Generic policy in Bulgaria: a policy of failure or success?

Figures & data

Table 1. Bulgarian legislation related to generics.

Regulation	Relation to generic medicinal products
National Drug Policy (draft) [23]	No conceptual framework of generic policy available. Proposal for change in update of Summary of Products Characteristics (SPCs) and Patient Information Leaflets (PILs) of generic products in relation to reimbursement of new indications.
Law on Medicinal Products in Human Medicine [24]	Facilitated simplified procedure for marketing authorization of essentially similar medicinal products and introduced external reference pricing based on lowest price in the reference basket.
Ordinance on conditions and order for prescribing and dispensing of medicinal products [26]	In case the physician points the generic substitution in the prescription as possible, the pharmacist is allowed to substitute, but this does not concern the reimbursed prescriptions.
Ordinance on the terms, rules and procedure for and registration of prices for medicinal products [27]	Internal reference reimbursement level within a group with the same international non-proprietary name (INN) with payment of the lowest price per defined daily dose (DDD). For some therapeutic groups, formation of jumbo groups is also possible.

Table 2. Generic policy elements [31]: implementation in Bulgaria.

Element of generic policy	Available in Bulgaria
Education of health care professionals	No
Faster or immediate pricing and reimbursement procedures	Yes
External reference pricing	Yes
Pharmaceutical prescription budgets	No
Prescription quota for generic medicines	No
Computerized prescribing systems	No
Guidelines, substitution lists, etc.	No
Generic substitution by pharmacists	No
Financial incentives for pharmacists (i.e. fee for prescription)	No^*
Information campaigns for patients^1	No
Financial incentives for patients (lower co-payments)	Yes

*There is an equal fee for every description regardless of the product, so it cannot be concluded that pharmacists receive financial incentive for promoting generic medicines.

Table 3. Sales of generic and originator medicinal products (mln units) in Bulgaria in 2006–2014*.

	Units year/2006	Units year/2007	Units year/2008	Units year/2009	Units year/2010	Units year/2011	Units year/2012	Units year/2013	Units MAT/M08/2014
Total market	217.39	235.25	250.70	248.85	242.89	253.48	253.46	259.82	268.54
Generics	187.93	201.37	209.94	203.84	195.52	202.76	200. 26	201.74	208.46
Originals	29.46	33.88	40.76	45.01	47.37	50.72	53.20	58.07	60.08

*IMS data (personal communication, 2015; unreferenced).

Figure 1. Share of generics and originals (of the total market in Bulgaria) in 2006–2014.

Table 4. Sales of generics (mln units) by ATC groups*.

	Units year/2006	Units year/2007	Units year/2008	Units year/2009	Units year/2010	Units year/2011	Units year/2012	Units year/2013	Units MAT/M08/2014
Generics	187.93	201.37	209.94	203.84	195.52	202.76	200.26	201.74	208.46
C0 cardiovascular system	G**-42.79	45.12	46.81	47.82	45.44	46.67	46.38	46.77	47.27
	O^***-8.52	9.79	11.19	13.21	13.86	14.77	15.64	16.69	17.11
C0 G-market share (%)	83.40	82.17	80.71	78.35	76.62	75.96	74.78	73.70	73.42
A0 alimentary T.and Metabol.	G-31.06	32.90	34.21	33.36	30.48	31.18	30.47	30.10	30.66
	О-2.29	2.80	3.54	3.99	4.44	4.85	5.42	6.24	6.68
A0 G-market share (%)	93.13	92.16	90.62	89.32	87.29	86.54	83.87	82.83	82.11
N0 nervous system	G-43.34	44.44	44.90	42.55	40.97	43.76	43.15	43.29	44.60
	О-5.10	5.62	6.61	6.45	6.14	6.77	7.00	7.73	8.17
N0 G-market share (%)	89.47	88.77	87.17	86.84	86.97	86.60	86.04	84.85	84.52
J0 systemic anti-infectives	G-18.63	19.49	18.98	16.75	16.08	16.17	15.51	15.09	16.11
	О-2.19	2.34	2.53	3.16	2.94	2.75	2.67	2.87	2.92
J0 G-market share (%)	89.48	89.28	88.24	84.13	84.54	85.47	85.31	84.02	84.66
R0 respiratory system	G-18.31	21.00	22.44	20.19	20.05	22.79	21.31	21.21	22.39
	2.48	2.78	3.60	3.69	4.23	4.86	4.98	5.64	5.80
R0 G-market share (%)	88.07	88.31	86.18	84.55	82.58	82.42	81.06	78.99	79.43
M0 musculo-skeletal	G-5.20	5.66	6.55	6.59	6.35	6.49	6.17	6.58	6.72
	О-2.34	2.67	3.20	3.17	3.00	3.18	3.23	3.66	3.97
М0 G-market share (%)	68.97	67.95	67.18	67.52	67.91	67.11	65.64	64.26	62.86
G0 G.U.system and sex hormone	G-2.39	2.59	2.73	2.73	2.88	2.99	2.91	3.12	3.19
	О-0.84	0.93	1.09	1.13	1.21	1.45	1.63	1.63	1.71
G0 G-market share (%)	73.99	73.58	71.47	70.73	70.42	67.34	64.10	65.68	65.10
D0 dermatologicals	G-7.31	9.38	10.95	10.39	10.50	10.72	11.32	11.65	11.91
	О-1.35	1.37	1.53	1.58	1.63	1.83	1.98	2.15	2.23
D0 G-market share (%)	84.41	87.26	87.74	86.80	86.56	85.42	85.11	84.42	84.23
K0 hospital solutions	G-10.23	11.39	12.73	14.00	14.30	12.81	12.84	13.12	14.35
К0 G-market share (%)	100	100	100	100	100	100	100	100	100
B0 blood + b. forming organs	G-1.29	1.41	1.41	1.33	1.35	1.87	2.39	2.44	2.57
	О-2.26	3.34	4.50	5.44	6.48	6.87	6.94	7.43	7.17
B0 G-market share (%)	36.34	36.00	23.86	19.65	17.24	21.40	20.04	24.72	26.39
L0 antineoplast + immunomodul	G-0.61	0.58	0.53	0.56	0.53	0.45	0.55	0.54	0.61
	О-0.24	0.30	0.40	0.39	0.44	0.47	0.54	0.58	0.60
L0 G-market share (%)	71.76	65.91	56.99	58.95	54.64	48.91	50.46	48.21	50.41
T0 diagnostic agents	G-0.62	0.62	0.60	0.70	0.59	0.65	0.61	0.65	0.65
	О-0.05	0.06	0.09	0.11	0.09	0.08	0.06	0.07	0.06
T0 G-market share (%)	92.54	91.18	86.96	86.42	86.76	89.04	91.04	90.28	91.55
H0 systemic hormones	G-3.59	3.95	3.91	3.80	3.17	3.31	3.73	4.09	4.19
	О-0.50	0.50	0.85	0.94	1.03	0.81	0.89	0.97	1.08
H0 G-market share (%)	87.78	88.76	82.14	80.17	75.48	80.34	80.74	80.83	79.51
S0 sensory organs	G-1.59	1.76	1.92	1.79	1.77	1.84	1.87	2.07	2.14
	О-1.18	1.28	1.49	1.60	1.74	1.89	2.12	2.29	2.35
S0 G-market share (%)	57.40	57.89	56.30	52.80	50.43	49.33	46.87	47.48	47.66
V0 various	G-0.85	0.92	1.14	1.19	0.98	0.98	0.96	0.96	1.01
	О-0.04	0.05	0.05	0.05	0.04	0.03	0.01	0.01	0.01
V0 G-market share (%)	95.51	94.85	95.80	95.97	96.08	97.03	98.97	98.97	99.02
P0 parasitology	G-0.12	0.12	0.12	0.10	0.09	0.08	0.08	0.08	0.09
	О-0.08	0.06	0.09	0.09	0.09	0.10	0.09	0.10	0.10
P0 G-market share (%)	60.00	66.67	57.14	52.63	50.00	44.44	47.06	44.44	47.37

*IMS data (personal communication, 2015; unreferenced).**G, generics; ***O, originals.

Figure 2. Dynamics of generics market share by ATC groups, 2006–2014.

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