ЕВА appealed to the Prime Minister regarding the GMP Verification Order

26/ 02/ 2020

On February 24, 2020, the European Business Association appealed to Prime Minister Oleksiy Honcharuk with the request to pay special attention to the amended Good Manufacturing Practice (GMP) Confirmation Order and recommended the Ministry of Health of Ukraine to withdraw the draft amendments to the Order from the public hearing. The reason for the appeal was that the draft amendments had been put to public discussion for a third time at the end of January 2020. Moreover, the draft text remained unchanged, and so are the risks implied by it. The European Business Association repeatedly pointed out the risks and consequences from the adoption of the Draft Order of the Ministry of Health of Ukraine during the discussions of the first two versions of the document. The EBA experts believe that in case the draft amendments to the GMP Confirmation Order are adopted, it will be impossible to register and re-register a range of medicines within the given timeframe; the import of those medicines will be disrupted unpredictably; and in some cases, the supply can be ceased. Thus, the main risks inherent in the Draft Amendment to the Ministry of Health of Ukraine Order, which could lead to adverse outcomes for the pharmaceutical market and patients in Ukraine, are the following: A discrepancy of the proposed amendments with the European practices; furthermore, one of the operating mechanisms with a direct impact on the availability of medicines for Ukrainian patients works incorrectly and causes a delay in registration/re-registration and medicines importation. At the same time, no solution to the problem was proposed in the draft document. There is no analysis to estimate the risks of how the entry-into-force of the draft document worsens the access for the patients to certain medicines, including the ones provided by the state programs. Removal of the separate provision on the operative communication between the government body of Ukraine in the field of the drug quality control and respective organ members of PIC/S in other countries, although the State Service for Medications and Drugs Control of Ukraine has been a member of PIC/S since 2011. A necessity for the repeated inspection of production districts in the EU member countries, although the producers have the respective GMP Certificates, to which will lead some of the changes introduced in the draft document. The European Business Association is convinced of the necessity to provide a solid and balanced approach to improve the procedure, which directly affects timely patients access to high-quality, effective and safe medicines of international manufacturers. Thus, we hope that the position of the business community will be considered.

The reason for the appeal was that the draft amendments had been put to public discussion for a third time at the end of January 2020. Moreover, the draft text remained unchanged, and so are the risks implied by it. The European Business Association repeatedly pointed out the risks and consequences from the adoption of the Draft Order of the Ministry of Health of Ukraine during the discussions of the first two versions of the document.

The EBA experts believe that in case the draft amendments to the GMP Confirmation Order are adopted, it will be impossible to register and re-register a range of medicines within the given timeframe; the import of those medicines will be disrupted unpredictably; and in some cases, the supply can be ceased. Thus, the main risks inherent in the Draft Amendment to the Ministry of Health of Ukraine Order, which could lead to adverse outcomes for the pharmaceutical market and patients in Ukraine, are the following:

A discrepancy of the proposed amendments with the European practices; furthermore, one of the operating mechanisms with a direct impact on the availability of medicines for Ukrainian patients works incorrectly and causes a delay in registration/re-registration and medicines importation. At the same time, no solution to the problem was proposed in the draft document.
There is no analysis to estimate the risks of how the entry-into-force of the draft document worsens the access for the patients to certain medicines, including the ones provided by the state programs.
Removal of the separate provision on the operative communication between the government body of Ukraine in the field of the drug quality control and respective organ members of PIC/S in other countries, although the State Service for Medications and Drugs Control of Ukraine has been a member of PIC/S since 2011.
A necessity for the repeated inspection of production districts in the EU member countries, although the producers have the respective GMP Certificates, to which will lead some of the changes introduced in the draft document.

The European Business Association is convinced of the necessity to provide a solid and balanced approach to improve the procedure, which directly affects timely patients access to high-quality, effective and safe medicines of international manufacturers. Thus, we hope that the position of the business community will be considered.