The Duma may conduct a parliamentary investigation into Rospatent, which gave preference to a foreign medicine to the detriment of Russian

The State Duma of the Russian Federation intends to decide to conduct a parliamentary investigation in connection with the decision of Rospatent, which gave preference to a foreign drug to the detriment of the Russian analogue. This decision will be made upon receipt of a response from the department to the parliamentary request.

Earlier on Thursday, January 31, State Duma Chairman Vyacheslav Volodin, at a meeting of the Legislative Council, instructed the Security and Anti-Corruption Committee to study this issue after the first deputy head of the United Russia faction, Andrei Isaev, presented an analysis of the situation on the domestic drug market to Council participants.

According to the vice-speaker of the lower house of parliament, Sergei Neverov, a complaint was sent to the Duma on behalf of a large Russian drug manufacturer operating as part of a state program. In this regard, parliamentarians sent a request to Rospatent. “Depending on the answers received, we will decide on further actions, including the possibility that a parliamentary investigation will be initiated,” Neverov warned.

As TASS notes, to launch the parliamentary investigation process, deputies need to collect 90 signatures. If they are collected, the document will be sent to the chairman of the lower chamber, and then it will be submitted to the Duma Council, which will initiate consideration at a plenary session.

According to the law, parliamentary investigation may be subject to “facts of gross or massive violation of the rights and freedoms of man and citizen guaranteed by the Constitution of the Russian Federation,” “circumstances associated with the occurrence of man-made emergency situations,” and “circumstances associated with the negative consequences of natural and man-made emergency situations.” ". In order to launch the parliamentary investigation procedure, its initiators must provide information about specific facts of violations.

First Deputy Leader of the United Russia faction Andrei Isaev spoke about these facts at a meeting of the Legislative Council under the Chairman of the State Duma on Thursday, presenting an analysis of the situation on the domestic drug market.

He explained that there is a tendency when imported drugs are crowding out domestic analogues from pharmacy shelves, and cited a specific case as an example: “We have a situation where a domestic drug, which was developed under a state program, for which federal budget money was spent, which received a patent in Rospatent, then, on the basis of a complaint from an obscure organization, this patent is lost.” According to him, as a result, this structure made a decision in favor of the foreign manufacturer.

“The Chamber of Patent Disputes makes a decision against our manufacturer. I don’t know of a single decision when the Chamber of Patent Disputes makes a decision in favor of our manufacturer, I don’t know,” added the representative of the parliamentary majority. He expressed the opinion that this issue needs a “separate discussion”, since we are talking about protecting the interests of domestic producers and the interests of the Russian Federation in general.

In addition, the deputy proposed forming a working group of deputies and representatives of the Ministry of Health and the Ministry of Industry and Trade and preparing bills to simplify the registration of new drugs and maintain reasonable prices for them.

How will drug prices increase in Russia in 2019?

Experts interviewed by RIA Novosti believe that medicines in Russia may become more expensive in 2019 due to the weakening of the ruble against the dollar, the introduction of labeling, as well as rising prices for electricity and logistics due to an increase in the VAT rate.

“The forecast for price increases for medicines not included in the regulated list is possible in the amount of general inflation in the country,” said Sergei Shulyak, CEO of the analytical agency DSM Group. The official Russian government inflation forecast for 2019 is 4.3%, the Central Bank forecast is 5-5.5%.

Nikolai Bespalov, development director of the analytical company RNC Pharma, notes that “by the end of the year, it is quite possible to expect an increase in prices for medicines at the level of 4-6%,” while the exact figure “will depend on the macroeconomic situation and the activity of regulators.”

Analysts at the consulting company IPT Group also expect a rise in price, but more significant. Imported drugs can increase in price by 3-15%, domestic ones - within 2-12%, says Yulia Petrischeva, director of pharmaceutical and innovation projects at IPT Group.

To a lesser extent, the price increase will affect drugs from the list of vital and essential drugs (VED), the cost of which is regulated by the state. The share of drug names from this list is 53% of the total number of drugs on the Russian market. It is expected that the cost of drugs from the Vital and Essential Drugs list will be reduced as a result of changes in the pricing methodology and the start of the price re-registration process.

According to an expert from RNC Pharma, the fall in the exchange rate of the ruble against the dollar and euro, which occurred at the end of 2018, may in particular lead to an increase in prices for domestic products. For the production of Russian drugs, foreign pharmaceutical substances, auxiliary components and equipment are purchased.

The increase in the VAT rate to 20% from the beginning of 2019, it would seem, should not affect medicines, since a reduced rate of 10% applies to them. However, an increase in VAT will lead to higher prices for electricity and logistics - related services, without which the production process is impossible, explained Petrishcheva from IPT Group. “As a result, the selling price of the drug increases non-linearly, and in some cases, unfortunately, several times,” she added.

The CEO of the analytical agency DSM Group noted that the impact of the increase in the VAT rate on logistics and cost growth will not occur immediately, but during the first quarter of 2019. At the same time, an increase in the VAT rate will affect the costs of manufacturers, distributors and pharmacies.

The cost of drugs will also be affected by labeling. In 2019, a pilot project on the traceability of medicines in the Russian Federation, operated by the Center for the Development of Advanced Technologies (CRPT), enters an active phase. The costs that manufacturing companies will bear at this stage will inevitably be included in the cost of the product.