Pharmaceutical industry needs to expand its e-communication with government agencies

01/ 04/ 2020

In the context of the nationwide quarantine and legislative restrictions on the activity of enterprises, on the one hand, it is recommended to work remotely at the state level, and on the other - state agencies cannot provide full-time remote work due to objective obstacles. For example, in certain state-owned enterprises, there are no systems of electronic document flow, no established processes that would allow the maximum use of electronic technologies with proper data security. In addition, there are regulatory requirements that limit electronic interaction with businesses by state-owned enterprises. The pharmaceutical industry needs special attention in this regard. Forced interferences in the industry can lead to disruptions or delays in the supply of medicines to the Ukrainian market. Nowadays, the effective work of pharmaceutical companies will depend on the effectiveness of state measures aimed at overcoming the epidemic in the country. Therefore, the European Business Association calls on the Ministry of Health of Ukraine and the Cabinet of Ministers of Ukraine to give due attention to the problematic procedural issues of the industry. Due to the quarantine restrictions imposed by the legislation, the State Expert Center was forced to introduce a temporary order of interaction with pharmaceutical companies that submit materials to the State Expert Center for the purpose of registration and re-registration of medicines and approval of clinical trials. However, the interaction order does not include all electronic solutions of the process optimization that should be used to minimize the need for visits and direct contact. The EBA Health Care Committee offers some optimization solutions which require minimal funding and human resources. Moreover, the implementation of those electronic instruments is technically possible. We ask the Ministry of Health of Ukraine and the Cabinet of Ministers of Ukraine to ensure the functioning of the following tools and mechanisms: Electronic filing of application and registration form for examination of registration/re-registration materials, amendments to registration materials of medicines, and examination of clinical trial materials and substantive amendments to protocols. Electronic submission of scanned documents in PDF format using the electronic signature of the applicant/applicants representative. Electronic submission of registration and clinical trial materials by granting special access to relevant medicinal products stored on a remote company resource. Allocation of additional e-mail addresses for the submission of clinical trial materials and the regular submission of scanned copies of the materials in compliance with the requirements of the current legislation, in particular, the one on pharmacovigilance. Possibilities of two-way electronic correspondence on any questions, namely, in order to receive expert comments and answers. In addition, we consider it extremely reasonable to prioritize procedures. The most critical procedures should get the green light as soon as possible. We believe that the priority should be given to the examination of materials for the purpose of re-registering medicines and making changes to the marking, as it directly affects the ability of manufacturers to ensure an uninterrupted supply of medicines (for example, SI marking). It is equally important to process and approve the clinical trial materials as promptly as possible as well as making substantive amendments to them, as it is directly related to ensuring the continued treatment of patients under clinical trials. We appreciate the efforts of the CMU and state-owned enterprises in ensuring a stable work under the current challenging conditions. However, without the extension of terms on bilateral electronic communication, we anticipate further procedural complications, including those regarding the priority list of medicines approved by CMU Resolution 224 of March 20, 2020, and those medicines which timely supply to the Ukrainian market is expected by other categories of patients. The Association considers that the measures outlined above need immediate implementation and asks the Ministry of Health of Ukraine and the Cabinet of Ministers of Ukraine to support them.

The pharmaceutical industry needs special attention in this regard. Forced interferences in the industry can lead to disruptions or delays in the supply of medicines to the Ukrainian market. Nowadays, the effective work of pharmaceutical companies will depend on the effectiveness of state measures aimed at overcoming the epidemic in the country. Therefore, the European Business Association calls on the Ministry of Health of Ukraine and the Cabinet of Ministers of Ukraine to give due attention to the problematic procedural issues of the industry.

Due to the quarantine restrictions imposed by the legislation, the State Expert Center was forced to introduce a temporary order of interaction with pharmaceutical companies that submit materials to the State Expert Center for the purpose of registration and re-registration of medicines and approval of clinical trials. However, the interaction order does not include all electronic solutions of the process optimization that should be used to minimize the need for visits and direct contact.

The EBA Health Care Committee offers some optimization solutions which require minimal funding and human resources. Moreover, the implementation of those electronic instruments is technically possible.

We ask the Ministry of Health of Ukraine and the Cabinet of Ministers of Ukraine to ensure the functioning of the following tools and mechanisms:

Electronic filing of application and registration form for examination of registration/re-registration materials, amendments to registration materials of medicines, and examination of clinical trial materials and substantive amendments to protocols.
Electronic submission of scanned documents in PDF format using the electronic signature of the applicant/applicant’s representative.
Electronic submission of registration and clinical trial materials by granting special access to relevant medicinal products stored on a remote company resource.
Allocation of additional e-mail addresses for the submission of clinical trial materials and the regular submission of scanned copies of the materials in compliance with the requirements of the current legislation, in particular, the one on pharmacovigilance.
Possibilities of two-way electronic correspondence on any questions, namely, in order to receive expert comments and answers.

In addition, we consider it extremely reasonable to prioritize procedures. The most critical procedures should get the green light as soon as possible. We believe that the priority should be given to the examination of materials for the purpose of re-registering medicines and making changes to the marking, as it directly affects the ability of manufacturers to ensure an uninterrupted supply of medicines (for example, SI marking). It is equally important to process and approve the clinical trial materials as promptly as possible as well as making substantive amendments to them, as it is directly related to ensuring the continued treatment of patients under clinical trials.

We appreciate the efforts of the CMU and state-owned enterprises in ensuring a stable work under the current challenging conditions. However, without the extension of terms on bilateral electronic communication, we anticipate further procedural complications, including those regarding the priority list of medicines approved by CMU Resolution 224 of March 20, 2020, and those medicines which timely supply to the Ukrainian market is expected by other categories of patients.

The Association considers that the measures outlined above need immediate implementation and asks the Ministry of Health of Ukraine and the Cabinet of Ministers of Ukraine to support them.