On 30 November 2023, a forum dedicated to the establishment of the state control authority – the Ukrainian Medical Agency (UMA) – was held in Kyiv.
Event organizer: the company “Proxima Research International”. Co-organizer: State Enterprise “State Expert Center of the Ministry of Health of Ukraine”.
Chief information partner: “APTEKA Weekly”, moderator: Yevhen Kunda, CEO of Proxima Research International.
The forum aimed to form a shared vision of the key stages and timelines of reforming the domestic pharmaceutical market in the context of creating a state control authority in the pharmaceutical sector – the Ukrainian Medical Agency (UMA).
During the forum, participants discussed practical issues of establishing and operating the UMA; challenges of the transition period; became familiar with best European regulatory practices; heard the opinions of market players; readiness for changes and manufacturers’ expectations; and staffing issues.
The Forum was joined by: representatives of the Ministry of Health of Ukraine, the State Service of Ukraine on Medicines and Drugs Control, the State Expert Center of the Ministry of Health of Ukraine, pharmaceutical companies, distributors and the pharmacy segment, foreign and Ukrainian business associations, pharmaceutical industry specialists, the clinical trials market, educators, and representatives of the scientific and medical community. In total, about 250 participants took part in the event (156 offline, 87 online).
Among the Forum speakers: Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration; Krzysztof Landa, adviser to the Minister of Health of Ukraine, former Deputy Minister of Health of Poland, healthcare expert; Roman Isaienko, Head of the State Service of Ukraine on Medicines and Drugs Control; Mykhailo Babenko, Director of the State Expert Center of the Ministry of Health of Ukraine; Iryna Mahdyk, Executive Director of the Clinical Trials Subcommittee of the European Business Association; Petro Bahrii, President of the Association "Manufacturers of Medicines of Ukraine"; Ivan Vyshnivetskyi, Head of the NGO "Ukrainian Association of Clinical Research"; Kostiantyn Kosiachenko, adviser to the Director of the State Expert Center of the Ministry of Health of Ukraine, Head of the Department of Pharmacy Organization and Economics at Bogomolets National Medical University; Serhii Ubohov, Head of the Department of Medical Personnel, Education and Science of the Ministry of Health of Ukraine; Alla Kotvitska, Rector of the National University of Pharmacy (NUPh); Viacheslav Kaminskyi, Rector of the P. L. Shupyk National Healthcare University of Ukraine; other honored guests.
The event was opened by the Adviser to the Minister of Health of Ukraine, former Deputy Minister of Health of Poland, healthcare expert Krzysztof Łanda. In his welcoming remarks, he noted that Ukraine, which is embarking on the path of powerful changes in the pharmaceutical sector, is not alone – the world is open to helping, and Ukraine should take into account the best European practices and attract all necessary technical and advisory assistance.
“Ukraine has strong expert and professional potential in the pharma sector, and I am confident that the task of establishing a unified regulatory authority will be successfully accomplished,” he stressed.
On its way to the EU, our country will receive the full support of the European Medicines Agency (EMA) and the European network. This was stated in a video address to the participants by the Executive Director of the European Medicines Agency (EMA) and Chair of ICMRA Emer Cooke.
“The EMA has been working for many years to prepare candidate countries for EU accession. In our experience, this path is long and politicized, but Ukraine is not alone on this path. Our experts and the European regulatory network are ready to provide assistance,” emphasized E. Cooke.
You can watch the original video message from Emer Cook on the Center's YouTube channel at the link https://www.youtube.com/watch?v=zV1palER1t8
Already during the Forum, European approaches to the regulation of medicinal products were shared by the heads of the national regulatory agencies of Sweden, Croatia, Poland, France, and Ireland, as well as representatives of the USAID/SafeMed project and the Medicines for Europe association.
Deputy Minister of Health of Ukraine for European Integration Maryna Slobodnichenko presented to those present a roadmap for establishing the Ukrainian Medical Agency: its mission, vision, structure, values and functions, sources of funding, and expectations regarding the timing of the start of operations.
As Maryna Slobodnichenko noted, the Medical Products Agency (UMA) is an independent, transparent, strong, financially capable, and Euro-integrated structure of European and global standing, whose main task is to unite regulatory functions in order to provide patients with high-quality, safe, effective, and affordable medicines, medical devices, and cosmetic products.
It is anticipated that the newly established body will combine the functions of state registration of medicinal products; technical regulation of medical devices and cosmetic products; expert evaluation in the field of medicine registration and clinical trial materials; pharmacovigilance; and all powers of the State Service of Ukraine on Medicines and Drugs Control, including control, supervision and licensing.
The estimated start date of the new body’s operation is January 1, 2025, after the relevant amendments are made to the Law “On Medicinal Products”. After the transitional period, from January 1, 2026, the new state control body will be able to begin full operation.
The Head of the State Service of Ukraine on Medicines and Drugs Control Roman Isaienko briefed the Forum participants on the main results, areas, and scope of work of the body he leads and on the potential of the State Service within the system of a single regulatory authority.
In his speech, Director of the State Expert Center of the Ministry of Health of Ukraine Mykhailo Babenko spoke in detail about the functions that will be transferred to the UMA, the tasks that need to be performed during the transition period, the main achievements, and the professional and expert level of the Center that should be preserved, and presented international experience and European integration work.
“We are ready to create the UMA, we understand the challenges that may arise along the way, and we have a vision for overcoming them. Our main task is to do everything possible so that patients and all market participants do not experience disruptions in the system's operation or a deterioration in access to medicinal products,” stressed Mykhailo Babenko.
After the speeches of public sector representatives, representatives of the pharmaceutical market shared their views on the creation and functioning of the new regulatory body. In particular, three panel discussions were held with the participation of representatives of the clinical trials sector, manufacturers of medicinal products, distributors and pharmacy chains, who expressed readiness for change and their expectations of the creation of the ODK.
A separate discussion panel addressed issues of staffing for the UMA. It was held under the moderation of the Advisor to the Director of the State Expert Center of the Ministry of Health of Ukraine, Head of the Department of Pharmacy Organization and Economics at Bogomolets National Medical University, Doctor of Pharmaceutical Sciences, Professor Kostiantyn Kosiachenko, and with the participation of the Head of the Directorate of Medical Personnel, Education and Science of the Ministry of Health of Ukraine, Doctor of Pharmaceutical Sciences, Professor Serhii Ubohov, the Rector of Shupyk National Healthcare University of Ukraine, Doctor of Medical Sciences, Professor, Academician of the National Academy of Medical Sciences of Ukraine, Honored Doctor of Ukraine Viacheslav Kaminskyi, and the Acting Rector of the National University of Pharmacy, Doctor of Pharmaceutical Sciences, Professor, Honored Worker of Science and Technology of Ukraine Alla Kotvitska. The participants raised a wide range of issues related to approaches to training medical and pharmaceutical specialists.
An important message that was repeatedly heard during the speeches of various stakeholders is that, despite the difficult conditions of war, Ukraine’s pharmaceutical industry demonstrates development, readiness for change, and a commitment to improvement in line with European trends and requirements.
The “PHARMEXPERT 2023” forum became the first effective platform for public and open dialogue between market participants and government representatives as part of the long road toward building a new state control body in the pharmaceutical sector – the Ukrainian Medical Agency.
More details in the material of the main information partner of the Forum – the weekly newspaper Apteka https://www.apteka.ua/article/681578?fbclid=IwAR2DjOHhSO9fI_Az3a4b6QqAxW9LBxFfiQvbWLT9ux97Oiqq9fLwFvP3pQo
