2008年-世界发展银行全球_Turkey___Pharmaceutical_Sector_Analysis_37页_1mb

Summary of TURKEY: Pharmaceutical Sector Analysis

Core Content

This document provides an in-depth analysis of the pharmaceutical sector in Turkey, focusing on policy objectives, institutional and regulatory frameworks, pricing mechanisms, reimbursement rules, and governance issues. It highlights the challenges and opportunities facing the sector, particularly in the context of Turkey's economic development and its aspirations to join the European Union.

Main Policy Objectives

• Universal Access to Healthcare: Ensuring that all citizens have access to essential medicines and equal levels of care.
• Affordability and Cost Containment: Managing pharmaceutical expenditures to ensure they remain within budget while maintaining access to modern medicines.
• Regulatory and Institutional Reform: Establishing an independent drug regulatory body to streamline and improve oversight.

Institutional and Regulatory Framework

• The Turkish Drug Law (1928) serves as the legislative basis, though its adequacy for EU accession is unclear.
• The Ministry of Health (MoH) oversees drug policy, including licensing, pricing, and market authorization.
• The General Directorate of Pharmaceuticals and Pharmacies (GDPP) is responsible for various regulatory functions.
• Several advisory commissions assist in evaluating pharmaceutical dossiers and conducting technical assessments.
• The Reimbursement Commission, coordinated by the Social Security Institution (SSI), determines which drugs are included in the reimbursement list.
• The National Institution of Medicine was proposed in 2003 to take over GDPP functions but remains stalled due to political reasons.

Pricing Mechanisms

• Reference Pricing System: Originator drugs are priced based on the lowest ex-factory price in five EU reference countries (France, Spain, Italy, Portugal, and Greece), with the possibility of expanding the number of reference countries.
• Generic Pricing: Generics are priced at 80% of the reference price (under discussion for a reduction to 70%).
• Wholesale and Retail Margins are regulated and depend on the drug's price range:
  • Up to YTL 10: 9% (wholesaler), 25% (pharmacist)
  • YTL 10–50: 8% (wholesaler), 24% (pharmacist)
  • YTL 51–100: 7% (wholesaler), 23% (pharmacist)
  • YTL 101–200: 4% (wholesaler), 16% (pharmacist)
  • Over YTL 200: 2% (wholesaler), 12% (pharmacist)
• Statutory Discounts: Applied to reimbursed drugs at both manufacturer and pharmacy levels:
  • Pharmacies up to 220,000 YTL: 3%
  • Pharmacies 220,000–440,000 YTL: 3.5%
  • Pharmacies 440,000–550,000 YTL: 4%
  • Pharmacies over 550,000 YTL: 4.5%

Reimbursement Rules

• The Reimbursement Commission includes representatives from the MoH, MoF, and SSI and meets every two months.
• Positive List: A unified list for all health insurance funds, though technically two lists exist for political reasons.
• Reimbursement Caps: Set at 22% above the cheapest brand in an equivalent group (based on INN).
• Prescription Practices: Physicians can prescribe branded drugs, which may exceed reimbursement limits, requiring patients to pay the difference.
• Copayment Rates:
  • Active members and their relatives: 20%
  • Retired members: 10%
  • In-patient drugs: Fully reimbursed.

Governance and Transparency Issues

• Regulatory Transparency: The decision-making process is relatively transparent, with a mix of public officials from different institutions.
• Lack of Public Oversight: Consumer representatives are not included in the decision-making process.
• Corruption Concerns: Although not a major issue in market access, the influence of the pharmaceutical industry on political decisions is significant.
• Supply Chain Practices: Manufacturers offer incentives to wholesalers and pharmacies, which can lead to unrecorded profits and inefficiencies.
• Prescription Fraud: While difficult due to barcodes, the new unique coding system may pose risks of double billing if not properly enforced.

Intellectual Property Rights

• Patent Protection: A national patent law was enacted in 1999, with new licensing regulations resembling EU standards.
• Bolar Provision: Allows generic companies to prepare registration files while the original drug is still patented.
• Data Protection and Marketing Exclusivity: Implemented to align with EU directives, providing additional protection to innovator products.

Public Procurement and Tendering

• Tendering Process: Conducted in public hospitals, with rules set by the Public Tendering Act.
• Drug Availability: Before 2008, hospitals often lacked necessary drugs, forcing patients to buy from private pharmacies.
• Free Drug Supply: Since 2008, public hospitals are required to provide in-patient drugs for free, though implementation effectiveness is unclear.

Key Challenges and Future Steps

• Affordability: Balancing access to state-of-the-art medicines with budget constraints.
• Reform of Reimbursement System: Introducing therapeutic equivalence groups to achieve cost savings.
• Creation of an Independent Drug Agency: A potential future step to improve governance and oversight.
• Transparency and Enforcement: Need for stronger mechanisms to prevent corruption and ensure fair pricing and distribution practices.

Conclusion

Turkey's pharmaceutical sector is characterized by a mix of industry-friendly policies, regulatory complexity, and growing pressure to control costs. While the country has made progress in expanding access to healthcare, the challenge lies in ensuring that affordability and transparency are maintained in the face of rising expenditures and industry influence. The path forward involves regulatory reform, improved oversight, and better alignment with international standards, particularly in the context of EU accession.