Analysis o medicinal p oduc sho ages
in Bulga ian hospi al se ings in 2023:
add essing p ocedu es and unme needs
Pe ya Milushewa1, Joanna Alexand o a1, Guenka Pe o a1
1 Depa men o O ganiza ion and Economics o Pha macy, Facul y o Pha macy, Medical Uni e si y o So ia, So ia, Bulga ia
Co esponding au ho :
Pe ya Milushewa (Pe ya.mil[email p o ec ed])
Recei ed
13 Oc obe 2025♦
Accep ed
28 Oc obe 2025♦
Published
18 No embe 2025
Ci a ion:
Milushewa P, Alexand o a J, Pe o a G (2025) Analysis o medicinal p oduc sho ages in Bulga ian hospi al se ings in
2023: add essing p ocedu es and unme needs. Pha macia 72: 1–8. h ps://doi.o g/10.3897/pha macia.72.e174755
Abs ac
Objec i e: This s udy aims o examine he na ional landscape o medicine sho ages in Bulga ia, wi h an emphasis on he supply and
p ocu emen o medicines eques ed by hospi al acili ies due o hei absence om he domes ic ma ke .
Ma e ials and me hods: A mixed-me hod app oach was employed, combining egula o y and eal-wo ld da a analysis. Eu opean
and na ional legisla ion go e ning he supply o una ailable medicines in Bulga ia, including he Medicinal P oduc s in Human
Medicine Ac and O dinance No. 10, we e e iewed. Da a on una ailable medicinal p oduc s impo ed in o Bulga ia in 2023 we e
ob ained om he Bulga ian D ug Agency. These da a we e ca ego ized in o he apeu ic classes, dosage o ms, and egula o y pa h-
ways, wi h addi ional analysis o p ice egula ion and Wo ld Heal h O ganiza ion Essen ial Medicines Lis s a us.
Resul s: In 2023, Bulga ia impo ed 165 INNs ha we e una ailable h ough he s anda d supply chain and eimbu semen sys em
due o hei absence om he local ma ke . O hese, 35% we e p ocu ed unde he egula o y amewo k es ablished by A icle
266a o he Medicinal P oduc s in Human Medicine Ac . These impo s comp ised 1,996 deli e ies o hospi al acili ies na ionwide.
The analysis iden i ied signi ican sho ages in key he apeu ic a eas, including oncology, ca dio ascula ca e, and c i ical ca e. The
impo ed p oduc s we e p edominan ly opioid analgesics, an icoagulan s, an icance medica ions, and diagnos ic ools. No ably, se -
e al o hese medicines a e lis ed in he Wo ld Heal h O ganiza ion Essen ial Medicines Lis , unde sco ing hei c i ical impo ance
in add essing unme heal hca e needs.
Conclusion: Medicine sho ages in Bulga ia p esen subs an ial challenges o heal hca e deli e y, u he complica ed by complex
egula o y, economic, and ma ke dynamics. Legisla i e mechanisms could no ensu e he a ailabili y o some essen ial medicines.
This s udy highligh s he need o comp ehensi e na ional s a egies o add ess sho ages e ec i ely, d awing on bes p ac ices om
o he Eu opean Union Membe S a es. Fu u e esea ch should ocus on expanding he assessmen o sho ages o enhance heal hca e
esilience and ensu e con inuous access o essen ial ea men s.
Keywo ds
comme cial ac o s, d ug sho ages, impo s, pa ien access o una o dable medicines
Copy igh Milushewa P e al. This is an open access a icle dis ibu ed unde he e ms o he C ea i e Commons A ibu ion Li-
cense (CC-BY 4.0), which pe mi s un es ic ed use, dis ibu ion, and ep oduc ion in any medium, p o ided he o iginal au ho and
sou ce a e c edi ed.
Pha macia 72: 1–8
DOI 10.3897/pha macia.72.e174755
Resea ch A icle
Milushewa P e al.: Medicine sho ages in Bulga ian hospi als: egula o y and ma ke gaps2
In oduc ion
Acco ding o he EU’s pha maceu ical amewo k (Eu-
opean Commission 2020; Eu opean Medicines Agency
2025), medicine sho ages ha e eme ged as a signi ican
challenge o heal hca e sys ems ac oss Eu ope, wi h im-
plica ions o pa ien ca e, public heal h, and pha maceu-
ical supply chains. These sho ages – de ined as he in-
abili y o mee he demand o medicines wi hin a gi en
ime ame – a ec a wide ange o he apeu ic a eas and
a e becoming inc easingly p e alen (Shuka e al. 2021;
A onson e al. 2023). The unde lying causes a e complex
and mul i ac o ial, encompassing dis up ions in manu-
ac u ing p ocesses, egula o y issues, economic ac o s,
and ma ke dynamics. In pa icula , he Eu opean con ex
p esen s unique challenges due o he di e se egula o y
amewo ks, economic policies, and ma ke s uc u es
ac oss Membe S a es.
To suppo he d ug selec ion p ocess a he na ional
le el, he Wo ld Heal h O ganiza ion de eloped he Es-
sen ial Medicines Lis (WHO EML), which plays a c ucial
ole in add essing sho ages by iden i ying he mos es-
sen ial medicines ha should always be a ailable as pa
o a unc ioning heal h sys em. This lis se es as a global
s anda d o medicine selec ion, guiding na ional policies
and p omo ing equi able access o ea men s. I is in end-
ed o ensu e ha key medicines ac oss all majo he a-
peu ic a eas a e accessible o all popula ions, suppo ing
e idence-based and a ional p esc ibing by heal hca e
p o essionals (Wo ld Heal h O ganiza ion 2025). How-
e e , ensu ing he a ailabili y o all hese medicines in
small and medium-sized Eu opean ma ke s appea s chal-
lenging. Comme cial conside a ions, such as he need o
manu ac u e s o p oduce small amoun s o coun y-spe-
ci ic packaging and lea le s, lead o diseconomies o scale
in small ma ke s, u he dec easing he appeal o ma ke -
ing p oduc s in hese coun ies.
The e a e addi ional si ua ions whe e medicines e-
main inaccessible o pa ien s wi hou being classi ied as
sho ages. Pha maceu ical companies may choose no
o launch a medicinal p oduc in ce ain coun ies i he
ma ke is pe cei ed as insu icien ly a ac i e – pa icu-
la ly due o limi ed pu chasing capaci y, as highligh ed in
a ecen EU-le el analysis (Eu opean Commission 2021).
Na ional p icing and eimbu semen policies, he o ga-
niza ion o heal h sys ems, and na ional adminis a i e
p ocedu es ela ed o heal h echnology assessmen could
also con ibu e o limi ed access o medicines and may e-
sul in medicine sho ages (Vogle 2022; Miljko ić e al.
2023). Ano he de ining aspec o medicine sho ages is
he discon inua ion o supply o a d ug ha has al eady
been in oduced o he ma ke . This can occu o a ious
easons, including shi s in ma ke demand, manu ac u -
ing issues, egula o y changes, o p ice e osion. Such dis-
con inua ions signi ican ly impac pa ien ca e and high-
ligh he complexi ies o main aining a s able d ug supply
chain (WHO Regional O ice o Eu ope 2023). Vogle and
Fische (2020) no ed ha , o o e come medicine sho ag-
es, some measu es ha e been in oduced – mos ly a he
na ional le el – and ha he e is a need o c oss-coun y
collabo a ion a he Eu opean le el o add ess he issue
sus ainably. No ably, excep o Sweden and he Uni ed
Kingdom, all Eu opean coun ies wi h egula ed p ic-
ing sys ems employ ex e nal p ice e e encing, a leas as
a supplemen a y p icing s a egy. A ecen s udy by he
Eu opean Pa liamen ’s Science and Technology Op ions
Assessmen Panel con i med ha he esponsibili y o
p icing and eimbu semen decisions es s wi h indi idu-
al Membe S a es, esul ing in a complex landscape whe e
pha maceu ical manu ac u e s make s a egic choices ha
can in luence pa ien ou comes. Delayed o absen p od-
uc launches in ce ain coun ies signi ican ly a ec access
o medicines, especially in smalle ma ke s and lowe -in-
come egions (Eu opean Pa liamen 2023).
To add ess hese challenges, he Eu opean Commis-
sion adop ed a se o pha maceu ical legisla i e e o ms
in 2023. These e o ms encompass se e al aspec s, includ-
ing a p oposed educ ion in he baseline da a p o ec ion
pe iod cu en ly g an ed o pha maceu ical inno a o s
wi hin he Eu opean Union, as ou lined in he legisla i e
oadmap and s akeholde analyses (EFPIA 2023; Eu ope-
an Commission 2025). Howe e , he new ules o e ma -
ke ing au ho iza ion holde s a no able ad an age: a 2-yea
ex ension o da a p o ec ion i he inno a o launches he
p oduc in all Membe S a es ( e e ed o as he “launch
condi ion”). This p o ision di ec ly a ec s inno a i e
p oduc s; ne e heless, sho ages and he inadequa e
a ailabili y o essen ial medicines emain signi ican chal-
lenges. The Eu opean Medicines Agency has unde aken
e o s o add ess medicine sho ages, including he es-
ablishmen o a c i ical sho ages lis moni o ed a he
EU le el. This lis p o ides de ailed in o ma ion on on-
going and esol ed sho ages o bo h human and e e -
ina y medicines. Howe e , he managemen o sho ages
o medicinal p oduc s ha a e no cen ally au ho ized
emains p ima ily he esponsibili y o na ional compe-
en au ho i ies – pa icula ly when such sho ages lack
c oss-bo de implica ions, as e lec ed in he EMA sho -
ages da abase (Eu opean Medicines Agency 2025).
In Bulga ia, medicinal p oduc s wi hin he s anda d
supply chain and included in he eimbu semen sys em
a e moni o ed h ough a na ional mechanism – he Spe-
cialized Elec onic Sys em o T acking and Analysis o
Medicinal P oduc s lis ed in he Posi i e Medicines Lis
– ia he na ional acking sys em (Minis y o Heal h o
Bulga ia 2025). Howe e , medicinal p oduc s ha a e ex-
cluded om he eimbu semen sys em o a e included
solely wi h a egis e ed p ice a e no acked wi hin his
sys em. These p oduc s a e ypically eques ed by hos-
pi al acili ies unde al e na i e egula o y mechanisms.
This dis inc ion p esen s an oppo uni y o an in-dep h
e iew, as i highligh s an impo an ye unde explo ed as-
pec o medicinal p oduc accessibili y and supply.
This s udy ocuses on medicinal p oduc s ha a e un-
a ailable on he Bulga ian ma ke no due o quali y o
supply chain issues, bu because o comme cial ac o s
such as he absence o a ma ke launch o he pe cei ed
una ac i eness o he local ma ke . In his wo k, he
Pha macia 72: 1–8 3
supply o una o dable o inaccessible- o-pa ien s medic-
inal p oduc s in Bulga ia is analyzed due o i s signi ican
ole in add essing unme medical needs and public heal h
challenges. Bea ing in mind ha heal hca e se ices a e a
na ional p io i y, we i s analyzed na ional legisla ion e-
ga ding he supply o medicines ha a e ei he una ailable
o ou side he scope o he eimbu semen sys em and hen
sea ched o in o ma ion on he impo o such p oduc s.
Ma e ials and me hods
A mixed-me hod app oach was employed, combining
egula o y and eal-wo ld da a analysis. Fi s , he ele-
an Eu opean and na ional legisla ion on he supply o
medicines ha we e no a ailable on he Bulga ian ma ke
was analyzed. Th ough his analysis, Regula ion (EC) No.
726/2004 o he Eu opean Pa liamen and o he Council,
he Medicinal P oduc s in Human Medicine Ac , and O -
dinance No. 10 o he Minis y o Heal h we e iden i ied.
These egula o y ac s es ablish p ocedu es o p oduc s
ha a e ypically no accessible h ough s anda d p esc ib-
ing and dispensing p ocesses due o ei he lack o au ho i-
za ion, absence o p oduc launch, o ma ke wi hd awal.
A comp ehensi e lis o medicinal p oduc s ha we e
una ailable on he Bulga ian ma ke ye eques ed by hos-
pi al ca e es ablishmen s in 2023 was ob ained om he
Bulga ian D ug Agency unde he Access o Public In-
o ma ion Ac . The da a we e sys ema ically analyzed and
ca ego ized in o se e al g oups. Key indings we e isually
ep esen ed and a e discussed in de ail in his a icle.
Resul s
Eu opean and Bulga ian legisla ion
The p ima y legisla ion egula ing medicinal p oduc s in
Bulga ia is he Medicinal P oduc s in Human Medicine
Ac . This Ac e e s o A icle 83 o Regula ion (EC) No.
726/2004 o he Eu opean Pa liamen and o he Council,
which go e ns he use o unau ho ized medicinal p od-
uc s in Compassiona e Use P og ams (CUPs). A icle
266a o he Ac speci ies ha , in cases whe e no al e na i e
ea men is a ailable o a pa icula disease in Bulga -
ia, a medicinal p oduc au ho ized o use in a Eu opean
Union Membe S a e may be adminis e ed o an indi idu-
al pa ien . Al hough au ho ized unde his law, such p od-
uc s a e no dis ibu ed on he Bulga ian ma ke . In line
wi h A icle 266a, a lis o medicinal p oduc s app o ed
o he ea men o Bulga ian ci izens who lack adequa e
he apeu ic op ions domes ically is es ablished. When
a medicinal p oduc is included unde A icle 266a, i is
p ocu ed h ough a special o de by a medical ins i u ion
o hospi al ca e.
The speci ic egula ions o ini ia ing ea men wi h
una ailable medicinal p oduc s ou side he eimbu se-
men sys em a e ou lined in O dinance No. 10 o 17 No-
embe 2011, which es ablishes he condi ions and p o-
cedu es o he use o medicinal p oduc s no au ho ized
in he Republic o Bulga ia. Acco ding o O dinance No.
10, h ee pa hways o accessing medicinal p oduc s wi h-
ou ma ke ing au ho iza ion can be iden i ied. The i s
in ol es he ea men o a g oup o pa ien s wi h a me-
dicinal p oduc o compassiona e use, as de ined in A -
icle 83 o Regula ion (EC) No. 726/2004 o he Eu opean
Pa liamen and o he Council. The second conce ns he
ea men o speci ic pa ien s wi h medicinal p oduc s
ha a e ei he unau ho ized o use in he Republic o Bul-
ga ia o una ailable wi hin he coun y due o he absence
o a ma ke launch o discon inua ion o supply. These
p oduc s a e supplied h ough a special o de om a hos-
pi al ca e acili y. Hospi al ca e acili ies submi p oposals
o he Minis e o Heal h o he inclusion o hese medic-
inal p oduc s in he lis unde A icle 266a, based on he
needs o he pa ien s hey a e ea ing. The hi d pa hway
conce ns he use o a medicinal p oduc ha is au ho ized
in he coun y bu adminis e ed ou side he pa ame e s o
i s au ho iza ion. In all cases, medicinal p oduc s ha a e
no au ho ized o use may be p esc ibed by a commi ee
o h ee physicians om he ele an hospi al ca e acili y,
wi h a leas one membe holding a ecognized special-
y in he disease p o ile. Addi ionally, a pha macis and
a lawye pa icipa e in he commi ee’s delibe a ions. The
commi ee p epa es a p o ocol ha mus be app o ed by
he Bulga ian D ug Agency (BDA). The BDA is espon-
sible o e iewing hese p o ocols o ensu e compliance
wi h legal equi emen s and o no i ying he dis ibu o s
esponsible o deli e ing he medicinal p oduc s.
Impo o una ailable and una o dable
medicines
In 2023, a o al o 165 INNs co esponding o una ailable
medicinal p oduc s we e supplied in Bulga ia. O hese,
58 (35%) we e go e ned by A icle 266a o he Medicinal
P oduc s in Human Medicine Ac , while he emaining
107 (65%) we e no dis ibu ed wi hin he coun y, as
illus a ed in Fig. 1. These INNs we e impo ed h ough
1,996 deli e ies o hospi al acili ies.
Figu e 1. Legisla i e ca ego ies o impo ed una ailable medic-
inal p oduc s.
Milushewa P e al.: Medicine sho ages in Bulga ian hospi als: egula o y and ma ke gaps4
Fu he analysis was conduc ed on he INNs by using
he publicly accessible websi e o he Na ional Council
on P ices and Reimbu semen (NCPR) in Bulga ia. This
analysis ocused on de e mining he a ailabili y o eg-
is e ed p ices o he impo ed medicinal p oduc s. The
indings indica e ha 29 o he INNs a e lis ed ei he in
he annexes o he Posi i e D ug Lis , which includes all
medicinal p oduc s eimbu sed h ough public unds, o
in he Regis e o ceiling p ices, which lies ou side he e-
imbu semen sys em. Con e sely, many o he INNs (n =
136) lack a na ionally egis e ed p ice and a e no p esen
on he na ional ma ke (Fig. 2).
An analysis o he pha macological ca ego ies o d ug
sho ages (Fig. 3) e eals ha opioid analgesics we e he
mos equen ly eques ed, wi h a o al o 334 deli e ies.
This high olume sugges s a signi ican demand o pain
managemen he apies in Bulga ia, likely due o limi ed o
una ailable al e na i es wi hin he coun y. O he com-
monly eques ed p oduc s include an icoagulan s (206
deli e ies), an icance d ugs (198), diagnos ic ools (127),
and neu omuscula blocke s (112). These indings high-
ligh ha he p ima y d i e s o una ailable medicinal
p oduc impo s in Bulga ia a e he unme needs in pain
managemen , ca dio ascula ca e, cance ea men , and
diagnos ic se ices. The subs an ial numbe o deli e ies
in hese ca ego ies unde sco es po en ial gaps in he a ail-
abili y o app o ed pha maceu ical op ions in he na ional
heal hca e sys em.
The quan i ies o medicinal p oduc s a e epo ed based
on hei espec i e dosage o ms, such as ampoules, ials,
and packs. Howe e , he p ecise quan i ies o ac i e ing e-
dien s o each INN could no be accu a ely de e mined
due o a ia ions in packaging and he numbe o dosage
uni s wi hin each p oduc . Fo example, a single pack may
con ain 5, 10, o 20 uni s, depending on he manu ac u e
o p oduc speci ica ions. To ensu e consis ency, he quan-
i ies we e ca ego ized by dosage o m as eco ded in he
a ailable da a. While e o s we e made o apply s anda d-
ized de ini ions o dosage o ms, no assump ions we e
made ega ding he speci ic uni con en o packs due o
inconsis encies in he supplied in o ma ion.
The analysis u he highligh ed dispa i ies in he e-
po ed sho ages ac oss INNs (Table 1). Fen anyl exhib-
i ed he highes eco ded quan i y a 426, 449, poin ing
o a no able supply issue o his essen ial medica ion.
Phy omenadione also demons a ed conside able usage,
wi h 144, 343 uni s epo ed in 2023. The quan i y o em-
desi i (2, 112) indica es ongoing challenges, po en ially
associa ed wi h i s ole in COVID-19 ea men e o s,
unde sco ing he con inued e ec s o he pandemic on
d ug a ailabili y.
Ten o he medicines cu en ly una ailable h ough he
s anda d dis ibu ion pa hway in Bulga ia a e included in
he WHO EML, emphasizing he se e i y o hese sho -
ages. These medicines a e i al o key he apeu ic a eas,
including oncology (e.g., inc is ine, melphalan, daca -
bazine), ca dio ascula ea men (e.g., adenosine, p o a-
Figu e 2. P ice egula ion s a us o impo ed medicinal p oduc s.
Figu e 3. Numbe o deli e ies pe pha macological class o impo ed una ailable medicinal p oduc s in 2023.
Opioid
analgesics
An i-
coagulan
An icance
d ugs
Diagnos ic
ools
Neu o-
muscula
blocke
Immuno-
globulins
D ugs
a ec ing
bone
s uc u e
and
mine al-
iza ion
An i-
epilep ics
An ido e
o benzo-
diazepene
oxici y
Seda i es
To al o de s 334 206 198 127 112 87 82 32 30 30
0
50
100
150
200
250
300
350
400
Pha macia 72: 1–8 5
Table 1. Mos common d ug sho ages in Bulga ia by INNs.
INN Dosage o m Quan i y To al deli e ed
quan i y
Pa o
WHO EML
Fen anyl Vials 2400 426,449 Yes
Packs 1829
Ampoules 422,220
Phy omenadione Ampoules 142,380 144,343 Yes
Packs 1763
Vials 200
A acu ium Ampoules 33,770 34,710 Yes
Packs 940
Rocu onium
b omide
Packs 170 32,400 No
Ampoules 28,230
Vials 4000
P o amine Ampoules 22,560 23,663 Yes
Packs 603
Vials 500
Ta amidis Capsules 7280 7280 No
Pe luo obu ane Packs 1300 6930 No
Ampoules 1310
Vials 4320
Dexmede omidine Ampoules 5470 5937 No
Packs 467
Vinc is ine Packs 346 5476 Yes
Ampoules 5130
Mil inone Packs 117 5288 No
Vials 56
Ampoules 5115
Sodium chlo ide Ampoules 3800 5203 Yes
In usion Bank 1000
Vials 300
Packs 103
Immunoglobulins
no mal human
o in a ascula
adminis a ion
Packs 553 4713 No
Vials 4160
Ciclospo ine Ampoules 4680 4680 Yes
Daca bazine Vials 2970 3170 Yes
Packs 200
Su en anyl Ampoules 3050 3050 No
Remdesi i Packs 750 2112 No
Vials 1362
Ca dioplegia
solu ions
Bo les 1470 1770 No
Bags 300
Melphalan Ampoules 50 1338 Yes
Vials 260
Packs 1028
Adenosine Ampoules 1026 1163 No
Packs 137
Fluo escein Ampoules 1030 1131 Yes
Packs 101
Table 2. Top 10 deli e ies o hospi al acili ies.
Ca ego y Hospi al acili y Numbe o deli e ies
Pedia ic hospi al Specialized Hospi al o Ac i e T ea men o Pedia ic Diseases – P o . D . I an Mi e , EAD, So ia. 253
Eme gency hospi al Uni e si y Mul ip o ile Hospi al o Ac i e T ea men and Eme gency Medicine ‘Nikolai I ano ich Pi ogo ,’ So ia 53
P i a e hospi al Acibadem Ci y Clinic Tokuda Hospi al, So ia 56
Ca diology hospi al Mul ip o ile Hospi al o Ac i e T ea men “Na ional Ca diology Hospi al,” So ia 27
Uni e si y hospi als (So ia) Uni e si y Mul ip o ile Hospi al o Ac i e T ea men ‘S e i I an Rilski,’ So ia 74
Uni e si y Mul idisciplina y Hospi al o Ac i e T ea men ‘Aleksand o ska,’ So ia 61
Uni e si y Mul i-P o ile Hospi al o Ac i e T ea men ‘Tsa ina Ioanna – ISUL,’ So ia 28
Uni e si y hospi al (Plo di ) Uni e si y Mul ip o ile Hospi al o Ac i e T ea men ‘S e i Geo gi,’ Plo di 170
Uni e si y hospi al (Va na) Uni e si y Mul ip o ile Hospi al o Ac i e T ea men ‘S e a Ma ina,’ Va na 41
mine), c i ical ca e (e.g., a acu ium, sodium chlo ide), and
suppo i e he apies such as i amin K (phy omenadione).
The speci ic INNs we e c oss- e e enced wi h he EMA
sho ages ca alogue o he pe iod om Janua y 2023 o
Decembe 2023, co esponding o he ime ame o he
analyzed da a. No ably, none o he INNs iden i ied as un-
a ailable a he na ional le el we e lis ed in he Eu opean
egis e o sho ages du ing his pe iod.
A no able pa e n in he dis ibu ion o una ailable me-
dicinal p oduc s ac oss Bulga ia was ound (Table 2). The
highes numbe o deli e ies was eco ded a he Special-
ized Hospi al o Ac i e T ea men o Pedia ic Diseases –
P o . D . I an Mi e in So ia, wi h a o al o 253 deli e ies.
This subs an ial olume indica es a signi ican ocus on
mee ing pedia ic heal hca e needs in he capi al, sugges -
ing a p io i iza ion o esou ces owa d pedia ic ca e.
Addi ionally, he p esence o exclusi ely uni e si y-a -
ilia ed hospi als among he op en ecipien s o hese
deli e ies highligh s he cen aliza ion o such essen ial
esou ces wi hin uni e si y hospi al se ings. These in-
s i u ions se e as key heal hca e hubs, e lec ing hei
i al ole in p o iding specialized ca e. This dis ibu ion
pa e n no only emphasizes he impo ance o uni e si y
hospi als in he na ional heal hca e sys em bu also sug-
ges s ha hese cen e s play a pi o al ole in he logis ics
o dis ibu ing high-demand medica ions.
Discussion
In his wo k, we sough o iden i y egula o y and supply
issues ela ed o medicine sho ages wi hin he Bulga ian
ma ke . We iden i ied one Eu opean and h ee na ional
egula o y p ocedu es go e ning he supply o una ailable
medicines. We also ound ha some o he mos essen ial
medicines a e absen om he na ional ma ke , mos like-
ly due o inancial easons om he pe spec i e o ma ke -
ing au ho iza ion holde s.
Medicine sho ages in Bulga ia signi ican ly a ec
a ious classes o medica ions, e lec ing a b oade issue
o access inequi y ac oss EU Membe S a es, pa icula -
ly ega ding well-es ablished medicines. The cen alized
access p ocedu e se es as a s eamlined mechanism o
he apid au ho iza ion o medicines a he Eu opean
le el. Howe e , ollowing au ho iza ion, pha maceu ical
companies e ain he disc e ion o de e mine he ma ke s
wi hin he EU whe e hey will dis ibu e hei p oduc s.
T adi ionally, nego ia ions be ween heal h au ho i ies
and pha maceu ical companies ha e aken place on an
indi idual basis, as obse ed in se e al Eu opean p icing
s a egies (Wenzl and Chapman 2019). Pha maceu ical
companies o en p io i ize en y in o la ge ma ke s i s ,
p ima ily because he legisla i e amewo ks and heal h
insu ance sys ems in hese egions a e mo e likely o
p o ide eimbu semen o new medicines – pa icula -
ly unde e ol ing ma ke condi ions (Leopold n.d.). This
app oach, while unde s andable om a business pe spec-
i e, pe pe ua es dispa i ies in d ug a ailabili y, pa icu-
Milushewa P e al.: Medicine sho ages in Bulga ian hospi als: egula o y and ma ke gaps6
la ly a ec ing smalle ma ke s wi hin he EU. Signi ican
a iabili y emains, wi h la ge , mo e economically obus
ma ke s ypically expe iencing sho e launch delays due
o a o able eimbu semen policies and ma ke sizes ha
a e mo e a ac i e o pha maceu ical companies. Coun-
ies wi h highe GDPs end o expe ience sho e launch
delays, sugges ing ha economic s eng h is a key ac o in
accele a ing d ug a ailabili y and highligh ing dispa i ies
in ma ke access (Büssgen and S a ga d 2022). In cases
whe e au ho ized ea men s a e una ailable, insu icien ,
o do no mee speci ic pa ien equi emen s, access o
hese medicinal p oduc s can o e li e-sa ing o essen ial
he apeu ic al e na i es. This issue is pa icula ly ele an
in Bulga ia, whe e he heal hca e sys em may ely on hese
mechanisms o ensu e pa ien s ecei e imely and e ec-
i e ea men s ha a e o he wise inaccessible.
Ou analysis highligh s ha among he p e alen d ug
sho ages in Bulga ia o 2023, only wo medicines – a-
amidis and emdesi i – can be classi ied as inno a i e.
Ta amidis is ecognized o i s no el app oach o ea ing
ans hy e in-media ed amyloidosis, while emdesi i was
epu posed o COVID-19 ea men a e ini ial de elop-
men o Ebola, ma king signi ican ad ancemen s in he -
apeu ic op ions. No ably, bo h medicines we e included in
Bulga ia’s Posi i e D ug Lis (PDL) a he end o 2024 and
will become pa o he coun y’s s anda d supply chain.
Con e sely, mos o he medicines expe iencing sho ag-
es, including well-es ablished ones such as en anyl, phy-
omenadione, sodium chlo ide, a acu ium, ocu onium
b omide, and dexmede omidine, a e in eg al o a ious
medical p ocedu es bu do no quali y as inno a i e.
These sho ages o en s em om economic disincen i es,
as lowe p o i ma gins discou age manu ac u e s om
p io i izing p oduc ion o less p o i able ma ke s such as
Bulga ia – pa icula ly in esou ce-cons ained se ings
(Néme h e al. 2022). Fu he mo e, logis ical complexi ies
and p icing s a egies compound hese issues, dis up ing
he supply chain o basic ye c i ical compounds such as
sodium chlo ide, as well as mo e complex o mula ions
like no mal human immunoglobulins o in a ascula
adminis a ion. The dispa i ies in d ug a ailabili y a e
u he in luenced by he EU’s p icing and eimbu semen
policies, which may ende ce ain d ugs such as ciclospo-
ine and daca bazine unp o i able in egula ed ma ke s,
p omp ing supplie s o ocus on mo e luc a i e egions.
In he con ex o newe o o phan d ugs such as emde-
si i and a amidis, limi ed manu ac u ing capaci ies and
s a egic ma ke p io i iza ion based on es ablished eim-
bu semen amewo ks can in ensi y hese challenges, un-
de sco ing he mul i ace ed na u e o d ug sho ages ha
a ec bo h inno a i e and non-inno a i e d ug ca ego-
ies. This si ua ion calls o a mul i ace ed s a egy encom-
passing imp o ed egula o y amewo ks, incen i es o
manu ac u ing less p o i able medicines, and enhanced
logis ical solu ions o ensu e equi able d ug dis ibu ion
ac oss all ma ke s.
Bulga ia, like many Eas e n Eu opean coun ies, allo-
ca es a ela i ely small pe cen age o i s GDP o heal hca e,
which may con ibu e o i s limi ed comme cial a ac-
i eness as a pha maceu ical ma ke (Eu opean Obse -
a o y on Heal h Sys ems and Policies and O ganisa ion
o Economic Co-ope a ion and De elopmen 2023). Be-
yond ex e nal ac o s such as manu ac u ing and quali y
issues, comme cial conside a ions and policy se ings also
likely play signi ican oles in exace ba ing d ug sho -
ages. While na ional legisla ion includes mechanisms o
ensu e Bulga ian pa ien s’ access o essen ial medicines,
hese medicines a e no consis en ly in eg a ed in o he
s anda d supply chain, as e lec ed in ecen s akeholde
policy ecommenda ions (EFPIA 2024). Wi hou eliable
p edic ions o hospi al demand, quan i ies lis ed unde
A icle 266a may be insu icien . The ac ha 50% o he
op 20 impo ed medicinal p oduc s in 2023 a e included
in he WHO EML highligh s he need o na ional-le el
mi iga ion s a egies o add ess hese sho ages e ec i ely.
Va ious s a egies exis ac oss Eu opean coun ies o
add ess he issue o sho ages, including egula o y ini-
ia i es such as special pe mi s, language exemp ions,
mul i-s akeholde collabo a ions, and medicine supply
ese es (Medicines o Eu ope 2024). The e is a p essing
need o a na ional s a egic plan in Bulga ia o add ess
hese challenges e ec i ely, d awing upon bes p ac ices
obse ed in o he EU coun ies.
The limi a ions o he cu en s udy s em om i s o-
cus on e iewing una ailable medicines impo ed in o
hospi al se ings h ough legisla i e mechanisms a he
han conduc ing a comp ehensi e analysis o sho ages a
he na ional le el, mainly due o a lack o such in o ma-
ion. Addi ionally, ano he limi a ion is he s udy’s na ow
ime ame, which spans only one yea .
Conclusion
Medicine sho ages in Bulga ia a e add essed h ough
legisla i e mechanisms ha acili a e access o essen ial
medicines no eadily a ailable domes ically. Howe e ,
he e ec i eness o hese measu es depends on imp o -
ing demand o ecas ing and in eg a ing hese medicines
in o s anda d supply chains. This s udy demons a es
he signi ican eliance on impo ed medicinal p oduc s
in Bulga ia, many o which a e essen ial medicines lis ed
in he WHO EML. These indings highligh he p essing
need o a ge ed na ional s a egies o add ess sho ag-
es e ec i ely. Fu u e esea ch should expand o include a
comp ehensi e assessmen o medicine sho ages a he
na ional le el. Such analysis will p o ide deepe insigh s
in o b oade implica ions and help e ine s a egies aimed
a s eng hening heal hca e esilience agains ongoing
challenges in medicine a ailabili y.
Addi ional in o ma ion
Con lic o in e es
The au ho s ha e decla ed ha no compe ing in e es s exis .
Pha macia 72: 1–8 7
E hical s a emen s
The au ho s decla ed ha no clinical ials we e used in he p es-
en s udy.
The au ho s decla ed ha no expe imen s on humans o hu-
man issues we e pe o med o he p esen s udy.
The au ho s decla ed ha no in o med consen was ob ained
om he humans, dono s o dono s’ ep esen a i es pa icipa -
ing in he s udy.
The au ho s decla ed ha no expe imen s on animals we e
pe o med o he p esen s udy.
The au ho s decla ed ha no comme cially a ailable immo -
alised human and animal cell lines we e used in he p esen s udy.
Use o AI
No use o AI was epo ed.
Funding
This s udy was inanced by he Eu opean Union – Nex Gene -
a ionEU, h ough he Na ional Reco e y and Resilience Plan o
he Republic o Bulga ia, p ojec № BG-RRP-2.004-0004-C01.
Au ho con ibu ions
P.M. conduc ed he egula o y analysis, analyzed cu en ends
in d ug sho ages, in e p e ed he esul s om he medicinal
p oduc deli e ies da a, c ea ed he ables and ollowed up wi h
a ho ough discussion. J.A. ex ac ed he esul s om he me-
dicinal p oduc deli e ies da a and c ea ed he co esponding
igu es. G.P. e iewed he manusc ip , p o ided eedback and
sugges ed imp o emen s, which we e inco po a ed. All au ho s
ha e ead and app o ed he inal manusc ip .
Au ho ORCIDs
Pe ya Milushewa h ps://o cid.o g/0000-0002-6606-5048
Au ho Name h ps://o cid.o g/0000-0001-8116-5138
Da a a ailabili y
All o he da a ha suppo he indings o his s udy a e a ailable
in he main ex .
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