2015-07-06-世界卫生组织-Launch_of_Ethiopian_National_Strategy_and_Plan_of_Action_for_Pharmaceutical_Manufacturing_Development_and_Improving_Access_16页_1mb

Summary of Ethiopian National Strategy and Plan of Action for Pharmaceutical Manufacturing Development and Improving Access

Core Content

The Ethiopian National Strategy and Plan of Action for Pharmaceutical Manufacturing Development and Improving Access was launched on 14 July 2015 in Addis Ababa. It was introduced as a flagship program of the Ethiopian Second Growth and Transformation Plan (GTP-II, 2015–2020) and represents a significant step towards enhancing the country's pharmaceutical manufacturing capacity and ensuring access to essential medicines.

The strategy aligns health policy with industrial development policy, aiming to transform Ethiopia's pharmaceutical sector into a competitive and sustainable industry. It is supported by the World Health Organization (WHO), the African Union, and various international partners, including the Bill & Melinda Gates Foundation, the European Union, and the Global Fund.

Main Objectives

• Improve access to medicines through quality local production, with a focus on Good Manufacturing Practice (GMP) compliance.
• Enhance export capacity of locally produced medicines from $2 million to $30 million by 2020 and $80 million by 2025.
• Meet 50% of local needs for essential medicines by 2020.
• Strengthen the national medicine regulatory system to ensure quality and safety standards.
• Develop human resources through education and training.
• Encourage cluster development and the production of active pharmaceutical ingredients (APIs).
• Create a research and development (R&D) platform to foster innovation and new product development.
• Attract foreign direct investment (FDI) to boost the pharmaceutical industry.

Key Strategic Objectives

1. Improve access to medicines through quality local production – implement the GMP Roadmap.
2. Strengthen the national medicine regulatory system.
3. Create incentives to move companies along the value chain.
4. Develop human resources through relevant education and training.
5. Encourage cluster development and production of APIs.
6. Create a research and development platform.
7. Attract foreign direct investment in the pharmaceutical sector.

Pharmaceutical Value-Chain Approach

The strategy is based on a value-chain approach, which spans from the importation of finished pharmaceutical products to the development of a research-based industry. The value chain includes:

• Level 1: Import of finished pharmaceutical products.
• Level 2: Packaging and labelling of imported products.
• Level 3: Product manufacturing (formulation from imported APIs and excipients).
• Level 4: API manufacturing.
• Level 5: Research and development (R&D) for new formulations, processes, and chemical entities.

Currently, most Ethiopian pharmaceutical companies are at Level 1. The goal is to move them along the chain, increasing the number of companies at each level. By 2018, all manufacturers are expected to comply with WHO GMP standards.

Challenges and Support Mechanisms

Despite a supportive policy environment, Ethiopia's pharmaceutical industry faces several challenges:

• Human resource capacity constraints.
• Limited access to foreign currency.
• Difficulties in raw material procurement.
• Need for GMP compliance and regulatory strengthening.

To address these, the Ethiopian Government plans to:

• Maintain a well-funded and independent regulatory system.
• Support the Food, Beverage and Pharmaceuticals Industry Development Institute (FBPIDI) in coordinating the strategy.
• Facilitate international and public-private partnerships.
• Catalyze R&D by encouraging the establishment of biotechnology companies and supporting the commercialization of their technologies.

International Collaboration and Commitment

The strategy was launched with the participation of high-level dignitaries and representatives from various international organizations, including:

• WHO Director General Dr. Margaret Chan
• African Union Chairperson Dr. Nkosazana Dlamini-Zuma
• UNDP Administrator Mrs. Helen Clark
• Global Fund Executive Director Mr. Mark Dybul
• GAVI CEO Dr. Seth Berkley
• UNIDO Director General Mr. Li Yong

These leaders emphasized the importance of the strategy for both public health and economic development, and pledged their support for its implementation.

Background and Context

• Ethiopia has made progress in expanding health service coverage, increasing from 30% to 89% between 2010 and 2012.
• The country has also made significant strides in reducing child and maternal mortality.
• The strategy is a key component of the African Union's Pharmaceutical Manufacturing Plan for Africa (PMPA), aiming to improve access to essential medicines and support the development of a knowledge-based economy.

Conclusion

The Ethiopian National Strategy and Plan of Action is a comprehensive and ambitious initiative aimed at enhancing pharmaceutical manufacturing, improving access to essential medicines, and promoting economic growth. It is supported by both national and international stakeholders and is expected to have a transformative impact on the pharmaceutical sector and public health outcomes in Ethiopia and the broader African region.