Compliance test

The authorities are building new relationships with participants in the pharmaceutical market

In the midst of the crisis, the Ministry of Industry and Trade decided to please participants in the pharmaceutical market with at least verbal encouragement for the diligence shown in the first three quarters of 2008. The report of the Ministry of Industry and Trade on the state of Russian industry, released recently, gave a rather flattering assessment of domestic pharmaceutical production. Over the nine months of this year, the industry experienced significant growth: production volume increased in price terms by 22.5% and amounted to 52.9 billion rubles. The volume of investments has also increased: investments in the first half of 2008 were 17.2% more than in the same period last year. Such a breakthrough cannot be called unprecedented, but for the pharmaceutical market, which is still dominated by imported drugs, the growth of domestic production is a significant event.

But due to the financial crisis, the boom may be interrupted just before it began . The only way out for the Russian pharmaceutical industry, as many market participants and experts believe, is government support. “If we don’t want to lose the industry, the state will have to intervene and include pharmaceuticals in the list of industries in need of support,” David Melik-Guseinov, director of marketing research at the Pharmexpert Center for Marketing Research, told Vremya Novostei. According to the expert, the dependence of domestic producers on the state, of course, in this case will become much higher than the current one. “But you will have to choose the lesser of two evils,” says Mr. Melik-Huseinov. By “less”, representatives of the domestic pharmaceutical industry mean reducing the tax burden and providing long-term loans at low interest rates.

It is possible that the state will want just more. For example, influence the assortment policy of individual companies or participate in decision-making on mergers and acquisitions. Signs of a tightening of the regime for communication between officials and market participants are already being observed by foreign manufacturers operating in the domestic market. “Officially, everything looks good: manufacturers’ associations work in a commission to organize drug provision and amend the law on medicines. But at one point we realized that we were removed from work on the law - our access to information was blocked,” Vladimir Shipkov, executive director of the Association of International Pharmaceutical Manufacturers (AIPM), told Vremya Novostey. “I was even forced to write a letter to the minister regarding the reasons for such changes, but received no answer.” In addition, according to Mr. Shipkov, members of his association waited a long time to be called to the ministry to discuss new lists of drugs for the program for providing essential medicines (ONLS, former DLO). They promised to invite people right up to the day when the new list was approved and, ready-made, fell into the hands of businessmen. “On October 25, instructions on pharmacovigilance appeared that previously did not exist in Russia,” says Vladimir Shipkov. “My name is also in the preamble, although I was not invited to a single meeting where this document was approved.” And not a single proposal from our association was taken into account.”

Russian manufacturers so far interpret the commands coming from the authorities as “building a normal working dialogue between officials and the pharmaceutical community.” “Relations between the state and the industry are now being streamlined. The Ministry of Health and Social Development is clearly striving for this, Gennady Shirshov, executive director of the Union of Professional Pharmaceutical Organizations (SPFO), assured Vremya Novostei. — The other day, Minister Tatyana Golikova announced the creation of an expert council, which included all the main specialists of this department. They are the ones who must create standards for the provision of medical care, including in the field of drug provision. Thus, we are moving away from the situation where negotiations were conducted with individual pharmaceutical companies. Now a system is emerging in which representatives of the medical community conduct a dialogue with pharmaceutical unions and associations.”

Director of the Institute of Public Health Problems, Yuri Krestinsky, believes that the methods currently used by the Ministry of Health and Social Development to some extent narrow the space for corruption. He admits that the system in which drug lists will be compiled by specialists is much more civilized than the current one. “But so far, up to 70% of the financial remuneration of prominent domestic doctors comes from pharmaceutical holdings - in the form of grants, awards, prizes, scholarships and simply gifts; it is not entirely correct to talk about them as independent,” Mr. Krestinsky told Vremya news."

At the same time, Mr. Krestinsky admits that already next year the dependence of pharmaceutical companies on government drug supply programs and ministry decisions may increase. According to the latest data from his institute, there is a widespread shortage of financial resources in the pharmaceutical industry. There is a reduction in the pharmacy assortment, a shortage of certain types of drugs, and rising prices. A so-called crisis of confidence has arisen between manufacturers and distributors - the former are releasing goods with significantly shorter installment payments than a month ago. “The worst situation is for those who have a large share of accounts payable in the banking system or in bond issues,” states Mr. Krestinsky. As is known from open information of companies, these include the Russian manufacturer “Domestic Medicines”, the largest pharmacy chain “36.6”, and the distributor from Novosibirsk “Katren”. Against this background, the compliance of pharmaceutical market players in communicating with officials may turn out to be significantly higher than before.

Galina PAPERNAYA