Resolution of the Fifth Scientific and Practical Conference

RESOLUTION

of the Fifth Scientific and Practical Conference with international participation “Safety and Regulatory Support of Medicinal Products: From Development to Medical Use”, dedicated to the memory of Professor, Doctor of Medical Sciences Oleksii Viktorov

The fifth scientific and practical conference with international participation “Safety and Regulatory Support of Medicinal Products: From Development to Medical Use,” dedicated to the memory of Prof., Doctor of Medical Sciences Oleksii Pavlovych Viktorov (hereinafter – the Conference), took place on October 22-23, 2019 in Kyiv and was organized by the Ministry of Health of Ukraine, the National Academy of Medical Sciences of Ukraine, and the State Enterprise “State Expert Center of the Ministry of Health of Ukraine” (hereinafter – the State Expert Center of the MoH).

The Conference was held in accordance with the Register of Congresses, Symposia, and Scientific and Practical Conferences planned to be held in 2019.

The Conference included a plenary session, 16 sections, and 2 round tables, at which topical issues of pharmacovigilance in Ukraine and the CIS, safety of immunoprophylaxis, bioequivalence and therapeutic drug monitoring, critical regulatory issues, and communication with public and patient organizations were discussed. Also considered were issues of safety at the stage of medicinal product development, risk and signal management systems during clinical trials of medicinal products and in the post-registration period, management of information and clinical data, including the use of electronic resources. Great attention was paid to issues of the registration dossier as a reflection of the life cycle of a medicinal product. Issues of the formulary system of providing medicinal products and the national list of essential medicines, and health technology assessment were also considered.

Participants in the Conference included representatives of the Ministry of Health of Ukraine, the State Expert Center of the MoH, the Public Health Center of the Ministry of Health of Ukraine, the State Service of Ukraine on Medicinal Products and Drugs Control, representatives of regulatory authorities of Ukraine and 6 CIS countries (Belarus, Moldova, Azerbaijan, Armenia, Uzbekistan, Kyrgyzstan), a representative of the WHO Regional Office for Europe, scientists and pharmacovigilance representatives from the United Kingdom and Switzerland, as well as experts from the Netherlands, Germany and the USA, who represented, among others, such organizations as: the International Society of Pharmacovigilance (ISOP), the Council for International Organizations of Medical Sciences (CIOMS), the Medicines and Healthcare products Regulatory Agency (MHRA).

Participants in the Conference included representatives of the practical healthcare system, pharmacists, heads of healthcare administration bodies and leading scientists of research institutes; lecturers of medical and pharmaceutical higher education institutions; employees, qualified persons responsible for pharmacovigilance, and applicants for medicinal products, as well as other specialists involved in the development, dispensing, prescribing and use of medicinal products; representatives of associations of medicinal product manufacturers; organizations that represent and protect the rights and safety of patients: “Parents for Vaccination”, “Health Platform”, “Orphan Diseases of Ukraine”, the International Renaissance Foundation, the Charitable Organization “Patients of Ukraine”.

The total number of conference participants was 458 people.

The Fifth Scientific and Practical Conference with International Participation “Safety and Regulatory Support of Medicinal Products: From Development to Medical Use”, dedicated to the memory of Prof., Dr. Med. Sci. Oleksii Viktorov, states that the State Expert Center of the MoH has fulfilled the tasks declared in the Resolution of the Fourth Scientific and Practical Conference with International Participation “Safety and Regulatory Support of Medicinal Products: From Development to Medical Use”, dedicated to the memory of Prof., Dr. Med. Sci. Oleksii Viktorov, held on 11-12 October 2016, in particular:

• The draft article “Pharmacovigilance” has been developed and submitted for the draft Law of Ukraine “On Medicinal Products”, which is registered in the Verkhovna Rada of Ukraine;
• The draft Procedure for Prohibiting and/or Terminating the Validity of a Registration Certificate has been developed and submitted to the MoH of Ukraine;
• a section on the development, improvement and ensuring the functioning of the pharmacovigilance system has been added to Resolution of the Cabinet of Ministers of Ukraine of December 5, 2018 No. 1022 “On approval of the State Strategy for implementing state policy on providing the population with medicinal products for the period until 2025”;
• Amendments and additions have been made to the Procedure for Pharmacovigilance, approved by MoH of Ukraine order of 27.12.2006 No. 898, registered with the Ministry of Justice of Ukraine on 19.12.2016 under No. 1649/29779 (as amended by MoH of Ukraine order of 26.09.2016 No. 996);
• the Standard “Guideline. Medicinal products. Good Pharmacovigilance Practices” (GVP), approved by MoH of Ukraine order of 05.04.2018 No. 620

Currently, the Automated Pharmacovigilance Information System (APIS) has been implemented in Ukraine to improve the collection, analysis and assessment of reports of adverse reactions and/or lack of efficacy of medicinal products, vaccines and tuberculin received from healthcare professionals, patients and applicants for medicinal products. Methodological and organizational assistance to healthcare facilities has been established by the Pharmacovigilance Directorate and by pharmacovigilance representatives of the State Expert Center of the MoH in the administrative-territorial units of Ukraine.

The development of the applicant's pharmacovigilance system in accordance with international standards continues.

The State Expert Center of the Ministry of Health of Ukraine conducted a number of training seminars and trainings on pharmacovigilance for applicants. Training seminars, trainings, conference calls and Skype meetings were held for the Center's pharmacovigilance representatives in the administrative-territorial units of Ukraine, including 25 Skype meetings for members of regional rapid response teams for adverse events following immunization on keeping the Investigation Protocols for adverse events following immunization.

In fulfillment of WHO requirements, active pharmacovigilance is carried out in Ukraine for new medicinal products used for the first time in Ukraine to treat socially dangerous diseases.

Also, on the instruction of the Ministry of Health of Ukraine, the Center carries out enhanced pharmacovigilance of medicinal products that require additional monitoring of their safety of use.

International relations have been established, including with the WHO Center for Monitoring Adverse Reactions; the role of pharmacovigilance in the procedural processes regulating the circulation of medicinal products in Ukraine has grown significantly.

At the same time, taking into account the existing achievements in the organization and implementation of pharmacovigilance in Ukraine, a number of issues remain that need to be resolved.

In this connection, the Conference participants resolved:

1. It is considered advisable to hold the Sixth Scientific and Practical Conference with international participation “Safety and Legal Support of Medicinal Products: from Development to Medical Use”, dedicated to the memory of Prof. Oleksii Pavlovych Viktorov, Doctor of Medical Sciences, in 2022, and to submit a proposal for its inclusion in the Register of Congresses, Conventions, Symposia, and Scientific and Practical Conferences of the Ministry of Health of Ukraine and the National Academy of Medical Sciences of Ukraine planned for 2022.
2. To continue developing the pharmacovigilance system in Ukraine in accordance with the requirements of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), European Union approaches and international recommendations, with the technical, organizational and methodological support of WHO, EMA and other partners, by:
   • conducting training on medicinal product safety and pharmacovigilance for pharmacovigilance specialists, representatives of public and patient organizations, healthcare professionals and applicants;
   • harmonization of approaches to pharmacovigilance processes and regulation of the circulation of medicinal products with the corresponding approaches in the EU;
   • optimizing information exchange on medicinal product safety with EU countries, CIS countries, as well as WHO and EMA;
3. With the aim of implementing positive international experience in rational pharmacotherapy and pharmacovigilance, to develop relevant draft legislative acts and submit them to the Ministry of Health of Ukraine for approval, namely:
   • develop and submit to the Ministry of Health of Ukraine a draft Procedure for conducting non-interventional studies of medicinal products;
   • jointly with the State Service of Ukraine on Medicines and Drugs Control, to develop a draft of amendments to MoH order of 22.11.2011 No. 809 “On Approval of the Procedure for Imposing a Ban (Temporary Ban) and Resuming Circulation of Medicinal Products in the Territory of Ukraine” regarding the grounds for imposing a ban (temporary ban) on the circulation of medicinal products in the territory of Ukraine;
   • to improve the existing legislative acts regulating the circulation of medicinal products and the conduct of pharmacovigilance, taking into account changes in European legislation and international regulations.
4. To facilitate communication among all stakeholders on medicinal product safety by:
   • creation of a vaccine safety communication plan in case of problematic issues;
   • development of an algorithm for interaction and exchange of information on adverse events following immunization between the State Expert Center of the Ministry of Health and the Public Health Center of the Ministry of Health of Ukraine;
   • effective interaction with the media and the formation of an objective view among the media on medicinal product safety issues, and the use of the media's potential to educate the medical community and the public on the safety of medicinal products and vaccines;
   • interaction with state, public, and international organizations related to the circulation and safety of medicinal products;
   • active involvement of patients in the process of reporting adverse reactions and lack of efficacy of medicinal products;
   • holding meetings of working groups, seminars, trainings, etc. to discuss pharmacovigilance issues and improve the legislative framework.
5. Recommend that the Ministry of Health of Ukraine, jointly with the State Expert Center of the MoH, promote the improvement of enhanced/active pharmacovigilance methods and the generation of signals.
6. Publish the resolution of the Conference in the journals “Pharmacology and Medical Toxicology”, “Ukrainian Medical Journal”, “Rational Pharmacotherapy”, “Weekly APTEKA”, “News of Medicine and Pharmacy”, “Health of Ukraine”, and other specialized medical publications, and also post it on the official websites of the Ministry of Health of Ukraine and the State Expert Center of the MoH.