Coming "Medicines Collapse" Discussed in the State Duma

Coming "Medicines Collapse" Discussed in the State Duma
State Duma deputy is convinced federal ministers must provide the Parliament in the long run with a list of planned measures to be taken by the government in order to avoid increases of prices of medicines, the absence of certain drugs and an overall shortage of pharmaceutical products.

Since the first days of discussion of new regulation for the labelling of drugs, representatives of the pharmaceutical market have been warning that the new norms for may result in a real “pharmaceutical collapse". A few months ago, it was argued that from January 1, 2020, a number of important medicines would disappear from Russian pharmacies. The remaining drugs might either see a price hike or become inaccessible. The problem escalated to a full-blown crisis that should have been addressed earlier but the government ignores it for some reason. The State Duma decided to draw attention to it. Today, a tough response of the parliamentarians is the only chance to avoid the “pharmaceutical collapse".

The acute and really pressing issue of drug labelling was raised last Thursday at a regular plenary session of the lower house of Russian Parliament. Not only opposition deputies, but also the State Duma majority decided to oppose the thoughtless implementation of this idea in the domestic market. Thus, Andrey Isaev, a member of the United Russia party faction, called the situation "blatant".

“Today, people cannot buy the medicines that are available in our country, for which, incidentally, billions of rubles are allocated from the budget,” Isaev said, adding that the drug labelling had been conceived as a tool in the fight against counterfeiting and abuse. However, “any good idea can be easily spoiled by poor performance”, he added.

It is noteworthy that last Tuesday, the question of the coming collapse of the pharmacological market was raised already by market operators at the parliamentary hearings. Business executives claimed that the existing system was simply not ready for launching. They are convinced that later on, from the very first days of next year, the Russians will lose the opportunity to buy medicines without new labels. Moreover, even if producers have time to meet these requirements and provide the market with drugs in new packages with appropriate labels, there will problems on the part of pharmacy chains, since most pharmacies simply cannot read the new code from the package.

More than 1,000 manufacturers, 2,500 distributors, 35,000 pharmacies and medical facilities are to be included in the new labelling system, with more than 6.5 billion packages to be labelled. “At present only 15% of the total number of market operators are registered in the system. Furthermore, data only on 8% of drugs are included. And the launch is in just two months,” Isaev said. He added that only 45% of operational packaging lines have been re-equipped, while there is no exact information if the pharmacies are prepared to work under the new rules, according to the report of the Association of Manufacturers. Preliminary figures show that only 12% to 40% of pharmacies are ready for innovations. It concerns just big pharmacy chains with no such data on small business. On the top of that, the new system has never been tested on a large scale, Isaev said.

Meanwhile, the federal government is conducting an experiment on labelling and hopes to summarize it by February, that is, by that time when the new system should become mandatory for everybody for over a month. But there is more to it. Isaev noted that the new obligatory labelling system would also lead to the price increase. The medicines will rise in price by only 2 rubles on the average. But this is an average figure, and the price increase for certain items might be more significant. For example, the price rises of some low-cost medicines will the most noticeable. “The quality of their packages is much lower, and the speed of the packaging is faster. It results in more frequent defects, already up to 30%. All this will be included in the prime cost,” Isaev said. According to him, there is another potential danger, which is a hike of costs for vital and essential drugs, the prices for which are strictly fixed. In this case, companies will refuse to produce these medicines due to their low or negative profitability. The producers themselves earlier indicated that such risks are not Isaev’s fantasy in any way.

In this regard, Isaev addressed his colleagues in the State Duma with a request to respond promptly to the situation and to draft amendments to the law, ensuring the smooth implementation of the new system by the participants. For instance, they could establish a transition period until at least the middle of 2020. Moreover, he suggested that the deputies

should press the government and oblige it to report on the results of the experiment no later than December 1 of this year. Lastly, Isaev is convinced that federal ministers must furnish the Duma with a list of planned measures to be taken by the government in order to avoid the increase of prices for medicines, the absence of certain items in pharmacies and an overall shortage of such products.