Pharmaceuticals and Healthcare in Kazakhstan

Introduction to the Industry

Kazakhstan’s pharmaceutical and healthcare sectors are undergoing significant transformation, driven by:
  • Government modernization programs (e.g. “Healthy Nation” strategy until 2025)
  • Rapid growth in public-private partnerships (PPPs)
  • Expansion of local pharmaceutical manufacturing
  • Growing interest from foreign pharmaceutical companies and medical device suppliers
The government aims to increase local pharmaceutical production from 17% to 50% by 2025, creating strong incentives and legal reforms to attract foreign investment.
Market Overview
➤ Healthcare Sector:
  • Universal healthcare system under Mandatory Social Health Insurance Fund (MSHIF)
  • Significant public procurement of medicines, equipment, and digital solutions
  • Demand for private clinics, diagnostic centers, telemedicine, and wellness services is growing
➤ Pharmaceutical Sector:
  • Estimated market size: USD 1.5 billion (2024)
  • Fastest-growing segments:
    • Generic drugs
    • Biopharmaceuticals
    • Nutraceuticals and dietary supplements
  • Key players: SANTO, Nobel AFF, Abdi Ibrahim, Kyzyl May
  • Strong reliance on imports (70%), especially for high-value medicines
Regulatory Landscape
Key Regulatory Bodies:
  • Ministry of Health of the Republic of Kazakhstan
  • Committee for Medical and Pharmaceutical Control
  • SK-Pharmacy LLP (state-owned monopoly on public medicine procurement)
  • Kazakhstan National Center of Expertise of Medicines
Major Laws & Regulations:
  • Code “On Public Health and Healthcare System” (2020)
  • Law “On Licensing and Notifications” (2021)
  • EAEU Technical Regulations (as Kazakhstan is part of the Eurasian Economic Union)
  • Rules on GMP/GDP Certification, drug registration, labeling, pricing, and import/export
Licensing:
  • Manufacturing, import, retail, and distribution of medicines require mandatory licenses
  • Licensing periods: typically 10 years, with compliance inspections every 2–3 years
Clinical Trials:
  • Permitted under strict guidelines via accredited institutions and ethical committees
  • Requires registration with the Unified State Register of Clinical Trials
Foreign Investment & Legal Protections
Kazakhstan offers a liberal investment climate with international protections:
Key Protections:
  • Bilateral Investment Treaties (BITs) with >50 countries
  • Membership in ICSID & New York Convention
  • Investor Dispute Resolution via AIFC Court & IAC (Astana International Financial Centre)
Tax & Customs Preferences:
  • Tax holidays in Special Economic Zones (SEZs)
  • Investment subsidies, customs duty exemptions
  • Priority status for foreign investors in pharma infrastructure projects
Intellectual Property Protection:
  • Patent protection for pharmaceutical products (20 years)
  • Brand/trademark registration through Kazpatent or Madrid Protocol
  • Strong legal tools to combat counterfeiting and parallel imports
Public Procurement in Pharmaceuticals
  • Centralized procurement via SK-Pharmacy LLP for hospitals and clinics
  • Requires:
    • Product registration in Kazakhstan
    • Pricing submission and approval
    • Tender or long-term supply agreements (up to 10 years)
Foreign pharmaceutical companies may participate through:
  • Kazakhstan-registered subsidiaries
  • Local distributors
  • Contract manufacturing partnerships
Challenges & Compliance Risks
  • Complex and evolving drug registration and certification procedures
  • Local content requirements in procurement
  • Delays in GMP inspections and EAEU harmonization
  • Stringent rules on advertising, pharma reps, and digital marketing
  • Risk of tax audits for foreign entities operating through distribution schemes
How Bond Stone Law Firm Can Help
Legal Services for the Pharma & Healthcare Sector:
Service Area
Our Expertise
Regulatory Licensing
Licensing for manufacturers, distributors, and clinics
Clinical Trial Approvals
Full cycle legal support for study protocols, ethics reviews, regulatory filings
Market Entry & M&A
Structuring joint ventures, distributor agreements, equity deals
GMP/GDP Compliance
Legal consulting for inspections, documentation, appeals
Public Procurement Support
SK-Pharmacy bidding strategies, contract drafting, dispute resolution
Contract Manufacturing & OEM
Legal structuring for toll manufacturing, contract R&D, co-branding
IP Protection & Anti-Counterfeiting
Registration of trademarks, patents, and legal enforcement
International Arbitration
Investor-state disputes at AIFC or international tribunals
Why Choose Bond Stone?
  • Multilingual team (Kazakh, Russian, English, Turkish)
  • Deep expertise in regulatory law, cross-border M&A, and intellectual property
  • Offices in Astana, Almaty, Tashkent, and Bishkek with regional reach
  • Recognized advisors to pharma startups, multinational drug firms, and medical device companies