up to 12 drugs from the list.