Kazakhstan

Regulatory

In December 2019, the government of Kazakhstan approved the state program for the development and improvement of the country’s Healthcare System for 2020-2050. A significant part of the program is devoted to increasing the number of clinical trials and bringing international clinical trials into the country. Currently, it takes 1 month to receive the approval for a clinical study from the Regulatory Authority. The submission to the Ethics Committee is performed in parallel. This allows to activate study sites in just 1.5 months. All regulatory documentation can be submitted in the Russian language.

Official links

https://www.gov.kz/memleket/entities/dsm?lang=en

Pharmaceutical Industry & Clinical Trials Market

There are 112 pharmaceutical manufacturers in Kazakhstan. It has a significant scientific groundwork in the development and implementation of more than 50 new original medicines in pharmaceutical production. The product volume produced by domestic manufacturers totaled KZT42bn in 2018. At present, the share of domestic manufacturers in the procurement of medicines and medical devices has grown to 30% and continues to grow constantly.

In recent years, the Government of Kazakhstan has actively sought to develop the pharmaceutical sector, localize production of medicines, and broaden its clinical research profile. Today, Kazakhstan is one of the most vibrant emerging markets for clinical trials. This has led some of the world’s largest pharmaceutical companies to invest in the country and consider Kazakhstan as a location for clinical studies.

Kazakhstan is part of The Eurasian Economic Union (EAEU). Among many economic and political areas, the union regulates and unifies the pharmaceutical and clinical trials industry. This includes an easier registration of drugs and medical devices, accelerated approval timelines, and a simplified customs and logistics process in other member countries. These advantages make Kazakhstan attractive for both regional and global companies.

Medical System in Kazakhstan

Healthcare facilities are largely owned and operated by the public sector represented by the Ministry of Health. About 70 percent of the country’s hospitals are government-owned.

Recently, the government has expanded primary-care services to combat the growing chronic disease mortality, such as diabetes and cancer, and blood pressure issues.

The newest reform, the Compulsory Social and Medical Insurance (CSMI) program, which went into effect in January 2020, aims to transition to a universal healthcare system with greater cost transparency and a better quality of life. The ultimate goal of the reforms is to create a single-payer healthcare system. The intent is for public insurance to pay for certain medical expenses and regulate healthcare quality. The country aims to reduce out-of-pocket expenses which made up 45.14% of Kazakhstan’s total health spending in 2014.