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Pharmaceutical Pricing, Reimbursement, and Market Access in Poland, Romania, and Ukraine

Notice
This publication has been discontinued on July 17, 2013.

Abstract

Introduction:

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

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
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