Two months after the start of the first stage of labeling (labeling of drugs for high cost nosology), the Government of the Russian Federation approved a new cryptocode length. On August 30, Dmitry Medvedev signed amendments to Decree of the Government of the Russian Federation No. 1556 "On approval of the Regulation on the system for monitoring the movement of drugs for medical use." This means that manufacturers have to reconfigure equipment from 88 characters to 44.
The pharmaceutical industry insisted on 20 or less characters, but, as practice shows, it was not heard. Will manufacturers succeed, reorganizing in less than a month to meet new requirements, or will the current situation inevitably lead to destabilization of drug supply in the Russian Federation?
The question is rhetorical: why are there 44 characters and will this save the situation? ..
“44 signs will not fundamentally improve the current situation with labeling. The defects will continue to grow and productivity will decline, and together these factors will lead to higher prices for the final product, that is, medicines, ”said Victor Dmitriev, Director General of the Association of Russian Pharmaceutical Manufacturers.
Why is this number of characters chosen? 88, 44, 4 — is it just the magic of numbers or a complex mathematical calculation? Who benefits from this length?
In addition to serious costs for the purchase and configuration of equipment, manufacturers with a code length of more than 20 characters incur losses due to the large number of defects, which in some cases reaches 89% with a rate of less than 1%.
Patients do not care how many characters there are — the main thing is to purchase high-quality, safe, effective and inexpensive medicines. And in this situation, all market participants predict an increase in prices, especially for drugs that are not included in VED. If we talk about drugs from the list of essentials, the state regulates prices for them, and manufacturers are not entitled to raise them, so the cost of producing these drugs will be reimbursed at the expense of others. Victor Dmitriev emphasized that “there are laws of physics, and there are laws of economics. If defectiveness increases, if productivity decreases, cost increases, then profitability decreases, which can fall to a loss. This is an axiom that does not require serious economic research and proof. In this situation, everyone will survive in their own way. If the company’s portfolio contains many vitally essential drugs, then they will compensate for the losses from their unprofitable production at the expense of other drugs that are not on the Vital and Essential Drug List, which we have been seeing for a number of years. If the compensatory mechanism does not work due to limited resources and production becomes unprofitable, then the drugs will be removed from production altogether, then the drug crisis will arise on the market. ”
Prednisolone is a recent example of the lack of drugs on the market. This medicine is used to save people in dangerous conditions such as Quincke’s edema and anaphylactic shock. At the end of August, this drug was not in ampoules either in pharmacies or in ambulances. This is likely due to the fact that the sale of the drug at state prices is not profitable.
The task of the Ministry of Health of the Russian Federation is to provide the population with affordable, effective and high-quality drugs. And the cryptocode length does not affect these criteria in any way. The advanced technology development center for any length will receive a fixed fee for the code in the amount of 50 kopecks, which is 3.5 billion rubles from the patient’s pocket. The Ministry of Industry and Trade needs to report on the successful launch of labeling. It turns out that no one benefits from the length of the code. So why can’t it be reduced to the optimum value that manufacturers insist on?
The Association of Russian Pharmaceutical Manufacturers fully supports the implementation of digital solutions in Russian reality. But the introduction of digital solutions should be primarily useful to people. Viсtor Dmitriev stressed that “in order to change the current situation, it is necessary to fully comply with 425 Federal Law dated 12/28/2017“ On Amending the Federal Law “On the Circulation of Medicines”. Pharmaceutical manufacturers hope that the situation will be improved before January 1, 2020.