Results of the round table ‘Medical cannabis: a public discussion of current issues’

The round table ‘Medical cannabis: a public discussion of current issues’ was organised as a platform for open professional dialogue between representatives of business and government regarding the current state of the medical cannabis system in Ukraine.

The main aim of the event was to discuss practical issues that are already arising as the market operates, to identify regulatory barriers and possible ways of removing them, and to outline further steps for the sector’s development.

Results of two years of development in the Ukrainian market

Over the past two years, the Ukrainian medical cannabis market has come a long way — from the adoption of legislative decisions to the development and first sale of the product.

Key achievements during this period include:

• 9 APIs have been registered in Ukraine;
• 2 APIs have already been imported into Ukraine;
• the first sale of a medicinal product based on medical cannabis has taken place;
• 2 medical cannabis production facilities are under construction;
• training sessions for doctors have been held;
• the ESORK system has been launched;
• the first cohort of participants on the UAMC GACP course has successfully completed their training and received their certificates;
• preparations are underway for the launch of the second intake of the GACP course.

These results indicate that the market is gradually moving from the stage of establishing a regulatory framework to practical implementation and infrastructure development. At the same time, the launch of the system has highlighted a number of issues that require further regulation.

Key issues raised during the roundtable

Regulation of products with minimal THC content

One of the topics of discussion was the need to amend Resolution No. 770 to regulate the status of products with minimal THC content, in particular CBD products. Participants discussed the need for a clearer regulatory approach to such products and potential changes that would resolve existing discrepancies.

Development of manufacturing pharmacies

Particular attention was paid to the issues faced by manufacturing pharmacies. Resolving practical issues will help, in particular, to move towards scaling up and increasing

the number of manufacturing pharmacies and a corresponding increase in the turnover of medical cannabis-based medicines through this channel.

Participants noted the need for further work on the practical and regulatory conditions that would enable manufacturing pharmacies to operate more effectively.

Necessary legislative changes

An important part of the discussion centred on the issue of further improving the legislation. Participants discussed:

• which issues already require regulatory addressing;
• the need for amendments to the law and which amendments have already been tabled;
• possible ways for market participants and other stakeholders to collaborate in developing and implementing the necessary changes.

Conclusions

Over the past two years, the Ukrainian medical cannabis market has made the transition from legislative decisions to practical results. Today, the first elements of the system are already in place: registered active pharmaceutical ingredients (APIs), imported raw materials, the first marketed medicinal product and a developing manufacturing infrastructure.

The next stage in the market’s development should be the refinement of the system already in place: removing regulatory barriers, scaling up existing mechanisms, developing the production infrastructure and ensuring coordinated interaction between the state, business and the professional community.

The round table provided an opportunity not only to identify current challenges, but also to discuss practical ways of addressing them and to set out directions for further work. It is precisely this open professional dialogue between all market participants that enables the creation of conditions for the further development of the medical cannabis system in Ukraine.