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Meliawati, et al.

DOI : https://doi.org/10.24843/JFU.2020.v09.i02.p02
pISSN: 2301-7716; eISSN: 2622-4607
Udayana Pharmacy Journal, Vol 9, No 2, Year 2020, 72-82

Pharmaceutical Industry Policy during the COVID-19 Pandemic

Meliawati, Rini. 1 , Holik, Holis Abdul1

1 Pharmacist Professional Study Program, Faculty of Pharmacy, Padjadjaran University

Jl. Raya Bandung-Sumedang Km. 21 Jatinangor, Sumedang 45363
tel. (022) 842 88888
Email: rini15003@mail.unpad.ac.id

Article history: Posted: 05/15/2020; Received: 20/06/2020, Published: 27/12/2020

ABSTRACT

Drug shortages has been global problem since 2000s until now, and it become in serious condition by the presence of
the pandemic COVID-19. The main causes of drug shortages were economic and regulation, business problem, manufacture
and supply chain. During this pandemic, the main causes of drug shortages are many pharmaceutical industries closures due to
quarantine, logistical problems caused by border closure, export bans, quarantine of exporting active subtances and
drugs’countries, increased demand and pilling up.
However, this problem has been overcome by making policies and good cooperation between governments, regulatory institution
and the pharmaceutical industry throughout the world. Several policies like increasing production capacity, restrict quantity of
drugs purchased by the public, facilitate the process of industrial license and making a systems such as i-SPOC (Industry Single
Point of Contact). It is expected to reduce drugs shortages problem during this pandemic.

Keywords: COVID-19, pharmaceutical industry, policy, drug shortages

ABSTRACT

The problem of drug supply shortages has been a global problem since the mid-2000s until now, but this drug shortage
problem has been exacerbated by the COVID-19 pandemic. Prior to the COVID-19 pandemic, the main causes of drug supply
shortages were related to economic and regulatory reasons, business-related issues as well as manufacturing and supply
chains. Meanwhile, during a pandemic, the causes of drug shortages were due to many factory closures due to quarantine,
logistical problems caused by border closures, export bans, quarantines from countries supplying raw materials and medicines,
increased demand for medicines and a lot of hoarding. However, this problem has been overcome by making good policies and
cooperation between governments, regulatory agencies and the pharmaceutical industry around the world. Several policies
have been implemented, starting from increasing production capacity, imposing regulations regarding limits on the amount of
drugs that can be prescribed to patients or purchased by the public to prevent hoarding, facilitating the industrial licensing
process to creating systems such as i-SPOC (Industry Single Point of Contact) . Some of these policies are expected to reduce
the problem of shortage of drug supplies during the COVID-19 pandemic.

Keywords: COVID-19, pharmaceutical industry, policy, drug supply shortage

1. INTRODUCTION unaffordable, one of the main reasons is the lack of

Access to medicines is a human right.
However, currently there are still many people who
have not received essential treatment. Apart from
price reasons
access to medicines
due to a shortage of medicines, which has become
a problem in Europe (Pauwels and Casteels, 2014).
Of course this problem also occurs in North America,
South America and

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Asia. Drug supply shortages have different
definitions. Different definitions from various
parties reflect perceptions
countries or their respective institutions against
drug supply shortages. Is it technically related to
supply chain issues or related to market issues
such as price, level of competition or financial
policy (De Weerdt et al., 2015). The Food and
Drug Administration (FDA) defines a drug supply
shortage as a condition where demand in the
United States exceeds the existing supply of drugs
(FDA, 2017). France defines drug supply shortages
as the inability of a community pharmacy in a
hospital to provide drugs to patients within 72
hours (Bocquet, 2017). Whereas in Germany,
they identified a shortage of drug supply at the
delivery level and compromised patient care when
alternative treatments were not available (Said et
al., 2018).
Meanwhile, Italy said that drug supply shortages
were related to the unavailability of drug products
in certain geographies due to supply chain
inefficiencies (Di Giorgio et al., 2019).
The problem of drug shortages has been a
problem since the mid-2000s.
and has become a concern of the World Health
Organization (WHO) since 2009 (Fox et al., 2014).
One of the actions taken by WHO to deal with the
problem of shortages in drug supply is that WHO
holds a meeting to discuss this problem globally.
WHO said that drugs that are experiencing a
shortage of supply are drugs whose patents have
expired and are difficult to formulate. Drug supply
shortages also occur in frequently used drugs
such as antibiotics, cancer drugs, cardiovascular
and anesthetics. In addition to its report, WHO
reports that “drug supply shortages can occur at
several points in the supply chain process due to
lack of capacity or no production capacity. ;
problems with active pharmaceutical ingredients
73
(FIRE); financial constraints; problem with
forecasting, challenges in the Supply Chain
Management section. Related financial constraints
include changes to the national budget as well as
payments at the patient's own expense” (WHO,
2016).
Although there are several reasons for the
shortage of drug supply, parallel trade in drugs is
estimated to be one of the main sources of drug
scarcity (De Weerdt et al., 2015). Drug scarcity
certainly has an unavoidable impact on public
health, especially patients, causing delays in
starting treatment or triggering patient non-
compliance (Bochenek et al., 2018).
Parallel trading originates from the concept of a
common market for European countries without
being limited by regional boundaries. This process
occurs when parallel traders buy drugs in European
Union member countries at low prices and resell
them to other EU countries at higher prices (De
Weerdt et al., 2015). If restrictions on goods in
parallel trade remain prohibited, then one day the
price and quantity of goods agreed upon by EU
member countries such as Poland, Slovakia,
Greece, Spain in parallel trade will be very
vulnerable to shortages. However, in the case of
declining margins at both pharmacies and
wholesalers, parallel distribution will be highly
considered to increase revenue. This can lead to
the development of a process known as “reverse
traffic” where pharmaceutical distribution
warehouses get medicines from community
pharmacies more frequently than they do from
pharmaceutical companies or other warehouses.
(Vazquez et al., 2015). Although illegal in the
European Union, “reverse traffic” is a real problem
for the pharmaceutical market in the European
Union and substantially increases drug shortages
in pharmacies and pharmaceutical services (Rada, 2015).
In some cases of medication shortage, it may be
possible to offer treatment
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DOI : https://doi.org/10.24843/JFU.2020.v09.i02.p02
pISSN: 2301-7716; eISSN: 2622-4607
Udayana Pharmacy Journal, Vol 9, No 2, Year 2020, 72-82

alternatively, parallel exports of pharmaceuticals
often relate to innovative drugs.
The problem of drug shortages can also be
caused by extraordinary geopolitical events such
as COVID-19. At the beginning of 2020, the world
was shocked by an outbreak of a new virus,
namely The Coronavirus Disease 2019
(COVID-19). Since April 2 2020, COVID-19 has
affected more than 200,000 Americans and killed
more than 5,000 lives (Shah, 2019). The
COVID-19 pandemic has not hampered the
production and delivery of pharmaceuticals in the
first quarter of 2020, although in the following
months chemical shipments began to slow and
stockpiles began to dwindle. The existence of the
COVID-19 pandemic has made regulators and
world leaders aware of the extent to which China
dominates the world's supply of active
pharmaceutical ingredients and chemical raw
materials. The industry's ongoing efforts in the
US and Europe to rebalance the supply chain of
pharmaceutical chemicals will likely be driven by
government initiatives to ensure domestic drug
production. During this pandemic, health workers
are living lives full of risks because they have to
face the threat of contracting this virus, face
enormous physical and emotional pressure. The
shortage of testing kits, masks, Personal Protective
Equipment (PPE) and ventilators is making things
even more difficult.
Apart from that, another big problem facing us is
the shortage of supplies of medicines which are
essential for dealing with COVID-19, this shortage
of drugs is expected to get worse with increasing
time. Not only does it affect COVID-19 patients
directly but also threatens the health and safety
of patients with other diseases. There are also
shortages of drugs touted as promising therapies
against COVID-19 such as chloroquine and
hydroxychloroquine.
Scarcity does not only occur in these two drugs
but also in sedatives, antibiotics and vasopressors.
The scarcity of sedative drugs such as midazolam
and propofol is quite worrying because these
drugs are needed by patients for intubation
(Esther and Vincent, 2020).
2. MATERIALS AND METHODS
The method in writing this article review is
literature study. Source used
namely the search for pharmaceutical industry
policy keywords , pharmaceutical companies
policy dan drug shortages COVID-19 di
ScienceDirect, NCBI dan Google Scholar.
The source of the articles used are articles
published from 2014 to the present.

3. RESULTS

Table 1. Estimated US and Global Needs for HCQ

Amount of HCQ Tablets (200 mg) Number of patients
substance (tons)
Normal needs in the world 300 1,500 million 3 million
Normal requirement in the US 100 500 million 1 million (chronic)
The need if 2% of the US population needs treatment 40 195 million 6.5 million
COVID-19

The need if 2% of the world's population needs treatment 1.000 4,680 million 156 million
for COVID-19
20% of global demand for prophylaxis 10.000 46,800 million 1,560 million
(Zhang and Zhong, 2020).

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75,4%
%
66%
Figure 1. Results of the Survey on the Impact of Drug Supply Shortages in European Hospitals (EAHP, 2014)
4. DISCUSSION
Before the COVID-19 pandemic, the main
cause was supply shortages
Drugs are related to raw materials that are difficult
to obtain, problems related to manufacturing, drug
prices that tend to be expensive, market
fragmentation, business problems and the impact
of new technology (WHO, 2016). In addition, the
causes of drug supply shortages are grouped into
three, namely:
1. Economic and regulatory reasons
2. Related to business matters
3. Manufacturing and supply chain issues
First, economic and regulatory problems.
Economic and regulatory factors that can lead to
drug shortages include tight fiscal policies,
changes in government policies, increased
regulatory requirements and changes in drug
demand due to new drug applications. Second,
business related reasons. The business problems
that lead to drug shortages are increasing prices,
decreasing margins, increasing domination by a
number of manufacturers, tender systems that
favor large producers, etc. The third is issues
related to manufacturing and supply chain. Some
of the main problems related to manufacturing are
adaptation problems with increasingly stringent
government policies, long production lead times,
increasing raw material bottlenecks , and quality-
related production failures (Beck, 2019).
Drug supply shortages can also be caused
by extraordinary geopolitical events such as
COVID-19. The number of drug shortages has
increased in recent years
Meliawati, et al.
Service problem
86%
Pharmaceutical installation activities
Patient care
in recent years and this problem has gotten worse
during this pandemic due to many factory closures
due to quarantine, logistical problems caused by
border closures, export bans, quarantine of
countries supplying raw materials and medicines,
increasing demand for medicines due to the
treatment of COVID-19 patients 19, hoarding in
certain hospitals, as well as individual hoarding by
residents. However, to avoid the problem of drug
shortages due to hoarding, several European
countries have enacted regulations regarding
limits on the number of packets that can be
prescribed to patients or purchased by citizens.
(EMAs, 2020). The existence of a pandemic has
disrupted the supply chain of pharmaceutical raw
materials because two countries providing
pharmaceutical raw materials, namely China and
India, are conducting regional quarantines so that
transportation and logistics will be hampered due
to road access restrictions.
In addition, during the regional quarantine many
industries were not operating. There is also a
scarcity of drugs that are reported to have activity
against COVID-19 such as hydroxychloroquine
due to many off-label prescribing and stockpiling,
as a result of which hydroxychloroquine is currently
difficult to obtain for non-covid patients who need
this drug such as rheumatoid arthritis patients and
other diseases . another autoimmunity. Even more
worrying is the dearth of sedative drugs
such as midazolam and propofol which patients
need for intubation (Esther and Vincent, 2020).
Chloroquine and hydroxychloroquine were
originally drugs used to treat malaria as
antiplasmodium. This drug is a drug that contains
a group
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Quinolines work by inhibiting the activity of the
heme polymerase enzyme. Apart from being an
antimalarial, chloroquine is also widely used in the
treatment of autoimmune diseases such as Lupus,
Rheumatoid Arthritis, etc. Apparently, chloroquine
and hydroxychloroquine can also be used for
antiviral therapy. Chloroquine has a strong antiviral
effect against the SARS-CoV virus in primate cells.
In addition, chloroquine and hydroxychloroquine
increase endosomal pH which inhibits viral
replication (Al Bari, 2017). This drug appears to
interact with cellular angiotensin-converting enzyme
2 (ACE2) receptors. This causes inhibition of the
binding of the virus and receptors so that it can
prevent infection and the spread of the SARS-CoV
virus at concentrations that can cause clinical
symptoms. During the COVID-19 pandemic in
China, chloroquine was used at a dose of 500 mg
for adults, 2 times a day, and the duration of
therapy was less than 10 days.
Chloroquine and hydroxychloroquine are also
being tested in Malaysia at the same doses used
in China (Du and Qu, 2020).
NPR has reports on how disruptions in China
have severely affected the ability of some drug
manufacturers to manufacture key ingredients .
The nine companies operating in China said they
make a variety of pharmaceuticals and some also
make other health products such as nasal strips
and insecticides. So far, serious supply disruptions
have not occurred. Many facilities have resumed
operations following production disruptions related
to COVID-19.
Some said they were working far enough from the
epicenter of the outbreak in Wuhan to be able to
continue working after the extended Lunar New
Year holiday. New York-based pharmaceutical
company Asymchem said many suppliers could
not be contacted. However, the company always
has stock for at least one month so that for now
the company has not experienced supply
disruptions. Facility
76
Asymchem production in China had reopened on
10 February, but the southernmost facility, the one
closest to Wuhan, was working with a smaller
number of staff. Some manufacturers also take
extra precautions to avoid spreading the virus,
including the industry requiring workers to eat
alone, wear masks while working, check
temperature at least once a day or more, not hold
gatherings such as meetings, etc.
(NPR, 2020).
Regarding the demand for hydroxychloroquine
which has skyrocketed in recent times. This
prompted several states and supply chains in the
United States to implement allocation programs,
namely a measure to reduce product hoarding that
aims to ensure the supply chain remains stable
even in limited quantities. Doctors are urged not to
prescribe these drugs for prophylactic use as many
non-COVID patients are dependent on these drugs
such as Rheumatoid Arthritis (RA) and Lupus
Erythematosus (SLE) patients. Meanwhile, the
industry promised to increase production or donate
a large number of tablets (Zhang and Zong, 2020).
On March 28, 2020, the FDA issued an Emergency
Use Authorization (EUA) to permit the emergency
use of hydroxychloroquine sulfate and will be
supplied from the Strategic National Stockpile to
treat adults and adolescents weighing 50 kg or
more and being hospitalized with COVID-19 where
testing clinics are not yet available for COVID-19
medicines. Currently hydroxychloroquine deficiency
is acute.
This situation could be mitigated by increasing
global production or conversely exacerbated by
increasing demand, if the efficacy of
hydroxychloroquine especially
in treating COVID-19 has been
proven by RCTs. India undoubtedly plays a central
role for the global supply of hydroxychloroquine. It
is estimated that the country produces around 60
metric tonnes
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hydroxychloroquine for the domestic market
(dominated by Ipca Laboratories Ltd.) with an 80%
market share and the same amount for export (led by
Zydus Cadila). Ipca is also a producer of chloroquine
(di)phosphate
in the world, which once owned 80% of the global
market share. Meanwhile, the Chinese market is led
by Shanghai Pharma with an 80% share in 2018.
The country produces about 35 metric tons of
hydroxychloroquine for the domestic market, and 20
tons for export, mostly to some non-ICH countries. In
China this drug is sold in tablet form of 100 mg, while
in the US it is produced in the form of film-coated
tablets at a dose of 200 mg.
mg. It is known that the current world demand is 300
metric tons a year and most of it is for chronic
diseases. Meanwhile, the demand for
hydroxychloroquine for COVID-19
It is also predicted that it will soon experience a surge.
For example, if 2% of the US population required
treatment with hydroxychloroquine, then 40 metric
tons of hydroxychloroquine would be needed
immediately. Whereas if 20% of the population of the
United States needed treatment, then 400 metric tons
of hydroxychloroquine would be needed in a few
weeks. Globally, it requires 1,000 metric tons of drugs
in a few weeks or three times the normal production
capacity.

Table 1 compares the market for

hydroxychloroquine before and after the COVID-19 Due to the surge in demand for
outbreak, as well as predictions for the need for hydroxychloroquine worldwide, several
hydroxychloroquine in the US and the world if this hydroxychloroquine producing industries are
drug has been shown to have efficacy against implementing various strategies to prevent
COVID-19 in clinical trials. It is predicted that the type hydroxychloroquine shortages. The strategy is
of COVID-19 therapy regimen will include 6 grams of described in table 2.
hydroxychloroquine sulfate or 30 tablets at a dose of 200

Table 2. Strategies for the Pharmaceutical Industry to Prevent Hydroxychloroquine Supply Shortages
No. Name of Strategic Pharmaceutical Industry
1. Candela Increase production 5x to produce 20 tonnes of HCQ per month
2. Amneal Pharmaceuticals Increase production to 20 million tablets (4 tons) in mid-April.

3. Laurus Increasing production from mid-April from 5 to 15-20 tons per month.

4. Novartis Donated 130 million tablets (26 tonnes) at the end of May, including a stock of 50 million
tablets at the 200 mg dose (10 tonnes).
5. Mylan Increase production to 50 million tablets (10 tonnes).
6. You go Donated 16 million tablets to hospitals in the US (6 million tablets on March 31 and more
than 10 million in a month or about 3.2 tons).
7. Bayer Donated 3 million tablets to US hospitals.
(Zhang and Zong, 2020).
China is the main supplier of raw materials for COVID-19 in India is quite troubling. The current and
the manufacture of hydroxychloroquine for domestic future impact on the supply of hydroxychloroquine
use and for export to other countries. and other pharmaceuticals is uncertain. Recently,
The spread of COVID-19 is mostly in this country but India banned the export of hydroxychloroquine and
the majority of industries continue production normally. chloroquine, but all hoped the decision could be
China's abundant hydroxychloroquine capacity is reversed once domestic supplies were met (Molina et
substantial and has not been fully utilized for global al., 2020).
demand. Meanwhile India's capacity in supplying
global medicines is also very important. Spread trend In the opinion of the Marketing Authorization Holder
(MAH), ups and downs in requests and changes in
regulations/GMP can affect

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external factors such as the availability of active
ingredients, excipients and equipment as well as
internal factors such as personnel, formulations and processes.
Collaboration between educational institutions and
the pharmaceutical industry is very important to
support R&D innovation and be able to reduce the
risk of drug supply shortages (Panzitta et al., 2017).
The impact of a shortage of drug supply on
several aspects of quality of care includes risks to
patients due to delays in handling or drug-related
errors, increased workload of pharmacists in hospitals
and the entire medical team to deal with shortages of
drug supply, economic burden on hospitals and the
National Health System. The European Association
of Hospital Pharmacists (EAHP) in 2014 conducted a
survey regarding drug supply shortages in European
Hospitals with 600 respondents from 36 European
countries, showing that the majority of respondents
were Hospital Pharmacists and they agreed that drug
supply shortages were a current problem. in providing
the best service to patients or managing hospital
pharmacy installations (86%), affecting the daily
activities of hospital pharmacy installations (66%) and
having a negative impact on patient care (75.4%),
can also delay treatment and worsen conditions
patients (EAHP, 2014).
Strategic steps must be taken by the State
immediately. First, the FDA should change its policy
procedures so as to speed up the process of ensuring
that essential drugs are available on the market (FDA,
2019). In addition, recommends the FDA to conduct
direct approval for selected generic drugs to be
produced in other countries. Second, the federal
government must work with the major brand and
generic pharmaceutical industries to increase the
number of approved drugs in rapid supply. If General
Motors can reuse its factories to make ventilators,
then major industries could be asked to shift their
production
to produce generic drugs that can help overcome
drug supply shortages.
If an industry that has infrastructure does not want to
do it voluntarily for the national interest, then the
government must force them to help meet the needs
of the state. Third, there needs to be a push to fund
non-profit generic drug production in the United States.
For example, Civica Rx was created to address drug
supply shortages and to manufacture and supply
them at lower prices. Although this requires a long
time in the preparation process, government-produced
essential drugs need to be considered for the long
term because generic drugs with small profit margins
are less attractive to profit-seeking companies even
though these drugs are urgently needed. Fourth, the
majority of active substances are produced in China.
In addition to negotiating with China to increase
supply, the United States should also consider
increasing domestic production of active substances.
Since many industries have closed in China, and India
has shut down the export of medicines, we are under
threat of a shortage of medicines (Esther and Vincent,
2020).
Drug shortages are also a common problem in
all Polish Pharmacies. Although there have been
several solutions aimed at alleviating the supply
shortages of medicine in Poland, these do not appear
to be sufficiently effective.
A clear and stringent system of fines and penalties
for the export of illicit drugs is the answer most often
associated with suggested solutions to alleviate the
problem of drug shortages. Despite the fact that
parallel trading is legal in the European Union,
substantial differences in drug prices can lead to drug
shortages
(Rada, 2015). Drug shortages and this phenomenon
usually involve drugs that are frequently used eg in
antithrombotic prophylaxis or in the treatment of
chronic and life-threatening disorders (risperidone,
lispro)
(Pauwels and Casteels, 2014).
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During this pandemic, many countries
implemented lockdowns , including one of the
largest exporters of active pharmaceutical
ingredients in the world, namely China. So, India,
which is also the largest exporter of active
pharmaceutical ingredients after China, is trying
to maintain supplies of active ingredients. As
China is currently in lockdown, the Indian
government and pharmaceutical industry assess
the vulnerability of supply chains in India. In the
last few weeks, the government and representatives production lines. Discussions were also held with
of the Indian pharmaceutical industry have held
discussions to increase the production capacity
of active pharmaceutical ingredients in India by
accelerating permits for factory construction
including permits with the ministry of environment,
providing facilities related to electricity, etc. Some
of these strategies can remove barriers to API
production in India (Chatterjee, 2020).
Meanwhile in Europe, the strategy to help
reduce disruption to the supply of medicines, The
EU Executive Steering Group on Shortages of
Medicines Caused by Major Events, took strategic from pharmacies and reporting drug shortages
decisions for immediate and coordinated action
to overcome the shortage of medicine supplies in
European countries during this pandemic.
Together with the pharmaceutical industry, a
system was designed called i SPOC (Industry
Single Point of Contact) , which is a system to
accelerate interaction between the industry and
the EU Executive Steering Group regarding drug
shortages. With this system, each pharmaceutical this outbreak in the future. The pharmaceutical
company will report directly to EMA to anticipate
shortages of important medicines used in handling collaboratively with all research facilities and
COVID-19.
The company will continue to report any
deficiencies to the relevant national authorities.
The i-SPOC system is similar to the Single Point
of Contact (SPOC) network set up in 2019 by the
EMA and authorized national authorities to share
information on drug shortages based on the i-
SPOC agreement in each pharmaceutical industry,
which will provide information to anticipate the
scarcity of medicines related to COVID-19 to
EMAs. This new mechanism enables better
oversight of ongoing supply chain issues,
regardless of the licensing route and accelerates
the flow of information for the pharmaceutical
industry aimed at reducing and preventing drug
supply shortages related to COVID-19 drugs. In
addition, EMA and European countries are
considering measures to prevent drug shortages
through actions to support increased production
capacity by accelerating the approval of new
the pharmaceutical industry to increase the
production capacity of drugs used to treat
COVID-19, especially drugs that are at risk of
experiencing a shortage of supply (EMA, 2020).
In addition, another solution to reduce the
shortage of drug supply is the ISMM (Integrated
System of Medicines Monitoring) system. This
ISMM is a system for collecting data on drug trade
and delivery plans, as well as the existence of
quotas (to ensure products are permitted for one
fixed market and can meet local demand).
(Bochenek et al., 2018).
The pharmaceutical industry in Europe is
committed to fighting the COVID-19 pandemic,
one of which is by preventing the recurrence of
industry in Europe is committed to working
healthcare establishments, leveraging their
knowledge and expertise to tackle this outbreak.
The aim of the pharmaceutical industry in doing
so during this time of health crisis is to ensure the
safe supply of medicines to patients who need
them, research and develop new vaccines,
diagnostics and treatments for use in the fight
against COVID-19. As a partner and support
organization in the field to fight COVID-19. In
addition, companies that are members of EFPIA

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(European Federation of Pharmaceutical Industries
and Associations) is committed to donating millions
of euros in the form of direct contributions in the form competes to ensure the availability of the necessary
of money to support health service agencies that
play a direct role in treating patients and communities are designed to work across borders.
infected with COVID-19. Various essential needs
including advanced surgical equipment, antibiotics,
disinfection kits, vitamins, protective clothing,
goggles, masks and gloves were donated. In
addition, antibacterial drugs approved for treating
secondary infections such as pneumonia were also
donated. EFPIA's steps to address the risk of drug
shortages caused by the coronavirus, namely as
many countries in Europe are approaching the peak
of the COVID-19 pandemic, the industries that are
members of EFPIA are continuing to work around
the clock to increase capacity and ensure the supply
of essential medicines for patients across Europe. In critical care. EFPIA is supporting a project initiated
fact, capacity building was one of the first actions
taken by a pharmaceutical manufacturer, as part of
its pandemic preparedness plan, activated back in
January.
However, it witnessed a significant increase in
demand in some European countries, which in some
cases could reach many times
fold from normal. In a communication with the
European Commission, EFPIA welcomed the
Commission's Guidelines for member countries on
optimizing the supply of medicines for COVID-19,
as well as to meet the needs due to stockpiling and
export bans, EFPIA members provided further
information regarding forecasts and estimating drug
demand -medicines match patient needs and ensure
optimal and timely supply of medicines to all Member
States and work together to support the continuation
of clinical trials across Europe. Export bans and
significantly increased demand for medicines
continue to occur in the European Union. This export
ban greatly affects companies that have distribution
warehouses
80
multi-markets in several countries, initially serving all
of Europe as well as parts of Africa. Each country
medicines for its citizens. However, supply chains
No single country can meet all of its needs on its
own, and through restrictions, countries risk isolating
themselves and their citizens from global supply
chains. COVID 19 is a global pandemic and requires
a global response. The most important effort made
by EFPIA to meet patient needs is to ensure accurate
forecasting data to meet patient drug demand. EFPIA
urgently needs detailed modeling data from the
European Center for Disease Control. COVID 19 has
put enormous pressure on European intensive care
units, including the demand for medicines used in
by Medicines for Europe and its members trying to
assess the total demand for ICU medicines needed
in Hospitals across the European Union Countries
and collect supply and capacity data from
manufacturers of these medicines under close
supervision by European Commission Directorates
General for Competition and Health (EFPIA, 2020).
5. CONCLUSION
The problem of shortage of medicine supply
globally during the COVID-19 pandemic can be
overcome by the existence of policies and
good cooperation between governments, regulatory
agencies and the pharmaceutical industry worldwide.
Several policies have been implemented, ranging
from increasing production capacity, facilitating the
industrial licensing process to creating systems such
as i-SPOC. Some of these policies are expected to
reduce the problem of shortage of drug supplies
during the COVID-19 pandemic.
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