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Table 5 Pharmaceutical policy framework – Indicators for equitable access to essential medicines

From: Inequalities in medicine use in Central Eastern Europe: an empirical investigation of socioeconomic determinants in eight countries

Indicator BG CZ HU LV PL RO SI SK
Reference year 2008 2008 2009 2008 2009 2008 2007 2009
Sustainable funding
 HC system SHI SHI SHI SHI SHI SHI SHI SHI
 TPE in % of THE 33.4 % (0.0 pp) 20.4 % (-4.4 pp) 32.5 % (+1.5 pp) 19.4 % (-2.6 pp) 22.9 % (-4.3 pp) 25.0 % (-3.2 pp) 19.6 % (-1.1 pp) 26.6 % (-3.2 pp)
 TPE share  (CEE-10 comparison) +9.0 pp −4.0 pp +6.7 pp −5.0 pp −1.5 pp +0.6 pp - 6.0 pp +3.2 pp
 TPE per capita € 109.9 (+50.3 %) € 205.6 (+17.1 %) € 229.4 (+0.8 %) € 134.3 (+66.6 %) € 134.5 (+11.7 %) € 92.2 (+59.1 %) € 264.0 (+12.0 %) € 283.5 (+56.6 %)
 TPE/capita  (CEE-10 comparison) −39.1 % +14.0 % +35.3 % −25.6 % −16.5 % −48.9 % +56.9 % +47.0 %
Affordability
 Private HE/THE 41.8 % (+6.5 %) 17.5 % (+37.5 %) 34.3 % (+13.5 %) 37.4 % (-12.7 %) 28.2 % (-6.0 %) 18.0 % (-6.2 %) 28.1 % (+4.6 %) 34.3 % (+8.3 %)
 Private HE/THE  (CEE-10 compar.) +13.6 pp −10.8 pp +4.7 pp +9.2 pp - 0.1 pp −10.3 pp −2.2 pp +4.0 pp
 Private PE/TPE 81.7 % (+4.8 %) 38.4 % (+56.9 %) 51.6 % (37.7 %) 62.2 % (-9.4 %) 61.4 % (0 %) 55.0 % (+4.8 %) 40.1 % (+2.9 %) 30.2 % (+11.3 %)
 Private PE/TPE  (CEE-10 comp.) +27.8 pp −15.5 pp −2.9 pp +8.3 pp +7.8 pp +1.2 pp −13.7 pp −25.2 pp
 Informal pays Yes, extensive Yes Yes Yes, extensive Yes Yes, large scale No Yes
 Medicine prices n.a. € 5.09 (-71.4 %) € 6.91 (-61.2 %) € 4.23 (-76.2 %) € 4.54 (-74.5 %) n.a. € 12.34 (-30.8 %) n.a.
 Co-pays (out-patient) No PF PF PF No PF PF for some indications No PF No PF PF
%: 0 %, >25 %, >50 % No fixed R rates %: 0 %, 10 %, 30 %; 25 %, 45 %, 75 % %: 0 %, 10 %, 25 %, 50 %, 25 % %: 0 %, 30 %, 50 % %: 0 %, 10 %, 50 % %: 0 %, 25 %, 75 % %: no fixed R rates
No D No D No D No D No D No D No D No D
 Changes in co-pays No Yes Yes, increase No, but planned (90 % R rate to be abolished) No since mid-1990-ties No No Yes, decrease in PF in 10/2006
 Co-pay exempt. None None Yes Yes Yes Yes, see comment Yes Yes
 De-listings No, see comment Not known Yes, see comment See comment Yes See comment No No major delisting
 Co-pays (in-patient) No co-payment No co-payment No co-payment No co-payment No co-payment No co-payment No co-payment No co-payment
 VAT on medicines 20 % (20 %) 9 % (19 %) 5 % (20 %) 5 % (18 %), planned increase from 1/2009 7 % (22) 9 % (19 %) 8.5 % (20 %) 10 % (19 %)
 OTC market 22 % 26.8 % 15.8 % n.a. 25.8 % 22.4 % 6.7 % 25.8 %
Availability and accessibility
 No. of medicines 5,8302006 7,8802006 5,525 2006 n.a. (8,0892005) 6,7112007 2,7912006 19,693 November 2006
4,4812006 4,1302006 3,1442006 5,7142007 4,2752006 ≈4,0002007 n.a. 19,320November 2006
1,598 6,9882006 2,8862006 2,3372007 2,7492006 5,7912007 2,6602006 17,804November 2006
See comment   See comment See comment See comment See comment See comment See comment
 Pharmacies 4,299/1,7952006 2,520/4,0962007 ≈2,500/≈4,0002010 899/2,2092007 10,632/3,5852007 5,660/3,7332007 271/7,3842005 1,523/3,528Oct. 2006
 OTC sale outside pharmacies permitted Yes Yes Yes No No Yes, but pharmacist must be present Yes No
Rational selection and use of medicines
 INN prescribing Yes, indicative Yes, indicative Yes, indicative Yes, indicative Yes, indicative Yes, indicative Yes, indicative Yes, indicative
 Generic substitution No, not allowed Yes, indicative Yes, indicative Yes, obligatory Yes, indicative Yes, indicative Yes, indicative Yes, obligatory
 Ref. price syst. Yes, ATC 5 Yes, ATC 4 + 5 Yes, ATC 4 + 5 Yes, ATC 3,4 + 5 Yes, ATC 3,4 + 5 Yes, ATC 5 Yes, ATC 4 Yes, ATC 4 + 5
 Generic market See comment 55 %/35 %2005 42 %/26 %2005 No data No data ≈70 %/≈40 %e 70 %/38 %2005 65 %/48 %2005
 Prescription monitoring Yes, but limited Yes Yes, but limitations in enforcement Yes Yes, but limitations in enforcement Yes, but limitations in enforcement Yes Yes
  1. Indicators:
  2. Reference year: data in this table refer to the year of the household survey unless indicated differently
  3. HC system: indicates the type of health care system: Semaskho system, social health insurance (SHI) or National Health Service (NHS)
  4. TPE in % of THE: Total pharmaceutical expenditure (TPE) in % of total health expenditure (THE) in the year of the survey; in brackets: change in the share of TPE in % of THE in percentage points compared to 3 years earlier
  5. TPE share (CEE-10 comparison): Difference of the share of TPE in % of THE in the surveyed country in 2008 compared to CEE-10 average (Bulgaria, Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Romania, Slovenia, Slovakia) in 2008, expressed in percentage points
  6. TPE per capita: Total pharmaceutical expenditure (TPE) per capita in the year of the survey, in Euro; in brackets: change in TPE per capita compared to 3 years earlier, expressed in per cent)
  7. TPE/capita (CEE-10 comparison): Difference of the TPE per capita in the surveyed country in 2008 compared to CEE-10 average in 2008, expressed in per cent
  8. Private HE/THE: Private health expenditure (HE) in % of total health expenditure (THE) in the year of the survey (unless BG – 2007 data); in brackets: change in the share of private HE in % of THE in per cent compared to 3 years earlier
  9. Private HE/THE (CEE-10 compar.): Difference of the share of private HE in % of THE in the surveyed country in 2008 compared to CEE-10 average in 2008 (unless BG – 2007 data), expressed in percentage points
  10. Private PE/TPE: Private pharmaceutical expenditure (PE) in % of total pharmaceutical expenditure (TPE) in the year of the survey; in brackets: change in the share of private PE in % of TPE in per cent compared to 3 years earlier
  11. Private PE/TPE (CEE-10 comp.): Difference of the share of private PE in % of TPE in the surveyed country in 2008 compared to CEE-10 average in 2008, expressed in percentage points
  12. Informal pays: Indications of informal payments in health care
  13. Medicine prices: Average pharmacy retail price in € per pack in the total out-patient market in 2006; differences in % to average of EU-15
  14. Co-pays (out-patient): Co-payments for medicines in the out-patient sector: PF = prescription fee, % = percentage co-payment rates (for reimbursable medicines different co-payment rates in per cent of the price of product apply, usually linked to the severity of the disease and therapeutic benefit of the medicine), D = deductible (upfront initial out-of-pocket payment up to a fixed amount for a service or over a defined period of time; then the rest of the cost is covered by a public party payer). Percentage co-payments due to the reference price system (see below indicator ‘Ref. pricing syst.’) are not considered.
  15. Changes in co-pays: Changes in co-payments in the years before the survey
  16. Co-pay exempt.: Mechanisms for vulnerable groups (e.g. exemptions, reductions) from co-payments in the out-patient sector
  17. De-listings: Exclusion of medicines from reimbursement in the years before the survey
  18. Co-pays (in-patient): Co-payments for medicines in the in-patient sector
  19. VAT on medicines: Value-added tax (VAT) rate on medicines; in bracket: standard VAT rate
  20. OTC market: Relevance of the Over-the-Counter (OTC) market expressed by the share of sales in total non-prescription market as per cent of total pharmaceutical market sales in the years of the EHIS survey (at consumer price level, unless indicated differently)
  21. No. of medicines: Number of medicines authorized, medicines on the market, and prescription-only medicines. Counted incl. different pharmaceutical forms and dosages, excl. different pack sizes unless indicated differently
  22. Pharmacies: Number of community pharmacies, and inhabitants per pharmacy served
  23. OTC sale outside pharmacies permitted: Information as to whether the sale of Over-the-Counter (OTC) medicines was permitted outside pharmacies, or not
  24. INN prescribing: Information as to whether prescribing by International Non-Proprietary Name (INN) was permitted, and if yes, whether the policy was voluntary (indicative) or mandatory for the prescriber
  25. Generic substitution: Information as to whether the practice of substituting a medicine, whether marketed under a trade name or generic name (branded or unbranded generic), with a less expensive medicine (e.g. branded or unbranded generic), often containing the same active ingredient, was permitted, and if yes, whether the policy was voluntary (indicative) or mandatory for the pharmacist
  26. Ref. price syst.: Information as to whether a reference price system was in place, i.e. a reimbursement policy, in which identical or similar medicines are clustered – the public payer reimburses a defined maximum amount (reference price) for all medicines of the cluster, and patients have to co-pay the remainder up to the pharmacy retail price gross), and its clustering: ATC-5: clustering of same active ingredients or groups of active ingredients, ATC-4: clustering of medicines of the same therapeutic group, clustering of medicines of the same pharmacological subgroup
  27. Generic market: Generic market share (in value and in volume) in the out-patient sector
  28. Prescription monitoring: Information as to whether prescription monitoring was performed
  29. Abbreviations: ATC Anatomical Therapeutic Chemical classification system, D deductible, HE health expenditure, OTC Over-the-Counter medicines, pp percentage points, PE pharmaceutical expenditure, PF prescription fee, R reimbursement, THE total health expenditure, TPE total pharmaceutical expenditure, VAT value-added tax
  30. Notes:
  31. BG:
  32. Private HE / THE and Private HE / THE (CEE-10 compar.): no data for private health expenditure in 2008 available; 2007 data used instead: change indicated for the years 2004-2007
  33. Changes in co-pays: Increase of percentage co-payments for some medicines, treating Parkinson, osteoporosis, Glaucoma, etc. took place after the EHIS survey, in 2010
  34. De-listings: No de-listings reported but constant increase of medicines included in the positive list during 2007
  35. No. of medicines: Different data sources and counting methods for medicines authorized and on the market compared to prescription-only medicines. The latter were counted per brand name, excl. different pharmaceutical forms, dosages and pack sizes. Counted according to that method, the number of the medicines on the market were 4,299, thus resulting in a share of prescription-only medicines of the medicines on the market of around 37 %.
  36. Pharmacies: High regional disparities in the density of pharmacies, concentration in larger cities
  37. Generic market: No data on generic market shares available. 74 % of the medicines on the market are generics.
  38. CZ:
  39. Co-pays (out-patient): Percentage co-payment rates result from application of the reference price system
  40. Changes in co-pays: In 2008 (year of the survey), a prescription fee was introduced, as well as further co-payments in health care (not medicines related) such as a co-payment for visit to a doctor
  41. Pharmacies: High regional disparities in the density of pharmacies, concentration in larger cities
  42. HU:
  43. Co-pays (out-patient): Percentage co-payment rates of 0, 10 and 30 % for out-patient medicines for specific indications, and of 25, 45 and 75 % for all other reimbursable medicines in the out-patient sector
  44. Co-pay exempt.: Exemptions from co-payment for socially disadvantaged persons. 100 % reimbursement for patients with long-term illness, however, the prescription fee had also to be paid by them
  45. De-listings: A few de-listings, and changes in reimbursement categories (pharmaceutical groups were granted a lower percentage reimbursement rate) at large scale since 2006/2007
  46. No. of medicines: Counted per brand name, excl. different pharmaceutical forms, dosages and pack sizes
  47. Pharmacies: In addition to pharmacies, around 370 doctors are also allowed to dispense prescription-only medicines
  48. Prescription monitoring: Limitations particularly related to off-patent medicines: guidelines for cost-effective prescribing are frequently not followed, no audit or feed-back of the social health insurance on generic prescribing by doctors
  49. LV:
  50. De-listings: De-listings were not explicitly reported but took place most probably: since 2005 major changes in the reimbursement list were reported, the principle of a limited number of medicines in the positive list was in place, and regular reimbursement reviews were performed. Medicines were included in the positive list for a period of 2 years, then the marketing authorization holder had to apply for re-inclusion.
  51. No. of medicines: Number of medicines authorized not included since medicines are only counted per trade name
  52. Pharmacies: Including 100 branch pharmacies, availability of pharmacies varied between towns and rural areas
  53. PL:
  54. OTC market: At manufacturer price level; refers to self-medication market
  55. No. of medicines: Data on number of prescription-only medicines includes hospital-only medicines. In 2009, 3,380 medicines (counted including different pharmaceutical forms, dosages and pack sizes) were on the reimbursement list. Data on authorized medicines have to be interpreted with caution due to a different counting method: counted including different dosages, pharmaceutical forms and pack sizes.
  56. Pharmacies: High regional disparities in the density of pharmacies, concentration in larger cities
  57. RO:
  58. Co-pay exempt.: Exemptions from co-payments are made for children, students and pregnant women as well as war veterans and disabled people on low income
  59. De-listings: Quarterly updates of the reimbursement lists; no confirmed information of major de-listings (however number of medicines on the reimbursement list is, in general, rather low)
  60. No. of medicines: 1,247 of the 5,791 prescription-only medicines were hospital-only medicines
  61. Pharmacies: High regional disparities in the density of pharmacies, concentration in larger cities
  62. Generic market: Estimate for the year 2007
  63. SI:
  64. Co-pays (out-patient): Co-payments covered by voluntary insurance that around 90 % of the population concluded
  65. Co-pay exempt.: Exemptions from co-payments for medicines for prevention, for defined social groups (such as people under 18 years) or for the treatment of specific diseases (e.g. HIV/AIDS, diabetes)
  66. De-listings: No major wave of de-listings reported; on the contrary, some new medicines could be included in the positive lists following changes in medicine prices due to change in pricing methodology
  67. OTC market: At wholesale price level, refers to self-medication market
  68. No. of medicines: Counted including different dosages, pharmaceutical forms and pack sizes
  69. Pharmacies: Some OTC medicines were ‘pharmacy-only’, whereas others were permitted to be sold in ‘specialised stores’ outside pharmacies
  70. SK:
  71. No. of medicines: Counted including different pharmaceutical forms, dosages and pack sizes; homeopathic medicines excluded
  72. Sources: Indicator 2: [7, 10, 8189]; Indicators 3-10: [49]; Indicator 11: [1416, 63, 83, 86, 88100]; Indicator 12: [68]; Indicators 13-16, 18, 20, 22-24, 26, 27: [9, 63, 101111]; Indicator 17: [112117]; Indicator 19: [5355]; Indicator 21: pharmacy data and information on disparities: [7, 9, 63, 82, 84, 86, 102, 103, 105, 111, 118, 119], population data: [49]; Indicator 25: RO: [12, 63]