What threatens Ukraine with restricting access to innovative agrochemistry

15/ 09/ 2017

In recent years, agriculture has been the engine of the Ukrainian economy and one of the key factors of financial and monetary stability. The issues of the land market, state subsidies in agriculture, export potential are constantly the topic of discussions and discussions at all levels. At the same time, do not forget about other branches of agriculture, which require no less attention. So historically, 100% of the original plant protection products (NWR) come to the agrarians of Ukraine from companies that are world leaders in the field of their creation and production. This is due to the very high cost and duration of their development before entering the market. The creation of a molecule with high biological efficiency lasts 10-15 years. But efficiency is not the only criterion. As international companies are socially responsible, much attention is paid to the safety of such pesticides for humans and the environment. The total cost of all studies for one original drug reaches 200-300 million euros. The developers of original products are companies from the EU, Switzerland, Japan, the United States, while their licensed and strictly controlled production can be located in other countries. But over time, the original molecules lose patent protection, after which the generic companies begin to synthesize the active substances and produce SZR based on them. Fig. 1. Geography of import of innovative NW in Ukraine If we analyze the process of registration of new active substances, we have a disappointing trend: 5 years ago in Ukraine about 20 innovative DVs were registered annually. In 2017, this figure fell sharply. It is also worth noting that the number of generic drugs is constantly increasing. For each original drug, up to 10 or more generic drugs are recorded. Fig. 3. The ratio of the number of original preparations to genericFor some traditional active substances, the situation looks even worse: 160-170 generic products account for only 7-10 original products. This growing dynamics is alarming. In many cases, in the production of generic products, synthesis processes are violated, which leads to their contamination by highly toxic technological additives.In addition, quantity does not always guarantee quality. Over time, the use of the same active substances causes the emergence of resistance (resistance) to pesticides. Accordingly, the effectiveness of drugs against pests, weeds and diseases begins to decline, and agrarians are forced to increase the application rates of the drug. This, in turn, leads to the accumulation of residues in soils and agricultural products. Given the recent world trends in reducing the level of pesticide residues in food and feed, in the medium term, lack of access to innovative NWR can lead to the fact that a number of key markets can be closed to Ukrainian agricultural products. Thus, it is the innovative agrochemistry that is the key to increasing the yield, quality and safety of crops. According to the European Plant Protection Association, up to 40% of the crop depends on a properly selected plant protection system. Accordingly, the issue of accessibility of innovative pesticides is a matter of food security of the state. To my great regret, from the end of last year the overwhelming majority of original innovative NWR of the new generation could not even enter the initial stage of state registration in Ukraine. The Law of Ukraine On Pesticides and Agrochemicals recently demanded that confirmation of their state registration in the country of production should be provided for the import of unregistered pesticides for government testing purposes and scientific research. In many cases, this requirement can not be met for a number of objective reasons. Thus, the registration of the drug in the country of its production or not at all is not carried out in connection with its inadvisability (which may be due to the absence in the country of production of a certain type of pests, diseases and agricultural crops that exist in the country of destination of such a preparation), or occurs simultaneously with registration in Ukraine. The consequence of the introduction of the aforementioned norm of the law was the automatic failure of innovative drugs to enter the State Register of Pesticides and Agrochemicals allowed for use in Ukraine, which already led to negative consequences in agriculture due to blocking access to high-quality agrochemical products of a new generation for Ukrainian farmers. From the inadmissibility of drugs of a new generation to the Ukrainian market, the predicted shortage of yields is from 10 to 40%, depending on the culture and direction of action of the drug. Thus, to date the issue of access to innovative agrochemistry is not only a question of the prestige of the state on the international arena, but, first of all, the issue of the quality and safety of agricultural products. Despite the efforts of the business community, today the issue of repealing this unjustified provision of the law is still unresolved. But there is hope: at the end of June this year the Peoples Deputies of Ukraine of the Verkhovna Rada Committee on Agrarian Policy and Land Relations initiated changes to the Law of Ukraine On Pesticides and Agrochemicals designed to abolish this bureaucratic barrier. We hope that the bill No. 6606 will be adopted in the near future and by the beginning of the new agrarian season the Ukrainian agrarian will be able to fully enjoy all the advantages of high-quality innovative agrochemistry. Source: Latifundist

So historically, 100% of the original plant protection products (NWR) come to the agrarians of Ukraine from companies that are world leaders in the field of their creation and production. This is due to the very high cost and duration of their development before entering the market. The creation of a molecule with high biological efficiency lasts 10-15 years. But efficiency is not the only criterion. As international companies are socially responsible, much attention is paid to the safety of such pesticides for humans and the environment. The total cost of all studies for one original drug reaches 200-300 million euros.

The developers of original products are companies from the EU, Switzerland, Japan, the United States, while their licensed and strictly controlled production can be located in other countries. But over time, the original molecules lose patent protection, after which the generic companies begin to synthesize the active substances and produce SZR based on them.

Fig. 1. Geography of import of innovative NW in Ukraine

If we analyze the process of registration of new active substances, we have a disappointing trend: 5 years ago in Ukraine about 20 innovative DVs were registered annually. In 2017, this figure fell sharply.

It is also worth noting that the number of generic drugs is constantly increasing. For each original drug, up to 10 or more generic drugs are recorded.

Fig. 3. The ratio of the number of original preparations to generic

For some “traditional” active substances, the situation looks even worse: 160-170 generic products account for only 7-10 original products. This growing dynamics is alarming. In many cases, in the production of generic products, synthesis processes are violated, which leads to their contamination by highly toxic technological additives.In addition, quantity does not always guarantee quality. Over time, the use of the same active substances causes the emergence of resistance (resistance) to pesticides. Accordingly, the effectiveness of drugs against pests, weeds and diseases begins to decline, and agrarians are forced to increase the application rates of the drug. This, in turn, leads to the accumulation of residues in soils and agricultural products. Given the recent world trends in reducing the level of pesticide residues in food and feed, in the medium term, lack of access to innovative NWR can lead to the fact that a number of key markets can be closed to Ukrainian agricultural products.

Thus, it is the innovative agrochemistry that is the key to increasing the yield, quality and safety of crops. According to the European Plant Protection Association, up to 40% of the crop depends on a properly selected plant protection system. Accordingly, the issue of accessibility of innovative pesticides is a matter of food security of the state.

To my great regret, from the end of last year the overwhelming majority of original innovative NWR of the new generation could not even enter the initial stage of state registration in Ukraine. The Law of Ukraine “On Pesticides and Agrochemicals” recently demanded that confirmation of their state registration in the country of production should be provided for the import of unregistered pesticides for government testing purposes and scientific research. In many cases, this requirement can not be met for a number of objective reasons. Thus, the registration of the drug in the country of its production or not at all is not carried out in connection with its inadvisability (which may be due to the absence in the country of production of a certain type of pests, diseases and agricultural crops that exist in the country of destination of such a preparation), or occurs simultaneously with registration in Ukraine.

The consequence of the introduction of the aforementioned norm of the law was the automatic failure of innovative drugs to enter the State Register of Pesticides and Agrochemicals allowed for use in Ukraine, which already led to negative consequences in agriculture due to blocking access to high-quality agrochemical products of a new generation for Ukrainian farmers. From the inadmissibility of drugs of a new generation to the Ukrainian market, the predicted shortage of yields is from 10 to 40%, depending on the culture and direction of action of the drug.

Thus, to date the issue of access to innovative agrochemistry is not only a question of the prestige of the state on the international arena, but, first of all, the issue of the quality and safety of agricultural products.

Despite the efforts of the business community, today the issue of repealing this unjustified provision of the law is still unresolved. But there is hope: at the end of June this year the People’s Deputies of Ukraine of the Verkhovna Rada Committee on Agrarian Policy and Land Relations initiated changes to the Law of Ukraine “On Pesticides and Agrochemicals” designed to abolish this bureaucratic barrier. We hope that the bill No. 6606 will be adopted in the near future and by the beginning of the new agrarian season the Ukrainian agrarian will be able to fully enjoy all the advantages of high-quality innovative agrochemistry.

Source: Latifundist