The report is a comprehensive analysis of six Central European countries:Poland, Romania, Slovakia, the Czech Republic, Hungary and Bulgaria. It
provides details of the characteristics of the generic and innovative
medicines segments in each of the countries featured, as well as forecasts for
the period 2012-2014. These forecasts take into account recent changes to
legislation in each of the countries, which is important given the impact
these changes are expected to have.
This analysis is supplemented by detailed characteristic of the factors
influencing these segments, especially reimbursement policies, pricing
policies and drug patent expiry and data exclusivity periods in particular
countries. Also included in this publication are profiles of the largest
producers of generic and innovative drugs in the region and details of each
country's policy with regard to counterfeit medicines.
Extract from this report:
According to our forecasts, over the next few years the generic drug
market in Poland will develop at a higher growth rate than that of innovative
medicines because of the Reimbursement Act and changes to the reimbursement
lists. All of this will lead to a cut in NFZ reimbursement spending, which
will affect the innovative drug market more severely.
Although many generic alternatives are produced and available in Romania,
patients in the country prefer to buy the originals at higher prices,
according to the CNAS. It is a typically Romanian trait that patients prefer
to buy new medicines even if they are more expensive - there is no
“generic culture”, according to the College of Pharmacists.
Questions that this report answers:
What is the value of the generic and innovative drug market in C entral
Europe 2009-2014?
What is the market size of the generic and innovative drug market in
particular Central European countries (Poland, Romania, Slovakia, the Czech
Republic, Hungary and Bulgaria)?
In which countries will the generic drug market develop fastest between
2012 and 2014?
In which countries will the innovative drug market develop fastest between
2012 and 2014?
What are patient and doctor attitudes towards generic and innovative
medicines?
What are the regulations governing prices of non-reimbursed and reimbursed
medicines in CE countries?
How does the reimbursement system function in particular CE countries?
What reforms have recently been implemented in Central European countries
and what impact will they have on the generic and innovative drug segments in
each country?
How does the reimbursement system work in Poland, Romania, Slovakia, the
Czech Republic, Hungary and Bulgaria?
What changes should we expect on the generic and innovative drug market,
and also in the reimbursement systems and lists of each country featured?
Which medicines have recently been included on/removed from reimbursement
lists in particular CE countries?
What are the drug patent expiry periods in Poland, Romania, Slovakia,
Hungary, Bulgaria and the Czech Republic?
Which Supplementary Protection Certificates are due to expire in Central
European countries in the nearest future?
What are the data exclusivity periods for medicines in each of the Central
European countries?
What are the best-selling generic and innovative medicines in CE?
Who are the leading producers of generic and innovative drugs in Poland,
Romania, Slovakia, the Czech
Republic, Hungary and Bulgaria?
What is the key value of this report?
Detailed characteristics of six Central European countries - Poland, Czech
Republic, S lovakia, Romania, Hungary and Bulgaria - as well as a comparative
analysis of them
Development forecasts for the generic and innovative drug market for the
period 2012-2014
Wide scope of analysis, including reimbursement policies, pricing
policies, drug patent expiry and data exclusivity periods in particular
countries.
All the key information regarding the generic and innovative drug markets
in Central Europe available in one competitively priced publication.
A word from the author:
“Governments in several Central European countries have recently
introduced solutions aimed at cutting their spending on pharmaceuticals.
Examples of this are the Reimbursement Act in Poland, the structural reform
programme based on the Szell Kalman Plan in Hungary, the amendment to the Act
on Public Health Insurance in the Czech Republic and the act governing the
scope and conditions of the reimbursement of drugs, medical appliances and
dietary foods covered by public health insurance in Slovakia. These will have
an impact on the generic and innovative drug segments in the countries in
question and may lead to a rebalancing of power and influence within the
pharmaceutical segments of each country.”Agnieszka Skonieczna,
Senior Pharmaceutical market Analyst.
PMR Market Insight Methodology:
This report was prepared using PMR Market Insight methodology developed by PMR
which assists in the complex preparation of industry reports.
About PMR
PMR Publications provides reliable market intelligence for business
professionals and analyse the business climate in particular in the
construction, retail, IT, telecommunications and pharmaceutical sectors. PMR
Publications offers both free and paid subscription newsletters, internet news
portals, and in-depth reports.
PMR Publications is part of PMR - a British-American company providing market
information, advice and services to international businesses interested in
Central and Eastern European countries as well as other emerging markets.
Table of Contents
Table of Contents
I. Report methodology
II. Executive summary
III. Characteristics of generic and innovative drug markets in Central European countries
Comparative analysis
Prices of generic and innovative drugs
Wholesale and pharmacy margins
Market entry of new innovative brands
Share of generic medicines in the market
Market value between 2009 and 2014
Average CAGR for generic and innovative drug markets in CE countries
2012-2014
API prescription
External price referencing systems
Poland
Main trends and events on the generic and innovative drug market
Main past trends and events
Main anticipated trends and events
Market size
Share of pharmaceutical market
Overall market
Rx pharmacy market
Market forecasts for 2012-2014
Czech Republic
Main trends and events on the generic and innovative drug market
Main past trends and events
Main anticipated trends and events
Market size
Share of pharmaceutical market
Market forecasts for 2012-2014
Attitudes towards generic and innovative drugs
Romania
Main trends and events on the generic and innovative drug market
Main past trends and events
Main anticipated trends and events
Market size
Share of pharmaceutical market
By value
By volume
Locally produced generics
Market forecasts for 2012-2014
Hungary
Main trends and events on the generic and innovative drug market
Main past trends and events
Main anticipated trends and events
Market size
Share of pharmaceutical market
Market forecasts for 2012-2014
Slovakia
Main trends and events on the generic and innovative drug market
Main past trends and events
Main anticipated trends and events
Market size
Share of pharmaceutical market
Market forecasts for 2012-2014
Bulgaria
Main trends and events on the generic and innovative drug market
Main past trends and events
Main anticipated trends and events
Market size
Share of pharmaceutical market
Market forecasts for 2012-2014
IV. Best-selling drugs in Central Europe
Poland
Drug patent expiry and data exclusivity periods
Czech Republic
Best-selling drugs
By value
By volume
Drug patent expiry and data exclusivity periods
Romania
Best-selling drugs
Drug patent expiry and data exclusivity periods
Hungary
Best-selling drugs
Drug patent expiry and data exclusivity periods
Slovakia
Best-selling drugs
Drug patent expiry and data exclusivity periods
Bulgaria
Drug patent expiry and data exclusivity periods
V. Counterfeit products
Poland
Czech Republic
Romania
Hungary
Slovakia
Bulgaria
VI. Reimbursement and pricing policies in Central Europe
Poland
Pricing policies
VAT rate
Non-reimbursed drugs on the pharmacy market
Reimbursed drugs on the pharmacy market
Generic substitution
Drugs on the hospital market
Reimbursement policies
Reimbursement system
Reimbursement process
Reimbursement spending
Reimbursement reform
Latest changes to reimbursement lists
Czech Republic
Pricing policies
VAT rate
Non-reimbursed drugs on the pharmacy market
Reimbursed drugs on the pharmacy market
Drugs on the hospital market
Reimbursement policies
Reimbursement system
Reimbursement process
Healthcare reform
Latest changes to reimbursement lists
Romania
Pricing policies
General trends
VAT rate
Non-reimbursed drugs on the pharmacy market
Reimbursed drugs on the pharmacy market
Reimbursement policies
Reimbursement system
Reimbursement process
Reimbursement spending
Reimbursement reform
Latest changes to reimbursement lists
Hungary
Pricing policies
VAT rate
Other taxes
Price-volume agreements
Non-reimbursed drugs on the pharmacy market
Reimbursed drugs on the pharmacy market
Generic drugs
Drugs on the hospital market
Reimbursement policies
Reimbursement system
Reimbursement process
Reimbursement spending
Szell Kalman Plan
Latest changes to reimbursement lists
Slovakia
Pricing policies
VAT rate
Non-reimbursed drugs on the pharmacy market
Reimbursed drugs on the pharmacy market
Generic and innovative drug prices
API prescription
Generic substitution
Drugs on the hospital market
Reimbursement policies
Reimbursement system
Reimbursement process
Healthcare reform
Latest changes to reimbursement lists
Bulgaria
Pricing policies
VAT rate
Non-reimbursed drugs on the pharmacy market
Reimbursed drugs on the pharmacy market
Drugs on the hospital market
Reimbursement policies
Reimbursement system
Reimbursement of medicines for rare and contagious diseases
Reimbursement process
Latest changes to reimbursement lists
VII. Key manufacturers
Profiles of selected leading generic drug manufacturers in CE
Profiles of selected leading innovative drug manufacturers in CE
Key players by individual CE countries
VIII. List of graphs
IX. List of tables
X. About PMR
XI. Contact PMR
List of graphs
1. Market value (€ bn) and y-o-y change (%) of the generic
drug market in Central Europe, 2009-2014
2. Market value (€ bn) and y-o-y change (%) of the innovative
drug market in Central Europe, 2009-2014
3. CAGR for generic drug markets in the CE countries analysed (%),
2012-2014
4. CAGR for innovative drug markets in the CE countries analysed
(%), 2012-2014
5. Average net manufacturer price per generic medicine in CE
countries in comparison with other European states (€ ), 2010
6. Average net manufacturer price per original medicine in CE
countries in comparison with other European states (€ ), 2010
7. Correlation between average net manufacturer price per original
and generic medicines in CE countries in comparison with other European
states, 2010
8. Average wholesale pharmacy margin on pharmaceuticals in CE
countries in comparison with other European sates (%), 2010
9. Average wholesale margin on pharmaceuticals in CE countries in
comparison with other European states (€ ), 2010
10. Average pharmacy margin on reimbursed pharmaceuticals in CE
countries in comparison with other European states (%), 2010
11. Average pharmacy margins on pharmaceuticals in CE countries in
comparison with other European states (€ ), 2010
12. Number of new original brands introduced and their sales value
(€ m) in CE countries in comparison with other European states, H2
2010-H1 2011
13. Sales value of new original brands introduced on the market in
CE countries (€ m), per one brand and per capita, H2 2010-H1 2011
14. Share of generic drugs in the pharmacy market in the CE
countries analysed (%), by value, 2010
15. Market value (€ bn) and y-o-y change (%) of the generic
drug market in Central Europe, 2009-2014
16. Market value (€ bn) and y-o-y change (%) of the
innovative drug market in Central Europe, 2009-2014
17. CAGR for generic drug markets in the CE countries analysed (%),
2012-2014
18. CAGR for innovative drug markets in the CE countries analysed
(%), 2012-2014
19. Number of new recommendations issued by the AOTM in Poland,
2007-2011
20. Effects of price negotiations between the MoH and manufacturers
prior to the entry into force of the reimbursed drugs list in Poland, 2012
21. Shares of generic and innovative drugs in the pharmaceutical
market in Poland (%), by value, 2011
22. Shares of generic and innovative drugs in the pharmaceutical
market in Poland (%), by volume, 2010
23. Shares of generic and innovative drugs in the Rx pharmacy
market in Poland (%), by volume, 2003-2011
24. Shares of generic and innovative drugs in the Rx pharmacy
market in Poland (%), by value, 2003-2011
25. Value (PLN bn) and y-o-y change (%) of the Polish generic drug
market, 2010-2014
26. Value (PLN bn) and y-o-y change (%) of the Polish innovative
drug market, 2010-2014
27. Attitude of Czechs towards the concept of API prescriptions
(%), 2011
28. Estimated market value of generic and innovative medicines in
the Czech Republic (CZK bn), 2009-2010
29. Sales value of generic Rx medicines in the Czech Republic (CZK
bn), 2005-2010
30. Sales volume of generic Rx medicines in the Czech Republic (bn
sales units), 2005-2010
31. Share of generic medicines in the Czech pharmaceutical market
(%), by value, 2010
32. Share of generic medicines in the Czech pharmaceutical market
(%), by volume, 2010
33. Value (CZK m) and y-o-y change (%) of the Czech generic drug
market, 2009-2014
34. Value (CZK m) and y-o-y change (%) of the Czech innovative drug
market, 2009-2014
35. Percentage of people asking for cheaper drug equivalent at
pharmacies in the Czech Republic, 2011
36. New claw-back tax formula in Romania, 2012
37. Share of locally manufactured drugs in the Romanian
pharmaceutical market (%), 2006 and 2010
38. Evolution of official payment deadlines for reimbursed drugs
and drugs covered by the National Health Programmes in Romania (number of
days), 2003-2011
39. Estimated share of generic and innovative drugs in the overall
pharmaceutical market in Romania (%), by value, 2011
40. Share of generic and innovative drugs in the Rx market in
Romania (%), by value, 2010
41. Share of local generic drugs in the pharmaceutical market in
Romania (%), by value, 2006 and 2010
42. Share of generic and innovative drugs in the overall
pharmaceutical market in Romania (%), by volume, Q1 2008 and Q1 2011
43. Share of local and foreign drugs in the generics market in
Romania (%), by volume, 2006 and 2010
44. Value (RON m) and y-o-y change (%) of the Romanian generic drug
market, 2007-2014
45. Value (RON m) and y-o-y change (%) of the Romanian innovative
drug market, 2007-2014
46. Effect of the economic crisis on Hungarian spending on Rx drugs
in comparison with OTC drugs (%), 2009 and 2011
47. Planned and actual public pharmaceutical spending in Hungary
(€ m), 1994-2013
48. Share of generic and innovative drugs in the overall
pharmaceutical market in Hungary (%), by value, 2010
49. Market share of generic medicines as a proportion of the
Hungarian pharmaceutical market (%), by value, 2006-2010
50. Market share of generic medicines in the Hungarian
pharmaceutical market (%), by volume, 2006-2010
51. Value (HUF bn) and y-o-y change (%) of the Hungarian generic
drug market, 2009-2014
52. Value (HUF bn) and y-o-y change (%) of the Hungarian innovative
drug market, 2009-2014
53. Value (€ m) and volume (m packages) of the generic
medicine market in Slovakia, 2009-2011
54. Value (€ m) and volume (m packages) of the innovative
medicine market in Slovakia, 2009-2011
55. Share of generic and innovative drugs in the overall
pharmaceutical market in Slovakia (%), by value, 2009-2011
56. Share of generic and innovative drugs in the overall
pharmaceutical market in Slovakia (%), by volume, 2009-2011
57. Value (€ m) and y-o-y change (%) of the Slovak generic
drug market, 2009-2014
58. Value (€ m) and y-o-y change (%) of the Slovak innovative
drug market, 2009-2014
59. Sales value of original and generic medicines in Bulgaria (BGN
m), 2007-H1 2011
60. Sales volume of original and generic medicines in Bulgaria
(million packages), 2007-H1 2011
61. Share of generic and innovative drugs in the overall
pharmaceutical market in Bulgaria (%), by value, H1 2010 and H1 2011
62. Share of generic and innovative drugs in the overall
pharmaceutical market in Bulgaria (%), by volume, H1 2010 and H1 2011
63. Value (BGN m) and y-o-y change (%) of the Bulgarian generic
drug market, 2007-2014
64. Value (BGN m) and y-o-y change (%) of the Bulgarian innovative
drug market, 2007-2014
65. Applications for SPCs filed and SPCs granted, pending and
effective in the Czech Republic, 2004-2010
66. Number of SPC applications in Hungary, 2004-2011
67. Number of applications and SPCs granted in Slovakia, 2006-2010
68. Average price of generic and innovative drugs in Poland (PLN),
2003-2010
69. Average margins for all drugs compared to margins for
reimbursed drugs on the pharmacy market in Poland (%), 2007-2011
70. Reimbursement process in Poland, 2012
71. NFZ spending on drug reimbursement (PLN bn) and y-o-y change
(%) in Poland, 2003-2012
72. NFZ spending on therapeutic programmes (PLN m) and y-o-y change
(%) in Poland, 2007-2012
73. NFZ spending on chemotherapy (PLN m) and y-o-y change (%) in
Poland, 2005-2011
74. Procedure for establishing maximum drug prices for reimbursed
medicines and reimbursement levels in the Czech Republic, 2012
75. Reimbursement process scheme in Romania, 2012
76. CNAS spending on drug reimbursement (RON m) and y-o-y change
(%) in Romania, 2006-2010
77. Spending on drug reimbursement in Romania (RON m, %), 2010
78. Categories of reimbursement in Hungary, 2012
79. Reimbursement process scheme in Hungary, 2012
80. Pharmaceutical reimbursement spending (HUF bn) and y-o-y change
(%) in Hungary, 2000-2011
81. Pharmaceutical reimbursement spending in Hungary (%), by
reimbursement category, 2006 - January-September 2011
82. Top 10 medicines in terms of most substantial reimbursement
spending in Hungary (HUF m), January-October 2011
83. Monthly reimbursement spending on Remicade, Glivec and Humira
in Hungary (HUF m), January-October 2011
84. Summary of the implementation of the Szell Kalman Plan in
Hungary, 2012
86. Average price per package of generic and innovative medicines
in Slovakia (€ ), 2009-2011
87. Average price per package of selected best-selling generic
medicines in Slovakia (€ ), 2011
88. Average price per package of selected best-selling innovative
medicines in Slovakia (€ ), 2011
89. Average price per drug package of selected leading generic drug
manufacturers in Slovakia (€ ), 2011
90. Average price per drug package of selected leading innovative
drug manufacturers in Slovakia (€ ), 2011
91. Actavis sales revenues in Bulgaria (BGN m) and y-o-y change
(%), 2009-2011
92. Actavis CZ sales revenues (CZK m) and y-o-y change (%),
2008-2010
93. Egis sales revenues in selected CE countries (€ m) and
y-o-y change (%), 2010/2011
94. Breakdown of Egis sales in CE countries, 2010/2011
95. Egis spending on research and development (HUF m), y-o-y change
and its share as a proportion of the company's net sales (%), FY
2002/2003-2010/2011
96. Gedeon Richter sales revenues in selected CE countries (€
m) and y-o-y change (%), 2011
97. Breakdown of Gedeon Richter sales in CE countries, 2011
98. Gedeon Richter spending on research and development (HUF m),
y-o-y change and its share as a proportion of the company's sales (%), 2000-Q3
2011
99. Krka sales revenues in selected CE countries (€ m) and
y-o-y change (%), Q1-Q3 2011
100. Breakdown of Krka sales in CE countries, Q1-Q3 2011
101. Number of new marketing authorisations for the Krka group, in
CE region, 2006-2010
102. Krka spending on research and development (€ m), y-o-y
change and its share as a proportion of the company's sales revenues (%),
2006-Q1-Q3 2011
103. Sandoz sales revenues in the Czech Republic (CZK m) and y-o-y
change (%), 2008-2010
104. Sandoz spending on research and development ($ m), y-o-y
change and its share as a proportion of the company's net sales (%), 2006-2011
105. Stada sales revenues in selected CE countries (€ m) and
y-o-y change (%), Q1-Q3 2011
106. Breakdown of Stada sales in CE countries, Q1-Q3 2011
107. Sales of generic and branded drugs of Stada in selected CE
countries (€ m), Q1-Q3 2011
108. Stada spending on research and development (€ m), y-o-y
change and its share in company's sales (%), 2002 - Q1-Q3 2011
109. Teva Czech Industries sales revenues (CZK m) and y-o-y change
(%), 2005-2010
110. Teva annual spending on research and development ($ m), y-o-y
change and its share in company's revenues (%), 2004 - Q1-Q3 2011
111. AstraZeneca sales revenues in the Czech Republic (CZK m) and
y-o-y change (%), 2004-2010
112. AstraZeneca sales revenues in Romania (RON m) and y-o-y change
(%), 2009-2011
113. AstraZeneca sales revenues in Bulgaria (BGN m) and y-o-y
change, 2009-2011
114. AstraZeneca sales in the Czech Republic, by therapeutic
categories (%), 2009-2010
115. AstraZeneca spending on research and development ($ m), y-o-y
change and its share as a proportion of the company's revenues (%), 2004-2011
116. Bayer sales revenues in Poland (PLN m) and y-o-y change (%),
2006-Q1 2011
117. Bayer sales revenues in the Czech Republic (CZK m) and y-o-y
change (%), 2008-2010
118. Bayer sales revenues in Romania (RON m) and y-o-y change (%),
2009-2011
119. Bayer sales in Bulgaria (BGN m) and y-o-y change (%), 2009-2011
120. Reasons for declaring trust in Bayer in Poland, 2011
121. Bayer HealthCare spending on research and development (€
m), y-o-y change and its share as a proportion of the company's net sales (%),
2004-2011
122. GSK sales revenues in the Czech Republic (CZK m) and y-o-y
change (%), 2005-2010
123. GSK sales revenues in Romania (RON m) and y-o-y change (%),
2009-2011
124. GSK sales revenues in Bulgaria (BGN m) and y-o-y change (%),
2009-2011
125. GlaxoSmithKline's spending on research and development
(£ m), y-o-y change and its share as a proportion of the company's
turnover (%), 2001-2011
126. Novartis sales revenues in the Czech Republic (CZK m) and
y-o-y change (%), 2005-2010
127. Novartis sales revenues in Romania (RON m) and y-o-y change
(%), 2009-2011
128. Novartis sales revenues in Bulgaria (BGN m) and y-o-y change
(%), 2009-2011
129. Novartis' spending on research and development ($ m), y-o-y
change and its share as a proportion of the company's net sales (%), 2004-2011
130. Pfizer sales revenues in Poland (PLN m) and y-o-y change (%),
2007-2010
131. Pfizer sales revenues in the Czech Republic (CZK m) and y-o-y
change (%), 2006-2010
132. Pfizer sales revenues in Romania (RON m) and y-o-y change (%),
2009-2011
133. Pfizer sales revenues in Bulgaria (BGN m) and y-o-y change
(%), 2009-2011
134. Pfizer spending on research and development ($ m), y-o-y
change and its share as a proportion of the company's revenues (%), 2004-2011
135. Roche sales revenues in Romania (RON m) and y-o-y change (%),
2009-2012
136. Roche sales revenues in the Czech Republic (CZK m) and y-o-y
change (%), 2006-2010
137. Roche sales revenues in Bulgaria (BGN m) and y-o-y change (%),
2009-2011
138. Roche Pharmaceuticals spending on research and development
(CHF m), y-o-y change and its share as a proportion of the company's sales
(%), 2004-2011
139. Sanofi sales revenues in the Czech Republic (CZK m) and y-o-y
change (%), 2003-2010
140. Sanofi sales revenues in Romania (RON m) and y-o-y change (%),
2009-2011
141. Sanofi sales revenues in Bulgaria (BGN m) and y-o-y change
(%), 2009-2011
142. Sanofi spending on research and development (€ m), y-o-y
change and its share as a proportion of the company's revenues (%), 2004-2011
143. Servier sales revenues in Romania (RON m) and y-o-y change
(%), 2009-2011
144. Servier sales revenues in Bulgaria (BGN m) and y-o-y change
(%), 2009-2011
145. Servier sales revenues in the Czech Republic (CZK m) and y-o-y
change (%), 2006-2010
146. Shares of generic and innovative companies in the Rx pharmacy
market in Poland, by value, 2003-2010
147. Shares of innovative and generic companies in the hospital
market in Poland, by value (%), 2003-2010
148. Aggregate R&D spending at pharmaceutical companies in Poland
(PLN m), 2009 and 2012
149. R&D spending (PLN m) at Polish companies and change (%),
2007-2010 and 2012
150. Boehringer Ingelheim in Romania sales revenues (RON m), by
product groups, 2009-2010
List of tables
1. Annual average exchange rates used for this report (€ to
national currency), 2006-2011
2. Policies of the CE countries with regard to API prescriptions,
2012
3. Policies of the CE countries with regard to external price
referencing systems while setting maximum price, 2012
4. Number of recommendations issued by the AOTM in Poland, by
category, 2007-2011
5. Number of drugs containing Montelukast, Losartan and Clopidogrel
as the main component in Poland, December 2009-January 2012
6. Facts and figures on healthcare spending in Hungary, 2006 and
2011
7. Most frequently prescribed drugs in Slovakia, by number of
packages, Q1 and Q3 2011
8. Top 10 best-selling innovative drugs in the Czech Republic, by
value (CZK m), 2010
9. Top 10 best-selling innovative drugs in the Czech Republic, by
value (CZK m), H1 2011
10. Top 5 best-selling generic drugs in the Czech Republic, by
volume (m packets), 2010
11. Top 5 best-selling generic drugs in the Czech Republic, by
volume(m packets), H1 2011
12. Fees for Supplementary Protection Certificates in the Czech
Republic, 2011
13. SPC certificates to expire within the next five years in the
Czech Republic, 2012
14. Top 10 best-selling innovative drugs in Romania, by value
(€ m), January-November 2011
15. 10 best-selling drugs in Romania, by volume, January-November
2011
16. Fees for Supplementary Protection Certificate in Romania, 2011
17. Top 10 best-selling innovative drugs in Hungary, by value (HUF
bn), 2010
18. Top 20 best-selling biological drugs in Hungary, pharmacy
sales, January-August 2011
19. Fees for Supplementary Protection Certificate in Hungary, 2012
20. SPCs to expire within the next five years in Hungary, 2012
103-
21. Top 20 best-selling innovative drugs in Slovakia, by value
(€ m), 2011
22. Top four best-selling generic drugs in Slovakia, by value
(€ m), 2011
23. Fees for Supplementary Protection Certificate in Slovakia, 2012
24. SPCs valid in Slovakia, 2012
25. Fees for Supplementary Protection Certificate in Bulgaria, 2012
26. Official retail margins for reimbursed drugs in Poland, 2011
27. Comparison of rules governing the operation of healthcare
programmes and drug programmes in Poland, 2012
28. Results of the increase in VAT on medicines in the Czech
Republic, 2012
29. Official margins for reimbursed drugs in the Czech Republic,
2012
30. Annual average changes in prices of generic and innovative
medicines in the Czech Republic (%), 2010
31. Summary of changes introduced through the amendment to the Act
on Public Health Insurance in the Czech Republic, 2012
32. Drugs placed on and withdrawn from the reimbursement list in
the Czech Republic, 12 January 2012
33. Drugs placed on and withdrawn from the reimbursement list in
the Czech Republic, 1 January 2012
34. Drugs placed on and withdrawn from the reimbursement list in
the Czech Republic, December 2012
35. Official wholesale margins for drugs in Romania, 2012
36. Official retail margins and gross margins for drugs in Romania,
2012
37. Number of drugs on reimbursement lists in Romania, February 2012
38. Solidarity fees paid by pharmacies in Hungary and their
correlation with quarterly incomes from reimbursed drugs, 2012
39. Price-volume agreements in the reimbursement system in Hungary,
2012
40. Official wholesale margins for reimbursed drugs in Hungary, 2012
41. Official retail margins for reimbursed drugs in Hungary, 2012
42. Categories of referencing in the reimbursement system in
Hungary, 2012
101. Top 10 leading generic and innovative companies on the
Hungarian pharmaceutical market, by sales value, 2010
102. 10 leading generic corporations on the Slovak pharmaceutical
market, by sales value, 2011
103. 10 leading innovative corporations on the Slovak
pharmaceutical market, by sales value, 2011
104. Top 10 leading generic and innovative companies on the
Bulgarian pharmaceutical market, by sales value, 2009-2011
Generic and innovative drugs market in Central Europe 2012 - Development forecasts for 2012-2014 published by PMR in April 13, 2012. This report consists of 303 Pages and the price starts from US $ 3500.
Press Release
Legislative changes to hamper innovative drugs market in Central Europe between 2012 and 2014
April 16th, 2012
Global Information Inc. would like to present a new market research report, "Generic and innovative drugs market in Central Europe 2012 - Development forecasts for 2012-2014" by PMR.
Due to legislative changes implemented during 2011 in most of the Central European (CE) countries, the innovative drug market in the region will decline in 2012 by 1%, to € 6.1bn at manufacturer prices, according to the latest report published by research and consulting company PMR, entitled "Generic and innovative drugs market in Central Europe 2012. Comparative analysis, reimbursement policies and development forecasts for 2012-2014". In all, the CAGR for innovative drugs in the region will be approximately 2% in 2012-2014.
Innovative markets to decline in some CE countries
In terms of the rate of change on the innovative market, huge differences are to be observed in the development of this subgroup in individual countries. In Bulgaria the growth rate will be substantial around 14% per annum on average, whereas in the Czech Republic and Romania it will fluctuate around 7% and 4% respectively. In Poland the innovative drug market is expected to develop at a 0% rate and, in 2014, it should, therefore, return to its 2011 value. In Slovakia and Hungary the year-on-year changes will be negative. On the other hand, in all of the CE countries analysed, between 2012 and 2014 the average annual rates of change in the value of the generic drugs market will be positive.
Szell Kalman Plan implications for Hungary
In general, in Hungary the climate for innovative medicines is the most unfavourable in CE. "2009 and 2010 have already been difficult for innovative drug manufacturers in the country. Many manufacturers complained that the country had not supported innovations. In 2011 the situation became even worse, with the introduction of changes to R&D expense deductions" says Agnieszka Skonieczna, PMR Senior Pharmaceutical Market Analyst and the report co-author. In addition, in recent months most medicines which appeared on the reimbursement lists in the country were generic. For example, the October 2011 update to the reimbursement list included 21 generic and eight innovative drugs.
In 2011 a structural reform programme based on the Szell Kalman Plan was launched in Hungary. The programme is aimed at consolidating the Hungarian public sector by instigating structural reforms, boosting economic growth, encouraging an increase in employment levels and enhancing the competitiveness of Hungarys economy, and it will have several consequences for the pharmaceutical industry in the country.
The main aim of the plan in to reduce the reimbursement costs for the OEP (National Health Insurance Fund) and drug prices for patients which will have the most severe effect on innovative medicines. In 2012 the drug budget is expected to be HUF 83bn (€ 301m) less than that of 2010, and in 2013 and 2014 budget cuts will fluctuate around HUF 120bn (€ 430m) each year. In February 2012 the Hungarian government announced that it was looking for further savings, and the situation could, therefore, become even worse in the future.
Slovakia favours generic medicines
Government reimbursement policy in Slovakia is favouring generics, rather than innovative drugs. This is why a slight reduction in the latter is expected in the foreseeable future, whereas the overall market will grow. There are several reasons for this. First of all, in Slovakia the market share of original drugs by value is relatively high in comparison with those of other countries, and this market subdivision, which is quite saturated, will develop at a slower rate than that of generics. Furthermore, the countrys policy in the pharmaceutical arena does not support innovative companies. In the five reference pricing rounds which have taken place so far, the prices of several hundred medicines have been reduced, and most of these were innovative medicines. The legal changes are also designed to support the generic market rather than that of innovative medicine. For example, in Slovakia a new reference pricing system (in which a drug price will be set at the level of the lowest price in a basket of prices of all of the EU countries) has come into force, with the aim of reducing medicine prices further. In addition, the prescription of APIs, instead of brand names, has been introduced in the country, and this could boost sales of generic medicines. Obligatory generic substitution at pharmacies is also planned to be standard practice in the country.
