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Without formalities: business asks to simplify the path of drugs to buyers

How changing the expertise of new medicines will avoid their shortage

The largest associations of manufacturers of pharmaceuticals asked the government and the State Duma to simplify the procedure for introducing drugs into civilian circulation. Now new drugs undergo a long and complex examination before they are allowed to be sent to pharmacies. Simplifying the procedure for admitting medicines to the market will help ensure uninterrupted delivery of both domestic and imported drugs in the network and saturate the market, experts say. What is especially important against the backdrop of increased demand for medicines in recent weeks.

Calculation for support

The Russian government should be given the right to simplify the procedure for introducing drugs into civilian circulation. It should use it in a situation of shortage of medicines or the risk of its occurrence due to sanctions. This proposal was made by four associations of pharmaceutical manufacturers (ARPM, AIPM, SPFO, APF) on the eve of the consideration in the State Duma of draft law No. 80712-8 on measures to protect Russian citizens under sanctions. The letter (available to Izvestia) was sent to Prime Minister Mikhail Mishustin and State Duma Chairman Vyacheslav Volodin.

Now the law "On the Circulation of Medicines" establishes a very complicated procedure for bringing new drugs to the market - both Russian and foreign. To do this, the first three batches of the drug must be submitted for examination in the laboratory of Roszdravnadzor. This entails unnecessary costs and slows down the process of bringing new drugs to the market, said Victor Dmitriev, General Director of the Association of Russian Pharmaceutical Manufacturers (ARPM).

- The parties themselves are expensive. In addition, now there are difficulties with the conduct of the examinations themselves. They involve the use of special equipment that we do not produce. That is, it also needs to be purchased and brought to Russia, now there will be problems with this. It may simply not be sold - such precedents already exist, it may not be delivered, because the sky is closed. We propose to simplify the procedure for bringing new drugs to the market,” he said.

The ability to test new drugs under a simplified procedure will reduce the time and cost of bringing drugs to the Russian market, agrees Vladimir Shipkov, Executive Director of the Association of International Pharmaceutical Manufacturers (AIPM).

Earlier, on March 1, AIPM, which unites 60 foreign drug manufacturers, sent an appeal to the Ministry of Health and the Ministry of Industry and Trade, in which it declared its readiness to continue supplying drugs to patients in Russia, Vladimir Shipkov told Izvestia. But under the sanctions, maintaining full testing of drugs before entering them into civil circulation is a sensitive moment for the industry, he added.

We are counting on the support of the Ministry of Health. It is important that the industry confirms its readiness to deliver to Russia. This is reported not only by local offices of companies operating in Russia, but also by headquarters abroad. We are also discussing issues of economic and financial inclusion. It will be possible to come out with decisions after some stabilization of the exchange rate. Therefore, now the paramount issue is to ensure the uninterrupted physical availability of medicines. We proceed from the fact that the pharmaceutical industry should not fall under sanctions from any side. Only in such conditions it is possible to look for ways to solve the difficulties that have arisen, - Vladimir Shipkov is convinced.

There are opportunities to simplify the procedure for bringing new drugs to the market, Viktor Dmitriev noted. For a number of drugs, studies are carried out remotely, which significantly reduces the time of the procedure. And sending not three, but one, for example, batches of medicines for examination would help reduce the costs of manufacturers. There is no talk of a complete abolition of testing yet, Viktor Dmitriev specified. There is already support for this initiative among representatives of the government and the State Duma, he stressed.

Izvestia sent requests to the Ministry of Health and Roszdravnadzor with a request to express their attitude to the proposal of pharmaceutical manufacturers associations.

Demand is growing

The priority of the joint work of business and government in the current conditions is to ensure the smooth operation of pharmaceutical production in the country, said Denis Manturov, head of the Ministry of Industry and Trade, at a meeting with industry representatives on March 2. “It is important that the products necessary for the Russians continue to be produced, and the teams of enterprises continue their work. And we are ready to do everything that is required for this, ”said the head of the Ministry of Industry and Trade.

At the meeting, it was also noted that at the moment Russia has a sufficient supply of medicines, including the nomenclature of Vital and Essential Drugs. According to the participants, this was largely due to the "antique" experience of the pharmaceutical industry.

Despite this, against the backdrop of the general anxiety of the situation in Russia, an increased demand for medicines has been observed for the second week. As Izvestiya wrote earlier, the volume of sales in pharmacies in the week from February 21 to February 27 increased year-on-year in physical terms by 44%. And compared to the previous week (from February 14 to 20) - by 26%.

— Now there are a lot of orders, and they take larger volumes than before. The system does not have time to process such a large number of orders, so customers receive confirmations for receiving medicines with a delay. But this is temporary, due to rising demand. Everyone wants to buy at the old prices, although we have already revalued imported goods, ”a pharmacist in one of the capital’s pharmacies told an Izvestia correspondent.

Customers complain about long queues at pharmacies and shortages of certain drugs. For example, Izvestia was unable to find certain anticoagulants, hormonal drugs, and antihypertensive drugs in five pharmacies in different parts of Moscow.

“We have enough medicines in stock, they are constantly being delivered. The fact that our pharmacy did not have one or the other does not mean that there is a shortage now. It’s just that we usually don’t import drugs in large quantities, and against the backdrop of high demand, we managed to sort everything out from the counter, ”said an employee of another Moscow pharmacy, offering to order the missing drug through the application and pick it up tomorrow.

The bill on the protection of Russians under sanctions was submitted to the State Duma on March 3. The document is intended to facilitate the delivery of medicines to Russia and to help students expelled from foreign universities. It also involves the introduction of additional credit holidays until September 30 this year and provides for additional social assistance for Russians. In particular, the authorities are planning to establish pensions and prevent the development of unemployment.


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