2009年-世界发展银行全球_The_Pharmaceutical_Sector_in_Ghana_36页_885kb

Summary of the Pharmaceutical Sector in Ghana

Core Content

The Policy Note provides an in-depth analysis of the pharmaceutical sector in Ghana, focusing on the challenges and opportunities in the context of the country's five-year program "Creating Wealth Through Health" (2007–2011). The document outlines the main policy goals, legal framework, market dynamics, and key stakeholders involved in the sector. It also presents policy options aimed at improving access, quality, and rational use of medicines, as well as addressing financial sustainability and supply chain inefficiencies.

Main Policy Goals

• Access to Essential Medicines: Ensure all citizens have access to necessary drugs.
• Quality Assurance: Maintain high standards for all drugs on the market.
• Efficient Supply Chain: Strengthen both public and private sector supply systems.
• Rational Use of Medicines: Promote appropriate prescribing and consumption by healthcare professionals and patients.
• Strengthen Domestic Industry: Develop a sustainable pharmaceutical manufacturing base.

Key Challenges

• Regulatory Enforcement: Limited capacity to enforce regulations, especially for high-risk products.
• Provider Indebtedness: High levels due to poor management and flawed payment systems.
• Public Sector Supply Chain Weakness: Increasing reliance on private sector for drug supply.
• Fragmented Private Sector: Lack of capital for quality improvements in manufacturing and distribution.
• NHIS Financial Sustainability: Risk of non-rational prescribing and fraud leading to higher drug expenditure.
• Illicit Drug Market: Estimated to account for 10–20% of the market, with potential for higher figures due to lack of data.
• Drug Quality Issues: Sub-standard and counterfeit drugs circulate, especially in the informal market.

Key Stakeholders and Institutions

• MOH/GNDP: Defines and coordinates pharmaceutical policies and programs.
• FDB (Food and Drugs Board): Regulates the pharmaceutical market, including manufacturing, import, and quality control.
• NHIA (National Health Insurance Authority): Largest payer for pharmaceuticals; influences prices and prescribing practices.
• Pharmacy Council: Licenses pharmacists and chemical sellers; governed by the Pharmaceutical Society of Ghana.
• PSGH (Pharmaceutical Society of Ghana): Ensures professional ethics and standards for pharmacists.
• Central Medical Stores (CMS) and Regional Medical Stores (RMS): Supply drugs to public and NGO facilities.
• National Programs (Malaria, TB, AIDS): Coordinate with international donors and manage supply chains for specific diseases.
• Universities and Research Institutions: Support policy development with studies on drug prices, quality, and usage.
• Teaching Hospitals and CHAG (Christian Health Association of Ghana): Some facilities procure independently, potentially deviating from national policies.
• PMAG (Pharmaceutical Manufacturers Association of Ghana): Focuses on improving the business environment for local manufacturers.
• MeTA (Medicines Transparency Alliance): A DFID initiative promoting transparency in the pharmaceutical sector.
• WHO and USAID/PMI: Provide technical assistance and support for regulatory and quality monitoring systems.

Market Overview

• Market Size: Estimated at $300 million USD in 2008, with a growth rate of 6–8%.
• Prescription Drugs: Account for 70% of the market, with retail sales of domestic manufacturers making up 30%.
• OTC Market: Represents 30% of the market in value, but significantly higher in volume due to cheaper prices.
• Import Dependency: Approximately 70% of the market is supplied by imported drugs, mainly from Indian and Chinese firms.
• Domestic Manufacturers: Around 6 major manufacturers and several smaller ones, with most operating their own distribution systems.

Regulatory and Quality Initiatives

• FDB's Role: Leads in regulating the pharmaceutical market, including quality control and inspections.
• Quality Control Lab (QCL): Conducts testing of drugs and is working towards WHO Prequalification.
• Pharmacovigilance Program: Monitors adverse drug reactions and has identified issues with certain anti-malarial drugs.
• WHO Prequalification: Aims to improve the quality of Ghanaian drugs and enable participation in international tenders.
• Minilab Initiative: Supported by the Global Pharma Health Fund (GPHF), used for rapid testing of malaria drugs.
• GMP Compliance: FDB introduces grading systems (A to E) to encourage adherence to Good Manufacturing Practices.

Policy Options

• Regulatory Measures: Focus on high-risk products and strengthen enforcement capacity.
• Supply Chain Solutions: Encourage private sector participation in procurement and improve coordination.
• Industrial Policy: Support local manufacturers to meet international quality standards.
• Financing and Payment Mechanisms: Address NHIS drug expenditure through better management and price controls.
• Rational Use of Medicines: Promote adherence to Standard Treatment Guidelines (STG) and Essential Medicines List (EML).

Conclusion

The Ghanaian pharmaceutical sector is at a critical juncture, with the National Health Insurance Scheme (NHIS) playing a pivotal role in shaping market dynamics and improving access to medicines. While the public sector faces significant challenges in supply chain management and regulatory enforcement, the NHIS has the potential to drive positive change through its purchasing power and influence on provider behavior. The government must coordinate efforts across all stakeholders to ensure the implementation of effective policies that address the sector's key issues and promote sustainable development.