Pharmaceutical Pricing, Reimbursement, and Market Access in Poland, Romania and Ukraine
Decision Resources, Inc, June 2011
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 totalled $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.
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
About the Author
Organizations
- Agentia Nationala a Medicamentului (ANM; National Medicines Agency)
- Asociatia Româna a Producatorilor Internationali de Medicamente (ARPIM; Romanian Association of International Pharmaceutical Manufacturers)
- Camera Federativa a Medicilor din România (CFMR; Federal Chamber of Physicians in Romania)
- Colegiul Farmacistilor din România (CFR; College of Romanian Pharmacists)
- European Medicines Agency
- FDA
- Oficiul de Stat pentru Inventii si Marci (OSIM; State Office for Inventions and Trademarks)
- Organization for Economic Cooperation and Development (OECD)
- Pharmaceutical Research and Manufacturers of America (PhRMA)
- U.S. Trade Representative (USTR)
- United Nations Population Division
- World Bank
- World Health Organization
- World Trade Organization
Legislation
- Legea 64/1991 privind Brevetele de Inventie (Law 64/1991 on Patents)
- Legea 93/1998 privind Protectia Tranzitorie a Brevetelor Inventie (Law 93/1998 on Transitional Patent Protection)
- Ustawa o Cenach z Dnia 5 Lipca 2001 (Pricing Act of July 5, 2001)
- Ustawa o Powszechnym Ubezpieczeniu Zdrowotnym (Universal Health Insurance Act)
- Ustawa o Refundacji Leków, Srodków Spozywczych Specjalnego Przeznaczenia Zywieniowego oraz Wyrobów Edycznych (Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Purposes, and Medical Devices Act)
- Zakon Ukrai ny pro Tsini i Tsinoutvorennya (Ukrainian Law on Pharmaceutical Prices and Price Regulation)
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