Recipe for panic

Another “improvement” of the Criminal Code has resulted in a stir in pharmacies

Representatives of the Federal Drug Control Service held a special press conference yesterday in order, in the words of the department’s deputy director Alexander Fedorov, to “dispel myths and rumors” generated by the adoption of government resolution No. 964 “On approval of lists of potent and toxic substances for the purposes of Art. 234 of the Criminal Code of the Russian Federation.” It was published and came into force last week, and concerns the practice of applying Article 234, which provides punishment for “illegal sale of potent and toxic substances.” As Mr. Fedorov noted, in terms of defining potent substances (DS), “everything was clear to them before,” and the adoption of this resolution was a purely “technical” decision - to clarify the legislation. However, as the very first hours of the new rules for the circulation of pharmaceuticals showed, they not only did not bring clarity, but also gave rise to new legal conflicts, which immediately resulted in problems with medicines in some regions and put pharmacists in a very ambiguous position, caught between two fires.

Even before the start of the press conference of representatives of the Federal Drug Control Service, alarming reports began to be received from different parts of the country that local pharmacies began to refuse to sell such common and still available drugs without prescriptions as Corvalol, Valocordin (Valoserdin), Pentalgin and some others. In the same regions, including Moscow, where these drugs remained on free sale, buyers began to stock up on them for future use, threatening to deplete the existing “on-duty” stocks of pharmacies. The reason is the fact that the substances included in these drugs were included in the “list of DM” approved by the resolution, from which it followed that from now on the sale of “all dosage forms, no matter what brand names they are designated” will be considered a crime. and “all mixtures and solutions containing the substances listed in this list, regardless of their concentration.” Of course, we are only talking about the illegal sale of these drugs, however, pharmacists were racking their brains as to what could be understood by this “illegal sale” - after all, the rules of “legal” or in other words, legal circulation of SVs are not regulated by law. And local specialists could not understand how they could now sell these medicines - either they need to obtain a new license to work not only with medicines, but also with SVs, or sell them only by prescription.

In this regard, even before the press conference, Mr. Fedorov had to contact the Minister of Health to “settle” the issue, and then reassure the journalists. “Corvalol and Valocordin have been and will remain freely available in a form accessible to the population,” said the deputy director of the Federal Drug Control Service, noting that no changes were made to the order of the Ministry of Health approving the list of over-the-counter drugs. “Medicines that are currently sold over-the-counter but contain certain amounts of potent and toxic substances will be dispensed in the same manner, over-the-counter,” he said.

However, Mr. Fedorov’s explanations and promises did not solve the problem. Many experts (both lawyers and pharmacists) admitted that a legal conflict had again occurred, formally giving rise to certain representatives of law enforcement agencies to regard the sale of these drugs even in pharmacies as a crime. After all, formally, one or another investigator or operative may find fault with the fact that legal sellers do not have any new license. And the fact that no one has yet handed them over, as the epic with drug police persecuting veterinarians showed at the time, cannot serve as an excuse at all.

Formally, the same harmless Valocordin may be “outside the law” because it contains phenobarbital as an active substance - a substance from the list, which means it should not be sold without a prescription. On the other hand, Corvalol, Valocordin and a number of other drugs that are subject to the regulation are included in the list of so-called “vital and necessary drugs” that pharmacies are required to stock in their assortment. In addition, according to experts, there is simply no replacement for Corvalol, Valocardin and Valoserdin. And if someone decides to meticulously follow the letter of the law - and there are legal grounds to involve the owner of the pharmacy, then, as one doctor puts it, “the old people will simply blow up the work of district clinics.” This “legal hole” forced pharmacists to play it safe and slow down the sale of medicines, which had so worried pensioners, including in St. Petersburg.

The Ministry of Health yesterday issued an explanation: “Combined medications containing potent substances and at the same time included in the List of Medicines Dispensed Without a Doctor’s Prescription (Order of the Ministry of Health and Social Development of Russia dated September 13, 2005 No. 578), as before, are dispensed to the population without a doctor’s prescription " After this, local authorities everywhere still allowed the over-the-counter sale of these drugs, but theoretically the problem remained.

And due to the unclear definition of what potent substances are, many companies and people have already suffered in the past . Moreover, yesterday the deputy director of the Federal Drug Control Service was unable to clearly answer the question of what law determines the procedure for the legal circulation of pharmaceuticals. According to Mr. Fedorov, there are “dozens of laws and regulations,” but he could actually name only two, and even then they related to the rules for exporting these substances abroad. As for the algorithm for licensing the activities of companies working with hydrocarbons, it again does not exist yet. “Each specific substance needs to be dealt with separately; different types have their own rules and legal acts,” said Mr. Fedorov. But he did not specify what to do for companies working with thousands of types of substances. In addition, it remains unclear on what grounds the Federal Drug Control Service previously initiated criminal cases under Article 234 - after all, there were no such legal lists before. But there were a lot of cases, and very scandalous ones. For example, the “chemists’ case” is against employees of the company “Sophex” who were “under attack” for the use of ethyl ether, announced by the drug police of the SV. People even managed to spend time in a pre-trial detention center, and suddenly it turned out that the accusations were in vain. And ethyl ether was not on the government list.

Mr. Fedorov commented briefly on this situation yesterday: “Act according to the law - you can’t go wrong. Today it’s prohibited - don’t do it, tomorrow they’ll allow it - do it.” What to do if there is no law, as now, remains a mystery.

As Sofya Malyavina, assistant to the head of the Ministry of Health and Social Development, explained, “it is clear from the resolution that combination medications, where potent substances are combined with pharmacologically inactive ones, should continue to be dispensed by pharmacies without prescriptions.”

But experts are inclined to see a bit of “therapeutic” deceit in the ministry’s statement. “It cannot be said that Moscow and St. Petersburg officials misinterpreted the resolution. Of course, drugs such as pentalgin, valocardine and corvalol contain phenobarbital, which means that after this document comes into force they should be sold only by prescription,” David Melik-Guseinov, leading analyst at the Pharmexpert Marketing Research Center, told Vremya Novostei. “This, by the way, is fully consistent with international practice.” According to Mr. Huseynov, now ministerial officials say that they were misunderstood locally, only because they do not want to provoke mass discontent among pensioners in a presidential election year. Sooner or later, all the listed drugs will still become prescription drugs, the expert is sure.

But even before everything becomes clear, and the usual drugs begin to be dispensed only by prescription, their prices may begin to rise. The fact is that Russians buy approximately $100 million worth of phenobarbital drugs per year. According to RMBC, in the first nine months of 2007, Russians drank $15.3 million worth of Valocardine, $13.3 million worth of Corvalol, and $39.5 million worth of Pentalgin. The introduction of prescription drugs will inevitably reduce sales. To keep profits at the same level, manufacturers will simply be forced to raise selling prices.

Eduard LOMOVTSEV, Galina PAPERNAYA, Alexey GRISHIN