Right to the first pill

Roszdravnadzor promised administrative support to pharmaceutical manufacturers

On the eve of today's meeting between First Deputy Prime Minister Dmitry Medvedev and the leadership of the Ministry of Industry and Energy to discuss the problems of the medical industry, domestic manufacturers of medicines and medical equipment subordinate to this ministry reminded the state of their requests. Actually, the request made at the 1st Congress of Medical Industry Enterprises was essentially the same. “Give me some money!” - cried the manufacturers, whose enterprises have changed little since Soviet times. They addressed the head of the Federal Agency for Industry, Boris Aleshin, and the head of Roszdravnadzor, Ramil Khabriev, two government officials who attended this event. They also recommended that domestic producers learn how to earn money. And as soon as possible, since there is not long left before joining the WTO. And then manufacturers who rely only on state support will not survive - after all, only a few production lines in the country meet the international GMP quality standard.

Although Mr. Khabriev is not yet the curator of medical enterprises under the wing of the Ministry of Industry and Energy, he nevertheless showed that Roszdravnadzor has a plan to bring them out of the tailspin. This plan, at first glance, is simple, has been announced several times already and boils down to the fact that our backward manufacturers need to master the production of generics (exact copies of original Western drugs, the patent protection of which has expired). “We need to be the first to enter the market with these drugs. We guarantee accelerated registration of generics; there is no need to wait for the end of patent protection; registration documents must be submitted in advance,” the head of Roszdravnadzor admonished the manufacturers gathered in the hall.

According to the official, the state is even ready to “prevent the emergence of second generics by creating a priority regime for the first.” That is, somehow prevent entry into the Russian market or create unfavorable competitive conditions for imported analogues, perhaps for some time. It is impossible to fulfill such a promise in a free market, without attracting administrative resources, says Pharmexpert CMI analyst David Melik-Guseinov. “The main principle of the WTO is free competition,” he told Vremya Novostei. -- Since Russian production sites generally do not comply with the international GMP standard, even if domestic manufacturers are the first with their generic product on the market, foreign companies will always be able to supplant them later. After all, their analogue will be positioned as made in accordance with global standards and sold all over the world. We won’t be able to get into the foreign market with our generic.”

The protectionism promised by Mr. Khabriev is, of course, very pleasant for industry. But for the budget that finances the drug provision program for beneficiaries, and the end consumer who buys drugs in pharmacies at their own expense, this measure is unlikely to seem effective and correct. “Generics differ from the original primarily in price,” Alexander Kuzin, general director of the marketing company DSMGroup, explained to Vremya Novostey. World and domestic practice shows that the first generic is usually only 10-15% cheaper than the original drug, and the third and fourth are ten times cheaper. “If the state protects the first “copy” from competitors, then it will never become cheaper,” Mr. Kuzin believes.

Let us remind you that starting from the new year, the list of drugs purchased within the framework of the state program for additional drug supply will be replenished with a significant number of domestic medicines. At the same time, the refusal to import was due not only to the desire of officials to support Russian producers, but also to the desire to reduce budget expenses for DLO.

Galina PAPERNAYA