With the help of amendments to the law "On the safe handling of pesticides and agrochemicals", it is planned to limit the range of registrants of new drugs to their developers and manufacturers. This should put a barrier to unscrupulous importers who use someone else's drugs for registration tests, and subsequently import a falsified product based on the received certificate of state registration. In addition, through amendments to the law "On Environmental Expertise", it is planned to exempt pesticide manufacturers from undergoing an examination when registering a drug for a new period - provided that no restrictions were imposed on the active substance, and the registrant did not change the composition of the product.
Draft law No. 1070685-7 is being prepared for consideration at the spring session in the State Duma of the Russian Federation (“On Amendments to Article 11 of the Federal Law“ On Environmental Expertise ”and the Federal Law“ On the Safe Handling of Pesticides and Agrochemicals ”). With its help, it is planned to legislatively consolidate a number of innovations designed to make the Russian agrochemical market more orderly and safer, as well as harmonize the regulatory legal acts regulating it with the sanitary norms and customs legislation of the EAEU.
Thus, the draft federal law includes the concept of "registrant". According to the proposed version of the Federal Law No. 109-FZ "On the Safe Handling of Pesticides and Agrochemicals", only their developers or manufacturers can act as registrants of new drugs in Russia. The draft law provides for the possibility of filing an application by a third-party individual or company, but only if they are authorized by the developer or manufacturer to carry out registration procedures.
According to Vladimir Alginin, Deputy General Director of Firm "August" JSC for General Issues and Executive Director of the Russian Union of Producers of Chemical Plant Protection Products, this is the next stage of legislative work, which should create barriers to the import of counterfeit and counterfeit products for the agricultural sector. The Ministry of Agriculture of the Russian Federation has included in the procedure for the import of pesticides and agrochemicals a mandatory requirement for the importer to have a certificate of state registration of the imported product, however, further measures are required to limit the flow of counterfeit pesticides.
“In the current situation, any person from the street can register a new plant protection product,” explains Vladimir Alginin. - Often the following happens: a product of a bona fide manufacturer is taken, all the necessary tests and examinations are carried out, the drug is registered, and then, according to the received certificate of state registration, drugs of dubious quality and with an unpredictable composition are imported into the country, which end up on domestic fields. We have been fighting this phenomenon for five years. If we open the state catalog of pesticides of any country, we will not find so many registrants there as in Russia. Our proposal was that the right to register the product remained with those who had the conditions for its creation. That is, developers and manufacturers with a certain set of laboratory equipment, qualified personnel and everything necessary for production. Now this provision, albeit in a somewhat truncated form, has been introduced into the bill and defines the circle of those who can act as a registrant of new drugs. "
Also, the draft federal law provides for a reduction in the timeframe for the examination of the results of registration tests of pesticides and agrochemicals from six to three months, as well as an increase in the period for state registration from two years to three (in accordance with the current law No. 109-FZ, state registration of pesticides and agrochemicals is carried out for a period ten years and two years).
“Practice shows that for the examination of the results of registration tests of pesticides and agrochemicals, three months are enough,” says Vladimir Alginin. - The period of creation and registration of the drug itself is very long - registration trials alone can take more than two years. In order for the costs invested in product development to pay off faster, it must be brought to market faster, and the innovation will allow manufacturers to accelerate this process. "
As for the increase in the period of state registration from two to three years, we are talking here about the preliminary registration of the drug, which is applied if, according to the results of the tests, questions about its effectiveness or safety remain. However, as stated in the explanatory note, two years is not enough to carry out all the additional research. Vladimir Alginin adds that an increase in the pre-registration period will help developers and manufacturers to more accurately understand whether the drug is promising and whether it is advisable to register it for ten years for further use.
With the help of the proposed amendments to the law on environmental expertise, the mechanism for its implementation is streamlined, and the obligation to undergo it is removed from registrants if they register a drug already on the market for a new period.
“Federal Law No. 174-FZ“ On Environmental Expertise ”implies that any new substance introduced into circulation must pass it without fail; manufacturers (and we among them) pass it according to the scheme developed by the Ministry of Natural Resources and Rosprirodnadzor, - says Vladimir Alginin. - The amendment implies that when the product is re-registered after ten years, a new environmental impact assessment may not be carried out - of course, provided that the registrant did not make any changes to the composition of the product, and also did not enter into force legislative changes or restrictions on active substances - active ingredients of the drug ".
It is worth noting that on December 30, 2020, Federal Law No. 522-FZ “On Amendments to the Federal Law“ On the Safe Handling of Pesticides and Agrochemicals ”in terms of improving state control (supervision) in the field of safe handling of pesticides and agrochemicals” was adopted. The new version of the law provides for the return to the Rosselkhoznadzor of the functions of checking the import, sale, use and disposal of plant protection chemicals. In 2011, the department was deprived of these powers, but at the same time they were not transferred to anyone, and as a result, for almost ten years, the supervisory authorities did not check either compliance with the regulations for the use of pesticides, or the composition of imported drugs, and the ability to control the circulation of pesticides and agrochemicals was extremely limited. The adopted amendments are designed to counteract the import, sale and use of counterfeit pesticides and agrochemicals that damage the agro-industrial complex, nature and human health. Thus, it is assumed that specialized checkpoints will appear at customs through which pesticides and agrochemicals will be imported.