The interview to Izvestia newspaper

The interview of the Head of the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation (Roszdravnadzor) to Izvestia newspaper.

Mikhail Murashko: “In the vast majority of cases, identified problems with drug provision in the regions are of an organizational nature. The most frequent cases are deficiencies in logistics, drug flow management in the RF subjects, the operation of regional information systems and a lack of control over the inventory management in the regions.”

Roszdravnadzor will catch drugstore staff red-handed

The Head of Roszdravnadzor Mikhail Murashko — about the drug labeling, increasing control over their sale and the purchase of essential drugs for people with HIV

This year, there have been several changes in the pharmaceutical market. Now, the Ministry of Health and not the regions, purchases antiretroviral drugs to treat HIV-infected patients. In addition, a pilot project was launched for the drug labelling, and Roszdravnadzor will get the opportunity to carry out unannounced inspections and perform test purchases in drugstores.

Mikhail Murashko, the Head of Roszdravnadzor, told to Nataliya Berishvili, the Izvestia correspondent, how these innovations will affect the price and range of medicines in pharmacies and when HIV-infected people will receive vital and essential drugs.

— How do you assess the population coverage with essential medicines?

— In general, the situation can be described as stable. For this purpose, the Government and the Ministry of Health have done a lot. The share of recipes that are on the deferred provision remains at the previous year’s level (0.01%).

According to the data obtained from authorities of the health departments of all the RF subjects, today, more than 3.8 million of Russians are entitled to subsidized medicines.

In the vast majority of cases, identified problems with drug provision in the regions are of an organizational nature. The most frequent cases are deficiencies in logistics, drug flow management in the RF subjects, the operation of regional information systems, as well as an insufficient control over the inventory management in the regions and a low availability of drug provision for residents in remote areas. In some cases, this leads to the fact that patients do not get medications timely.

Roszdravnadzor has several resources to ensure control over the situation. Firstly, we conduct a monthly monitoring of prices and range of essential drugs (EDL) for outpatient treatment, i.e. drugs that are sold in pharmacies. Secondly, each manufacturer and importer-supplier informs us of the quantities of medicines produced and imported into the territory of the Russian Federation. Thirdly, we analyze public appeals and conduct scheduled and unscheduled inspections.

 — Do you receive many complaints?

— We receive regularly public appeals. For example, in the first quarter of this year, we received 150 complaints about the medicinal provision of HIV-patients and each complaint has been considered and a decision taken. We assessed the stocks of medicines in health facilities and identified several tense points in some regions. The Ministry of Health promptly solved the problem.

In addition, starting from 2017 the Ministry of Health has implemented a more effective mechanism of centralized purchases of antiretroviral drugs (ARV) for treatment of patients infected with the human immunodeficiency virus.

Tendering procedures have already been held. The state contracts provide for the 40-60% ARV supply until May 1, and by the end of May, all regions should receive the necessary medication.

— How effective is this practice? 

—The first results showed that the decision of the Ministry of Health to consolidate the purchases was correct. Now, we completed the placement of the purchase order for about 80% of the annual volume requirements of drugs for the HIV treatment, and if last year we paid 20 billion rubles, then, this year – only 17 billion rubles. For example, according to the Ministry of Health, it managed to reduce the price of Lopinavir+Ritonavir from 61 to 38 rubles per pill.

— Will the savings be spent on additional purchases of drugs for HIV-infected people? 

— In April 2017, the Ministry of Health approved the rules of maintaining the Federal register of persons infected with the human immunodeficiency virus and individuals with tuberculosis. This will allow personalizing the need for specific drugs for each patient in any region of the country. Decisions will be made based on these data.

— Prices for vital and essential drugs increased by 1.4% over the past year, which is even lower than the rate of inflation. Could it lead to the situation when cheap drugs will disappear from the market because it will not be profitable to produce them?

— Our monitoring showed that last year did not witness a significant shortage of drugs. The whole range of drugs under international nonproprietary names for pharmaceutical substances (INN) was present.

It should be noted that the manufacturer has the right to conduct the price indexation for specific trade names within the framework of established procedures.

— In 2016, Roszdravnadzor paid special attention to the control over the sale of prescription drugs for medical abortion. Why did you focus on these medicines?

—Their use without the supervision of medical staff can threaten health and even life. There were cases of admission of women to hospitals with heavy bleeding. However, for some pharmacy staff the main thing is to get profit, so they sell these drugs without a doctor’s prescription. We stopped a few chains of such sales in 2016, and we continue this work in 2017. Moreover, we will be able to catch these sellers red-handed thanks to changes in the legislation. For the violation of the established procedure of the sale of the prescription drugs, they will be charged with administrative responsibility, up to the suspension of activities.

— Can you be more specific?

— From January 1, 2017 the Federal law “On protection of rights of legal entities and individual entrepreneurs when exercising state control (supervision) and municipal control” includes one more control measure — a test purchase. Now, the Supervisory authority without notice may buy products to verify the compliance with the legislation. However, Roszdravnadzor staff will get the right to make test purchases after making amendments to a number of Federal laws.

Currently, the draft law is being agreed upon. In case of its adoption, the staff of Roszdravnadzor will be able to make sudden test purchases of prescription drugs disguised as a regular buyer. It will be a new form of control.

— March witnessed the launch of a pilot project for the drug labelling. What does the labelling look like?

— It is a two-dimensional code, i.e. a square with applied pixels. Now, the Federal Tax Service, which implements this project jointly with us, develops a software product. However, six companies-volunteers already installed the necessary equipment. This year, in the framework of the pilot project 10% of drugs will be labelled in value terms.

At the initial stage, the experiment covers nine regions. After the software development and expansion of technical capabilities, the system will be gradually extended to all the subjects of the Russian Federation.

From January 1, 2019 the labeling will be compulsory for all. In addition, since about 6.5 billion packages are sold annually in the Russian pharmaceutical market, we are facing quite a challenge.

— Perhaps with the help of the labels it will be easier to control OTC trade?

— No doubt. Each package will have its own number in the newly created database. And, its sale will take place not just in pharmacy, but also through the online cashier. The drug sale information will go to Roszdravnadzor and the Federal Tax Service. Therefore, the labelling system will allow not only to control the movement of drugs from the producer to the consumer, to prevent offences and to protect patients from substandard, falsified, counterfeit drugs, but also to protect them from drug sale violations.

— It is likely that the producers will install the labelling equipment at their own expense. Will it affect the drug prices?

— All expenses will be incurred by manufacturers, the cost for whom per a drug package shall not exceed 50 kopecks for a 1.5-year period. It should be recalled that the cost of drugs from the essential drugs list are fixed by the state and will not change.