More than 450 people with a rare genetic disease have not received imiglucerase for two to six months, according to the All-Russian Union of Patients. Recently, in Russia, there have been more and more reports of a shortage of one or another urgently needed drug. The situation should be changed by a government decree, a draft of which was developed by the Ministry of Health. It empowers Roszdravnadzor with the authority to control the volume and range of drugs from the list of vital drugs.
The document was published on the federal portal of draft regulatory legal acts; its public discussion will take place until March 5. Whether the amendments to the legislation will solve the situation with drug provision, Parlamentskaya Gazeta was investigating.
Deficit from Crimea to Amur
Back in February 2020, Prime Minister Mikhail Mishustin ordered to strengthen control over the range of drugs. Then he held a meeting on improving cancer care - doctors complained to the prime minister about interruptions in the supply of original cancer drugs.
But problems with a shortage of essential drugs arise not only among cancer patients. At the end of February this year, the Moscow Society of Multiple Sclerosis reported that a shortage of drugs for this and other autoimmune diseases has been observed since the fall of 2020.
Now the problem has also affected patients with Gaucher disease, in which the human body lacks an enzyme that breaks down fats in cells. If such a patient does not receive enzyme replacement therapy, his cells begin to die.
Recently, patients with HIV and cystic fibrosis, as well as pregnant women, have been complaining about the lack of necessary drugs. At the same time, it is impossible to buy the necessary tablets either at a low or at a high price.
“Now there is such a situation that the beneficiary can wait for his medication for a month or two, and it does not matter that it is, for example, insulin,” Aleksandr Petrov, a member of the State Duma Committee on Health Protection, told Parlamentskaya Gazeta. - They just say: wait. And no one at the pharmacy demands to immediately transmit the data that such a medicine is not available”. According to the deputy, state monitoring should be added to the control of the assortment of drugs that is now carried out by public organizations. This will help to avoid delays in the supply of drugs, primarily for beneficiaries.
Interruptions in drugs, and quite long, are also recorded by Roszdravnadzor itself. According to the department's report for 2019, problems with the provision of vital medicines arose in 15 regions - in Karelia, Crimea, Chuvashia, Ingushetia, Chechnya, Belgorod, Moscow, Tver, Yaroslavl, Leningrad, Pskov, Amur and Kemerovo regions, as well as in Moscow and Petersburg.
The marking is back
Where did the medicines disappear, and even from the list of vital ones, - all the last time experts, officials, manufacturers and sellers have been trying to figure it out. The versions have diverged.
So, in the Ministry of Industry and Trade, one of the reasons was called “the lack of a formed forecast demand for drugs” and called for tightening control over the market.
Manufacturers and sellers, on the other hand, blamed excessive control for the situation. Today, the state regulates the prices of essential drugs, and as a result, the production and sale of some drugs has become unprofitable for business.
“Each of us has come across a situation when you come to a pharmacy, ask for a drug for one hundred rubles, and they tell you: not for a hundred, but there is a similar one for four hundred,” Valery Ryazansky, first deputy chairman of the Federation Council Committee on Social Policy, gave an example.- And I think that the role of Roszdravnadzor is precisely to ensure that pharmacies do not get carried away with expensive drugs, but provide the entire line of drugs in stock and at an affordable price. That is, they, as a supervisory authority, must ask: why is there such a drug in a neighboring pharmacy, and there is such a drug in a wholesale warehouse, but you do not? And this, of course, will benefit us, the consumers."
Suppliers also have their own opinion on the deficit. They blame the problem on the new labeling system introduced on July 1 of last year. Because of her, 40 million packages of more than 450 different drugs have not entered the country, experts said.
“The labeling has really led to a certain deficit on the drug market,” acknowledged Vladimir Krugly, a member of the Federation Council Committee on Social Policy. “Including because of this, the question arose about controlling the availability of drugs: to assess which and where stocks, to identify the problem, to promptly purchase or redistribute existing resources.” The senator is sure that the introduction of monitoring is now especially relevant, since since February the marking system, suspended due to disruptions in November, has again been fully operational.
Until now, Roszdravnadzor only monitored the drug mark-up. However, drugs available on paper were often not available in pharmacies and hospitals. The new powers will allow the department to keep a full inventory of drugs, reacting in time to a possible shortage.
In pharmacies and hospitals, a supply of medicines will be created, which should be sufficient for at least six months. Roszdravnadzor will bring together in a single list all drugs produced in Russia, imported into the country, as well as stored in warehouses. The amount of sold or destroyed drugs will be subtracted from this volume, and then the remainder will be compared with the needs of the population. If it turns out that some medicine is left in the pharmacy or hospital for less than six months, its stocks will be replenished - for example, they will be transported from another region where there is an excess in this drug. If some medicine is not in Russia at all, it will be bought abroad.
“I hope that the introduction of monitoring will make us think once again what the system of drug delivery to privileged categories of the population should be,” noted Alexander Petrov. - This will speed up the remote delivery of prescription drugs, as well as speed up the full launch of the electronic prescription system, and launch a number of other important initiatives, as a result of which we can say that the drug supply system in Russia is working well. So far, unfortunately, we cannot say that."
Earlier, Parlamentskaya Gazeta reported that the Ministry of Health has also prepared a draft government decree that allows regions to exchange vital medicines with narcotic substances that are not registered in Russia. The document obliges regional health departments to send data on residues of drugs that are not needed every quarter, or, conversely, to submit applications for additional batches of drugs. Based on this information, the ministry will redirect a batch of necessary drugs from one region to another.
The VED list is regularly reviewed by the Government. In the last edition of November 23, 2020, 25 drugs were added to it. Now the total number of vital and essential medicines is 788.