Maria Shipuleva, Head of AstraZeneca’s Representative Office in Kazakhstan shared the company’s priorities in the country with Natalia Baeva, Director of the Global Pharmaceutical Leaders’ Club. They discussed the company’s direction in Kazakhstan and ways to enhance market regulation efficiency to expand patient access to innovative medicines. The interview was taken at the Kazakhstan Pharmaceutical Forum. AstraZeneca will participate in the Eurasian Pharmaceutical Summit, which focuses on market trends in Central Asia, the Caucasus, and Eastern Europe. The dialogue with regulators from various countries, including Kazakhstan, will continue at the summit.

Natalia Baeva, Director of the Global Pharmaceutical Leaders’ Club: What trends do you see in the Kazakhstan market and what priorities do you set for your company in the current conditions?

Maria Shipuleva, Head of AstraZeneca’s Representative Office in Kazakhstan: In 2023, AstraZeneca’s workforce in Kazakhstan more than doubled, and we entered 2024 with a robust team of 200 employees. However, we are not stopping there; growth remains our focus. To solidify our presence, we registered an LLP in September 2023, paving the way for long-term collaboration with the state and various market associations. In 2024, we will transition to full-fledged LLP operations, including opening our own warehouse to reduce logistics dependency and ensure reliable medicine supply.

2023 underscored the importance of innovative healthcare in Kazakhstan, with numerous regulatory documents signed to boost the presence of innovative companies. A key focus is contract manufacturing within Kazakhstan, and we are already progressing towards this goal. We aim to sign a contract manufacturing agreement this year to start technology transfer and local production by 2025 – an ambitious but achievable timeline.

We are also initiating steps to include patients in Kazakhstan in clinical trials, marking the first time local patients will participate in phase 3 trials. Additionally, we plan to launch at least four real-world evidence studies in 2024. 

Expanding cooperation in diagnostics is critical for us. We have a longstanding commitment to oncology and orphan diseases in Kazakhstan, and we are poised to increase our contributions in these vital areas.

Natalia Baeva, Director of the Global Pharmaceutical Leaders’ Club: As an innovative company, what improvement opportunities would you discuss with regulators? Where do you see potential in Kazakhstan to make medicines more accessible to patients? 

Maria Shipuleva, Head of AstraZeneca’s Representative Office in Kazakhstan: We would like to keep strengthening the dialogue between business and government in Kazakhstan. While this dialogue is ongoing, closer cooperation is essential. Regulation here is evolving quickly, so we must focus on upcoming changes over the next few years. Our industry is particularly concerned about the harmonization of pharmaceutical drugs registration certificates. We as an industry faced challenges with document compliance in the past, so we need clear communication to minimize the risk of medicines shortages.

Another urgent matter is the labeling of unregistered pharmaceutical drugs, which could hinder access for orphan patients, especially minors. It’s crucial to ensure these essential medicines can be imported without unnecessary hurdles.

Natalia Baeva, Director of the Global Pharmaceutical Leaders’ Club: What were your takeaways from the forum? How does your company benefit from participating in such gatherings?

Maria Shipuleva, Head of AstraZeneca’s Representative Office in Kazakhstan: Your platform facilitates vital communication between industry and government bodies, enabling us to exchange experiences, expectations, and concerns. Without such forums, our opportunities for dialogue would be limited. It’s crucial for us to hear the regulator’s position and understand the approach. Equally important is for the regulator to grasp the intricacies of doing business, including not just long-term strategy but also specific proposals for smoother collaboration with the industry.

With participation from both innovative companies and manufacturers of dietary supplements and generics, these forums offer a unique opportunity to collaborate on long-term regulatory improvements. Together, we can explore avenues to enhance regulation for the benefit of all stakeholders.