The Pharmaceutical Industry in Türkiye: Legal Landscape and Investment Opportunities

1. Introduction: Türkiye’s Pharma Market on the Rise

Türkiye’s pharmaceutical industry stands at a unique crossroads of rapid domestic growth and increasing international relevance. With a population of over 85 million, a robust healthcare infrastructure, and a strategically central location bridging Europe and Asia, Türkiye offers both significant market potential and a dynamic export platform.
In recent years, foreign direct investment, R&D incentives, and evolving regulations have positioned Türkiye as an attractive base for both multinational pharma giants and agile biotech startups.

2. Legal Framework: Key Regulations Shaping Turkish Pharma

a) Core Legislation

• Pharmaceuticals and Medical Preparations Law (Law No. 1262):
  The main statute for the manufacturing, licensing, and distribution of medicinal products.
• Turkish Medicines and Medical Devices Agency (TITCK):
  The primary regulatory authority overseeing drug registration, clinical trials, safety, and market surveillance.
• Turkish Commercial Code, Patent Law, and Competition Law:
  Applicable for corporate structure, IP rights, and anti-trust matters.
• Personal Data Protection Law (KVKK):
  Regulates all health-related personal data, impacting clinical trials, marketing, and pharmacovigilance.

b) Key Regulatory Requirements

• Drug Registration (Marketing Authorization):
  All pharmaceuticals must be registered and authorized by TITCK before sale.
  Dossier requirements, local clinical data, and GMP certification are mandatory.
• Manufacturing Licensing:
  Strict GMP compliance and TITCK inspections required for both local and foreign manufacturers.
• Import and Export Regulation:
  Importers and exporters must comply with customs, health, and pricing controls.

3. Foreign Investment Environment

a) Ownership and Market Entry

• 100% Foreign Ownership Permitted:
  No local partnership required; foreign entities can directly establish subsidiaries or acquire existing Turkish pharma companies.
• Technology Development Zones & Free Zones:
  Special investment incentives, tax breaks, and streamlined procedures for pharma and biotech R&D.

b) Acquisition, Joint Venture, and Greenfield Options

• Mergers & acquisitions, strategic alliances, or new company formations are all common entry strategies.
• Due diligence on regulatory compliance, IP, and licensing is essential.

4. Key Opportunities for Investors

a) Growing Domestic Demand

• Increasing healthcare spending, aging population, and expanding social security coverage drive steady pharma growth.
• Fast-track registration procedures exist for critical/innovative drugs.

b) Regional Export Hub

• Türkiye exports pharmaceuticals to more than 170 countries—EU, MENA, CIS, and Africa.
• Export incentives, international GMP alignment, and logistics infrastructure support cross-border growth.

c) Biosimilars, Biotech, and Orphan Drugs

• Government policies encourage R&D, clinical trials, and local manufacturing in advanced therapeutic fields.
• Regulatory pathways for biosimilars and orphan drugs are evolving rapidly.

5. Legal and Compliance Risks

a) Market Access and Pricing Controls

• The Ministry of Health sets maximum retail prices and regulates reimbursement—companies must adapt pricing strategy accordingly.
• Reference pricing and annual review can affect profitability.

b) IP, Patent and Data Protection

• Strong patent laws exist, but enforcement can be challenging.
• Data exclusivity applies for new molecules; generic entry is closely monitored by TITCK and the courts.

c) Anti-Corruption and Promotional Activities

• Strict rules apply for pharma marketing, healthcare professional interactions, and public tenders.
• Violations can result in fines, product bans, or criminal liability.

d) Pharmacovigilance and Product Liability

• Ongoing reporting of adverse events is mandatory.
• Product liability litigation is rising, with both administrative and civil remedies available.

6. Recent Developments and Trends

• Covid-19 Pandemic:
  Accelerated digitization, local vaccine production, and regulatory flexibility for emergency approvals.
• Harmonization with EU Standards:
  Ongoing convergence with EMA and ICH guidelines for quality, safety, and efficacy.
• Digital Health & E-Prescriptions:
  Growth in telemedicine, digital prescriptions, and health IT regulation.

7. Practical Steps for Market Entry

1. Regulatory Strategy:
   Engage local legal and regulatory advisors early to navigate TITCK and Ministry of Health procedures.
2. IP Due Diligence:
   Secure patents, trademarks, and data protection before market launch.
3. Compliance Programs:
   Implement robust anti-corruption, data protection, and pharmacovigilance protocols.
4. Local Partnerships:
   Collaborate with distributors, CROs, or R&D centers to accelerate market access.

8. Why Legal Support Matters

Türkiye’s pharma sector offers major rewards, but only for companies who master the regulatory environment and protect their interests from the outset. A qualified legal advisor can:

• Streamline licensing and compliance,
• Avoid common pitfalls in documentation,
• Resolve IP and market access disputes,
• Guide on partnership, M&A, or tax incentives,
• Act as your point of contact with authorities and industry stakeholders.

Stj.Öğr.Esmanur AKTAŞ