2008年-世界发展银行全球_The_Pharmaceutical_Sector_of_the_Western_Balkan_Countries_38页_1mb

Summary of "The Pharmaceutical Sector of the Western Balkan Countries"

Core Content

This paper provides an overview of the pharmaceutical sector in the Western Balkan States (WBS), focusing on regulatory frameworks, expenditure management, price control mechanisms, and access to medicines. It highlights the alignment of pharmaceutical policies with the European Union (EU) and the challenges that persist in the region despite these efforts.

Main Views and Key Information

1. Political and Regulatory Alignment with the EU

• There is a strong political will among Western Balkan countries to align their pharmaceutical legislation and practices with EU standards.
• Several countries have updated or re-written national drug laws in recent years, including Serbia (2004), Albania (2005), and Montenegro.
• New regulations cover drug registration, licensing of professionals and businesses, pharmacovigilance, marketing, and clinical trials.
• Some countries have established independent drug agencies (e.g., Serbia, Albania) to enhance political independence and technical focus in pharmaceutical oversight.

2. Drug Expenditure and Trends

• Drug expenditure in the Western Balkans ranges from 15–30% of total health expenditure.
• Compared to developed countries, the per capita drug expenditure is significantly lower, typically below USD 100, while in developed countries it is around USD 400–600.
• The rate of growth in drug expenditure is generally twice the GDP growth rate, driven by factors such as aging populations, higher standards of living, and the introduction of new, expensive medicines.
• In some countries, the share of out-of-pocket spending on drugs is increasing, which can be attributed to higher income levels and limited insurance coverage for certain medications.

3. Drug Expenditure Management Mechanisms

• Most WBS countries have implemented positive lists to define which drugs are covered by national health insurance funds (HIF).
• Co-payment systems are common, with co-payments ranging from 25–75% of the drug price, depending on the drug's importance and cost.
• Some countries have introduced expenditure caps and budget quotas for physicians to manage costs.
• Pooled procurement and open tenders are used by some institutional buyers to achieve lower prices.

4. Price Regulation and Reimbursement

• Reference pricing is being adopted in several Western Balkan countries, aligning with EU practices.
• Price controls are implemented through various mechanisms, including positive lists and competitive tendering.
• In Albania, a regressive margin system is used, where co-payments increase with the price of the drug.
• Kosovo does not have a health insurance fund and relies on a limited essential drugs program managed directly by the Ministry of Health (MoH).

5. Pharmaceutical Market and Stakeholders

• Market size and number of manufacturers vary across the region, with Serbia having the largest market and most manufacturers.
• Wholesalers and pharmacies are numerous, but the distribution chain is inefficient in some countries.
• Pharmacists and physicians play a key role in drug access and pricing, with some influencing the choice of more expensive imported drugs.

6. Access and Equity Issues

• Limited access to drugs for low-income populations persists due to high co-payments and out-of-pocket costs.
• Counterfeit drugs are a concern, especially in the absence of routine quality checks in retail pharmacies.
• Coordination problems exist in Bosnia and Herzegovina (BiH), where separate positive lists are maintained by different entities (Federation, Republika Srpska, cantons), leading to inconsistencies in drug coverage and pricing.

7. Governance and Corruption

• Weak enforcement of rules and standards is a common challenge, with low salaries and limited resources for inspectors.
• Corruption risks are present in the pharmaceutical sector, particularly in the procurement and reimbursement processes.
• Institutional buyers are using competitive procurement to reduce costs, but this is not universally adopted.

8. Rational Use of Medicines

• The rational use of drugs is a priority, especially with the growing use of more expensive and branded medications.
• Physician prescribing behavior is not always controlled, which can lead to unnecessary or overprescription.
• The paper emphasizes the need for capacity building, increased oversight, and higher professional standards to ensure equitable and efficient drug access.

9. Future Challenges and Recommendations

• Drug expenditure is expected to grow in the region due to demographic and economic factors.
• Efficient resource allocation and cost containment measures are essential for long-term sustainability.
• The paper suggests that pooled procurement, standardized positive lists, and improved enforcement mechanisms could help address these challenges.
• Strengthening governance and reducing corruption are critical for ensuring fair and effective pharmaceutical systems.

Key Tables and Figures

• Table 1: Socio-demographic and fiscal indicators for the WBS countries.
• Table 2: Pharmaceutical expenditure in the WBS in 2005.
• Table 3: Price comparison between the positive lists in Tuzla and a comparable canton.
• Table 4: Price comparison for frequently prescribed drugs between Serbia and Montenegro.
• Figure 1: Drug expenditure as a share of GDP in eight OECD countries.
• Figure 2: Reimbursement and co-payments in a real-life example from a BiH cantonal pharmacy.

Conclusion

The pharmaceutical sector in the Western Balkans is undergoing significant reforms to align with EU standards, but challenges such as weak enforcement, inefficiencies in the distribution chain, and limited access for low-income populations remain. The paper calls for further capacity building, stronger governance, and rational drug use policies to ensure equitable and sustainable drug access in the region.