Business calls on the Government to engage in a constructive dialogue regarding the GMP compliance procedure

17/ 02/ 2021

The European Business Association appeals to Mr. Denys Shmyhal, Prime Minister of Ukraine, and Mr. Maksym Stepanov, Minister of Health, to ensure proper implementation by the State Medical Service of the powers and responsibilities defined by the current legislation of Ukraine on the procedure of confirming the requirements of good manufacturing practice (GMP). Also, we request the Service to start a constructive dialogue with the business by establishing a respective working group aimed at harmonizing Ukrainian legislation on GMP certification with European Union regulation, ensuring maximum use of GMP recognition procedures in countries with strict regulatory environment and international industry associations, including Pharmaceutical Inspection Cooperation Systems (PIC / S), of which Ukraine is a member, as well as deregulation in certain procedural issues. According to EBA Health Care Committee experts, the accumulated set of problems in the implementation of the existing GMP confirmation procedure in Ukraine poses a real threat to the sustainability of the pharmaceutical business and the guarantees of providing Ukrainian citizens with the necessary quality treatment. We have drawn attention to these issues in previous appeals. The text of the appeal can be found hereunder. The EBA hopes for a proper and prompt response to the requests of the business! Ref. № 66/2021/13 of February 10, 2021 To: Prime Minister of Ukraine - Mr. Denys Shmyhal Minister of Health - Mr. Maksym Stepanov Copy: Deputy Minister of Health of Ukraine Mr. Ivashchenko I.A Director-General of the Directorate for Pharmaceutical Support of the Ministry of Health of Ukraine Mr. Komaridi O.O. Head of the State Service of Ukraine on Medicines and Drug Control Mr. Isaenko R.M. Re: the draft order of the Ministry of Health of Ukraine On approval of the Procedure for involving enterprises, institutions, and organizations for the examination of documents and performance of certain works during the procedure of confirming compliance of medicinal products production conditions with the requirements of good manufacturing practice Dear Mr. Denys Shmyhal, Dear Mr. Maksym Stepanov, The European Business Association presents its compliments to You and would like to make an appeal regarding the draft order of the Ministry of Health of Ukraine On approval of the Procedure for involving enterprises, institutions, and organizations for the examination of documents and performance of certain works during the procedure of confirming compliance of medicinal products production conditions with the requirements of good manufacturing practice, published for public discussion on the official website of the Ministry of Health of Ukraine on January 12, 2021. Considering the results of the preliminary discussion of the EBA with the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drug Control (hereinafter – the State Medical Service), the member companies of the EBA Health Committee emphasize the long-existing problems in the procedure of verifying compliance with the requirements of good manufacturing practice which includes the non-observance of the procedure terms defined by sectoral legislation, in particular, the current Procedure for confirming compliance of the conditions of production of medicinal products with the requirements of good manufacturing practice, approved by the order of the Ministry of Health of Ukraine №1130 dated 27 December 2012. Such delays, which are due, inter alia, to a significant increase in the volume of activities and the abolition of simplifications that previously existed as a result of changes to the Order №1130, already now, according to EBA Health Care Committee member companies, have direct negative consequences for conducting economic activity by pharmaceutical manufacturers, and for the stability of providing the citizens of Ukraine with the necessary medicines. In its previous appeal, the EBA noted the inadmissibility and risks of introducing additional paid services during the GMP confirmation procedure by involving third parties as it would not comply with current legislation, which does not provide paid services and administrative fees for the GMP procedure. At joint meetings with EBA representatives, the State Medical Service stated that the introduction of paid services is necessary because of the lack of finances and staffing. Accordingly, the EBA Health Care Committee responded that then measures to eliminate the above-mentioned problems should be simultaneously taken with the introduction of paid services for the GMP procedure. However, the EBA member companies do not have information about any of such measures at this time, and, according to our data, the relevant information is not publicly available. Unfortunately, after more than 6 months of involving enterprises in the GMP confirmation procedure by the State Medical Service, the EBA member companies do not notice any improvements that could potentially occur due to paid GMP confirmation procedure. Therefore, according to business representatives, we state that there are no appropriate changes in the staffing or financial support of the State Medical Service and/or optimization of available resources by the State Medical Service, which, in our opinion, should have been a key task under the above conditions. It should be noted that as a result of changes to the Order №1130, adopted on June 9, 2020, on which the EBA provided reasonable comments and suggestions to both the State Medical Service and the Ministry of Health of Ukraine, according to experts of the EBA Committee, the number of GMP confirmation procedures increased by a third due to the reduction of the list of countries to which the procedure of recognition [1] can be applied at confirmation of GMP, ie by verification of documents. Thus, the workload of the State Medical Service experts increased, and the necessary funding and provision of qualified human resources were not provided. As there are no positive changes for the pharmaceutical industry from the actual 6-month application of procedures and provisions set out in the Draft Order, as well as at this time the State Medical Service does not provide the professional community with a plan to resolve the situation regarding the proper performance of its direct function in the context of the GMP confirmation, we would like to request You the followings: 1. urgently ensure proper implementation by the State Medical Service of the powers and responsibilities defined by the current legislation of Ukraine on the GMP confirmation procedure, taking into account the proper personnel and financial basis of the State Medical Service following the current GMP confirmation procedure which must be previously assessed and approved; 2. establish a working group to improve the legislation of Ukraine in the field of GMP certification, harmonize it with EU regulation, ensure maximum use of GMP recognition procedures of countries with strict regulatory environment and international industry associations, including Pharmaceutical Inspection Cooperation System, of which Ukraine is a member, as well as deregulate certain procedural issues. Work should also be initiated to further ensure reciprocity of recognition for international and domestic producers, in particular as part of the Agreement on Conformity Assessment and Acceptance of Industrial Goods with the EU; 3. in case the WG identifies the need to involve enterprises, institutions, organizations, individual scientists, and specialists in the GMP confirmation procedure, to provide the WG with the task to work out comprehensive changes to sectoral legislation that will provide clear grounds, deadlines, conditions for their involvement, which are not currently contained in the proposed Draft Order. At the same time, this should not lead to significant complications, non-transparency in the interaction of experts and manufacturers, opportunities for abuse, and risks of a further increase in the number of violations of GMP confirmation procedures, in contrast to the provisions currently proposed in the Draft Order; 4. withdraw from public discussion the Draft Order as such, which will not have positive consequences for the improvement of operating conditions on the territory of Ukraine for the subjects of the pharmaceutical market, until the comprehensive elaboration of the relevant above-mentioned problematic issues of the WG. We thank you in advance for considering our application and we hope to take into account the position of the business. Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.

According to EBA Health Care Committee experts, the accumulated set of problems in the implementation of the existing GMP confirmation procedure in Ukraine poses a real threat to the sustainability of the pharmaceutical business and the guarantees of providing Ukrainian citizens with the necessary quality treatment. We have drawn attention to these issues in previous appeals.

The text of the appeal can be found hereunder. The EBA hopes for a proper and prompt response to the requests of the business!

Ref. № 66/2021/13 of February 10, 2021

To:

Prime Minister of Ukraine – Mr. Denys Shmyhal

Minister of Health – Mr. Maksym Stepanov

Copy:

Deputy Minister of Health of Ukraine

Mr. Ivashchenko I.A

Director-General of the Directorate for Pharmaceutical Support of the Ministry of Health of Ukraine

Mr. Komaridi O.O.

Head of the State Service of Ukraine on Medicines and Drug Control

Mr. Isaenko R.M.

Re: the draft order of the Ministry of Health of Ukraine “On approval of the Procedure for involving enterprises, institutions, and organizations for the examination of documents and performance of certain works during the procedure of confirming compliance of medicinal products production conditions with the requirements of good manufacturing practice”

Dear Mr. Denys Shmyhal,

Dear Mr. Maksym Stepanov,

The European Business Association presents its compliments to You and would like to make an appeal regarding the draft order of the Ministry of Health of Ukraine “On approval of the Procedure for involving enterprises, institutions, and organizations for the examination of documents and performance of certain works during the procedure of confirming compliance of medicinal products production conditions with the requirements of good manufacturing practice”, published for public discussion on the official website of the Ministry of Health of Ukraine on January 12, 2021.

Considering the results of the preliminary discussion of the EBA with the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drug Control (hereinafter – the State Medical Service), the member companies of the EBA Health Committee emphasize the long-existing problems in the procedure of verifying compliance with the requirements of good manufacturing practice which includes the non-observance of the procedure terms defined by sectoral legislation, in particular, the current Procedure for confirming compliance of the conditions of production of medicinal products with the requirements of good manufacturing practice, approved by the order of the Ministry of Health of Ukraine №1130 dated 27 December 2012. Such delays, which are due, inter alia, to a significant increase in the volume of activities and the abolition of simplifications that previously existed as a result of changes to the Order №1130, already now, according to EBA Health Care Committee member companies, have direct negative consequences for conducting economic activity by pharmaceutical manufacturers, and for the stability of providing the citizens of Ukraine with the necessary medicines.

In its previous appeal, the EBA noted the inadmissibility and risks of introducing additional paid services during the GMP confirmation procedure by involving third parties as it would not comply with current legislation, which does not provide paid services and administrative fees for the GMP procedure.

At joint meetings with EBA representatives, the State Medical Service stated that the introduction of paid services is necessary because of the lack of finances and staffing. Accordingly, the EBA Health Care Committee responded that then measures to eliminate the above-mentioned problems should be simultaneously taken with the introduction of paid services for the GMP procedure. However, the EBA member companies do not have information about any of such measures at this time, and, according to our data, the relevant information is not publicly available. Unfortunately, after more than 6 months of involving enterprises in the GMP confirmation procedure by the State Medical Service, the EBA member companies do not notice any improvements that could potentially occur due to paid GMP confirmation procedure. Therefore, according to business representatives, we state that there are no appropriate changes in the staffing or financial support of the State Medical Service and/or optimization of available resources by the State Medical Service, which, in our opinion, should have been a key task under the above conditions.

It should be noted that as a result of changes to the Order №1130, adopted on June 9, 2020, on which the EBA provided reasonable comments and suggestions to both the State Medical Service and the Ministry of Health of Ukraine, according to experts of the EBA Committee, the number of GMP confirmation procedures increased by a third due to the reduction of the list of countries to which the procedure of “recognition” [1] can be applied at confirmation of GMP, ie by verification of documents. Thus, the workload of the State Medical Service experts increased, and the necessary funding and provision of qualified human resources were not provided.

As there are no positive changes for the pharmaceutical industry from the actual 6-month application of procedures and provisions set out in the Draft Order, as well as at this time the State Medical Service does not provide the professional community with a plan to resolve the situation regarding the proper performance of its direct function in the context of the GMP confirmation, we would like to request You the followings:

1. urgently ensure proper implementation by the State Medical Service of the powers and responsibilities defined by the current legislation of Ukraine on the GMP confirmation procedure, taking into account the proper personnel and financial basis of the State Medical Service following the current GMP confirmation procedure which must be previously assessed and approved;

2. establish a working group to improve the legislation of Ukraine in the field of GMP certification, harmonize it with EU regulation, ensure maximum use of GMP recognition procedures of countries with strict regulatory environment and international industry associations, including Pharmaceutical Inspection Cooperation System, of which Ukraine is a member, as well as deregulate certain procedural issues. Work should also be initiated to further ensure reciprocity of recognition for international and domestic producers, in particular as part of the Agreement on Conformity Assessment and Acceptance of Industrial Goods with the EU;

3. in case the WG identifies the need to involve enterprises, institutions, organizations, individual scientists, and specialists in the GMP confirmation procedure, to provide the WG with the task to work out comprehensive changes to sectoral legislation that will provide clear grounds, deadlines, conditions for their involvement, which are not currently contained in the proposed Draft Order. At the same time, this should not lead to significant complications, non-transparency in the interaction of experts and manufacturers, opportunities for abuse, and risks of a further increase in the number of violations of GMP confirmation procedures, in contrast to the provisions currently proposed in the Draft Order;

4. withdraw from public discussion the Draft Order as such, which will not have positive consequences for the improvement of operating conditions on the territory of Ukraine for the subjects of the pharmaceutical market, until the comprehensive elaboration of the relevant above-mentioned problematic issues of the WG.

We thank you in advance for considering our application and we hope to take into account the position of the business.

Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.