Doctors are now twice as likely to accept gifts from drug manufacturers and agree to recommend drugs from specific companies to patients. This was shown by the inspections of Roszdravnadzor, with the report on the results of which Izvestia got acquainted. Typically, to circumvent legal restrictions, physicians are rewarded for "consultations" or "lectures." At the same time, doctors are interested not only in money, but also in acquaintance with the novelties of the pharmaceutical industry, therefore, it is not worth completely excluding their communication with companies, experts say.

The fact that physicians have begun to neglect professional ethics more often when communicating with representatives of pharmaceutical companies is stated in the report on the results of the work of Roszdravnadzor in 2018. In particular, 7.3% of inspections showed that doctors entered into agreements on the prescription or recommendation of a specific drug, and also received drugs and medical devices from companies to hand over to patients. A year earlier, such cases were detected only in 3.1% of audits due to professional restrictions. Also, in 7.3% of cases last year, doctors received gifts or money from organizations whose activities are related to the circulation of drugs or medical devices. In 2017, such facts were discovered during 4.2% of inspections.

The report of the department stipulates that last year the employees of the service carried out 1.6 thousand inspections of the observance of professional restrictions by medical and pharmaceutical workers. Both legal entities and individual entrepreneurs fell under the audit. Roszdravnadzor did not promptly respond to Izvestia's request to provide details of the violations identified. In turn, the press service of the Ministry of Health said that these issues fall within the competence of the supervisory authorities.

Gift vs compensation

Since 2011, accepting gifts from pharmaceutical companies and recommending specific drugs to doctors has been prohibited by the law "On the Fundamentals of Health of Citizens in the Russian Federation." By the way, doctors are allowed to receive gifts from patients, but gifts should not be more expensive than 3 thousand rubles.

At the same time, drug manufacturers are not prohibited from organizing events for doctors, giving them samples of drugs not for patients, and paying for lectures or participation in clinical research, reminded the general director of the Association of Russian Pharmaceutical Manufacturers Viktor Dmitriev.

There can be no written contracts specifically for the recommendation of a specific drug - they are illegal, most likely, we are talking about oral agreements, - he told Izvestia. - You can transfer funds to a physician, for example, for a lecture at a scientific and educational event of the company - the cost varies depending on the level of the specialist, on average it is from 5 thousand to 25 thousand rubles.

The expert noted that pharmacists try not to give gifts to doctors. However, representatives of Roszdravnadzor could consider it illegal to transfer, for example, a notebook or pens with the company's symbols, the specialist suggested.

Some companies are required to report spending on payments to doctors - such a requirement is put forward by the European Federation pharmaceutical industry and associations. Through membership in the Association of International Pharmaceutical Manufacturers (part of the federation), this rule applies to Pfizer, AstraZeneca, MSD, Sanofi, Ipsen and others operating in Russia. The companies are due to publish their last year reports by June 30th. In 2017, payments to doctors amounted to up to 0.5 million rubles, it follows from the data provided by firms. Basically, the expenses are indicated in the documents as payment of registration fees for participation in conferences, compensation for travel expenses and fees for consultations.

There are tens of thousands of medical representatives in the states of pharmaceutical companies in Russia, said Yury Krestinsky, Chief Executive Officer for the Healthcare Industry of Sberbank.

Their task is to inform about new technologies, methods of their application, comparative effectiveness. Doctors, as a rule, do not have the opportunity to study new items on their own - many of them cannot afford further training. Therefore, I would not interpret communication with pharmaceutical representatives as something criminal. Of course, there are distortions and attempts at bribery, but not everywhere, the specialist is sure.

It is quite problematic to track whether a doctor has recommended a drug to a patient from a particular company, says Gennady Shcherbakov, deputy chairman of the trade union of healthcare workers in Russia. The prescription, as a rule, contains the international non-proprietary name, and the conversation with the patient takes place outside the office door. However, while pharmaceutical companies are ready to use such a dubious method of promotion, there will be doctors ready for agreements who are not satisfied with their income, the expert said.

The average salary of a doctor in Russia last year was 75 thousand rubles, or 198% of the average salary in the country, follows from the data of Rosstat. According to the instructions of the president, the income of doctors should be twice the average for the region.

An important innovation recent years in the sphere of circulation medicines are the requirements for the organization of scientific events by pharmaceutical companies. One of the aspects of these requirements is the obligation of pharmaceutical companies to disclose information about scientific events to Roszdravnadzor, as well as to ensure the publicity of information about events by posting information about the event on their website.

However, provisions Federal law dated 12.04.2010 No. 61-FZ "On the Circulation of Medicines" (hereinafter - the Law on the Circulation of Medicines) only outlines the scope of such disclosure. These provisions are discussed in more detail in the documents of Roszdravnadzor, first of all, in its information letters, which are not normative legal acts (see. Letter of Roszdravnadzor dated December 25, 2013 No. 16I-1595/13 (as amended on March 26, 2015) "On informing Roszdravnadzor about scientific and other measures" taking into account the Letter of Roszdravnadzor dated March 26, 2015 No. 01I-468/15 "On informing Roszdravnadzor on scientific and other activities "and Letter of Roszdravnadzor dated December 16, 2014 No. 01I-2001/14" On informing Roszdravnadzor about scientific and other activities "). In this regard, the question remains how to properly such disclosure should be carried out in order to minimize the risks of the pharmaceutical company conducting the event.

Subjects of information disclosure

First of all, it is worth highlighting the subjects of information disclosure. According to Part 2 of Art. 67.2 and para. 1 h. 1 tbsp. 67.1 of the Law on Circulation of Medicines, the following persons are required to disclose information about the event:

• organizations engaged in the development, production and (or) sale drugs for medical use;
• organizations that have the rights to use the trade name of a medicinal product for medical use;
• organization of wholesale trade in medicines;
• pharmacy organizations;
• their representatives and other individuals and legal entities operating on behalf of these organizations, organizing and (or) financing events.

In the latter case, in our opinion, the presence of relations of representation in the sense of Ch. 10 of the Civil Code Russian Federation for example, a contractual clause clearly indicating that a person is acting on behalf of another party (for example, an agency agreement). In order to protect their interests, such agreements should include a clause concerning the fulfillment of the obligation to notify Roszdravnadzor. In the event that the relations of representation are not clearly established in the agreement between the parties, then it cannot be assumed that the person acts on behalf of the above organizations.

List of information to be disclosed

The second question is related to the list of disclosed information. Part 1 of Art. 67.2 of the Law on Circulation of Medicines provides that information on:

• scientific events;
• measures aimed at improving the professional level of medical workers;
• measures aimed at providing information related to the monitoring of the safety of medicinal products.

To date, there is no clarification of the competent authorities on the interpretation of the criteria for assigning activities to these categories. In this regard, when determining whether an event refers to a scientific or other event within the meaning of Art. 67.2 of the Law on the Circulation of Medicines, it is necessary to use the concept of scientific activity provided for by the legislation of the Russian Federation (Article 2 of the Federal Law of 23.08.1996 No. 127-FZ "On Science and State Scientific and Technical Policy").

In addition, the current legislation does not specify the forms of events. The event can take place in the form round table, conference, congress, lecture, seminar, master class, etc. Regardless of the form of the event, information about the event must be submitted to Roszdravnadzor.

In this case, the following information must be submitted to Roszdravnadzor:

• date of the event;
• location of the event;
• time of the event;
• event plan;
• program of the event;
• topic planned for consideration;
• list of participants.

Disclosure period

In accordance with the Law on the Circulation of Medicines, information is sent and posted on the website no later than 2 months before the event.

Confirmation of the fulfillment of the obligation within the prescribed period is the information of the AIS "List of notifications on the conduct of scientific events". However, as practice shows, there are failures in the operation of this system. The simplest solution in this situation is to duplicate the disclosed information by e-mail. The employees of Roszdravnadzor recognized the legitimacy of this method of disclosure, however, there is no official clarification on this issue, and therefore, in order to avoid the risks of prosecution, in our opinion, it is necessary to notify Roszdravnadzor by registered mail with notification of technical problems, attaching the information necessary to disclosure, which will indicate that the person has taken all measures depending on him to comply with the requirements, which means, in accordance with Art. 2.1. The Code of Administrative Offenses excludes the fault of a legal entity.

Form and procedure for disclosing information

First of all, a pharmaceutical company needs to get access to the AIS "List of notifications on scientific events" of Roszdravnadzor: for this, it is necessary to send information according to the form established by Roszdravnadzor information letters to the email address This email address is being protected from spambots. You need JavaScript enabled to view it. and on paper with the seal of the organization at the address: 109074, Moscow, Slavyanskaya square, 4, bldg. 1.

Since the submitted form requires the indication of an authorized person, it is necessary to issue an order from the head of the organization on the appointment of a person responsible for providing information to Roszdravnadzor. Depending on the content of the employee's duties, it may be necessary to amend the job description.

Disclosure of information is directly organized through the AIS "List of notifications on scientific events." In addition, it is required to post similar information on the official website of the organization. It is advisable to create a separate section of the website in Russian ("Notice of scientific and other events with the participation of medical workers of third-party organizations"), in which the relevant information will be posted. In practice, the website of pharmaceutical companies in this section duplicates a table sent to Roszdravnadzor, indicating the update of the information.

One of the most pressing issues is the question of proving the placement of information on the company's website. The Internet Archive Wayback Machine or other analogs can be used as evidence of posting information on the official website. Arbitrage practice acknowledges as evidence the information posted on this website. However, the disadvantage of this method is the irregularity of fixing information, and therefore it is impossible to obtain information for any date.

An alternative way to reduce the risks of prosecution is to maintain a Journal for posting information on scientific and other events with the participation of medical workers of third-party organizations, which will keep track of the dates of posting the relevant information on the official website. The form of such a journal should be approved by order of the head of the organization, in which it is also necessary to appoint a person responsible for maintaining the specified journal (it is advisable to appoint the same person who is responsible for sending information to Roszdravnadzor).

The most reliable way to confirm the placement of information on the site is a notarial examination of the site. However, this will require a notarial examination every time you make changes to the section of the site related to the notification of events, which, accordingly, will be associated with additional costs.

A responsibility

There is no practice of holding accountable for non-fulfillment by an organization of its obligation to provide information. In our opinion, liability for failure to fulfill the obligation to notify scientific or other events is provided for by Art. 19.7.8 of the Code of Administrative Offenses of the Russian Federation "Failure to submit information or submission of knowingly false information to the federal executive body exercising control and supervision functions in the healthcare sector."

The sanction provided for by this article: an administrative fine in the amount of ten thousand to fifteen thousand rubles - for officials; in the amount of thirty thousand to seventy thousand rubles - for legal entities.

Thus, to date, a number of aspects of the disclosure of information about scientific events remain poorly regulated. Starting with the issue of classifying an event as a scientific one, ending with procedural issues, including confirmation of the posting of information on the company's website. In the face of such uncertainty, pharmaceutical companies are primarily required to fulfill their disclosure obligations in good faith, including in the event of technical problems.

Alexey Shadrin, junior lawyer of the Law Firm " BRACE "

In chapter

The Russian authorities are seriously interested in the selfless friendship of large pharmaceutical companies with health workers... The drug manufacturers actually take the doctors “in share,” offering them a percentage of their sales. And they sell expensive imported tablets to patients instead of more affordable domestic counterparts. The officials decided to put an end to this long-term vicious practice. Now the doctor, who has prescribed this or that drug for the patient for mercantile reasons, can pay with his career. Only now it is almost impossible to prove the fact of bribery of the doctor by pharmacists.

This fall, a huge scandal erupted in America: the US Department of Justice fined Pfizer Corporation $ 2.3 billion. A record fine was issued to the company for "promoting" products through doctors - they prescribed drugs to patients that they did not need. Meanwhile, in our country, such "cooperation" has existed since the beginning of the 90s of the last century.

According to statistics, 2/3 of all drug packages sold in Russia are domestic. That is, we buy our tablets twice as often as imported ones. However, experts are calculating differently - according to the total cost of the pills sold. So, in monetary terms, it turns out that overseas medicines occupy 77% of our market, and Russian ones - only 23. Moreover, the dominance of expensive imported medicines in our pharmacies is not only because they are considered to be of better quality. Not quite so: just, unlike our companies, global pharmaceutical giants spend huge amounts of money on promoting their products, including through health workers.

The biggest "signs of attention" from drug manufacturers go to the so-called opinion leaders - scientific authorities in a particular branch of medicine, as well as the heads of large clinics. In addition to substantial monetary rewards, they are regularly taken to foreign conferences, often supplied with a car with a driver, or even a personal assistant who has a job in a pharmaceutical company.

However, Western companies have never hidden the fact that they have a whole staff of medical representatives, whose duties include "recruiting" doctors who prescribe drugs. Fortunately, Russian legislation does not prevent this in any way. (Moreover, as noted by recruiting agencies, it was medical representatives who became the first specialty that was in demand by the labor market after the crisis shock at the end of 2008.) Agents of pharmaceutical companies literally besiege medical institutions. First, they make connections, introduce products, give souvenirs and distribute gowns with logos (so that the name of the drug is always in front of the doctor's eyes). Then "kickbacks" are used. The conditions for obtaining them are different, depending on the company's policy and the wishes of the doctor. It could be like lump sum payment and the percentage of sales. They say that the most expensive drugs in promotion are dietary supplements. From the sale of something "fortifying", improving metabolism, etc. etc. aesculapius has 10-15%.

According to experts, the costs of pharmaceutical companies for the maintenance of the staff of medical representatives are comparable to the costs of production and amount to 10-15% of turnover. And for representative offices of foreign companies that do not have production in our country, this figure can reach 40-50%. “Today, one medical representative costs a pharmaceutical company, taking into account his salary, renting a car, buying a computer, paying for a telephone, Internet, etc., on average 160-200 thousand rubles a month,” the director of marketing research of the Pharmexpert company David Melik-Huseynov.

Even more impressive sums are spent on encouraging doctors. Large companies annually allocate tens of millions of rubles for these purposes. It is clear that this money is not evenly distributed in the medical community. For this, the scientific luminaries include trade marks into treatment standards and recommend them for public procurement programs. Ordinary doctors can usually count on more modest gifts - from a pen with a notebook to a trip to a seminar in a boarding house near Moscow. Naturally, all these expenses are included in the cost of medicines. According to market analysts, the budgets for the promotion of any serious drugs in Russia are estimated by large foreign manufacturers at 10–20% of the cost of the goods. Moreover, the non-gratuitous medical fashion for certain brands hurts not only the wallets of patients, but also the state treasury. According to Roszdravnadzor, in 2008-2009, the Russian budget could save about 4 billion rubles if government purchases instead of foreign drugs were purchased with home-grown analogues that are not inferior in quality.

In the West, laws regulating the activities of medical representatives have been adopted long ago. In Russia, there are none at all, there are only internal instructions. In some clinics, for example, there is a ban on communication between employees and representatives of pharmaceutical companies. True, this prohibition cannot be called effective: only 3% of doctors do not let such visitors into the office, 5% let them in after the phrase "I will quickly", and the remaining 92% say: "We are not allowed, but okay, come in."

Recently, he drew attention to the problem of the involvement of domestic aesculapians Special attention Vladimir Putin. “The situation is unacceptable when pharmaceutical concerns pay extra to specialists for prescribing drugs produced by these companies to patients,” the prime minister said. - Manufacturers sponsor corporate events, seminars, including trips to warm seas. This vicious practice must be stopped. " After that, the Federal Antimonopoly Service took a keen interest in the methods of work of foreign manufacturers. She checked several large pharmaceutical companies and found many irregularities. And besides, I prepared whole package amendments to the "Fundamentals of the legislation of the Russian Federation on the protection of public health", the law "On the circulation of medicines" and the Administrative Code.

The new bill strictly prohibits pharmacists in any way to stimulate medical workers and heads of healthcare institutions to distribute drugs. Including it is forbidden to present them money or gifts more expensive than 3 thousand rubles, to pay for rest and travel expenses. You cannot organize festivals, conferences, congresses with the participation of only one manufacturer, especially if, following the results of the event, the participants must take on some obligations. And doctors will be banned from taking medical representatives during working hours.

For prescribing drugs for mercantile reasons, the doctor will face a fine of 20-30 thousand rubles or disqualification for a period of one to two years. Chief doctors who turn a blind eye to such collusion will pay 100 thousand rubles or more or will also lose the right to engage in professional activities. The companies themselves are subject to a fine in the amount of 1 to 15% of the proceeds from the sale of a drug promoted through doctors (but not less than 300 thousand rubles). Anti-monopoly officials hope that the inevitable harsh punishment will make doctors and pharmacists cleaner. In turn, in Roszdravnadzor (the FAS proposes to impose control over compliance with the new requirements on this service) they emphasize: in order to use punitive measures, you must first prove the fact of collusion between the doctor and the pharmaceutical company. And this is extremely difficult to do.

The experts agree in principle with the proposed initiatives. “Pharmaceutical companies - to be honest - are building loyalty programs for doctors to themselves and their products. And in order not to infringe upon the interests of patients, this process must be regulated, made more transparent, more controlled by the relevant authorities, says Mr. Melik-Huseynov. "But here it is very important not to go too far." According to our interlocutor, it is impossible to completely prohibit the interaction of pharmacists with doctors. Indeed, for the latter, communication with representatives of pharmaceutical companies and attending events organized by these companies is often the only way to get information about new drugs and treatment methods.

MOSCOW, February 3 - RIA Novosti. Doctors and pharmacy workers from this year cannot cooperate with the pharmaceutical business, participate in cultural and entertainment events, travel to conferences and rest at the expense of pharmaceutical companies, said Mikhail Murashko, acting head of Roszdravnadzor in an interview with RIA Novosti.

"Now there is a legislative restriction, which is associated with the receipt of remuneration for the prescription of certain drugs with trade names, tied to a specific manufacturer. Also, healthcare workers are prohibited from participating in cultural and entertainment events, participating in dinners, going on vacation and at conferences sponsored by pharmaceutical companies. ", - Murashko explained.

The fine for a doctor for violating this legislation is from 3 to 5 thousand rubles, for the head of a medical organization - from 5 to 10 thousand rubles, for an individual entrepreneur - from 3 to 5 thousand rubles. For a repeated violation under this article, not only a fine is provided, but also disqualification for a period of six months.

At the same time, it is allowed by law to organize a coffee break within the framework of a scientific and practical conference. "But for this, pharmaceutical and pharmacy organizations must notify Roszdravnadzor about the holding of the conference two months in advance: it is necessary to fill out an application about who is the organizer of the event, designate the venue, familiarize with the program. Such notifications, by the way, have already begun to come to us," - said Murashko. He noted that it is possible that the law will also include the liability of pharmaceutical companies.

How to educate a doctor about the law?

Most WHO experts and analysts agree that, along with the regulation of the activities of medical representatives, the state should also provide professional information to doctors. Experts believe that the state is obliged to provide doctors with information materials, reference books, computer libraries, to regulate and stimulate the permanent postgraduate education of doctors. In Russian realities, however, the purchase and study of reference books is limited not only by the usual lack of money for doctors, but also by the lack of knowledge of English. Many states regulate the relationship of doctors with the pharmaceutical industry. For example, in Hungary, those companies that promote medicines with the help of medical representatives pay additional contributions to the state. In Germany, pharmaceutical company employees are prohibited from visiting the same doctor more than twice a year. But in Poland, in Belarus, "medical representatives" are generally prohibited from entering clinics and hospitals.