ARPM: It’s Time to Change the Paradigm of Presumption of Guilty Customer

Partnering session “Modernization of the pharmaceutical health sector at the regional level. Features of the drug supply system in the regions of Russia ”was held as part of the IV All-Russian GMP conference with international participation in Svetlogorsk.

The Association of Russian Pharmaceutical Manufacturers together with the Ministry of Health of the Kaliningrad Region, leading representatives of the pharmaceutical industry addressed urgent issues and prepared constructive proposals for the formation and implementation of a national drug policy.

Today, the cost of providing stationary and high-tech assistance is rising in the country. The issues of financial affordability of drug therapy, especially at the outpatient stage, were given special attention by the expert community. The pilot drug reimbursement project, which is being successfully implemented in the Kirov region, was examined in detail.

The program operates in 15 districts of the region, and over 7 months of operation has shown its effectiveness. Its essence is that the patient, on the basis of the prescribed prescription, chooses the drug in the pharmacy for any trade name, but in strict accordance with the approved list of international nonproprietary names formed as part of the VED list. The patient pays only half the cost of the medicine, and the pharmacy receives the remaining funds in the form of subsidies from the state. In order to avoid duplication of benefits, a rule has been introduced: if a patient received this drug by INN for a regional or federal benefit, then a prescription for drug reimbursement is not issued to him. In just six months of testing the project, more than 16 thousand recipes were stocked.

According to the Minister of Health of the Kirov Region Andrei Chernyaev: “The project is in demand not only for patients who are not eligible for preferential drug provision, but also for preferential categories of citizens who purchase drugs according to their usual trade names. The total amount of drugs sold is more than 29 million rubles. The average retail price of a package is 135 rubles, and the co-payment is 69 rubles. The most popular are basic drugs: beta-blockers, statins, sartans, antiplatelet agents. ”

Alexander Hadzhidis, chief clinical pharmacologist of the Health Committee of the Government of St. Petersburg, did not agree with some points of the experiment: “patients have the right to choose a doctor, and the doctor must choose the brand name of the medicine. Any primary care doctor should have a list of drugs with proven efficacy. ”

In general, the session participants supported the initiative. They suggest introducing similar pilot projects in 10-15 regions. Such an approach should be in the treatment of all classes of diseases, the mortality rate from which is the highest, and these are cardiovascular, endocrine, oncological diseases, that is, the most common. Our society has absolutely clear objectives — reducing mortality from the main causes.

Scientific supervisor of the Federal State Budgetary Scientific Institution National Research Institute of Public Health named after N.A. Semashko Ramil Khabriev during the discussion emphasized: “Kilograms, prices, number of packages, domestic or foreign — there are many indicators, but first of all we must take into account the interests of patients”!

The issues of quality of drug provision are invariably associated with the provision of medical care in general. Today in Russia a number of unique projects are being implemented, so the program “12 high-cost nosologies” has no analogues in the world. Unprecedented measures of social support are being carried out in the country, including in the field of drug provision on a reimbursable basis.

“Ensuring the availability and quality of drugs is closely linked to the reaching of a common state objective to increase the life expectancy of Russians,” said Victor Dmitriev, Director General of the Association of Russian Pharmaceutical Manufacturers.

The regulatory framework in the field of drug provision is constantly being improved. Despite the work done, a number of unresolved issues remain. Difficulties arise due to lack of logistics, inventory management by regional health authorities. Competitive procedures for the procurement of drugs are not conducted on time. Substantial territorial disparities in funding remain. These issues are constantly monitored by regulators and law enforcement agencies, they are no less acute in business.

Considering the interim results of the procurement campaign 2018-2019 in the framework of FL-44, Alexander Hadzhidis noted that “now we treat patients with rare diseases better than patients with frequent diseases. In St. Petersburg, funding increased by 9%. 1.3 billion rubles were spent on orphan diseases for 290 patients, which is 30% of all funds allocated for privileged patients. ”

Disruptions in public procurement of vital medicines are becoming commonplace, in the first half of 2019, the number of failed tenders doubled, accounting for 28% of the total number of tenders. The main reason was the methodology for the formation of the initial maximum contract price, which increasingly sounds like a “sad maximum contract price”, because of which suppliers do not enter tenders, because sale at the proposed price leads to losses.

According to experts, the idea of ​​using reference prices in the formation of the initial contract price is not bad, and will allow moving forward in this matter. However, the Ministry of Health does not support this idea. Our goal-setting has moved — we think not how to conduct tenders more efficiently, but how to protect the customer from inspections by law enforcement agencies. With such a paradigm, we will remain at the debacle of failed trades. It’s time for our valiant law enforcement officers to abandon the presumption of guilty customers, to care for patients, because among them may be their close and relatives.

The cartel theme is painful for the pharmaceutical industry. Every year, the Federal Antimonopoly Service (FAS) of Russia draws attention to violations. Over the past two years, 82 regions are covered by cartels, in Moscow alone there are dozens of cases, hundreds of companies, more than 11 thousand electronic auctions. Participants in these anti-competitive agreements are distributors, customers, manufacturers and government officials at various levels. A distinctive feature of these crimes is that the activities of cartels are lobbied by government officials.

By tradition, the participants in the Partnering session summarized the discussion:

Alexander Hadzhidis: “The process is difficult, it is moving forward, it is good, but it is necessary to create registers, a single regulatory framework”

Ekaterina Eliseeva, chief freelance clinical pharmacologist of the Russian Ministry of Health in the Far Eastern Federal District: "Let’s look for compromises and effective ways of working for the benefit of our patients."

Ilya Wesker, Director for Government Relations at Takeda: “We have important and ambitious goals. Only together can they be achieved. ”

Vadim Kukava, Executive Director of the Infarma Association of the Leading World Innovative Pharmaceutical Companies: “At present, the reform of the pharmaceutical supply system of the Russian Federation is beginning. Now a fundamental thing is happening, which on the horizon of 3-5 years can change the paradigm of drug provision throughout the country. ”

Whether this happens or not, we will discuss it in a year at the VIII Partnership “Russian Medicines — Towards an Interdisciplinary Dialogue”, which will again meet the participants on the Baltic Sea in Svetlogorsk.

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