Economic indicators
Exchange rates

Challenges
Candidates
Other countries
Requirements
Progress
European Monetary Union (EMU)

Expenditure
Provision
Outcomes
Country profiles

Domestic industry
Company profiles
Balkanpharma
Egis
Gedeon Richter
Krka
Lé iva
Lek
Pliva
Polfas
Sanitas
Slovakofarma
Multinational presence
National markets
Bulgaria
Croatia
Czech Republic
Estonia
Hungary
Latvia
Lithuania
Poland
Romania
Slovakia
Slovenia
OTC sector

Aspects of IP
Patents
Compulsory licensing
Early working
Pipeline protection
Supplementary protection certificates
Data protection
Trademarks
Evolving situation in CEE
National picture

Clinical trials
Marketing authorisation
CADREAC
PERF
Good manufacturing practice (GMP)

Methods employed
EU requirements

Czech Republic
Introductory pricing
Entry to reimbursement
Special agreements
Reference pricing
Price changes
Demand-side controls
Patient co-payment
Generics
Hospital market
Payment times
OTCs

Hungary
Introductory pricing
Entry to reimbursement
Reimbursement rates

Tenders
Price changes
Demand-side controls
Patient co-payment
Generics
Hospital market
OTCs

Poland
Introductory pricing
Entry to reimbursement
Reference pricing
Reimbursement rates
Impact of universal Health Insurance Law
Price changes
Demand-side controls
Patient co-payment
Generics
Hospital market
OTCs

Other countries
Albania
Bulgaria
Croatia
Estonia
Latvia
Lithuania
Macedonia
Romania
Slovakia
Slovenia
Yugoslavia

Wholesalers
National situation

Pharmacies
Distribution margins

Price build-up

Impact of CEECs
Evidence of EU-CEE price differentials

Western research-based companies
Potential solutions to parallel trade
Transitional protection?
German precedent?
Iberian precedent?
CEE industry

When will accession take place?
Main pharmaceutical implications
Intellectual property protection
Pricing and reimbursement
Industrial policy
Impact of freedom of movement
Health professionals
Patients
Health insurers
Changing demographics
Conclusion

European Union
Albania
Bosnia and Herzegovina (Federation)
Bulgaria
Croatia
Czech Republic
Estonia
Hungary
Latvia
Lithuania
Macedonia
Poland
Romania
Slovakia
Slovenia
Yugoslavia

Table 1.1: Countries of CEE
Table 1.2: Gross domestic product (GDP) of CEECs in euro purchasing power parities (PPP), 1999
Table 1.3: Inflation, annual average 1995-99 (%)
Table 1.4: CEE economic forecasts
Table 1.5: Exchange rates, local currency per US dollar (approximate monthly average)
Table 1.6: Exchange rates, local currency per euro (approximate monthly average)
Table 2.1: CEECs and the EU
Table 3.1: Year in which comprehensive social health insurance introduced
Table 3.2: Healthcare expenditure in selected CEECs, 1996
Table 3.3: Healthcare provision in selected CEECs 1996-97
Table 3.4: Healthcare indices in selected CEECs, 1996-97
Table 4.1: Significance of CEE pharmaceutical industry to local economy
Table 4.2: Approximate market share of local pharmaceutical production, 1997
Table 4.3: Leading pharmaceutical manufacturers in CEE
Table 4.4: Foreign investment in CEE pharmaceutical industry
Table 4.5: Estimates of CEE pharmaceutical markets, 1997
Table 4.6: Pharmaceutical expenditures in CEECs (% GDP) 1997 vs 1999
Table 4.7: Leading imported products sold in Bulgaria, 1999
Table 4.8: Top 10 pharmaceutical companies in the Czech Republic by 1998 sales
Table 4.9: Hungarian pharmaceutical sales, 1995-98
Table 4.10: Drug consumption in Hungary by therapeutic class (DDD/1,000 inhabitants/day)
Table 4.11: Top 10 pharmaceutical companies in Hungary by 1998 sales
Table 4.12: Top 10 brands in Hungary by 1997 sales
Table 4.13: Pharmaceutical sales in Poland, 1995-98 (at manufacturer selling prices)
Table 4.14: Top 10 pharmaceutical companies in Poland by 1997 sales
Table 4.15: Top 10 pharmaceutical companies in Romania by 1998 sale
Table 4.16: Top 10 therapeutic categories in Romania, 1998
Table 4.17: Top 10 pharmaceutical companies in Slovakia by 1999 sales
Table 4.18: Top 10 brands in Slovakia by 1999 sales
Table 4.19: Value sales of OTC healthcare in CEE (US$m, at current retail prices)
Table 5.1: Introduction of pharmaceutical product patents in CEE
Table 5.2: Patent applications filed in the Czech Republic in class A61K (pharmaceuticals), 1991-98
Table 6.1: Numbers of clinical trials in the Czech Republic, 1994-96
Table 6.2: Numbers of clinical trials in Hungary, 1994-97
Table 6.3: Clinical trial regulatory requirements in the CEECs
Table 6.4: Ethical committee approval in CEE
Table 6.5: CEE marketing authorisation requirements for products already reviewed through the EMEA centralised procedure
Table 7.1: Comparison of average income and medicines expenditure, 1999
Table 7.2: Main features of pharmaceutical cost containment in CEECs
Table 8.1: Pharmaceutical price development in the Czech Republic (1994 = 100)
Table 8.2: Czech reimbursement entry for rectal ketoprofen (M01AE03)
Table 8.3: Example of proposed merger of ATC groups in Czech reimbursement system
Table 9.1: Normative reimbursement status in Hungary of specimen international brands, 1999
Table 10.1: Impact of reimbursement changes on antibiotic usage in Poland (DDDs)
Table 10.2: Medicines on Polish reimbursement lists 1 and 2
Table 11.1: Approximate comparative specimen prices for leading international 12 brands in the Czech and Slovak republics
Table 12.1: Approximate numbers of pharmaceutical wholesalers in CEE, 1998
Table 12.2: CEE operations of Europe's leading wholesale groups
Table 12.3: Leading Estonian pharmaceutical wholesalers, 1999
Table 12.4: Leading Polish pharmaceutical wholesalers, 1998
Table 12.5: Market shares (%) of leading Polish wholesaling groups, 1999
Table 12.6: Wholesaler concentration in Poland (I)
Table 12.7: Wholesaler concentration in Poland (II) (number of wholesalers)
Table 12.8: Estimates of pharmacy numbers across the CEECs, 1999
Table 12.9: Wholesale mark-ups in Estonia, 1999
Table 12.10: Pharmacy mark-ups in Estonia, 1999
Table 12.11: Wholesale mark-ups in Hungary, 2000
Table 12.12: Pharmacy mark-ups in Hungary, 2000
Table 12.13: Mark-up structure in Lithuania, 1999
Table 12.14: Pharmacy mark-up structure in Poland, 1999
Table 12.15: How margin structure and cash collection from patient pushes Polish pharmacists to supply more expensive products
Table 12.16: Margins for Romanian-produced medicines (%)
Table 12.17: Margins for medicines imported into Romania (%)
Table 12.18: Price build-up in selected CEECs
Table 13.1: Estimated penetration of PIs (%) in main importing states, 1999
Table 13.2: Approximate manufacturer selling prices (euro) of selected major international brands in selected countries
Table 14.1: Possible patent scenarios in EU from CEE accession