Short and Long Term Impacts of COVID-19 On The Pharmaceutical Sector
Short and Long Term Impacts of COVID-19 On The Pharmaceutical Sector
https://doi.org/10.1007/s40199-020-00358-5
SHORT COMMUNICATION
Abstract
Background The novel coronavirus disease 2019 (COVID-19) was characterized as a global pandemic by the WHO on
March 11th, 2020. This pandemic had major effects on the health market, the pharmaceutical sector, and was associated with
considerable impacts; which may appear in short and long-term time-horizon and need identification and appropriate planning to
reduce their socio-economic burden.
Objectives Current short communication study assessed pharmaceutical market crisis during the COVID-19 era; discussing
short- and long-term impacts of the pandemic on the pharmaceutical sector.
Results Short-term impacts of COVID-19 pandemic includes demand changes, regulation revisions, research and development
process changes and the shift towards tele-communication and tele-medicine. In addition, industry growth slow-down, approval
delays, moving towards self-sufficiency in pharm-production supply chain and trend changes in consumption of health-market
products along with ethical dilemma could be anticipated as long-term impacts of COVID-19 pandemic on pharmaceutical sector
in both global and local levels.
Conclusion The pandemic of COVID-19 poses considerable crisis on the health markets, including the pharmaceutical sector;
and identification of these effects, may guide policy-makers towards more evidence-informed planning to overcome accompa-
nying challenges.
Keywords COVID-19 . Corona virus . Pharmaceutical industry . Pharmaceutical market . Health market . Tele-health .
SARS-CoV-2
developing country that was extremely affected by COVID-19              Short-term impacts Demand change, supply shortages, panic
disease could be a good example for demonstration.                      buying and stocking, regulation changes and shift of commu-
    To the best of our knowledge, this is the first to identify these   nication and promotions to remote interactions through tech-
challenges in the context of a developing country with a                nology and research and development (R&D) process changes
pharmerging market. Iran, as a developing middle-income                 can be seen as short-term impacts of COVID-19 on the health
country, has a generic-based pharmerging market [3]; which              market.
is regulated under local national drug policy (NDP), last up-
dated on 2014. The main components of Iran’s NDP are                    1. Demand change, which leads to shortage, in the case of
generic-based medicine policy, promotion of local production,              induced demand and panic-buying of oral home-
price control and formulation-based national industry [4]. Iran            medications especially for chronic disease may be due to
ministry of health (MOH) supported local production aiming to              the pandemic (COVID-19-related), and also shortages
improve availability and affordability of medicines; which are             due to supply-chain inconsistencies.
resulted in improved access to the quality medicines in Iran [5].
Although more than 95% (in terms of sale volume) of marketed                &   COVID-19-related: Increased hospitalization, inci-
pharmaceuticals in Iran are produced locally [6], but the depen-                dence of COVID-19-related pneumonia and in-
dence of the production of these medicines on the import of raw                 creased demand for assigning patients to ventilators,
materials is a challenging issue. Currently, more than half of the              contributes to related prescription medicine shortages.
active pharmaceutical ingredient (API) are produced in the                      A medicine shortage is defined as a “supply issue that
country, and the remaining are supplied by reputable compa-                     affects how the pharmacy prepares or dispenses a
nies in India and China, and in some cases by some European                     drug product or influences patient care when pre-
and eastern European companies [4]. The dependence of med-                      scribers must use an alternative agent” [9]. On the
icine production on the importation of raw materials from coun-                 global levels, many regulatory authorities announced
tries such as China, which are affected by COVID-19, is one of                  confirmed shortage list, mostly including potential
the serious concerns of pharmaceutical sector.                                  COVID-19 treatments and also associated pneumo-
    As of April 28, 2020, the number of people infected with                    nia. For example, United States food and drug admin-
the SARS-CoV-2 in Iran was 0.9 million [7] with death ratio                     istration (FDA) shortage list included anti-COVID-19
of 1.38%; which was consistent with the adjusted statistics of                  potential pharmacotherapies, hydroxychloroquine
the world [8]. The overall cumulative COVID-19-associated                       (HQC) and chloroquine (QC), and also frequently
hospitalization rate was from <0.1% in 10–19 year-olds to                       prescribed medications for COVID-19 hospitalized
4.3% in 40–49 year-olds and doubled in 50–59 year-olds to                       patients with respiratory signs in critical care units,
8.2% based on worldwide data [8].                                               azithromycin, dopamine, dobutamine, fentanyl, hep-
    Current short-communication study assessed pharmaceuti-                     arin, midazolam, propofol and dexmedetomidine
cal market crisis during the COVID-19 era; discussing short-                    [10]. In addition, the American Society of Health-
and long-term impacts of the pandemic on pharmaceutical                         System Pharmacists (ASHP) announced an 11-
market natural flow and regulations, first at the global and                    medicine list of shortage; which mainly included hos-
then at Iran’s national level as a case in point for developing                 pital level antibiotics and anesthetic medications; in-
countries. Identification of these effects is essential for policy-             cluding meropenem, ceftazidim, ampicillin and doxy-
maker guidance towards more evidence-informed planning to                       cycline, as antibiotics and vecuronium, rocuronium,
overcome accompanying challenges.                                               as anesthetics. Also, this list included albuterol and
                                                                                fluticasone which are used to open airways in the
                                                                                lungs [11].
Results                                                                             In global levels, the impact on medicine shortage
                                                                                was differed by medicine access level, retail and hos-
COVID-19 short and long-term impacts on pharma-                                 pital-only, and type. Use of medicines currently being
ceutical sector                                                                 investigated in trials but not yet fully approved by
                                                                                FDA or so-called investigational treatments—
COVID-19 may be seen as a century’s opportunity for                             including hydroxychloroquine, lopinavir+ritonavir,
pharmaceutical industry; as it increases the demand for                         tocilizumab and sarilumab—had seen a two-fold in-
prescription medicines, vaccines and medical devices.                           crease in use over the past month, with 8 times higher
This can be seen as one of the main short-term effect                           use in hospitals [12]. Medicines used in hospitals for
of COVID-19 epidemic; however, there are more short                             COVID-19—including respiratory treatments, seda-
and long-term implications to it; which will be discussed                       tives and pain treatments—had experienced an in-
below:                                                                          crease of 100% to 700%, since the beginning of
DARU J Pharm Sci
        January [12].                                                 March 2020, asthma medications spiked by 65%, and type
            In local levels, Iran food and drug administration        2 diabetes medications increased by 25% [17]. Similarly,
        (IFDA) sale’s data indicates that HQ, QC and                  medicines treating high cholesterol, migraine, and hypo-
        lopinavir+ritonavir experiences 2, 6 and 23 times in-         thyroidism also saw a noteworthy increase in claims [17].
        crease in their monthly sale volume, respectively;            Also, in USA, Excess buying for hypertension, Diabetes,
        however, IFDA’s list of medicine shortage for                 respiratory, and mental health and anxiety was 0.6%,
        emergency-supply did not report any shortage of               0.3%, 0.4%, 0.4% and 0.1% respectively [12]. In
        aforementioned medicines and/or the drugs required            Australia, a one-month-stock regulation for dispensing
        by pneumonia-related hospitalized COVID-19 pa-                of prescription medicines, is somehow handling the situa-
        tients. One of the explanations for this may be the           tion of panic-buying [18]. In Germany, German Federal
        high stock of raw materials; which is justified by the        Institute for Drugs and Medical Devices (BfArM) pub-
        market uncertainties due to Iran’s economic and po-           lished an allocation order on the storage and demand-
        litical factors, which leads companies to over-stock.         driven supply of human medicines, on March 2020. The
        The other reason was currency allocation to importa-          allocation order requested the pharmaceutical companies
        tion of COVID-19 required medications, by the gov-            and wholesalers not to supply medicines beyond the usual
        ernment. For example, lopinavir+ritonavir accounted           demand [19]. In contrast, the “stay at home” order in some
        for 0.18% (2 of 1101 billion US Dollars) of six-month         countries may have caused a decrease in demand; howev-
        approved currency order by IFDA to Iran central               er, in Iran, due to lack of such regulation only induced
        bank, for raw materials, finished pharmaceuticals             demand was reported informally by retail pharmacies.
        and dietary formula.                                      &   Supply shortage of both active pharmaceutical ingredi-
            This COVID-19 related shortage also affected the          ents (APIs) and finished products: China and India are
        health market for medical devices and personal pro-           the world’s main supplies of APIs, key starting materials
        tective equipment (PPE), which includes protective            (KSMs) and also finished pharmaceuticals. As they are
        goggles and visors, mouth-nose protection equip-              struggling with the disease and also a slow-down in pro-
        ment, and protective clothing and gloves, that made           duction, this may have contributed to shortage and also
        countries to legislate regulations in this regards. The       price increase in essential prescription medicines, includ-
        market entry facilitation and export restrictions of          ing antibiotics. This is more critical when non-
        PPE and selected medical devices European                     substitutional essential APIs, such as amoxicillin, potassi-
        Commission (2020/403 of 13 March 2020) is one                 um clavulanate, ceftriaxone potassium sterile,
        example, in global levels [13]. In Iran on March 1st          meropenam, vancomycin, gentamycin and ciprofloxacin
        2020, national medical device directorate of Iran an-         are being concerned. In India, the Indian Pharmaceutical
        nounced that restrictions on PPE export is legislated         Alliance (IPA) asked government to restrict of all pharma-
        by Iran custom office [14]. Also, in order to expedite        ceutical products, APIs and formulation to domestic con-
        the supply of required goods and also to reduce the           sumption only. This shortage has already begun to affect
        number of face-to-face visits, the process of issuing         API and bulk prices in Indian party trades. The average
        emergency licenses for medical equipment supplies             increase was reported to be about 10–15%; however, may
        has been accelerated by sending them to the online            reach to 50% in some cases [20].
        communication system and receiving initial approval              In global levels, to avoid shortages, FDA and European
        within one business day. Customs measures to com-             Commission proposed and published regulations focusing
        bat this pandemic included banning the export of              on both demand optimization and rational supply [21].
        masks, medical gown, gloves, disinfectants, soap, de-         These regulation revisions include:
        tergents and alcohol, and also expediting the issuance
        of clearance permits for imported items related to co-    &   Fast-track approvals for COVID-19-related treatments; In
        ronavirus and exemptions from costume tariffs [15].           Iran, this is in terms of Iran medicine list (IML) inclusion
                                                                      and registration process.
&   Induced demand and panic buying: Induced demand for           &   Compulsory licensing for potential COVID-19 treatments;
    stocking medication by public, which is called “panic buy-        however, this is in the context of countries who are World
    ing”, may cause periodic shortage in the market; especial-        Trade Organization (WTO) members and are following
    ly for chronic disease medications. Studies reported that         intellectual property laws; and it is not subjected to Iran.
    induced demand in global pharmaceutical market, mainly        &   More regulations to enhance importation, in order to
    due to “panic buying” of pharmaceuticals for chronic dis-         maintain integration of supply chain; however, regarding
    orders, was estimated to be +8.9%, by March 2020 [16].            the economic crisis and currency shortage in Iran and also
    An study in USA indicated that from 13th to the 21st of           Iran’s NDP component on enhancing local production and
                                                                                                                     DARU J Pharm Sci
    importation minimization, this regulation is not subjected          investigation through Iran MOH-registered clinical trials
    to current context.                                                 [23, 24]. This medication was obtained emergency autho-
       In Iran, again due to over-stocking based on economic            rization approval by the FDA on May 1st, 2020 for hos-
    and political uncertainties, this impact has not yet to be          pitalized patients with severe disease condition [25].
    sensed completely; however, as about 5% of sale volume                 Above being noted, there is a dilemma regarding
    and 30% of sale-value of finished pharmaceuticals [6] and           pseudo-researches and industrial investments on medi-
    about 50% of the API are being imported into the country            cines which will be identified as non-effective in the near
    [4], this shortage type will impact the local pharmaceutical        future; which may eventually pose a considerable burden
    industry.                                                           on the health system. Ethical considerations must be taken
                                                                        into account within the excited decision making about the
2. Shift of communication and promotions to remote inter-               use of the treatment strategies based on the results of these
   actions through tele-communication and tele-health: In               pseudo-researches [26].
   both global and local levels, due to the social distancing
   precautions, marketing and promotions of health-care
   products to providers are being shifted from face-to-face        Long-term impacts Approval delays, moving towards self-
   towards remote interactions and tele-communications; for         sufficiency in pharm-production supply chain, industry
   both promotional and patient-support acts. In USA, the           growth slow-down and possible trend changes in consump-
   number of patients who have visited physician offices or         tion could be seen as long-term impacts of COVID-19 on the
   clinics reduced by 70 to 80% [12].                               health and pharmaceutical market.
      In Iran insurance coverage for tele-medicine is legislat-
   ed for the first time by high council of insurance on            1. Delayed approvals for non-COVID-related pharmaceuti-
   May 2020. This may lead to long-term behavioral chang-              cal products; as all countries, including Iran, are being
   es in the health market.                                            under pressure of the crisis and their priority is COVID-
3. Research and development changes                                    19 management, approval delays may be seen due to sev-
      In global levels, at least 113 medicines or regimens and         eral month of application review postponements. In Iran,
   53 vaccines are in research and development pipelines or            due to economic crisis, IML inclusion, registrations and
   active clinical trials, as therapeutics for patients diagnosed      reimbursement decisions was being made with a consid-
   with COVID-19 [12]. As of April 23, 2020, there are                 erable delay; and this situation may maximize it. It also is
   about 924 ongoing trials in the world for the treatment             affected by about one-month semi-closure of regulatory
   of COVID-19. Only 15% of these studies are based on                 agencies.
   conventional RCT methods, double-blind and multi-                2. Moving towards self-sufficiency in pharma industry; po-
   center randomized with comparator arm, but about 40%                tential shortages due to export bans in India and China,
   are not even randomized [12].                                       who are main suppliers of API and generics, made gov-
      In Iran, HCQ is available through local production with          ernments of many countries to consider self-sufficiency in
   five active suppliers and a price of 0.1 US$ and is being           supply chain and they have announced regulations to
   investigated in 64 MOH-registered clinical trials on                avoid shortages in such crisis [27]. In this regards, on
   COVID-19 patients. CQ, which is also available by one               March 2020 the European commission has published a
   local manufacturer with the price of 0.03 US$, is the in-           new guideline concerning foreign direct investment and
   tervention arm in 29 Iran MOH trials and lopinavir/rito-            free movement of capital from third countries; stating that
   navir, which is included in Iran local COVID-19 manage-             foreign investments, especially those which affect the
   ment guideline for high risk patients as an additive to CQ          health market, in European Union (EU), must be subject-
   or HCQ regimen [22] and is available through generics               ed to risk-assessments to avoid any harmful impact on the
   importation from Indian suppliers with a registered price           EU’s capacity to cover the health needs of its citizens [28].
   of 0.82 US$ per unit, is being investigated in 20 Iran                 In Iran, due to sanctions and difficulties in importation,
   MOH trials on patients with confirmed COVID-19. In                  Iran’s pharmaceutical industry was going towards self-
   addition, multiple clinical trials are being conducted to           sufficiency prior to this crisis; however, COVID-19 pan-
   test non-IML-included medications; naming favipiravir               demic may lead to more importation restrictions and fur-
   and remdesevir. Favipiravir is currently being tested               ther regulation incentives for local manufacturing.
   through three MOH-supervised clinical trials in Iran and         3. Ph armaceutical indu stry growth slo w-do wn ;
   three local manufacturers are conducting pharmacokinetic             Coronavirus pandemic resulted in economical slow-
   and stability analysis on aforementioned pharmaceutical              downs for many countries and this will possibly lead
   strategy. Also, Remdesivir which is an antiviral in first            to pharma industry growth slow-down, which are
   steps of drug development, is being under clinical                   sensitive to country economic growth; especially, in
DARU J Pharm Sci
Table 1 The world-wide reported short- and long impact of COVID-19 on pharmaceutical sector
Short-term Medication shortage    COVID-19 related            +10.8%: OTC category          +10.8%: OTC           Investigational treatments have
            due to induced                                      (cold, cough)                 category              seen a 2-fold increase
            demand                                                                            (vitamin--
                                                                                              minerals,…)
                                                              +403%: Personal hygiene       +62%: Personal        Medicines used in hospitals for
                                                                                              hygiene              the treatment of COVID-19
                                                                                                                   have increased between
                                                                                                                   100% and 700% since the
                                                                                                                   beginning of January
                                                              +67%: ICU medications
                                  General (panic buying)      +23%: Lipid lowering          +7.0%: Highest        7, 6, 5, 4 and 2 million excess
                                                                                              volume growth in       prescription in hypertension,
                                                                                              ATC N class of         mental health, respiratory,
                                                                                              RX-category in         diabetes and anxiety
                                                                                              Spain
                                                              +40%: Anti-diabetes
                                                              +29.1%:
                                                                Anti-hypertensives
                                  Supply shortage             Medicines for chronic                               Supply shortage of both active
                                                                diseases are at high risk                           APIs and finished products
                                                                of shortage or supply                               (About 40% of APIs for the
                                                                chain                                               U.S. generic drug market
                                                                                                                    come from India)
                                                                                                                  Supply shortage of the
                                                                                                                    COVID-19 related complica-
                                                                                                                    tions treatment
           R & D shifts                                       156 clinical trials are   140 clinical trials are
                                                                running for COVID-19      running for
                                                                                          COVID-19
           Shifts towards       WhatsApp calls is the most    320% increase (v. PY) in 70–80% reduction in
             tele-medicine        preferred digital channel     remote interactions in    the number of
                                  for both patient              Spain. The                patient visits to
                                  consultation and              corresponding increase    doctor offices
                                  communication with            in Italy (v. PY) was
                                  peers                         471%
                                Digital channel has wide      51% decline in specialist Tele-medicine
                                  adoption with over 75%        consultations and 25%     growth accounts
                                  of physicians but             decline in GPs visits     for 23% of
                                  physicians prefer                                       interactions
                                  traditional F2F
                                  communication
Long-term Approval delays       Clinical trial 8% delay      Pharma companies report
            (non-COVID-rela-      existing enrolment           delay in new trial starts
            ted products)
                                16% delay new trials only Product launches delayed,
                                  32% delay new trials and     disrupted or impacted
                                  existing patient enrolment
          Shifts towards                                     Direct investment and free
            self-sufficiency in                                movement of capital
            pharma industry                                    from other countries
OTC Over the Counter, ICU Intensive Care Unit, ATC N Anatomical Therapeutic Chemical Classification Nervous system, U.S. United States, v. PY:
versus Previous Year, F2F Face-to-Face, GPs General Practitioners, APIs Active Pharmaceutical Ingredients, R&D Research and Development
     countries with pharmerging markets, like Iran. This                         However, it should be noted that in previous reces-
     slowdown in market growth is more due to the entry                          sions, there were cases in which the health industry
     of newer medications. Because the priorities of phar-                       was less sensitive to slowing economic growth and
     maceutical companies change in their portfolio.                             did not always follow this trend [29].
                                                                                                                                  DARU J Pharm Sci
4. Ethical considerations: One of the long-term effects of                Compliance with ethical standards
   growing clinical research related to the current pandemic
   is the use of poorly evidence centered therapies. Ethical              Conflicts of interest/competing interests All the authors declare no con-
                                                                          flict of interests which may affect our objectivity.
   issues should be considered in the use of these medicines
   as off-label [26]. In confirming the proposed therapies, the
                                                                          Code availability Not applicable.
   long-term clinical effects of the use of these strategies in
   the coming years should be examined and healthcare pro-
   viders should make informed decisions on using off-label
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