2024: UPRA in achievements and figures

In February 2024, the President of Ukraine signed the Law "On Amendments to Certain Laws of Ukraine on State Regulation of the Turnover of Plants of the Cannabis Genus". Changes in the wording of Article 20 of the Law of Ukraine "On Narcotic Drugs, Psychotropic Substances and Precursors" expand the range of psychotropic substances with which scientific research is allowed. Scientific work with not only natural, but also synthetic and semi-synthetic psychotropic drugs becomes legal. This opens up the possibility of planning clinical trials in Ukraine with MDMA and other psychotropic substances used in PJSCs.

In order to conduct internal research in Ukraine, in addition to amendments to Article 20 of the Law of Ukraine "On Narcotic Drugs, Psychotropic Substances and Precursors," a procedure for conducting such research is needed, which is currently lacking. That is why this aspect is the main focus of our advocacy. We have developed a draft of the relevant procedure. The Temporary Special Commission on Veterans' Affairs; the Subcommittee on Veterans' Rehabilitation of the Committee on Social Policy and Protection of Veterans' Rights; the Committee on National Health, Medical Care and Health Insurance supported UPRA's proposals to streamline the legislation governing research with psychotropic drugs from Table 1.

As of today, the Project is under internal discussion at the Ministry of Health of Ukraine. Unfortunately, the working group to develop the procedure for conducting trials at the Ministry of Health has not yet been established, so the discussion takes place in communication with representatives of the Ministry of Health, not at meetings of the working group.

In cooperation with PAREA, consultations were organized and held between Ukrainian stakeholders from public authorities (such as the Ministry of Health, the State Expert Center, the State Service on Medicines and Drugs, etc.) and foreign experts (in particular, representatives of the European Psychiatric Association, government officials, and scientists), which resulted in the formulation of the Ministry of Health's position on the regulation of PAS in Ukraine. The position is to transfer a number of the most studied and promising psychoactive substances for mental health to Table 2. The relevant draft regulations were developed and submitted to the Ministry of Health with the assistance of the said VRU Committee represented by MP D. Gurin. As of January 2025, the Ministry of Health is expected to process these documents and publish them for public discussion on the Ministry's website.

Preparation of the organizational part of the study has begun. Several contract research organizations (CROs) have prepared a draft budget for a pilot study of MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) for 100 patients, and the study design is being actively discussed, which requires taking into account Ukrainian specifics.

16 events were held, the largest of which were the symposium "Ketamine-Assisted Therapy" (in cooperation with the Lisova Polyana Center of the Ministry of Health of Ukraine and Heal Ukraine Trauma), and a film screening of the movie "From Shock to Healing" (in cooperation with the Charitable Foundation "Patronage Service "Angels"). 80 units of thematic content and 48 popular science digests were published.

Translated and published guidelines and protocols: "Yale University Guidelines for Psilocybin Therapy for Depression"; "MDMA-Assisted Psychotherapy for the Treatment of PTSD"; "Psilocybin Researcher's Brochure"; "Guidelines for the Use of Ketamine in Acute Emotional Trauma and Distress"; "MDMA Researcher's Brochure" is awaiting publication.

In total, 3196 people registered for UPRA events, and 1220 people attended them. We held 1 offline event in Poltava, 8 offline events in Kyiv, and 7 online lectures with people from 74 cities of Ukraine (including Kyiv, Kharkiv, Zaporizhzhia, Sumy, Zhytomyr, Gostomel, Bucha, Sevastopol, Kremenchuk, Mariupol, Rubizhne, etc.)

In 2024, the site had 15752 browsing sessions, including 9970 new users; 95 people filled out the therapist questionnaire, 61 people filled out the activist questionnaire, and 828 people subscribed to the news.

In partnership with the Center for Mental Health and Rehabilitation "Lisova Polyana" of the Ministry of Health of Ukraine, a lecture on a comprehensive approach to PTSD was held and work has begun on developing and disseminating a series of lectures on psychopharmacology and harm reduction. The cooperation is coordinated with the director and is carried out directly with the specialists of "Lisova Polyana" who develop educational materials and lecturers.

Together with the NGO "Heal Traumas International", a lecture and panel discussion on the traumatic experience of war were held, cooperation was initiated on the implementation of group ketamine-assisted therapy for veterans, and a symposium on ketamine-assisted psychotherapy was held. Experts from "Heal Traumas International" participated in the Association's events as lecturers.

In cooperation with the ICF "Alliance for Public Health" (Drugstore project), joint events were held, and the Drugstore project provided lecture space for some events.

Together with the Charitable Foundation "Angels'Patronage Service", a screening of the documentary "From Shock to Awe" was organized, including communication in social networks. The head of the Charitable Foundation "Angels" took part in a panel discussion after the screening. As part of the event, the Association raised more than UAH 40,000 in donations for the "Angels'Patronage Service".

It is worth noting the active support of the Renaissance Foundation in addressing additional issues, assistance in finding new partners and organizing related important events (such as a conference in Warsaw in the summer of 2024 in cooperation with PAREA, which allowed for further effective organization and consultation with the Ministry of Health and other government stakeholders).

We will create the information prerequisites in Ukraine for amending the current legislation to ensure the legal conduct of research and the use of psychedelic-assisted psychotherapy in clinical practice (the Procedure for conducting research using substances from Table 1 and/or 2 will be developed and approved, and MDMA and/or psilocybin will be transferred from Table 1 to Table 2).

Changes to the legislation, along with stakeholder awareness, will contribute to Ukrainian scientific research, the development of national protocols, and the emergence of legal access to psychedelic-assisted therapy for people in need. The translated materials will be further distributed and used in the training of specialists. The established relationships with informed stakeholders will be useful in future research, educational projects and service delivery initiatives.

We call on representatives of contract research organizations to join us as lecturers to conduct educational events on clinical trials, as well as to advocate in professional medical circles. We invite veteran NGOs to join the development and implementation of educational activities to reduce the possible harm from the abuse of psychotropic drugs outside the therapeutic context.