The crisis of the regulatory genre

The crisis of the regulatory genre 17 September 2019

Regulation in the field of drug circulation, innovations and upcoming changes in pharmaceutical legislation: pricing, state procurement, online commerce, circulation of drugs in the EAEU, “regulatory guillotine”, interchangeability, labeling, import of unregistered drugs are the main topics of heated discussion in the plenary session of the annual conference of the newspaper Vedomosti "Legal issues of the pharmaceutical industry."


The main task of the business is not to make a profit, but to create a comfortable environment for business development. Decrease in efficiency, relevance and loyalty to the company, caused by clumsy regulation with poor prediction of the consequences of the introduction of one or other regulatory act. Victor Dmitriev, Director General of the Association of Russian Pharmaceutical Manufacturers, emphasized that "sometimes a momentary minimum effect is achieved, which in the long term is offset by economic and social failures, with a subsequent decrease in the level of confidence in the authorities."


In turn, the State Duma deputy, member of the Health Protection (Healthcare) Committee Alexander Petrov noted that "the pharmaceutical industry is not a business, but a tool in the hands of the state to provide citizens with medicine." He expressed concern about the current critical situation in the pharmaceutical market, and proposed the formation of a State system of drug safety in the Russian Federation. Representatives of the pharmaceutical industry agreed with this. The experts reiterated the problems and proposed solutions in the hope that they would be addressed and resolved at the highest level.


The assessment of the prospects and risks of the proposed initiatives for the regulatory activities of the retail pharmaceutical market was presented by the Executive Director of the Russian Association of Pharmacy Networks, Nelly Ignatieva. “Medicines should be here and now. From the point of view of accessibility - all the regulations came down to the fact that drugs should be the cheapest in price. We should recommend the cheapest drug. I can’t call it a measure of stimulation of the sale of drugs of a domestic manufacturer, in this segment we can find not only domestic manufacturers, ”she emphasized. In her opinion, “under the slogan“ we are moving towards lower prices ”there is no systematic approach to considering this approach, but there are high-profile initiatives.”


Most of the conference was devoted to the regulation of pharmacy retail. Were considered amendments to the tax code developed by the Ministry of Finance of the Russian Federation and adopted by the State Duma on July 10, 2019 in the first reading, providing for the abolition of the use of UTII and PTS (Patent Tax System) in the implementation of the sale of goods, which are subjects to mandatory labeling. With the abolition of the special tax regime, the activities of regional pharmacies will become unprofitable. This will lead to increase in prices for medicines, and as a result – decrease in their availability.


Technological progress does not stand still, Internet commerce is developing in the world. The bill allowing the remote sale of medicines may be adopted this fall in the second reading of the State Duma. But there is no unequivocal opinion, who and how can sell OTC drugs? Who will be the courier? What are the requirements for pharmacists - "walkers"? Are there any risks of counterfeit and expired products?


“Today, the Internet is the main way to spread counterfeit products. Online sales should be strictly controlled. In Russia, it is necessary to legalize this type of activity in stages. First you need to allow only specialized outlets that are controlled and audited by the regulator. In order to start online trading, you need to clearly establish the rules, otherwise we will release such a genie that will poison people who are already not very healthy, ”Victor Dmitriev added.


Another acute and painful issue is the labeling of medicines. Why is it 44 characters? During the experiment, different lengths of cryptocode were tried. Pharmaceutical manufacturers associations still insist on 20 characters. They wrote about this to the Prime Minister, citing their arguments. In particular, with such amount of signs, the cost price will not increase, productivity will not decrease, and defect will not grow. But, nevertheless, manufacturers were not heard, and 44 characters remain. This means that there will be an increase in prices and there may be medicines out of stock situation on the market. This is the technical side of the labeling. Lawyers also have questions to the DMM (Drug Movement Monitoring) system. Thus, Vladimir Anikeev, Advisor to the General Director for Legal Issues of Biocad Company, demonstrated some gaps to the professional community using examples: “The medicine has arrived at the hospital, but the code has been damaged, because a large number of characters can fail. Can a doctor use such a medicine? He has 10 packs of this medicine, there is a patient who needs this medicine right now, then he has a choice: to save the patient or not to use a medicine that has problems with labeling. In either case, there is either criminal or administrative liability, ”the expert emphasized. Another example is the result of testing of the system. Vladimir Anikeev said that drugs were found in Nizhny Novgorod that, according to the label, were supplied in hospitals in St. Petersburg and Moscow, and in huge quantities: “89 packages were supposed to be in St. Petersburg in a state hospital. How did it happen? It is necessary to institute criminal proceedings. They contacted the investigator, and he asks, is this sufficient evidence? Then the question is: is labeling a direct-acting system? And how do we deal with the huge amount of reports of unauthorized drug trafficking starting in January 2020? ”


Pharmaceutical companies do not criticize the system, the positive economic effect for all participants in the process is obvious, but it is necessary to finalize regulatory documents and only after that introduce the system.


Interchangeability - is now very acute. The draft amendments to 61-FL regarding the improvement of the procedure for determining the interchangeability of drugs does not comply with the EAEU law. It seems necessary to harmonize the requirements of Russian legislation with the requirements of the EAEU. It is necessary to clarify the criteria for determining interchangeability and the requirements for the composition of the dossier of a bio-analogue drug. Particular risks of a lack of unified approach is for vaccines, which are a key element of the country's epidemiological safety system. Methods of conducting an examination to establish interchangeability also raise questions.


It is not enough to provide the population with medicines, it is necessary that they be of high quality, effective and safe. In matters of interchangeability, a mechanical approach cannot be used, it is dangerous for patients, for the legislator, and for the manufacturer.


In everything there should be a specific responsibility of specific people for the adopted decrees, decisions and for the absence of laws of direct action.


We need a professional constructive dialogue between the authorities and the industry, incentives are needed for the withdrawal of modern high-quality effective drugs that are so necessary for the population.


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