Interchangeability in Russia was, is and will be

The round table “Interchangeability of medicines” was held on the initiative of the Association of Russian Pharmaceutical Manufacturers in the press center of the publishing house “Komsomolskaya Pravda”. The discussion of the amendments adopted at the end of 2019 in 61-FL “On Circulation of Medicines” was joined by: the Federal Antimonopoly Service, the medical and patient communities, manufacturers and market experts. All parties have their own questions to the implementation of the rule of law.

One of the initiators of the bill was the Federal Antimonopoly Service. According to Timofey Nizhegorodtsev, Head of the FAS Russia Social Sphere and Trade Control Department, "the interchangeability of medicines has always been, is and will be." In world medical practice, interchangeability issues have been resolved; there are a large number of scientific articles on this topic. And the doubts and fears that the generic drugs are completely interchangeable with respect to the reference drugs, and the reference drugs for generics the expert called “the phenomenon of the Russian Federation”. He called on everyone to report without fail about undesirable effects to Federal Service for Surveillance in Healthcare (Roszdravnadzor), for a detailed analysis and appropriate work to be carried out for each individual case.

“We have remained in the habit since Soviet times: to assemble a collective and write a collective complaint, but the pharmacovigilance system does not work like that anywhere in the world. Reporting is always individual. There is a specific person, there is a doctor who sees the indicators, and only he can draw official conclusions about the effectiveness of the drug. After that, the person is transferred to another drug. We have the opportunity to purchase any drug at the conclusion of a medical commission. Only like that and not in any other way,” summed up Nizhegorodtsev.

The main goal of the adopted amendments is to transfer the existing medical practice to the legal plane. Align the quality of registration dossiers for each drug, thereby eliminating doubts about the quality, effectiveness and safety of drugs in the domestic market.

The President of the All-Russian Society “Assistance” Lilia Matveeva stated that our Russian drugs are effective. All drugs, both original and generic, are tolerated differently by patients. It all depends on the individual characteristics of the patient, and effectiveness is associated with a strict regimen of medication taking. Valery Breder, a leading researcher at the Oncological Department of Medicinal Methods of Treatment of the N.N. Blokhin National Medical Research Center of Oncology, fully agrees with her. “Quality control of drugs, not only at the production and registration stage, but throughout the drug’s life, should be carried out continuously, and pharmacovigilance is an important component of this process, which will be our basis for the future,” Breder emphasized.

Manufacturers to this rule of law have their own questions and concerns. The Director General of the Association of Russian Pharmaceutical Manufacturers Victor Dmitriev supports the adopted law, but “interchangeability should be applied at the registration stage, and not after the drug has been on the market for 20 years.” So today, pharmaceutical manufacturers of generic drugs are faced with the issue of conducting additional examinations for low-price drugs from the list of essential drugs that were registered on the market many years ago. A bioequivalence study worth 10 million rubles will not only make production unprofitable, but will cause the drug to disappear altogether. The general director of Sun Pharma Russia, Arthur Valiev, emphasized that it is impossible to approach absolutely all products with identical requirements.

But the FAS has a different opinion: “Reproduced drugs should be registered in the same form and dosage, as the reference drugs. We have many drugs registered as reproduced, but at the same time they may have different forms and dosages, this is not entirely legal, but nevertheless there is a legally significant fact — this is the registration of the drug. Now we have to spend some effort in order to bring everything in line. If the drug is registered according to all the rules of the law, then no additional evidence is required. ”

According to lawmakers, amendments to the law on interchangeability are the foundation of state standards for the provision of medical care. According to deputy Alexander Petrov, “The doctor began to work in the legal field, prescribing one or another drug.”

Alexander Saversky, president of the «Patients League», does not agree with this, he believes that “as a result of the fight against corruption, the doctor was simply taken away the right to prescribe the medicine that he considers necessary.”

The professional community is awaiting further clarification and by-laws. There are a lot of questions to the adopted norm of the law, heated discussions continue. But one thing is important: conditions must be created in the country to increase confidence in the safety, efficacy and quality of domestic medicines.

April 7, 2020 at the World Trade Center (WTC) a round table will be held on “Drug interchangeability. Legal / regulatory aspects ”in the framework of the XII scientific-practical conference“ State regulation and the pharmaceutical industry: the continuation of the dialogue ”. Registration for the event and a detailed program on the website of the Association of Russian Pharmaceutical Manufacturers (ARPM):

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