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D E B A T E Open Access
Addressing the impact of economic
sanctions on Iranian drug shortages in the
joint comprehensive plan of action:
promoting access to medicines and health
diplomacy
Sogol Setayesh
1
and Tim K. Mackey
2,3,4*
Abstract
Background: The U.S Congress initiated sanctions against Iran after the 1979 U.S. Embassy hostage crisis in Tehran,
and since then the scope of multilateral sanctions imposed by the United States, the European Union, and the
United Nations Security Council have progressively expanded throughout the intervening years. Though primarily
targeted at Iran’s nuclear proliferation activities, sanctions have nevertheless resulted in negative public health
outcomes for ordinary Iranian citizens. This includes creating vital domestic shortages to life-saving medicines,
leaving an estimated 6 million Iranian patients with limited treatment access for a host of diseases. Sanctions have
also crippled Iran’s domestic pharmaceutical industry, leading to the disruption of generic medicines production
and forcing the country to import medicines and raw materials that are of lower or questionable quality.
Discussion: Countries such as the United States have responded to this medical crisis by implementing export
control exemptions with the aim of easing the trade of humanitarian goods (including certain pharmaceuticals and
medical devices). However, despite these efforts, pharmaceutical firms and international banking institutions remain
cautious about doing business with Iran, leaving the country faced with continuing shortages. We conducted a
review of key characteristics of the Iranian drug shortage that identified 73 shortage drugs that closely tracked with
the disease burden in the country. Additionally, 44 % of these drugs were also classified as essential medicines by
the World Health Organization. A vast majority of these drugs were also covered under export control exemptions
that theoretically should make them easier to procure, but nevertheless will still in shortage.
Summary: Based on our review of the sanctions regulatory framework and key characteristics of the Iranian drug
shortage, we propose policy intervention leveraging the recently negotiated P5 + 1 agreement that begins the
process of providing Iran relief from the international economic sanctions regime. This specifically includes
advocating for the application of “health diplomacy”in ongoing multilateral negotiations following commencement
of “implementation day,”by advocating for an additional set of reform measures incorporated into this historic
negotiation that will finally address the humanitarian and medical crisis of drug shortages in Iran.
Keywords: Iran, Economic sanctions, Medical shortage, Humanitarian crisis, Health diplomacy, Human rights
* Correspondence: tmackey@ucsd.edu
2
Department of Anesthesiology, University of California, San Diego School of
Medicine, San Diego, CA, USA
3
Department of Medicine, Division of Global Public Health, University of
California, San Diego School of Medicine, San Diego, CA, USA
Full list of author information is available at the end of the article
© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Setayesh and Mackey Globalization and Health (2016) 12:31
DOI 10.1186/s12992-016-0168-6
Background
On October 18, 2015, the United States approved a set
of conditional sanction waivers for the Islamic Republic
of Iran following agreement on the historic Joint
Comprehensive Plan of Action (JCPOA) reached by the
P5 + 1 (comprised of the five permanent members of the
UN Security Council and Germany) in July 2015 [1]. On
January 16, 2016, this agreement reached a critical mile-
stone, with the International Atomic Agency (IAEA)
certifying that Iran had successfully complied with a set
of JCPOA nuclear dismantlement requirements, trigger-
ing commencement of “Implementation Day.”
Importantly, “Implementation Day”marks a critical
first step towards the lifting of a host of multilateral
nuclear-related sanctions imposed by the United States,
the European Union (EU), the United Nations Security
Council, and other countries, that had been increasing
in scope and have crippled the Iranian economy for
more than three decades. Compliance to the terms of
the JCOPA represents a possible end to Iran’s nuclear
weapons ambitions and also marks the beginning of a
period of transition that will reintegrate Iran back into
the global economy [1, 2]. However, overlooked in this
landmark development in foreign policy and diplomacy
is an unresolved public health crisis directly related to
economic sanctions: an ongoing critical domestic medi-
cines shortage in Iran.
Although the primary intentions of the historically im-
posed Iranian sanction regime were to limit economic
development, international trade, and scientific and mili-
tary assistance, sanctions have also directly contributed
to creating critical medicine shortages within the coun-
try that persist to this day [3]. This is despite the fact
that revisions have been made to export controls by the
United States (U.S.) Office of Foreign Assets Control
(OFAC) in an attempt to better facilitate humanitarian
trade [4]. Despite these efforts, Iran continues to face
ongoing challenges to importing life-saving medicines,
supplies, and medical raw materials from the United
States and EU [4, 5]. This has resulted in an estimated 6
million Iranian patients who lack access to essential
treatment needed to address highly prevalent commu-
nicable and non-communicable diseases (NCDs) within
the country [6]. The once self-sufficient domestic
pharmaceutical industry has also had its production of
generic drugs severely disrupted, a situation that has
introduced risks to patients, including the detection of
substandard and counterfeit medicines [7, 8].
In response, this debate piece conducts a review of the
history, regulatory export policies, public health impacts,
and identifies key characteristics associated with the
Iranian medicines shortage. We first examine the history
of Iranian sanctions and how it has influenced trade
and financial regulatory responses that have directly
contributed to the medicines shortage. We then assess
the public health impact of the economic sanctions
regime by identifying and characterizing the types of
drugs currently in shortage. Finally, the article con-
cludes with a policy proposal designed to take advan-
tage of the historic JCPOA agreement specifically
advocating for the application of the concept of “health
diplomacy.”This would be accomplished by introdu-
cing a set of policy interventions that could be included
in ongoing implementation of the JCPOA aimed at
ensuring the protection of health and human rights of
the Iranian people by promoting equitable and safe
access to medicines.
Breif history of the Iranian economic sanctions
regime
The decades-long comprehensive unilateral and multi-
lateral Iranian economic sanctions regime led by the
United States, the European Union, the UN Security
Council, and several other countries, has historically
focused on resolving the nuclear impasse between Iran
and the West. The origin of U.S.-led sanctions against
Iran dates as far back as 1967, when Iran acceded to the
Non-Proliferation Treaty (NPT) and later in 1974 to the
IAEA Safeguards Agreement, both of which required
non-nuclear weapon states to agree to international
norms of nonproliferation, peaceful uses of nuclear en-
ergy, disarmament, and consent to IAEA inspections [3].
During intervening years, domestic political upheaval
followed, and Iran was accused of restarting its nuclear
program in violation of its treaty obligations, which led
to a series of economic sanctions [3]. This included
sanctions imposed by the U.S. government, which passed
legislation and issued executive orders that have crippled
Iran’s economy, oil exports, and also weakened its public
health system [9, 10] (see Fig. 1 for timeline).
The first of a series of U.S. sanctions were imposed in
1979, when then U.S. President Jimmy Carter ordered a
freezing of Iranian assets in response to U.S. diplomats
being held hostage at the U.S. Embassy in Tehran, a
turning point in U.S.–Iranian relations [3]. Additional
sanctions were imposed in 1984 when Iran was desig-
nated a state sponsor of terrorism, in the wake of Hez-
bollah’s bombing of a marine base in Beirut, leading to
an embargo of Iranian crude oil imports followed by
sanctions on all Iranian goods [3]. Western powers im-
posed further unilateral sanctions from 1996–2006,
starting with the United States’enactment of the Iran
Sanctions Act (ISA) that prohibited investment of over
$20 million per annum by foreign companies in Iran’s
energy sector. From 2006–2010, sanctions were also
pursued multilaterally, with the UN Security Council
adopting several resolutions in response to international
Setayesh and Mackey Globalization and Health (2016) 12:31 Page 2 of 14
concerns about Iran’s nuclear weapons ambitions and its
continued operation of its nuclear program [3, 10].
In 2010, the United States enacted a set of new sanc-
tions as part of the Comprehensive Iran Sanctions,
Accountability, and Divestment Act (CISADA) that tar-
geted energy-sector activities, including insurance and
shipping companies involved with Iranian imports and
exports [11]. From 2011–2012, the U.S. Congress also
voted in favor of a series of new and unprecedented
sanctions against Iran’s financial sector, specifically its
Central Bank, which barred companies and countries
from doing business with Iranian financial institutions,
implemented as part of the specifications in the National
Defense Authorization Act and the Iran Threat Reduc-
tion and Syria Human Rights Act [11, 12].
These financial sanctions were aimed at blocking Iran’s
access to the global banking system and the Society for
Worldwide Interbank Financial Telecommunication
(SWIFT), which serves 212 countries and provides se-
cure message exchange services for over 10,000 banking
organizations [13]. Discontinuing Iran’s SWIFT access
meant all transactions became both expensive and
lengthy [4]. These sanctions also placed certain Iranian
banks on the OFAC’s Specially Designated Nationals List
(SDN List), which identifies individuals and entities
prohibited from accessing the U.S. financial system [14].
Eventually, these banking sanctions would expand to over
16 Iranian banks and the Islamic Revolutionary Guard, all
entities heavily involved in the Iranian economy [15].
In addition to economic sanctions imposed by the
United States, the European Union has utilized a series
of regulations and sanctions that have arguably had a
greater negative impact on Iran’s economy given the
large volume of shared trade and economic activity
shared between the regions [16]. Council of the European
Union sanctions that came into effect in July 2010
targeted specific Iranian companies, froze assets, and
suspended economic activity, with a primary focus on sec-
tors of energy, insurance, transport, finance, and aviation.
These sanctions went beyond implementation of UN-
mandated sanctions, instead imposing what has been
termed as a set of “comprehensive restrictive measures”
that have played a key role in damaging Iran’s economy
and disrupting key trade activities, including medicines
procurement [16].
The economic impact of sanctions on Iran
Crucially, the impact of collective sanctions imposed by
the US, the EU, and other countries, has made exporting
and importing to and from Iran extremely challenging,
primarily due to potential trading partners’inability to
transfer money to Iran in foreign currency and vice
versa. This forces the Iranian government and domestic
companies to either accept the trading partner’s national
Fig. 1 History of Iran sanctions
Setayesh and Mackey Globalization and Health (2016) 12:31 Page 3 of 14
currency or to barter for other goods [4, 17, 18]. Ac-
cordingly, many companies have ceased doing business
with the Iran all together, fearing reprisal for sanction
violations.
For example, several leading international financial in-
stitutions, including Swiss financial firm Credit Suisse
and London-based Standard Chartered Bank, incurred
hundreds of millions of dollars in fines for sanctions
violations for trading with Iran [5]. In December 2012,
the U.K.’s Standard Chartered Bank paid a $327 million
penalty to the U.S. Department of the Treasury because
it had conducted 60,000 transactions in the interest of
Iranian financial institutions [19]. Other institutions also
have been the subject of Iranian sanction violation in-
vestigations, including the Royal Bank of Scotland, Uni-
Credit, HSBC, Deutsche Boerse, Société Générale, and
Crédit Agricole [20].
International sanctions have also contributed to a
compromised and declining Iranian economy, though
other factors such as economic mismanagement, corrup-
tion, and trepidation by investors due to political in-
stability and potential military conflict have also taken
their toll [16]. For example, Iran’s GDP shrank by 9 %
and its overall economy is 15 to 20 % smaller since the
latest round of sanctions in 2012 [2]. Since 2010, the
Iranian currency has destabilized and lost two thirds of
its value against the U.S. dollar, marked by an inflation
rate of 40–50 % in 2013 [15, 21]. Iran has also lost $160
billion in oil revenue, and more than $100 billion in
Iranian assets were frozen in foreign financial institu-
tions [2]. This significant drop in energy-related revenue
is pivotal because the national economy is so highly
dependent on the oil industry as part of its export econ-
omy, which under the sanctions regime has been heavily
embargoed [15, 22].
Successive waves of sanctions have also led to a dra-
matic increase in the cost of doing business in Iran. Cir-
cumventing sanctions to carry out customary business
and trading activities costs Iranian companies millions
of dollars because businesses must find alternative ways
to transfer money and ship goods [23]. To address the
inherent risk of doing business with Iran, some foreign
banks charge fees as high as 5 % to transfer money in
and out of the country and, in some cases, Iranian busi-
nesses have to pay middlemen to produce documents
that show an origin or destination other than Iran [24].
Most importantly, sanctions have also had a substan-
tial and negative impact on Iran’s public health programs
and institutions [25, 26]. According to the World Bank,
per capita health expenditures in Iran were last reported
(in 2013) at US $432; conversely per-capita health ex-
penditures before the latest round of sanction (in 2012)
were reported as US $485. The negative trend illustrates a
potential direct relationship between loss of oil revenues
and corresponding declines in the country’sabilityto
invest in national health expenditures. Declines in
health expenditures act to exacerbate critical medicine
shortages, as economic sanctions make it extremely
difficult to obtain medicines, medical supplies and
medical devices from abroad and also inhibit the ability
to finance the cost of procurement.
Legal and regulatory framework impacting
medicine access
Although ratcheting up of Iranian economic sanctions has
intensified due to geopolitical factors and nuclear diplo-
macy, the need to ease trade of humanitarian goods, in-
cluding certain medical products, has not gone unnoticed.
Prior to October 2012, under the U.S. Trade Sanctions Re-
form and Export Enhancement Act of 2000 (TSRA), ex-
porters were required to apply for a specific license issued
by OFAC (which enforces economic and trade sanctions
for the U.S.) to export pharmaceuticals and medical de-
vices to Iran [27]. Stringent requirements for export licen-
sure made it administratively difficult to export medical
products, because each product required a specific classifi-
cation determination by the Bureau of Industry and Secur-
ity (BIS) under Export Administration Regulations (EAR)
[28].
In October 2012, OFAC published new provisions that
amended most of the Iranian Transactions Regulations.
The renamed Iranian Transactions and Sanctions
Regulations (ITSR) clarified the CISADA provisions and
further tightened sanctions by blocking the property of
Iran’s government and financial institutions [29]. How-
ever, in these revisions, OFAC also recognized the
humanitarian challenges associated with sanctions and
revised the regulations with the aim of easing export of
certain pharmaceuticals and medical devices. This
resulted in OFAC adding a general license category (i.e.,
EAR99) that specifically authorized export or re-export
of most medicines and medical supplies by allowing
items that previously required a specific TSRA license to
be exported under a general license that is easier for ex-
porters to obtain [29]. Hence, currently pharmaceutical
products are grouped into two different categories:
“EAR99”(easier to export as they fall under a “general
license”) and “Non-EAR99”(harder to export as add-
itional export controls are required for an export license)
drugs (see Table 1).
Subsequently, in July 2013, OFAC significantly ex-
panded its list of basic medical supplies and issued a set
of clarifying guidelines for the sale of medicine and
medical devices [30]. These new exportation guidelines
exempted transactions for medical export payments by
foreign banks that hold Iranian oil revenues, which were
previously prohibited under the Iranian financial sanc-
tions regulations. Changes from the ITSR technically
Setayesh and Mackey Globalization and Health (2016) 12:31 Page 4 of 14
had the effect of authorizing the humanitarian sale of a
specific subset of medical products to Iran by a U.S.
person or companies. The intent of the revised OFAC
guidance was to provide regulatory clarity and facilitate
trade in humanitarian goods, including for U.S. entities.
However, not all medicines qualify under OFAC’s2013
revised guidelines. The TSRA defines the terms “medi-
cine”and “medical devices”by the definitions of “drug”
and “device”in section 201 of the Federal Food, Drug,
and Cosmetic Act (FFDCA) (21 U.S.C. 321) [27]. These
definitions include prescription and over-the-counter
medicines and medical devices, most of which are classi-
fied as EAR99 and hence should be easier to export.
However, certain vaccines, biological and chemical prod-
ucts, and medical devices (including medical supplies,
instruments, equipment, equipped ambulances, institu-
tional washing machines for sterilization, and vehicles
carrying medical testing equipment) are specifically
classified as Non-EAR99, and therefore are more diffi-
cult or cannot be exported to Iran [27].
The rationale for controlling Non-EAR99–classified
drugs is to ensure that transferring certain chemicals,
pathogens, toxins, dual-use chemicals, and biological fa-
cilities and equipment does not contribute to Chemical
and Biological Warfare proliferation. Vaccines, for in-
stance, are integral to public health and are a legitimate
and essential pharmaceutical commodity, but may also
be used to illegitimately produce a biological weapon,
agent, or toxin [28]. Similar concerns have also arisen in
the Syrian conflict, where chlorine has been used as a
chemical weapon against civilians, while also represent-
ing a key commodity in water purification, sanitation,
and medicines manufacture [31].
Impact of sanctions on medicines access in Iran
Public health impact
Although the revised and current Iranian sanctions regime
does not specifically prohibit the export of humanitarian
goods and pharmaceuticals, many of the administrative
and regulatory processes have made it difficult to export
life-saving medicines to Iran. This includes the need to
navigate a complex export control regulatory process,
the inability of Iranian banks to do business with the
international banking system and U.S. corporations,
currency shortages, and the inability to secure terms
of shipping, insurance and other services needed to
facilitate medicines trade [4]. As a result, millions of
Iranians that suffer from life-threatening diseases have
experienced “exorbitant prices”, stock outs of medi-
cines, and are often forced to purchase drugs from
the black market [8].
In Iran, the right to health care and public health
services is a constitutional right and is implemented
through a network of public providers, the private sector,
and NGOs active in health [32]. Iran’s healthcare system
is primarily driven by an insurance-based system and
has undergone a number of reforms over the last
30 years focusing on expanding primary care coverage
(including for rural populations,) the integration of health
services and medical education, and improving services
in hospital settings [33, 34]. With the second largest
population in the Middle East and North Africa, Iran’s
growing dual burden of communicable and non-
communicable diseases in Iran creates urgency of en-
suring access to medicines and illustrates how acute
drug shortages disproportionately affect different pa-
tient groups in various ways [35].
As an example, HIV/AIDS cases in Iran are rapidly
increasing - UNICEF’s 2013 statistics indicate there are a
total of 71,000 Iranian HIV/AIDS patients - representing
a critical need to ensure adequate access to antiretroviral
drugs [36]. Diseases that require expensive and advanced
therapeutics to manage chronic or degenerative condi-
tions are also increasingly being diagnosed (e.g., 37,000
Iranian patients suffer from multiple sclerosis.) [37]
NCDs are also on the rise with 85,000 patients diag-
nosed with cancer every year, a phenomenon character-
ized as a “cancer tsunami”[38, 39]. All of these patients
require uninterrupted, sustainable, and safe access to
essential drugs.
Consequentially, patients struggling with cancer, mul-
tiple sclerosis, blood disorders, and other serious condi-
tions are some of the most negatively impacted by drug
scarcities [40, 41]. Medications needed to treat these
complicated diseases manufactured by multinational
pharmaceutical companies such as Pfizer Inc. (U.S,),
GlaxoSmithKline plc (U.K,), and Bayer AG (Germany),
are especially hard to find in Iranian pharmacies [42].
Table 1 EAR99 classified drugs vs. non-EAR99 classified drugs
EAR99 Non-EAR99
(Easier to export) (Harder to export)
General export license Specific export license
Not identified on commerce
control list
Identified on commerce control list
No export control classification
number
Export control classification number
Most medicines, including
over-the-counter items, are
considered EAR99
Non-NSAID analgesics, cholinergics,
anticholinergics, opiods, narcotics,
benzodiazipine and and bioactive
peptide, vaccines, “immunotoxins”
(antibody–toxin conjugates intended
to destroy specific target cells such
as tumor cells that bear antigens
homologous to the antibody), certain
toxin-containing medical products and
diagnostics, food testing kits, certain
medical devices and medical devices
parts controlled under export control
classification number
Setayesh and Mackey Globalization and Health (2016) 12:31 Page 5 of 14
Patented medicines originating from these largely U.S.
and European producers are hard to substitute, resulting
in a lack of availability of drugs that treat specific
diseases for which an alternative form of treatment or
generic equivalent is not available from foreign suppliers
[43]. Most crucially, the complicated and lengthy export
approval process and difficulties in trading in Iranian
currency have introduced significant disincentives for
pharmaceutical companies seeking to supply drugs to
Iran. As an example, a $60 million order from an
American pharmaceutical company for an anti-rejection
transplant drug failed to reach Iran because no bank
would facilitate the transaction [44].
Severe medication shortages in Iran are diverse and
span several therapeutic classes and disease states. This
includes drug shortages for other critical areas of
healthcare delivery, including organ transplant drugs,
and even vaccine shortages [4, 41]. Other examples in-
clude patients suffering from epilepsy who have devel-
oped poor drug adherence due to high drug prices and
lack of availability [45]. Patients with blood disorders,
including over 7000 hemophilic patients and 8000
thalassemia patients in Iran, are also adversely impacted
and have developed certain disabilities because antihe-
mophilia drugs and antibleeding agents are in such
short supply [46, 47].
Individual patient cases evidencing the human toll of
sanctions have also emerged in media reports [48]. One
such case involved a 15-year-old boy, Manouchehr
Esmaili, who suffered from hemophilia and died of
excessive bleeding because his family failed to find the
necessary drugs to save his life [49]. Another example
includes the routine child vaccine that protects against
the bacterium haemophilus influenzae, which causes
severe pneumonia and meningitis in infants, in critically
short supply in Iran [5]. Additionally, patients waiting
years to receive a liver transplant had unsuccessful
outcomes due to the inaccessibility of anti-rejection
medications—yet another of many illustrations of Iran’s
inability to import critical medical supplies.
Medicines manufacturing and supply challenges
The multilateral sanction regime in place prior to the
JCOPA effectively cut off Iran’s financial institutions from
the rest of the global banking system, and thus negatively
affected almost every segment of Iran’s economy, includ-
ing the health sector [4]. As a result, medication prices
increased 30 to 40 % as a result of dollar–currency fluctu-
ations, making vital medications unaffordable even if
they are available to purchase on the local market [3].
Individuals who could afford to pay for expensive drugs
often stockpiled medications in fear of future drug scarci-
ties, with such practices often resulting in expiry and waste
of medications despite nationwide shortages [41]. Hence,
the dual specter of drug shortages and price disruptions
due to sanctions has fomented a complex medicines-access
dilemma that directly impacts patients’ability to treat
and maintain therapy for their health conditions [50].
The negative impact of sanctions blocking financial
transactions in the Iranian public sector has also crip-
pled the struggling domestic pharmaceutical industry. A
study by the Woodrow Wilson Center estimated that
pharmaceutical products importation has decreased
30 % under the round of economic sanctions prior to
JCOPA and the export of pharmaceuticals to Iran from
the United States was reduced by half from $31.1 million
in 2011 to $14.5 million in 2013 [3–5]. Media outlets
have reported that Iranian drug companies and im-
porters encounter numerous challenges while trying to
stay profitable and keep their production and distribu-
tion channels open [44, 48]. Due to financial-sector and
banking sanctions that were in place, many Iranian
pharmaceutical companies managed their purchases
through foreign banks; reportedly only one bank in
Turkey was conducting pharmaceutical transactions with
Iran because most financial institutions are concerned
about potential sanction violations [44].
More than 85 pharmaceutical manufacturers and 20
API manufacturers exist in Iran, although compounding
pharmacies started closing in 2014 as a result of short-
ages [38]. Iran’s national pharmaceutical industry has
always played a major role in producing local generic
drugs [51]. Domestic manufacturers produced 96 % of
generic medicines and relied on imported raw materials
and APIs to compound more complex drugs available in
Western countries [52]. Despite domestic production,
imported medicines nevertheless accounted for approxi-
mately 40 % of the total domestic market value in 2012
[38]. Due to increased sanctions, Iranian producers
experienced significant disruptions in imported APIs
and finished products that forced them to import these
products from Indian and Chinese firms [4]. As a result,
high-quality medicines reportedly have been replaced
with inferior-quality substitution drugs, which presents
unknown quality or patient safety issues [4, 53].
Inaccessibility of vital medications and their raw in-
gredients combined with Iran’s weakening domestic
pharmaceutical industry has also resulted in an influx of
counterfeit, fraudulent, and substandard medicines into
Iran’s health care system. An unregulated black market
has developed as a byproduct of drug shortages, introdu-
cing medications whose origins and authenticity are often
unknown, and has led to expired medications’distribution
and sale, even at potentially very high prices [8]. Hence,
the global counterfeit medicines trade, recognized as a
serious public health concern, is one that is currently
being enabled as a consequence of drug shortages and
ongoing Iranian economic sanctions [54, 55].
Setayesh and Mackey Globalization and Health (2016) 12:31 Page 6 of 14
Key characteristics of Iran’s drug shortage
To better understand the scope and magnitude of
economic sanctions on the ongoing medicine shortage
crisis in Iran, we also examined multiple data sources to
identify key characteristics of medicines currently being
reported in short supply or unavailable. This was
completed by reviewing secondary data sources in both
English and Farsi including information in the peer-
reviewed literature, technical reports by foundations and
non-governmental organizations (NGOs), and informa-
tion from official Iranian health-related government
websites (see more detail regarding the methodology and
sources in Fig. 2). Based on these data sources, we
compiled a list of drugs identified as in shortage and also
characterized: (1) the primary therapeutic indication of
the drug; (2) whether the drug was an essential medicine
(as determined by the World Health Organizations’most
recent 19th Essential Medicines List, updated April 2015);
and (3) whether they would be classified as EAR99 or
Non-EAR99. A final list of Iranian shortage drugs and
their characteristics is provided in Table 2.
Based on this review, we identified 73 drugs reported
as subject to shortage in Iran (referred to further as
“shortage drugs”). After examining the therapeutic
classifications of shortage drugs, it was determined that
89 % (n= 65) were for medications used to treat NCDs,
Fig. 2 Methodology for drug shortage review
Setayesh and Mackey Globalization and Health (2016) 12:31 Page 7 of 14
Table 2 List of current medications in shortage in Iran
Disease treated Drug name (INN/Brand name) EAR status WHO EML
status
Non-EAR
99
EAR
99
Diabetes Glucagon Glucagon/GlucaGen Y N Y
Insulin injection Insulin/ Novofine Y N Y
Glocophage Metformin/Fortamet Y N Y
Anticancer chemotherapy Cytarabine Cytarabine/Cytosat Y N Y
Lomustine Lomustine/Gleostine Y N N
Doxorubicin Doxorubicin/Adriamycin Y N Y
Flurouracil Flurouracil/Adrucil Y N Y
MabThera Rituximab Y N Y
Chlorambucil Chlorambucil/Leukeran Y N N
Xeloda Capecitabine/Xeloda Y N Y
Flutamide Flutamide/Eulexin no equivalency in U.S. Y N N
Diphereline Active ingrediate: Triptorelin embonate Y N N
Tykerb Lapatinib/Tykerb Y N N
Leukeran Chlorambucil/Leukeran Y N Y
Erbitux Cetuximab/Erbitux Y N N
Nexavar Sorafenib/NexAVAR Y N N
Thalidomide Thalidomide/Thalomid Y N N
Zometa Zoledronic acid/Reclast Y N N
Microrelin decapeptyl Triptoreln/Microrelin Decapeptyl Y N Y
Infliximab Infliximab/Remicade Y N N
Anti-asthmatic and chronic
obstructive pulmonary disease
Symbicort Budesonide and Formoterol/Symbicort Y N Y
Salmeterol Salmeterol/Serevent diskus Y N N
Aminophyline Aminophylline/Phyllocontin Y N N
Seroflo Ingredients are Fluticasone and Salmeterol in
Peru and Hong Kong
YNN
Atrovent Ipratropium inhalation/ Atrovent HFA Y N Y
Zaditen ZyrTEC itchy eye Y N N
Seretide Advair in U.S. Fluticasone and
salmeterol/Advair Diskus
YNN
Cardiovascular medicine Furosemide Furosemide/Lasix Y N Y
Amiodarone Amiodarone/Cordarone Y N Y
Flecainide Flecaidide/Tambocor Y N N
Lisinopril Lisinopril/prinivil Y N N
Sotahexal (available in Poland) Sotalol/Betapace Y N N
Multiple sclerosis (M.S.) Ziferon Manufactured in Iran Interferon beta-1b/ziferon Y N N
Extavia Interferon beta-1b/ Betaseron Y N N
Betaferon Active substance interferon beta-1b Y N N
CinnoVex Active substance interferon beta-1b
(manufactured in Iran)
YNN
Avonex Interferon beta-1b/Avonex Y N N
Setayesh and Mackey Globalization and Health (2016) 12:31 Page 8 of 14
and the remaining 11 % (n= 8) addressed infectious
diseases. Of the 65 shortage drugs treating NCDs, 44 %
(n= 32) were used to treat the four most prevalent NCDs
in the Iranian population (based on WHO data,) including
cancer (23 %, n= 17), respiratory disease (10 %, n=7),
cardiovascular disease (7 %, n= 5), and diabetes (4 %,
n= 3). The remaining 45 % (n= 33) of shortage medi-
cations were used to treat a variety of other NCDs
Table 2 List of current medications in shortage in Iran (Continued)
Radiocontrast media Iopromide Iopromide/Ultravist Y N N
Iodixanol Iodixanol/Vasipaque Y N N
Scanlux Active ingredient in iopamidol, available in
Greece, Spain, Switzerland, Bulgaria, Italy,
Hungary and Tunisia
YNN
Omnipaque Omnipaque 180, 240, 300 /iohexol Y N Y
Antidote/
haemoglobinopathies
Deferoxamine Deferoxamine/Desferal Y N Y
Tegretol CR Carbamazepine/Carbatrol Y N Y
Sodium valproate Sodium valproate Y N Y
Depakin Active substance: valproic acid sodium
available in Italy and Turkey
YNY
Orlept Active substance: Valporic Sodium
Available in U.K.
YNY
Exjade Deferasirox/Exjade Y N Y
Antiviral Ganciclovir Ganciclovir/Cytovene Y N N
Tenofovir Tenofovir/viread Y N Y
Antidepressant Asentra Available in listed countries:
Latvia, Poland, and Serbia
Active ingredient sertraline Y N N
Doneurin available in Germany Doxepin Y N N
Doxepin Doxepin/SINEquan Y N N
Sertraline Sertraline/Zoloft Y N N
Infertility treatment Human Chorionic Gonadotropin
(HCG)
HCG/Novarel Y N N
Cetrorelix Cetrorelix/Cetrotide Y N N
Pregnancy termination Misoprostol Misoprostol/Cytotec Y N Y
Antiparkinsonism medication Madopar available in U.K. Levodopa and Benserazide Y N N
Levodopa Levodopa/Larodopa Y N Y
Antibacterial Medication/
Antibiotics
Azithromycin Azithromycin/ Z-pack, Zmax Y N Y
Klacid available in Australia Klacid/Clarithromycin Y N Y
Antimalarial Pyrimethamine Pyrimethamine/Daraprim Y N N
Transplant CellCept Mycophenolate mofetil/ CellCept Y N N
Anticoagulant Warfarin Warfarin/Coumadin Y N Y
Vaccines Influenza vaccine Influenza virus vaccine/ Afluria N Y Y
BCG (Bacillus Calmette-Guerin) BCG/TheraCys N Y Y
Gardasil Human Papillomavirus Vaccine (HPV)/
Gardasil
NYY
ADHD treatment Ritalin Methylphenidate/Concerta Y N N
Alzheimer’s disease Galantamine Galantamine/Razadyne Y N N
Reminyl Reminyl/galantamine hydrobromide Y N N
Prevention of endometrial
hyperplasia
Progesterone Progesterone/Prometrium Y N N
Cyctogest Cyclogest 200/progestron Y N N
Antiepileptic/Anticonvulsant Tegretol CR Carbamazepine/Carbatrol Y N Y
Sodium valproate Sodium valproate Y N Y
Setayesh and Mackey Globalization and Health (2016) 12:31 Page 9 of 14
including hemophilia, Parkinson’s disease, Alzheimer’s
disease, multiple sclerosis, fertility issues, various mental
health issues (antidepressants), Attention Deficit Hyper-
activity Disorder, and transplant drugs. The eight identi-
fied shortage drugs that were used to treat infectious
diseases included treatments for malaria, tuberculosis,
and HPV.
To assess whether shortage drugs represented therap-
ies needed to treat conditions and diseases with a high
disease burden in Iran, we compared the therapeutic
classification of identified shortage drugs to data con-
tained in WHO’s non-communicable disease country
profiles [56]. According to data available from 2014,
the leading cause of death for Iran’spopulationof76
million people (395,000 reported deaths) was NCDs,
which accounted for 76 % of all patient mortality.
The mortality breakdown for NCDs in Iran comprised
of: cardiovascular disease (46 %), cancers (13 %),
other NCDs (11 %), and chronic respiratory disease and
diabetes (both 2 % respectively). In comparison, commu-
nicable, maternal, perinatal and nutritional conditions
comprised a total of 10 % of mortality [56].
When comparing the aforementioned shortage drug
rankings to WHO mortality data based on therapeutic
class, we noticed similar distributions. Among therapeutic
drugs, other NCDs ranked first among the shortages,
specifically medications used to treat multiple sclerosis,
Alzheimer’s, Parkinson’s disease, hemophilia, thalassemia,
and depression. Cancer medications ranked second,
infectious-disease medications ranked third, respiratory
disease medications ranked fourth, cardiovascular medica-
tions ranked fifth, and diabetes medications ranked sixth.
A similar pattern was observed in the WHO mortality rate
chart: the major leading causes of death were cardiovascu-
lar disease, ranked first and road accidents and injuries
ranked second (the only significant deviation.) Cancer was
the third leading cause of death in Iran, followed by other
NCDs which ranked fourth, infectious diseases ranked
fifth, and respiratory disease and diabetes ranked sixth
(See Ranking Comparison, Fig. 3). These comparisons
indicate that the ranking of shortage drugs in Iran
tracks reasonably well with the overall disease burden
(specifically disease-related mortality) of the Iranian
population.
We then cross-referenced shortage drugs with infor-
mation from the WHO Essential Medicines List (19th
Edition), which yielded identification of a subset of 32
shortage drugs (44 %) that are also categorized by the
WHO as essential medicines. The EML is a critical in-
strument that informs medicines’selection in national
formularies and is also an effective tool in assessing if a
given population has access to essential medicines,
which is a fundamental right generally recognized in
international health and human rights law [57]. This
finding indicates that close to half of all drugs subject to
shortage in Iran are necessary and crucial to ensure a
functioning public health system. Finally, we assessed
EAR classifications and found that 70 shortage drugs
(96 %) were EAR99–classified, fall under the general
OFAC license, and should in theory be easier to export
when compared to non-EAR99 drugs. Conversely, we
identified only three shortage drugs (4 %) as non-EAR99–
classified drugs that are harder to export because they
require greater effort to secure export clearance under the
current OFAC regulations.
Discussion
Based on our examination of the history of the multilat-
eral economic sanctions regime against Iran, current
regulatory requirements for exporting medicines to Iran,
and the characteristics of drugs currently in shortage, it
is clear that the public health consequences of economic
sanctions have not been appropriately addressed to en-
sure equitable and safe access to essential medicines.
This is despite the fact that Iranian sanctions have
historically been characterized as “smart”and “targeted,”
and argued as primarily aimed at the Iranian govern-
ment and its leaders as a diplomatic tactic to curb
nuclear proliferation activities, not intended to harm the
civilian population. However, the reality of the situation
for most ordinary Iranians is that ongoing medicine
shortages are denying access to needed treatment for
debilitating and often life-threatening diseases. This
brings into question whether economic sanctions are
violating internationally-agreed upon principles of the
human right to health and whether, in the context of
their expansive nature and impact far beyond nuclear
proliferation activities, they have a sufficient legal basis
under international law [26, 58].
Additionally, our review of current acute medicine
shortages in Iran also indicates there is a possible “three-
pronged effect”that directly negatively impacts public
health outcomes in Iran. First, the therapeutic character-
istics of shortage drugs generally align with disease-
related mortality in the country, inferring that shortages
may be exacerbating the country’s overall disease bur-
den. The human toll of these shortages is undeniable,
given multiple reports of vulnerable Iranian patients suf-
fering from lack of treatment and poor health outcomes,
including children, women, the elderly, and patients with
advanced diseases [4, 59]. Second, almost half of the
drugs in short supply are deemed “essential”by the
WHO, indicating that Iran’s health system lacks suffi-
cient access to drugs that are the minimum of what is
required to ensure a functioning health system. Third,
96 % of the drugs in shortfall are EAR99–classified med-
icines that technically should be easier to export to Iran
but nevertheless remain in critical shortage despite
Setayesh and Mackey Globalization and Health (2016) 12:31 Page 10 of 14
regulatory changes to facilitate humanitarian trade in
U.S. export regulations. This signals that OFAC’s
revisions and recent efforts to ease sanctions for hu-
manitarian reasons may not be effective in addressing
the underlying factors that restrict trade in medicines:
primarily the complexity of the export licensing regime
and financial restrictions on the operational banking
system that continue to create significant disincentives
for companies seeking to supply life-saving medications
to Iran [4].
Given these findings and the limitations of current
policy and regulatory approaches, it is clear that add-
itional health advocacy and diplomacy are needed to ad-
dress this acute and underserved public health crisis.
Herein lies the opportunity to leverage the historical op-
portunity presented by the 2015 international negoti-
ation of the JCPOA, by inserting this critical public
health issue into ongoing discussions of implementing
the various stages of the agreement. This should include
advocating for the tangible application of “global health
diplomacy”, generally defined as diplomatic activities
that prioritize global health issues in the foreign policy
context, in order to ensure that ongoing multilateral ne-
gotiations do not neglect the public health and humani-
tarian needs of Iranians to gain access to life-saving and
essential medicines [60]. Specifically, the historic JCPOA
agreement can serve as a facilitating mechanism to inte-
grate public health objectives into foreign policy through
applied health diplomacy by directly incorporating
health and humanitarian conditions into the construc-
tion and implementation of the agreement moving for-
ward. As currently constructed, the JCPOA does not
contain any specific mechanisms that ensure greater ac-
cess to life-saving drugs or measures to ensure that
sanctions do not continue to harm the health of the
Iranian people, but does contain provisions that can be
built upon for this goal.
Specifically, following commencement of “Implemen-
tation Day”, OFAC issued an updated guidance docu-
ment that outlines the U.S. Government’s commitment
and steps taken towards lifting nuclear-related sanctions
on non-US persons and companies in several sectors in-
cluding the banking, finance, energy, trade, transport,
raw materials, and energy industries consistent with the
terms of the JCPOA [61]. This included removing over
400 individuals from the SDN List and other sanctioned
lists of persons (which will also allow these entities to re-
connect to the global banking system via SWIFT) and
gave Iran access to an estimated $60 billion in foreign
exchange reserves that were previously frozen [61].
However, though the guidance supersedes several pro-
visions of U.S. sanction legislation and Executive Orders,
it leaves in place the broader U.S. domestic trade em-
bargo on Iran and generally continues to prohibit U.S.
entities from engaging in transactions or dealings with
Iran unless these activities are specifically exempt or
authorized by OFAC regulations [61]. The EU has also
followed suit, although has more broadly lifted economic
Fig. 3 Shortage drug ranking and mortality ranking* (*excluding road accidents and injury)
Setayesh and Mackey Globalization and Health (2016) 12:31 Page 11 of 14
and financial sanctions in connection with the Iranian
nuclear program, including allowing economic and trade
activity directly for EU persons and entities for the
finance, banking, insurance, energy, transport, and other
sectors [62].
Though the JCOPA represents a critical pathway
forward paving the way for Iran’s reintegration in to the
global economy, international businesses may continue
to take a cautious approach. This is largely due to the
fact that U.S. banks remain prohibited from engaging in
direct transactions with Iran, limiting the country’s ac-
cess to US dollar-denominated transactions, a condition
that will continue to disincentivize medicines procure-
ment from U.S. pharmaceutical companies [63]. There is
also confusion regarding how consistently sanction relief
is being applied, with 86 % of the Iranian entities on the
UK HM Treasury sanction list being removed compared
to only 68 % on the US OFAC sanctions list [64].
In addition, the terms of the JCOPA also allow
nuclear-related sanctions pre-JCOPA to “snap back”or
be reinstated in the event of Iran’s failure to comply its
international commitments. These provisions may create
an undesirable business environment for potential trad-
ing partners and foreign banks, as a “snap back”of sanc-
tions would effectively negate any investments made in
financial operations made in Iran [63]. Further, the Fi-
nancial Action Task Force, an international body for
anti-money laundering and terrorist financing rules and
regulations, recently issued a statement that it remained
“exceptionally concerned”about the Iranian banking sys-
tem, reflecting ongoing concerns about the current and
future role of Iran in the international financial system
[65]. This continued scrutiny of Iran’s finance system,
combined with the fact that the country’s banking infra-
structure is seriously outdated, may make doing business
with Iran unattractive despite recent sanctions relief
under the JCOPA [63].
Hence, to address these policy gaps that continue to
persist in the Iranian sanctions regime and the construc-
tion of the JCOPA, we recommend a set of additional
policy measures that can be built into the JCPOA’s non-
nuclear sanctions relief and phasing plan with the defini-
tive aim of alleviating the current Iranian medicines
shortage. Our recommendations focus on addressing
underlining challenges as already identified including:
establishing regulatory export harmonization; amending
the OFAC EAR99 classification system to make it easier
for U.S. companies to export medicines; exempting vac-
cine products from stringent export controls; allocating
a protected SWIFT line specifically for humanitarian
medicines trade; providing additional clarification that
Iranian oil revenues can be freely used for medicines
procurement without reservations; and exempting medi-
cine and medical commodities from “snap back”provi-
sions (see Table 3). These policy measures need to be
acted upon before the next JCPOA milestone, “Transi-
tion Day,”which is still some 8 years away.
Equally critical is ensuring that the deleterious impacts
of economic sanctions on human health as have oc-
curred due to Iran’s drug shortages are not repeated in
the future. This should include advocating for the inte-
gration of Health Impact Assessments (HIAs) that iden-
tify the health consequences of sanctions while also
ensuring proper planning, monitoring, and implementa-
tion to prevent or mitigate potential negative effects on
population health [66, 67]. This could be accomplished
Table 3 Policy proposals for improving access to medicines in JCPOA
Topic Description
Regulatory sanction
harmonization
Existing contradictions in various U.S. and European sanctions must be resolved to harmonize the process of permitting
humanitarian transactions to take place. Most importantly, the United States must make it unambiguously clear that both
U.S. and financial institutions from other countries are fully authorized to transfer funds in support of procuring and
supplying humanitarian medical goods to Iran that are not classified as “dual-use”commodities.
OFAC classification The U.S. government should revisit its OFAC classification process for non-EAR99 medications and exempt specific
products that meet critical Iranian population health needs, including those drugs, medical devices, and diagnostic
products which address diseases with high mortality rates or disease burden. Additionally, OFAC should specify medical
products that are non-EAR99–classified in lieu of listing broad categories of products.
Vaccines OFAC should specifically remove vaccine products from the Non-EAR99–classified drugs list and add them instead to
the EAR99–classified drugs list because they are crucial tools in disease prevention and public health outcomes.
SWIFT line All international partners should allocate a dedicated SWIFT line to transfer funds for medical purposes and designate
certain Iranian and foreign banks as specifically authorized to transfer funds for these medicines and medical devices.
This would be similar to proposed OFAC SWIFT line that will be dedicated for medicine and medical devices purchases
following the JCOPA.
Oil revenues Provide definitive clarification of the terms for waivers/exemptions for purchasing Iranian crude oil in a way ensures
trading partners that Iran can access to its oil revenues deposited in foreign banks and allow the currency to be used
for life-saving medicines to be purchased from U.S. and EU companies.
Exemption from
“Snap Back”provisions
Policy proposals above should be exempt from “snap back”provisions in the event of non-compliance to the terms of
the JCPOA. This will ensure reliable and ongoing access to life-saving treatments and provide trading partners and
banking institutions with confidence to invest in medicines procurement.
Setayesh and Mackey Globalization and Health (2016) 12:31 Page 12 of 14
by establishing procedures that require an HIA to be
carried out by the UN Security Council for any economic
sanctions supported by a UN resolution or enacted by
its permanent and non-permanent Security Council
members. These HIAs could be carried out independ-
ently by the WHO or other public health organizations,
and would allow for scientific evaluation to determine
if sanctions violate the health and human rights of
communities, while also focusing on improving health
outcomes through policy change that could translate
into action during diplomatic negotiations.
Conclusions
Clearly, the decades-long economic sanctions regime has
had a severe, detrimental public health impact and led to
poor health outcomes among Iranians. Although the
economic sanctions may have had their intended effect of
bringing Iran to the negotiating table and ending decades
of diplomatic impasse between Iran and the West regard-
ing nuclear proliferation, the unintended and serious public
health consequences of sanctions have yet to be addressed
sufficiently. The expansion of economic sanctions against
Iran have played a key role in creating a medication short-
age that directly impacts ordinary Iranian citizens and
arguably denies their human right to health. Further, revi-
sions to regulatory processes and actions taken under the
JCOPA do not appear to be sufficient, as ongoing concerns
about the ability to facilitate financial transactions continue
to make it difficult for Iranian health care providers and
their patients to access essential medicines. As in all other
countries, an undisrupted supply of safe and affordable
medicines originating from domestic manufacturing and
imports is vital to a functioning health system. Acknow-
ledging this fundamental need, we argue that the time is
now for a practical application of health diplomacy that
takes advantage of the historical JCPOA agreement with
the aim of finally addressing the immediate humanitarian
and public health needs of the people of Iran and what
should be their fundamental right to access safe medicines.
Acknowledgements
Authors wish to acknowledge and thank the UC San Diego Joint Masters
Program in Health Policy and Law program for their partial support of open
access fees through the MAS Capstone Research Scholarship.
Authors’contributions
We note that with respect to author contributions, Tim K. Mackey (TKM) and
Sogol Setayesh (SS) jointly conceived the study, wrote the manuscript, edited
the manuscript, and TKM supervised its legal and policy analysis. Both authors
read and approved the final manuscript.
Competing interests
The authors declare that they have no competing interests.
Author details
1
Joint Masters Degree Program in Health Policy and Law, University of
California, San Diego School of Medicine –California Western School of Law,
San Diego, CA, USA.
2
Department of Anesthesiology, University of California,
San Diego School of Medicine, San Diego, CA, USA.
3
Department of
Medicine, Division of Global Public Health, University of California, San Diego
School of Medicine, San Diego, CA, USA.
4
Global Health Policy Institute, 6256
Greenwich Dr., Room 137, San Diego, CA 92122, USA.
Received: 14 January 2016 Accepted: 13 May 2016
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