Poland, Romania, and Ukraine have by far the largest populations in Central
and Eastern Europe, and their pharmaceutical markets are experiencing strong
growth. To succeed in these markets, however, multinational companies must
overcome some daunting obstacles, including underinvestment in healthcare,
deficient healthcare infrastructures, limited patient access to health
insurance and drug benefits, weak intellectual property protection, and
competition from local manufacturers of inexpensive generic drugs.
Questions Answered in This Report:
In 2009, pharmaceutical sales in Poland totaled $6.6 billion, a 10.1%
increase over the preceding year. What is the procedure for setting the
prices of new drugs in Poland? What is the scope of the national positive
list, and what must manufacturers do to have their products added to this
list? What reforms to the pricing system has the Polish government recently
proposed? What are the key elements of the government' s cost-containment
strategy?
Retail drug prices in Romania are among the lowest in the EU. How do
the pricing procedures for imported and domestic drugs differ? What are the
international implications of Romania' s low drug prices? How does the Casei
Nationale de Asigurari de Sanatate (CNAS; National Health Insurance Fund) make
drug reimbursement decisions? What changes has the government recently made to
the Romanian reference pricing system?
Compared with most other European countries, Ukraine exercises relatively
limited control over prescription drug prices. To what extent does the
Ukrainian government regulate drug prices, and what reforms has it proposed in
recent months? How extensive is reimbursement of prescription medicines in
Ukraine? How has the government tried to contain pharmaceutical spending?
Scope:
Socioeconomic and demographic background: projections of total
population, senior population, and life expectancy at birth to 2030; key
economic indicators; investment in healthcare.
Organization and funding of the healthcare system: healthcare provision
in the communist era; key reforms in the last two decades; access to health
insurance and prescription drug coverage.
Intellectual property protection: reforms adopted in recent years;
duration of exclusivity periods; challenges facing international brands.
Pharmaceutical pricing: procedure for setting prices; pharmacy and
wholesaler margins; use of external reference pricing.
Admission to reimbursement: bodies involved in reimbursement decision
making; reimbursement procedures; data requirements for manufacturer dossiers;
reimbursement rates.
Cost containment: reference pricing; pharmaceutical budgets;
prescription monitoring; measures to promote greater use of generics; patient
copayments.
Outlook and implications for the pharmaceutical industry: need for
increased investment in healthcare; implications of low drug prices in Poland,
Romania, and Ukraine for these three markets and for other European markets;
challenges in securing reimbursement; prospects for increased cost-containment
activity.
Table of Contents
Table of Contents
Executive Summary
Strategic Considerations
Stakeholder Implications
Introduction
Socioeconomic and Demographic Background
Poland.
Organization and Funding of the Healthcare System
Regulatory Reform and Intellectual Property Protection
Pharmaceutical Pricing and Reimbursement
Historical Pricing Procedure
Current Pricing Procedures
Admission to Reimbursement
Cost-Containment Measures
Patient Copayments
Reference Pricing
Prescription Monitoring.
Measures to Promote Greater Use of Generics
Prospective Reforms in the Drug Reimbursement Act.
Romania
Organization and Funding of the Healthcare System
Intellectual Property Protection
Pharmaceutical Pricing and Reimbursement
Pricing Procedures
Admission to Reimbursement
Cost-Containment Measures
Patient Out-of-Pocket Payments
Reference Pricing
Prescription Limits
Pharmaceutical Budgets
Prescription Monitoring.
Measures to Promote Greater Use of Generics
Ukraine
Organization and Funding of the Healthcare System
Regulation and Intellectual Property Protection
Lax Control of the Distribution of Prescription Drugs
Pharmaceutical Pricing and Reimbursement
Pricing Procedures
Limited Reimbursement of Pharmaceuticals
Cost-Containment Measures
Outlook and Implications for the Pharmaceutical Industry
Tables
1. Population Projections for Poland, Romania, Ukraine, and Other Major
Markets in Select Years, 2010-2030
2. Life Expectancy at Birth in Poland, Romania, Ukraine, and Other Major
Markets, 1950-1955 and 2010-2030
3. Percentage of the Population Aged 65 or Older in Poland, Romania,
Ukraine, and Other Major Markets in 1950 and Select Years, 2010-2030
4. Healthcare Spending as a Percentage of Gross Domestic Product in
Poland, Romania, Ukraine and Other Major Markets, 1995-2009
5. Total Healthcare Spending Per Capita in Poland, Romania, Ukraine and
Other Major Markets, 1995-2009 (U.S. Dollars)
6. Breakdown of Drug Reimbursement by Reimbursement Rate in Poland, 2010
7. Drug Reimbursement Categories in Romania
8. Proposed New Wholesale Margins in Ukraine
9. Proposed New Pharmacy Margins in Ukraine
Pharmaceutical Pricing, Reimbursement, and Market Access in Poland, Romania, and Ukraine published by Decision Resources, Inc. in June 27, 2011. This report price starts from US $ 4600.
