2023-12-06-联合国贸易发展委员会-改善埃塞俄比亚当地生产基本抗生素的投资环境_一份咨询报告_51页_1mb

报告摘要

Executive Summary

Local antibiotic production in Ethiopia accounts for approximately 50% of total antibiotic consumption, though market share has remained stagnant over the past three years.
Key challenges include importing high-cost raw materials, geographic import concentration (India and China account for 83% of imports), and limited access to foreign exchange.
Public procurement favors local production with a 25% price preference, but locally produced antibiotics remain more expensive than imports in this context.
Investment incentives for antibiotics are generic and lack specific measures for this therapeutic area. The government is urged to shift from tax-based to expenditure-based incentives and strengthen coordination between health and investment authorities.
Recommendations include re-assessing fiscal incentives, refining procurement policies, and fostering technical capacity and regional integration.

Core Findings & Policy Recommendations

1. Market Dynamics

Local production covers half of Ethiopia's antibiotic market, yet faces competition from cheaper imports, particularly in public procurement.
Prices in the private market favor local products, but public procurement and payment systems remain challenging.

2. Incentive System

Expand product-specific incentives for antibiotics, such as exporting GMP compliance requirements and targeting high-priority products (e.g., "Watch/Reserve" antibiotics from WHO’s AWaRe classification).
Evaluate fiscal incentives to move from tax holidays (profit-based) to accelerated depreciation/expenses-based incentives and integrate sustainability/climate goals.

3. Infrastructure & Localization

Foster a collaborative mechanism among manufacturers to manage API supply chains and reduce forex dependency through pooled regional procurement.
Prioritize investments in waste management for specialized antibiotic production.

4. Stakeholder Engagement

Strengthen institutional coordination (health vs. investment authorities) and leverage multinationals for technology/know-how transfer.
Enhance transparency via digital single windows and better data-sharing platforms (e.g., via UNCTAD’s e-regulations program).

5. Long-Term Planning

Link antibiotic production to AMR policies, ensuring local supply aligns with stewardship goals.
Explore export potential and regional supply chain integration (e.g., targeting East African markets).

Key Challenges and Opportunities

Challenge	Opportunity
High import dependence on active pharmaceutical ingredients (API)	Joint ventures (JMT) with multinationals to secure supply & quality
Limited GMP compliance (only ~50% of generic medicines certified)	Incentivize API localization & raise quality standards
Cumbersome forex allocation (often delayed)	Partner with multinationals to access forex directly for imports/operations
Weak public procurement policies (price preferences may not reflect cost reduction)	Align procurement with standardized quality & GMP benchmarks
Shortage of skilled labor & expired tax holidays	Align incentive packages with new policy drives (clinical trials, stewardship)

Innovation & Synthesis

The study indicates that local production is feasible but requires strategic targeting to address market-specific constraints. Governments should:

Tailor incentives based on antibiotic priorities (e.g., clinical need, AMR, misuse potential).
Leverage data-driven decision-making, updating pricing and availability studies regularly.
Establish public-private partnerships to catalyze sustainable investment, such as the Austrian case study (Sandoz Plant) for antibiotic GMP compliance.

Detailed Markdown for Reference

## 1. Market Dynamics  
- Local production in Ethiopia is mature but faces competition from imports, especially in public procurement.  
- Public procurement prices are 18-47% higher than imports in some cases, despite preferring local products with 25% price preference.  

## 2. Current Incentives  
### a. Fiscal Incentives  
- Income tax holidays (e.g., 10-14 years for APIs, 7-8 for packaging).  
- Strong reliance on profit-based incentives (tax holidays), requiring shift to expenditure-based.  

### b. Market Shaping  
- Public procurement: 25% preference for local products, exclusivity in some tenders.  

## 3. New Policy Directions  
### a. Specificity via Prioritization  
- Design targeted incentives for "high-value" antibiotics (e.g., Ceftriaxone, Amoxicillin-co-clavulanate),  
  aligning with the AWaRe classification.  

### b. Accountability & Evaluation    - Codify criteria for incentives based on quality standards, environment, AMR stewardship.  
- Mandate periodic cost-benefit reviews.  

## 4. Implementation & Design  
### a. Digital Transformation  
- Utilize capabilities like digital single windows (DSW) for streamlined regulation.  
- Explore public blockchain registries for quality compliance.  

### b. Capacity Building  
- Foster knowledge transfer through joint technical ventures.  

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