Import of unregistered pesticides for testing: debunking myths

20/ 10/ 2017

On September 21, 2017, the Verkhovna Rada Committee on Agrarian Policy and Land Relations considered and approved in the first reading the draft law No. 6606, which proposes to revoke the confirmation of registration in the country of production for unregistered pesticides imported to the territory of Ukraine for state tests and scientific research. During the discussion, some peoples deputies voiced the need to introduce into the legislation a number of fuses that could guarantee the impossibility of importing both commercial parties of unregistered products of dubious quality, as well as obvious falsification, and also prevent any corruption risks. We propose to understand why the bill No. 6606 was developed and whether the fuses sounded are not available in the current system of admission of drugs to the Ukrainian agrochemical market. Lets start with the legal part The Ukrainian system of state testing and state registration of pesticides and agrochemicals originates in the mid-1990s. It was then that key laws and by-laws were written and adopted, namely: 1. Law of Ukraine of March 2, 1995 No. 86/95-ВР On Pesticides and Agrochemicals; 2. Resolution of the Cabinet of Ministers of Ukraine of March 4, 1996, No. 295 On Approval of the Procedure for Conducting State Tests, State Registration and Re-registration, Publication of Lists of Pesticides and Agrochemicals Permitted for Use in Ukraine. Its easy to see that the documents are 20+ years old and during this time they have changed so many times that some provisions are either irrelevant or taken out of context. This also happened with Part 2 of Article 4 of the Law of Ukraine On Pesticides and Agrochemicals, in the last sentence of which the requirement for registration of a pesticide in the country of its production as a condition for importing unregistered samples for state tests has been prescribed recently. It is obvious that the original target purpose of this rule was distorted in the final wording, it obviously lost its urgency and it had to be canceled long ago. This is confirmed by the fact that up to the beginning of 2017 this norm was not applied by the Ministry of Ecology as a basis for obtaining a permit for import of unregistered samples. Moreover, prior to the above innovation, the importation of unregistered SZR samples for the purposes of scientific research and state tests was carried out for decades without the need to confirm registration in the country of production. After the entry into force of the above innovation, nothing has changed with regard to quality control of imported pesticides in comparison with the quality level that existed before the beginning of 2017. But the harm from it is obvious: this norm significantly limits scientific research and access to innovative technologies of the world level. This is confirmed by the Ukrainian state scientific institutes directly involved in the process of state testing of the Northwestern Ukraine in Ukraine. Lets turn to practical moments So is it really in the current system of state tests in Ukraine that there are no mechanisms to prevent the import of substandard products and falsification under the guise of samples? Of course, no: such safety devices are more than enough! We can responsibly state that the current process of admission of the drug to state tests and control over its import and use is the most protected and tightly controlled procedure in the entire cycle of pesticide trafficking in Ukraine. The problem arises much later, at the stage of temporary state registration, but about this further. As for the probability of importation of commercial lots of pesticides under the guise of samples of unregistered SZR: this practice is completely excluded! If we do not make premature conclusions and read Article 4 of the Law of Ukraine On Pesticides and Agrochemicals completely, and not only one - a sentence torn from the context, it becomes obvious that 1) importation into the customs territory of Ukraine, 2) production, 3) trade , 4) use and even 5) advertising of pesticides and agrochemicals before they receive state registration are FORBIDDEN! Coming back to the fears of importing an explicit falsification under the guise of samples, it must be said that this fear is absurd and has no grounds for it: to our great regret, the falsifiers do not submit their products either to scientific research or to state tests, nor especially on state registration! Accordingly, the import of counterfeit under the guise of samples and speech can not be, because the importation of the sample in Ukraine is regulated and controlled in the most careful manner. In the process of importing an unregistered sample, four parties are involved: the Ministry of Ecology - as a state regulator, the State Institute - as a performer, the importer - as an applicant, customs - as a controller when importing. If we analyze the scheme, we can draw the following conclusions. 1. Only the scientifically justified amount of the sample is allowed to be imported: the State Institute justifies the required amount, and the Ministry of Ecology approves. 2. All information on volumes, applicants and drugs is in the public domain and any opportunities for speculation are excluded: the Ministry of Ecology annually publishes the state testing plan after approval of the Ministry of Health. The plan for 2017 is available under the link. Since 2017, the Ministry of Ecology has begun publishing a register of permits for the importation of unregistered pesticides, indicating all key information. The registry is accessible by the link. 3. Upon receipt of a permit to import an unregistered sample, all necessary information (importer data, sample size, border crossing point, sample storage location and validity period during which import can be imported) is indicated. 4. When importing a sample, the customs control all the above requirements. 5. At the end of each year the applicant submits a report to the Ministry of Ecology on the use of the sample. Accordingly, the turnover of unregistered samples for state tests in Ukraine is tightly regulated and closely monitored by the competent authorities. Why then in Ukraine so many pesticides of questionable quality are registered? The answer to this question is simple - a huge hole at the stage of state registration. For today in Ukraine there are two types of registration of pesticides: temporary and permanent. Both types are needed, but there are questions to the current regulation of temporary registration. And the problem is very simple: in order to obtain the status of a temporarily registered drug (and this is 2 + 1 years of such status and 2 more years for the realization of balances), you do not need to file a complete dossier for the drug, that is, to pass the above-described scientific tests and procedures in full least. Thus, a conscientious importer who registers a drug with a full dossier (which is tens of thousands of pages of research and data ensuring safety for the health of the population and its environment) and pays all the legal fees (taking into account the tests, the amount may reach € 100 thousand ), receives 10 years of registration. And the unscrupulous company, in fact, without documents that would confirm the safety of the drug, registers it for 5 years with minimal expenses at all stages of the process. That is, in fact, there is a policy of double standards. The Agro-chemical Committee of the EBA has been trying for many years to close this gap in the legislation of Ukraine, but, unfortunately, today the issue has not been resolved yet. Therefore, we very much hope that draft law No. 6606 will be adopted in the very near future, and the problem of unfair temporary state registration of drugs will also be given due attention. Source: AgroPortal

During the discussion, some people’s deputies voiced the need to introduce into the legislation a number of “fuses” that could guarantee the impossibility of importing both commercial parties of unregistered products of dubious quality, as well as obvious falsification, and also prevent any corruption risks.

We propose to understand why the bill No. 6606 was developed and whether the “fuses” sounded are not available in the current system of admission of drugs to the Ukrainian agrochemical market.

Let’s start with the legal part

The Ukrainian system of state testing and state registration of pesticides and agrochemicals originates in the mid-1990s. It was then that key laws and by-laws were written and adopted, namely:

1. Law of Ukraine of March 2, 1995 No. 86/95-ВР “On Pesticides and Agrochemicals”;

2. Resolution of the Cabinet of Ministers of Ukraine of March 4, 1996, No. 295 “On Approval of the Procedure for Conducting State Tests, State Registration and Re-registration, Publication of Lists of Pesticides and Agrochemicals Permitted for Use in Ukraine”.

It’s easy to see that the documents are 20+ years old and during this time they have changed so many times that some provisions are either irrelevant or taken out of context.

This also happened with Part 2 of Article 4 of the Law of Ukraine “On Pesticides and Agrochemicals”, in the last sentence of which the requirement for registration of a pesticide in the country of its production as a condition for importing unregistered samples for state tests has been prescribed recently.

It is obvious that the original target purpose of this rule was distorted in the final wording, it obviously lost its urgency and it had to be canceled long ago. This is confirmed by the fact that up to the beginning of 2017 this norm was not applied by the Ministry of Ecology as a basis for obtaining a permit for import of unregistered samples. Moreover, prior to the above innovation, the importation of unregistered SZR samples for the purposes of scientific research and state tests was carried out for decades without the need to confirm registration in the country of production.

After the entry into force of the above innovation, nothing has changed with regard to quality control of imported pesticides in comparison with the quality level that existed before the beginning of 2017. But the harm from it is obvious: this norm significantly limits scientific research and access to innovative technologies of the world level. This is confirmed by the Ukrainian state scientific institutes directly involved in the process of state testing of the Northwestern Ukraine in Ukraine.

Let’s turn to practical moments

So is it really in the current system of state tests in Ukraine that there are no mechanisms to prevent the import of substandard products and falsification under the guise of samples?

Of course, no: such “safety devices” are more than enough! We can responsibly state that the current process of admission of the drug to state tests and control over its import and use is the most protected and tightly controlled procedure in the entire cycle of pesticide trafficking in Ukraine. The problem arises much later, at the stage of temporary state registration, but about this further.

As for the probability of importation of commercial lots of pesticides under the guise of samples of unregistered SZR: this practice is completely excluded! If we do not make premature conclusions and read Article 4 of the Law of Ukraine “On Pesticides and Agrochemicals” completely, and not only one – a sentence torn from the context, it becomes obvious that 1) importation into the customs territory of Ukraine, 2) production, 3) trade , 4) use and even 5) advertising of pesticides and agrochemicals before they receive state registration are FORBIDDEN!

Coming back to the fears of importing an explicit falsification under the guise of samples, it must be said that this fear is absurd and has no grounds for it: to our great regret, the falsifiers do not submit their “products” either to scientific research or to state tests, nor especially on state registration! Accordingly, the import of counterfeit under the guise of samples and speech can not be, because the importation of the sample in Ukraine is regulated and controlled in the most careful manner.

In the process of importing an unregistered sample, four parties are involved: the Ministry of Ecology – as a state regulator, the State Institute – as a performer, the importer – as an applicant, customs – as a controller when importing.

If we analyze the scheme, we can draw the following conclusions.

1. Only the scientifically justified amount of the sample is allowed to be imported: the State Institute justifies the required amount, and the Ministry of Ecology approves.

2. All information on volumes, applicants and drugs is in the public domain and any opportunities for speculation are excluded: the Ministry of Ecology annually publishes the state testing plan after approval of the Ministry of Health. The plan for 2017 is available under the link.

Since 2017, the Ministry of Ecology has begun publishing a register of permits for the importation of unregistered pesticides, indicating all key information. The registry is accessible by the link.

3. Upon receipt of a permit to import an unregistered sample, all necessary information (importer data, sample size, border crossing point, sample storage location and validity period during which import can be imported) is indicated.

4. When importing a sample, the customs control all the above requirements.

5. At the end of each year the applicant submits a report to the Ministry of Ecology on the use of the sample.

Accordingly, the turnover of unregistered samples for state tests in Ukraine is tightly regulated and closely monitored by the competent authorities.

Why then in Ukraine so many pesticides of questionable quality are registered?

The answer to this question is simple – a huge hole at the stage of state registration. For today in Ukraine there are two types of registration of pesticides: temporary and permanent. Both types are needed, but there are questions to the current regulation of temporary registration. And the problem is very simple: in order to obtain the status of a temporarily registered drug (and this is 2 + 1 years of such status and 2 more years for the realization of balances), you do not need to file a complete dossier for the drug, that is, to pass the above-described scientific tests and procedures in full least.

Thus, a conscientious importer who registers a drug with a full dossier (which is tens of thousands of pages of research and data ensuring safety for the health of the population and its environment) and pays all the legal fees (taking into account the tests, the amount may reach € 100 thousand ), receives 10 years of registration. And the unscrupulous company, in fact, without documents that would confirm the safety of the drug, registers it for 5 years with minimal expenses at all stages of the process. That is, in fact, there is a policy of double standards.

The Agro-chemical Committee of the EBA has been trying for many years to close this gap in the legislation of Ukraine, but, unfortunately, today the issue has not been resolved yet.

Therefore, we very much hope that draft law No. 6606 will be adopted in the very near future, and the problem of unfair temporary state registration of drugs will also be given due attention.

Source: AgroPortal